CN101574504B - Medical composition for treating mammary gland diseases and preparation method thereof - Google Patents

Medical composition for treating mammary gland diseases and preparation method thereof Download PDF

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CN101574504B
CN101574504B CN2009101199276A CN200910119927A CN101574504B CN 101574504 B CN101574504 B CN 101574504B CN 2009101199276 A CN2009101199276 A CN 2009101199276A CN 200910119927 A CN200910119927 A CN 200910119927A CN 101574504 B CN101574504 B CN 101574504B
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rhizoma curcumae
standby
curcumae longae
gentianae macrophyllae
radix
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CN101574504A (en
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刘海龙
高虹
黄玉兰
路杰
陈丽娟
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Gansu Qizheng Tibetan Medicine Co Ltd
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Gansu Qizheng Tibetan Medicine Co Ltd
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Abstract

The invention discloses a medical composition for treating mammary gland diseases and preparation method thereof. The medical composition is composed of lamiophlomis rotata, gentiana macrophylla, cluster mallow fruit, curcuma, borneol, camphor and procumbent speedwell. The preparation method of the medical composition comprises the following steps: the lamiophlomis rotata, gentiana macrophylla, cluster mallow fruit, curcuma and procumbent speedwell are respectively decontaminated, cleaned, dried and put for standby; then, the lamiophlomis rotata, gentiana macrophylla and procumbent speedwell are crushed into coarse powder and extracted with water respectively; extract liquids are mixed, and then the mixture is condensed into paste for standby; subsequently, curcuma and cluster mallow fruitare crushed into fine powder for standby; the paste, the fine powder, borneol and camphor are mixed, and finally, common minor ingredients are added to prepare the clinical acceptable medicament form . Cataplasm is the preferable form for the medical composition of the invention. The medical composition has the favorable efficiency on treating mammary gland diseases, especially hyperplasia of mammary glands.

Description

A kind of pharmaceutical composition for the treatment of cystic hyperplasia of breast and preparation method thereof
Technical field
The present invention relates to a kind of pharmaceutical composition and preparation method thereof, particularly a kind of pharmaceutical composition for the treatment of cystic hyperplasia of breast and preparation method thereof.
Background technology
Cyclomastopathy is one of women's commonly encountered diseases, frequently-occurring disease, and its sickness rate accounts for the first place of mastopathy.Have investigation to show, should be the trend that rises year by year by the disease sickness rate in the last few years, the age also more and more becomes younger.According to expert introduction, there is the women of 70%-80% that in various degree cyclomastopathy is all arranged approximately, be more common in the 25-45 women in year.City women's sickness rate is than the rural area height.Therefore, there is the people also it to be called women " modern disease ".The result shows with regard to most studies, suffers from the women of cyclomastopathy, and the danger that breast carcinoma takes place wants big than normal person group, particularly has family history of breast cancer then to increase this danger especially greatly.
Modern medicine thinks that periodic disorder of hormone secretion or mammary gland tissue are the main causes of morbidity to the sensitivity increase of hormone, adopts the hormone preparation treatment more, and uncertain therapeutic efficacy is cut and the relapse rate height, and toxic and side effects is big.In treatment, Western medicine does not have effective medicine, and conventional medicament is carried out dialectical executing and controlled, but medicine is confined to oral drugs mostly, and the curative effect of receiving is not very remarkable.And Chinese medicine and Tibetan medicine and pharmacology treatment have remarkable advantages and characteristic.Therefore, the purpose of our research is to adopt the traditional Chinese medicine and the Therapeutic Method of Tibetan medicine and pharmacology to reach certain therapeutical effect, and the pain that alleviation and treatment cyclomastopathy are brought reaches the effect of eliminating stagnation.In medicine of the present invention, added cyclomastopathy is played Flos Cannabis Macrophylla, Herba veronicae, the Fructus Malvae of main therapeutical effect and Radix Lamiophlomidis Rotatae and the Rhizoma Curcumae Longae that is extensive use of the basis and the curing mammary gland hyperplasia effect is arranged arranged, to strengthen invigorating blood circulation and regulating the flow of vital energy effect of this side, mix in addition and have sensible, priming Borneolum Syntheticum and the Camphora in going into, formed the basic components of this medicine.
In the treatment of mastopathy, tradition adopts oral formulations to treat, the mode that also has minority to adopt ointment and external rubber-emplastrum to stick is treated, though oral drugs can reach certain therapeutic effect, but the oral formulations onset is slow, is difficult to the symptom of reduction of patient, and the medication cycle is long, and will often take medicine, this brings inconvenience for the Ms that present high-quality life requires; Ointment also is difficult to the patient and accepts because pollution clothes is restricted in treatment; Though the external rubber-emplastrum can overcome above-mentioned shortcoming in addition, but the irritated rate height of rubber-emplastrum, and comfortableness is poor, the patient is beyond affordability, therefore seeking a kind of comfortable external use plaster is the emphasis that we study, in present external use plaster, cataplasma is as an emerging dosage form, is to be the external plaster agent that substrate and medicine are made with water-soluble high-molecular compound or hydroaropic substance.Compare with exterior-applied formulations such as rubber-emplastrum, ointment, black plasters, it is good that cataplasma has a drug capacity height, transdermal characteristic, applicating property, moisture retention, pasting comfortable, advantage such as pollution clothes not, is the external novel form with good development prospect, is the ideal dosage form of treatment mastopathy.
Summary of the invention
One object of the present invention is to disclose a kind of pharmaceutical composition for the treatment of cystic hyperplasia of breast, also is to disclose a kind of analgesic ointment unguentum for the treatment of cystic hyperplasia of breast; Another object of the present invention is a kind of method for the treatment of the pharmaceutical composition of cystic hyperplasia of breast of open preparation, also is a kind of method for the treatment of the analgesic ointment unguentum of cystic hyperplasia of breast of open preparation.
The present invention seeks to be achieved through the following technical solutions:
The crude drug of pharmaceutical composition of the present invention consists of:
Radix Lamiophlomidis Rotatae 1~50 weight portion, Radix Gentianae Macrophyllae flower 1~30 weight portion, Fructus Malvae 1~30 weight portion, Rhizoma Curcumae Longae 1~30 weight portion, Borneolum Syntheticum 1~10 weight portion, Camphora 1~10 weight portion, Herba veronicae 1~30 weight portion.
