阅读说明：本技术 药物组合物的制备方法 (Process for preparing pharmaceutical composition ) 是由 任亚东 夏春森 刘志强 汪刘恒 蔡乐 袁海成 于 2020-08-30 设计创作，主要内容包括：本申请提供一种药物组合物的制备方法。上述的药物组合物的制备方法包括如下步骤：提供正元胶囊干膏粉；采用羟丙基β-环糊精对正元胶囊干膏粉进行包合操作；得到正元胶囊干膏粉包合物；将正元胶囊干膏粉包合物、龟粉和鳖粉进行混合,得到中药混合粉体；将中药混合粉体溶解于乙醇中,得到混合物；将崩解剂与混合物进行混合操作,得到混悬液；将混悬液喷雾至流化床中的木糖醇颗粒上进行包衣载药操作,得到载药颗粒；将载药颗粒与无糖填料进行混合,得到装囊物；将装囊物装入胶囊壳内,得到药物组合物。上述的药物组合物的制备方法中,通过添加木糖醇颗粒实现了包衣载药,且减少了药物组合物内糖分含量,提高了制备得到的药物组合物的适用范围。(The present application provides a method for preparing a pharmaceutical composition. The preparation method of the pharmaceutical composition comprises the following steps: providing Zhengyuan capsule dry paste powder; clathrating the dried powder with hydroxypropyl beta-cyclodextrin; obtaining a Zhengyuan capsule dry paste powder inclusion compound; mixing the extract powder, tortoise powder and turtle powder to obtain mixed powder; dissolving the mixed powder of the traditional Chinese medicines in ethanol to obtain a mixture; mixing the disintegrating agent and the mixture to obtain a suspension; spraying the suspension onto xylitol particles in a fluidized bed to carry out coating and drug loading operation to obtain drug-loaded particles; mixing the drug-loaded particles with sugar-free filler to obtain a capsule filling material; and filling the capsule filling material into a capsule shell to obtain the pharmaceutical composition. In the preparation method of the pharmaceutical composition, coating and drug loading are realized by adding the xylitol particles, the content of sugar in the pharmaceutical composition is reduced, and the application range of the prepared pharmaceutical composition is improved.)

1. A method for preparing a pharmaceutical composition, comprising the steps of:

providing Zhengyuan capsule dry paste powder;

performing inclusion operation on the vital essence capsule dry extract powder by adopting hydroxypropyl beta-cyclodextrin to obtain a vital essence capsule dry extract powder inclusion compound;

mixing the extract powder, tortoise powder and turtle powder to obtain mixed powder;

dissolving the mixed powder of the traditional Chinese medicines in ethanol to obtain a mixture;

mixing a disintegrating agent with the mixture to obtain a suspension;

spraying the suspension onto xylitol particles in a fluidized bed to carry out coating and drug loading operation to obtain drug-loaded particles;

mixing the drug-loaded particles with sugar-free filler to obtain a capsule filling material; and

and filling the capsule filling material into a capsule shell to obtain the pharmaceutical composition.

2. The preparation method of the pharmaceutical composition according to claim 1, wherein the mass ratio of the Zhengyuan capsule dry extract powder inclusion, the tortoise powder and the turtle powder is (1.2-1.7): 1: 2.

3. the preparation method of the pharmaceutical composition according to claim 1, wherein the mass ratio of the traditional Chinese medicine mixed powder, the disintegrant and the xylitol particles is 1: (0.08-0.10): (1.5-2).

4. The preparation method of the pharmaceutical composition according to claim 3, wherein the mass ratio of the traditional Chinese medicine mixed powder, the disintegrant and the xylitol particles is 1: (0.07-0.12): (1.0-5).

5. The preparation method of the pharmaceutical composition according to claim 1, wherein the mass ratio of the hydroxypropyl beta-cyclodextrin to the Zhengyuan capsule dry extract powder is (1-7): (0.2-0.5).

6. The method for preparing a pharmaceutical composition according to claim 1, wherein the mixing time of the disintegrant and the mixture is 3 to 10 min.

