CN105998164B - Traditional Chinese medicine composition for treating atopic dermatitis and granules and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating atopic dermatitis and granules and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine composition for treating atopic dermatitis, granules thereof and a preparation method thereof, belonging to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the raw materials of artificial bezoar, amber and liquorice extract in a weight ratio of 3:10: 2. The traditional Chinese medicine granules comprise active ingredients and a pharmaceutically acceptable carrier, wherein the active ingredients comprise raw material medicines of artificial bezoar, amber and liquorice extract in a weight ratio of 3:10: 2. The invention has the following advantages: (1) the components are simple and effective, and the atopic dermatitis can be effectively treated; (2) meanwhile, the problems of difficult dissolution, gravel feeling and the like of the amber can be effectively solved by adopting a nano suspension technology.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating atopic dermatitis, granules and a preparation method thereof.
Background
Atopic dermatitis is an inflammatory skin disease occurring at the site of seborrhea for an unknown reason. Infection, mental factors, dietary habits, sleep, sunshine and the like can all influence the development of the disease, and no specific therapy is available at present, and the specific therapy is generally symptomatic treatment.
Disclosure of Invention
The traditional Chinese medicine considers that the atopic dermatitis is caused by damp-heat overflowing or spleen deficiency and internal dampness, and the treatment principle mainly comprises clearing heat, cooling blood, promoting diuresis or clearing heat, strengthening spleen, eliminating dampness, dispelling wind and moistening dryness. The inventor finally finds a medicament for effectively treating the atopic dermatitis according to the research of the theory of the traditional Chinese medicine and the repeated clinical tests and verification, thereby completing the invention. The medicine of the invention is prepared from artificial bezoar, amber and licorice extract. The bezoar is sweet and cool in nature and taste, has the effects of clearing heat, detoxifying and cooling blood, can be used for treating carbuncle, cellulitis and sore toxin, and also has the effect of harmonizing drug properties, the amber has the effects of soothing nerves, relieving itching, clearing heat and cooling blood, and the cortex hormone-like effect of the liquorice is also helpful for treating atopic dermatitis. The three medicines are combined to play the effects of clearing heat, cooling blood and promoting diuresis.
The invention aims to disclose a traditional Chinese medicine composition for treating atopic dermatitis.
The second purpose of the invention is to disclose a traditional Chinese medicine granule for treating atopic dermatitis.
The third purpose of the invention is to disclose a preparation method of traditional Chinese medicine granules for treating atopic dermatitis.
The purpose of the invention is realized by the following technical scheme:
a traditional Chinese medicine composition for treating atopic dermatitis is composed of artificial bezoar, amber and extractum glycyrrhizae, and the weight ratio of the artificial bezoar to the amber to the extractum glycyrrhizae is 3:10: 2.
A traditional Chinese medicine granule for treating atopic dermatitis comprises an active ingredient and a pharmaceutically acceptable carrier, wherein the active ingredient comprises calculus bovis factitius, amber and extractum glycyrrhizae, and the weight ratio of the components is that the calculus bovis factitius to the amber to the extractum glycyrrhizae is 3:10: 2.
The traditional Chinese medicine granule according to the technical scheme, wherein the pharmaceutically acceptable carrier is dextrin.
A traditional Chinese medicine composition for treating atopic dermatitis is composed of artificial bezoar, amber and extractum glycyrrhizae, and the weight ratio of the artificial bezoar to the amber to the extractum glycyrrhizae is 3:10: 2.
A traditional Chinese medicine granule for treating atopic dermatitis comprises an active ingredient and a pharmaceutically acceptable carrier, wherein the active ingredient comprises calculus bovis factitius, amber and extractum glycyrrhizae, and the weight ratio of the components is that the calculus bovis factitius to the amber to the extractum glycyrrhizae is 3:10: 2.
The traditional Chinese medicine granule according to the technical scheme, wherein the pharmaceutically acceptable carrier is dextrin.
