CN103432145A - Scar treatment external application western medicine composition preparation and application thereof - Google Patents
Scar treatment external application western medicine composition preparation and application thereof Download PDFInfo
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- CN103432145A CN103432145A CN2013102710566A CN201310271056A CN103432145A CN 103432145 A CN103432145 A CN 103432145A CN 2013102710566 A CN2013102710566 A CN 2013102710566A CN 201310271056 A CN201310271056 A CN 201310271056A CN 103432145 A CN103432145 A CN 103432145A
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Abstract
The present invention relates to an external application western medicine composition preparation with functions of scar treatment, anti-inflammation, itching relieving and pain relieving, and an application thereof. The external application western medicine composition preparation comprises a medicine active ingredient and a pharmaceutically acceptable auxiliary material, wherein the medicine active ingredient mainly comprises 3-10% of acetylsalicylic acid and 8-15% of captopril. According to the present invention, the conventional preparation process is adopted to prepare different external application formulations in the clinic; pharmacodynamics experiment results show that: skin wound fibroblast proliferation is significantly inhibited, collagen fiber content is reduced, skin growth is promoted, and effects of anti-inflammation, itching relieving and pain relieving are provided; and the external application western medicine composition preparation has characteristics of synergetic effect of the compound medicine, significant treatment effect, low price and simple preparation, is a safe and effective skin scar treatment medicine, and has broad application prospects.
Description
Technical field
The present invention relates to a kind of cicatrix for the treatment of, and the external Western medicine compound preparation that site of action is there is to antiinflammatory, antipruritic and analgesic effect, the active constituents of medicine of this external Western medicine compound preparation be mainly aspirin, captopril and pharmaceutically the acceptable adjuvant form.
Background technology
Cicatrix is the pathological phenomenon of the abnormal and collagen fiber hyperplasia of fibroblast proliferation in the skin wound healing process, hypertrophic cicatrix belongs to pathologic scar, the hypertrophic cicatrix sickness rate is high, not only destroy body surface U.S., red and swollen, the strong pruritus of cicatrix local organization appearance and have an intense pain, also hinder linked groups or organ dysfunction, even cause deformity.Along with people's living standard improves constantly, the requirement of beautiful and quality of life is constantly increased, the expected value of scar treatment effect is also generally increased.The control of hypertrophic cicatrix is one of difficult problem of modern medicine, at present the basic research of cicatrix be there is no to breakthrough progress, clinical prevention there is no desirable scheme, the method of existing clinical treatment hypertrophic cicatrix has compression therapy, the silica gel therapy, pharmacotherapy, X-ray therapy, physiotherapy, the functional rehabilitation composite treatment, laser therapy, cryotherapy, attrition, the method such as skin soft-tissue expansion and scar excision, but these methods all can not obtain promising result, and treatment time is long, domestic scholars Cai Jing dragon is thought generally needs the 6-12 month (Cai Jinglong. to the understanding [J] of cicatrization and control. China's damage and reparation magazine (electronic edition), 2010, 5 (5): 573-577).
Captopril (Captopril), claim again mercaptomethyl propionyl proline, i.e. 1-(3-sulfydryl-2-D-methylpropionyl)-L-PROLINE, and structural formula is:
The crystallization that captopril is white or off-white color or crystalline powder, have the special smell of similar Bulbus Allii, tasteless.Easily, in solution and methanol, ethanol, chloroform and acetone, be slightly soluble in water.Captopril is that first contains and dredge the base class angiotensin converting enzyme inhibitor in whole world listing, within 1976, brings into use in clinical, within 1981, in Britain, puts on market, and clinical treatment essential hypertension and intractable congestive heart failure are effective in cure.With deepening continuously of studying, enlarged prevention and the treatment of clinical application range as hypertensive pulmonary vascular disease, myocardial infarction, diabetic nephropathy, rheumatoid arthritis, hyperthyroidism, pheochromocytoma, idiopathic edema, vascular scleroderma and preeclampsia etc. in recent years.