7. The preparation method of the pharmaceutical composition according to claim 1, wherein the ethanol is contained in an amount of 50 to 60% by mass.

8. The preparation method of the pharmaceutical composition according to claim 1, wherein the volume of the mixed powder of ethanol and traditional Chinese medicine is (0.5-1.2): (3-9).

9. The method of preparing a pharmaceutical composition according to claim 1, wherein the disintegrant is at least one of crospovidone, croscarmellose sodium, and sodium carboxymethyl starch.

10. Process for the preparation of a pharmaceutical composition according to claim 1, wherein said sugarless filler is talc.

Technical Field

The invention relates to the technical field of dry paste powder, in particular to a preparation method of a pharmaceutical composition.

Background

At present, the vital essence capsule is used as a medicine composition for enhancing immunity, the formula of the medicine composition is applied for a long time and continuously improved, the functions of all the medicines in the formula are complemented, the functions of tonifying qi and spleen, tonifying kidney and replenishing essence are realized together, the symptoms of mental fatigue and hypodynamia, qi deficiency and no speaking desire, short breath, grain fragrance, waist soreness and back pain, spontaneous perspiration and the like of a patient can be improved, the toxic and side effects of the patient after radiotherapy and chemotherapy are reduced, and the immune function and the life quality are improved. In the preparation process of the traditional Chinese medicine capsule, an extraction part adopts an alcohol extraction method, a volatile oil extraction method and a water decoction method, so that fat-soluble ingredients, volatile oil and water-soluble active ingredients in the medicines can be effectively extracted, a drying part adopts a spray drying technology, the quality of an intermediate product is stable and controllable, the process technology is standard, the extraction rate of the active ingredients is high, and a finished product is safe, free of toxic and side effects, convenient to carry and convenient to take.

The vital essence capsule is prepared from the following raw material medicines in parts by weight: 24 to 48 parts of epimedium, 6 to 10 parts of ginseng, 24 to 48 parts of radix astragali preparata, 16 to 32 parts of glossy privet fruit, 4 to 8 parts of tortoise powder and 8 to 16 parts of turtle powder.

Particularly, the zhengyuan capsule is used as a pharmaceutical composition for enhancing immunity, and the ingredients of the zhengyuan capsule still contain more sugar, so that a preparation method of the zhengyuan capsule pharmaceutical composition with lower sugar content in the pharmaceutical composition is needed.

Disclosure of Invention

The invention aims to overcome the defects in the prior art and provides a preparation method of a pharmaceutical composition with lower sugar content.

The purpose of the invention is realized by the following technical scheme:

a method for preparing a pharmaceutical composition, comprising the steps of:

providing Zhengyuan capsule dry paste powder;

performing inclusion operation on the vital essence capsule dry extract powder by adopting hydroxypropyl beta-cyclodextrin to obtain a vital essence capsule dry extract powder inclusion compound;

mixing the extract powder, tortoise powder and turtle powder to obtain mixed powder;

dissolving the mixed powder of the traditional Chinese medicines in ethanol to obtain a mixture;

mixing a disintegrating agent with the mixture to obtain a suspension;

spraying the suspension onto xylitol particles in a fluidized bed to carry out coating and drug loading operation to obtain drug-loaded particles;

mixing the drug-loaded particles with sugar-free filler to obtain a capsule filling material; and

and filling the capsule filling material into a capsule shell to obtain the pharmaceutical composition.

In one embodiment, the mass ratio of the Zhengyuan capsule dry paste powder inclusion, the tortoise powder and the turtle powder is (1.2-1.7): 1: 2.

in one embodiment, the mass ratio of the traditional Chinese medicine mixed powder, the disintegrating agent and the xylitol particles is 1: (0.08-0.10): (1.5-2).

In one embodiment, the mass ratio of the traditional Chinese medicine mixed powder, the disintegrating agent and the xylitol particles is 1: (0.07-0.12): (1.0-5).

In one embodiment, the mass ratio of the hydroxypropyl beta-cyclodextrin to the Zhengyuan capsule dry paste powder is (1-7): (0.2-0.5).