A preparation method of traditional Chinese medicine granules for treating atopic dermatitis comprises the following steps:
(1) weighing active ingredients and a pharmaceutically acceptable carrier, wherein the weight ratio of the active ingredients to the raw materials is artificial bezoar to amber to extractum glycyrrhizae liquidum is 3:10: 2; grinding artificial bezoar, amber and licorice extract into powder, and sieving with 100 mesh sieve for later use;
(2) dispersing the amber in the step (1) in water, feeding into a wet grinder at a feeding speed of 80-120mL/min, a rotating speed of 2500-3000rpm/min and a pressure of 0.4-0.6bar, and grinding for several circles to obtain an amber nano suspension;
(3) 1/3 of the total amount of the liquorice extract powder is weighed and added into the amber nano suspension to be fully mixed and dissolved; adopting a fluidized bed bottom spraying process, taking a pharmaceutically acceptable carrier, the residual 2/3 liquorice extract powder and the calculus bovis factitious mixture as the carrier, putting the carrier into a fluidized bed material groove, and setting the frequency of the extension machine to be 14.46Hz, the air inlet temperature to be 57.5-58 ℃, the material temperature to be 40 ℃, the atomizing pressure to be 0.1MPa and the liquid supply rotating speed of a peristaltic pump to be 8 r/min; and after the nano suspension is sprayed, drying at the temperature of 40 ℃ for 30min, and taking out.
(4) Sieving the above granules with a vibrating screen powder machine, wherein the upper layer screen mesh is 16 mesh, and the lower layer screen mesh is 30 mesh, and collecting granules to obtain the granule.
The preparation method according to the above technical scheme, wherein the pharmaceutically acceptable carrier is dextrin.
The invention is composed of three medicines of artificial bezoar, amber and licorice extract, wherein the artificial bezoar is the monarch medicine, has the functions of clearing heat, detoxifying and cooling blood, can be used for treating carbuncle-abscess sore toxin, and also has the efficacy of harmonizing medicine property; the amber has the functions of soothing the nerves, relieving itching, clearing heat and cooling blood, and is a ministerial drug; the cortex hormone-like effect of Glycyrrhrizae radix is also helpful for treating atopic dermatitis. The three medicines are combined to play the effects of clearing heat, cooling blood and promoting diuresis.
The traditional Chinese medicine granule is orally taken, 5g is taken once, and the traditional Chinese medicine granule is taken three times a day.
The product of the invention is in the form of granules, and the granules have the characteristics of gray yellow; the taste is slightly sweet, the use method is oral administration, and the inspection of the loading amount, the granularity, the moisture, the dissolubility and the microbial limit conforms to the relevant regulations under the item of granules in the appendix of the second part of the Chinese pharmacopoeia 2015 edition.
The invention has the following beneficial effects:
1. the active ingredients of the medicine only consist of three medicines, the ingredients are simple and effective, and the medicine can effectively treat atopic dermatitis.
2. The invention adopts the nano suspension technology to effectively solve the problems of difficult dissolution, gravel feeling and the like of amber.
Description of the drawings:
1. FIG. 1 is identification of calculus bovis factitius in Chinese medicinal granule by thin layer chromatography;
2. FIG. 2 is a thin-layer chromatography for identifying Glycyrrhrizae radix extract in Chinese medicinal granule.
The specific implementation mode is as follows:
in order to facilitate understanding of the technical scheme of the invention, the traditional Chinese medicine composition for treating atopic dermatitis, the granules and the preparation method thereof are further described in the following with specific test examples, and the raw materials in the invention are all purchased in the market.
Example 1:a Chinese medicinal composition for treating atopic dermatitis:
weighing 90g of calculus bovis factitius, 300g of amber and 60g of liquorice extract, grinding the raw materials into powder, and uniformly mixing to obtain the traditional Chinese medicine composition.
Example 2:a traditional Chinese medicine granule for treating atopic dermatitis:
(1) weighing raw material medicines and auxiliary materials according to the weight ratio of 90g of calculus bovis factitius, 300g of amber, 60g of licorice extract and 550g of dextrin, grinding the calculus bovis factitius, the amber and the licorice extract into powder, and sieving the powder by a 100-mesh sieve for later use;
(2) dispersing the amber in the step (1) in a proper amount of water, feeding into a wet grinder at a feeding speed of 80-120ml/min, a rotating speed of 2500-3000rpm/min and a pressure of 0.4-0.6bar, and grinding for several circles to obtain an amber nano suspension;
(3) weighing 20g of licorice extract powder, adding the licorice extract powder into the amber nano suspension, and fully mixing and dissolving; the method adopts a fluidized bed bottom spraying process, takes 550g of dextrin, the rest 40g of licorice extract powder and 90g of calculus bovis factitious mixture as carriers, and puts the carriers into a fluidized bed material tank, and sets the frequency of a separating machine to be 14.46Hz, the air inlet temperature to be 57.5-58 ℃, the material temperature to be 40 ℃, the atomizing pressure to be 0.1MPa, the liquid supply rotating speed of a peristaltic pump to be 8r/min and the like. After the nano suspension is sprayed, drying for 30min (at the temperature of 40 ℃), and taking out;
(4) sieving the above granules with a vibrating screen powder machine, wherein the upper layer screen mesh is 16 mesh, and the lower layer screen mesh is 30 mesh, and collecting granules to obtain the granule.
