CN105998164A - Traditional Chinese medicine composition and granules for treating atopic dermatitis and preparation method - Google Patents
Traditional Chinese medicine composition and granules for treating atopic dermatitis and preparation method Download PDFInfo
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- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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Abstract
The invention provides a traditional Chinese medicine composition and granules for treating atopic dermatitis and a preparation method, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from calculus bovis factitius, amber and a licorice root extract, and the weight ratio of calculus bovis factitius to amber to licorice root extract is 3:10:2. The traditional Chinese medicine composition granules comprise active ingredients and a pharmaceutically acceptable carrier, wherein the active ingredients comprise calculus bovis factitius, amber and licorice root extract, and the weight ratio of calculus bovis factitius to amber to licorice root extract is 3:10:2. The traditional Chinese medicine composition and granules for treating the atopic dermatitis and the preparation method have the following advantages that the ingredients are simple and effective and can effectively treat the atopic dermatitis; the problems that amber is difficult to dissolve, and a gravel feeling exists can be effectively solved by adopting a nano suspension technology.
Description
Technical field
The invention belongs to technical field of Chinese medicine, be specifically related to a kind of Chinese medicine composition treating atoipc dermatitis and granule thereof
Agent and preparation method.
Background technology
Atoipc dermatitis system betides a kind of inflammatory dermatoses at seborrhea position, and reason is the most clear.Infection, essence
God factor, dietary habit, sleep, Exposure to Sunlight etc. all can affect the development of primary disease, there is no specific short at present, the most right
Disease is treated.
Summary of the invention
The traditional Chinese medical science thinks that atoipc dermatitis is damp and hot excessive or insufficiency of the spleen wet caused, the rule for the treatment of with heat clearing away, removing heat from blood, dampness removing or heat clearing away,
Spleen invigorating, removing dampness, to dispel the wind, moisturize be main.The present inventor according to the test repeatedly of the research of theory of Chinese medical science and clinic and checking,
Finally have found the medicine effectively treating atoipc dermatitis, thus complete the present invention.Medicine of the present invention is to select artificial cattle
Huang, succinum and Radix Glycyrrhizae extractum.Calculus Bovis nature and flavor are sweet cool, have the effect of heat clearing away, removing toxic substances, removing heat from blood, can be used for treating carbuncle
Sore, also have be in harmonious proportion the property of medicine effect, succinum have calm the nerves antipruritic, the effect of clearing away heat and cooling blood, the cortex that Radix Glycyrrhizae has
Hormone-like effect is also helpful to treatment atoipc dermatitis.Three medicines share, and play the effect of heat clearing away, removing heat from blood, dampness removing altogether.
It is an object of the invention to disclose a kind of Chinese medicine composition treating atoipc dermatitis.
Second object of the present invention is to disclose a kind of Chinese medicine granules treating atoipc dermatitis.
Third object of the present invention is to disclose the preparation method of a kind of Chinese medicine granules treating atoipc dermatitis.
It is an object of the invention to be achieved through the following technical solutions:
A kind of Chinese medicine composition treating atoipc dermatitis, wherein, described Chinese medicine composition is by artificial Calculus Bovis, succinum and sweet
Grass extractum composition, the weight ratio of each composition is artificial Calculus Bovis: succinum: Radix Glycyrrhizae extractum=3:10:2.
A kind of Chinese medicine granules treating atoipc dermatitis, including active component and pharmaceutically acceptable carrier, wherein,
Described active component is made up of artificial Calculus Bovis, succinum and Radix Glycyrrhizae extractum, and the weight ratio of each composition is artificial Calculus Bovis: succinum: Radix Glycyrrhizae
Extractum=3:10:2.
Chinese medicine granules described in technique scheme, wherein, described pharmaceutically acceptable carrier is dextrin.
A kind of Chinese medicine composition treating atoipc dermatitis, wherein, described Chinese medicine composition is by artificial Calculus Bovis, succinum and sweet
Grass extractum composition, the weight ratio of each composition is artificial Calculus Bovis: succinum: Radix Glycyrrhizae extractum=3:10:2.
A kind of Chinese medicine granules treating atoipc dermatitis, including active component and pharmaceutically acceptable carrier, wherein,
Described active component is made up of artificial Calculus Bovis, succinum and Radix Glycyrrhizae extractum, and the weight ratio of each composition is artificial Calculus Bovis: succinum: Radix Glycyrrhizae
Extractum=3:10:2.
Chinese medicine granules described in technique scheme, wherein, described pharmaceutically acceptable carrier is dextrin.