In one embodiment, the mixing time of the disintegrant and the mixture is 3min to 10 min.

In one embodiment, the ethanol is 50-60% by mass.

In one embodiment, the mass of the ethanol and the mixture is (0.5-1.2): (3-6).

In one embodiment, the disintegrant is at least one of crospovidone, croscarmellose sodium, and sodium carboxymethyl starch.

In one embodiment, the sugarless filler is talc.

Compared with the prior art, the application at least comprises the following advantages:

in the preparation method of the pharmaceutical composition, coating and drug loading are realized by adding the xylitol particles, the content of sugar in the pharmaceutical composition is reduced, and the application range of the prepared pharmaceutical composition is improved.

Drawings

FIG. 1 is a flow chart of the steps of a method of preparing a pharmaceutical composition according to one embodiment of the present invention.

Detailed Description

To facilitate an understanding of the invention, the invention will now be described more fully with reference to the accompanying drawings. Preferred embodiments of the present invention are shown in the drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

The application provides a preparation method of a pharmaceutical composition, which comprises the following steps: providing Zhengyuan capsule dry paste powder; clathrating the dried powder with hydroxypropyl beta-cyclodextrin; obtaining a Zhengyuan capsule dry paste powder inclusion compound; mixing the extract powder, tortoise powder and turtle powder to obtain mixed powder; dissolving the mixed powder of the traditional Chinese medicines in ethanol to obtain a mixture; mixing the disintegrating agent and the mixture to obtain a suspension; spraying the suspension onto xylitol particles in a fluidized bed to carry out coating and drug loading operation to obtain drug-loaded particles; mixing the drug-loaded particles with sugar-free filler to obtain a capsule filling material; and filling the capsule filling material into a capsule shell to obtain the pharmaceutical composition.

In the preparation method of the pharmaceutical composition, coating and drug loading are realized by adding the xylitol particles, the content of sugar in the pharmaceutical composition is reduced, and the application range of the prepared pharmaceutical composition is improved.

For a better understanding of the process for preparing the pharmaceutical composition of the present application, the process for preparing the pharmaceutical composition of the present application is further explained below, referring to fig. 1, and the process for preparing the pharmaceutical composition of one embodiment comprises the steps of:

s100, providing vital essence capsule dry paste powder. It is understood that the Zhengyuan capsule dry extract powder is the main effective component of the pharmaceutical composition, and the preparation of the Zhengyuan capsule dry extract powder is required for the subsequent preparation of the pharmaceutical composition when the pharmaceutical composition is prepared.

S200, performing inclusion operation on the Zhengyuan capsule dry paste powder by adopting hydroxypropyl beta-cyclodextrin to obtain a Zhengyuan capsule dry paste powder inclusion compound. It can be understood that the granule diameter of the Zhengyuan capsule dry extract powder inclusion formed by hydroxypropyl beta-cyclodextrin and Zhengyuan capsule dry extract powder is more uniform and has higher stability, thereby improving the stability of the Zhengyuan capsule dry extract powder and further improving the stability of the pharmaceutical composition.

S300, mixing the Zhengyuan capsule dry paste powder inclusion, the tortoise powder and the turtle powder to obtain traditional Chinese medicine mixed powder. It can be understood that the tortoise powder and the turtle powder are main effective components of the pharmaceutical composition, and the Zhengyuan capsule dry paste powder inclusion, the tortoise powder and the turtle powder are uniformly mixed, so that the uniformity of the effective components of the pharmaceutical composition is improved, the accuracy of the effective components of the pharmaceutical composition is improved, and the quality of the pharmaceutical composition is further improved.

S400, dissolving the mixed powder of the traditional Chinese medicines in ethanol to obtain a mixture. It can be understood that ethanol is volatile at high temperature, and the mixed powder of traditional Chinese medicines is easily dissolved in ethanol, so that the ethanol is adopted to prepare the mixture, the content of residual solvent of the pharmaceutical composition is reduced, and the quality of the pharmaceutical composition is improved.