The crude drug composition of pharmaceutical composition of the present invention is preferably:
Radix Lamiophlomidis Rotatae 10~30 weight portions, Radix Gentianae Macrophyllae flower 1~10 weight portion, Fructus Malvae 1~10 weight portion, Rhizoma Curcumae Longae 1~10 weight portion, Borneolum Syntheticum 1~5 weight portion, Camphora 1~5 weight portion, Herba veronicae 1~10 weight portion.
The crude drug composition of pharmaceutical composition of the present invention is preferably:
Radix Lamiophlomidis Rotatae 50 weight portions, Radix Gentianae Macrophyllae flower 10 weight portions, Fructus Malvae 5 weight portions, Rhizoma Curcumae Longae 30 weight portions, Borneolum Syntheticum 5 weight portions, Camphora 2 weight portions, Herba veronicae 10 weight portions.
The crude drug composition of pharmaceutical composition of the present invention is preferably:
Radix Lamiophlomidis Rotatae 30 weight portions, Radix Gentianae Macrophyllae flower 2 weight portions, Fructus Malvae 28 weight portions, Rhizoma Curcumae Longae 2 weight portions, Borneolum Syntheticum 8 weight portions, Camphora 5 weight portions, Herba veronicae 28 weight portions.
The crude drug composition of pharmaceutical composition of the present invention is preferably:
Radix Lamiophlomidis Rotatae 5 weight portions, Radix Gentianae Macrophyllae flower 28 weight portions, Fructus Malvae 10 weight portions, Rhizoma Curcumae Longae 15 weight portions, Borneolum Syntheticum 2 weight portions, Camphora 8 weight portions, Herba veronicae 2 weight portions.
Get the above-mentioned composition crude drug, add conventional adjuvant, according to common process, make the dosage form of clinical acceptance, include but not limited to concentrated pill, capsule, drop pill, granule, tablet, soft capsule, slow releasing agent, oral liquid, lyophilized injectable powder, ointment or emplastrum.
Preparation of drug combination method of the present invention is a kind of in the following method:
Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Fructus Malvae, Rhizoma Curcumae Longae and Herba veronicae are carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower and Herba veronicae are ground into coarse powder, add 1~30 times of water gaging and extract 1~5 time, each 10~150 minutes, merge extractive liquid, is condensed into relative density and is 1.05~1.35 clear paste, and was standby; Again Rhizoma Curcumae Longae and Fructus Malvae are ground into fine powder, standby; Clear paste, fine powder, Borneolum Syntheticum and Camphora are mixed, add the dosage form that conventional adjuvant is made clinical acceptance;
Or Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Fructus Malvae, Rhizoma Curcumae Longae and Herba veronicae carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae and Fructus Malvae are ground into coarse powder, add 1~30 times of water gaging and extract 1~5 time, each 10~150 minutes, merge extractive liquid, is condensed into the clear paste that relative density is 1.05-1.35, and was standby; Clear paste, Borneolum Syntheticum and Camphora are mixed, add conventional adjuvant and make clinical acceptable forms;
Or Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Fructus Malvae, Rhizoma Curcumae Longae and Herba veronicae carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae and Fructus Malvae are ground into fine powder, standby; Fine powder, Borneolum Syntheticum and Camphora are mixed, add conventional adjuvant and make clinical acceptable forms.
Preparation of drug combination method of the present invention is preferably a kind of in the following method:
Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Fructus Malvae, Rhizoma Curcumae Longae and Herba veronicae are carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower and Herba veronicae are ground into coarse powder, add 10-20 times of water gaging and extract 1-3 time, each 20-90 minute, merge extractive liquid, is condensed into the clear paste that relative density is 1.05-1.35, and was standby; Again Rhizoma Curcumae Longae and Fructus Malvae are ground into fine powder, standby; Clear paste, fine powder, Borneolum Syntheticum and Camphora are mixed, add conventional adjuvant and make clinical acceptable forms;
Or Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Fructus Malvae, Rhizoma Curcumae Longae and Herba veronicae carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae, Fructus Malvae are ground into coarse powder, add 10~20 times of water gagings and extract 1~3 time, each 20~120 minutes, merge extractive liquid, is condensed into the clear paste that relative density is 1.05-1.35, and was standby; Clear paste, Borneolum Syntheticum and Camphora are mixed, add conventional adjuvant and make clinical acceptable forms;
Or Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Fructus Malvae, Rhizoma Curcumae Longae and Herba veronicae carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae and Fructus Malvae are ground into fine powder, standby; Fine powder, Borneolum Syntheticum and Camphora are mixed, add conventional adjuvant and make clinical acceptable forms.
Preparation of drug combination method of the present invention is preferably a kind of in the following method:
Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Fructus Malvae, Rhizoma Curcumae Longae and Herba veronicae are carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower and Herba veronicae are ground into coarse powder, add 14 times of water gagings and extract 3 times, each 60 minutes, merge extractive liquid, is condensed into the clear paste that relative density is 1.05-1.35, and was standby; Again Rhizoma Curcumae Longae and Fructus Malvae are ground into fine powder, standby; Clear paste, fine powder, Borneolum Syntheticum and Camphora are mixed, add conventional adjuvant and make clinical acceptable forms;
Or Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Fructus Malvae, Rhizoma Curcumae Longae and Herba veronicae carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae, Fructus Malvae are ground into coarse powder, add 14 times of water gagings and extract 3 times, each 60 minutes, merge extractive liquid, is condensed into the clear paste that relative density is 1.05-1.35, and was standby; Clear paste, Borneolum Syntheticum and Camphora are mixed, add conventional adjuvant and make clinical acceptable forms;
Or Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Fructus Malvae, Rhizoma Curcumae Longae and Herba veronicae carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae and Fructus Malvae are ground into fine powder, standby; Fine powder, Borneolum Syntheticum and Camphora are mixed, add conventional adjuvant and make clinical acceptable forms.
The raw material of pharmaceutical composition analgesic ointment unguentum of the present invention consists of:
Radix Lamiophlomidis Rotatae 1~50 weight portion, Radix Gentianae Macrophyllae flower 1~30 weight portion, Herba veronicae 1~30 weight portion, Fructus Malvae 1~30 weight portion, Rhizoma Curcumae Longae 1~30 weight portion, Borneolum Syntheticum 1~10 weight portion, Camphora 1~10 weight portion, sodium polyacrylate 1~5 weight portion, gelatin 0.5~1.5 weight portion, glycerol 7~21 weight portions, propylene glycol 3~11 weight portions, dihydroxyaluminum aminoacetate 0.1~0.3 weight portion, methyl hydroxybenzoate 0.1~0.3 weight portion, butoben 0.1~0.3 weight portion.
