CN1850202A - Vagina external-use medicine composition and its preparing method and use - Google Patents
Vagina external-use medicine composition and its preparing method and use Download PDFInfo
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- CN1850202A CN1850202A CN 200510020778 CN200510020778A CN1850202A CN 1850202 A CN1850202 A CN 1850202A CN 200510020778 CN200510020778 CN 200510020778 CN 200510020778 A CN200510020778 A CN 200510020778A CN 1850202 A CN1850202 A CN 1850202A
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Abstract
The present invention provides a Chinese medicine composition for external application for vagina. Said Chinese medicine composition is made up by using 7 Chinese medicinal materials of sophora alopecuroides, baeckea frutescens, phellodendron bark, violet, cnidium seed, borneol and licorice through a certain preparation process. Said invention has the effects of resisting bateria, relieving inflammation, resisting trichomonad and relieving itching, etc.
Description
Technical field
The present invention relates to a kind of is the pharmaceutical composition that raw material is made with Chinese medicine, specifically, relates to a kind of externally-applied medicinal composition for the treatment of the gynaecologic vaginal inflammation, belongs to the field of Chinese medicines.
Background technology
According to various kinds of document such as " Chinese mother ands child care ", show through survey result: the sickness rate in the adult female such as all kinds of gynecological inflammations such as female private part pruritus, leucorrhoea grow in quantity, lower body abnormal flavour and disease is up to more than 69%; WHO World Health Organization (WHO) announces that the gynaecopathia sickness rate is 40% according to statistics, and the married woman almost is 70%.If it is untimely that above-mentioned gynecological inflammation is handled, can have a strong impact on quality of life and happy family life, and learn, work, cause the household economy burden; Very then cause influence and the able-bodied diseases of harm people such as constipation, obesity, infertility.
From the theory of Chinese medical science angle, women's pudendum and pruritus of vagina, it itches pain unbearably, and the uneasy in either sitting or lying person is called " pudendal pruritus ", also claims " vaginal orifice pruritus ".Disease is seen: pudendum has the intravaginal pruritus, very then very itch unbearably, and uneasy in either sitting or lying, profuse leukorrhea, Se Bai or oxious gas is arranged, vaginal secretions increases, and is yellow thick and smelly, companion's bitter taste, dry pharynx, yellowish fur, wiry and frequent pulse.How the cause of disease is by insufficiency of the spleen stagnation of liver-QI, damp invasion of lower energizer, or cloudy anemia consumption, and living air slaking are dry, or infect worm, and worm disturbs pudendum, and sending out is that clothes are itched, and causes various colpitis.If damp and hot heavier person can be involved back the moon and femoribus internus.The treatment aspect is as causing because of damp and hot, when eliminating damp-heat is main.Pruritus vulvae due to damp-heat pathogen flowing down to lower-JIAO is controlled and should be let out dampness-heat in the liver and gallbladder clearly.For oral administration and two kinds of method for makings of washout are often arranged clinically, and general outer washing medicine Cortex Phellodendri commonly used, Semen Arecae, Rhizoma Smilacis Glabrae, Fructus Cnidii, living Alumen, Pericarpium Zanthoxyli, Radix Glycyrrhizae etc. are fried in shallow oil water smoking and are washed pudendum.Or embrocate vagina and pudendum with 1% Gentian Violet aqueous solution, and 3～4 times weekly, 2 weeks of logotype.But above-mentioned external used medicine commonly used, life cycle is long, curative effect is not obvious, defectives such as inconvenience, the smell is awful are carried in use.
Summary of the invention
Technical scheme to be solved by this invention provides a kind of pharmaceutical composition of new vagina external, and another technical scheme of the present invention has provided the preparation of drug combination method and the purposes of this vagina external.
The invention provides a kind of vagina external-use medicine composition, it is to contain the medicament that the following weight proportion raw material is prepared from:
20～160 parts of Folium Baeckeaes, 20～160 parts of Sophora Alopecuroides L.s, 14～26 parts of Cortex Phellodendris, 4～16 parts of Herba Corydalis Bungeanaes, 4～16 parts of Fructus Cnidiis, 4～10 parts in Radix Glycyrrhizae.
Its raw material also contains: 0.04～0.16 part of Borneolum Syntheticum.
Further, it is the medicament that is prepared from by the following weight proportion raw material:
20～160 parts of Folium Baeckeaes, 20～160 parts of Sophora Alopecuroides L.s, 14～26 parts of Cortex Phellodendris, 4～16 parts of Herba Corydalis Bungeanaes, 4～6 parts of Fructus Cnidiis, 4～10 parts in Radix Glycyrrhizae, 0.04～0.16 part of Borneolum Syntheticum.
Further, it is the medicament that is prepared from by the following weight proportion raw material:
40～120 parts of Folium Baeckeaes, 40～120 parts of Sophora Alopecuroides L.s, 16～24 parts of Cortex Phellodendris, 6～14 parts of Herba Corydalis Bungeanaes, 6～14 parts of Fructus Cnidiis, 4～10 parts in Radix Glycyrrhizae, 0.04～0.16 part of Borneolum Syntheticum.
Wherein, the extractive of volatile oil with Folium Baeckeae is active component I; The acid extraction thing of Sophora Alopecuroides L., Cortex Phellodendri is active component II; Medicinal residues after Herba Corydalis Bungeanae, Fructus Cnidii, Radix Glycyrrhizae and Folium Baeckeae, Sophora Alopecuroides L., the Cortex Phellodendri extraction mix, water is carried, and gained water extract and Folium Baeckeae aqueous solution are active component III; With active component I, II, III and Borneolum Syntheticum, add acceptable accessories or complementary composition, be prepared into vagina external preparation pharmaceutically commonly used.
Wherein, described preparation is external-use lotion, suppository, vagina soft capsule, vaginal gel, vagina with membrane, vaginal effervescent tablet, vagina with foam, vagina with aerosol, vagina with ointment, vagina with lozenge, vagina pill.
The pH value of described external-use lotion is: 4～7; The hydrochloric berberine C of described external-use lotion
20H
17NO
4.HCl must not be less than 0.4mg/ml.
The present invention also provides this preparation of drug combination method, comprises the steps:
A, be active component I with the extractive of volatile oil of Folium Baeckeae;
The acid extraction thing of b, Sophora Alopecuroides L., Cortex Phellodendri is active component II;
Medicinal residues after c, Herba Corydalis Bungeanae, Fructus Cnidii, Radix Glycyrrhizae and Folium Baeckeae, Sophora Alopecuroides L., the Cortex Phellodendri extraction mix, water is carried, and gained water extract and Folium Baeckeae aqueous solution are active component III;
D, with active component I, II, III and Borneolum Syntheticum, add acceptable accessories or complementary composition, be prepared into vagina external preparation pharmaceutically commonly used.