And S500, mixing the disintegrating agent and the mixture to obtain a suspension. It is understood that the addition of the disintegrant facilitates rapid disintegration of the pharmaceutical composition, reduces the onset time of the pharmaceutical composition, and increases the therapeutic time-effectiveness of the pharmaceutical composition.

S600, spraying the suspension onto xylitol particles in a fluidized bed to carry out coating and drug loading operation, so as to obtain drug-loaded particles. The xylitol particles are non-sugar substances, the coating and drug loading effect is good, the xylitol particles are added into the pharmaceutical composition to realize coating and drug loading, the content of sugar in the pharmaceutical composition is reduced, and the application range of the prepared pharmaceutical composition is widened.

S700, mixing the drug-loaded particles with sugar-free fillers to obtain the capsule filling material. It will be appreciated that the above-described,

and S800, filling the encapsulated substance into a capsule shell to obtain the pharmaceutical composition.

In the preparation method of the pharmaceutical composition, coating and drug loading are realized by adding the xylitol particles, the content of sugar in the pharmaceutical composition is reduced, and the application range of the prepared pharmaceutical composition is improved.

In one embodiment, the mass ratio of the Zhengyuan capsule dry extract powder inclusion, the tortoise powder and the turtle powder is (1.2-1.7): 1: 2. it can be understood that when the weight ratio of the Zhengyuan capsule dry extract powder inclusion, the tortoise powder and the turtle powder is (1.2-1.7): 1: 2, the prepared medicinal composition has better pharmacodynamic property.

In one embodiment, the mass ratio of the traditional Chinese medicine mixed powder, the disintegrating agent and the xylitol particles is 1: (0.08-0.10): (1.5-2). It can be understood that the mass ratio of the traditional Chinese medicine mixed powder, the disintegrating agent and the xylitol particles is 1: (0.08-0.10): (1.5-2), the prepared medicinal composition has good medicinal effect.

In one embodiment, the mass ratio of the traditional Chinese medicine mixed powder, the disintegrating agent and the xylitol particles is 1: (0.07-0.12): (1.0-5). It can be understood that the mass ratio of the traditional Chinese medicine mixed powder, the disintegrating agent and the xylitol particles is 1: (0.07-0.12): (1.0-5), the prepared medicinal composition has good medicinal effect.

In one embodiment, the mass ratio of the hydroxypropyl beta-cyclodextrin to the Zhengyuan capsule dry paste powder is (1-7): (0.2-0.5). It can be understood that when the mass ratio of the hydroxypropyl beta-cyclodextrin to the vital capsule dry extract powder is (1-7): (0.2-0.5), the particle size of the prepared Zhengyuan capsule dry extract powder inclusion is uniform, the stability is high, the stability of the Zhengyuan capsule dry extract powder is improved, and the stability of the pharmaceutical composition is further improved.

In one embodiment, the mixing time of the disintegrant and the mixture is 3min to 10 min. It can be understood that when the mixing time of the disintegrating agent and the mixture is 3min to 10min, the disintegrating agent and the mixture are fully and uniformly dissolved in the ethanol, the uniformity degree of each effective component in the pharmaceutical composition is improved, and the content accuracy of each effective component in the pharmaceutical composition is further improved.

In one embodiment, the mass percentage of the ethanol is 50-60%. It can be understood that the content of 50-60% by mass has a good dissolving effect on each active ingredient in the pharmaceutical composition.

In one embodiment, the mass of the ethanol and the mixture is (0.5-1.2): (3-6). It can be understood that when the mass of the ethanol and the mixture is (0.5-1.2): (3-6), the dissolution effect of each effective component in the pharmaceutical composition is better.

In one embodiment, the disintegrant is at least one of crospovidone, croscarmellose sodium, and sodium carboxymethyl starch. It can be understood that the crospovidone, the croscarmellose sodium and the sodium carboxymethyl starch have better disintegration effect on the pharmaceutical composition, so that the disintegration time of the pharmaceutical composition is prolonged, and the treatment time of the pharmaceutical composition is further prolonged.

