CN104524463B - A kind of pharmaceutical composition for treating acne - Google Patents
A kind of pharmaceutical composition for treating acne Download PDFInfo
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- CN104524463B CN104524463B CN201410836294.1A CN201410836294A CN104524463B CN 104524463 B CN104524463 B CN 104524463B CN 201410836294 A CN201410836294 A CN 201410836294A CN 104524463 B CN104524463 B CN 104524463B
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Classifications
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
- A61K36/8966—Fritillaria, e.g. checker lily or mission bells
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/618—Molluscs, e.g. fresh-water molluscs, oysters, clams, squids, octopus, cuttlefish, snails or slugs
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
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Abstract
The invention belongs to pharmaceutical technology field, and in particular to a kind of pharmaceutical composition for treating acne.Described pharmaceutical composition includes following component：Fritillaria thunbergii, oyster, curcuma zedoary, Fructus Aurantii, safflower, coix seed, radix scutellariae, chrysanthemum indicum, cape jasmine, the dried rhizome of rehmannia.Pharmaceutical composition reasonable recipe of the present invention, dialectical administration, the effect with clearing heat and detoxicating yin-nourishing dissipating bind, for acne especially phlegm wet stasis type acne determined curative effect, is adapted to clinical application.
Description
Technical field
The invention belongs to pharmaceutical technology field, and in particular to a kind of pharmaceutical composition for treating acne.
Background technology
With the improvement of people ' s living standards and habits and customs change, such as excessively edible stodge, stay up late,
Stress is big etc., and the morbidity of acne is from youth to the middle age and juvenile extension, but its illness rate is still with puberty men and women's highest.
Acne is also known as acne, is the common chronic inflammation hair follicle sebum gland disease of dept. of dermatology, is apt to occur in hebetic masculinity and femininity.
《Yizong Jinjian》Record：" lung-wind comedo, this disease is formed by lung channel blood-head, is often sent out in nasal surface, plays broken pimple, and shape such as broomcorn millet is considered to be worth doing, and color is red
Swell and ache, break out white powder juice." this disease is more by interior raw phlegm wet, hot and suffocatingization fire is upper to steam head and send out.
The cause of disease of acne is complicated, is a kind of multifactor disease, and mainly and endocrinopathy, hair follicle, sebaceous glands are big for morbidity
Amount is secreted, microorganism infection, immunology factor, diet, mood, physics, and the factor such as chemistry is relevant.The basic principle of western medical treatment
It is：Eliminate intrafollicular bacterium and inflammation；Suppress smegma superfluous；Improve hair follicle and sebaceous gland duct dyskeratosis.It is main
Anti-agent, vitamin etc. are closely questioned using antibiotic, retinoid, corticosteroid hormone, estrogen, male sex hormone.Severe patient can
Drug combination.The side effect of western medicine acne is big, high recurrence rate.
The traditional Chinese medical science is more, and according to etiology and pathogenesis and clinical experience, differentiation of symptoms and signs for classification of syndrome is dialectical to treat, and matches with oral medicinal herb plus external application
The treatment method of conjunction, achieves more satisfied curative effect.Therefore, play TCM Features, seek simple and easy to do, Small side effects,
The reliable Traditional Chinese medicine composition of curative effect is the direction that we study.
The content of the invention
The invention provides a kind of new pharmaceutical composition for treating acne, the pharmaceutical composition is rapid-action, good effect, poison
Small side effects, it is made by following raw material：Fritillaria thunbergii, oyster, curcuma zedoary, Fructus Aurantii, safflower, coix seed, radix scutellariae, chrysanthemum indicum, cape jasmine,
The dried rhizome of rehmannia.
The technical scheme used to solve its technical problem is the pharmaceutical composition of the treatment acne, by following weight
The medicine material composition of part proportioning：5-10 parts of fritillaria thunbergii, 10-20 parts of oyster, 8-14 parts of curcuma zedoary, 10-20 parts of Fructus Aurantii, safflower 1-8
Part, 15-20 parts of coix seed, 10-20 parts of radix scutellariae, 5-10 parts of chrysanthemum indicum, 2-6 parts of cape jasmine, 5-10 parts of the dried rhizome of rehmannia.
