CN114832065B - Traditional Chinese medicine composition and preparation for treating acne and preparation method thereof - Google Patents

Traditional Chinese medicine composition and preparation for treating acne and preparation method thereof Download PDF

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CN114832065B
CN114832065B CN202210579555.0A CN202210579555A CN114832065B CN 114832065 B CN114832065 B CN 114832065B CN 202210579555 A CN202210579555 A CN 202210579555A CN 114832065 B CN114832065 B CN 114832065B
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CN114832065A (en
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陈程
廉婷
刘瑞
兰凯
闫梦茹
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Xian Medical University
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Abstract

The invention discloses a traditional Chinese medicine composition for treating acne, a preparation and a preparation method thereof, belonging to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition comprises the following raw materials: 15.12 to 19.77 percent of red sage root, 15.12 to 19.77 percent of coptis root, 6.98 to 11.63 percent of dahurian angelica root, 6.98 to 11.63 percent of Japanese ampelopsis root, 11.63 to 16.28 percent of common bletilla tuber, 9.30 to 13.95 percent of astragalus root, 4.65 to 9.30 percent of Mongolian snakegourd root, 4.65 to 9.30 percent of dandelion and 4.65 to 9.30 percent of honeysuckle flower, wherein the sum of the mass percentages of the components is 100 percent. The external gel prepared by the invention has good treatment effect on acne, promotes skin injury symptom relief and facial skin rehabilitation, avoids the problem of irritation of chemical drugs to skin and drug resistance caused by long-term use, and has high patient compliance.

Description

Traditional Chinese medicine composition and preparation for treating acne and preparation method thereof
Technical Field
The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating acne, a preparation and a preparation method thereof.
Background
Acne is a chronic inflammatory skin disease of pilosebaceous glands, commonly called acne and comedo, and the face is the main disease part. About 80% of people in puberty suffer from acne with different degrees, serious people suffer from scar formation to influence the appearance of the patients, even more people have serious influence on the mind and social activities of teenagers, and the incidence rate of acne of middle-aged men and women is increased due to factors such as eating habits, life pressures and the like.
Modern medicine holds that the cause of acne is related to genetic factors, increased secretion of androgens, microbial infection of propionibacterium acnes, abnormal keratinization and inflammation of the pilosebaceous ducts, immune disorder and the like. At present, the treatment scheme mainly adopts oral administration and local administration, wherein the external treatment medicaments comprise tretinoin medicaments, benzoyl peroxide, antibacterial medicaments and the like, and external azelaic acid, dapsone and the like are also recommended in guidelines. Although the skin injury of the patient is obviously reduced by adopting the treatment scheme, the problems of skin irritation, drug resistance, easy recurrence after drug withdrawal, low compliance of the patient and the like exist. Therefore, the acne becomes a common disease affecting the life quality and physical and mental health of people in the current society, and the research on the effective treatment method of the acne has important scientific significance and social value.
The traditional Chinese medicine has clear external treatment characteristics on treating acne, and the natural components of the traditional Chinese medicine source have the double advantages of efficacy and safety, so that the combination of the dialectical advantages of traditional Chinese medicine on acne and the multi-target characteristics of traditional Chinese medicine has important clinical value and social significance. In addition, the traditional Chinese medicine is adopted to treat acne internally and externally, wherein external treatment plays a vital role in acne treatment, and the traditional Chinese medicine mask, lotion and fumigation treatment means all achieve satisfactory clinical effects, but have the defects of low drug loading, unstable drug release, poor patient compliance and the like.
The hydrogel has good biocompatibility, biodegradability and water-retaining property, can keep a highly moist environment of a wound and further promote self-absorption of necrotic tissues, has a special three-dimensional grid space in a structural formula, has the advantages of water, oxygen, metabolite permeation and the like, and has been applied to biomedical applications. The materials for preparing the hydrogel at present are mainly synthetic polymers and natural polymers. The polysaccharide is used as natural active polymer, has important function in preparation and application of hydrogel due to good compatibility and abundant sources, and has definite pharmacological activity, such as traditional Chinese medicine polysaccharide hydrogel. Therefore, the active development of the traditional Chinese medicine hydrogel agent for treating acne has important social significance and clinical application prospect.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for treating acne, a preparation and a preparation method thereof, which are used for solving the problems existing in the prior art and realizing effective treatment of acne.
In order to achieve the above object, the present invention provides the following solutions:
the invention aims at providing a traditional Chinese medicine composition for treating acne, which comprises the following traditional Chinese medicine components in percentage by mass:
15.12 to 19.77 percent of red sage root, 15.12 to 19.77 percent of coptis root, 6.98 to 11.63 percent of dahurian angelica root, 6.98 to 11.63 percent of Japanese ampelopsis root, 11.63 to 16.28 percent of common bletilla tuber, 9.30 to 13.95 percent of astragalus root, 4.65 to 9.30 percent of Mongolian snakegourd root, 4.65 to 9.30 percent of dandelion and 4.65 to 9.30 percent of honeysuckle flower, wherein the sum of the mass percentages of the components is 100 percent.