In one embodiment, the filler is talc. It can be understood that the talcum powder has the function of protecting mucosa, and the harm of the pharmaceutical composition to gastric mucosa and other mucosa of human body is reduced by adding the talcum powder into the pharmaceutical composition.

In one embodiment, the preparation method of the Zhengyuan capsule dry paste powder comprises the following steps:

providing the following components in parts by mass: 24 to 48 parts of epimedium, 6 to 10 parts of ginseng, 24 to 48 parts of radix astragali preparata, 16 to 32 parts of glossy privet fruit, 4 to 8 parts of tortoise powder, 8 to 16 parts of turtle powder, 16 to 32 parts of fried bighead atractylodes rhizome and 8 to 16 parts of dried orange peel. It can be understood that in the process of preparing the Zhengyuan capsule dry paste powder, the preparation of each component is needed, the omission of substances is avoided, the back-and-forth movement is reduced, and the preparation efficiency of the Zhengyuan capsule dry paste powder is improved.

Further, the glossy privet fruit with wine is crushed to obtain glossy privet fruit with wine fine powder, ethanol is added for reflux extraction, and then the first concentration operation is carried out to obtain glossy privet fruit with wine extract. The method has the advantages that the glossy privet fruit is crushed into fine glossy privet fruit powder, so that the leaching of active ingredients is facilitated, the leaching rate of ethanol on the glossy privet fruit is high, the extraction of the active ingredients of the glossy privet fruit is facilitated, and the content of the active ingredients of the glossy privet fruit in the vital capsule dry extract powder is increased.

Further, mixing parched Atractylodis rhizoma and pericarpium Citri Tangerinae, adding pure water, decocting, and collecting volatile oil, first water extractive solution and first residue. The volatile oil in the fried bighead atractylodes rhizome and the dried orange peel is soluble in water and is volatile after heating, the volatile oil can be fully separated from the residual active ingredients of the fried bighead atractylodes rhizome and the dried orange peel through water decoction, and the volatile oil is volatile after heating, so that the volatile oil is separated and stored firstly, the loss problem of the volatile oil is avoided, and the content of the active ingredients of the fried bighead atractylodes rhizome and the dried orange peel in the vital essence capsule dry paste powder is improved.

Further, the volatile oil is subjected to inclusion operation by adopting hydroxypropyl beta-cyclodextrin to obtain the inclusion compound. It can be understood that the volatile oil is volatile when heated, even if the volatile oil is stored separately, the volatile oil still volatilizes in the high-temperature drying process, so that the volatile oil is subjected to inclusion operation by adopting hydroxypropyl beta-cyclodextrin to obtain an inclusion compound, the loss of the volatile oil in the high-temperature drying process is reduced, and the contents of the active ingredients of the fried bighead atractylodes rhizome and the dried orange peel in the vital essence capsule dry paste powder are increased. It can also be understood that the hydroxyl group of the hydroxypropyl beta-cyclodextrin and the volatile oil in the fried bighead atractylodes rhizome and the dried orange peel are easy to generate hydrogen bonds, and the inclusion rate and the stability of the volatile oil in the fried bighead atractylodes rhizome and the dried orange peel are improved.

Further, herba Epimedii, Ginseng radix, radix astragali and the first residue are mixed to obtain a mixture, followed by a decoction operation, followed by a second concentration operation to obtain a mixed extract. It can be understood that the first medicine residue also contains a large amount of active ingredients of the fried rhizoma atractylodis macrocephalae and the dried orange peel, so that the first medicine residue is continuously added into the epimedium, the ginseng and the astragalus root for extracting the active ingredients, and the content of the active ingredients in the vital essence capsule dry paste powder is improved.

Further, the wine glossy privet fruit extract, the mixed extract and the inclusion compound are mixed and then cut and crushed to obtain cut and crushed products. It can be understood that the alcohol glossy privet fruit extract and the mixed extract are sticky substances, the alcohol glossy privet fruit extract, the mixed extract and the inclusion compound are difficult to be uniformly mixed, the cutting and crushing operation is adopted to improve the mixing uniformity and the dispersion degree of the alcohol glossy privet fruit extract, the mixed extract and the inclusion compound, and further improve the quality of the vital essence capsule dry extract powder. It can also be understood that if the dispersion degree of the alcohol glossy privet fruit extract, the mixed extract and the inclusion compound is poor, the alcohol glossy privet fruit extract, the mixed extract and the inclusion compound are difficult to dry, and the condition of local drying or local wetting is formed, so that the problem of poor quality of the vital essence capsule dry extract powder is caused.

