CN1513543A - Gel agent for treating acne and its preparation method - Google Patents

Gel agent for treating acne and its preparation method Download PDF

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Publication number
CN1513543A
CN1513543A CNA2004100023052A CN200410002305A CN1513543A CN 1513543 A CN1513543 A CN 1513543A CN A2004100023052 A CNA2004100023052 A CN A2004100023052A CN 200410002305 A CN200410002305 A CN 200410002305A CN 1513543 A CN1513543 A CN 1513543A
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gel
radix isatidis
medicine
mixing
weight
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CN1233313C (en
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牛余珍
林桂涛
孙明江
邓华亮
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Shandong University of Traditional Chinese Medicine
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Shandong University of Traditional Chinese Medicine
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Abstract

A Chinese medicine in the form of gel for treating acne is prepared from 10 Chinese-medicinal materials including isatis root, pig gall, borax, borneol, etc and pharmacologically receptable additives. Its advantages are high curative effect and cure rate, quickly taking its effect and no toxic by-effect.

Description

A kind of gel for the treatment of acne and preparation method thereof
(1) described technical field
The present invention relates to a kind of gel for the treatment of acne and preparation method thereof, belong to domestic Chinese medicine route of administration and the dosage form technical field of having gone on the market of change.
(2) background technology
The Chinese medicine of Xiao Shouing " pills for throat disease " function cures mainly clearly in the market, clinical pharyngitis, laryngitis, tonsillitis and the general skin ulcer scabies of being used for.But owing to be oral drugs, the medicine clothes must absorb through gastrointestinal and enter the region of disease again, and curative effect is slow, and medicine is difficult to reach the region of disease.For the treatment of general skin ulcer scabies such as acne etc., curative effect is slow especially, and therapeutic effect is poor.Therefore, pills for throat disease is mainly used in treatment pharyngitis, laryngitis, tonsillitis at present, generally is not used in treatment skin ulcer scabies such as acne.
(3) summary of the invention
The present invention provides a kind of curative effect fast in order to overcome above deficiency, and therapeutic effect is good, by treated in vitro, does not bring the gel of painful treatment acne to patient, and the preparation method of above-mentioned gel.
The present invention realizes by following measure:
The invention discloses a kind of gel for the treatment of acne, by the following weight proportion raw material,
Radix Isatidis 420 Fel Sus domestica 400 Realgars 46 Pulvis Fumi Carbonisatuss 16
Calculus Bovis 30 Matrii Sulfas Exsiccatus 20 Boraxs 20 Borneolum Syntheticums 14
Indigo Naturalis 12 Venenum Bufoniss 40
The gel made from pharmaceutically useful adjuvant and/or auxiliary agent.
The preparation method of above-mentioned gel may further comprise the steps,
A. Radix Isatidis extracting in water filters, the extracting solution oven dry, pulverize Radix Isatidis extract;
B. Radix Isatidis extract and all the other raw materials mix, and grinding and sieving gets fine powder;
C. card taking Bai Mujia water is made into the concentration of 1-8% (weight), places mixing 12-48 hour, hydro-oxidation sodium solution or triethanolamine are transferred PH6-8, place 12-48 hour, add the propylene glycol of 2-20% (weight), the azone of 1-5% (weight), mixing, basic after;
D. fine powder is joined in the base back, mixing, packing promptly gets the gel medicine.
The present invention is that the dosage form of carrying out on the basis of Chinese medicine " pills for throat disease " is improved, and has changed route of administration, is mainly used in dermatosis such as treatment acne.Become treated in vitro by original oral administration, its using method is that a little medicine is applied in the affected part skim, sooner or later respectively once.
Gel of the present invention is compared with oral administration, has avoided medicine to degrade and first pass effect of hepar in gastro-intestinal Fluid, the bioavailability height, and the small-molecule drug bioavailability is near quiet notes, and the macromole polypeptide drug is higher than oral.
Gel of the present invention is compared with drug administration by injection, have easy to use, medication voluntarily, light or do not have to body injury, patient's compliance is good, is suitable for long term administration, simultaneously, also be suitable for since a variety of causes can't oral administration the patient.
Therefore, gel of the present invention can avoid degraded and the liver medicine of medicine in gastro-intestinal Fluid to cross effect, has improved bioavailability, absorbs simultaneously rapidly, and is rapid-action.In addition, the preparation method of gel of the present invention, craft science is reasonable, and is simple to operate.
A. below is the pharmacodynamic study of gel of the present invention
1. medicine antiinflammatory action research of the present invention
1.1 to the swollen outgrowth influence of rat granuloma
Three dosage groups and positive pills for throat disease matched group, the continuous administration of speed 8 days, sacrifice of animal took by weighing body weight on 1, granuloma weight thymus, spleen, adrenal gland's weight.The result shows that three dosage of medicine of the present invention and pills for throat disease group all can obviously suppress the hypertrophy (P<0.01) of chronic granuloma.