The preferred technical solution of the present invention is that the pharmaceutical composition of the present invention is made by the raw material of following parts by weight：Zhejiang
7 parts of fritillaria, 15 parts of oyster, 11 parts of curcuma zedoary, 15 parts of Fructus Aurantii, 4 parts of safflower, 18 parts of coix seed, 15 parts of radix scutellariae, 8 parts of chrysanthemum indicum, cape jasmine
4 parts, 8 parts of the dried rhizome of rehmannia.
Present invention also offers the preparation method of described pharmaceutical composition, following steps are specifically included：By above-mentioned parts by weight
Raw material fritillaria thunbergii, oyster, curcuma zedoary, Fructus Aurantii, safflower, coix seed, radix scutellariae, chrysanthemum indicum, cape jasmine, the dried rhizome of rehmannia be respectively crushed into coarse powder
Afterwards, the water of 8 times of amounts of dosing material gross weight, after soaking 60 minutes, is decocted 60 minutes, filtration, and concentrate filtrate to thick
Cream is produced.
Those skilled in the art can directly be used as medicine on the basis of obtained active constituents of medicine of the present invention to be used or adds
Required preparation is produced in conventional fashion into acceptable auxiliary material in pharmacy.Conventional tablet (dispersible tablet, effervesce can be such as made
Piece, oral disnitegration tablet, lozenge, chewable tablets, effervescent tablet), capsule (hard shell capsules, soft capsule), granule, pill (dripping pill
Agent), the oral drugs of the solid dosage form such as powder, the liquid systems such as syrup, oral liquid, aqua, mixture, decoction can also be made
The oral drugs of dosage form formula.Therefore, can also be auxiliary containing pharmaceutically acceptable in the pharmaceutical composition in addition to active ingredient
Material.Preferably, pharmaceutical composition of the present invention is prepared into oral liquid, aqua, electuary, capsule according to conventional fabrication process or dissipated
Agent etc..
It is stagnant particularly in the preparation treatment phlegm wet stasis of blood in preparation treatment acne that aforementioned pharmaceutical compositions are also claimed in the present invention
Purposes in type acne medicine.By clinical test, two groups of patients treat total effectses after 1 course for the treatment of and compared, and treatment group cures
Rate is 62.5%, and control group is 33.3%, and cure rate compares, the equal ＜ 0.05 of P values, there is significant difference；Total effective rate treatment group
For 97.9%, control group is 81.3%, total effective rate compares, the equal ＜ 0.05 of P values, there is significant difference.
In safety evaluatio, the change without exception such as blood routine, routine urinalysis, electrocardiogram, is controlled before and after treatment group patient treatment
Vital sign is steadily and without adverse reactions such as nausea and vomiting, allergy during treatment.
Side's solution of pharmaceutical composition of the present invention is as follows：The fritillaria thunbergii, it is bitter, tremble with fear.Return lung, the heart channel of Hang-Shaoyin.Heat-clearing dissipating bind, changes
Phlegm and relieving cough, for wind-heat affecting lung, phlegm-fire cough, lung carbuncle, acute mastitis, scrofula, sore.Oyster, it is salty, it is slightly cold.Return liver, courage, kidney channel.Weight
Zhenan County god, checking exuberance of yang tonifying yin, softening and resolving hard mass.For insomnia of palpitating with fear, dizziness and tinnitus, scrofula subcutaneous nodule , abdominal lump of mass in abdomen.