Further, the cut pulverized material is subjected to a low-temperature drying operation, and a primary grinding and pulverizing operation is performed to obtain a ground pulverized material. It can be understood that the low-temperature drying operation is carried out under the vacuum drying condition, the risk of damaging the effective components of the Chinese herbal medicine raw materials of the vital essence capsule is reduced, the volatilization of part of volatile oil which does not form inclusion compound is reduced, and the content of the effective components of the dry paste powder of the vital essence capsule is further improved. It can also be understood that the purpose of performing low-temperature drying operation before freeze drying is to reduce the moisture in the extract, mixed extract and inclusion compound of glossy privet fruit, and avoid the moisture from being cooled to shoulder height and being frozen at low temperature to form a block, so that the moisture in the block is difficult to volatilize, and the freeze drying efficiency is reduced.

Further, the ground and pulverized material is freeze-dried, and then subjected to secondary grinding and pulverization to obtain a vital essence capsule dry extract powder. It can be understood that the freeze drying is to directly volatilize the frozen ice into water vapor to remove under the vacuum condition, thereby reducing the risk that the effective components of the traditional Chinese medicine herb are easily damaged and avoiding the reduction problem of the volatile oil of the vital essence capsule dry extract powder.

In the preparation method of the vital essence capsule dry paste powder, the low-temperature drying operation, the primary grinding and crushing operation, the freeze drying operation and the secondary grinding and crushing operation are adopted, so that the risk of damaging the effective components of the traditional Chinese medicine herbs in the vital essence capsule dry paste powder is reduced under the condition of ensuring that the vital essence capsule dry paste powder has a good dispersion effect.

In one embodiment, after the glossy privet fruit is crushed, the glossy privet fruit fine powder is screened by a 24-mesh screen. It can be understood that the glossy privet fruit fine powder obtained by the screening operation of the 24-mesh screen is not easy to generate the condition of dust flying, and is easy to extract to obtain the effective components of the glossy privet fruit, so that the content of the effective components of the glossy privet fruit in the vital essence capsule dry extract powder is improved, and the preparation efficiency of the vital essence capsule dry extract powder is improved.

In one embodiment, the reflux extraction with ethanol comprises the following steps:

adding 10 times (ml/g) of 75% (volume concentration) ethanol into the fine powder of fructus Ligustri Lucidi, reflux extracting for 2 hr, and filtering to obtain first residue and first ethanol extractive solution. It can be understood that in the first reflux extraction, the content of the effective components in the glossy privet fruit fine powder is higher, the content of ethanol needs to be increased to leach the effective components in the glossy privet fruit fine powder, and the leaching time needs to be prolonged, so that 10 times (ml/g) of 75% (volume concentration) ethanol is added into the glossy privet fruit fine powder, the first reflux extraction is carried out for 2 hours, and the leaching efficiency of the effective components in the glossy privet fruit fine powder is improved.

Further, 8 times (ml/g) of 70% (volume concentration) ethanol was added to the primary residue, and the mixture was subjected to secondary reflux extraction for 1.5 hours, followed by secondary filtration to obtain secondary residue and a secondary ethanol extract. It can be understood that in the secondary reflux extraction, the content of the active ingredients in the glossy privet fruit fine powder is relatively low, but the content is still high, the content of ethanol needs to be increased to carry out the active ingredient leaching on the glossy privet fruit fine powder, but the leaching time can be properly reduced, so that 8 times (ml/g) of ethanol with the concentration of 70 percent (volume concentration) is added into the primary medicine residue, the secondary reflux extraction is carried out for 1.5 hours, and the leaching efficiency of the active ingredients of the glossy privet fruit fine powder is improved.