The preparation method of a kind of Chinese medicine granules treating atoipc dermatitis, comprises the steps:
(1), weighing active component and pharmaceutically acceptable carrier, wherein in active component, weight ratio between each raw material is
Artificial Calculus Bovis: succinum: Radix Glycyrrhizae extractum=3:10:2；The equal grinds of artificial Calculus Bovis, succinum and Radix Glycyrrhizae extractum, crosses 100 mesh sieves, standby
With；
(2), by the succinum in step (1), it is dispersed in water, enters wet milk, feed rate 80-120mL/min, rotating speed
2500-3000rpm/min, pressure is 0.4-0.6bar, grinds a few and obtains succinum nanosuspension；
(3), weigh the 1/3 of Radix Glycyrrhizae extractum powder total amount, add it to, in succinum nanosuspension, be sufficiently mixed, dissolve；
Use pressure spray process at the bottom of fluid bed, with pharmaceutically acceptable carrier, remain 2/3 Radix Glycyrrhizae extractum powder, artificial Calculus Bovis's mixture
For carrier, put it in fluidised bed material groove, extension set frequency 14.46Hz, inlet temperature 57.5-58 DEG C, material are set
Temperature 40 DEG C, atomizing pressure 0.1MPa, peristaltic pump feed flow rotating speed 8r/min；After nanosuspension has sprayed, temperature 40 DEG C
Under be dried 30min, take out.
(4), being sieved by above-mentioned granule oscillating sieving machine, upper sieve mesh is 16 mesh, and lower screen mesh is that 30 mesh sieves are received
Collection granule, obtains granule.
Preparation method described in technique scheme, wherein, described pharmaceutically acceptable carrier is dextrin.
The present invention is made up of artificial Calculus Bovis, succinum, Radix Glycyrrhizae extractum three taste medicine, and wherein artificial Calculus Bovis is monarch, have heat clearing away,
Removing toxic substances, the effect of removing heat from blood, can be used for treating skin sore, also have effect of the mediation property of medicine；Succinum have calm the nerves antipruritic,
The effect of clearing away heat and cooling blood, for ministerial drug；The 17-hydroxy-11-dehydrocorticosterone sample effect that Radix Glycyrrhizae has is also helpful to treatment atoipc dermatitis.
Three medicines share, and play the effect of heat clearing away, removing heat from blood, dampness removing altogether.
The Chinese medicinal granule of the present invention is administered orally, a 5g, three times on the one.
The dosage form of product of the present invention is granule, and character is the granule of lark；Taste is micro-sweet, and using method is oral, loading amount,
Granularity, moisture, melting and limit test of microbe all meet to be had under Chinese Pharmacopoeia two annex granule items of version in 2015
Close regulation.
The method have the advantages that
1, the active component of medicine of the present invention is only made up of three taste medicines, and composition is simply effective, can effectively treat atoipc dermatitis.
2, the present invention uses nanometer suspension technology can effectively solve the problems such as the indissoluble of succinum, grittiness.
Accompanying drawing illustrates:
1, Fig. 1 is that thin layer chromatography is to the discriminating of artificial Calculus Bovis in Chinese medicine granules；
2, Fig. 2 is that thin layer chromatography is to the discriminating of Radix Glycyrrhizae extractum in Chinese medicine granules.
Detailed description of the invention:
For making technical scheme readily appreciate, below in conjunction with concrete test example, one of the present invention is treated atopy skin
Scorching Chinese medicine composition and granule and preparation method thereof are further described, and in the present invention, raw material is market purchase.
Embodiment 1:A kind of Chinese medicine composition treating atoipc dermatitis:
Weigh artificial Calculus Bovis 90g, succinum 300g, Radix Glycyrrhizae extractum 60g, above-mentioned raw materials is clayed into power, in i.e. obtaining after mixing
Drug composition.
Embodiment 2:A kind of Chinese medicine granules treating atoipc dermatitis:
(1), with weight proportion be artificial Calculus Bovis 90g, succinum 300g, Radix Glycyrrhizae extractum 60g, dextrin 550g weighting raw materials
And adjuvant, by equal to artificial Calculus Bovis, succinum and Radix Glycyrrhizae extractum grinds, cross 100 mesh sieves, standby；
(2), by the succinum in step (1), after being scattered in suitable quantity of water, enter wet milk, feed rate 80-120ml/min, turn
Speed 2500-3000rpm/min, pressure is 0.4-0.6bar, grinds a few and obtains succinum nanosuspension；
(3), weigh 20g Radix Glycyrrhizae extractum powder, add it to, in succinum nanosuspension, be sufficiently mixed, dissolve；Use
Pressure spray process at the bottom of fluid bed, with 550g dextrin, residue 40g Radix Glycyrrhizae extractum powder, 90g artificial Calculus Bovis's mixture as carrier, will
It puts into fluidised bed material groove, arrange extension set frequency 14.46Hz, inlet temperature 57.5-58 DEG C, temperature of charge 40 DEG C,
Atomizing pressure 0.1MPa, peristaltic pump feed flow rotating speed 8r/min etc..After nanosuspension has sprayed, it is dried 30min (temperature
40 DEG C), take out；
(4), being sieved by above-mentioned granule oscillating sieving machine, upper sieve mesh is 16 mesh, and lower screen mesh is that 30 mesh sieves are received
Collection granule, obtains granule.