Curcuma zedoary, pungent, hardship, temperature.Return liver, the spleen channel.Promoting the circulation of qi blood-breaking, Xiao Ji Zhi Tong.For Dan lump in the abdomen lump in the abdomens, blood stasis closed, dyspepsia
Distending pain；Early cervical carcinoma.Fructus Aurantii, bitter, pungent, acid, temperature.Returns spleen, stomach.Regulating the flow of QI to ease the stomach, the stagnant dissipate-swelling of row.It is swollen for the chest side of body stagnation of the circulation of vital energy
Stop in full pain, accumulation of food in the stomach and intes tine due to indigestion, phlegm and retained fluid；Gastroptosis, prolapse of the anus, sub-official prolapses.Safflower, pungent, temperature.The thoughts of returning home, Liver Channel.Invigorate blood circulation,
Blood stasis removing analgesic.For Amenorrhea, dysmenorrhoea, lochia , abdominal lump of mass in abdomen, injury from falling down, sore swell and ache curative.
Coix seed, it is sweet, light, it is cool.Returns spleen, stomach, lung channel.Invigorating the spleen excreting dampness, remove numbness antidiarrheal, heat-clearing row is dense.For oedema, pin
Gas, difficult urination, arthritis with fixed pain caused by dampness contraction, splenasthenic diarrhea, lung carbuncle, acute appendicitis；Flat wart.Radix scutellariae, it is bitter, tremble with fear.It is return lung, courage, spleen, large intestine, small
Intestines are passed through.Heat-clearing and damp-drying drug, purging intense heat and detonicating, hemostasis is antiabortive.For damp-warm syndrome, heat temperature evil of vomitting uncomfortable in chest, damp and hot feeling of fullness, rush down dysentery, jaundice, lung
Heat cough, hyperpyrexia polydipsia, blood-head tells nosebleed, carbuncle sore tumefacting virus, fetal irritability.
Chrysanthemum indicum, it is bitter, pungent, it is slightly cold.Return liver, the heart channel of Hang-Shaoyin.It is clearing heat and detoxicating.For furunculosis carbuncle swells, red eye, swell pain, dizziness of having a headache.
Cape jasmine, it is bitter, tremble with fear.The thoughts of returning home, lung, tri-jiao channel.Purging intense heat relieving restlessness, reducing fever and causing diuresis, removing pattogenic heat from the blood and toxic material from the body.For Vexed, jaundice, blood
Drench puckery pain, blood-head tells nosebleed, red eye, swell pain, pathogenic fire,toxin and furuncles；Control bruise pain outside.The dried rhizome of rehmannia, it is sweet, tremble with fear.The thoughts of returning home, liver and kidney channel.The dried rhizome of rehmannia
It is yellow：Clearing heat and cooling blood, yin-nourishing is promoted the production of body fluid.For the deep red polydipsia of pyreticosis tongue, yin asthenia generating intrinsic heat, hectic fever due to yin labor heat, Heat Diabetes is spitted blood, bleeding from five sense organs or subcutaneous tissue,
Spot dermexanthesis.
It is clear that Chinese medicine composition of the present invention becomes fritillaria thunbergii in principle of reatment, side, oyster yin-nourishing with clearing heat and detoxicating, Yangyin Powder
Heat, reducing phlegm and resolving masses；Curcuma zedoary, Fructus Aurantii, safflower are promoting blood circulation and removing blood stasis, insertion channels and collaterals；Coix seed, scutellaria detoxification disappear carbuncle, clearing heat and promoting diuresis；Mother chrysanthemum
Flower, cape jasmine, dried rhizome of rehmannia cooling and activating blood dissolving stasis, removing toxicity for detumescence.Rationally, diagnosis and treatment based on an overall analysis of the illness and the patient's condition serves treating a disease by looking into both its root cause and symptoms to medicament composing prescription of the present invention
Effect, can effectively cure acne particularly phlegm wet stasis type acne conditions.Verify by clinic application, determined curative effect, mild in medicine property
With do not occur toxic side effect and serious adverse reaction, safety coefficient is high, clinical observation total effective rate reaches more than 95%, be worth
Further research and popularization and application.
Embodiment
The present invention is further described below by way of specific embodiment, but the present invention is not limited only to implement in detail below
Example.Within the scope of the invention or not departing from present disclosure, in spirit and scope, the change that is carried out to the present invention,
Combination is replaced, and will be apparent to the person skilled in the art, and be included within the scope of the present invention.