Further, 6 times (ml/g) of 85% (volume concentration) ethanol was added to the second residue, and the mixture was subjected to reflux extraction for three times for 0.5 hour, followed by filtration for three times to obtain the third residue and the third ethanol extract. It can be understood that, in the three times of reflux extraction, the content of the effective components in the glossy privet fruit fine powder is relatively less than that of the effective components in the glossy privet fruit fine powder, and the actual content is also less, so that the content of ethanol needs to be reduced, and the extraction time needs to be reduced, therefore, 6 times (ml/g) of ethanol with the concentration of 85% (volume concentration) is added into the secondary medicine residue, and the three times of reflux extraction is carried out for 0.5 hours, so that the extraction efficiency of the effective components in the glossy privet fruit fine powder is improved.

The first reflux extraction, the second reflux extraction and the third reflux extraction are arranged, so that the leaching efficiency of the effective components in the glossy privet fruit fine powder is improved. If only the first reflux extraction is carried out, or only the first reflux extraction and the second reflux extraction are carried out, the content of the effective components in the glossy privet fruit fine powder is reduced. It can be understood that, during the three-reflux extraction, the residual content of the active ingredients of the glossy privet fruit fine powder is very small, the concentration of the active ingredients of the glossy privet fruit fine powder in the secondary ethanol extraction solution is high, and the residual active ingredients of the glossy privet fruit fine powder are difficult to be continuously leached, so that three-time reflux extraction is needed, the concentration of the active ingredients of the glossy privet fruit fine powder in the three-time ethanol extraction solution is low, the leaching capacity of continuously leaching the residual active ingredients of the glossy privet fruit fine powder is realized, but after the extraction time is 0.5 hour, the content of the active ingredients of the glossy privet fruit fine powder in the three-time ethanol extraction solution is basically not changed, and therefore, the first reflux extraction.

In one embodiment, the first concentrating operation specifically comprises the following steps:

mixing the primary ethanol extract, the secondary ethanol extract and the tertiary ethanol extract to obtain a mixed ethanol extract.

Further, carrying out reduced pressure distillation and concentration operation on the mixed ethanol extract, and carrying out recovery operation on the volatilized ethanol to obtain the alcohol-treated fructus ligustri lucidi extract, wherein the relative density of the alcohol-treated fructus ligustri lucidi extract is 1.30-1.35 (measured at 50 ℃). It can be understood that the mixed ethanol extract contains a large amount of ethanol, the mixed ethanol extract needs to be subjected to reduced pressure distillation and concentration operation, on one hand, the water content in the alcohol glossy privet fruit extract is reduced, on the other hand, the impurity content of the Zhengyuan capsule dry extract powder is reduced for removing the ethanol, and when the relative density of the alcohol glossy privet fruit extract is 1.30-1.35 (measured at 50 ℃), the alcohol glossy privet fruit extract is favorably mixed with the mixture extract and the clathrate compound.

In one embodiment, in the inclusion operation, the inclusion operation is performed at a temperature of 50 to 60 degrees celsius. It can be understood that the inclusion operation of the volatile oil is carried out at the temperature of 50-60 ℃, so that the inclusion rate of the volatile oil is improved, and the content of effective components of the vital essence capsule dry paste powder is further improved.

In one embodiment, the time for the inclusion operation is 2.5 hours to 3.5 hours. It can be understood that the time of the inclusion operation is 2.5 hours to 3.5 hours, the inclusion rate of the volatile oil is improved, and the content of the effective components of the vital essence capsule dry extract powder is further improved.

In one embodiment, the decoction operation specifically comprises the steps of:

to the mixture was added 8 times (ml/g) the amount of pure water, boiled for 1 hour, and then subjected to a first filtration operation to obtain a second residue and a second aqueous extract. It can be understood that the content of each effective component in the mixture is high, the content of pure water needs to be increased for effective component leaching, and the leaching time needs to be prolonged, so that the leaching efficiency of the effective components is improved by adding 8 times (ml/g) of pure water to the mixture and boiling for 1 hour.