More than seven flavors, get the Folium Baeckeae medical material, with steam distillation 2～3 hours, collect volatile oil and Aromatic water in addition device preserve.Sophora Alopecuroides L., Cortex Phellodendri make solvent with 10～18 times of 0.6%v/v hydrochloric acid solutions, flood to carry out percolation after 24 hours, and it is standby that percolate is condensed into clear paste; (mainly contain the alkaloids composition in the Sophora Alopecuroides L., as bitter legumin etc., according to alkaloidal character, the form that is salt with acid solution exists, and is soluble in sour water, so select for use hydrochloric acid as the extraction solvent.Contain berberine in the Cortex Phellodendri, phellodendrine is biological alkali components, so select for use hydrochloric acid solution to extract); Medicinal residues after Herba Corydalis Bungeanae, Fructus Cnidii, Radix Glycyrrhizae and above three flavors extract decoct with water secondary, and each 2 hours, collecting decoction, filter, add ethanol after filtrate concentrates and make that to contain the alcohol amount be 60～75%v/v, left standstill 24 hours, add Cortex Phellodendri, Sophora Alopecuroides L. clear paste behind the filtrate recycling ethanol, add Folium Baeckeae volatile oil and Aromatic water, Borneolum Syntheticum, make dissolving, add the 10g sodium benzoate again, mixing adds above-mentioned solution, adds water to about 1000ml, mixing promptly gets lotion of the present invention.
The purposes of each raw material of described weight proportion in antibiotic, the antiinflammatory of preparation vagina local application, anti-trichomonal, itching relieving medicine.
The function of pharmaceutical composition of the present invention cures mainly: heat-clearing and toxic substances removing, dehumidifying, parasite killing is only overworked.Be applicable to the vulvovaginal pruritus, vaginal secretions increases, and is yellow thick and smelly, and the vaginitis that causes of infusorian property, mycotic etc.
Each proportioning raw materials of pharmaceutical composition of the present invention, the guidance of pressing Chinese medical theory has heat-clearing and toxic substances removing, dehumidifying, the effect of killing parasites for relieving itching.(this product is the dried leaves that myrtle Folium Baeckeae Beackea frutescens L. that in 1977 one one of version of Chinese Pharmacopoeia is recorded has flowers and fruits to Folium Baeckeae in the side.Bitter, puckery, cold.Clearing away heat-damp and promoting diuresis, killing parasites for relieving itching.Be used for acute gastroenteritis; External treatment trichomonal vaginitis, skin eczema.) nature and flavor hardship, puckery, cold, eliminating damp-heat, killing parasites for relieving itching, the treatment skin eczema, diseases such as trichomonal vaginitis are we's monarch drug.Sophora Alopecuroides L. (starts from that " Xinjiang Chinese herbal medicine handbook is the ground drying nest of leguminous plant Herba Sophorae alopecuroidis Sophora alopecuroides L..The Herb flavor is extremely bitter, cold in nature.Have heat clearing and damp drying, pain relieving parasite killing.Laryngalgia, cough, dysentery and eczema etc. are treated in its radical cure commonly used among the people.In 1977 version of China's pharmacopeia and some areas drug standard are recorded Sophora Alopecuroides L. and " Sophora Alopecuroides L. sheet ", cure mainly bacillary dysentery and enteritis.) the nature and flavor bitter cold, heat clearing and damp drying, killing parasites for relieving itching, treatment leucorrhea with red and white discharge, swelling of the vulva, pudendal pruritus and trichomonal vaginitis.Cortex Phellodendri nature and flavor bitter cold, heat clearing and damp drying, eliminating fire and detoxication, specially clear damp-heat in lower-JIAO, treatment damp-heat vaginal discharge, sore swollen toxin, eczema eczema; Ministerial drug in the two side of being combined into.The Herba Corydalis Bungeanae bitter in the mouth, cold in nature, heat-clearing and toxic substances removing.Imitate good for controlling the various inflammation that the epidemic febrile disease hyperpyrexia causes; Borneolum Syntheticum acrid in the mouth, hardship, property is flat, and it is refreshing clearly to be used to have one's ideas straightened out, promoting flow of QI and blood, reducing swelling and alleviating pain.Fructus Cnidii acrid in the mouth, hardship, warm in nature, be used for warming the kidney to invigorate YANG, dampness is dispeled the wind, parasite killing.External treatment vulval eczema married woman pudendal pruritus, trichomonal vaginitis; Adjuvant drug in the side of being combined into.Radix Glycyrrhizae sweet in the mouth, flat has coordinating the actions of various ingredients in a prescription, antiinflammatory, anticancer assosting effect, is the messenger drug in the side.We's prescription treating both the principal and secondary aspects of a disease can heat-clearing and toxic substances removing, removing damp to relieve itching, and for controlling the vulvovaginal pruritus that damp invasion of lower energizer causes, vaginal secretions increases, and yellowly thickly and smelly waits disease, and infusorian property, colpitis mycotica are seen the good recipe of above-mentioned disease.
Curative effect of medication of the present invention is definite, therapeutic domain is clear and definite, and administration time is short, and is easy to carry, flavour of a drug delicate fragrance, and quality control standard is provided, and make safety of medicine of the present invention, effective, stable, controlled.
Obviously, according to foregoing of the present invention,,, can also make modification, replacement or the change of other various ways not breaking away under the above-mentioned basic fundamental thought of the present invention prerequisite according to the ordinary skill knowledge and the customary means of this area.
The specific embodiment of form is described in further detail foregoing of the present invention again by the following examples.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.
The specific embodiment
The preparation method of embodiment 1 drug lotion of the present invention
Folium Baeckeae 400g, Sophora Alopecuroides L. 350g, Cortex Phellodendri 100g, Herba Corydalis Bungeanae 50g, Fructus Cnidii 40g, Radix Glycyrrhizae 30g, Borneolum Syntheticum 0.5g;
Medicine production method of the present invention is:
More than seven flavors, get the Folium Baeckeae medical material, with steam distillation 2 ~ 3 hours, collect volatile oil and Aromatic water in addition device preserve.Sophora Alopecuroides L., Cortex Phellodendri make solvent with 10 ~ 18 times of 0.6%v/v hydrochloric acid solutions, flood to carry out percolation after 24 hours, and it is standby that percolate is condensed into clear paste; (mainly contain the alkaloids composition in the Sophora Alopecuroides L., as bitter legumin etc., according to alkaloidal character, the form that is salt with acid solution exists, and is soluble in sour water, so select for use hydrochloric acid as the extraction solvent.Contain berberine in the Cortex Phellodendri, phellodendrine is biological alkali components, so select for use hydrochloric acid solution to extract); Medicinal residues after Herba Corydalis Bungeanae, Fructus Cnidii, Radix Glycyrrhizae and above three flavors extract decoct with water secondary, and each 2 hours, collecting decoction, filter, add ethanol after filtrate concentrates and make that to contain the alcohol amount be 60～75%v/v, left standstill 24 hours, add Cortex Phellodendri, Sophora Alopecuroides L. clear paste behind the filtrate recycling ethanol; Get Folium Baeckeae volatile oil and Aromatic water and add Borneolum Syntheticum, make dissolving, add the 10g sodium benzoate again, mixing adds above-mentioned solution, adds water to about 1000ml, and mixing promptly gets lotion of the present invention.
Usage and consumption: vagina medicinal.This product washing liquid stock solution is made into 10～15% liquid wash pudendums, vagina.1 time on the one.