Below by way of series of experiments illustrate product of the present invention a kind of treat atoipc dermatitis Chinese medicine granules (hereinafter referred to as:
Antipyretic and itching-stopping granule) relatively reasonable and there is higher safety and good clinical treatment in terms of preparation prescription composition
Effect.Experiment content is as follows:
Experimental example 1:Quality standard research of the present invention:
Differentiate:
(1), Example 2 prepare product 2g, finely ground, add chloroform 20ml, shaking is dissolved, and filters, and filtering residue is for mirror
Not (2) use.Filtrate is evaporated, and adds ethanol 0.5ml and makes dissolving, as need testing solution.Separately take cholic acid reference substance appropriate,
Add ethanol and make every 1ml solution containing 1mg, as reference substance solution.According to thin layer chromatography (" Chinese Pharmacopoeia " 2015
Version general rule 0502) test, draw each 5 μ 1 of above two solution, put respectively on same silica gel g thin-layer plate, with n-hexane
The upper solution of-ethyl acetate-acetic acid-methanol (20:25:2:3) is developing solvent, launches, and takes out, dries, and spray is with 10% sulphuric acid
Ethanol solution, heats about 10 minutes at 105 DEG C, puts and inspect under ultra-violet lamp (365nm), and result is as it is shown in figure 1, supply examination
In product chromatograph, on position corresponding with reference substance chromatograph, the fluorescence speckle of aobvious same color, wherein Fig. 11 is classified as
Cholic acid reference substance, 2～4 are classified as three batches of test samples, the 5 negative solution being classified as scarce artificial Calculus Bovis.
(2), the residue that takes under discriminating (1) item, volatilize chloroform, add water 20ml, stirring, centrifugal, point takes supernatant,
With n-butanol extraction 2 times, each 20ml (is centrifuged) if desired, merges n-butanol extracting liquid, puts and be evaporated in water-bath, residue
Add methanol 1ml and make dissolving, as need testing solution.Another extracting liquorice control medicinal material 0.5g, adds methanol 15ml, supersound process
15 minutes, filtering, filtrate is concentrated into 1ml, as control medicinal material solution.According to thin layer chromatography (" Chinese Pharmacopoeia " 2015
Version general rule 0502) test, draw each 5 μ 1 of above two solution, put the silica gel G prepared in same 1%NaOH liquid respectively
On lamellae, with acetic ether-methanoic acid-glacial acetic acid-water (15:1:1:2) as developing solvent, launching, take out, dry, spray is with 10%
Ethanol solution of sulfuric acid, is heated to spot development at 105 DEG C clear.Put and inspect under ultra-violet lamp (365nm), result such as Fig. 2
Shown in, in test sample chromatograph, on position corresponding with control medicinal material chromatograph, aobvious identical orange-yellow fluorescence speckle, wherein
In Fig. 2 row 1 be Radix Glycyrrhizae reference substance, row 2～4 be three batches of test samples, row 5 be the negative solution lacking Radix Glycyrrhizae extractum.
[assay] measures according to high performance liquid chromatography (" Chinese Pharmacopoeia " 2015 editions general rules 0512)
Chromatographic condition and system suitability are with octadecylsilane chemically bonded silica as filler, with acetonitrile-1% ice vinegar
Acid (90:10) is flowing phase；Detection wavelength is 450nm.Number of theoretical plate is calculated by bilirubin should be not less than 3000.
It is appropriate that the preparation of reference substance solution takes bilirubin reference substance, and accurately weighed, adding methylene chloride to make in every 1ml contains
The solution of 10 μ g, to obtain final product.