Chinese patent publication No. CN102335167A discloses a kind of new clinical application of the application of captopril in suppressing scar hyperplasia as captopril, points out that the curative effect time of occurrence of captopril in suppressing scar hyperplasia is generally the 3-7 month.
Aspirin (Acetylsalicylic acid), claim again aspirin, and structural formula is:
Aspirin is white needles or flaky crystal, the micro-band tart flavour of odorlessness.Water-soluble, methanol.Aspirin be apply the earliest, the most extensive and prevailing antipyretic analgesic and antirheumatic, there is many-sided pharmacological actions such as analgesic, analgesia, antiinflammatory, the gentle antiplatelet aggregation of wind resistance, be usually used in cold, fever, toothache, headache, myalgia, neuralgia, arthralgia, rheumatic fever, acute rheumatic arthritis, rheumatoid arthritis etc.
Chinese patent Granted publication CN100364543C disclose aspirin in the application that suppresses the neoplastic external preparation of cicatrix as acetysalicylic a kind of new clinical application, point out that the curative effect time of occurrence of aspirin in suppressing rats after burn model scar hyperplasia is 24 days.
Even to this day the inventor proposes aspirin and captopril as the external Western medicine compound, be used for the treatment of that cicatrix is evident in efficacy, the time is short, simultaneously to the cicatrix position there is antiinflammatory, external Western medicine compound preparation antipruritic and analgesic effect has no pertinent literature and patent literature.
Summary of the invention
The objective of the invention is for the deficiencies in the prior art, a kind of cicatrix externally used Western medicine compound preparation for the treatment of be provided, the active constituents of medicine of this external Western medicine compound preparation be mainly aspirin, captopril and pharmaceutically the acceptable adjuvant form.
Second purpose of the present invention is to provide a kind of preparation method for the treatment of cicatrix externally used Western medicine compound preparation.
The 3rd purpose of the present invention is to provide a kind of application for the treatment of cicatrix externally used Western medicine compound preparation.
For achieving the above object, the technical scheme that the present invention takes is: a kind ofly treat cicatrix externally used Western medicine compound preparation, described medicine is by the ingredients of following percentage by weight: aspirin 0.01-50%, captopril 5-20%, and the acceptable adjuvant of medicine.
Described medicine is by the ingredients of following percentage by weight: aspirin 3-10%, captopril 8-15%, and the acceptable adjuvant of medicine.
Described medicine is by the ingredients of following percentage by weight: aspirin 5%, captopril 10%, and the acceptable adjuvant of medicine.
For realizing above-mentioned the second order, the technical scheme that the present invention takes is, as follows according to composition and the preparation method of solution, ointment, ointment and the gel preparation of the arbitrary described external Western medicine compound preparation of claims 1-4:
A: solution is comprised of the following ingredients percentage by weight, aspirin 5%, captopril 10%.Crotamiton 1.0%, Squalene 3.0%, hexadecanol 3.0%, Sorbitan Sesquioleate 0.5%, Polyoxy (20) cetyl ether 1.5%, propylene glycol 5.0%, triethanol ammonium 0.4%, pure water 70.6%.Manufacture method: aspirin is dissolved in the pure water of heating to obtain to A liquid under continuous stirring condition; Then B liquid will be dissolved to obtain before and after captopril, crotamiton, Squalene, hexadecanol, Sorbitan Sesquioleate, Polyoxy (20) cetyl ether, propylene glycol and triethanol ammonium; Under stirring condition, then A liquid and B liquid are added respectively in the pure water of 80 ℃, obtain solution.