Further, the red sage root is wine-processed red sage root.
The second purpose of the invention is to provide a traditional Chinese medicine preparation for treating acne, which contains the traditional Chinese medicine composition.
The invention also aims to provide a traditional Chinese medicine gel for treating acne, which contains the traditional Chinese medicine composition.
The fourth purpose of the invention is to provide a preparation method of the traditional Chinese medicine gel, which comprises the following steps:
(1) Soaking radix Salviae Miltiorrhizae, rhizoma Coptidis, radix Angelicae Dahuricae, radix Ampelopsis, herba Taraxaci, and flos Lonicerae in ethanol according to mass ratio, reflux-extracting, and removing ethanol to obtain material I;
(2) Soaking rhizoma bletilla, radix astragali and radix trichosanthis in water according to the mass ratio, performing reflux extraction, concentrating, adding ethanol, and standing;
(3) Centrifuging the system in the step (2) to obtain supernatant and precipitate, and drying the precipitate to obtain a material II; the drying mode is spray drying; spray drying parameters conditions: the temperature of the air inlet is 160-170 ℃, the sample injection speed is 8-10 r/min, and the atomization pressure is 0.25-0.35 Mpa.
(4) Mixing the supernatant obtained in the step (3) with the material I, and concentrating to obtain medicinal material extract, wherein the medicinal material extract is material III.
(5) Weighing the following substances in percentage by mass: 5 to 7 percent of humectant, 0.095 to 0.16 percent of preservative, 0.5 to 2.5 percent of antioxidant, 16.77 to 24.36 percent of material III, 1.2 to 1.8 percent of material II, 0.15 to 0.35 percent of carbomer 941, and the balance of purified water, wherein the sum of the mass percentages of the components is 100 percent;
(6) Preparing the material II into an aqueous solution according to the mass ratio in the step (5), then adding carbomer 941, heating and standing; then adding a humectant, a preservative and an antioxidant, stirring, and adjusting the pH value to 8.2-8.6 to obtain a material IV;
(7) Dissolving the material III weighed in the step (5) by using 95% ethanol in an ultrasonic manner to obtain a material V;
(8) And mixing and stirring the material V and the material IV to obtain the traditional Chinese medicine composition gel.
Further, in the step (1), the reflux extraction temperature is 65-75 ℃, and the vacuum degree of the reflux extraction is-0.06-0.07 MPa.
Further, the concentration of the concentrated solution in the step (2) is 0.4-0.6 g/mL. In the step (2), the reflux extraction temperature is 70-80 ℃, and the vacuum degree of the reflux extraction is-0.07-0.09 MPa.
Further, the water content of the medicinal material extract in the step (4) is 16-18%.
Further, the humectant is a mixture of 1, 2-propylene glycol and polyethylene glycol 400 in a mass ratio of 5:1; the antioxidant is a mixture of vitamin C and anhydrous sodium sulfite in a mass ratio of 3:1; the preservative is a mixture of ethyl hydroxybenzoate and propyl hydroxybenzoate in a mass ratio of 1:1.
Further, in the step (7), the volume ratio of the material III to the 95% ethanol is 4:1.
Polysaccharide in rhizoma Bletillae, radix astragali and radix Trichosanthis is used as gel main matrix.
The Chinese medicinal polysaccharide has various biological activities such as reducing blood sugar, resisting oxidation, resisting virus, resisting bacteria, resisting inflammation, resisting aging and the like, and has the characteristics of auxiliary materials such as water retention property, biocompatibility, biodegradability and the like, and has good application prospect in the research of a drug release system. The bletilla striata polysaccharide is water-soluble high molecular polysaccharide extracted from traditional Chinese medicine bletilla striata, has a complex chemical structure, is prepared by polymerizing 4 molecules of mannose and 1 molecule of glucose, has a relative molecular weight of 400kDa, is white powder, is insoluble in cold water, and is soluble in hot water. The bletilla striata polysaccharide has pharmacological activities such as antioxidation, antibiosis, anti-inflammation, anti-fibrosis, hemostasis, tissue repair and the like, has no antigenicity and pyrogenicity, can be well compatible with organism tissues, is slowly degraded and absorbed by organisms, has the characteristics of slow function release, local detention, targeting, self degradation, high biological safety, no toxicity, no stimulation and the like, and has been widely used as a novel biomedical polymer carrier material, such as hydrophilic gel, wound dressing microspheres, gastric detention preparations, embolic agents and the like. Polysaccharide in radix astragali and radix Trichosanthis has good bioactivity and biocompatibility; the astragalus polysaccharide has the function of reducing blood sugar, and has the antibacterial effect on staphylococcus aureus, salmonella and the like through the regulation of the immune defense function of the organism; the radix Trichosanthis polysaccharide has effects of regulating immunity, reducing blood sugar, and resisting bacteria.
