阅读说明：本技术 治疗***的凝胶组合物及其制备方法 (Gel composition for treating cervical erosion and preparation method thereof ) 是由 郭东辉 秦国新 于 2020-07-30 设计创作，主要内容包括：本发明涉及一种治疗宫颈糜烂的凝胶组合物及其制备方法,技术方案如下:治疗宫颈糜烂的凝胶组合物,以重量份计,包括：中药40~80份,和医学可接受辅料700~1300份,其中所述中药包括选自由蛇床子、苦参和五倍子所组成的物质组中的至少两种。由于凝胶组合物中的中药可选包括选自由蛇床子、苦参和五倍子所组成的物质组中的两种且两者之间在提高宫颈糜烂的治疗效果上具有明显的促进作用；凝胶组合物的制备方法没有特别限制,把所述各组成按任意顺序混合均匀即可且中药和/或辅助药,可以采用中药提取物的形式,可以采取未经提取的中药原材料,所述中药原材料需以粉碎成粉末的形式使用。(The invention relates to a gel composition for treating cervical erosion and a preparation method thereof, and the technical scheme is that the gel composition for treating cervical erosion comprises the following components in parts by weight: 40-80 parts of traditional Chinese medicine and 700-1300 parts of medically acceptable auxiliary materials, wherein the traditional Chinese medicine comprises at least two of substances selected from the group consisting of fructus cnidii, radix sophorae flavescentis and gallnut. The traditional Chinese medicine in the gel composition can be selected from two substances consisting of fructus cnidii, radix sophorae flavescentis and gallnut, and the two substances have obvious promotion effect on improving the treatment effect of cervical erosion; the preparation method of the gel composition is not particularly limited, and the components are uniformly mixed in any order, and the traditional Chinese medicine and/or the auxiliary medicine can be in the form of traditional Chinese medicine extract, and can be the traditional Chinese medicine raw material which is not extracted, and the traditional Chinese medicine raw material is required to be crushed into powder for use.)

1. The gel composition for treating cervical erosion is characterized by comprising the following components in parts by weight: 40-80 parts of traditional Chinese medicine and 700-1300 parts of medically acceptable auxiliary materials, wherein the traditional Chinese medicine comprises at least two of substances selected from the group consisting of fructus cnidii, radix sophorae flavescentis and gallnut.

2. The gel composition of claim 1, wherein the Chinese medicine comprises two selected from the group consisting of cnidium monnieri, sophora flavescens and gallnut.

3. The gel composition of claim 2, wherein the weight ratio between the two is 1: a, and a = 0.5-2.

4. The gel composition of claim 1, wherein said Chinese herbs comprise cnidium monnieri, sophora flavescens and gallnut.

5. The gel composition of claim 4, wherein cnidium fruit: Sophora flavescens: Galla chinensis is 1: b: c, and b is 0.5-2, and c is 0.5-2, in weight ratio.

6. The gel composition of claim 1, wherein the medically acceptable excipients comprise, by weight, 5 to 10 parts of a gelling agent, 1 to 3 parts of a humectant, and 800 to 1200 parts of water.

7. The gel composition of claim 6, wherein the humectant comprises at least one member selected from the group consisting of glycerin, xylitol, alkali metal salts of lactic acid, triethanolamine salts of lactic acid, and aloe vera.

8. The gel composition of claim 6, wherein the gelling agent comprises at least one selected from the group consisting of gelatin, gum arabic, tragacanth, alginic acid, alkali metal alginates, hyaluronic acid, alkali metal hyaluronates, starch, and agar.

9. A method of preparing a gel composition, said method comprising the steps of:

1) obtaining a mixed aqueous solution of the gelling agent and the humectant;

2) uniformly mixing the powder or extract of the traditional Chinese medicine with the mixed aqueous solution in the step 1);

3) cooling to obtain the gel composition.

10. The method for preparing a gel composition according to claim 9, wherein the gel composition comprises 40-80 parts of traditional Chinese medicines and 700-1300 parts of medically acceptable auxiliary materials, wherein the traditional Chinese medicines comprise at least two selected from the group consisting of fructus cnidii, radix sophorae flavescentis and gallnut, and the mixture prepared by the four times of gradient impregnation is cooled to 25 ℃ to prepare the clinically applied medicine suitable for treating cervical erosion.

Technical Field

The invention relates to a gel medicament for treating gynecological diseases and a preparation method thereof, in particular to a gel composition for treating cervical erosion and a preparation method thereof.

Background

Cervical erosion is a chronic inflammation, one of the most common types of chronic cervicitis. The inflammation area is bright red due to the appearance of capillary vessels of the columnar epithelium, which is called cervical erosion. Cervical erosion is a common disease of women, frequently occurs and is frequently occurred in married women.

Epidemiological investigation results show that the incidence rate of cervical erosion of rural women is higher. With the change of living environment and habits of people, the incidence of cervical erosion in women is on an increasing trend. Statistics show that the cervical erosion is common gynecological diseases of women aged 35 to 50 years, however, clinical statistics in recent years show that the phenomenon of cervical erosion aging is increasingly serious and the trend of cervical erosion aging is obvious. The results of general investigation on women's gynecological diseases by Beijing aerospace university Hospital in 1996 show that the prevalence rate of common gynecological diseases is 50.24%, wherein the prevalence rate of cervical erosion is 39.54%, the first of the prevalence rates of gynecological diseases, and the statistical results of the prevalence ages show that the prevalence rate of cervical erosion of women of 30-39 years old is 82.73%; the results of gynecological general examinations of married women in Danyang city of Jiangsu province in 2001 show that 22.40% of cervical erosion, 2.49% of uterine fibroids and 2.5% of breast tumors are respectively found in the first 3 common gynecological disease incidence of women, wherein the prevalence rate of the cervical erosion is highest between 21 and 25 years and is 33.58%; since 2002, in the health examination of married women of childbearing age in Binzhou city, Shandong province, the prevalence rate of gynecological diseases is 52.2%, the incidence rate of cervical erosion accounts for 27% of the total prevalence rate of gynecological diseases, wherein the degree of cervical erosion I accounts for 75.5%, the degree of cervical erosion II accounts for 16.7%, and the degree of cervical erosion III accounts for 1.5%.

