CN101513487A - Oral medicine for the treatment of vaginitis - Google Patents
Oral medicine for the treatment of vaginitis Download PDFInfo
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- CN101513487A CN101513487A CNA200910021672XA CN200910021672A CN101513487A CN 101513487 A CN101513487 A CN 101513487A CN A200910021672X A CNA200910021672X A CN A200910021672XA CN 200910021672 A CN200910021672 A CN 200910021672A CN 101513487 A CN101513487 A CN 101513487A
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Abstract
An oral medicine for the treatment of vaginitis is disclosed in the invention, which is a medicament prepared in accordance with general preparation methods and from Chinese medicines comprising, based on the weight parts, 15-25 parts of cape jasmine, 15-25 parts of china root, 7-15 parts of honeysuckle and 5-10 parts of gentian. As demonstrated by test of medicinal effectiveness, the inventive medicine has the effect of preventing Candida albicans from infecting vagina. The invention can reduce the amount of pseudohypha and bacterial amount in a vaginal lavage fluid of mouse and rat, alleviate tissue edema, inflammatory infiltration and hypha. The invention also has the effect of anti-inflammation, reinforcing the phagocytic function of reticulo-endothelial system of the mouse and relieving itching. The effecting dosage for the mouse is 1.5g/kg (being amounted to 1.836g/kg of crude drug), the effecting dosage for the rat is 1.2g/kg (being amounted to 1.4688g/kg of crude drug). The inventive medicine is heat-clearing, damp-drying, insecticidal and itch-relieving, is mainly used for treating colpomycosis damp-heat disease and is an oral medicine for the treatment of the vaginitis with relatively small side effect and excellent treatment effect.
Description
Technical field
Invention belongs to the medicinal preparation technical field of the product that contains raw material or itself and not clear structure, is specifically related to derive from the material of plant.
Background technology
Vaginitis is the commonly encountered diseases of gynecological, frequently-occurring disease, and its sickness rate is in rising trend in recent years, and relapse rate is higher, has a strong impact on normal work and life.Along with the extensive use of broad-spectrum antibiotic and steroid hormone, and the increasing of diabetes, colpitic sickness rate and relapse rate are also increasing year by year.Report is arranged, and 3/4 women of child-bearing age suffered from once in life at least should disease, and wherein 45% women has the repeated infection history.Colpitis mycotica is that its pathogen is in the majority with Candida albicans by the microbial vaginitis of beads.Generally speaking, Candida albicans can be hidden on the pars oralis pharyngis of human body, intestinal, skin and vaginal mucosa, does not cause disease.But when resistance of human body decline, or suffer from serious disease, when Vitamin B-complex deficiency or prolonged application immunosuppressant were arranged, pathogenic bacteria bred in a large number, and colpitis mycotica is morbidity easily just.Suffer from diabetes or gravid woman,, intravaginal acidity is increased, help oidiomycetic growth and breeding and fall ill because the glycogen content in the vaginal epithelial cell increases.Use antibiotic under certain conditions in a large number, make the disorder of intravaginal flora, the intravaginal environment changes, and also can cause colpitis mycotica when helping Candida albicans and breeding in a large number.In addition, bad hygienic habit is arranged in the daily life, contacted infected utensil,, also can cause cross infection as public toilet seat, bathtub, seat, towel and public medicated clothing etc.Foreign data shows that the women suffered from vaginitis in life at least one time.Because its sickness rate height, clinical symptoms is heavier and have a strong impact on women's physical and mental health, routine work and life.Simple application antifungal drug (as nystatin, hachimycin, ketoconazole, Methylpartricin Sodium Laurylsulfate etc.) effect is very dissatisfied.And Chinese medicine is according to integrally-regulated theory, and determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs is expected obviously to shorten the course of treatment, even reduces relapse rate greatly, and Chinese medicine is cheap, and curative effect is reliable, and characteristics such as have no side effect are easy to be accepted by the patient, so have more wide prospect.And the colpitic method of Chinese medicine is based on external treatment at present, and oral medicine is less.Medicine for external use usually is difficult for being accepted by the patient, uses inconvenience.
Technical problem to be solved by this invention is to overcome the shortcoming of said medicine, provides the treatment that a kind of side effect is smaller, therapeutic effect is good colpitic oral drugs.