Embodiment 1
Each raw material of the invention is weighed by following parts by weight：It is 7 parts of fritillaria thunbergii, 15 parts of oyster, 11 parts of curcuma zedoary, 15 parts of Fructus Aurantii, red
Spend 4 parts, 18 parts of coix seed, 15 parts of radix scutellariae, 8 parts of chrysanthemum indicum, 4 parts of cape jasmine, 8 parts of the dried rhizome of rehmannia.
Preparation technology is as follows：By the raw material fritillaria thunbergii of above-mentioned parts by weight, oyster, curcuma zedoary, Fructus Aurantii, safflower, coix seed, Huang
A kind of reed mentioned in ancient books, chrysanthemum indicum, cape jasmine, the dried rhizome of rehmannia are respectively crushed into after coarse powder, the water of 8 times of amounts of dosing material gross weight, after soaking 60 minutes, are decocted
60 minutes, filtration, and concentrate filtrate to thick paste and produce.Those skilled in the art can directly be used as medicine and make on this basis
With or add auxiliary material conventional formulation technique the conventional oral formulations such as oral liquid, aqua, electuary, capsule or powder be made.
During using medicine composite for curing acne disease of the present invention, prepared electuary or powder is taken, every bag contains crude drug amount
3g, 3 times a day, 1 bag every time, after meal half an hour clothes.
Embodiment 2
Each raw material of the invention is weighed by following parts by weight：5 parts of fritillaria thunbergii, 10 parts of oyster, 8 parts of curcuma zedoary, 10 parts of Fructus Aurantii, safflower
1 part, 15 parts of coix seed, 10 parts of radix scutellariae, 5 parts of chrysanthemum indicum, 2 parts of cape jasmine, 5 parts of the dried rhizome of rehmannia.
Preparation technology be the same as Example 1.
Embodiment 3
Each raw material of the invention is weighed by following parts by weight：It is 10 parts of fritillaria thunbergii, 20 parts of oyster, 14 parts of curcuma zedoary, 20 parts of Fructus Aurantii, red
Spend 8 parts, 20 parts of coix seed, 20 parts of radix scutellariae, 10 parts of chrysanthemum indicum, 6 parts of cape jasmine, 10 parts of the dried rhizome of rehmannia.
Preparation technology be the same as Example 1.
Embodiment 4
Each raw material of the invention is weighed by following parts by weight：5 parts of fritillaria thunbergii, 20 parts of oyster, 8 parts of curcuma zedoary, 20 parts of Fructus Aurantii, safflower
1 part, 15 parts of coix seed, 20 parts of radix scutellariae, 5 parts of chrysanthemum indicum, 6 parts of cape jasmine, 5 parts of the dried rhizome of rehmannia.
Preparation technology be the same as Example 1.
Embodiment 5
Each raw material of the invention is weighed by following parts by weight：It is 10 parts of fritillaria thunbergii, 10 parts of oyster, 14 parts of curcuma zedoary, 10 parts of Fructus Aurantii, red
Spend 8 parts, 20 parts of coix seed, 10 parts of radix scutellariae, 10 parts of chrysanthemum indicum, 2 parts of cape jasmine, 10 parts of the dried rhizome of rehmannia.
Preparation technology be the same as Example 1.
The clinical observation of the medicine composite for curing acne of the present invention of embodiment 6
1st, case-data：Select the patient for meeting acne (the stagnant card of the phlegm wet stasis of blood) diagnostic criteria of hospital ward and outpatient clinic
96.Studied using the method for random packet, parallel control.
In the included object of observation, treatment group 48, wherein man 20, female 28 is 18 years old~30 years old age, average
(25.34 ± 2.15) year, course of disease January~4 year, I grade 16, II grade 26, III grade 6；Control group 48, man 19, female 29
Example, 18~30 years old age, average (24.80 ± 2.16) year, course of disease January~4 year, I grade 17, II grade 26, III grade 5.Two
Group Gender, age, the course of disease and severity Scaling have a comparativity (P ＞ 0.05) through statistical analysis no difference of science of statistics.