The Chinese medicine believes that there are acne and comedo in the book of interior meridian (Cold book, yu Naicuo). Jindai, "rear elbow" records "annual Qi-filled, face-growing and sore". In the "disease sources and treatises": the "sore on the face" means sore on the face caused by wind-heat and the like with big head, such as big valley and white face ". The records of acne appear in Huangdi Nei Jing-Sun-Mi and Sheng Ji Zong Lu. From the "Huangdi Nei Jing" the understanding of the pathogenesis of acne is gradually clear and unified. The sweat is seen as dampness, which is the mixed of acnes, dampness and cold, and is the original knowledge and theoretical source of the ancient medical science on the pathogenesis of acnes, and the sweat is accumulated dampness, the dampness evil is accumulated on the muscular surface, the pores and body surface venation are blocked, and the fat congeals evil and gathers to develop acnes. In the surgical Xuan (surgical open and Xuan), the description of "the lung is affected by wind-heat" and stasis is not dispersed to form acne, and modern doctors clinically take the syndrome of wind-heat in lung channel, syndrome of stasis-heat in spleen and stomach and accumulation of phlegm-stasis as the basic syndrome of acne and apply theoretical treatment. The topical herbs mainly have the actions of clearing heat and purging fire, cooling blood and removing toxicity, dispersing pathogenic qi, resolving masses and relieving swelling. Therefore, the invention provides the treatment principle of 'strengthening body resistance and removing necrotic tissue and promoting tissue regeneration' for the external treatment of acne, namely clearing heat and removing toxicity, activating blood and dissolving stasis and expelling toxin; has effects of invigorating qi, resolving hard mass, dredging collaterals and promoting granulation.
The invention discloses the following technical effects:
the invention provides a traditional Chinese medicine composition for treating acne, which solves the side effects of drug resistance reaction, irritation, endocrine disturbance and the like in western medicine treatment, takes 'body resistance strengthening, toxin binding, decay removing and tissue regeneration' as a formula principle, and provides antipyretic, toxin clearing, blood circulation activating, blood stasis removing and toxin expelling for dialectical recognition of the pathogenesis of acne in traditional Chinese medicine; the prescription is reasonable and effective according to the targeted therapeutic principle of tonifying qi, resolving hard mass, dredging collaterals and promoting granulation. On the other hand, by analyzing the basis of drug effect substances, polysaccharide components in the bletilla striata, the astragalus mongholicus and the radix trichosanthis in the composition play a role of 'drug auxiliary source', which is different from the traditional synthetic polymer hydrogel, further increases the drug loading capacity of the preparation and has no influence on formability.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are needed in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
Fig. 1 is a graph comparing Liu Mou treatment before and after treatment in typical case 1; wherein A is before treatment and B is after treatment;
fig. 2 is a graph comparing Liu Mou treatment before and after treatment in typical case 2; wherein A, B is before treatment and C, D is after treatment.
Detailed Description
Various exemplary embodiments of the invention will now be described in detail, which should not be considered as limiting the invention, but rather as more detailed descriptions of certain aspects, features and embodiments of the invention.
It is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. In addition, for numerical ranges in this disclosure, it is understood that each intermediate value between the upper and lower limits of the ranges is also specifically disclosed. Every smaller range between any stated value or stated range, and any other stated value or intermediate value within the stated range, is also encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range.
Unless otherwise defined, 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. Although only preferred methods and materials are described herein, any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention. All documents mentioned in this specification are incorporated by reference for the purpose of disclosing and describing the methods and/or materials associated with the documents. In case of conflict with any incorporated document, the present specification will control.
It will be apparent to those skilled in the art that various modifications and variations can be made in the specific embodiments of the invention described herein without departing from the scope or spirit of the invention. Other embodiments will be apparent to those skilled in the art from consideration of the specification of the present invention. The specification and examples are exemplary only.
As used herein, the terms "comprising," "including," "having," "containing," and the like are intended to be inclusive and mean an inclusion, but not limited to.
The traditional Chinese medicine composition gel for treating acne comprises the following traditional Chinese medicine components in percentage by mass:
15.12 to 19.77 percent of red sage root, 15.12 to 19.77 percent of coptis root, 6.98 to 11.63 percent of dahurian angelica root, 6.98 to 11.63 percent of Japanese ampelopsis root, 11.63 to 16.28 percent of common bletilla tuber, 9.30 to 13.95 percent of astragalus root, 4.65 to 9.30 percent of Mongolian snakegourd root, 4.65 to 9.30 percent of dandelion and 4.65 to 9.30 percent of honeysuckle flower, wherein the sum of the mass percentages of the components is 100 percent.