Aiming at the gynecological diseases, the practical cases that the same person in the traditional Chinese medicine field has the kernel and the person with the kernel and the intelligence are shown in the public:

for example, chinese patent document CN111184829A discloses a plant probiotic bacteria-inhibiting liquid for treating gynecological inflammation such as cervical erosion, which is an external product prepared from herba patriniae, fructus xanthil, cyrtomium rhizome, giant knotweed rhizome, subprostrate sophora, folium isatidis, gentian, cortex meliae, fructus rosae laevigatae, rheum officinale, radix sophorae flavescentis, fructus cnidii, oldenlandia diffusa, gentian flower, radix stemonae, probiotics (lactobacillus and bifidobacterium), sodium chloride and purified water. The advantages are scientific and reasonable prescription of raw materials, stable and controllable preparation process, no irritation in use, definite curative effect and wider application range. Has the effects of clearing away heat and toxic materials, dispelling pathogenic wind, removing dampness, killing parasites and relieving itching, and has remarkable curative effects on gynecological diseases, dermatosis, STDs, etc. And meanwhile, the pH value of the vagina is regulated to form an acidic barrier, so that the vagina is protected to be long-lasting and healthy.

For another example, chinese patent document CN111035816A discloses a composition for maintaining microecological balance of female lower reproductive system and its application. The composition takes bacillus fermentation liquor as a substrate, and contains 0.1 to 0.5 mass percent of decarboxylated carnosine and 3 to 10 mass percent of soluble pachyman. The fermentation liquor prepared by natural fermentation of bacillus is adjusted to a specific pH value range to be used as a substrate, so that flora reproduction can be inhibited under the condition of not adding a thickening agent and a chemical bacteriostatic agent, decarboxylated carnosine is kept from being oxidized and decomposed for a long time, and the decarboxylated carnosine and soluble pachyman are added, so that immune cells of a female lower reproductive system are bidirectionally adjusted under a reducing condition, and the microenvironment on the surface of skin with abnormal flora tends to be normal by combining the effects, thereby maintaining the micro-ecological balance of the female lower reproductive system. The invention can be applied to the preparation of daily necessities of female lower reproductive system, anti-gynecological inflammation drugs and drugs for preventing sexually transmitted diseases.

For example, chinese granted patent CN 102772458B reports a composition for treating cervical erosion using cnidium fruit total coumarin extract as an effective component: chinese granted patent CN 103381196B reports a composition for treating cervical erosion, which is composed of nano silver, kurarinone, sophorae wood essential oil and placenta.

Disclosure of Invention

The invention aims to solve the technical problem of providing a gel composition for treating cervical erosion, and the composition has a targeted and prominent treatment effect on gynecological diseases such as cervical erosion.

The technical problem to be solved is to provide a preparation method of the gel composition; the method highlights the preparation characteristics of the composition containing fructus Cnidii, radix Sophorae Flavescentis and Galla chinensis, and the preparation conditions of the gel composition applied to clinic.

Therefore, the technical scheme for solving the problems is as follows:

a gel composition for treating cervical erosion comprises the following components in parts by weight: 40-80 parts of traditional Chinese medicine and 700-1300 parts of medically acceptable auxiliary materials, wherein the traditional Chinese medicine comprises at least two of substances selected from the group consisting of fructus cnidii, radix sophorae flavescentis and gallnut.

Further, the Chinese medicine includes two selected from the group consisting of cnidium fruit, sophora flavescens and gallnut.

Preferably, the weight ratio of the two Chinese medicinal materials selected from the group consisting of fructus cnidii, radix sophorae flavescentis and gallnut is 1: a, and a = 0.5-2.

Further, the Chinese medicine comprises fructus Cnidii, radix Sophorae Flavescentis and Galla chinensis.

Preferably, the weight ratio of the common cnidium fruit to the lightyellow sophora root to the nutgall is 1: b: c, b is 0.5-2, and c is 0.5-2.

Further, the medically acceptable auxiliary materials comprise, by weight, 5-10 parts of a gelling agent, 1-3 parts of a humectant and 800-1200 parts of water.

Further, the moisturizer includes at least one selected from the group consisting of glycerin, xylitol, alkali metal salts of lactic acid, triethanolamine salts of lactic acid, and aloe vera.

Preferably, the gelling agent includes at least one selected from the group consisting of gelatin, gum arabic, tragacanth gum, alginic acid, alkali metal alginate, hyaluronic acid, alkali metal hyaluronate, starch and agar.

Also, a method for preparing a gel composition, comprising the steps of:

1) obtaining a mixed aqueous solution of the gelling agent and the humectant;

2) uniformly mixing the powder or extract of the traditional Chinese medicine with the mixed aqueous solution in the step 1);

3) cooling to obtain the gel composition.