The preparation of need testing solution takes this product about 2g, accurately weighed, puts in tool plug conical flask, accurate addition 0.2mol/l
Calcium Disodium Versenate solution (suitably heat during preparation and make to be completely dissolved, let cool, face by brand-new) 5ml, accurate addition
Water saturation dichloromethane 50ml, weighed weight, supersound process (ice bath) 30 minutes, put to room temperature, more weighed weight, use
Water saturation dichloromethane supplies the weight of less loss, shakes up, centrifugal, takes dichloromethane solution, filters, and precision measures subsequent filtrate
5ml, puts in 10ml measuring bottle, adds dehydrated alcohol dilution and is settled to scale, and mixing to obtain final product.
Algoscopy precision respectively draws reference substance solution and each 20 μ l of need testing solution, injects chromatograph of liquid, measures,
Obtain.
The every g of this product contains artificial Calculus Bovis with bilirubin (C33H36N4O6) meter, 0.2mg must not be less than.
Test example 2:Acute toxicity test of the present invention:
One, test objective:
Observe animal subject after giving maximum volume and maximal dose antipyretic and itching-stopping granule, institute under not producing death condition
The toxic reaction produced.
Two, test material and method
1, animal and rearing conditions: Switzerland's Kunming outbred mice, body weight 18-22g, for 20, male and female half and half, by
Military Medical Science Institute's animal center provides.Animal House temperature 25 ± 3 DEG C, 12 hours bright, and 12 hours dark.Animal divides cage
Raise, 10, every cage, free diet and drinking-water.Animal starts test after adapting to 3 days.
2, medicine and preparation: antipyretic and itching-stopping granule, dissolves with distilled water before using, and embodiment 2 prepares gained.
3, dosage and route of administration: 8.3g/kg, 0.8ml/, gavage.
4, observation index: after administration, every day observes the poisoning manifestations of animal, Continuous Observation 7 days.
Three, result:
Do not observe that animal has Novel presentation.
Four, conclusion:
1, Mouse oral antipyretic and itching-stopping granule 8.3g/kg performance without exception.
2, antipyretic and itching-stopping granule is administered orally the maximum tolerated dose (MTD) of mice is 8.3g/kg, is equivalent to adult every for every day
100 times of secondary oral dose.
Test example 3: the present invention treats atoipc dermatitis clinical trial:
The Chinese medicine granules (antipyretic and itching-stopping granule) that the embodiment of the present invention 2 prepares gained is main containing Calculus Bovis, succinum and Radix Glycyrrhizae
Extractum, has heat clearing away, removing toxic substances, removing heat from blood, antipruritic effect of calming the nerves.The method using opening experiment observes this medicine to 50
The curative effect of example patients with atopic dermatitis, is now reported as follows.
One, case and method:
1, case selection:
(1), inclusion criteria: the patients with atopic dermatitis made a definite diagnosis according to typical clinical symptoms and sign, the age is at 14-60
Year, and do not take in one week or external used medicine person.
(2), exclusion standard:
1. gestation and women breast-feeding their children.
2. serious hepatic and kidney function obstacle.
3. neuropsychopathy is suffered from and noncooperationist.
4. allergy or be not resistant to person.
(3), standard is rejected:
The most all uncooperative, the most do not complete person's course for the treatment of.
2. after medication, occur that serious adverse reaction is forced therapy discontinued person.
2, test method:
(1), research method: use random opening method.
(2), medicine for treatment (antipyretic and itching-stopping granule).
1. medicament composing prescription: Calculus Bovis, succinum, Radix Glycyrrhizae extractum.
2. packaging: powder, 5 grams/bag.
(3), Therapeutic Method:
1. have a blood test respectively before and after treatment, routine urinalysis, ALT, AST and BUN, CR.
It is administered orally two bags, every twice-daily the most every time.
Taking medicine the most continuously 15 days is a course for the treatment of.Therapeutic evaluation is made after two courses for the treatment of.
(4), untoward reaction observe, notes observation untoward reaction, and is recorded in detail.
(5), curative effect determinate standard
Recovery from illness: deflorescence >=90%, without new breakout；
Effective: deflorescence<90%,>=60%；
Effective: deflorescence<60%,>=20%；
Invalid: deflorescence < 20%.
Two, result:
1, physical data: observe 50 examples altogether, the ordinary circumstance of patient is shown in Table 1.
The basic condition of table 1 patient
2, severity extent: be shown in Table 2.
Table 2 conditions of patients degree
3, Chinese medical discrimination situation: be shown in Table 3
Table 3 patient's Chinese medical discrimination situation
4, the medicine impact on lab index: such as table 4, being worth before and after lab index treatment, (T value is through T inspection
12.67), P > 0.05, before and after showing treatment, difference is not notable, shows that two medicines are the safest.
The impact (x ± s n=30) on lab index of table 4 medicine
5, efficacy determination: as shown in table 5.