The raw material composition of pharmaceutical composition analgesic ointment unguentum of the present invention is preferably:
Radix Lamiophlomidis Rotatae 10~30 weight portions, Radix Gentianae Macrophyllae flower 1~10 weight portion, Herba veronicae 1~10 weight portion, Fructus Malvae 1~10 weight portion, Rhizoma Curcumae Longae 1~10 weight portion, Borneolum Syntheticum 1~5 weight portion, Camphora 1~5 weight portion, sodium polyacrylate 1~5 weight portion, gelatin 0.5~1.5 weight portion, glycerol 7~21 weight portions, propylene glycol 3~11 weight portions, dihydroxyaluminum aminoacetate 0.1~0.3 weight portion, methyl hydroxybenzoate 0.1~0.3 weight portion, butoben 0.1~0.3 weight portion.
The raw material composition of pharmaceutical composition analgesic ointment unguentum of the present invention is preferably:
Radix Lamiophlomidis Rotatae 20 weight portions, Radix Gentianae Macrophyllae flower 5 weight portions, Herba veronicae 5 weight portions, Fructus Malvae 4 weight portions, Rhizoma Curcumae Longae 4 weight, Borneolum Syntheticum 2 weight portions, Camphora 2 weight portions, sodium polyacrylate 3 weight portions, gelatin 1 weight portion, glycerol 14 weight portions, propylene glycol 7 weight portions, dihydroxyaluminum aminoacetate 0.2 weight portion, methyl hydroxybenzoate 0.2 weight portion, butoben 0.2 weight portion.
Get the combinations thereof raw material, add conventional adjuvant,, make the analgesic ointment unguentum of clinical acceptance according to common process.
The preparation method of pharmaceutical composition analgesic ointment unguentum of the present invention is a kind of in the following method:
Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Fructus Malvae and Rhizoma Curcumae Longae are carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae and Fructus Malvae are ground into coarse powder, in Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae coarse powder, add 1~30 times of water gaging and extract 1~5 time, each 10~150 minutes, filter, it is 1.05~1.35 clear paste that merging filtrate, filtrate are concentrated into relative density; It is standby that Fructus Malvae and Rhizoma Curcumae Longae coarse powder are ground into fine powder; Clear paste, fine powder, Borneolum Syntheticum, Camphora, sodium polyacrylate, gelatin, glycerol, propylene glycol, dihydroxyaluminum aminoacetate, methyl hydroxybenzoate, butoben and 20~70 weight parts waters are mixed, stir, coating, the lid lining cuts, and packing is promptly;
Or Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Fructus Malvae, Rhizoma Curcumae Longae and Herba veronicae carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae and Fructus Malvae are ground into coarse powder, add 1~30 times of water gaging and extract 1~5 time, each 10~150 minutes, merge extractive liquid, is condensed into relative density and is 1.05~1.35 clear paste, and was standby; Clear paste, Borneolum Syntheticum, Camphora, sodium polyacrylate, gelatin, glycerol, propylene glycol, dihydroxyaluminum aminoacetate, methyl hydroxybenzoate, butoben and 20~70 weight parts waters are mixed, stir, coating, the lid lining cuts, and packing is promptly.
The preparation method of analgesic ointment unguentum of the present invention is preferably a kind of in the following method:
Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Fructus Malvae and Rhizoma Curcumae Longae are carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae and Fructus Malvae are ground into coarse powder, in Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae coarse powder, add 14 times of water gagings and extract 3 times, each 60 minutes, filter, it is 1.25~1.32 clear paste that merging filtrate, filtrate are concentrated into relative density; It is standby that Fructus Malvae and Rhizoma Curcumae Longae coarse powder are ground into fine powder; Clear paste, fine powder, Borneolum Syntheticum, Camphora, sodium polyacrylate, gelatin, glycerol, propylene glycol, dihydroxyaluminum aminoacetate, methyl hydroxybenzoate, butoben and 20~70 weight parts waters are mixed, stir, coating, the lid lining cuts, and packing is promptly;
Or Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Fructus Malvae, Rhizoma Curcumae Longae and Herba veronicae carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae and Fructus Malvae are ground into coarse powder, add 14 times of water gagings and extract 3 times, each 60 minutes, merge extractive liquid, is condensed into relative density and is 1.25~1.32 clear paste, and was standby; Clear paste, Borneolum Syntheticum, Camphora, sodium polyacrylate, gelatin, glycerol, propylene glycol, dihydroxyaluminum aminoacetate, methyl hydroxybenzoate, butoben and 20~70 weight parts waters are mixed, stir, coating, the lid lining cuts, and packing is promptly.
Pharmaceutical composition of the present invention has blood circulation promoting and blood stasis dispelling, the eliminating stagnation of regulating the flow of vital energy, and the effect of heat clearing away is particularly useful for the nodules of the breast of caused by energy stagnation and blood stasis, the patient of distending pain of the breast, tuberosity and cyclomastopathy; After the medication, cyclomastopathy patient's body weight unknown significance reduces, breast wt significantly reduces, hormone serum level significantly reduces, breast is not seen enlargement, and lobules of mammary gland and body of gland are not seen hypertrophy, and acinus, conduit are not seen expansion, obviously suppress the rising of whole blood reduced viscosity and plasma viscosity, inhibited to nonspecific inflammation, pain there is certain inhibition trend, that the analgesic ointment unguentum is compared with other dosage forms is more soft, comfortable, drug loading is bigger, convenient drug administration, longer duration, interruption of the administration at any time, irritated rate is low, be easy to carry, not pollution clothes.
Description of drawings
Fig. 1: HE 10 * 40 normal rats lobules of mammary gland that dye
Fig. 2: HE 10 * 40 normal rats lobules of mammary gland that dye
Fig. 3: HE 10 * 40 model group rat mammary gland lobules that dye
Fig. 4: HE 10 * 40 model group rat mammary gland lobules that dye
Fig. 5: HE 10 * 40 positive drug group rat mammary gland lobules that dye
Fig. 6: HE dyeing 10 * 40 heavy dose of group rat mammary gland lobules
Dosage group rat mammary gland lobule in Fig. 7: the HE dyeing 10 * 40
Fig. 8: HE 10 * 40 small dose group rat mammary gland lobules that dye
Experiment and embodiment are used to further specify but are not limited to the present invention below.