Preferably, the gel composition is a clinical application medicine suitable for treating cervical erosion after the mixture prepared by soaking 40-80 parts of traditional Chinese medicines and 700-1300 parts of medically acceptable auxiliary materials respectively in four times of gradient is cooled to 25 ℃.

Compared with the prior art, the gel composition for treating cervical erosion has the following positive effects: the traditional Chinese medicine in the gel composition can be selected from two of substances consisting of fructus cnidii, radix sophorae flavescentis and gallnut, and the two substances have obvious promotion effect on improving the treatment effect of cervical erosion; the preparation method of the gel composition is not particularly limited, and the components are uniformly mixed in any order, and the traditional Chinese medicine and/or the auxiliary medicine can be in the form of traditional Chinese medicine extract, and can be the traditional Chinese medicine raw material which is not extracted, and the traditional Chinese medicine raw material is required to be crushed into powder for use.

Drawings

FIG. 1 is a process flow diagram of a method for preparing a gel composition according to the present invention.

Detailed Description

Referring to fig. 1, the gel composition provided by the invention has broad clinical significance and strong specific significance in treating cervical erosion in gynecological diseases. The technical scheme is embodied in the proportion of the raw material components of the gel composition, such as: a gel composition for treating cervical erosion comprises the following components in parts by weight: 40-80 parts of traditional Chinese medicine, but not limited to 42 parts, 44 parts, 46 parts, 48 parts, 50 parts, 52 parts, 54 parts, 56 parts, 58 parts, 60 parts, 62 parts, 64 parts, 66 parts, 68 parts, 70 parts, 72 parts, 74 parts, 76 parts, 78 parts and the like, and 700-1300 parts of medically acceptable auxiliary materials (such as but not limited to 750 parts, 800 parts, 850 parts, 900 parts, 950 parts, 1000 parts, 1050 parts, 1100 parts, 1150 parts, 1200 parts, 1250 parts and the like), wherein the traditional Chinese medicine comprises at least two selected from the group consisting of fructus cnidii, radix sophorae flavescentis and gallnut.

In the above technical scheme, the Chinese medicine may be selected from two selected from the group consisting of fructus cnidii, radix sophorae flavescentis and gallnut. The two have obvious promotion effect on improving the treatment effect of cervical erosion. Such as fructus Cnidii and radix Sophorae Flavescentis, radix Sophorae Flavescentis and Galla chinensis, and fructus Cnidii and Galla chinensis. In terms of weight ratio, the weight ratio between the two is preferably 1: a, and a = 0.5-2, but a is not limited to 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9 and the like.

In the technical scheme, the traditional Chinese medicine extract can simultaneously comprise fructus cnidii, radix sophorae flavescentis and gallnut, and the three have an obvious combined effect on improving the treatment effect of cervical erosion. The ratio of fructus Cnidii to radix Sophorae Flavescentis to Galla chinensis is preferably 1: b: c, and b is 0.5-2 but not limited to b being 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, etc., and c is 0.5-2 but not limited to c being 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, etc.

In the above technical scheme, the traditional Chinese medicine preferably comprises a curative effect promoting medicine, the curative effect promoting medicine comprises at least one selected from the group consisting of ginseng and motherwort, and the curative effect promoting medicine promotes the effect of the gel composition in treating cervical erosion. Preferably, the ratio by weight of fructus Cnidii to therapeutic effect promoter is 1: d, and d is 0.1-0.4, such as but not limited to d is 0.15, 0.2, 0.25, 0.3, 0.35, etc.

In the above technical scheme, the efficacy-promoting drug preferably comprises both ginseng and motherwort, which have a deliberate interaction in the treatment of cervical erosion. The weight ratio of ginseng and motherwort is not particularly limited, and is, for example, but not limited to, for example, 0.5 to 2, and more specifically, the weight ratio may be 0.6, 0.7, 0.8, 0.9, 1, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, and the like.

In the technical scheme, the medically acceptable auxiliary materials preferably comprise 5-10 parts of gelling agent, 1-3 parts of humectant and 800-1200 parts of water in parts by weight.

In the above technical solution, specific values of the parts by weight in the range of the gelling agent may be 5.5 parts, 6 parts, 6.5 parts, 7 parts, 7.5 parts, 8 parts, 8.5 parts, 9 parts, and 9.5 parts, as non-limiting examples.

In the above technical solution, within the range of the weight parts of the humectant, specific points of the weight parts may be, by way of non-limiting example, 1.2 parts, 1.4 parts, 1.6 parts, 1.8 parts, 2.0 parts, 2.2 parts, 2.4 parts, 2.6 parts, 2.8 parts, and the like.

In the above technical solution, within this range of water weight parts, specific points of the weight parts may be 850 parts, 900 parts, 950 parts, 1000 parts, 1050 parts, 1100 parts, 1150 parts, and so on, as non-limiting examples.

In the above technical solution, the humectant preferably includes at least one selected from glycerol, xylitol, alkali metal salt of lactic acid, triethanolamine salt of lactic acid, and aloe.

In the above technical solutions, the gelling agent is not particularly limited, and may be selected from natural and/or chemically synthesized gelling agents. Natural gelling gums such as, but not limited to, at least one selected from the group consisting of gelatin, gum arabic, tragacanth gum, alginic acid, alkali metal alginate, hyaluronic acid, alkali metal hyaluronate, starch and agar; the chemically synthesized gelling agent is, for example, but not limited to, at least one selected from the group consisting of polyethylene glycol, poloxamer, carbomer, polyvinyl alcohol, and polycaprolactone.