B: ointment is comprised of the following ingredients percentage by weight, aspirin 5%, captopril 10%.Oleum sesami 5.0%, hexadecanol 10.0%, white vaseline 8.0%, Polyethylene Glycol monostearate 2.0%, Polyoxy (23) cetyl ether 2.0%, Polyoxy (9) lauryl ether 2.8%, propylene glycol 12.0%, methyl parahydroxybenzoate 0.1%, propylparaben 0.1%, pure water 43%.Manufacture method: under condition of heating and stirring at first captopril be dissolved in hexadecanol, propylene glycol obtains A liquid; Aspirin is dissolved in 80 ℃ of pure water and obtains B liquid under condition of heating and stirring; Then A liquid and B liquid-phase mixing, then add Polyoxy (23) cetyl ether, Polyoxy (9) lauryl ether, methyl parahydroxybenzoate, propylparaben, Polyethylene Glycol monostearate, white vaseline and Oleum sesami to obtain ointment.
C: ointment is comprised of the following ingredients percentage by weight, aspirin 5%, captopril 10%.Oleum sesami 5.0%, ethanedioic acid isopropyl ester 5.0%, isopropyl myristate 5.0%, white vaseline 50.0%, hydrocarbon glue 20.0%.Manufacture method: first white vaseline and hydrocarbon glue heated and stirred are dissolved to obtain to substrate, after captopril and ethanedioic acid isopropyl ester, isopropyl myristate, Oleum sesami heated and stirred are dissolved to obtain to A liquid in succession; Again aspirin and A liquid are added to substrate respectively under condition of heating and stirring in.
D: gel is comprised of the following ingredients percentage by weight, aspirin 3%, captopril 8%, crotamiton 5.0%, isopropyl alcohol 3.0%, propylene glycol 45.0%, polyacrylic acid 25.0%, triethanol ammonium 0.7%, pure water 10.3%.Manufacture method: respectively crotamiton, isopropyl alcohol, propylene glycol, polyacrylic acid, triethanol ammonium heating for dissolving are obtained to substrate; Then obtain A liquid with the water dissolution aspirin; Under stirring condition, captopril is dissolved in to B liquid in propylene glycol; Under stirring condition, A liquid and B liquid are dissolved in to substrate and finally obtain gel.
For realizing above-mentioned the 3rd purpose, the technical scheme that the present invention takes is that described external Western medicine compound preparation is used for the treatment of the application in the cicatrix medicine.
Characteristics of the present invention are, aspirin and captopril are as the external Western medicine compound, there is the effect of compound recipe cooperative compensating, be used for the treatment of that cicatrix is evident in efficacy, treatment time is short, the cicatrix position is had to antiinflammatory, antipruritic and analgesic effect simultaneously, overcome single drug weak curative effect, the long shortcoming of administration time.And cheap, simple for production etc., be a kind of cicatrix of skin medicine safely and effectively for the treatment of, have broad application prospects.
The accompanying drawing explanation
Fig. 1-2 is that external Western medicine compound preparation is to contrast before and after the human body skin trauma care
The normal healing contrast of wound burn front and back is cut for mouse skin in Fig. 3-6
Fig. 7-10 are cut and are hindered the contrast of burn treating front and back mouse skin for external Western medicine compound preparation
The contrast (* 200) that Figure 11-13 are external Western medicine compound ointment group after 3 weeks (fibroblast obviously reduces, nucleus marshalling), normal healing matched group (fibroblast is intensive greatly than multinuclear, arrangement disorder) and positive drug matched group (fibroblast reduces obviously, nucleus marshalling) fibroblast expression
the specific embodiment
The preparation of external Western medicine compound ointment:
Ointment is comprised of the following ingredients percentage by weight, aspirin 5%, captopril 10%.Oleum sesami 5.0%, hexadecanol 10.0%, white vaseline 8.0%, Polyethylene Glycol monostearate 2.0%, Polyoxy (23) cetyl ether 2.0%, Polyoxy (9) lauryl ether 2.8%, propylene glycol 12.0%, methyl parahydroxybenzoate 0.1%, propylparaben 0.1%, pure water 43%.Manufacture method: under condition of heating and stirring at first captopril be dissolved in hexadecanol, propylene glycol obtains A liquid; Aspirin is dissolved in 80 ℃ of pure water and obtains B liquid under condition of heating and stirring; Then A liquid and B liquid-phase mixing, then add Polyoxy (23) cetyl ether, Polyoxy (9) lauryl ether, methyl parahydroxybenzoate, propylparaben, Polyethylene Glycol monostearate, white vaseline and Oleum sesami to obtain ointment.