Experimental example 1 test of pesticide effectiveness data
1. experiment material
1.1 medicine
Sample is that (preparation method: elder generation carries out remove impurity, cleaning, drying respectively with Radix Lamiophlomidis Rotatae 20g, Radix Gentianae Macrophyllae flower 5g, Herba veronicae 5g, Fructus Malvae 4g, Rhizoma Curcumae Longae 4g to drug extract of the present invention, and is standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae, Fructus Malvae are ground into coarse powder, get Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae coarse powder and add 14 times of water gagings and extract 3 times, each 60 minutes, filter, merging filtrate, it is 1.32 clear paste that filtrate is concentrated into relative density; With Fructus Malvae, that the Rhizoma Curcumae Longae coarse powder is ground into fine powder is standby.With clear paste, fine powder, Borneolum Syntheticum 2g, Camphora 2g mix homogeneously, promptly get extractum): every gram extract contains crude drug 1.1g, and Gansu Qizheng Tibetan Medicine Co., Ltd produces; Excipient; RUKANG PIAN: the 0.3g/ sheet, Ankang Chia Tai Pharmaceutical Co., Ltd. produces; Aspirin: the 40mg/ sheet, Beijing dawn Pharmaceutical Co., Ltd produces; Diclofenac diethylamine emulsion agent: 0.2g/g, Novartis Pharma AG produces; Estradiol benzoate injection: 2mg/ml, Shanghai General Pharmaceutical Co., ltd. produces; Progesterone injection: 20mg/ml, Shanghai General Pharmaceutical Co., ltd. produces; Iodine [ 125I] estradiol, progesterone radioimmunity test kit, the Beimian-Dongya Inst. of Biotechnology, Beijing; Pentobarbital sodium: BR, Chemical Reagent Co., Ltd., Sinopharm Group produces; Barium sulfate: CP, Chemical Reagent Co., Ltd., Sinopharm Group produces; Sodium citrate: AR, Beijing chemical reagents corporation produces; Carrageenin: U.S. SIGMA company produces; Dimethylbenzene: AR, chemical plant, Changhai, Beijing; Acetic acid: AR, Beijing chemical reagents corporation; Sodium chloride injection: 0.9%, Siyao Co., Ltd., Shijiazhuang produces.Cyclophosphamide is produced by Hengrui Medicine Co., Ltd., Jiangsu Prov., specification: every bottle of 200mg.
1.2 animal
Rat: the Wistar kind, female, body weight 200-220g, SPF level; Rat SD kind, body weight 120-140g, the SPF level, all available from Military Medical Science Institute's Experimental Animal Center, the quality certification number: SCXK (army) 2002-001.Mice: the ICR kind, body weight 20-30g, the SPF level, available from Inst. of Genetics and Development Biology, CAS's animal center, the quality certification number: SCXK (capital) 2002-0006.
1.3 instrument
Electronic analytical balance: the AR3130 type, degree of accuracy 0.001g, U.S. Ohaus company produces; Centrifuge: the J-6B type, U.S. Beckman company produces; The radioimmunity enumerator: GC-911-γ type, Chinese University of Science and Technology's industry head office is produced; Self-cleaning rotary viscosimeter: LBY-N6A, Beijing Puli gives birth to company and produces.SAKURA automatic dehydration machine, Japan produces; The Leitz microtome, Germany produces; The RAH-100 automatic staining machine, Japan; The automatic microphotograph of OLYMPUS BH-2 system, Japan produces.
2 experimental techniques and result
The setting of dosage:
Clinical plan dosage is: everyone intended external and was affixed on mammary gland place consumption: 4.2g (crude drug)/sheet * 2 slice=8.4g (crude drug)/d/ people every day, every day per kilogram people consumption: 8.4g ÷ 60kg=0.14g (crude drug)/kg.
Convert with body weight:
The quite clinical plan of rat, high dose is 5g (crude drug)/kg with 36 times of dosage; The quite clinical plan of middle dosage is 2.5g (crude drug)/kg with 18 times of dosage; The quite clinical plan of low dosage is 1.25g (crude drug)/kg with 9 times of dosage.
Convert with body surface area:
The quite clinical plan of rat, high dose is with 6.66 times of dosage, and the quite clinical plan of middle dosage is with 3.33 times of dosage, and the quite clinical plan of low dosage is with 1.67 times of dosage.
[high dose: 8.4g (crude drug) ÷ 56 (coefficient) ÷ 0.2=0.75g (crude drug)/kg, 5g (crude drug)/kg ÷ 0.75=6.66 (doubly)]
Data statistical approach:
Continuous data adds standard deviation with mean and represents, is expressed as: X ± S, add up with t check between group, and data are done two prescription difference test of homogeneity (F check); Enumeration data (breast lesion degree result) add up with the nonparametric rank test.
2.1 inhibitory action to hyperplasia of mammary gland model
Method: get the Wistar kind female rats of body weight 200-220g, around the 2nd, 3 pairs of breast of mammary gland with 35% BaSO 4The batter external application, depilation, the about 4 * 4cm of preserved skin 2, be divided into 6 groups at random, i.e. normal control group, model control group, positive drug (RUKANG PIAN) matched group, the high, medium and low dosage group of sample, 10 every group.Except that normal group, all the other equal intramuscular injection estradiol benzoate 0.5mg/kg, 1 time/day, continuous 20 days, intramuscular injection Progesterone 5mg/kg after 20 days, 1 time/day, continuous 5 days.Normal control group intramuscular injection normal saline 0.2ml/ only injected 25 days continuously.Each group of modeling administration simultaneously evenly is applied in the 2nd, 3 pairs of breast places of rat chest according to dosed administration in the table 1 with sample, and the coating area of every pair of breast is 1 * 2cm 2, the coating gross area of every rat is 4cm 2(1 * 2 * 2cm 2), the administration volume is 1g.Sample high dose 5g (crude drug)/kg, middle dosage 2.5g (crude drug)/kg, low dosage 1.25g (crude drug)/kg, 36,18,9 times of suitable clinical dosage respectively, model group gives the equal-volume excipient, positive drug RUKANG PIAN 0.675g/kg gastric infusion, dosage is equivalent to 15 times of clinical dosage, every day 1 time, successive administration 25 days.Take by weighing body weight weekly once, and adjust dosage according to body weight.Each organizes rat fasting 16h before the last administration, and administration took by weighing the weight of animals after 1 hour, the anesthesia of injection sodium pentobarbital, and femoral artery is got blood, and is centrifugal, gets determination of serum estradiol (E 2) and progesterone (P) level; Taking off cervical vertebra and put to death animal, is the card punch of 10mm with diameter, respectively with the 2nd, 3 pairs of breast are to draw materials in the center, and the back of drawing materials is fixed in 10% the formalin with organizing balance to weigh rapidly, paraffin embedding, section, HE dyeing is observed the tectology of respectively organizing rat mammary gland and is changed under light microscopic, 2 visuals field of every sample picked at random, get the quantity of its meansigma methods counting lobules of mammary gland and the height of lumen of gland, add up the comparable group differences according to the sxemiquantitative grade scale of lesion degree.