In practice, the molecular weight of polyethylene glycol is selected by the inventor, and polyethylene glycol with the number average molecular weight of 400-5000 is taken as a non-limiting example. For example, poloxamers, also known as pluronics, are polyoxyethylene polyoxypropylene block copolymers having the sequence structure ethylene oxide-propylene oxide-ethylene oxide triblock copolymers, preferably having from 15 to 300 ethylene oxide structural units and from 15 to 70 propylene oxide structural units in the molecule. Carbomer is a high molecular polymer of acrylic acid crosslinked with allyl sucrose, and in order to meet the requirements of gel dosage forms, practically, the carbomer is not limited to the options of carbomer 934, carbomer 934P, carbomer 940 and carbomer 941.

In addition, a natural gelling agent is a preferable object of the present inventors, and for example, at least one of gelatin, gum arabic, tragacanth gum, alginic acid, alkali metal alginate, hyaluronic acid, alkali metal hyaluronate, starch and agar is optional. More specifically, gelatin is a preferred object of the present invention because it has a high solubility in hot water and is easily gelled or frozen by proteins when cooled to 35 to 40 ℃.

In the above technical scheme, the alkali metal salt in the humectant and/or the gelling agent is a sodium salt and/or a potassium salt.

In the above technical scheme, the traditional Chinese medicine and/or the adjuvant in the gel composition of the present invention may be in the form of a traditional Chinese medicine extract, and may be an unextracted traditional Chinese medicine raw material, which is required to be pulverized into powder for use.

In the technical scheme, the traditional Chinese medicine extract can be obtained by extracting with ethanol water solution as an extraction solvent. The extraction method may be impregnation, percolation, reflux, etc.

In the above technical scheme, the ethanol concentration of the ethanol aqueous solution is preferably 55-75% by weight, for example, but not limited to, 55%, 60%, 65%, 70%, 75%, and 65% is preferably adopted in the invention.

In the above technical solution, as a non-limiting example, the method of extracting with an ethanol aqueous solution, which is exemplified by the immersion method, may include, but is not limited to, the following steps:

(1) sequentially extracting for two to four times:

extracting for the first time:

soaking the decoction pieces of the Chinese medicinal materials in ethanol water solution, and filtering to obtain primary filtrate and primary residue;

and (3) second extraction:

soaking the primary filter residue in ethanol water solution, and filtering to obtain a secondary filtrate and a secondary filter residue;

and (3) extracting for the third time:

soaking the second filter residue in ethanol water solution, and filtering to obtain third filtrate and third filter residue;

and (3) fourth extraction:

soaking the third filter residue in ethanol water solution, and filtering to obtain fourth filtrate and fourth filter residue;

(2) the filtrate was concentrated.

In the above technical scheme, in the first to fourth extraction steps, the ethanol concentration of the ethanol aqueous solution is preferably 55 to 75% by weight concentration independently. Such as but not limited to 55%, 60%, 65%, 70%, 75%.

In the technical scheme, in the first to fourth extraction steps, the ratio of the weight of the ethanol water solution to the weight of the traditional Chinese medicine (or the weight of the traditional Chinese medicine filter residue) is preferably 4-15 independently. Such as but not limited to 5, 6, 7, 8, 9, 10, 11, 12, 3, 14, etc.

In the technical scheme, in the first to fourth extraction steps, the dipping temperature is independently preferably 10-50 ℃. For example, but not limited to, 15 deg.C, 20 deg.C, 25 deg.C, 30 deg.C, 35 deg.C, 40 deg.C, 45 deg.C, etc.

In the technical scheme, in the first to fourth extraction steps, the dipping time is preferably 6 to 48 hours independently. Such as, but not limited to, 8 hours, 10 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, and the like.

In the above technical scheme, the step (2) of concentrating may optionally comprise drying.

In the above technical solutions, it is obvious for those skilled in the art that, in order to achieve the object of the present invention, the preparation process of the traditional Chinese medicine extract does not need to be dried or even dried to a pure effective substance with a constant weight after step (2), and the effective substance content can be in the form of a solid, paste or concentrated material flow with a high concentration and a certain amount of water, as long as the effective substance content is equivalent, that is, the water impurities in the extract are subtracted, and the additional amount of water added in the formula is adjusted accordingly to maintain the total amount of water in the formula as a required amount.

In the technical scheme, the purpose of the invention can be achieved by combining the filtrates in the step (1) into mixed filtrate and then performing the step (2), or performing the step (2) on each filtrate and then mixing the dried substances of each filtrate.

The extraction method can be implemented by respectively carrying out the operation of the step (1) on single raw material medicine decoction pieces, or can also be implemented by mixing all the raw material medicines of the traditional Chinese medicine extract in the gel and then carrying out the operation of the step (1).

In the technical scheme, the filtrate obtained in the step (1) can be independently subjected to the step (2); the filtrates obtained in step (1) may be combined and then subjected to step (2).

For the sake of simple process, it is recommended to soak all the raw material decoction piece mixtures together with an ethanol aqueous solution, and the filtrates are combined and then processed in step (2).

In the above technical scheme, the temperature for concentration in step (2) can be selected from 50-80 ℃, and within this temperature range, for example, but not limited to, 55 ℃, 60 ℃, 65 ℃, 70 ℃, 75 ℃, and the like.