The preparation method comprises the following steps:
(1) Pulverizing Saviae Miltiorrhizae radix, coptidis rhizoma, radix Angelicae Dahuricae, radix Ampelopsis, herba Taraxaci and flos Lonicerae decoction pieces according to mass ratio into coarse powder, sieving with No. 1 sieve, mixing, adding 10-14 times of 65-75% ethanol, soaking for 20min, reflux-extracting under reduced pressure at low temperature for 3 times, 45min each time, extracting at 65-75deg.C under vacuum degree of-0.06-0.07 MPa, mixing the 3 times extractive solutions, recovering ethanol under reduced pressure until odorless, refrigerating, and recording as material I.
(2) Pulverizing rhizoma Bletillae, radix astragali and radix Trichosanthis decoction pieces into coarse powder according to mass ratio, sieving with No. 1 sieve, mixing uniformly, adding 12-16 times of purified water, soaking for 30min, reflux-extracting under reduced pressure and low temperature for 3 times, each time for 60min, extracting at 70-80deg.C and vacuum degree-0.07-0.09 MPa, mixing 3 times of extractive solutions, concentrating under 70-80deg.C and vacuum degree-0.07-0.09 MPa to mass concentration of 0.4-0.6 g/mL, placing in a stirrer, controlling rotation speed to 40-50 r/min, adding 95% ethanol according to volume ratio of 4-6:1, controlling flow rate to 200-300 mL/min, and standing at low temperature (-4deg.C) for 12 hr for use.
(3) Centrifuging the system obtained in the step (2) for 8-12 min at 3500-4000 r/min, collecting supernatant and precipitate respectively, adding purified water into the precipitate until the crude drug content is 0.2-0.4 g/mL, and performing spray drying under the condition of spray drying parameters: the temperature of the air inlet is 160-170 ℃, the sample injection speed is 8-10 r/min, the atomization pressure is 0.25-0.35 Mpa, and the polysaccharide powder is obtained and is marked as a material II.
(4) And (3) combining the supernatant in the step (3) with the material I, concentrating under reduced pressure to obtain medicinal material extract with the water content of 16-18%, and recording as a material III for later use.
(5) Weighing 5-7% of humectant, 0.095-0.16% of preservative, 0.5-2.5% of antioxidant according to mass percentage, obtaining 16.77-24.36% of material III medicinal material extract in step (4), obtaining 1.2-1.8% of material II polysaccharide powder in step (3), 0.15-0.35% of carbomer 941 and the balance of purified water.
Wherein the humectant is a mixture of 1, 2-propylene glycol and polyethylene glycol 400 in a mass ratio of 5:1; the antioxidant is a mixture of vitamin C and anhydrous sodium sulfite in a mass ratio of 3:1, and the preservative is a mixture of ethyl hydroxybenzoate and propyl hydroxybenzoate in a mass ratio of 1:1.
(6) Placing the material II polysaccharide powder weighed in the step (5) into a stirrer, and adding purified water to prepare a polysaccharide water solution with the concentration of 2%; adding carbomer 941 in the step (5) into the polysaccharide water solution, heating to 65-70 ℃ and continuously standing for 3 hours, adding the humectant, the preservative and the antioxidant weighed in the step (5), keeping the stirring speed at 35-45 r/min, stirring for 10-15 min, adjusting the pH value to 8.2-8.6, and recording as a material IV for standby.
(7) And (3) adding the material III medicinal material extract weighed in the step (5) into 95% ethanol according to the volume ratio of 4:1, and ultrasonically dissolving to obtain a material V for later use.
(8) Adding the material V into the material IV, stirring at 25-35 r/min for 30min and at 35-45 ℃ to obtain the gel of the traditional Chinese medicine composition for treating acne, and storing in shade.
The present invention will be described in further detail with reference to examples.
The red sage root used in the embodiment of the invention is wine-processed red sage root.
Example 1
A traditional Chinese medicine composition gel for treating acne comprises the following traditional Chinese medicine components in percentage by mass:
15.12% of red sage root, 15.12% of coptis root, 11.63% of dahurian angelica root, 11.63% of Japanese ampelopsis root, 16.28% of bletilla striata, 13.95% of astragalus root, 6.6% of radix trichosanthis, 4.97% of dandelion and 4.7% of honeysuckle flower.