Different Weight proportion raw material medicine in the by specification can prepare the lotion of the present invention of different size.
The preparation of embodiment 2 suppositorys of the present invention
Folium Baeckeae 800g, Sophora Alopecuroides L. 700g, Cortex Phellodendri 150g, Herba Corydalis Bungeanae 100g, Fructus Cnidii 100g, Radix Glycyrrhizae 80g, Borneolum Syntheticum 1g;
More than seven flavors, get the Folium Baeckeae medical material, with steam distillation 2 ~ 3 hours, collect volatile oil and Aromatic water in addition device preserve.Sophora Alopecuroides L., Cortex Phellodendri make solvent with 10 ~ 18 times of 0.6%v/v hydrochloric acid solutions, flood to carry out percolation after 24 hours, and it is standby that percolate is condensed into clear paste; (mainly contain the alkaloids composition in the Sophora Alopecuroides L., as bitter legumin etc., according to alkaloidal character, the form that is salt with acid solution exists, and is soluble in sour water, so select for use hydrochloric acid as the extraction solvent.Contain berberine in the Cortex Phellodendri, phellodendrine is biological alkali components, so select for use hydrochloric acid solution to extract); Medicinal residues after Herba Corydalis Bungeanae, Fructus Cnidii, Radix Glycyrrhizae and above three flavors extract decoct with water secondary, and each 2 hours, collecting decoction, filter, add ethanol after filtrate concentrates and make that to contain the alcohol amount be 60～75%v/v, left standstill 24 hours, add Cortex Phellodendri behind the filtrate recycling ethanol, the Sophora Alopecuroides L. clear paste is condensed into dried cream; It is an amount of to get glycerol gelatin matrix, put be heated in the water-bath dissolve after, add concentrated medicament and Borneolum Syntheticum, Folium Baeckeae volatile oil, after stirring evenly, pour into rapidly in the bolt film that has scribbled liquid Paraffin, cooling is wipeed off, promptly.
Different Weight proportion raw material medicine in the by specification can prepare the suppository of the present invention of different size.
The capsular preparation of embodiment 3 the present invention
Folium Baeckeae 800g, Sophora Alopecuroides L. 500g, Cortex Phellodendri 200g, Herba Corydalis Bungeanae 70g, Fructus Cnidii 70g, Radix Glycyrrhizae 50g, Borneolum Syntheticum 1.5g;
More than seven flavors, get the Folium Baeckeae medical material, with steam distillation 2 ~ 3 hours, collect volatile oil and Aromatic water in addition device preserve.Sophora Alopecuroides L., Cortex Phellodendri make solvent with 10 ~ 18 times of 0.6%v/v hydrochloric acid solutions, flood to carry out percolation after 24 hours, and it is standby that percolate is condensed into clear paste; (mainly contain the alkaloids composition in the Sophora Alopecuroides L., as bitter legumin etc., according to alkaloidal character, the form that is salt with acid solution exists, and is soluble in sour water, so select for use hydrochloric acid as the extraction solvent.Contain berberine in the Cortex Phellodendri, phellodendrine is biological alkali components, so select for use hydrochloric acid solution to extract); Medicinal residues after Herba Corydalis Bungeanae, Fructus Cnidii, Radix Glycyrrhizae and above three flavors extract decoct with water secondary, and each 2 hours, collecting decoction, filter, add ethanol after filtrate concentrates and make that to contain the alcohol amount be 60～75%v/v, left standstill 24 hours, add Cortex Phellodendri behind the filtrate recycling ethanol, the Sophora Alopecuroides L. clear paste is condensed into dried cream, drying is pulverized, and granulates, Folium Baeckeae volatile oil adds Borneolum Syntheticum, spray in the granule, incapsulate, promptly.
Different Weight proportion raw material medicine in the by specification can prepare the capsule of the present invention of different size.
The preparation of embodiment 4 aerosols of the present invention
Sophora Alopecuroides L. 400g, Folium Baeckeae 400g, Cortex Phellodendri 160g, Herba Corydalis Bungeanae 60g, Fructus Cnidii 60g, Radix Glycyrrhizae 50g, Borneolum Syntheticum 0.5g;
More than seven flavors, get the Folium Baeckeae medical material, with steam distillation 2 ~ 3 hours, collect volatile oil and Aromatic water in addition device preserve.Sophora Alopecuroides L., Cortex Phellodendri make solvent with 10 ~ 18 times of 0.6%v/v hydrochloric acid solutions, flood to carry out percolation after 24 hours, and it is standby that percolate is condensed into clear paste; (mainly contain the alkaloids composition in the Sophora Alopecuroides L., as bitter legumin etc., according to alkaloidal character, the form that is salt with acid solution exists, and is soluble in sour water, so select for use hydrochloric acid as the extraction solvent.Contain berberine in the Cortex Phellodendri, phellodendrine is biological alkali components, so select for use hydrochloric acid solution to extract); Medicinal residues after Herba Corydalis Bungeanae, Fructus Cnidii, Radix Glycyrrhizae and above three flavors extract decoct with water secondary, and each 2 hours, collecting decoction, filter, add ethanol after filtrate concentrates and make that to contain the alcohol amount be 60～75%v/v, left standstill 24 hours, add Cortex Phellodendri, Sophora Alopecuroides L. clear paste behind the filtrate recycling ethanol, get Folium Baeckeae volatile oil and add Borneolum Syntheticum, make dissolving, add Arlacel-80 20g again, mix homogeneously adds water to 1000ml, filters, packing, every bottle is pressed into propellant F
12About 6g, promptly.
Different Weight proportion raw material medicine in the by specification can prepare the aerosol of the present invention of different size.
The preparation of embodiment 5 membrane of the present invention
Sophora Alopecuroides L. 1600g, Folium Baeckeae 800g, Cortex Phellodendri 200g, Herba Corydalis Bungeanae 100g, Fructus Cnidii 50g, Radix Glycyrrhizae 50g, Borneolum Syntheticum 1.6g;
More than seven flavors, get the Folium Baeckeae medical material, with steam distillation 2 ~ 3 hours, collect volatile oil and Aromatic water in addition device preserve.Sophora Alopecuroides L., Cortex Phellodendri make solvent with 10 ~ 18 times of 0.6%v/v hydrochloric acid solutions, flood to carry out percolation after 24 hours, and it is standby that percolate is condensed into clear paste; (mainly contain the alkaloids composition in the Sophora Alopecuroides L., as bitter legumin etc., according to alkaloidal character, the form that is salt with acid solution exists, and is soluble in sour water, so select for use hydrochloric acid as the extraction solvent.Contain berberine in the Cortex Phellodendri, phellodendrine is biological alkali components, so select for use hydrochloric acid solution to extract); Medicinal residues after Herba Corydalis Bungeanae, Fructus Cnidii, Radix Glycyrrhizae and above three flavors extract decoct with water secondary, each 2 hours, collecting decoction, filter, add ethanol after filtrate concentrates and make that to contain the alcohol amount be 60～75%v/v, left standstill 24 hours, add Cortex Phellodendri behind the filtrate recycling ethanol, the Sophora Alopecuroides L. clear paste is condensed into dried cream, drying, pulverizing, mixing, standby.Get Rhizoma Bletillae gel (or other filmogen) distilled water immersion of heating, and the heating make dissolving, add dry extract and Folium Baeckeae volatile oil and Borneolum Syntheticum again, stir, remove bubble, the system film, drying, packing, promptly.