1.2 Oleum Tiglii is brought out the influence of Mice Auricle edema
Press Vam Arman and Zhu Xiu beautiful woman improved method, there were significant differences (P<0.05) with normal saline matched group ratio for three dosage groups of result's medicine of the present invention, pills for throat disease group.
1.3 on Carrageenan causes the influence that rat is swelling
Three dosage groups of medicine of the present invention, pills for throat disease group difference administration 8 days, about 1 hour subcutaneous injection 1% carrageenin of the sufficient sole of the foot behind the 9th day medicine, 0.1ml/ only cause scorching back and measured sufficient sole of the foot volume in 1-6 hour respectively, calculate the swelling rate, carry out T and check.Three dosage groups of result's medicine of the present invention all can suppress the rat paw edema that carrageenin can cause significantly, and effect lasted till 3 hours and pills for throat disease has similar action.
1.4 the influence that mouse peritoneal hair cell pipe permeability is increased
Press the whittle method, three dosage groups of result's medicine of the present invention and pills for throat disease group are all resisted H significantly +Stimulate the mouse peritoneal blood capillary that newly causes to lead to increasing of show.(P<0.01)
2. bacteriostasis
External paper disk method: experiment prompting, medicine of the present invention can suppress golden Portugal bacterium external more than finite concentration (0.125mg/m), mlicrococcus catarrhalis, and the growth of first, hemolytic streptococcus, wherein comparatively responsive with the second key.
3. phlegm-dispelling functions
The phenol red expelling phlegm method of mice, in three dosage groups of result's medicine of the present invention, big or middle dosage group and suitable two batches of experiments of disease ball group can make the phenol red discharge rate of mice trachea increase by 135.0~141.4%; A collection of experiment only has the tendency of increasing.
4. to Immune Effects
4.1 influence to non-specific immunity
Remove method by colloid carbon granules in the mice blood, the result gave three dosage groups of medicine of the present invention and the administration of pills for throat disease group 8 days, normal mouse or acetic acid cortisone are caused immunologic hypofunction, and the carbon granule removing speed regulating liver-QI splenocyte phagocytic function of mice all can obviously improve (P<0.05).
4.2 influence to the inductive antibody horizontal of sheep red blood cell
Three dosage groups of medicine of the present invention and the continuous administration of pills for throat disease group speed 8 days can obviously improve (P<0.05) to the inductive antibody horizontal of erythrocyte.
4.3 the influence that causes the white mice delayed hypersensitivity to 2,4 dinitrochlorobenzene
The result shows that medicine of the present invention and pills for throat disease newly cause the white mice delayed hypersensitivity to dinitrochlorobenzene significant inhibitory effect.(P<0.05)
5. conclusion
Three dosage groups of medicine of the present invention and pills for throat disease group can suppress the formation that carrageenin newly causes rat paw edema and chronic granuloma induced by implantation of cotton pellets significantly; Mice ear that barlan oil is brought out and abdominal cavity capillary permeability increase the obvious inhibitory action of tool; Extracorporeal bacteria inhibitor test shows, to suppressing golden Fructus Vitis viniferae, card ground Neisseria, the growth of first, hemolytic streptococcus; To nonspecific immunity, antibody generates and can obviously improve, can obviously suppress delayed hypersensitivity, above presentation of results, medicine of the present invention and pills for throat disease, two kinds of dosage forms are at aspect pharmacodynamics no significant differences such as antiinflammatory, antibacterial, immunologic functions, for treatment treatment acne provides pharmacological basis preferably.
B. the gel to invention below carries out clinical research
Gel of the present invention and Benzamycin agent (the Shandong dolantin is restrained the production of medicine company limited) treatment acne clinical efficacy controlled observation is the result be summarized as follows:
1. clinical data
In 10 examples, male 8 examples, women 2 examples are the students of Shandong Traditional Chinese Medicine University.The course of disease 2~6 years.Be divided into classifications such as hoary hair's acne, blackhead, inflammatory pimple, pus born of the same parents, tuberosity, cyst according to the skin lesion high-quality.Hoary hair's acne 8 examples wherein, blackhead 2 examples, inflammatory pimple 10 examples, pustule 2 examples.
2. Therapeutic Method
Earlier with the thorough cleaning skin of warm water, wipe driedly gently before each treatment, a little medicine is smeared skim in the affected part, avoid positions such as thing contact opening, eye, need not any cosmetics during the treatment and be used for the treatment of the medicine of acne inside and outside other.Be coated with gel of the present invention outside same patient left side is facial, the right side face is coated with Benzamycin outward.Sooner or later respectively put 15 days courses of treatment on the skin 1 time.
3. curative effect determinate standard and result
Curative effect determinate standard: skin lesion disappears>95% for curing; Skin lesion disappears 60~95% for produce effects; Skin lesion disappears 20~59% for effective; Skin lesion disappears<20% for invalid.