2.1.1 influence to the hyperplasia of mammary gland model rat body weight
Compare with normal group, the back appearance obviously alleviates the model group rat body weight in 1 week of modeling, and lasts till that always modeling finishes; Compare with model group, each administration group rat body weight unknown significance reduces.See Table 1.
The influence of table 1 pair hyperplasia of mammary gland model rat body weight (X ± S, n=10, g)
Figure G2009101199276D00091
Annotate: compare #P<0.05, ##P<0.01 with normal group
2.1.2 influence to hyperplasia of mammary gland model rat breast weight
Compare with normal group, the 2nd, 3 pairs of breast wts of model group rat all significantly increase.Compare with model group, sample height, middle dosage group can obviously reduce the weight of the 2nd, 3 pairs of breast of cyclomastopathy rat, low dose group can obviously reduce the weight of the 2nd pair of breast of cyclomastopathy rat, but low dose group is not obvious to the influence of the 3rd pair of breast wt, sees Table 2.
The influence of table 2 pair hyperplasia of mammary gland model rat breast weight (X ± S, n=10)
Figure G2009101199276D00092
Annotate: compare #P<0.05, ##P<0.01 with normal group; Compare * P<0.05 with model group; * P<0.01
2.1.3 influence to hyperplasia of mammary gland model rat blood serum hormonal readiness
Compare the E of model group rat with normal group 2Level significantly raises, and the P level significantly reduces, E 2/ P ratio significantly raises.Compare the E of RUKANG PIAN group rat with model group 2Level obviously reduces, E 2/ P ratio significantly reduces; The E of sample high dose group rat 2/ P ratio significantly reduces, and high, medium and low dosage group is to E 2With all influential trend of P level, but there was no significant difference sees Table 3.
The influence of table 3 pair hyperplasia of mammary gland model rat hormonal readiness (X ± S, n=10)
Figure G2009101199276D00101
Annotate: compare #P<0.05, ##P<0.01 with normal group; Compare * P<0.05 with model group; * P<0.01
2.1.4 influence to hyperplasia of mammary gland model rat mammary gland pathological tissue
To the rat breast perusal as seen, the rats in normal control group nipple is not seen increase.Model control group rat nipple obviously increases, and the breast most of fat in edge of drawing materials turns up.High, medium and low dosage group of administration and positive drug group rat nipple are not seen obvious increase.
As seen mirror is observed down, and rats in normal control group lobules of mammary gland and body of gland do not see and increase that acinus does not see that expansion is arranged, and organizational structure is normal.Model control group rat mammary gland lobule increases, number increases, and merges mutually to form irregular leaflet structure, and acinus is many and close, and lobule tip ductal epithelium has hypertrophy; The acinus expansion, the acinus size of expansion is irregular, and the pink colour exudate is arranged, and conduit has expansion in various degree, and a matter has a small amount of inflammatory cell infiltration, based on primary lymphedema.High, medium and low three dosage groups of administration and positive drug group rat mammary gland lobule increase, the acinus expansion, between matter have pathological changes such as mild inflammation that alleviating in various degree all arranged, add up according to the sxemiquantitative grade scale, high, middle dosage group is compared significant difference with model group, low dosage has effect trend, but there was no significant difference; High, middle dosage all can obviously suppress the lobules of mammary gland number, and high, medium and low three dosage all can obviously suppress mammary gland lumen of gland height, with the model group significant difference, sees Table 4,5,6; Accompanying drawing 1-8.
Table 4 couple hyperplasia of mammary gland model rat breast perusal result (n=10)
Figure G2009101199276D00111
Annotate: compare #P<0.05, ##P<0.01 with normal group; Compare * P<0.05 with model group; * P<0.01
Grade scale:
"-": breast is not seen enlargement;
"+": breast silght enlargement, tangent plane are seen the yellow fat granule, do not see and ooze out;
" ++ ": breast moderate swelling, tangent plane are seen the yellow fat granule, do not see and ooze out;
" +++": the obvious enlargement of breast, tangent plane is seen the yellow fat granule, has and oozes out.
Table 5 pair hyperplasia of mammary gland model rat mammary gland pathological tissue influence I (n=10)
Figure G2009101199276D00112
Annotate: compare #P<0.05, ##P<0.01 with normal group; Compare * P<0.05 with model group; * P<0.01
Grade scale:
"-": lobules of mammary gland and body of gland are not seen hypertrophy, and acinus, conduit are not seen expansion;
"+": lobules of mammary gland and body of gland have hypertrophy, and acinus does not see to have and increase that conduit is not seen expansion;
" ++ ": lobules of mammary gland and body of gland have hypertrophy, and acinus has and increases, and conduit is not seen expansion, and a matter has inflammatory infiltration;
" +++": lobules of mammary gland and body of gland have obvious hypertrophy, and the acinus number has showed increased, and conduit is slightly expanded, and a matter has inflammatory infiltration.
Table 6 pair hyperplasia of mammary gland model rat mammary gland pathological tissue influence II (n=10) (200 times light microscopics measure down)
Figure G2009101199276D00121
Annotate: compare with normal group, #P<0.05, ##P<0.01; Compare with model group *P<0.05; *P<0.01
2.2 inhibitory action to the nonspecific inflammation model
2.2.1 on Carrageenan causes the influence of rat paw edema model
Getting body weight is the male SD kind of 120-140g rat, shaves hair, the about 4 * 4cm of preserved skin around the 2nd, 3 pairs of breast of mammary gland 2, be divided into 5 groups at random, i.e. model control group, positive controls, the high, medium and low dosage group of sample, 10 every group.According to dosage in the table 7 sample evenly is applied in the 2nd, 3 pairs of breast places of rat chest, the coating area of every pair of breast is 1 * 2cm 2, the coating gross area of every rat is 4cm 2(1 * 2 * 2cm 2), dosage is 1.2g.Sample high dose 5g (crude drug)/kg, middle dosage 2.5g (crude drug)/kg, low dosage 1.25g (crude drug)/kg, 36,18,9 times of suitable clinical dosage respectively, model group gives commensurability substrate.Positive drug aspirin gastric infusion, 37mg/kg is equivalent to 8 times of clinical dosages, and the administration volume is 1ml/100g, every day 1 time, successive administration 6 days.1h after the inferior administration, the carrageenin with 1% inject rat foot (it is subcutaneous to inject the sufficient sole of the foot, and the animal hind leg is stretching, and syringe needle thrusts the subcutaneous elder generation in sufficient sole of the foot middle part, and upwards injection is a part of, turns syringe needle again to having made a bet, altogether 0.1ml).Respectively at injecting back 30min, 1.0h, 1.5h, 2.0h, with threeway capillary tube measurement by magnification foot sole of the foot volumetric method, survey sufficient sole of the foot volume, calculate swelling rate and suppression ratio.