It is with the following Chinese medicinal raw materials in portion by weight medicinal preparation for oral administration made of formulation method routinely to solve the problems of the technologies described above the technical scheme that adopted:
15～25 parts of 15～25 parts of Rhizoma Smilacis Glabraes of Fructus Gardeniae
5～10 parts of 7～15 parts of Radix Gentianae of Flos Lonicerae
The preferred raw material of Chinese medicine weight portion proportioning of preparation medicine of the present invention is:
15～20 parts of 15～20 parts of Rhizoma Smilacis Glabraes of Fructus Gardeniae
5～8 parts of 7～12 parts of Radix Gentianae of Flos Lonicerae
The best raw material of Chinese medicine weight portion proportioning of preparation medicine of the present invention is:
18 parts of 18 parts of Rhizoma Smilacis Glabraes of Fructus Gardeniae
6 parts of 9 parts of Radix Gentianae of Flos Lonicerae
The medicinal preparation for oral administration that above-mentioned each component is made according to a conventional method is said tablet or granule or capsule or an oral liquid on the galenic pharmacy.
Fructus Gardeniae in the proportioning of the present invention, bitter in the mouth, cold in nature, GUIXIN, liver, lung, stomach, tri-jiao channel, the pathogenic fire purging relieving restlessness, clearing away heat-damp and promoting diuresis, removing heat from blood, detoxifcation arrogates to oneself that to control calentura vexed, liver-fire conjunctival congestion, headache, damp and hot all cards; Rhizoma Smilacis Glabrae, sweet in the mouth, light, property is flat, returns liver, stomach warp, and removing damp-heat is let out turbid detoxifcation, is usually used in damp and hot stranguria with turbid discharge, leukorrhagia, carbuncle, diseases such as scabies; Flos Lonicerae, sweet in the mouth, cold in nature, heat-clearing and toxic substances removing; Radix Gentianae, bitter in the mouth, cold in nature, return liver, gallbladder meridian, heat clearing and damp drying, eliminating pathogen in the liver gallbladder fire is apt to control jaundice due to damp-heat, swelling of the vulva pudendal pruritus, damp-heat vaginal discharge, eczema pruritus, hypochondriac pain, diseases such as bitter taste.
The preparation method of medicinal granule of the present invention is as follows:
With the Fructus Gardeniae in the proportioning of the present invention, Rhizoma Smilacis Glabrae, Flos Lonicerae, Radix Gentianae decocts with water three times, adds 10 times of water gagings for the first time and decocts second 1.5 hours, adding 8 times of water gagings for three times respectively respectively decocted 1 hour, filter, merging filtrate, and be concentrated into relative density 1.10～1.20 (60 ℃) adds ethanol and makes and contain the alcohol amount and reach 60%, left standstill 24 hours, get supernatant, decompression recycling ethanol is not to there being the alcohol flavor, and being concentrated into relative density is the clear paste of 1.30～1.40 (60 ℃), add dextrin, sucrose, mixing, dextrin, the addition of sucrose is pressed galenic pharmacy granule conventional method consumption and is added, mixing, make granule, drying, pack, every bag heavy 10g, every gram contains raw material of Chinese medicine 1.224g.
The used raw material of Chinese medicine of raw material of Chinese medicine that medicinal tablet of the present invention is used and weight proportion and medicinal granule of the present invention is identical, the extraction process step of raw material of Chinese medicine is identical with the extraction process step of granule preparation technology raw material of Chinese medicine of the present invention, and used adjuvant and other processing step are undertaken by the conventional preparation technology of tablet.Every heavy 0.4g, every gram contains crude drug 10.2g.
The preparation technology of medicine capsule of the present invention is as follows:
The used raw material of Chinese medicine of raw material of Chinese medicine that medicine capsule of the present invention is used and weight proportion and medicinal granule of the present invention is identical, the extraction process step of raw material of Chinese medicine is identical with the extraction process step of granule preparation technology raw material of Chinese medicine of the present invention, and used adjuvant and other processing step are undertaken by the conventional preparation technology of capsule.Every heavy 0.3g, every gram contains raw material of Chinese medicine 9.067g.
The preparation technology of medicine oral liquid of the present invention is as follows:
Raw material of Chinese medicine that medicine oral liquid of the present invention is used and weight proportion and medicinal granule of the present invention are identical, the extraction process step of raw material of Chinese medicine is identical with the extraction process step of granule preparation technology raw material of Chinese medicine of the present invention, and used adjuvant and other processing step carry out according to the conventional preparation technology of oral liquid.Every bottle of 10mL, every milliliter contains raw material of Chinese medicine 0.816g.