The result: curative effect sees attached list 1, table 2
Table 1 liang group clinical drug curative effect relatively
Group The example number Cure Produce effects Effectively Invalid Cure-remarkable-effectiveness rate Total effective rate
This gel group ????10 ????1 ????5 ????2 ????2 ??60% ??80%
The Benzamycin group ????10 ????0 ????3 ????4 ????3 ??30% ??70%
Table 2 liang group clinical drug skin lesion extinction rate relatively
Figure A20041000230500061
Acne is a common disease of sebaceous glands of a kind of adolescence, and the traditional Chinese medical science is referred to as rosacea caused by lung-wind, and total pathogenesis is based on heat in blood.Gel of the present invention is made up of medicines such as Radix Isatidis, Calculus Boviss, has heat-clearing and toxic substances removing, reducing swelling and alleviating pain effect.Two kinds of medicines compare, and gel of the present invention is having the obvious treatment effect than Benzamycin aspect hoary hair's acne, blackhead, the inflammatory pimple.This medicine is a substrate with the gel, and moisture retention, stretchability and stability are preferably arranged, and clinical prerun shows nontoxic nonirritant, and configuration is simple, the curative effect height, and it is fast to produce effects, and has no side effect, and to use convenient, cheap in addition, possesses exploitation and be worth.
Benzamycin treatment acne vulgaris has certain curative effect, and said preparation contains 3% erythromycin and 5% benzoyl peroxide, and erythromycin is the biocidal property Macrolide, sterilization, bacteriostasis is arranged, but easily develop immunity to drugs.Benzoyl peroxide can suppress Propiobacterium effectively, but zest is more obvious.And this product costs an arm and a leg, and has limited the part of the consumer group.
Table 3 liang group clinical drug curative effect comparision table
Name Sex Gel of the present invention (experimental group) Benzamycin (matched group)
Hoary hair's acne Blackhead The inflammatory pimple Pustule Tuberosity Cyst Hoary hair's acne Blackhead The inflammatory pimple Pustule Tuberosity Cyst
Han Xiujuan The woman ??92.3% ??60% ??80% ??11.1%
Yin Yukun The woman ??16.7% ??100% ??100% ??13.3% ??57% 50%
Guo Yunlong The man ??100% ??50% ??100% ??66.7% ??50% ??100%
Peng Rui The man ??41.7% ??50% 40% ??25% ??15.4%
In imperial Tan The man ??60% ??50% ??50% ??0% 25%
Zhan Baoming The man ??9.5% ??5.5% ??8.6% ??5% 100%
Jia Dao The man ??30% ??9% 20% ??16.7% ??10%
Xin Chao The man ??90% ??91% 12.5%
Du Hengchen The man ??100% ??7.7%
Qi Fujian The man ??66.7% ??70%
Coating is average (classification) skin lesion extinction rate % after 15 days ??50% ??75% 63.1% 30% ?37.2% 36% 45.8%
Total skin lesion extinction rate % Total skin lesion extinction rate 54.5% Total skin lesion extinction rate 43.1%
4. conclusion: gel of the present invention is compared with Benzamycin, the curative effect height, and it is fast to produce effects, and the cure rate height has no side effect, nontoxic nonirritant, it is convenient, cheap to use.
In sum, the beneficial effect of medicine of the present invention is that the curative effect height produces effects soon cure rate height, easy to use, nontoxic, side effect.Its preparation method has makes simply the advantage that the effective ingredient loss is few.
(4) specific embodiment
1. embodiment 1
The gel of treatment acne of the present invention, its proportioning raw materials and preparation method are as follows:
A. take by weighing the following weight proportion raw material,
Radix Isatidis 420g Fel Sus domestica 400g Realgar 46g Pulvis Fumi Carbonisatus 16g
Calculus Bovis 30g Matrii Sulfas Exsiccatus 20g Borax 20g Borneolum Syntheticum 14g
Indigo Naturalis 12g Venenum Bufonis 40g
B. Radix Isatidis extracting in water filters, the extracting solution oven dry, pulverize Radix Isatidis extract; Radix Isatidis extract and all the other raw materials mix, and grinding and sieving gets fine powder; And above-mentioned raw material powder is broken into fine powder, sieve;
C. card taking Bai Mujia water is made into 3% concentration, places 20 hours, and mixing, hydro-oxidation sodium solution are transferred PH6, places 48 hours, adds 8% propylene glycol, 2% azone, mixing, must the 10L base after;
D. fine powder is joined in the base back, mixing, 10g/ props up by packing, promptly gets the gel medicine.
Usage: a little medicine is smeared skim in the affected part, sooner or later respectively put on the skin 1 time, 15 is a course of treatment.
Function cures mainly: heat-clearing and toxic substances removing, reducing swelling and alleviating pain is used for the treatment of general furuncle such as acne.
2. embodiment 2
The gel of treatment acne of the present invention,
A. take by weighing and state materials of weight proportions
Radix Isatidis 420g Fel Sus domestica 400g Realgar 46g Pulvis Fumi Carbonisatus 16g
Calculus Bovis 30g Matrii Sulfas Exsiccatus 20g Borax 20g Borneolum Syntheticum 14g
Indigo Naturalis 12g Venenum Bufonis 40g
B. Radix Isatidis extracting in water filters, the extracting solution oven dry, pulverize Radix Isatidis extract; Radix Isatidis extract and all the other raw materials mix, and grinding and sieving gets fine powder;
And above-mentioned raw material powder is broken into fine powder, sieve;
C. card taking Bai Mujia water is made into 7% concentration, places 40 hours, and mixing, hydro-oxidation sodium solution are transferred PH8, places 18 hours, adds 18% propylene glycol, 5% azone, mixing, must the 8L base after;
D. fine powder is joined in the base back, mixing, 10g/ props up by packing, promptly gets the gel medicine.
Usage and function cure mainly with embodiment 1.