Different Weight proportion raw material medicine in the by specification can prepare the membrane of the present invention of different size.
The preparation of embodiment 6 tablets of the present invention
Sophora Alopecuroides L. 400g, Folium Baeckeae 400g, Cortex Phellodendri 160g, Herba Corydalis Bungeanae 60g, Fructus Cnidii 60g, Radix Glycyrrhizae 50g, Borneolum Syntheticum 1.5g;
More than seven flavors, get the Folium Baeckeae medical material, with steam distillation 2 ~ 3 hours, collect volatile oil and Aromatic water in addition device preserve.Sophora Alopecuroides L., Cortex Phellodendri make solvent with 10 ~ 18 times of 0.6%v/v hydrochloric acid solutions, flood to carry out percolation after 24 hours, and it is standby that percolate is condensed into clear paste; (mainly contain the alkaloids composition in the Sophora Alopecuroides L., as bitter legumin etc., according to alkaloidal character, the form that is salt with acid solution exists, and is soluble in sour water, so select for use hydrochloric acid as the extraction solvent.Contain berberine in the Cortex Phellodendri, phellodendrine is biological alkali components, so select for use hydrochloric acid solution to extract); Medicinal residues after Herba Corydalis Bungeanae, Fructus Cnidii, Radix Glycyrrhizae and above three flavors extract decoct with water secondary, each 2 hours, collecting decoction, filter, add ethanol after filtrate concentrates and make that to contain the alcohol amount be 60～75%v/v, left standstill 24 hours, add Cortex Phellodendri behind the filtrate recycling ethanol, the Sophora Alopecuroides L. clear paste is condensed into dried cream, drying, pulverizing, mixing are granulated.Again Borneolum Syntheticum is added Folium Baeckeae volatile oil and make dissolving, spray in the granule, tabletting, promptly.
Different Weight proportion raw material medicine in the by specification can prepare the tablet of the present invention of different size.
Embodiment 7 pharmaceutical composition qualitative, quantitative control methods of the present invention
Quality control qualitative identification method:
This product 10ml is got in [discriminating] (1), puts in the separatory funnel, regulates pH value to 11 with ammonia solution, adds chloroform 20ml jolting and extracts, and divides and gets chloroform solution, and evaporate to dryness, residue add chloroform 2ml makes dissolving, as need testing solution.Other gets sophoridine reference substance and matrine reference substance, and chlorination is copied into the solution that every 1ml contains 1mg respectively, in contrast product solution.According to thin layer chromatography (" an appendix IV of Chinese pharmacopoeia version in 2000 B) test, draw above-mentioned need testing solution 3 μ l, each 5 μ l of reference substance solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, with benzene-acetone-ethyl acetate (7: 3: 3) is developing solvent, put in the chromatography cylinder of ammonia saturated with vapor, launch, take out, dry, spray is with bismuth potassium iodide test solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(2) get this product 10ml, put in the separatory funnel, add petroleum ether (60～90 ℃) jolting and extract twice, each 15ml merges petroleum ether liquid, volatilizes, and residue adds chloroform 1ml makes dissolving, as need testing solution.Other gets Folium Baeckeae control medicinal material 5g, adds water 50ml distillation extraction, collects distillate 20ml, gets wherein 10ml, put in the separatory funnel, add petroleum ether (60～90 ℃) jolting and extract twice, each 15ml merges petroleum ether liquid, volatilize, residue adds chloroform 1ml makes dissolving, in contrast medical material solution.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2000) test, draw each 10 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, with petroleum ether (60～90 ℃)-ethyl acetate (5: 1) is developing solvent, launch, take out, dry, spray is with 1% vanillin hydrochloric acid solution, and it is clear to be heated to the speckle colour developing at 105 ℃.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the principal spot of same color.
(3) get this product 10ml, put in the separatory funnel, the 20ml jolting that adds diethyl ether is extracted, and divides and gets ether solution, volatilizes, and residue adds ethyl acetate 0.5ml makes dissolving, as need testing solution.Other gets the Borneolum Syntheticum reference substance, adds ethyl acetate and makes the solution that every 1ml contains 0.5mg, in contrast product solution.According to thin layer chromatography (" an appendix VI of Chinese pharmacopoeia version in 2000 B) test, draw each 5 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, with benzene-ethyl acetate (19: 1) is developing solvent, launch, take out, dry, spray is with 1% vanillin hydrochloric acid solution, and it is clear to be heated to the speckle colour developing at 105 ℃.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(4) get this product 10ml, put in the separatory funnel, add the n-butyl alcohol jolting and extract twice, each 15ml merges n-butyl alcohol liquid, and evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution.Other gets Cortex Phellodendri control medicinal material 0.1g, adds methanol 5ml, and reflux 15 minutes filters, and filtrate is replenished methanol to 5ml, in contrast medical material solution.Other gets the berberine hydrochloride reference substance, adds methanol and makes the solution that every 1ml contains 0.5mg, in contrast product solution.Draw each 5 μ l of above-mentioned three kinds of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, be developing solvent with n-butyl alcohol-glacial acetic acid-water (7: 1: 2), put in the vapour-saturated chromatography cylinder of ammonia, launch, take out, dry, put under the uviol lamp (365nm) and inspect.In the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, all show the fluorescence speckle of same color.
[inspection] pH value should be 4.5～6.5 (" 2000 editions one appendix VII G of Chinese pharmacopoeia).
Other should meet every regulation relevant under the lotion item (" two appendix IS of Chinese pharmacopoeia version in 2000).
[volatile material] precision is measured this product 200ml, adds water 100ml and bead number, according to determination of volatile oil method (" 2000 editions one appendix X D of Chinese pharmacopoeia first method is from " jolting mixes the back ") mensuration.Volatile material must not be less than 0.5% (ml/ml).
[assay] photograph high performance liquid chromatography (" an appendix VI of Chinese pharmacopoeia version in 2000 D) measure.
It is filler with octadecylsilane chemically bonded silica that chromatographic condition and system are suitable for test; Acetonitrile: phosphate buffer (0.7% triethylamine solution is with phosphoric acid adjust pH to 3.0) (27: 73) is a mobile phase; The detection wavelength is 349nm.Number of theoretical plate calculates by the berberine hydrochloride peak should be not less than 3000.
The preparation precision of need testing solution is measured this product 1ml, places the 10ml volumetric flask, and methanol is diluted to scale, promptly.
The accurate respectively reference substance solution 6ul that draws of algoscopy, need testing solution 5ul, injecting chromatograph is measured, promptly.
Hydrochloric berberine (the C of this product
20H
17NO
4.Hcl) must not be less than 0.4mg/ml.
Below prove beneficial effect of the present invention by pharmacodynamics test.