The preparation method comprises the following steps:
(1) Pulverizing Saviae Miltiorrhizae radix, coptidis rhizoma, radix Angelicae Dahuricae, radix Ampelopsis, herba Taraxaci and flos Lonicerae decoction pieces according to mass ratio into coarse powder, sieving with No. 1 sieve, mixing, adding 10 times of 75% ethanol, soaking for 20min, reflux-extracting under reduced pressure and low temperature for 3 times at each time for 45min at 70deg.C under vacuum degree of 0.07MPa, mixing the 3 times extractive solutions, recovering ethanol under reduced pressure until odorless, refrigerating, and recording as material I.
(2) Pulverizing rhizoma Bletillae, radix astragali and radix Trichosanthis decoction pieces into coarse powder according to mass ratio, sieving with No. 1 sieve, mixing, adding 12 times of purified water, soaking for 30min, reflux extracting under reduced pressure and low temperature for 3 times at 60min each time, extracting at 75deg.C and vacuum degree of 0.09MPa, mixing the 3 times of extractive solutions, concentrating to mass concentration of 0.5g/mL under 80 deg.C and vacuum degree of-0.07 MPa, placing in a stirrer, controlling rotation speed at 40r/min, adding 95% grain alcohol according to volume ratio of 4:1, controlling flow rate at 200mL/min, standing at-4deg.C for 12 hr, and standing for use.
(3) Centrifuging the system obtained in the step (2) for 8min at 3500r/min, collecting supernatant and precipitate respectively, adding purified water into the precipitate to reach crude drug content of 0.4g/mL, and spray drying under spray drying parameter conditions: the temperature of the air inlet is 165 ℃, the sample injection speed is 8r/min, the atomization pressure is 0.35Mpa, and the polysaccharide powder is obtained and is marked as a material II.
(4) And (3) combining the supernatant in the step (3) with the material I, concentrating under reduced pressure to obtain a medicinal material extract with the water content of 17%, and recording the medicinal material extract as a material III for later use.
(5) Weighing 5% of humectant, 0.095% of preservative and 0.5% of antioxidant according to mass percentage, obtaining 16.77% of material III medicinal extract in the step (4), obtaining 1.2% of material II polysaccharide powder in the step (3), 940.15% of carbomer and the balance of purified water.
Wherein the humectant is a mixture of 1, 2-propylene glycol and polyethylene glycol 400 in a mass ratio of 5:1; the antioxidant is a mixture of vitamin C and anhydrous sodium sulfite in a mass ratio of 3:1, and the preservative is a mixture of ethyl hydroxybenzoate and propyl hydroxybenzoate in a mass ratio of 1:1.
(6) Placing the material II polysaccharide powder weighed in the step (5) into a stirrer, and adding purified water to prepare a polysaccharide water solution with the concentration of 2%; adding carbomer 941 in the step (5) into the polysaccharide water solution, heating to 65 ℃ and continuously standing for 3 hours, adding the humectant, the preservative and the antioxidant weighed in the step (5), keeping the stirring speed at 35r/min, stirring for 10min, adjusting the pH value to 8.2, and recording as a material IV for standby.
(7) Adding 95% ethanol into the material III medicinal material extract weighed in the step (5) according to the volume ratio of 4:1, ultrasonically dissolving, and marking as a material V for later use.
(8) Adding the material V into the material IV, stirring at 25r/min for 30min at 35 deg.C to obtain gel of the Chinese medicinal composition for treating acne, and storing in shade.
Example 2
A traditional Chinese medicine composition gel for treating acne comprises the following traditional Chinese medicine components in percentage by mass:
15.44% of red sage root, 15.46% of coptis root, 11.31% of dahurian angelica root, 11.63% of Japanese ampelopsis root, 15.94% of bletilla striata, 11.84% of astragalus root, 8.71% of radix trichosanthis, 5.02% of dandelion and 4.65% of honeysuckle flower.
The preparation method comprises the following steps:
(1) Pulverizing Saviae Miltiorrhizae radix, coptidis rhizoma, radix Angelicae Dahuricae, radix Ampelopsis, herba Taraxaci and flos Lonicerae decoction pieces according to mass ratio into coarse powder, sieving with No. 1 sieve, mixing, adding 14 times of 65% ethanol, soaking for 20min, reflux-extracting under reduced pressure and low temperature for 3 times at each time for 45min at 72 deg.C and vacuum degree of-0.06 MPa, mixing the 3 times extractive solutions, recovering ethanol under reduced pressure until odorless, refrigerating, and recording as material I.
(2) Pulverizing rhizoma Bletillae, radix astragali and radix Trichosanthis decoction pieces into coarse powder according to mass ratio, sieving with No. 1 sieve, mixing, adding 14 times of purified water, soaking for 30min, reflux extracting under reduced pressure and low temperature for 3 times at 60min each time, extracting at 70deg.C under vacuum degree-0.07 MPa, mixing 3 times of extractive solutions, concentrating at 70deg.C under vacuum degree 0.09MPa to mass concentration of 0.4g/mL, placing in a stirrer, controlling rotation speed of 50r/min, adding 95% grain alcohol according to volume ratio of 5:1, controlling flow rate at 300mL/min, standing at-4deg.C for 12 hr, and standing for use.