Claims (2)

1. gel for the treatment of acne is characterized in that: by the following weight proportion raw material,
Radix Isatidis 420 Fel Sus domestica 400 Realgars 46 Pulvis Fumi Carbonisatuss 16
Calculus Bovis 30 Matrii Sulfas Exsiccatus 20 Boraxs 20 Borneolum Syntheticums 14
Indigo Naturalis 12 Venenum Bufoniss 40
The gel made from pharmaceutically useful adjuvant and/or auxiliary agent.
2. the preparation method of the described gel of claim 1 is characterized in that: may further comprise the steps,
A. Radix Isatidis extracting in water filters, the extracting solution oven dry, pulverize Radix Isatidis extract;
B. Radix Isatidis extract and all the other raw materials mix, and grinding and sieving gets fine powder;
C. card taking Bai Mujia water is made into the concentration of 1-8% (weight), places mixing 12-48 hour, hydro-oxidation sodium solution or triethanolamine are transferred PH6-8, place 12-48 hour, add the propylene glycol of 2-20% (weight), the azone of 1-5% (weight), mixing, basic after;
D. fine powder is joined in the base back, mixing, packing promptly gets the gel medicine.
CN 200410002305 2003-01-28 2004-01-06 Gel agent for treating acne and its preparation method Expired - Fee Related CN1233313C (en)

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CN03111837.2 2003-01-28
CN 200410002305 CN1233313C (en) 2003-01-28 2004-01-06 Gel agent for treating acne and its preparation method

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101112418B (en) * 2007-08-15 2010-05-19 济南康众医药科技开发有限公司 Medicinal composition for partial use for treating acne and method for preparing the same
CN1895365B (en) * 2006-06-13 2011-03-23 天津生机集团有限公司 Oral liquid for treating fowl upper disease and its preparation

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101991664B (en) * 2010-11-01 2012-02-29 周传巧 Gel agent for treating acnes and preparation method thereof

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1895365B (en) * 2006-06-13 2011-03-23 天津生机集团有限公司 Oral liquid for treating fowl upper disease and its preparation
CN101112418B (en) * 2007-08-15 2010-05-19 济南康众医药科技开发有限公司 Medicinal composition for partial use for treating acne and method for preparing the same

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