The bacteriostasis of experimental example 1 pharmaceutical composition of the present invention
1, experiment material
1.1 the pharmaceutical composition washing liquid of the present invention of medicine and reagent embodiment 1 preparation.Positive control: penicillin g potassium for inj (BJ Pharmaceutical Co., Ltd.).Streptomycin hydrochloride (Shanghai the 4th pharmaceutical factory).
1.2 strain: staphylococcus aureus
26113, staphylococcus epidermidis
12228, micrococcus scarlatinae
19615, gonococcus
29106, bacillus pyocyaneus
10102, escherichia coli
44141, provide by microbial room of Huaxi Medical Univ.
1.3 culture medium: common sterilization broth bouillon is provided by the institute for drug control, Sichuan Province.
2, method and result
2.1 liquid diluting method: get some of tubules of sterilization, making its concentration with the culture medium dilution is 0.2,0.1,0.05,0.025,0.0125,0.006 and 0.003125g/ml, and every pipe adds 0.1 milliliter 10
-3The fresh bacterium liquid of dilution is observed after cultivating 18 hours in 37 ℃ and to be had or not bacterial growth, and is opaque if medicine medicine color is dark, can't judge to have or not bacterial growth, can be on the plate culture medium above-mentioned pastille bacterium subcultivation, in 37 ℃ cultivate 18 hours after observed result.The highest drug dilution degree that antibacterial does not grow is the minimum inhibitory concentration of this medicine.
Table 1 pharmaceutical composition washing liquid of the present invention bacteriostatic test result (liquid tube method)
| Thalline | MIC/g·ml -1 | Positive control | Blank antibacterial contrast |
| Staphylococcus aureus staphylococcus epidermidis micrococcus scarlatinae gonococcus bacillus pyocyaneus escherichia coli | - 0.05 0.0125 0.025 0.0125 0.05 | - - - - - - | + + + + + + |
Annotate :-be no bacterial growth ,+for bacterial growth is arranged.
Table 1 as seen, pharmaceutical composition washing liquid of the present invention is aseptic, puts 37 ℃ and cultivates and not have bacterial growth in 18 hours.Pharmaceutical composition washing liquid of the present invention has in various degree inhibitory action to staphylococcus aureus, staphylococcus epidermidis, micrococcus scarlatinae, gonococcus, bacillus pyocyaneus, escherichia coli.
Experimental example 2 pharmaceutical compositions of the present invention suppress the fungus effect
1, experiment material
1.1 the pharmaceutical composition washing liquid of the present invention of medicine and reagent embodiment 1 preparation.
Positive control: nystatin: every contains 500,000 units (Shanghai is executed expensive precious pharmaceutical Co. Ltd and produced).JIEERYIN XIYE (the prosperous pharmaceutical Co. Ltd of Chengdu grace prestige generation).
1.2 the strain Candida albicans, experiment is provided by microbial room of Huaxi Medical Univ with second filial generation fresh cultured thing.
1.3 the husky Lei Shi fungi culture medium of culture medium
1.4 animal: large ear rabbit, female, provide by Chengdu University of Traditional Chinese Medicine's Experimental Animal Center.
2, method and result
2.1 some of sterilization tubules are got in the in-vitro antibacterial experiment, making its concentration with culture medium dilution is 0.5,0.25,0.125 and 0.06g/ml, every pipe adds 1ml, 18 hours fungal cultures 0.1ml that add 200 times of dilutions again, observe after cultivating 18 hours in 37 ℃ and to have or not conk, because of dark, opaque by the reagent color, with above-mentioned pastille bacterium subcultivation on husky Lei Shi agar plate, in 37 ℃ cultivate 18 hours after observed result.Positive controls is a nystatin.The highest drug dilution degree that fungus does not grow the results are shown in Table 2 for the minimum inhibitory concentration of this medicine.
Table 2 pharmaceutical composition washing liquid of the present invention antifungal result of the test (liquid tube method)
| Thalline | MIC/g·ml -1 | Positive control | Blank antibacterial contrast |
| Candida albicans | 0.25 | - | + |
Annotate :-be no bacterial growth ,+for bacterial growth is arranged.
2.2 antibacterial experiment is got 50 of Female rabbits to the influence of rabbit experimental colpitis mycotica that Candida albicans causes in the body, is divided into 5 groups at random, 10 every group.(concentration is 6 * 10 to the Candida albicans selected with trial test
9/ ml) 0.8ml/kg splashes into rabbit vagina, infected through 24 hours, and vagina external then, model control group is given sterile distilled water, and positive controls gives JIEERYIN XIYE, and continuous 7 days, analyse animal, observe its gradient of infection, the results are shown in Table 3.
Table 3 pharmaceutical composition washing liquid of the present invention is to the colpitic influence of rabbit experiment
X±SD
| Thalline | Dosage | Number of animals | Gradient of infection |
| Dosage group pharmaceutical composition washing lotion of the present invention low dose group in the model control group positive controls pharmaceutical composition washing lotion of the present invention high dose group pharmaceutical composition washing lotion of the present invention | - 10％ 2％ 1％ 0.5％ | 10 10 10 10 10 | 4.26±0.41 1.96±0.79 ** 1.68±0.47 ** 1.95±0.89 ** 2.68±0.99 * |
Annotate: * and matched group be P＜0.05 relatively, and * * and matched group be P＜0.01 relatively
The result shows that positive drug nystatin bacteriostasis is obvious, and pharmaceutical composition washing liquid of the present invention has inhibitory action to Candida albicans.And compare with positive control, dosage is little, has but brought into play the effect that is equal to.
Experimental example 3 pharmaceutical composition anti-trichomonal of the present invention effects
1, experiment material
1.1 the pharmaceutical composition washing liquid of the present invention of medicine and reagent embodiment 1 preparation.Metronidazole 0.2mg/ sheet (Shanghai Xinyi Pharmaceutical Plant's production).
1.2 the strain trichomonas vaginitis is provided by microbial room of Huaxi Medical Univ
1.3 culture medium adopts 1640 culture medium+10% calf serum.
2 methods and result
Same specimen is placed in 5 in vitro.Add 1/4 of pharmaceutical composition washing liquid low dosage of the present invention (0.25ml), middle dosage (0.5ml), high dose (1ml), metronidazole respectively; Make the blank pipe not add medicine.Put 37 ℃ and hatch 30min to 1h.The result can kill infusorian after showing middle and high dosage of pharmaceutical composition washing liquid of the present invention and metronidazole 30min, and pharmaceutical composition washing liquid low dosage of the present invention also can kill infusorian behind the 1h; Contrast in vitro behind infusorian 3～4h still very active.Illustrate that pharmaceutical composition washing liquid of the present invention has the anti-trichomonal effect.
Experimental example 4 pharmaceutical composition itching-relieving actions of the present invention
1, experiment material
1.1 the pharmaceutical composition washing liquid of the present invention of medicine and reagent embodiment 1 preparation.
Positive drug: JIEERYIN XIYE (the prosperous pharmaceutical Co. Ltd of Chengdu grace prestige generation).
1.2 50 of animal Cavia porcelluss, body weight 250g～300g, ♀ ♂ half and half (providing) by Chengdu University of Traditional Chinese Medicine zoopery center.