Experimental example
The external Western medicine compound ointment that above-mentioned embodiment is made is as follows to different cases and white mice enforcement acquired results:
Embodiment 1 wound and burns scar patient's clinical treatment
Experimental subject selects to have patient's 62 examples of cicatrix, wherein 36 examples, wound 16 examples and rear 10 examples of burn after common surgical procedures.Man 46 examples, female's 16 examples, age 14-50 year.The cicatrix position is respectively face, cervical region, breast face, abdominal part and upper and lower extremities.
The routine patient of test method 62 is divided into test group 32 examples at random, asiaticoside ointment group 30 examples.Wound is smeared with 5% aspirin and 10% captopril external Western medicine compound ointment in test group patient's cicatrix position, and wound is smeared with asiaticoside ointment in asiaticoside ointment group patient's cicatrix position, and two groups of wounds are smeared 3 times/days, each 6-100mg/cm
2, the next day normal saline clean a wound 1 time, be used in conjunction 4 weeks-12 weeks, every 2 weeks observed and recorded wound healing situations.
The standard of curative effect evaluation is cured: pruritus pain disappears, and cicatrix is softening flattening or volume-diminished fully, and it is normal that skin colour recovers, and 3 months without recurrence; Produce effects: pruritus pain disappears or significantly alleviates, and the 60%-70% cicatrix is softening to flatten, and skin colour is thin out, nothing recurrence in 3 months; Invalid: even have pruritus, and cicatrix volume-diminished<30% even increases, and quality is obviously unchanged, and skin colour is dark red, unchanged after treatment.
Therapeutic outcome: table 1 liang group patient clinical curative effect is [n (%)] relatively
Annotate: ▲ P and asiaticoside group group compare<0.05; * P and asiaticoside group compare<0.01.
1. learn by statistics and process clinical efficacy total effective rate test group and asiaticoside ointment group more variant (P<0.05); 2. relatively there were significant differences (P<0.01) for average cure time test group and asiaticoside ointment group; 3. skin allergy and other untoward reaction in use do not occur in test group and asiaticoside ointment group patient, and model case is as Fig. 1-2.
Experiment conclusion 5% aspirin and 10% captopril external Western medicine compound ointment can promote various cicatrix of skin to revert to normal skin tissue's structure and elasticity.
Embodiment 2 white mice skins are cut wound and burn experiment
Laboratory animal: clean level male mouse of kunming 18-22g.
The test grouping is divided into 4 groups at random, test A1 group (cut and hinder group), test A2 group (burn group), normal healing matched group (B group), positive drug matched group (C group, asiaticoside ointment group), every group each 10.
Under etherization, test A1 group is wiped out 5 * 5cm size skin with operating scissors at mouse back for test method test A1 group, test A2 group, normal healing matched group and each mice of positive drug matched group.Test A2 group uses hot iron (1.5cm * 1.5cm, 100 ℃, 5 seconds) at mouse back burn 5 * 5cm size skin.Normal healing matched group, positive drug matched group, two groups of 5 mices of wound of respectively burning and cut.5% aspirin and 10% captopril external Western medicine compound ointment for test group A1 and A2 mice wound, normal healing matched group wound external normal saline, positive drug matched group wound is coated with asiaticoside ointment (trade name: Fukang ointment outward, Baoshan Pharmaceutical Factory, Yadong medicine Corp., Shanghai medicine Industr produces, authentication code: the accurate word H20053708 of traditional Chinese medicines), each is organized mice and smears 3 times/days of wounds, the next day normal saline clean a wound 1 time, be used in conjunction 3 weeks, observe the wound healing situation after experiment in 3 weeks finishes and draw materials and do the pathology section.
