阅读说明：本技术 解毒生肌组合物、凝胶剂、该凝胶剂的制备方法以及应用 (Detoxifying and tissue regeneration promoting composition, gel, preparation method and application of gel ) 是由 周忠志 陈丽 于 2020-05-29 设计创作，主要内容包括：本发明提供一种解毒生肌组合物、凝胶剂、该凝胶剂的制备方法以及应用,所述组合物按质量份计,含有以下原料：蜈蚣10-20份、全蝎10-20份、乳香20-60份、没药20-60份、紫草20-60份、石灰华10-20份、冰片4-10份。本发明的解毒生肌组合物的配方中的石灰华呈碱性,本身具有解毒杀菌的作用,此外,其还具有很强的吸附性和渗透性,可将各有效成分吸附后渗透到肌理深处,从而增强治疗效果；本发明的解毒生肌组合物中不存在有毒物质,可从皮肤、粘膜、口腔、阴道、直肠等部位或腔道用药,易涂抹、不刺激,祛腐生肌、清热止痛,主要用于天疱疮、湿疹以及不同部位的溃疡等。(The invention provides a detoxifying and tissue regeneration promoting composition, a gel, a preparation method and an application of the gel, wherein the composition comprises the following raw materials in parts by mass: 10-20 parts of centipede, 10-20 parts of scorpion, 20-60 parts of frankincense, 20-60 parts of myrrh, 20-60 parts of lithospermum, 10-20 parts of travertine and 4-10 parts of borneol. The travertine is alkaline in the formula of the detoxifying and tissue regeneration promoting composition, has detoxifying and sterilizing effects, and has strong adsorbability and permeability, and can permeate all effective components to deep skin treatment after adsorption, so that the treatment effect is enhanced; the detoxifying and tissue regeneration promoting composition does not contain toxic substances, can be applied to skin, mucous membrane, oral cavity, vagina, rectum and other parts or cavities, is easy to apply and non-irritant, can remove slough and promote tissue regeneration, can clear away heat and relieve pain, and is mainly used for pemphigus, eczema, ulcers of different parts and the like.)

1. The composition for detoxifying and promoting tissue regeneration is characterized by comprising the following raw materials in parts by mass: 10-20 parts of centipede, 10-20 parts of scorpion, 20-60 parts of frankincense, 20-60 parts of myrrh, 20-60 parts of lithospermum, 10-20 parts of travertine and 4-10 parts of borneol.

2. The composition for removing toxicity and promoting tissue regeneration as claimed in claim 1, wherein the mass portions of the Chinese medicinal raw materials are: 12-18 parts of centipede, 13-18 parts of scorpion, 25-50 parts of frankincense, 28-55 parts of myrrh, 23-52 parts of lithospermum, 12-17 parts of travertine and 5-8 parts of borneol.

3. A gel prepared from the detoxifying and tissue regeneration promoting composition of claim 1 or 2 as a raw material.

4. A process for preparing the gel of claim 3, comprising the steps of:

1) extracting volatile oil of Olibanum and Myrrha

Mixing Olibanum granule and Myrrha granule, soaking in water, heating to boil until the oil amount of the collected volatile oil is not increased, stopping heating to obtain volatile oil, and filtering the extraction residue to obtain first filtrate and residue;

2) beta-cyclodextrin inclusion of frankincense, myrrh volatile oil and borneol

Dissolving the volatile oil obtained in the step 1) in absolute ethyl alcohol to obtain absolute ethyl alcohol solution of the volatile oil;

at the temperature of 55-60 ℃ and under the stirring condition, the beta-cyclodextrin is put into water to obtain a beta-cyclodextrin saturated solution;

dissolving Borneolum Syntheticum in anhydrous ethanol to obtain Borneolum Syntheticum anhydrous ethanol solution;

adding the volatile oil anhydrous ethanol solution and the borneol anhydrous ethanol solution into the beta-cyclodextrin saturated solution under the condition of stirring, dissolving, standing, filtering, washing filter residues, drying the filter residues and then crushing the filter residues into powder to obtain a beta-cyclodextrin inclusion compound;

3) decocting Scolopendra, Scorpio, Olibanum, and Myrrha in water

Mixing centipede, scorpion, lithospermum and the dregs obtained after the volatile oil extraction of the frankincense and the myrrh in the step 1), soaking in water, heating to boil for extraction, and filtering the extraction residues to obtain a second filtrate;