A series of experiments prove that the traditional Chinese medicine granules for treating atopic dermatitis (hereinafter referred to as heat-clearing and itching-relieving granules) are reasonable in formulation composition, have high safety and good clinical curative effect. The experimental contents are as follows:
experimental example 1:the invention researches the quality standard:
and (3) identification:
(1) taking 2g of the product prepared in the example 2, grinding, adding 20ml of trichloromethane, shaking for dissolving, filtering, and using filter residues for identification (2). The filtrate was evaporated to dryness, and 0.5ml of ethanol was added to dissolve the filtrate to obtain a sample solution. And adding ethanol into appropriate amount of cholic acid control to obtain 1mg per 1ml solution as control solution. According to a thin-layer chromatography test (the general rule of Chinese pharmacopoeia 2015 0502), sucking 5 mu 1 of each of the two solutions, respectively dropping the two solutions on the same silica gel G thin-layer plate, taking an upper layer solution of n-hexane-ethyl acetate-acetic acid-methanol (20:25:2:3) as a developing agent, developing, taking out, drying, spraying a 10% sulfuric acid ethanol solution, heating at 105 ℃ for about 10 minutes, placing under an ultraviolet lamp (365nm) for inspection, and displaying fluorescent spots with the same color in a position corresponding to a reference substance chromatogram, wherein 1 in the figure 1 is a cholic acid reference substance, 2-4 columns are three test samples, and 5 columns are negative solutions of calculus bovis lacking man.
(2) Collecting residue under identification (1), volatilizing chloroform, adding water 20ml, stirring, centrifuging, collecting supernatant, extracting with n-butanol for 2 times, each time extracting with 20ml (centrifuging if necessary), mixing n-butanol extractive solutions, evaporating on water bath, and dissolving residue with methanol 1ml to obtain sample solution. And adding 15ml of methanol into 0.5g of licorice control medicinal material, carrying out ultrasonic treatment for 15 minutes, filtering, and concentrating the filtrate to 1ml to obtain a control medicinal material solution. According to a thin layer chromatography test (the general rule of Chinese pharmacopoeia 2015 0502), sucking the two solutions by 5 mu 1 respectively, respectively dropping the two solutions on a same silica gel G thin layer plate prepared by using 1% NaOH solution, developing by using ethyl acetate-formic acid-glacial acetic acid-water (15:1:1:2) as a developing agent, taking out, drying in the air, spraying 10% sulfuric acid ethanol solution, and heating at 105 ℃ until spots are clearly developed. Inspecting under an ultraviolet lamp (365nm), wherein the result is shown in FIG. 2, and in the chromatogram of the test solution, at the position corresponding to the chromatogram of the control solution, the same orange-yellow fluorescent spots appear, wherein in FIG. 2, column 1 is the control solution of Glycyrrhrizae radix, columns 2-4 are three batches of test solutions, and column 5 is the negative solution lacking Glycyrrhrizae radix extract.
[ MEASUREMENT ] the content is determined by high performance liquid chromatography (the general rule 0512 in the Chinese pharmacopoeia 2015)
Chromatographic conditions and system applicability test with octadecylsilane chemically bonded silica as filler and acetonitrile-1% glacial acetic acid (90: 10) as mobile phase; the detection wavelength was 450 nm. The number of theoretical plates should not be less than 3000 calculated according to bilirubin.
Preparation of reference substance solution A proper amount of bilirubin reference substance is precisely weighed, and dichloromethane is added to prepare a solution containing 10 μ g of bilirubin per 1 ml.
Preparing a test solution, precisely weighing about 2g of the test solution, placing the test solution in a conical flask with a plug, precisely adding 5ml of 0.2mol/l disodium ethylene diamine tetraacetate solution (properly heating to completely dissolve the disodium ethylene diamine tetraacetate solution during preparation, cooling, and preparing the disodium ethylene diamine tetraacetate solution for new use), precisely adding 50ml of water-saturated dichloromethane, weighing, carrying out ultrasonic treatment (ice bath) for 30 minutes, placing the test solution to room temperature, weighing again, complementing the weight loss with the water-saturated dichloromethane, shaking up, centrifuging, taking dichloromethane liquid, filtering, precisely weighing 5ml of subsequent filtrate, placing the subsequent filtrate in a 10ml measuring flask, adding absolute ethyl alcohol to dilute the subsequent volume to a certain volume, and mixing uniformly to obtain the test solution.