2 methods and result
Get 50 of Cavia porcelluss, be divided into 5 groups at random: (1) model control group; (2) positive controls is clean: and the cloudy washing liquid of that (10%v/v, 0.1ml/100g); (3) pharmaceutical composition washing liquid high dose group of the present invention (2%v/v, 0.1ml/100g); (4) dosage group in the pharmaceutical composition washing liquid of the present invention (1%v/v, 0.1ml/100g) (5) pharmaceutical composition washing liquid of the present invention low dose group (0.5%v/v, 0.1ml/100g).Test the preceding 1 day right back foot of each treated animal and shave mao back coating 1 time, experiment is shaved hair place, area 1cm when daily coarse sandpaper abrades right back instep
2Local repaste medicine 1 time, matched group is coated with the equivalent distilled water, 10min behind the last coating, beginning is only dripped 0.01% histamine phosphate 0.05ml/ on wound surface, after this comply with 0.01%, 0.02%, 0.03% every 3min ... progressive concentration only is 0.05ml/ at every turn, later lick right back foot up to Cavia porcellus occurring, later to lick the right back histamine phosphate total amount that is given when sufficient be itch-threshold to occur Cavia porcellus at last, and record and itch-threshold of each group relatively the results are shown in Table 4.
Table 4 pharmaceutical composition washing liquid of the present invention causes the X ± SD that influences of overworked reaction to histamine phosphate
| Group | Dosage | Itch-threshold (the total amount μ g of histamine phosphate) |
| Dosage group pharmaceutical composition washing lotion of the present invention low dose group in the model control group positive controls pharmaceutical composition washing lotion of the present invention high dose group pharmaceutical composition washing lotion of the present invention | 10％ 2％ 1％ 0.5％ | 35.45±14.2 458.65±56.41 ** 359.45±11.6 * 157.56±35.81 ** 40.21±12.30 |
Annotate: * and matched group be P＜0.05 relatively, and * * and matched group be P＜0.01 relatively
The result shows that pharmaceutical composition washing liquid of the present invention has been compared significant difference in the effect that high, middle dosage all obviously improve the Cavia porcellus itch-threshold with blank.Point out pharmaceutical composition washing liquid of the present invention to cause the reaction of itching by anti-histamine phosphate, have itching-relieving action.
Experimental example 5 pharmaceutical composition antiinflammatory actions of the present invention
1, experiment material
1.1 the pharmaceutical composition washing liquid of the present invention of medicine and reagent: embodiment 1 preparation.JIEERYIN XIYE (the prosperous pharmaceutical Co. Ltd of Chengdu grace prestige generation).Dimethylbenzene (Beijing Chemical Plant's production);
1.2 the animal kunming mice, body weight 18g～20g; Wistar rat 120g～150g, ♀ ♂ half and half (above animal is provided by Chengdu University of Traditional Chinese Medicine zoopery center).
2 methods and result
2.1 pharmaceutical composition washing liquid of the present invention is to the influence of the scorching test of Mice Auricle caused by dimethylbenzene xylene
Get 50 of Kunming mouses, be divided into model control group at random, positive controls: the JIEERYIN group (10%V/V, 0.05ml/20g), the high, medium and low dosage group of pharmaceutical composition washing liquid of the present invention (2%, 1%, 0.5%V/V, 0.05ml/20g).Each treated animal is in experiment auris dextra coating 1 time on the same day, and matched group is coated with the equivalent distilled water, and each administration group is with distilled water flush away medicinal liquid behind the 1h, after dry cotton ball is dried, every Mus auris dextra with dimethylbenzene 0.05ml/ only is coated with, and left ear compares, and puts to death animal behind the 15min, with diameter 9mm card punch ears are downcut with the position homalographic, weigh respectively on ten thousand/balance, the difference that left and right sides auricle is heavy is the swelling degree, calculates and respectively organizes difference, obtain inhibitory rate of intumesce, see Table 5.
Table 5 pharmaceutical composition washing liquid of the present invention xylol induced mice swelling of auricle influence
| Group | Dosage | Swelling degree (mg) X ± SD | Suppression ratio |
| Dosage group pharmaceutical composition washing lotion of the present invention low dose group in the model control group positive controls pharmaceutical composition washing lotion of the present invention high dose group pharmaceutical composition washing lotion of the present invention | 10％ 2％ 1％ 0.5％ | 18.5±4.6 6.6±3.9 ** 10.5±3.6 ** 12.4±2.8 * 15.8±3.7 | 76％ 69％ 36％ 12％ |
Annotate: * and matched group be P＜0.05 relatively, and * * and matched group be P＜0.01 relatively
2.2 pharmaceutical composition washing liquid of the present invention is to the influence of the swollen test of the rat Ovum Gallus domesticus album foot sole of the foot
Get the Wistar rat, it is the same to divide into groups.Respectively organize the right back sufficient normal volume of rat (ml) by capillary tube measurement by magnification method mensuration before each treated animal experiment, behind experiment administration on the same day group coating 1h (0.1ml/100g), after each organizes the right back sufficient subcutaneous injection 10% fresh albumen 0.05ml/ of rat, repaste medicine 1 time, matched group is coated with the equivalent distilled water, measures to cause scorching front and back 0.5,1,2,4, the right back sufficient volume of 6h, the sufficient volume difference that each Mus causes scorching front and back is the swelling degree, respectively organize the dynamic change of difference and different time, see table 6 for details.
Table 6 pharmaceutical composition washing liquid of the present invention is to the bullate influence of the rat Ovum Gallus domesticus album foot sole of the foot
X±SD
| Group | Dosage | Cause scorching front foot sole of the foot volume | Cause scorching back different time swelling degree of the paw (ml) | |||
| 1h | 2h | 4h | 6h | |||
| Dosage group pharmaceutical composition washing lotion of the present invention low dose group in the model control group positive controls pharmaceutical composition washing lotion of the present invention high dose group pharmaceutical composition washing lotion of the present invention | 10％ 2％ 1％ 0.5％ | 1.03±0.06 1.05±0.04 1.10±0.05 1.09±0.05 1.12±0.07 | 0.61±0.12 0.38±0.07 ** 0.36±0.03 ** 0.43±0.08 * 0.57±0.06 | 0.57±0.11 0.37±0.05 ** 0.39±0.09 ** 0.51±0.09 0.52±0.05 | 0.51±0.08 0.34±0.09 ** 0.33±0.04 ** 0.37+0.03 * 0.49±0.08 | 0.48±0.08 0.24±0.09 ** 0.26±0.04 ** 0.36±0.06 * 0.45±0.09 |
Annotate: * and matched group be P＜0.05 relatively, and * * and matched group be P＜0.01 relatively
Experimental result shows, pharmaceutical composition washing liquid of the present invention all has an obvious suppression effect to mice dimethylbenzene swelling of auricle and the rat Ovum Gallus domesticus album foot sole of the foot are swollen under high, middle dosage, and prompting this product has antiinflammatory action.