The result shows, compares with model group, and the big or middle dosage group of sample extractum can obviously suppress carrageenin and cause the rat paw edema rate, and its onset time is 1.5-2.5h behind the medicine, and low dose group shows certain inhibition trend, but does not relatively have significant difference with model group, sees Table 7.
The influence of table 7 on Carrageenan rat paw edema (X ± S, n=10)
Figure G2009101199276D00131
Annotate: compare #P<0.05, ##P<0.01 with normal group; Compare * P<0.05 with model group; * P<0.01.
3.2 xylol causes the influence of mice ear model
Getting body weight is the male ICR kind of 25-30g mice, shaves hair, the about 2 * 3cm of preserved skin around the 2nd, 3 pairs of breast of mammary gland 2, be divided into 5 groups at random according to body weight, i.e. model control group, positive drug control group, the high, medium and low dosage group of sample extractum, 10 every group.According to dosage in the table 8 sample evenly is applied in around the 2nd, 3 pairs of breast of mice chest respectively, the coating gross area of every mice is 2cm 2(1 * 1 * 2cm 2), dosage is 0.8g.Positive drug diclofenac ethylenediamine emulsion agent 1ml (preparation)/kg, sample high dose 3.9g (crude drug)/kg, middle dosage 1.95g (crude drug)/kg, low dosage 0.98g (crude drug)/kg, the dose,equivalent of suitable rat administration respectively.Model control group is smeared the equal-volume excipient.Successive administration 5 days, 1h is applied in the wide both sides of mouse right ear with dimethylbenzene 50 μ l after the last administration, puts to death behind the 40min, cuts two ears, takes off left and right sides auricle with the card punch of diameter 8mm, organizes balance to weigh, calculating swelling degree and swelling rate, comparable group differences.
The result shows, with model group relatively, sample extractum high dose group can obviously suppress the dimethylbenzene mice ear, in, low dose group all shows certain inhibitory action, sees Table 8.
The influence of table 8 sample extractum xylol mice ear (X ± S, n=10)
Figure G2009101199276D00132
Annotate: compare #P<0.05, ##P<0.01 with normal group; Compare * P<0.05 with model group; * P<0.01.
3.3 sample extractum is to the inhibitory action (glacial acetic acid being caused the influence of mouse writhing reaction) of pain model
Getting body weight is the male ICR kind of 20-22g mice, shaves hair, the about 2 * 3cm of preserved skin around the 2nd, 3 pairs of breast of mammary gland 2, be divided into 5 groups at random according to body weight, i.e. model control group, positive drug control group, the high, medium and low dosage group of sample extractum, 10 every group.According to dosage in the table 9 sample extractum evenly is applied in around the 2nd, 3 pairs of breast of mice chest respectively, the coating gross area of every mice is 2cm 2(1 * 2cm 2), dosage is 0.8g.Positive drug diclofenac ethylenediamine emulsion agent 1ml (preparation)/kg, sample extractum high dose 3.9g (crude drug)/kg, middle dosage 1.95g (crude drug)/kg, low dosage 0.98g (crude drug)/kg, the dose,equivalent of suitable rat respectively.Model control group is smeared the equal-volume excipient, successive administration 5 days, and 1h lumbar injection 0.6% glacial acetic acid solution 0.2ml after the last administration observes the time (incubation period) that occurs writhing response in every mice 30min and turns round the body number of times, the comparable group differences.
The result shows, compares with model group, and the positive drug group can obviously prolong the incubation period that writhing response appears in mice, reduces and turns round the body number of times, and the high, medium and low three dosage groups of sample extractum all show certain inhibitory action, see Table 9.
Table 9 pair chemical stimulation cause mouse writhing reaction influence (X ± S, n=10)
Figure G2009101199276D00141
Annotate: compare #P<0.05, ##P<0.01 with normal group; Compare * P<0.05 with model group; * P<0.01
4 conclusions
Change 4.1 sample extractum can obviously suppress the pathologic of mammary gland due to the rat mammary gland model of hyperplasia, obviously suppress the rising of whole blood reduced viscosity and plasma viscosity due to the model.Prompting, this product is inhibited to tentative hyperplasia of mammary gland model, and has certain function of promoting blood circulation to disperse blood clots.
4.2 sample extractum can obviously suppress chondrus ocellatus Holmes colloidality rat paw edema and dimethylbenzene mice ear.Prompting, this product is inhibited to the nonspecific inflammation model.
4.3 sample extractum shows certain inhibition trend to glacial acetic acid induced mice pain model.
The contrast of experimental example 2 dosage forms
The analgesic ointment unguentum obviously is better than other dosage forms, and comparing result is as follows:
Table 11: dosage form selection screening table:
Figure G2009101199276D00151
Following embodiment all can realize the effect of above-mentioned experimental example.
The specific embodiment
Embodiment 1: the analgesic ointment unguentum
Earlier Radix Lamiophlomidis Rotatae 20g, Radix Gentianae Macrophyllae flower 5g, Herba veronicae 5g, Fructus Malvae 4g, Rhizoma Curcumae Longae 4g are carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae, Fructus Malvae are ground into coarse powder, get Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae coarse powder and add 14 times of water gagings and extract 3 times, each 60 minutes, filter, merging filtrate, it is 1.32 clear paste that filtrate is concentrated into relative density; With Fructus Malvae, that the Rhizoma Curcumae Longae coarse powder is ground into fine powder is standby.Clear paste, fine powder, Borneolum Syntheticum 2g, Camphora 2g, sodium polyacrylate 3g, gelatin 1g, glycerol 14g, propylene glycol 7g, dihydroxyaluminum aminoacetate 0.2g, methyl hydroxybenzoate 0.2g, butoben 0.2g and 50g water are mixed, stir coating, lid lining, cut, packing promptly gets emplastrum.