Table 5 observation of curative effect
6, untoward reaction: 50 examples have no adverse reaction.
Three, discuss:
Atoipc dermatitis system betides a kind of diseases associated with inflammation at seborrhea position, and reason is the most clear.Infection, spirit
Factor, dietary habit, sleep, Exposure to Sunlight etc. all can affect it and develop, and there is no specific short at present, generally suits the medicine to the illness
Treatment.The traditional Chinese medical science thinks that it is caused by damp and hot excessive or insufficiency of the spleen endogenous dampness, the rule for the treatment of with clearing away heat and cooling blood, dampness removing or heat clearing away, spleen invigorating,
Removing dampness, wind dispelling, to moisturize be main.Antipyretic and itching-stopping granule is mainly composed of Calculus Bovis, succinum and Radix Glycyrrhizae extractum, and Calculus Bovis has clearly
Heat, removing toxic substances, the effect of removing heat from blood, succinum have calm the nerves antipruritic, the effect of clearing away heat and cooling blood, Radix Glycyrrhizae extractum have QI invigorating invigorating middle warmer,
Eliminating fire and detoxication, the effects such as the property of medicine that are in harmonious proportion.Our observation shows that this medicine has good therapeutic effect, total effective rate to atoipc dermatitis
Reaching 74%, especially to dialectical evident in efficacy for heat symptom-complex person, observed 13 examples are all fully recovered.One of the present invention treats atopy skin
Scorching Chinese medicine granules is easy to use, have no side effect, curative effect is high, is the preferable selection for the treatment of atoipc dermatitis.
The above, only presently preferred embodiments of the present invention, not the present invention is made any formal and substantial restriction,
All those skilled in the art, in the range of without departing from technical solution of the present invention, when available disclosed above skill
Art content, and a little change made, the equivalent variations modifying and develop, be the Equivalent embodiments of the present invention；Meanwhile,
The change of any equivalent variations that above example is made by all substantial technological according to the present invention, modify and develop, the most still
Belong in the range of technical scheme.
Claims (5)
1. the Chinese medicine composition treating atoipc dermatitis, it is characterised in that described Chinese medicine composition by artificial Calculus Bovis,
Succinum and Radix Glycyrrhizae extractum composition, the weight ratio of each composition is artificial Calculus Bovis: succinum: Radix Glycyrrhizae extractum=3:10:2.
2. treating a Chinese medicine granules for atoipc dermatitis, including active component and pharmaceutically acceptable carrier, it is special
Levying and be, described active component is made up of artificial Calculus Bovis, succinum and Radix Glycyrrhizae extractum, and the weight ratio of each composition is artificial Calculus Bovis:
Succinum: Radix Glycyrrhizae extractum=3:10:2.
Chinese medicine granules the most according to claim 2, it is characterised in that: described pharmaceutically acceptable carrier is for sticking with paste
Essence.
4. treat a preparation method for the Chinese medicine granules of atoipc dermatitis, comprise the steps:
(1), weighing active component and pharmaceutically acceptable carrier, wherein in active component, weight ratio between each raw material is
Artificial Calculus Bovis: succinum: Radix Glycyrrhizae extractum=3:10:2；The equal grinds of artificial Calculus Bovis, succinum and Radix Glycyrrhizae extractum, crosses 100 mesh sieves, standby
With；
(2), by the succinum in step (1), it is dispersed in water, enters wet milk, feed rate 80-120mL/min, rotating speed
2500-3000rpm/min, pressure is 0.4-0.6bar, grinds a few and obtains succinum nanosuspension；
(3), weigh the 1/3 of Radix Glycyrrhizae extractum powder total amount, add it to, in succinum nanosuspension, be sufficiently mixed, dissolve；
Use pressure spray process at the bottom of fluid bed, with pharmaceutically acceptable carrier, remain 2/3 Radix Glycyrrhizae extractum powder, artificial Calculus Bovis's mixture
For carrier, put it in fluidised bed material groove, extension set frequency 14.46Hz, inlet temperature 57.5-58 DEG C, material are set
Temperature 40 DEG C, atomizing pressure 0.1MPa, peristaltic pump feed flow rotating speed 8r/min；After nanosuspension has sprayed, temperature 40 DEG C
Under be dried 30min, take out；
(4), being sieved by above-mentioned granule oscillating sieving machine, upper sieve mesh is 16 mesh, and lower screen mesh is that 30 mesh sieves are received
Collection granule, obtains granule.
Preparation method the most according to claim 4, it is characterised in that: described pharmaceutically acceptable carrier is dextrin.
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