4) concentrating, drying and mixing the filtrate

Mixing the first filtrate obtained in the step 1) and the second filtrate obtained in the step 3), concentrating and drying to obtain dry paste, crushing the dry paste into powder, and mixing the powder with the travertine powder obtained by crushing travertine and the beta-cyclodextrin inclusion compound obtained in the step 2) to obtain mixed medicinal powder;

5) preparation of gel

Dissolving the mixed medicinal powder obtained in the step 4) in water to obtain a mixed medicinal powder solution;

dissolving carbomer in water, standing to make it fully swell to obtain carbomer solution;

dissolving polysorbate and glycerol in water at 55-60 deg.C under stirring, mixing with carbomer solution, and stirring to obtain gel matrix;

mixing the mixed medicinal powder solution with the gel matrix and ethylparaben under stirring.

5. The method for preparing the gel according to claim 4, wherein in the step 1), the amount of the soaking water is 8-10mL relative to 1g of the mixture of the frankincense particles and the myrrh particles, and the soaking time is 30-40 min.

6. The preparation method of the gel according to claim 4 or 5, wherein in the step 2), the amount of the absolute ethyl alcohol is 2-3mL relative to 1mL of the volatile oil;

the dosage of water is 38-45mL relative to 1g of the beta-cyclodextrin;

the dosage of the absolute ethyl alcohol is 2-3mL relative to 1g of the borneol;

the mass of the beta-cyclodextrin is 8-12g relative to 1mL of the volatile oil.

7. The preparation method of the gel according to any one of claims 4 to 6, wherein in the step 3), the amount of soaking water is 8 to 10mL, the soaking time is 30 to 40min, and the extraction times are 1 to 3 times, relative to 1g of the mixture of the centipede, the scorpion, the lithospermum and the dregs after the volatile oil extraction in the step 1).

8. The method for preparing the gel according to any one of claims 5 to 7, wherein in the step 5), the amount of water is 8 to 10mL relative to 1g of the mixed powder;

the mass concentration of the carbomer solution is 5-6%, the mass concentration of polysorbate in the polysorbate and glycerin solution is 8-12%, and the mass concentration of glycerin is 8-12%;

the content of the ethylparaben is 1-2% of the total mass of the mixed medicinal powder solution and the gel matrix;

the mass ratio of the carbomer to the polysorbate to the glycerin to the mixed medicinal powder is 1 (5-6) to (45-50).

9. The method for preparing the gel of any one of claims 5 to 8, wherein the method further comprises, in step 5), adjusting the pH to 6 to 8, preferably 7 to 7.5, after mixing the mixed powder solution with the gel matrix and ethylparaben.

10. A gel is used as ointment for removing toxic substance and promoting granulation.

Technical Field

The invention relates to a detoxifying and tissue regeneration promoting composition, in particular to a detoxifying and tissue regeneration promoting composition prepared by taking traditional Chinese medicines as raw materials, in particular to a detoxifying and tissue regeneration promoting composition in a gel dosage form, and also relates to a preparation method and application of the detoxifying and tissue regeneration promoting gel.

Background

At present, Western medicines for resisting bacteria and diminishing inflammation are generally adopted to treat surgical diseases such as sores, furuncles, carbuncles, gangrene and skin diseases, the curative effect is quick, but recurrence is possible, and repeated treatment of recurrence brings much pain to patients. The skin diseases are treated by western medicines, the effect is not ideal, and the repeated attack course is long. And the use of a large amount of antibiotics can increase the drug resistance of patients, so that the subsequent effect is worse and worse, and therefore, the nation does not advocate the use of a large amount of antibiotics.