Pharmaceutical composition lotion body of the present invention is interior, external pharmacodynamics test shows has certain inhibition Candida albicans to give birth to and long effect; External pharmaceutical composition of the present invention all has inhibitory action to staphylococcus aureus, staphylococcus epidermidis, micrococcus scarlatinae, gonococcus, bacillus pyocyaneus, infusorian etc.; Pharmaceutical composition external preparation for skin of the present invention has the mice ear of inhibition and rat chondrus ocellatus Holmes to cause the swollen effect of foot; Pharmaceutical composition of the present invention causes that to histamine the guinea pig skin pruritus has certain inhibitory action.
Experimental example 6 medicine acute toxicity testings of the present invention
1 experiment material
1.1 the pharmaceutical composition washing liquid of the present invention of medicine and reagent embodiment 1 preparation.
1.2 50 of animal KM kind mices, male and female half and half, body weight 18～22g is provided by Chengdu University of Traditional Chinese Medicine zoopery center.
2 methods are in the result
Experimentize by improvement KarberShi method, determine respectively to organize dosage, group is seen dose ratio: 1.1361, after the subcutaneous injection administration, observed 7 days.Subcutaneous injection LD as a result
50Be 64.81 ± 5.29, be equivalent to 2121 times of clinical outer consumptions.Clinical is preparation for external application to skin, absorbs to subcutaneous that this is few, so can think this product external safety and low toxicity.
Experimental example 7 long term toxicity tests
80 of Wistar1 rats, divide 4 groups at random, smear once to rat skin with pharmaceutical composition washing liquid of the present invention, continuous 30 days, dosage is respectively three dosage groups, be equivalent to respectively clinical common dose 20 (20%), 40 (40%), 80 (80%) doubly, matched group is smeared and is given with the volume distilled water.
Smeared the outward appearance of three dosage treated animals, sign, behavioral activity Non Apparent Abnormality continuously 30 days.The feedstuff day consumption is stable, and each treated animal does not have significant difference to the consumption of feedstuff.Weight average increases no difference of science of statistics.Indexs such as routine blood test, liver, renal function show no obvious abnormalities.No abnormality seens such as the arrangement position of 30 days each tissues of each animal of anatomic observation of administration, color, quality; Compare no significant difference between each main organs coefficient sets; The histopathological examination heart, liver, lung, spleen, kidney, hypophysis, thyroid, thymus, adrenal gland, prostate, testis, epididymis, ovary, uterus, trachea, esophagus, stomach, duodenum, ileum, colon, pancreas, brain, spinal cord, breastbone, bladder etc. are organized for 25 kinds does not all have the pathology change, and other each organs and tissues also there is no unusually.
The test of experimental example 8 skin irritation
1 experiment material
1.1 the pharmaceutical composition washing liquid of the present invention of medicine and reagent embodiment 1 preparation.
1.2 4 of animal large ear rabbits are female, body weight 2.0 ± 0.2kg is provided by Chengdu University of Traditional Chinese Medicine zoopery center.
2 methods and result
4 of rabbit, with rabbit back spinal column both sides depilations (not injured skin), scope is 5cm * 10cm before the experiment.Administration district and check plot are divided in the depilation of one side.The check plot is coated with the distilled water with 1ml, and 50% pharmaceutical composition washing liquid 1ml of the present invention is smeared in the administration district.Opposite side depilation district is divided into administration district and check plot equally, marks the scratch of " # " shape with syringe needle on skin before the administration, the long 2cm of wound, and wound is 1cm at interval, to stab epidermis, do not hinder corium, slight oozing of blood degree of being is arranged.The coating method is the same.More than all cover the reuse immobilization with adhesive tape after 4 groups of administrations with 1 layer of oilpaper, 2 layers of gauze.Behind the administration 24h, with wet gauze flush away medicine, write down respectively 1,24,48 and the 72h medicine-feeding part situation of erythema and edema appears, go forward side by side to assassinate by the list of references scoring and swash intensity evaluation, see table 7 for details.
The skin irritation test of table 7 pharmaceutical composition washing liquid of the present invention
| Group | The integration summation | The average response value | ||||||
| 1 | 24 | 48 | 72h | 1 | 24 | 48 | 72h | |
| The distilled water group, (normal skin) pharmaceutical composition washing liquid of the present invention, (normal skin) distilled water group, (injured skin) pharmaceutical composition washing liquid of the present invention, (injured skin) | 1 2 7 8 | 1 1 5 5 | 0 0 0 0 | 0 0 0 0 | 0.3 0.5 1.8 2 | 0.25 0.25 1.25 1.25 | 0 0 0 0 | 0 0 0 0 |
Pharmaceutical composition washing liquid of the present invention as a result and matched group do not have significant difference to the average response value of normal skin and injured skin, illustrate that pharmaceutical composition washing liquid of the present invention is to normal skin and the equal nonirritant of injured skin.
Experimental example 9 mucomembranous pungency tests
1 experiment material
1.1 the pharmaceutical composition washing liquid of the present invention of medicine and reagent embodiment 1 preparation.
1.2 6 of animal large ear rabbits are female, body weight 2.0 ± 0.2kg is provided by Chengdu University of Traditional Chinese Medicine zoopery center.
2 methods and result
Animal is divided into matched group and administration group, 3 every group.Pharmaceutical composition washing liquid 0.2ml of the present invention is injected the animal intravaginal, observe 24 hours parts and general reaction, put to death animal subsequently, the taking-up vaginal mucosa is carried out histopathologic examination.Naked eyes and tissue slice there is no the administration group as a result has pathological change in matched group.Experiment confirm, pharmaceutical composition washing liquid of the present invention does not have bad stimulation to vaginal mucosa.
Experimental example 10 skin anaphylactic tests
1 experiment material
1.1 the pharmaceutical composition washing liquid of the present invention of medicine and reagent embodiment 1 preparation.
1.2 the animal Cavia porcellus, male and female half and half, body weight 250 ~ 300g is provided by Chengdu University of Traditional Chinese Medicine zoopery center.
2 methods and result
Get 30 of Cavia porcelluss, male and female half and half are divided into 3 groups at random, and 10 every group, before experiment, give guinea pig back spinal column left and right sides skin depilatory with clipper and scraper, respectively be 4cm * 4cm.First group is the administration group, and second group is the blank group, and the 3rd group of positive matched group gives 1%2,4-dinitro-chloro-benzene 0.2ml.The district carries out sensitization contact in the left side depilation, and the 7th day and the 14th day repeats 1 time; Excited sensitization on the right side on the 14th day behind the last coating, remove medicine behind the 6h, clean skin, observe the skin allergy situation at once, experimental result is pressed the scoring of skin allergy standards of grading, calculates mean scores, the results are shown in following table.
The skin irritation test of table 8 pharmaceutical composition washing liquid of the present invention
| Group | The integration summation | Sensitization rate (%) | Sensitization intensity | |||||||||
| 1 | 24 | 48 | 72h | 1 | 24 | 48 | 72h | 1 | 24 | 48 | 72h | |
| Administration group blank group positive controls | 1 1 38 | 1 1 34 | 0 0 25 | 0 0 18 | 10 10 100 | 10 10 100 | 0 0 0 | 0 0 0 | The utmost point gently | The utmost point gently | --Gao | --in |
Experimental result shows that administration group and matched group respectively have 1 guinea pig skin inadequate visible erythema to occur, disappears in 24 hours, and the reaction average mark 24 hours was 0.1 minute, and 24～72 hours is 0 minute, and administration group and matched group be difference more not, can think that its sensitization rate is 0.Positive controls sensitization rate is 100%.