Embodiment 2: rubber-emplastrum
Earlier Radix Lamiophlomidis Rotatae 30g, Radix Gentianae Macrophyllae flower 2g, Herba veronicae 28g, Fructus Malvae 28g, Rhizoma Curcumae Longae 2g are carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae, Fructus Malvae are ground into coarse powder, add 10 times of water gagings and extract 2 times, each 50 minutes, merge extractive liquid, is condensed into relative density and is 1.25 clear paste, and was standby; Clear paste, Borneolum Syntheticum 8g, Camphora 5g are mixed, add natural rubber, zinc oxide, lanoline, liquid paraffin is made rubber-emplastrum, and coating cuts, packing, packing is promptly.
Embodiment 3: capsule
Earlier Radix Lamiophlomidis Rotatae 50g, Radix Gentianae Macrophyllae flower 10g, Herba veronicae 10g, Fructus Malvae 5g, Rhizoma Curcumae Longae 30g are carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae, Fructus Malvae are ground into coarse powder, add 15 times of water gagings and extract 3 times, each 60 minutes, merge extractive liquid, is condensed into relative density and is 1.05 clear paste, and was standby; Clear paste, Borneolum Syntheticum 5g, Camphora 2g are mixed, add starch, sodium carboxymethyl cellulose, carboxymethyl starch sodium is granulated, and fills, and packing is promptly.
Embodiment 4: tablet
Earlier Radix Lamiophlomidis Rotatae 5g, Radix Gentianae Macrophyllae flower 28g, Herba veronicae 2g, Fructus Malvae 10g, Rhizoma Curcumae Longae 15g are carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae, Fructus Malvae are ground into coarse powder, add 20 times of water gagings and extract 2 times, each 70 minutes, merge extractive liquid, is condensed into relative density and is 1.35 clear paste, and was standby; Clear paste, Borneolum Syntheticum 2g, Camphora 8g are mixed, add starch, sodium carboxymethyl cellulose, carboxymethyl starch sodium is granulated, and adds Pulvis Talci, mix homogeneously, tabletting, packing is promptly.
Embodiment 5: aerosol
Earlier Radix Lamiophlomidis Rotatae 20g, Radix Gentianae Macrophyllae flower 30g, Herba veronicae 10g, Fructus Malvae 7g, Rhizoma Curcumae Longae 6g are carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae, Fructus Malvae are ground into coarse powder, add 20 times of water gagings and extract 2 times, each 70 minutes, merge extractive liquid, is condensed into relative density and is 1.35 clear paste, and was standby; Clear paste, Borneolum Syntheticum 2g, Camphora 4g are mixed, add polyoxyethylene sorbitan monoleate, polyvinylpyrrolidone, propellant is filled in fill, and packing is promptly.
Embodiment 6: gel
Earlier Radix Lamiophlomidis Rotatae 500g, Radix Gentianae Macrophyllae flower 30g, Herba veronicae 40g, Fructus Malvae 20g, Rhizoma Curcumae Longae 60g are carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae, Fructus Malvae are ground into coarse powder, add 20 times of water gagings and extract 2 times, each 70 minutes, merge extractive liquid, is condensed into relative density and is 1.35 clear paste, and was standby; Clear paste, Borneolum Syntheticum 20g, Camphora 40g are mixed, add card pool nurse, glycerol, propylene glycol, triethanolamine and suitable quantity of water are mixed, stir, fill, packing is promptly.
Embodiment 7: ointment
Earlier Radix Lamiophlomidis Rotatae 100g, Radix Gentianae Macrophyllae flower 30g, Herba veronicae 40g, Fructus Malvae 100g, Rhizoma Curcumae Longae 20g are carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae, Fructus Malvae are ground into coarse powder, add 20 times of water gagings and extract 2 times, each 70 minutes, merge extractive liquid, is condensed into relative density and is 1.35 clear paste, and was standby; With clear paste, medicated powder, glycerol, polyoxyethylene sorbitan monoleate mixes, and is heated to 80 degree as water, with liquid paraffin, span mix homogeneously, be heated to 80 degree as oil phase, then that oil phase is mixed with water, stir and cooling, when reducing to 40 °, equitemperature adds borneo camphor ethanol liquid, continue to be stirred to below 37 degrees centigrade, go out cream, fill, packing is promptly.
Embodiment 8: concentrated pill
Earlier Radix Lamiophlomidis Rotatae 200g, Radix Gentianae Macrophyllae flower 300g, Herba veronicae 40g, Fructus Malvae 150g, Rhizoma Curcumae Longae 300g are carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae, Fructus Malvae are ground into coarse powder, get Radix Lamiophlomidis Rotatae, Herba veronicae, Radix Gentianae Macrophyllae flower coarse powder and add 20 times of water gagings and extract 2 times, each 70 minutes, merge extractive liquid, is condensed into relative density and is 1.35 clear paste, and was standby; Fructus Malvae, Rhizoma Curcumae Longae coarse powder are ground into fine powder, and with clear paste, fine powder, Borneolum Syntheticum 20g, Camphora 40g mix, pill, and oven dry, coating, packing is promptly.
Embodiment 9: injectable powder
Earlier Radix Lamiophlomidis Rotatae 20g, Radix Gentianae Macrophyllae flower 10g, Herba veronicae 10g, Fructus Malvae 7g, Rhizoma Curcumae Longae 10g are carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae, Fructus Malvae are ground into coarse powder, add 20 times of water gagings and extract 2 times, each 70 minutes, merge extractive liquid, is condensed into relative density and is 1.35 clear paste, and was standby; Clear paste, Borneolum Syntheticum 2g, Camphora 4g are mixed, lyophilization, packing, packing is promptly.
Embodiment 10: soft capsule
Earlier Radix Lamiophlomidis Rotatae 30g, Radix Gentianae Macrophyllae flower 10g, Herba veronicae 4g, Fructus Malvae 16g, Rhizoma Curcumae Longae 20g are carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae, Fructus Malvae are ground into coarse powder, add 20 times of water gagings and extract 2 times, each 70 minutes, merge extractive liquid, is condensed into relative density and is 1.35 clear paste, and was standby; Clear paste, Borneolum Syntheticum 2g, Camphora 4g are mixed, and the soft capsule of packing into divides packing promptly.