In order to solve the above problems, CN1179744C discloses a plaster with the effects of relieving pain and itching, removing toxicity and promoting granulation, which is prepared from the following raw materials in parts by weight: 1000-2000 g of sesame oil, 500-1000 g of minium, 10-20 g of frankincense, 10-20 g of myrrh, 10-20 g of calomel, 10-20 g of camphor, 10-20 g of borneol and 1-2 g of musk. The traditional Chinese medicine has the effects of relieving itching and pain, activating blood and dissolving stasis, clearing heat, diminishing inflammation, detoxifying, removing necrotic tissue and promoting granulation, is short in treatment course and quick in effect, and can radically treat patients. CN107252450A discloses an external plaster with the functions of detoxification and tissue regeneration, which is prepared from the following raw materials: the Chinese medicinal composition is prepared from cinnamon, angelica dahurica, angelica, figwort root, red peony root, radix rehmanniae, raw rhubarb, ground beetle, cochinchina momordica seed, crinis carbonisatus, yellow lead, fried frankincense, fried myrrh, Chinese asafetida, light powder and sesame oil through medicament preparation, explosive oil decoction, oil refining, pellet addition and ointment formation, has the effects of relieving pain and itching, removing blood stasis, drawing out pus and removing putrefaction, and reducing swelling and promoting granulation, and has the advantages of low price, short curative effect and quick response. The two schemes adopt a traditional Chinese medicine formula to prepare the detoxifying and tissue regeneration promoting ointment, so that repeated relapse is avoided, however, in order to enhance the effect, calomel is used, the calomel mainly contains mercurous chloride, although the toxicity of the calomel is low, the calomel or metallic mercury which is highly toxic is not completely avoided in the preparation process, so that the use of the detoxifying and tissue regeneration promoting ointment is likely to cause mercury poisoning while treating diseases, and the use of the ointment is avoided for some symptoms such as oral ulcer and the like.

Disclosure of Invention

The invention provides a detoxifying and tissue regeneration promoting composition which can ensure good curative effect and has no toxic or side effect.

The invention also provides a gel which is prepared from the detoxifying and muscle-growing composition as a raw material, and has good curative effect and no toxic or side effect.

The third aspect of the invention aims to solve the problem of providing a preparation method of the gel, and the gel prepared by the method can ensure good curative effect and has no toxic or side effect.

The problem to be solved by the fourth aspect of the invention is to provide application of the gel.

In order to achieve the above purpose, one aspect of the present invention provides a composition for detoxifying and promoting tissue regeneration, which comprises the following raw materials by mass: 10-20 parts of centipede, 10-20 parts of scorpion, 20-60 parts of frankincense, 20-60 parts of myrrh, 20-60 parts of lithospermum, 10-20 parts of travertine and 4-10 parts of borneol.

Preferably, the traditional Chinese medicine comprises the following raw materials in parts by mass: 12-18 parts of centipede, 13-18 parts of scorpion, 25-50 parts of frankincense, 28-55 parts of myrrh, 23-52 parts of lithospermum, 12-17 parts of travertine and 5-8 parts of borneol.

The scorpion and centipede in the composition have the functions of promoting blood circulation, removing obstruction in channels, detoxifying, removing blood stasis, dispelling wind, relieving itching, removing putrefaction and promoting granulation. Ru Xiang has the actions of activating blood and qi, and relieving swelling and pain. Myrrha, dissipating blood stasis, alleviating pain, promoting the subsidence of swelling, and promoting granulation. Zi Cao clears heat and cools blood, detoxifies and activates blood. Shihua limes dry dampness and cure sore, stop bleeding and relieve pain. Borneol has the functions of clearing away heat and toxic material. The combined formula has the effects of removing putrefaction, promoting granulation, clearing heat and relieving pain.

The traditional Chinese medicine considers that the ulcer is mostly broken due to the loss of smoothness of local qi and blood and the loss of nourishment of the skin, and the meat is necrotic; or due to deficiency of qi and blood, weakness of blood circulation, accumulation of damp-heat in the lower part, and repeated affection of toxic factors. This disease is caused by the loss of nourishment locally and the loss of qi and blood. Through local external application, the medicine is effectively, widely and fully contacted with the sore surface, the action time is long, the medicine absorption is facilitated, the medicine property is mild, no irritation is caused, and adverse reactions are rarely caused. Has good clinical curative effect, quick response, low price and high cure rate.

In another aspect, the invention provides a gel, which is prepared from the detoxifying and tissue regeneration promoting composition as a raw material. The gel is a thick liquid or semisolid preparation which is prepared by mixing the medicament and auxiliary materials capable of forming gel and is uniform, suspension or emulsion, and has the characteristics of good solubility, attractive appearance (smooth appearance, thin, greasy and transparent), easy coating, no irritation, stable property, no compatibility change with main medicaments and the like.