The above ethanol aqueous solution extraction, and the Chinese medicinal extract in solid state can be pulverized specially and pulverized in the manner commonly used in the art, such as dry pulverization or wet grinding pulverization. Or spray drying by combining concentration, drying and pulverization. The particle size after pulverization is not particularly limited, but the finer the particles of the extract, the better the effect is exerted. For example, but not limited to, the extract powder has a standard mesh size of 80 to 800 mesh, such as 100 mesh, 120 mesh, 180 mesh, 200 mesh, 300 mesh, 400 mesh, 500 mesh, 600 mesh, 700 mesh, and the like, as non-limiting examples. The extract nanoparticles are prepared by adopting the nanotechnology in the prior art, and the application effect is better.

If the concentrated solution obtained in step (2) is directly used for preparing the traditional Chinese medicine composition of the invention without further drying the extract, the concentration degree of the concentrated solution obtained in step (2) can be selected to be 0.5-2 times of the total weight of the traditional Chinese medicine and the auxiliary medicine, such as but not limited to 0.6 time, 0.7 time, 0.8 time, 0.9 time, 1.0 time, 1.1 time, 1.2 times, 1.3 times, 1.4 times, 1.5 times, 1.6 times, 1.7 times, 1.8 times, 1.9 times and the like.

In the above technical scheme, the names of all plants adopt the pharmacopoeia of the people's republic of China (2015 edition).

In the above technical scheme, the cnidium fruit is cnidium monnieri (L.) dandy of UmbelliferaeCnidium monnieri (L. )Cuss.) Dried mature fruit of (4).

In the above technical scheme, the radix sophorae flavescentis is leguminous plant radix sophorae flavescentis (sophora flavescens: (sophora flavescens))Sophora flavescens Ait.) The dried root of (b) to obtain decoction pieces.

In the technical scheme, the gallnut is Rhus chinensis Mill (Rhus chinensis Mill.) Roxb (Rhus chinensis Mill.) Kuntze of AnacardiaceaeRhus chinensis Mill.) Qing Yun Yang (a)Rhus potaninii Maxim.) Or cottonwood (Populus deltoides)Rhus punjabensis Stew．var． sinica (Diels) Rehd. et Wils .) Decoction pieces prepared from insect gall on leaves. The gallnuts from the sources have the same or similar technical effects, and the gallnuts adopted in the specific embodiment of the invention are Rhus chinensis (Rhus chinensis) of Anacardiaceae (for convenience of same proportion)Rhus chinensis Mill.) Decoction pieces prepared from insect gall on leaves.

In the above technical scheme, the ginseng is Panax ginseng C.A. (ginseng C.A.)Panax ginseng C. A. Mey．) The dried root and rhizome of (b) to obtain decoction pieces.

In the above technical scheme, the herba Leonuri is herba Leonuri (herba Leonuri) of LabiataeLeonurus ja ponicus Houtt.) The dried aerial parts of (1) are prepared into decoction pieces.

In the above technical scheme, the aloe is preferably Aloe barbadensis Miller (Aloe vera, A. RTM. of Liliaceae, as described in Chinese pharmacopoeia 2015 editionAloe barbadensisMiller) juice from the leaves of the plant, commonly known in the medical field as "aloe vera".

To solve the second technical problem, the technical solution of the present invention is as follows:

the method for preparing the gel composition according to one of the above-mentioned technical problems is not particularly limited, and the above-mentioned components may be mixed in an arbitrary order.

However, to obtain a uniformly dispersed gel composition, the production efficiency is high by adopting the following steps:

the process for the preparation of a gel composition according to one of the above technical problems, comprising the steps of:

1) obtaining a mixed aqueous solution of the gelling agent and the humectant;

2) uniformly mixing the powder or extract of the traditional Chinese medicine with the mixed aqueous solution in the step 1);

3) cooling to obtain the gel composition.

Preferably, the temperature of the mixed aqueous solution in the step 1) and the temperature of the mixing operation in the step 2) are independently selected from 50 to 90 ℃, and more specific non-limiting examples thereof are independently selected from 55 ℃, 60 ℃, 65 ℃, 70 ℃, 75 ℃, 80 ℃, 85 ℃ and the like; in this case, the temperature of step 3) may be reduced to, for example, but not limited to, 10 to 40 ℃, and more specifically, the temperature may be reduced to, for example, 15 ℃, 20 ℃, 25 ℃, 30 ℃, 35 ℃ or the like.

In order to solve the third technical problem, the technical scheme of the invention is as follows:

the application of the traditional Chinese medicine or the gel composition in the preparation of the medicine for treating cervical erosion in one of the technical schemes of the technical problems.

The method for evaluating the therapeutic effect in the embodiment of the gel composition of the present invention is as follows:

1. participants and groups

350 trial patients with cervical erosion degree III who are not more than 59 years old and not more than 20 years old are selected for outpatient service in hospitals, and the trial patients are randomly divided into 7 groups: 50 observation groups in example 1 to example 7 were used.

2. Mode of administration

The administration mode of each patient in the observation group was: the gel composition of the invention is evenly applied to the deep part of the vagina 1 time and 4.0 g each time before sleeping at night.