(3) Centrifuging the system obtained in the step (2) for 10min at 4000r/min, collecting supernatant and precipitate respectively, adding purified water into the precipitate to reach crude drug content of 0.2g/mL, and spray drying under the condition of spray drying parameters: the temperature of the air inlet is 160 ℃, the sampling speed is 9r/min, the atomization pressure is 0.25Mpa, and the polysaccharide powder is obtained and is marked as a material II.
(4) And (3) combining the supernatant in the step (3) with the material I, concentrating under reduced pressure to obtain a medicinal material extract with the water content of 16%, and recording the medicinal material extract as a material III for later use.
(5) Weighing 6% of humectant, 0.16% of preservative and 2.5% of antioxidant according to mass percentage, obtaining 24.36% of material III medicinal material extract in the step (4), obtaining 1.8% of material II polysaccharide powder in the step (3), 941.35% of carbomer and the balance of purified water.
Wherein the humectant is a mixture of 1, 2-propylene glycol and polyethylene glycol 400 in a mass ratio of 5:1; the antioxidant is a mixture of vitamin C and anhydrous sodium sulfite in a mass ratio of 3:1, and the preservative is a mixture of ethyl hydroxybenzoate and propyl hydroxybenzoate in a mass ratio of 1:1.
(6) Placing the material II polysaccharide powder weighed in the step (5) into a stirrer, and adding purified water to prepare a polysaccharide water solution with the concentration of 2%; adding carbomer 941 in the step (5) into the polysaccharide water solution, heating to 70 ℃ and continuously standing for 3 hours, adding the humectant, the preservative and the antioxidant weighed in the step (5), keeping the stirring speed at 45r/min, stirring for 12min, adjusting the pH value to 8.6, and recording as a material IV for standby.
(7) Adding 95% ethanol into the material III medicinal material extract weighed in the step (5) according to the volume ratio of 4:1, ultrasonically dissolving, and marking as a material V for later use.
(8) Adding the material V into the material IV, stirring at 35r/min for 30min at 45 deg.C to obtain gel of the Chinese medicinal composition for treating acne, and storing in shade.
Example 3
A traditional Chinese medicine composition gel for treating acne comprises the following traditional Chinese medicine components in percentage by mass:
19.53% of red sage root, 15.57% of coptis root, 11.2% of dahurian angelica root, 7.51% of Japanese ampelopsis root, 13.83% of bletilla striata, 10.83% of astragalus root, 7.69% of radix trichosanthis, 6.07% of dandelion and 7.77% of honeysuckle flower.
The preparation method comprises the following steps:
(1) Pulverizing Saviae Miltiorrhizae radix, coptidis rhizoma, radix Angelicae Dahuricae, radix Ampelopsis, herba Taraxaci and flos Lonicerae decoction pieces according to mass ratio into coarse powder, sieving with No. 1 sieve, mixing, adding 12 times of 70% ethanol, soaking for 20min, reflux-extracting under reduced pressure and low temperature for 3 times at 45min each time at 65deg.C under vacuum degree of 0.02MPa, mixing the 3 times extractive solutions, recovering ethanol under reduced pressure until odorless, refrigerating, and recording as material I.
(2) Pulverizing rhizoma Bletillae, radix astragali and radix Trichosanthis decoction pieces into coarse powder according to mass ratio, sieving with No. 1 sieve, mixing, adding 16 times of purified water, soaking for 30min, reflux extracting under reduced pressure and low temperature for 3 times at 60min each time, extracting temperature of 80deg.C and vacuum degree of 0.02MPa, mixing 3 times of extractive solutions, concentrating at 75deg.C and vacuum degree of 0.04MPa to mass concentration of 0.6g/mL, placing in a stirrer, controlling rotation speed of 45r/min, adding 95% alcohol according to volume ratio of 6:1, controlling flow rate at 250mL/min, standing at-4deg.C for 12 hr, and standing for use.
(3) Centrifuging the system obtained in the step (2) for 12min by 3800r/min, collecting supernatant and precipitate respectively, adding purified water into the precipitate to reach crude drug content of 0.3g/mL, and spray drying under the condition of spray drying parameters: the temperature of the air inlet is 170 ℃, the sampling speed is 10r/min, the atomization pressure is 0.30Mpa, and the polysaccharide powder is obtained and is marked as a material II.
(4) And (3) combining the supernatant in the step (3) with the material I, concentrating under reduced pressure to obtain a medicinal material extract with the water content of 18%, and recording the medicinal material extract as a material III for later use.