Embodiment 11: the oral sustained release sheet
Earlier Radix Lamiophlomidis Rotatae 15g, Radix Gentianae Macrophyllae flower 30g, Herba veronicae 20g, Fructus Malvae 10g, Rhizoma Curcumae Longae 30g are carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae, Fructus Malvae are ground into coarse powder, add 20 times of water gagings and extract 2 times, each 70 minutes, merge extractive liquid, is condensed into relative density and is 1.35 clear paste, and was standby; Clear paste, Borneolum Syntheticum 2g, Camphora 4g are mixed, and polyacrylic resin is granulated, tabletting, and packing is promptly.
Embodiment 12: oral liquid
Earlier Radix Lamiophlomidis Rotatae 20g, Radix Gentianae Macrophyllae flower 8g, Herba veronicae 9g, Fructus Malvae 4g, Rhizoma Curcumae Longae 10g are carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae, Fructus Malvae are ground into coarse powder, add 20 times of water gagings and extract 2 times, each 70 minutes, merge extractive liquid, is condensed into relative density and is 1.35 clear paste, and was standby; Clear paste, Borneolum Syntheticum 2g, Camphora 4g are mixed, add protein sugar, mannitol, suitable quantity of water etc. mix, fill, packing is promptly.

Claims (7)

1. treat cyclomastopathy for one kind, the analgesic ointment unguentum of nonspecific inflammation or inhibition of pain is characterized in that the raw material of this analgesic ointment unguentum consists of: Radix Lamiophlomidis Rotatae 10~30 weight portions, Radix Gentianae Macrophyllae flower 1~10 weight portion, Herba veronicae 1~10 weight portion, Fructus Malvae 1~10 weight portion, Rhizoma Curcumae Longae 1~10 weight portion, Borneolum Syntheticum 1~5 weight portion, Camphora 1~5 weight portion, sodium polyacrylate 1~5 weight portion, gelatin 0.5~1.5 weight portion, glycerol 7~21 weight portions, propylene glycol 3~11 weight portions, dihydroxyaluminum aminoacetate 0.1~0.3 weight portion, methyl hydroxybenzoate 0.1~0.3 weight portion, butoben 0.1~0.3 weight portion.
2. analgesic ointment unguentum as claimed in claim 1 is characterized in that the raw material of this analgesic ointment unguentum consists of: Radix Lamiophlomidis Rotatae 20 weight portions, Radix Gentianae Macrophyllae flower 5 weight portions, Herba veronicae 5 weight portions, Fructus Malvae 4 weight portions, Rhizoma Curcumae Longae 4 weight, Borneolum Syntheticum 2 weight portions, Camphora 2 weight portions, sodium polyacrylate 3 weight portions, gelatin 1 weight portion, glycerol 14 weight portions, propylene glycol 7 weight portions, dihydroxyaluminum aminoacetate 0.2 weight portion, methyl hydroxybenzoate 0.2 weight portion, butoben 0.2 weight portion.
3. the preparation method of analgesic ointment unguentum as claimed in claim 1 or 2 is characterized in that this method is a kind of in the following method:
Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Fructus Malvae and Rhizoma Curcumae Longae are carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae and Fructus Malvae are ground into coarse powder, in Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae coarse powder, add 1~30 times of water gaging and extract 1~5 time, each 10~150 minutes, filter, it is 1.05~1.35 clear paste that merging filtrate, filtrate are concentrated into relative density; It is standby that Fructus Malvae and Rhizoma Curcumae Longae coarse powder are ground into fine powder; Clear paste, fine powder, Borneolum Syntheticum, Camphora, sodium polyacrylate, gelatin, glycerol, propylene glycol, dihydroxyaluminum aminoacetate, methyl hydroxybenzoate, butoben and 20~70 weight parts waters are mixed, stir, coating, the lid lining cuts, and packing is promptly;
Or Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Fructus Malvae, Rhizoma Curcumae Longae and Herba veronicae carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae and Fructus Malvae are ground into coarse powder, add 1~30 times of water gaging and extract 1~5 time, each 10~150 minutes, merge extractive liquid, is condensed into relative density and is 1.05~1.35 clear paste, and was standby; Clear paste, Borneolum Syntheticum, Camphora, sodium polyacrylate, gelatin, glycerol, propylene glycol, dihydroxyaluminum aminoacetate, methyl hydroxybenzoate, butoben and 20~70 weight parts waters are mixed, stir, coating, the lid lining cuts, and packing is promptly.
4. the preparation method of analgesic ointment unguentum as claimed in claim 3 is characterized in that this method is a kind of in the following method:
Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Fructus Malvae and Rhizoma Curcumae Longae are carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae and Fructus Malvae are ground into coarse powder, in Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae coarse powder, add 14 times of water gagings and extract 3 times, each 60 minutes, filter, it is 1.25~1.32 clear paste that merging filtrate, filtrate are concentrated into relative density; It is standby that Fructus Malvae and Rhizoma Curcumae Longae coarse powder are ground into fine powder; Clear paste, fine powder, Borneolum Syntheticum, Camphora, sodium polyacrylate, gelatin, glycerol, propylene glycol, dihydroxyaluminum aminoacetate, methyl hydroxybenzoate, butoben and 20~70 weight parts waters are mixed, stir, coating, the lid lining cuts, and packing is promptly;
Or Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Fructus Malvae, Rhizoma Curcumae Longae and Herba veronicae carried out remove impurity, cleaning, drying respectively, standby; Again Radix Lamiophlomidis Rotatae, Radix Gentianae Macrophyllae flower, Herba veronicae, Rhizoma Curcumae Longae and Fructus Malvae are ground into coarse powder, add 14 times of water gagings and extract 3 times, each 60 minutes, merge extractive liquid, is condensed into relative density and is 1.25~1.32 clear paste, and was standby; Clear paste, Borneolum Syntheticum, Camphora, sodium polyacrylate, gelatin, glycerol, propylene glycol, dihydroxyaluminum aminoacetate, methyl hydroxybenzoate, butoben and 20~70 weight parts waters are mixed, stir, coating, the lid lining cuts, and packing is promptly.
5. the application of analgesic ointment unguentum as claimed in claim 1 or 2 in the medicine of preparation treatment cyclomastopathy.
6. the application of analgesic ointment unguentum as claimed in claim 1 or 2 in the medicine of preparation treatment nonspecific inflammation.
7. the application of analgesic ointment unguentum as claimed in claim 1 or 2 in the medicine of preparation inhibition of pain.
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