Experimental result is naked eyes and the healing of histological observation assess wound 1.: normal healing matched group cicatrix piece color is redder, and quality is harder, and cicatrix exceeds skin plane or is recessed to form dryness ulcer, and the hypertrophy scope does not exceed former wound edge of wound, as Fig. 3-6.Test A1 group (cut and hinder group), test A2 group (burn group) and positive drug matched group skin color is light or nothing, matter is soft, and healing skin is consistent with the normal skin plane, as Fig. 7-10; 2. hematoxylin-eosin staining shows, test group: the skin corium attenuation, and the fibroblast negligible amounts, fibroblast is dispersed in, core is less, and collagen fiber density descends, the arrangement of collagen fibers rule, collagen-free tuberosity or collagen tuberosity are not obvious, as Figure 11.The normal healing matched group: skin corium is thicker, and blood capillary proliferation is obvious, and fibrocyte quantity is a lot, fibroblast is intensive, core is large, the collagen fiber swirl shape, and arrangement of collagen fibers is irregular, forms the collagen tuberosity, as Figure 12.The positive drug matched group: the skin corium attenuation, the fibroblast negligible amounts, fibroblast is dispersed in, core is less, and collagen fiber density descends, the arrangement of collagen fibers rule, collagen-free tuberosity or collagen tuberosity are not obvious, as Figure 13; 3. test group obviously suppresses the content of skin flbroblast propagation and reduction collagen fiber, has compared significant difference (P<0.01) with the normal healing matched group, compares variant (P<0.05) with the positive drug matched group.4. test group mouse skin healing time is average 13 days, positive drug control group mice skin healing time average 21 days.Test group is compared significant difference (P<0.01) with the normal healing matched group, test group is compared variant (P<0.05) with the positive drug matched group.
Experiment conclusion: 5% aspirin and 10% captopril external Western medicine compound ointment obviously suppress fibroblast proliferation and reduce the content of collagen fiber, promote skin growth and healing; The curative effect of 5% aspirin and 10% captopril external Western medicine compound emulsifiable paste is better than asiaticoside ointment.
Embodiment 3 cicatrixs and keloid causes inflammation, the treatment of pruritus and pain
Experimental subject selects to have that cicatrix causes inflammation, patient's 60 examples of pruritus and pain, wherein 8 examples after 14 examples and burn after 38 examples, wound after surgical operation.Man 44 examples, female's 16 examples, age 18-50 year.The cicatrix position is respectively face, cervical region, chest, abdominal part and upper and lower extremities.
The routine patient of test method 60 is divided into test group 30 examples at random, asiaticoside ointment group 30 examples.Wound is smeared with 5% aspirin and 10% captopril external Western medicine compound ointment in test group patient's cicatrix position, and wound is smeared with asiaticoside ointment in asiaticoside ointment group patient's cicatrix position, and two groups of wounds are smeared 3 times/days, each 6-100mg/cm
2, the next day normal saline clean a wound 1 time, be used in conjunction 4 weeks-12 weeks, every 2 weeks observed and recorded wound healing situations.
The observation of the standard of curative effect evaluation cicatrix symptom value is carried out the scoring of cicatrix symptom value to the patient before and after treatment, according to cicatrix symptom value numerical grade scale, the patient is measured: three grades of minute red and swollen, pruritus and pain, every grade is divided again in light (1 grade) (2 grades) heavy (3 grades) secondary.The 1-9 level is to cure (red and swollen disappearance, pruritus disappearance, pain disappearance, skin colour recover normal); The 10-18 level is for being produce effects (redness alleviates, pruritus alleviates, pain relief, skin colour thin out); The 19-27 level is for being invalid (unchanged after redness, pruritus, pain, skin colour treatment).
Therapeutic outcome: the treatment of table 2 cicatrix and keloid symptom relatively
Annotate: * P and asiaticoside group group compare<0.05; ▲ P and asiaticoside group compare<0.05;
* P and asiaticoside group compare<0.01.