The determination method comprises precisely sucking 20 μ l of each of the reference solution and the sample solution, injecting into liquid chromatograph, and determining.
The product contains artificial bezoar and bilirubin (C) per g33H36N4O6) Calculated, the content of the active ingredient should not be less than 0.2 mg.
Test example 2:the acute toxicity test of the invention comprises:
firstly, the purpose of the test is as follows:
the animals were observed to produce a toxic response after maximum volume and maximum dose of the heat-clearing antipruritic granule without death.
Second, test materials and methods
1. Animal and feeding conditions: switzerland Kunming inbred line mice, weighing 18-22g, supplying 20 mice, half female and half male, are provided by the animal center of military medical academy of sciences. The temperature of the animal room is 25 +/-3 ℃, the light time is 12 hours, and the dark time is 12 hours. Animals were housed in cages of 10 animals each, with free access to food and water. The experiment was started 3 days after the animals were acclimated.
2. The preparation of the medicine comprises the following steps: heat-clearing and antipruritic granules are prepared in example 2 by dissolving the granules in distilled water before use.
3. Dose and route of administration: 8.3g/kg, 0.8 ml/pig, and perfusing the stomach.
4. Observation indexes are as follows: animals were observed daily for signs of intoxication after dosing and 7 consecutive days.
Thirdly, obtaining a result:
no abnormal performance of the animals was observed.
Fourthly, conclusion:
1. 8.3g/kg of oral heat-clearing and itching-relieving granules for mice have no abnormal expression.
2. The Maximum Tolerated Dose (MTD) of the heat-clearing and itching-relieving granules orally administered to mice is 8.3g/kg, which is equivalent to 100 times of the daily oral dose per adult.
Test example 3: hair brushClinical trial of treating atopic dermatitis:
the traditional Chinese medicine granules (heat-clearing and itching-relieving granules) prepared in the embodiment 2 mainly contain bezoar, amber and licorice extract, and have the effects of clearing heat, detoxifying, cooling blood, soothing nerves and relieving itching. The efficacy of the drug was observed in 50 patients with atopic dermatitis using an open-ended test method, and the following is reported.
First, case and method:
1. case selection:
(1) and inclusion standard: atopic dermatitis patients diagnosed with typical clinical symptoms and signs are 14-60 years old and have not been taken or externally administered within a week.
(2) And exclusion criteria:
① pregnant and lactating women.
② severe hepatic and renal insufficiency.
③ go against neuropsychiatric disease.
④ allergic or intolerant.
(3) And the elimination standard is as follows:
① the treatment course is incomplete when there is no cooperation or failure.
② severe adverse reactions occur after medication and the therapist is forced to discontinue.
2. The test method comprises the following steps:
(1) and the research method comprises the following steps: a random open method was used.
(2) And therapeutic medicine (heat-clearing and itching-relieving granule).
① the composition comprises calculus bovis, Succinum, and radix Glycyrrhizae extract.
② packaging powder, 5 g/bag.
(3) The treatment method comprises the following steps:
① before and after treatment, blood, urine, ALT, AST, BUN, and CR are checked respectively.
② it is administered orally twice a day.
③ the medicine is taken continuously for 15 days as a course of treatment, and the curative effect is evaluated after two courses of treatment.
(4) And observing adverse reactions, paying attention to the observation of the adverse reactions, and making detailed records.
(5) And therapeutic efficacy judgment criteria
And (3) healing: the fading of the rash is more than or equal to 90 percent, and no new eruption exists;
the effect is shown: the rash subsides by less than 90% and is more than or equal to 60%;
the method has the following advantages: the rash subsides less than 60% and more than or equal to 20%;
and (4) invalidation: the rash resolved < 20%.
Secondly, the result is:
1. general data: a total of 50 patients were observed, and the general condition of the patients is shown in Table 1.
TABLE 1 basic conditions of the patients
2. The disease degree: see table 2.
TABLE 2 degree of illness of patients
3. The traditional Chinese medicine syndrome differentiation condition is as follows: see Table 3
TABLE 3 Chinese medicine syndrome differentiation of patients
4. Effect of drug on laboratory indices: as shown in table 4, the values before and after treatment of the laboratory index, which are tested by T (T value of 12.67), P >0.05, show that the difference between before and after treatment is not significant, and both drugs are safe.