2nd, diagnosis basis：
1) acne tcm diagnosis standard：
(1) from the beginning of in follicular orifice, small rice grain size red papules is presented, can also develop into warts.Hereafter scleroma can be formed
Sample Whiteheads or blackhead, several cases can form scleroma property tumour；
(2) face and chest and back in men and women's puberty are mainly in, seborrhea is often accompanied by；
(3) there are eating and drinking without temperance, overfeeding delicious food savoury, or sense exopathogen etc. to induce more；
(4) after puberty, majority can mitigate naturally；
(5) women is more with irregular menstruation.
2) TCM syndrome diagnostic criteria：
The stagnant card of the phlegm wet stasis of blood：Fash forms tumour, or has indigestion and loss of appetite, loose stool.Pale tongue is fat, and tongue is thin, slippery.
3) Western medicine diagnostic criteria：
(1) it is mainly in puberty men and women；
(2) the flourishing position of the sebaceous glands such as facial, upper chest and back is apt to occur in, can be symmetric；
(3) skin damaged is inflamed papules, acne, warts, tubercle, tumour and scar, with seborrhea, in chronic process.
4) acne grade scale：
I grade (slight) main skin damaged is blackhead, is distributed or multiple, inflamed papules are distributed.Total focus number 10~30.
II grade (lighter moderate) main skin damaged is acne, and has the papule and superficial fester of moderate quatity, total focus number
31~50.It is confined to face.
III grade (heavier moderate) main skin damaged is deep-seated inflamed papules and warts, total focus number 50~100, tubercle ＜
3.
IV grade (severe) main skin damaged is deep-seated inflamed papules and warts, total focus number ＞ 100, tubercle/tumour ＞ 3
It is individual.
3rd, inclusive criteria：
(1) accordance acne diagnostic criteria and the stagnant card TCM syndrome diagnostic criteria of the phlegm wet stasis of blood.
(2) age between 18~30 years old, male or female.
(3) " informed consent form " person is signed.
4th, exclusion standard：
(1) " informed consent form " person is not signed.
(2) gestation or women breast-feeding their children.
(3) used this sick medicine for the treatment of, and/or the used medicine related to this disease inside and outside 7d are taken nearly January orally.
(4) occupational acne or acne medicamentosa sample fash patient.
(5) it is known or may be to trial drug and its component allergy sufferers.
5th, reject and the standard that comes off：
(1) after case is selected, discovery does not meet inclusive criteria or the person that meets exclusion standard.
(2) there are serious adverse events, judged that case clinical test person should be stopped according to doctor.
(3) data is not entirely or by regulation drug user after case is selected.
(4) in process of the test, subject's compliance is poor, and affect the treatment estimator.
6th, usage and dosage：
Treatment group：Take drug therapy of the present invention, electuary prepared by Example 1, every bag of 3g containing crude drug amount, 3 times a day,
1 bag every time, after meal half an hour take.
Control group：Tanshinone capsule (Chinese medicines quasi-word Z13020110) warm water delivery service, l 1g, three times a day, half is small after meal
When take.
The above two group 4 weeks is a course for the treatment of, avoids during medication and drinks, avoids eating the stimulating food such as beef and mutton and fish, shrimp, seafood, eat more
Fresh water fruits and vegetables etc..Avoid scratching, extrude fash.1 course for the treatment of terminates rear efficacy evaluation.
7th, efficacy evaluation：
(1) cure：Skin lesion is disappeared, and subjective symptoms disappears.
(2) take a turn for the better：Subjective symptoms substantially mitigates, skin damaged regression more than 30%.
(3) it is invalid：Skin damaged and symptom are unchanged or regression is less than 30%.
8th, therapeutic effect：
Without rejecting and the case that comes off in therapeutic process, clinical observation is completed.
Two groups of patients treat total effectses after 1 course for the treatment of and compared, and treatment group's cure rate is 62.5%, and control group is 33.3%, is controlled
More rate compares, the equal ＜ 0.05 of P values, there is significant difference；Total effective rate treatment group is 97.9%, and control group is 81.3%, is always had
Efficiency comparison, the equal ＜ 0.05 of P values, there is significant difference.