(5) Respectively weighing 7% of humectant, 0.095% of preservative and 2.1% of antioxidant according to mass percentage, obtaining 18.31% of material III medicinal extract in the step (4), obtaining 1.6% of material II polysaccharide powder in the step (3), 940.25% of carbomer and the balance of purified water.
Wherein the humectant is a mixture of 1, 2-propylene glycol and polyethylene glycol 400 in a mass ratio of 5:1; the antioxidant is a mixture of vitamin C and anhydrous sodium sulfite in a mass ratio of 3:1, and the preservative is a mixture of ethyl hydroxybenzoate and propyl hydroxybenzoate in a mass ratio of 1:1.
(6) Placing the material II polysaccharide powder weighed in the step (5) into a stirrer, and adding purified water to prepare a polysaccharide water solution with the concentration of 2%; adding carbomer 941 in the step (5) into the polysaccharide water solution, heating to 68 ℃ and continuously standing for 3 hours, adding the humectant, the preservative and the antioxidant weighed in the step (5), keeping the stirring speed at 40r/min, stirring for 15min, adjusting the pH value to 8.4, and recording as a material IV for standby.
(7) Adding 95% ethanol into the material III medicinal material extract weighed in the step (5) according to the volume ratio of 4:1, ultrasonically dissolving, and marking as a material V for later use.
(8) Adding the material V into the material IV, stirring at 30r/min for 30min at 40 deg.C to obtain gel of the Chinese medicinal composition for treating acne, and storing in shade.
Effect verification example
1. Patient data
30 clinical cases were collected according to clinical manifestations of acne, inflammatory and papules, pustules, and node cysts. Wherein 20 men and 10 women are aged 15-18 years. Clinical cases are classified according to skin damage property classification in Chinese acne treatment guidelines, and are in line with 12 cases of mild (grade I: acne only), 16 cases of moderate (grade II: inflammatory papule) and 2 cases of moderate (grade III: pustule).
2. Therapeutic method
Treatment with the gel formulation of example 1 of the present invention:
stage I: proper amount of the composition is singly used (the thickness is about 1mm, the next day of warm water is used for cleaning the face), 1 time/day (half an hour before sleeping), and the composition is continuously treated for 30 days (1 treatment course);
stage II: proper amount of the composition is singly used (the thickness is about 1mm, the next day of warm water is used for cleaning the face), 1 time/day (half an hour before sleeping), and the composition is continuously treated for 30 days (1 treatment course);
class III: the composition is applied singly (thickness is about 1mm, the next day is warm water for cleaning face), 1 time/day (half an hour before sleeping), and the treatment is continued for 30 days (1 treatment course).
3. Therapeutic effects
After 30 days of treatment, the facial skin quality of 28 patients is obviously improved, the number of acnes and pimples is obviously reduced, and 9 cases are healed (subjective symptoms completely disappear, and 90-100% of wound surfaces are recovered); the symptoms and signs of 12 patients are obviously improved (60-89%), and the medicine is obvious in effect; 7 patients are improved (subjective symptoms are obviously relieved, skin damage is resolved by more than 30-59%), and 1 patient with moderate (grade III: pustule) has obvious change of the vaccinia, improves pigmentation, and has tender color, so that the expected acne removing and whitening effects are achieved. The other 2 cases have poor effects, specifically: a moderate (grade II: inflammatory papule) patient had less than 30% resolution of skin lesions and was asked to drink a carbonated beverage multiple times during treatment; a moderate (grade III: pustule) patient had less than 30% resolution of skin lesions, but individual pocks were significantly improved, and the patient was questionnaired that did not ban spicy food during treatment, 2 times consumption of the chafing dish. The condition that the skin is reddened in the primary treatment of 1 patient is accompanied by slight burning sensation, and the condition is improved and gradually adapted after cold compress treatment; other patients do not reflect the discomfort of the application part and do not have any serious adverse reaction.
Through statistical analysis, 9 cases are cured, accounting for 30%; the obvious effect is 40%; the effective rate is 23.3%, the total clinical effective rate is 93.3%, and the incidence rate of adverse reaction is 3.3%. The external gel has good therapeutic effect on acne, can promote skin injury symptom relief and facial skin rehabilitation, avoids the problem of irritation of chemical drugs to skin and drug resistance caused by long-term use, and has high patient compliance.
Exemplary case 1
Liu Mou Male, 17 years old. Before administration, a large number of papules and pustules on the face have larger inflammatory skin injury, obvious spelt feeling appears in the mind, people are reluctant to see at low head in school for a long time, and the clinical diagnosis is moderate (grade III: pustule) acne. The prior art has poor effects through external tretinoin gel, erythromycin ointment, facial mask and the like. After the product of the embodiment 1 of the invention is used for treating 1 course of treatment, the change of the vaccinia mark of a patient is obvious, the pigmentation is improved, the color is pink, and the expected acne removing and whitening effects are achieved.