In a third aspect, the present invention provides a method for preparing a gel, comprising the steps of:

1) extracting volatile oil of Olibanum and Myrrha

Mixing Olibanum granule and Myrrha granule, soaking in water, heating to boil until the amount of volatile oil is not increased, stopping heating to obtain volatile oil, and filtering the residue to obtain first filtrate and residue;

2) beta-cyclodextrin inclusion of frankincense, myrrh volatile oil and borneol

Dissolving the volatile oil obtained in the step 1) in absolute ethyl alcohol to obtain absolute ethyl alcohol solution of the volatile oil;

at the temperature of 55-60 ℃ and under the stirring condition, the beta-cyclodextrin is put into water to obtain a beta-cyclodextrin saturated solution;

dissolving Borneolum Syntheticum in anhydrous ethanol to obtain Borneolum Syntheticum anhydrous ethanol solution;

adding the volatile oil anhydrous ethanol solution and the borneol anhydrous ethanol solution into the beta-cyclodextrin saturated solution under the condition of stirring, dissolving, standing, filtering, washing filter residues, drying the filter residues and then crushing the filter residues into powder to obtain a beta-cyclodextrin inclusion compound;

3) decocting Scolopendra, Scorpio, Olibanum, and Myrrha in water

Mixing centipede, scorpion, lithospermum and the dregs of decoction obtained after the volatile oil extraction of the frankincense and the myrrh in the step 1), soaking in water, heating to boil for extraction, and filtering the extraction residues to obtain a second filtrate;

4) concentrating, drying and mixing the filtrate

Mixing the first filtrate obtained in the step 1) and the second filtrate obtained in the step 3), concentrating and drying to obtain dry paste, crushing the dry paste into powder, and mixing the powder with the travertine powder obtained by crushing travertine and the beta-cyclodextrin inclusion compound obtained in the step 2) to obtain mixed medicinal powder;

5) preparation of gel

Dissolving the mixed medicinal powder obtained in the step 4) in water to obtain a mixed medicinal powder solution;

dissolving carbomer in water, standing to make it fully swell to obtain carbomer solution;

dissolving polysorbate and glycerol in water at 55-60 deg.C under stirring, mixing with carbomer solution, and stirring to obtain gel matrix;

mixing the mixed medicinal powder solution with the gel matrix and ethylparaben under stirring.

In the step 1), the amount of the soaking water is only required to ensure that the mixture of the frankincense particles and the myrrh particles can be soaked. Preferably, in order to ensure a sufficient amount of water to extract as much as possible the effective components of Olibanum and Myrrha, the amount of soaking water is 8-10mL relative to 1g mixture of Olibanum and Myrrha particles. The longer the soaking time is, the more beneficial the full leaching of the medicinal components, preferably, the soaking time is 30-40min for the combined consideration of efficiency and cost. Wherein the diameters of the frankincense particle and the myrrh particle are generally 400-2000 μm.

In addition, in the step 1), the volatile oil is continuously heated during extraction to keep the liquid level in a slightly boiling state, so that continuous extraction is realized. The extraction of the volatile oil is generally carried out in a volatile oil extraction device known by persons skilled in the art, the heating is stopped after the volatile oil is collected by a measuring device until the scales do not rise any more, the extraction is completed, the amount of the volatile oil can be observed more intuitively by collecting the volatile oil by the measuring device, and the amount of the volatile oil is accurately determined not to increase any more, so that the extraction work is completed more quickly. The method for collecting the volatile oil by the tester can refer to the routine operation in the field.

Preferably, in the step 2), the dosage of the absolute ethyl alcohol is 2-3mL relative to 1mL of the volatile oil;

the dosage of water is 38-45mL relative to 1g of the beta-cyclodextrin;

the dosage of the absolute ethyl alcohol is 2-3mL relative to 1g of the borneol;

the mass of the beta-cyclodextrin is 8-12g relative to 1mL of the volatile oil.

In the step 2), the frankincense, myrrh volatile oil and borneol are included by beta-cyclodextrin, so that the volatile oil and the borneol can be powdered, and the effective components can be prevented from volatilizing.

In addition, in the step 2), the borneol absolute ethanol solution and the volatile oil absolute ethanol solution are added into the beta-cyclodextrin saturated solution to be dissolved and stirred uniformly, and then are preferably placed in an environment with the temperature of 4-5 ℃ for standing for 24-30h for a sufficient time to facilitate the subsequent filtering work. Among them, the filtration method is known to those skilled in the art, and for example, reduced pressure filtration can be used, which accelerates the filtration and makes the precipitate dry by suction. The washing method after filtering can be respectively washing the filter residue with water and petroleum ether, and washing the hydrophilic component and the lipophilic component. The drying method and drying conditions after washing can refer to the conventional method in the field, and preferably, the filter residue is dried in vacuum at 45-50 ℃ for 4-5h, and the vacuum drying is carried out at the preferable temperature, so that the denaturation of heat-sensitive components in the filter residue can be effectively prevented.