The treatment group of table 1. and the comparitive study of control group
Vital sign is put down in blood routine, routine urinalysis, electrocardiogram change without exception before and after treatment group patient treatment, therapeutic process
Surely and without adverse reactions such as nausea and vomiting, allergy, illustrate that the clinical application of we is safe and reliable.Treatment results show treatment
Group cure rate and effective percentage are substantially better than control group, there is significant difference.
Thus illustrate particularly to treat using medicine composite for curing acne of the present invention and belong to phlegm wet stasis type acne,
Significant curative effect is achieved, clinical practice is safe and reliable, be worth further research and popularization and application.
Claims (7)
1. a kind of pharmaceutical composition for treating acne, it is characterised in that it is made by the raw material of following parts by weight：Fritillaria thunbergii 5-10
Part, 10-20 parts of oyster, 8-14 parts of curcuma zedoary, 10-20 parts of Fructus Aurantii, 1-8 parts of safflower, 15-20 parts of coix seed, 10-20 parts of radix scutellariae, open country
5-10 parts of chrysanthemum, 2-6 parts of cape jasmine, 5-10 parts of the dried rhizome of rehmannia.
2. pharmaceutical composition as claimed in claim 1, it is characterised in that it is made by the raw material of following parts by weight：Fritillaria thunbergii 7
Part, 15 parts of oyster, 11 parts of curcuma zedoary, 15 parts of Fructus Aurantii, 4 parts of safflower, 18 parts of coix seed, 15 parts of radix scutellariae, 8 parts of chrysanthemum indicum, 4 parts of cape jasmine,
8 parts of the dried rhizome of rehmannia.
3. pharmaceutical composition as claimed in claim 1 or 2, it is characterised in that described pharmaceutical composition is oral formulations.
4. pharmaceutical composition as claimed in claim 3, it is characterised in that the oral formulations be oral liquid, aqua, electuary,
Capsule or powder.
5. pharmaceutical composition as claimed in claim 4, it is characterised in that the oral formulations are electuary.
6. a kind of method for preparing pharmaceutical composition as claimed in claim 1 or 2, it is characterised in that comprise the following steps：Will
The raw material fritillaria thunbergii of above-mentioned parts by weight, oyster, curcuma zedoary, Fructus Aurantii, safflower, coix seed, radix scutellariae, chrysanthemum indicum, cape jasmine, dried rhizome of rehmannia difference powder
It is broken into after coarse powder, the water of 8 times of dosing material gross weight amounts, after immersion 60 minutes, decocts 60 minutes, filtration, and by filtrate decompression
Thick paste is concentrated into produce；Those skilled in the art can directly be used as medicine on the basis of this obtained active constituents of medicine to be used or adds
Enter acceptable auxiliary material in pharmacy and required preparation is produced in conventional fashion into.
7. purposes of the pharmaceutical composition as claimed in claim 1 or 2 in treatment phlegm wet stasis type acne medicine is prepared.
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| CN101152475A (en) * | 2007-09-18 | 2008-04-02 | 尹克山 | Traditional Chinese medicine for treating lung wind acne |
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| CN101152475A (en) * | 2007-09-18 | 2008-04-02 | 尹克山 | Traditional Chinese medicine for treating lung wind acne |
Non-Patent Citations (4)
| Title |
|---|
| 中西医结合治疗痤疮疗效观察;谢依名;《亚太传统医药》;20130915;第9卷(第9期);第117-118页 * |
| 清热祛痘汤治疗痤疮的体会;李学文;《中国医药导报》;20100225;第7卷(第6期);第90页 * |
| 痤疮合剂治疗寻常痤疮肺胃湿热证的临床和实验研究;杨岚 等;《中华中医药杂志》;20100301;第25卷(第3期);第470-472页 * |
| 金起凤运用清热法治疗皮肤病经验;于建红;《中国医药学报》;19990815;第14卷(第4期);第53-55页 * |
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