Two weeks is a treatment course, and the examination is repeated after one treatment course to judge the treatment effect of a single treatment course. In order to highlight the essential features and the remarkable progress of the present invention, the following examples are further described in more detail:

[ example 1 ]

1. Preparation of Chinese medicinal extract

(1) Impregnation

First impregnation:

taking traditional Chinese medicine raw material medicinal slices (for convenience of comparison, the composition of the raw material medicinal slices is listed in table 1) according to the weight ratio of common cnidium fruit, lightyellow sophora root, Chinese gall, ginseng and motherwort being 1:1:0:0, mixing to obtain a traditional Chinese medicine mixture, soaking the traditional Chinese medicine mixture in an ethanol aqueous solution (the ethanol weight concentration of the ethanol aqueous solution is 65%) with the weight of which is 5 times that of the traditional Chinese medicine mixture at 25 ℃ for 12 hours, and filtering to obtain primary filtrate and primary filter residue;

second impregnation:

soaking the first residue in 5 times of ethanol water solution (ethanol concentration of the ethanol water solution is 65%) at 25 deg.C for 6 hr, and filtering to obtain second filtrate and second residue;

and (3) third impregnation:

soaking the second residue in 5 times of ethanol water solution (ethanol concentration of the ethanol water solution is 65%) at 25 deg.C for 6 hr, and filtering to obtain third filtrate and third residue;

fourth impregnation:

soaking the third residue in 5 times of ethanol water solution (ethanol concentration of the ethanol water solution is 65%) at 25 deg.C for 6 hr, and filtering to obtain fourth filtrate and fourth residue;

(2) concentrating

The filtrates obtained by the respective extractions obtained in step (1) are combined, and the filtrate is concentrated at 70 ℃ until the weight of the filtrate is equal to the weight of the traditional Chinese medicine used for impregnation, and the filtrate is directly used for preparing the gel composition of the invention as the traditional Chinese medicine extract.

2. Preparation of gel compositions

(1) Adding 8 parts of gelatin and 2 parts of aloe into 1000 parts of water, and dissolving at 70 ℃ under stirring to obtain a 70 ℃ solution I;

(2) adding 60 parts of the traditional Chinese medicine extract into the solution I, and uniformly mixing at 70 ℃ to obtain a mixture II;

(3) and cooling to 25 ℃ under stirring to obtain the gel composition.

3. Gel composition efficacy test

The results of the drug efficacy test of the gel composition are shown in table 2.

[ example 2 ]

1. Preparation of Chinese medicinal extract

(1) Impregnation

First impregnation:

taking traditional Chinese medicine raw material medicinal slices (for convenience of comparison, the composition of the raw material medicinal slices is listed in table 1) according to the weight ratio of fructus cnidii, radix sophorae flavescentis, Chinese gall, ginseng and motherwort being 0:1:1:0:0, mixing to obtain a traditional Chinese medicine mixture, soaking the traditional Chinese medicine mixture in an ethanol aqueous solution (the ethanol weight concentration of the ethanol aqueous solution is 65%) with the weight of which is 5 times that of the traditional Chinese medicine mixture at 25 ℃ for 12 hours, and filtering to obtain primary filtrate and primary filter residue;

second impregnation:

soaking the first residue in 5 times of ethanol water solution (ethanol concentration of the ethanol water solution is 65%) at 25 deg.C for 6 hr, and filtering to obtain second filtrate and second residue;

and (3) third impregnation:

soaking the second residue in 5 times of ethanol water solution (ethanol concentration of the ethanol water solution is 65%) at 25 deg.C for 6 hr, and filtering to obtain third filtrate and third residue;

fourth impregnation:

soaking the third residue in 5 times of ethanol water solution (ethanol concentration of the ethanol water solution is 65%) at 25 deg.C for 6 hr, and filtering to obtain fourth filtrate and fourth residue;

(2) concentrating

The filtrates obtained by the respective extractions obtained in step (1) are combined, and the filtrate is concentrated at 70 ℃ until the weight of the filtrate is equal to the weight of the traditional Chinese medicine used for impregnation, and the filtrate is directly used for preparing the gel composition of the invention as the traditional Chinese medicine extract.

2. Preparation of gel compositions

(1) Adding 8 parts of gelatin and 2 parts of aloe into 1000 parts of water, and dissolving at 70 ℃ under stirring to obtain a 70 ℃ solution I;

(2) adding 60 parts of the traditional Chinese medicine extract into the solution I, and uniformly mixing at 70 ℃ to obtain a mixture II;

(3) and cooling to 25 ℃ under stirring to obtain the gel composition.

3. Gel composition efficacy test

The results of the drug efficacy test of the gel composition are shown in table 2.

[ example 3 ]

1. Preparation of Chinese medicinal extract

(1) Impregnation

First impregnation:

taking traditional Chinese medicine raw material medicinal slices (for convenience of comparison, the composition of the raw material medicinal slices is listed in table 1) according to the weight ratio of common cnidium fruit, lightyellow sophora root, Chinese gall, ginseng and motherwort being 1:0:1, mixing to obtain a traditional Chinese medicine mixture, soaking the traditional Chinese medicine mixture in an ethanol aqueous solution (the ethanol weight concentration of the ethanol aqueous solution is 65%) with the weight of which is 5 times that of the traditional Chinese medicine mixture at 25 ℃ for 12 hours, and filtering to obtain primary filtrate and primary filter residue;

second impregnation:

soaking the first residue in 5 times of ethanol water solution (ethanol concentration of the ethanol water solution is 65%) at 25 deg.C for 6 hr, and filtering to obtain second filtrate and second residue;

and (3) third impregnation:

soaking the second residue in 5 times of ethanol water solution (ethanol concentration of the ethanol water solution is 65%) at 25 deg.C for 6 hr, and filtering to obtain third filtrate and third residue;

fourth impregnation:

soaking the third residue in 5 times of ethanol water solution (ethanol concentration of the ethanol water solution is 65%) at 25 deg.C for 6 hr, and filtering to obtain fourth filtrate and fourth residue;

(2) concentrating

The filtrates obtained by the respective extractions obtained in step (1) are combined, and the filtrate is concentrated at 70 ℃ until the weight of the filtrate is equal to the weight of the traditional Chinese medicine used for impregnation, and the filtrate is directly used for preparing the gel composition of the invention as the traditional Chinese medicine extract.