In the step 3), the amount of the soaking water is only required to ensure that the mixture of the centipede, the scorpion, the lithospermum and the dregs after the volatile oil is extracted in the step 1) can be immersed. Preferably, in order to ensure that a sufficient amount of water is used to extract the active ingredients in the centipede, the scorpion, the lithospermum and the decoction dregs after the volatile oil extraction of the frankincense and the myrrh in the step 1) as much as possible, the dosage of the soaking water is 8-10mL relative to 1g of the mixture of the centipede, the scorpion, the lithospermum and the decoction dregs after the volatile oil extraction in the step 1). The longer the soaking time, the more beneficial the full leaching of the medicinal components, preferably, the soaking time is 30-40min for the comprehensive consideration of efficiency and cost. The extraction times can be 1-3 times. In the step, each extraction time is 40-45min for sufficiently extracting the effective components of the medicine. The extraction frequency is preferably 2 times or more, and effective components in Scolopendra, Scorpio, Olibanum, and Myrrha can be extracted sufficiently to reduce waste. The water addition amount can be properly reduced when the extraction is carried out for 2 times or more, for example, the water with the volume about 6 times of the original total weight of the centipede, the scorpion, the lithospermum, the frankincense and the myrrh is added into the medicine residue obtained after the filtration.

Preferably, in step 5), the amount of the dissolving water is enough to ensure that the mixed medicinal powder can be completely dissolved. Preferably, in order to ensure a sufficient amount of water to sufficiently mix the mixed powder with other components, the amount of water is preferably 8 to 10mL per 1g of the mixed powder.

The mass concentration of the carbomer solution is generally 5-6%, the mass concentration of polysorbate and glycerin solution is generally 8-12%, and the mass concentration of glycerin is generally 8-12%.

Preferably, the content of the ethylparaben is 1-2% of the total mass of the mixed medicinal powder solution and the gel matrix.

Preferably, the mass ratio of the carbomer to the polysorbate to the glycerin to the mixed medicinal powder is 1 (5-6) to (45-50).

In the preferred scheme, ethylparaben is used as a bacteriostatic preservative, so that the shelf life of the gel can be effectively prolonged.

In addition, in the step 5), the carbomer is dissolved in the distilled water and then stands for 48 to 60 hours, so that the carbomer can be fully swelled.

In step 5), the method further comprises: mixing the mixed medicinal powder solution with the gel matrix and ethylparaben, and adjusting pH to 6-8, preferably 7-7.5. In the preferred scheme, the detoxification granulation-promoting gel is best formed by adjusting the pH value to 7-7.5, and the skin irritation is minimal. Among them, the method of adjusting the pH is well known to those skilled in the art, and for example, the adjustment can be carried out using an inorganic base such as an aqueous solution of sodium hydroxide. More preferably, the concentration of the NaOH aqueous solution is 10 mol/L.

The fourth aspect of the invention provides an application of the gel as an ointment for detoxifying and promoting tissue regeneration. Can be used for treating pemphigus, eczema, pressure sore, ulcer of different parts, etc. The application method comprises changing the medicine once every day with 2 weeks as 1 treatment course.

Through the technical scheme, the invention has the following beneficial effects:

1. the travertine is alkaline in the formula of the detoxifying and tissue regeneration promoting composition, has detoxifying and sterilizing effects, and has strong adsorbability and permeability, and can absorb all effective components and permeate into deep texture, so that the treatment effect is enhanced.

2. The detoxifying and tissue regeneration promoting composition does not contain toxic substances, can be applied to skin, mucosa, oral cavity, vagina, rectum and other parts or cavities, is easy to apply and non-irritant, can remove slough and promote tissue regeneration, can clear heat and relieve pain, and is mainly used for pemphigus, eczema, ulcers of different parts and the like.

3. The traditional Chinese medicine is a traditional Chinese medicine formula, has a good treatment effect, greatly reduces the use of antibiotics, and accords with the drug use trend advocated by the state.

Detailed Description

The following examples are provided to explain the present invention in detail. It should be understood that the detailed description and specific examples, while indicating the present invention, are given by way of illustration and explanation only, not limitation.