1. learn by statistics and process clinical efficacy and effective percentage test group and asiaticoside ointment group more variant (P<0.05); 2. relatively there were significant differences (P<0.01) for average cure time test group and asiaticoside ointment group; 3. skin allergy and other untoward reaction in use do not occur in test group and asiaticoside ointment group patient.
Experiment conclusion 5% aspirin and 10% captopril external Western medicine compound ointment have antiinflammatory, antipruritic and analgesic effect.
Above enforcement is only for setting forth the preferred embodiment of the present invention; and protection scope of the present invention is not limited to following embodiment; for those skilled in the art; under the premise of not departing from the present invention; can also make some improvement and supplement, these improvement and supplement and also should be considered as protection scope of the present invention.
Claims (5)
1. an external Western medicine compound preparation for the treatment of cicatrix and antiinflammatory, antipruritic and pain relieving, it is characterized in that, described external Western medicine compound preparation is comprised of following bulk drugs: aspirin 0.01-50%, captopril 5-20%, and the acceptable adjuvant of medicine.
2. according to the described external Western medicine compound of claims 1 preparation, it is characterized in that, described external Western medicine compound preparation is comprised of following bulk drugs: aspirin 3-10%, captopril 8-15%, and the acceptable adjuvant of medicine.
3. according to the described external Western medicine compound of claims 1 preparation, it is characterized in that, described external Western medicine compound preparation is comprised of following bulk drugs: aspirin 5%, captopril 10%, and the acceptable adjuvant of medicine.
4. according to the described external Western medicine compound of claims 1-3 preparation, with conventional formulation technique, make common formulations clinically, comprise solution, ointment, ointment, gel.
5. refer to general cicatrix and pathology (hypertrophy) property cicatrix (ripe cicatrix, immaturity cicatrix, contracted scar, keloid) according to the described external Western medicine compound of claims 1-4 preparation for treating cicatrix.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107617107A (en) * | 2017-09-18 | 2018-01-23 | 浙江大学 | A kind of anti-scar preparation of compound Angiotensin-Converting class |
| CN107648611A (en) * | 2017-09-18 | 2018-02-02 | 浙江大学 | The anti-cicatrix externally used preparation of compound Angiotensin-Converting class |
| CN108478799A (en) * | 2018-02-11 | 2018-09-04 | 浙江大学 | Compound chitosan skin repair preparation containing Angiotensin-Converting related inhibitors |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1684692A (en) * | 2002-09-30 | 2005-10-19 | 帝国制药株式会社 | External preparation for inhibiting keloid formation |
| CN101700248A (en) * | 2009-04-14 | 2010-05-05 | 青岛科技大学 | Preparation method of Aspirin and Captopril enteric sustained-release capsule |
| CN102335167A (en) * | 2010-07-28 | 2012-02-01 | 中国医学科学院整形外科医院 | Application of captopril to inhibition of scar hyperplasia |
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2013
- 2013-07-01 CN CN2013102710566A patent/CN103432145A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1684692A (en) * | 2002-09-30 | 2005-10-19 | 帝国制药株式会社 | External preparation for inhibiting keloid formation |
| CN101700248A (en) * | 2009-04-14 | 2010-05-05 | 青岛科技大学 | Preparation method of Aspirin and Captopril enteric sustained-release capsule |
| CN102335167A (en) * | 2010-07-28 | 2012-02-01 | 中国医学科学院整形外科医院 | Application of captopril to inhibition of scar hyperplasia |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107617107A (en) * | 2017-09-18 | 2018-01-23 | 浙江大学 | A kind of anti-scar preparation of compound Angiotensin-Converting class |
| CN107648611A (en) * | 2017-09-18 | 2018-02-02 | 浙江大学 | The anti-cicatrix externally used preparation of compound Angiotensin-Converting class |
| CN108478799A (en) * | 2018-02-11 | 2018-09-04 | 浙江大学 | Compound chitosan skin repair preparation containing Angiotensin-Converting related inhibitors |
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Application publication date: 20131211 |