2. Preparation of gel compositions

(1) Adding 8 parts of gelatin and 2 parts of aloe into 1000 parts of water, and dissolving at 70 ℃ under stirring to obtain a 70 ℃ solution I;

(2) adding 60 parts of the traditional Chinese medicine extract into the solution I, and uniformly mixing at 70 ℃ to obtain a mixture II;

(3) and cooling to 25 ℃ under stirring to obtain the gel composition.

3. Gel composition efficacy test

The results of the drug efficacy test of the gel composition are shown in table 2.

[ example 4 ]

1. Preparation of Chinese medicinal extract

(1) Impregnation

First impregnation:

taking traditional Chinese medicine raw material medicinal slices (for convenience of comparison, the composition of the raw material medicinal slices is listed in table 1) according to the weight ratio of common cnidium fruit, lightyellow sophora root, Chinese gall, ginseng and motherwort being 1:1:1:0:0, mixing to obtain a traditional Chinese medicine mixture, soaking the traditional Chinese medicine mixture in an ethanol aqueous solution (the ethanol weight concentration of the ethanol aqueous solution is 65%) with the weight of which is 5 times that of the traditional Chinese medicine mixture at 25 ℃ for 12 hours, and filtering to obtain primary filtrate and primary filter residue;

second impregnation:

soaking the first residue in 5 times of ethanol water solution (ethanol concentration of the ethanol water solution is 65%) at 25 deg.C for 6 hr, and filtering to obtain second filtrate and second residue;

and (3) third impregnation:

soaking the second residue in 5 times of ethanol water solution (ethanol concentration of the ethanol water solution is 65%) at 25 deg.C for 6 hr, and filtering to obtain third filtrate and third residue;

fourth impregnation:

soaking the third residue in 5 times of ethanol water solution (ethanol concentration of the ethanol water solution is 65%) at 25 deg.C for 6 hr, and filtering to obtain fourth filtrate and fourth residue;

(2) concentrating

The filtrates obtained by the respective extractions obtained in step (1) are combined, and the filtrate is concentrated at 70 ℃ until the weight of the filtrate is equal to the weight of the traditional Chinese medicine used for impregnation, and the filtrate is directly used for preparing the gel composition of the invention as the traditional Chinese medicine extract.

2. Preparation of gel compositions

(1) Adding 8 parts of gelatin and 2 parts of aloe into 1000 parts of water, and dissolving at 70 ℃ under stirring to obtain a 70 ℃ solution I;

(2) adding 60 parts of the traditional Chinese medicine extract into the solution I, and uniformly mixing at 70 ℃ to obtain a mixture II;

(3) and cooling to 25 ℃ under stirring to obtain the gel composition.

3. Gel composition efficacy test

The results of the drug efficacy test of the gel composition are shown in table 2.

[ example 5 ]

1. Preparation of Chinese medicinal extract

(1) Impregnation

First impregnation:

taking traditional Chinese medicine raw material medicinal slices (for convenience of comparison, the composition of the raw material medicinal slices is listed in table 1) according to the weight ratio of common cnidium fruit, lightyellow sophora root, Chinese gall, ginseng and motherwort being 1:1:0.3:0, mixing to obtain a traditional Chinese medicine mixture, soaking the traditional Chinese medicine mixture in an ethanol aqueous solution (the ethanol weight concentration of the ethanol aqueous solution is 65%) with the weight of which is 5 times that of the traditional Chinese medicine mixture at 25 ℃ for 12 hours, and filtering to obtain a first filtrate and a first filter residue;

second impregnation:

soaking the first residue in 5 times of ethanol water solution (ethanol concentration of the ethanol water solution is 65%) at 25 deg.C for 6 hr, and filtering to obtain second filtrate and second residue;

and (3) third impregnation:

soaking the second residue in 5 times of ethanol water solution (ethanol concentration of the ethanol water solution is 65%) at 25 deg.C for 6 hr, and filtering to obtain third filtrate and third residue;

fourth impregnation:

soaking the third residue in 5 times of ethanol water solution (ethanol concentration of the ethanol water solution is 65%) at 25 deg.C for 6 hr, and filtering to obtain fourth filtrate and fourth residue;

(2) concentrating

The filtrates obtained by the respective extractions obtained in step (1) are combined, and the filtrate is concentrated at 70 ℃ until the weight of the filtrate is equal to the weight of the traditional Chinese medicine used for impregnation, and the filtrate is directly used for preparing the gel composition of the invention as the traditional Chinese medicine extract.

2. Preparation of gel compositions

(1) Adding 8 parts of gelatin and 2 parts of aloe into 1000 parts of water, and dissolving at 70 ℃ under stirring to obtain a 70 ℃ solution I;

(2) adding 60 parts of the traditional Chinese medicine extract into the solution I, and uniformly mixing at 70 ℃ to obtain a mixture II;

(3) and cooling to 25 ℃ under stirring to obtain the gel composition.

3. Gel composition efficacy test

The results of the drug efficacy test of the gel composition are shown in table 2.