Fig. 1 is a graph comparing Liu Mou treatment before and after treatment in typical case 1; wherein A is before treatment and B is after treatment.
Exemplary case 2
Liu Mou female, 28 years old. Prior to administration, the face had a large number of papules, pustules and a severe partial pigmentation, and was clinically diagnosed as moderate (grade III: pustule) acne. The external preparation is assisted by laser treatment in the early stage, and the effect is general. After 2 treatment courses using the product of example 1 of the invention, the change of the patient's pockmark is obvious, and the pigmentation is improved.
Fig. 2 is a graph comparing Liu Mou treatment before and after treatment in typical case 2; wherein A, B is before treatment and C, D is after treatment.
The above embodiments are only illustrative of the preferred embodiments of the present invention and are not intended to limit the scope of the present invention, and various modifications and improvements made by those skilled in the art to the technical solutions of the present invention should fall within the protection scope defined by the claims of the present invention without departing from the design spirit of the present invention.

Claims (6)

1. The traditional Chinese medicine gel for treating acne is characterized by comprising a traditional Chinese medicine composition, wherein the traditional Chinese medicine composition comprises the following traditional Chinese medicine components in percentage by mass:
15.12 to 19.77 percent of red sage root, 15.12 to 19.77 percent of coptis root, 6.98 to 11.63 percent of dahurian angelica root, 6.98 to 11.63 percent of Japanese ampelopsis root, 11.63 to 16.28 percent of common bletilla tuber, 9.30 to 13.95 percent of astragalus root, 4.65 to 9.30 percent of Mongolian snakegourd root, 4.65 to 9.30 percent of dandelion, 4.65 to 9.30 percent of honeysuckle flower, and the sum of the mass percentages of the components is 100 percent;
the preparation method of the traditional Chinese medicine gel comprises the following steps:
(1) Soaking radix Salviae Miltiorrhizae, rhizoma Coptidis, radix Angelicae Dahuricae, radix Ampelopsis, herba Taraxaci, and flos Lonicerae in ethanol according to mass ratio, reflux-extracting, and removing ethanol to obtain material I;
(2) Soaking rhizoma bletilla, radix astragali and radix trichosanthis in water according to the mass ratio, performing reflux extraction, concentrating, adding ethanol, and standing;
(3) Centrifuging the system in the step (2) to obtain supernatant and precipitate, and drying the precipitate to obtain a material II;
(4) Mixing the supernatant obtained in the step (3) with the material I, and concentrating to obtain a medicinal material extract which is a material III;
(5) Weighing the following components in percentage by mass: 5 to 7 percent of humectant, 0.095 to 0.16 percent of preservative, 0.5 to 2.5 percent of antioxidant, 16.77 to 24.36 percent of material III, 1.2 to 1.8 percent of material II, 0.15 to 0.35 percent of carbomer 941, and the balance of water, wherein the sum of the mass percentages of the components is 100 percent;
(6) Preparing the material II into an aqueous solution according to the mass ratio in the step (5), then adding carbomer 941, heating and standing; then adding a humectant, a preservative and an antioxidant, stirring, and adjusting the pH value to 8.2-8.6 to obtain a material IV;
(7) Dissolving the material III weighed in the step (5) by using 95% ethanol in an ultrasonic manner to obtain a material V;
(8) Mixing and stirring the material V and the material IV to obtain the traditional Chinese medicine gel;
the radix Salviae Miltiorrhizae is wine-processed radix Salviae Miltiorrhizae.
2. The traditional Chinese medicine gel according to claim 1, wherein in the step (1), the reflux extraction temperature is 65-75 ℃, and the vacuum degree of the reflux extraction is-0.06-0.07 MPa.
3. The traditional Chinese medicine gel according to claim 1, wherein the concentration of the solution after concentration in the step (2) is 0.4-0.6 g/mL; in the step (2), the reflux extraction temperature is 70-80 ℃, and the reflux extraction vacuum degree is-0.07-0.09 MPa.
4. The traditional Chinese medicine gel according to claim 1, wherein the water content of the medicinal material extract in the step (4) is 16-18%.
5. The traditional Chinese medicine gel according to claim 1, wherein the humectant is a mixture of 1, 2-propylene glycol and polyethylene glycol 400 in a mass ratio of 5:1; the antioxidant is a mixture of vitamin C and anhydrous sodium sulfite in a mass ratio of 3:1; the preservative is a mixture of ethyl hydroxybenzoate and propyl hydroxybenzoate in a mass ratio of 1:1.
6. The traditional Chinese medicine gel according to claim 1, wherein the volume ratio of the material III to 95% ethanol in the step (7) is 4:1.
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