By the explanation of above-mentioned pharmacodynamics test and toxicological experiment, pharmaceutical composition washing liquid of the present invention has antiinflammatory, antibacterial, parasite killing, effect such as antipruritic, low toxicity, to the skin nonirritant.Other dosage form of pharmaceutical composition of the present invention (suppository, vagina soft capsule, vaginal gel, vagina membrane, vaginal effervescent tablet, vagina foam, vagina aerosol, vagina ointment, vagina lozenge, vagina pill) is except using method, outside the bioavailability difference, possess curative effect identical and safety equally with lotion, therefore, pharmaceutical composition of the present invention is a kind of safe, effective, stable, controlled medicine, provides a kind of new selection for clinical.
Claims (10)
1, a kind of vagina external-use medicine composition is characterized in that: it is to contain the medicament that the following weight proportion raw material is prepared from:
20～160 parts of Folium Baeckeaes, 20～160 parts of Sophora Alopecuroides L.s, 14～26 parts of Cortex Phellodendris, 4～16 parts of Herba Corydalis Bungeanaes, 4～16 parts of Fructus Cnidiis, 4～16 parts in Radix Glycyrrhizae.
2, vagina external-use medicine composition according to claim 1 is characterized in that: its raw material also contains: 0.04～0.16 part of Borneolum Syntheticum.
3, vagina external-use medicine composition according to claim 2 is characterized in that: it is the medicament that is prepared from by the following weight proportion raw material:
20～160 parts of Folium Baeckeaes, 20～160 parts of Sophora Alopecuroides L.s, 14～26 parts of Cortex Phellodendris, 4～16 parts of Herba Corydalis Bungeanaes, 4～16 parts of Fructus Cnidiis, 4～10 parts in Radix Glycyrrhizae, 0.04～0.16 part of Borneolum Syntheticum.
4, vagina external-use medicine composition according to claim 3 is characterized in that: it is the medicament that is prepared from by the following weight proportion raw material:
40～120 parts of Folium Baeckeaes, 40～120 parts of Sophora Alopecuroides L.s, 16～24 parts of Cortex Phellodendris, 6～14 parts of Herba Corydalis Bungeanaes, 6～14 parts of Fructus Cnidiis, 4～10 parts in Radix Glycyrrhizae, 0.04～0.16 part of Borneolum Syntheticum.
5, vagina external-use medicine composition according to claim 4 is characterized in that: the extractive of volatile oil with Folium Baeckeae is active component I; The acid extraction thing of Sophora Alopecuroides L., Cortex Phellodendri is active component II; Medicinal residues after Herba Corydalis Bungeanae, Fructus Cnidii, Radix Glycyrrhizae and Folium Baeckeae, Sophora Alopecuroides L., the Cortex Phellodendri extraction mix, water is carried, and gained water extract and Folium Baeckeae aqueous solution are active component III; With active component I, II, III and Borneolum Syntheticum, add acceptable accessories or complementary composition, be prepared into vagina external preparation pharmaceutically commonly used.
6, vagina external-use medicine composition according to claim 5 is characterized in that: described preparation is external-use lotion, suppository, vagina soft capsule, vaginal gel, vagina with membrane, vaginal effervescent tablet, vagina with foam, vagina with aerosol, vagina with ointment, vagina with lozenge, vagina pill.
7, vagina external-use medicine composition according to claim 6 is characterized in that: the pH value of described external-use lotion is: 4～7.
8, vagina external-use medicine composition according to claim 6 is characterized in that: the hydrochloric berberine C of described external-use lotion
20H
17NO
4.HCl must not be less than 0.4mg/ml.
9, a kind of method for preparing the described medicinal composition for vagina of claim 4, it comprises the steps:
A, be active component I with the extractive of volatile oil of Folium Baeckeae;
The acid extraction thing of b, Sophora Alopecuroides L., Cortex Phellodendri is active component II;
Medicinal residues after c, Herba Corydalis Bungeanae, Fructus Cnidii, Radix Glycyrrhizae and Folium Baeckeae, Sophora Alopecuroides L., the Cortex Phellodendri extraction mix, water is carried, and gained water extract and Folium Baeckeae aqueous solution are active component III;
D, with active component I, II, III and Borneolum Syntheticum, add acceptable accessories or complementary composition, be prepared into vagina external preparation pharmaceutically commonly used.
10, the purposes of each raw material of the described weight proportion of claim 1 in antibiotic, the antiinflammatory of preparation vagina local application, anti-trichomonal, itching relieving medicine.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB200510020778XA CN100525797C (en) | 2005-04-22 | 2005-04-22 | Vagina external-use medicine composition and its preparing method and use |
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| CNB200510020778XA CN100525797C (en) | 2005-04-22 | 2005-04-22 | Vagina external-use medicine composition and its preparing method and use |
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| CN100525797C CN100525797C (en) | 2009-08-12 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105943622A (en) * | 2016-05-28 | 2016-09-21 | 广西南宁科冠医药科技开发有限公司 | Compound Fukang gel for treating gynecological diseases and preparation method thereof |
| CN106822325A (en) * | 2017-04-07 | 2017-06-13 | 成都标典生物科技开发有限公司 | The new preparation method of compound baeckea frutescen washing lotion |
| CN108519457A (en) * | 2018-04-18 | 2018-09-11 | 贵州景诚制药有限公司 | A kind of masson pine branchlet-tip drug quality detection method |
| CN112546114A (en) * | 2020-12-16 | 2021-03-26 | 四川郡益康健康管理有限公司 | Gynecological bacteriostatic nursing lotion and preparation method and use method thereof |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1193779C (en) * | 2001-12-13 | 2005-03-23 | 中国石化集团齐鲁石油化工公司 | Vagina cleaning and antiphlogistic suppository and its preparing method |
-
2005
- 2005-04-22 CN CNB200510020778XA patent/CN100525797C/en not_active Expired - Fee Related
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105943622A (en) * | 2016-05-28 | 2016-09-21 | 广西南宁科冠医药科技开发有限公司 | Compound Fukang gel for treating gynecological diseases and preparation method thereof |
| CN106822325A (en) * | 2017-04-07 | 2017-06-13 | 成都标典生物科技开发有限公司 | The new preparation method of compound baeckea frutescen washing lotion |
| CN108519457A (en) * | 2018-04-18 | 2018-09-11 | 贵州景诚制药有限公司 | A kind of masson pine branchlet-tip drug quality detection method |
| CN112546114A (en) * | 2020-12-16 | 2021-03-26 | 四川郡益康健康管理有限公司 | Gynecological bacteriostatic nursing lotion and preparation method and use method thereof |
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| Publication number | Publication date |
|---|---|
| CN100525797C (en) | 2009-08-12 |
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