Further, 6 times (ml/g) of pure water was added to the second residue, and the mixture was decocted at 60 to 75 ℃ for 5 hours, followed by a second filtration operation to obtain a third residue and a third aqueous extract. It can be understood that in the secondary reflux extraction, the content of the active ingredients in the second herb residue is relatively low, but still high, and the content of the pure water needs to be increased for leaching the active ingredients, but the leaching time can be properly reduced, so that the leaching efficiency of the active ingredients is improved by adding 6 times (ml/g) of the pure water into the second herb residue and decocting the mixture for 5 hours at the temperature of between 60 and 75 ℃.

Further, 2 times (ml/g) of pure water was added to the third residue, and the mixture was decocted at 35 to 50 ℃ for 2 hours, followed by a third filtration operation to obtain a fourth residue and a fourth aqueous extract. It can be understood that the content of the effective components in the third herb residue is relatively low, the actual content is also low, so that the content of pure water needs to be reduced, and the extraction time needs to be reduced, so that 2 times (ml/g) of pure water is added into the third herb residue, and the third herb residue is decocted for 2 hours at the temperature of 35-50 ℃, so that the extraction efficiency of the effective components in the wine glossy privet fruit fine powder is improved.

It is noted that the extraction efficiency of the effective components of the mixture is improved by decocting the mixture for three times to extract the effective components. If only one or two times of decoction is carried out, the content of the effective components of the mixture is reduced. It can be understood that, during the third decoction extraction, the residual content of the effective components of the mixture is very small, and at the moment, the concentration of the effective components of the mixture in the three-water extracting solution is high, and the residual effective components of the mixture are difficult to be leached continuously, so that the three decoction extractions are needed, the concentration of the effective components of the mixture in the third decoction extraction is low, and the mixture has the capability of continuously leaching the effective components of the mixture, but after the extraction time is 5 hours, the content of the effective components of the mixture in the third decoction extraction solution is basically not changed, so that the three decoction extractions are arranged, and the leaching efficiency of the effective components of the mixture is favorably.

In one embodiment, the second concentration operation specifically comprises the following steps:

and mixing the first water extracting solution, the second water extracting solution and the third water extracting solution to obtain a mixed water extracting solution.

Further, carrying out reduced pressure distillation and concentration operation on the mixed water extract to obtain a mixture extract, wherein the relative density of the mixture extract is 1.04-1.08 (measured at 50 ℃). And (3) carrying out reduced pressure distillation and concentration operation on the mixed water extract, reducing the water content of the mixture extract, and when the relative density of the mixture extract is 1.04-1.08 (measured at 50 ℃), being beneficial to mixing the mixture extract with the alcohol glossy privet fruit extract and the inclusion compound.

In one embodiment, the low-temperature drying operation is carried out at the temperature of 35-50 ℃;

and the low-temperature drying operation is carried out in a closed environment. It will be appreciated that the low temperature drying operation is conducted in a closed environment to facilitate a reduction in the amount of volatile oils that are not included.

In one embodiment, the mass ratio of the volatile oil to the hydroxypropyl beta-cyclodextrin is 1: (7-9). It can be understood that the mass ratio of the volatile oil to the hydroxypropyl beta-cyclodextrin is 1: (7-9), the inclusion rate of the volatile oil is improved, and the content of effective components in the vital essence capsule dry paste powder is further improved.

In one embodiment, the water content of the vital capsules is 3% to 5%. It can be understood that when the water content of the vital essence capsule dry powder paste is 3% -5%, the vital essence capsule dry powder paste has relatively uniform particle size distribution, and the moisture absorption of the vital essence capsule dry powder paste is relatively poor.

Compared with the prior art, the application at least comprises the following advantages:

in the preparation method of the pharmaceutical composition, coating and drug loading are realized by adding the xylitol particles, the content of sugar in the pharmaceutical composition is reduced, and the application range of the prepared pharmaceutical composition is improved.

The following examples are given by way of illustration, and it is noted that the following examples are not intended to be exhaustive of all possible and that the materials used in the following examples are commercially available without specific recitation.