Table 4 effect of drugs on laboratory indices (x ± s n ═ 30)
5. And (3) judging the curative effect: as shown in table 5.
TABLE 5 Observation of the therapeutic effects
6. Adverse reactions: 50 cases have no adverse reaction.
Thirdly, discussion:
atopic dermatitis is an inflammatory disease occurring in the seborrhea for an unknown reason. Infection, mental factors, dietary habits, sleep, sunshine and the like can all influence the occurrence and development of the infection, and no specific therapy is available at present, and the specific therapy is generally symptomatic treatment. The traditional Chinese medicine considers that the external dampness-heat is caused by the external dampness-heat or the internal dampness due to spleen deficiency, and the treatment principle mainly comprises clearing heat and cooling blood, removing dampness or clearing heat, strengthening spleen, eliminating dampness, dispelling wind and moistening dryness. The heat-clearing and itching-relieving granules mainly comprise bezoar, amber and licorice extract, wherein the bezoar has the functions of clearing heat, detoxifying and cooling blood, the amber has the functions of soothing nerves, relieving itching, clearing heat and cooling blood, and the licorice extract has the functions of tonifying qi, strengthening middle-jiao, purging intense heat, detoxifying, harmonizing drug properties and the like. Our observation shows that the medicine has better curative effect on atopic dermatitis, the total effective rate reaches 74 percent, the curative effect is particularly obvious for patients with syndrome differentiation of heat symptoms, and 13 observed cases are all cured. The traditional Chinese medicine granule for treating atopic dermatitis is convenient to use, free of side effects and high in curative effect, and is a better choice for treating atopic dermatitis.
While the invention has been described with reference to a preferred embodiment, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention as defined by the appended claims; meanwhile, any equivalent changes, modifications and variations of the above embodiments according to the essential technology of the present invention are within the scope of the technical solution of the present invention.
Claims (5)
1. The traditional Chinese medicine composition for treating atopic dermatitis is characterized by comprising artificial bezoar, amber and extractum glycyrrhizae, wherein the weight ratio of the artificial bezoar to the amber to the extractum glycyrrhizae is 3:10: 2.
2. A traditional Chinese medicine granule for treating atopic dermatitis comprises an active ingredient and a pharmaceutically acceptable carrier, and is characterized in that the active ingredient comprises artificial bezoar, amber and extractum glycyrrhizae liquidum, and the weight ratio of the active ingredient to the artificial bezoar to the amber to the extractum glycyrrhizae liquidum is 3:10: 2.
3. The traditional Chinese medicine granule as claimed in claim 2, wherein: the pharmaceutically acceptable carrier is dextrin.
4. A preparation method of traditional Chinese medicine granules for treating atopic dermatitis comprises the following steps:
(1) weighing active ingredients and a pharmaceutically acceptable carrier, wherein the weight ratio of the active ingredients to the raw materials is artificial bezoar to amber to extractum glycyrrhizae liquidum is 3:10: 2; grinding artificial bezoar, amber and licorice extract into powder, and sieving with 100 mesh sieve for later use;
(2) dispersing the amber in the step (1) in water, feeding into a wet grinder at a feeding speed of 80-120mL/min, a rotating speed of 2500-3000rpm/min and a pressure of 0.4-0.6bar, and grinding for several circles to obtain an amber nano suspension;
(3) 1/3 of the total amount of the liquorice extract powder is weighed and added into the amber nano suspension to be fully mixed and dissolved; adopting a fluidized bed bottom spraying process, taking a pharmaceutically acceptable carrier, the residual 2/3 liquorice extract powder and the calculus bovis factitious mixture as the carrier, putting the carrier into a fluidized bed material groove, and setting the frequency of the extension machine to be 14.46Hz, the air inlet temperature to be 57.5-58 ℃, the material temperature to be 40 ℃, the atomizing pressure to be 0.1MPa and the liquid supply rotating speed of a peristaltic pump to be 8 r/min; after the nano suspension is sprayed, drying at the temperature of 40 ℃ for 30min, and taking out;
(4) sieving the above granules with a vibrating screen powder machine, wherein the upper layer screen mesh is 16 mesh, and the lower layer screen mesh is 30 mesh, and collecting granules to obtain the granule.
5. The method of claim 4, wherein: the pharmaceutically acceptable carrier is dextrin.
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