[ example 6 ]

1. Preparation of Chinese medicinal extract

(1) Impregnation

First impregnation:

taking traditional Chinese medicine raw material medicinal slices (for convenience of comparison, the composition of the raw material medicinal slices is listed in table 1) according to the weight ratio of common cnidium fruit, lightyellow sophora root, Chinese gall, ginseng and motherwort being 1:1:1:0:0.3, mixing to obtain a traditional Chinese medicine mixture, soaking the traditional Chinese medicine mixture in an ethanol aqueous solution (the ethanol weight concentration of the ethanol aqueous solution is 65%) with the weight of which is 5 times that of the traditional Chinese medicine mixture at 25 ℃ for 12 hours, and filtering to obtain a first filtrate and a first filter residue;

second impregnation:

soaking the first residue in 5 times of ethanol water solution (ethanol concentration of the ethanol water solution is 65%) at 25 deg.C for 6 hr, and filtering to obtain second filtrate and second residue;

and (3) third impregnation:

soaking the second residue in 5 times of ethanol water solution (ethanol concentration of the ethanol water solution is 65%) at 25 deg.C for 6 hr, and filtering to obtain third filtrate and third residue;

fourth impregnation:

soaking the third residue in 5 times of ethanol water solution (ethanol concentration of the ethanol water solution is 65%) at 25 deg.C for 6 hr, and filtering to obtain fourth filtrate and fourth residue;

(2) concentrating

The filtrates obtained by the respective extractions obtained in step (1) are combined, and the filtrate is concentrated at 70 ℃ until the weight of the filtrate is equal to the weight of the traditional Chinese medicine used for impregnation, and the filtrate is directly used for preparing the gel composition of the invention as the traditional Chinese medicine extract.

2. Preparation of gel compositions

(1) Adding 8 parts of gelatin and 2 parts of aloe into 1000 parts of water, and dissolving at 70 ℃ under stirring to obtain a 70 ℃ solution I;

(2) adding 60 parts of the traditional Chinese medicine extract into the solution I, and uniformly mixing at 70 ℃ to obtain a mixture II;

(3) and cooling to 25 ℃ under stirring to obtain the gel composition.

3. Gel composition efficacy test

The results of the drug efficacy test of the gel composition are shown in table 2.

[ example 7 ]

1. Preparation of Chinese medicinal extract

(1) Impregnation

First impregnation:

taking decoction pieces of traditional Chinese medicine raw material medicines (for convenience of comparison, the composition of the decoction pieces of the raw material medicines is listed in table 1) according to the weight ratio of common cnidium fruit, lightyellow sophora root, ginseng and motherwort being 1:1:1:0.2:0.1, mixing to obtain a traditional Chinese medicine mixture, soaking the traditional Chinese medicine mixture in an ethanol aqueous solution (the ethanol weight concentration of the ethanol aqueous solution is 65%) with the weight of which is 5 times that of the traditional Chinese medicine mixture at 25 ℃ for 12 hours, and filtering to obtain a first filtrate and a first filter residue;

second impregnation:

soaking the first residue in 5 times of ethanol water solution (ethanol concentration of the ethanol water solution is 65%) at 25 deg.C for 6 hr, and filtering to obtain second filtrate and second residue;

and (3) third impregnation:

soaking the second residue in 5 times of ethanol water solution (ethanol concentration of the ethanol water solution is 65%) at 25 deg.C for 6 hr, and filtering to obtain third filtrate and third residue;

fourth impregnation:

soaking the third residue in 5 times of ethanol water solution (ethanol concentration of the ethanol water solution is 65%) at 25 deg.C for 6 hr, and filtering to obtain fourth filtrate and fourth residue;

(2) concentrating

The filtrates obtained by the respective extractions obtained in step (1) are combined, and the filtrate is concentrated at 70 ℃ until the weight of the filtrate is equal to the weight of the traditional Chinese medicine used for impregnation, and the filtrate is directly used for preparing the gel composition of the invention as the traditional Chinese medicine extract.

2. Preparation of gel compositions

(1) Adding 8 parts of gelatin and 2 parts of aloe into 1000 parts of water, and dissolving at 70 ℃ under stirring to obtain a 70 ℃ solution I;

(2) adding 60 parts of the traditional Chinese medicine extract into the solution I, and uniformly mixing at 70 ℃ to obtain a mixture II;

(3) and cooling to 25 ℃ under stirring to obtain the gel composition.

3. Gel composition efficacy test

The results of the drug efficacy test of the gel composition are shown in table 2.

As can be seen from the comparison between table 1 and table 2, the subjects of the gel compositions of examples 1 to 7 all got rid of the trouble of the degree III of cervical erosion after a treatment course, and even the subjects got rid of the trouble of the degree II of cervical erosion by the gel compositions of example 7.

As can be seen from the number of recovery cases, the effect of example 4 is obviously better than that of examples 1-3, while examples 5 and 6 are obviously better than that of example 4, and in all the examples, the effect of example 7 is optimal.

TABLE 1

(weight ratio)

	Fructus cnidii	Sophora flavescens ait	Galla chinensis	Ginseng radix	Motherwort herb
						Example 1	1	1	0	0	0
Example 2	0	1	1	0	0
						Example 3	1	0	1	0	0
Example 4	1	1	1	0	0
						Example 5	1	1	1	0.3	0
Example 6	1	1	1	0	0.3
						Example 7	1	1	1	0.2	0.1

TABLE 2

	Number of cases of III degree of cervical erosion	Cervical erosion in II degree	Number of cases of degree I of cervical erosion	Number of recovery cases
					Example 1	0	7	16	27
Example 2	0	9	17	24
					Example 3	0	6	16	28
Example 4	0	5	13	32
					Practice ofExample 5	0	2	9	39
Example 6	0	1	7	42
					Example 7	0	0	2	48