Medicine of the present invention shows that through the test of pesticide effectiveness medicine of the present invention has the effect that anti-candida albicans infects vagina.Can reduce the pseudohypha quantity in mice, the rat vagina irrigating solution and carry the bacterium amount, alleviate tissue edema, inflammatory infiltration and mycelia.And have antiinflammatory, strengthen the phagocytic function and the itching-relieving action of mice reticuloendothelial system.Mice onset dosage is 1.5g/kg (amounting to crude drug 1.836g/kg), and rat onset dosage is 1.2g/kg (amounting to crude drug 1.4688g/kg).Medicine of the present invention can enter clinical trial.
The specific embodiment
The present invention is described in more detail below in conjunction with embodiment, but the invention is not restricted to these embodiment.
Embodiment 1
With production medicinal granule product of the present invention 1000 grams is that the used raw material of Chinese medicine of example and adjuvant and proportioning thereof are:
Fructus Gardeniae 432g
Rhizoma Smilacis Glabrae 432g
Flos Lonicerae 216g
Radix Gentianae 144g
Sucrose 400g
Dextrin adds to 1000g.
Fructus Gardeniae in the proportioning of the present invention, Rhizoma Smilacis Glabrae, Flos Lonicerae, Radix Gentianae are decocted with water three times, adding for the first time 10 times of water gagings decocted 1.5 hours, second and third time adds 8 times of water gagings respectively and respectively decocted 1 hour, filters merging filtrate, and be concentrated into relative density 1.10～1.20 (60 ℃), add ethanol and make and contain the alcohol amount and reach 60%, left standstill 24 hours, get supernatant, decompression recycling ethanol is not to there being the alcohol flavor, and being concentrated into relative density is the clear paste of 1.30～1.40 (60 ℃).Qinghuo reagent adds dextrin, and mixing adds cane sugar powder again, and mixing is made granule, drying, and pack, every bag heavy 10g, every gram contains raw material of Chinese medicine 1.224g
With 1000 of production medicinal tablet products of the present invention is that the used raw material of Chinese medicine of example and adjuvant and proportioning thereof are:
Fructus Gardeniae 1440g
Rhizoma Smilacis Glabrae 1440g
Flos Lonicerae 720g
Radix Gentianae 480g
Starch adds to 400g.
Its preparation technology is undertaken by the preparation technology of tablet of the present invention.Every heavy 0.4g, every gram contains raw material of Chinese medicine 10.2g.
With 1000 of production medicine capsule products of the present invention is that the used raw material of Chinese medicine of example and adjuvant and proportioning thereof are:
Fructus Gardeniae 960g
Rhizoma Smilacis Glabrae 960g
Flos Lonicerae 480g
Radix Gentianae 320g
Beta-schardinger dextrin-adds to 300g.
Its preparation technology is undertaken by the preparation technology of capsule of the present invention.Every heavy 0.3g, every gram contains raw material of Chinese medicine 9.067g.
With production oral liquid product of the present invention 1000mL is that the used raw material of Chinese medicine of example and adjuvant and weight proportion thereof are:
Fructus Gardeniae 288g
Rhizoma Smilacis Glabrae 288g
Flos Lonicerae 144g
Radix Gentianae 96g
Sucrose 400g
Distilled water adds to 1000mL.
Its preparation technology is undertaken by the preparation technology of oral liquid of the present invention.Every bottle of 10mL, every milliliter contains raw material of Chinese medicine 0.816g.
In the proportioning of present embodiment, the weight portion of each component of raw material of Chinese medicine is:
18 parts of 18 parts of Rhizoma Smilacis Glabraes of Fructus Gardeniae
6 parts of 9 parts of Radix Gentianae of Flos Lonicerae
Embodiment 2
With production medicinal granule product of the present invention 1000 grams is that the used raw material of Chinese medicine of example and adjuvant and proportioning thereof are:
Fructus Gardeniae 437g
Rhizoma Smilacis Glabrae 437g
Flos Lonicerae 204g
Radix Gentianae 146g
Sucrose 400g
Dextrin adds to 1000g.
Its preparation technology is identical with the preparation technology of embodiment 1 granule.Every bag heavy 10g, every gram contains raw material of Chinese medicine 1.224g.
With 1000 of production medicinal tablet products of the present invention is that the used raw material of Chinese medicine of example and adjuvant and proportioning thereof are:
Fructus Gardeniae 1457g
Rhizoma Smilacis Glabrae 457g
Flos Lonicerae 680g
Radix Gentianae 486g
Starch adds to 400g.
Its preparation technology is undertaken by the preparation technology of tablet of the present invention.Every heavy 0.4g, every gram contains raw material of Chinese medicine 10.2g.
With 1000 of production medicine capsule products of the present invention is that the used raw material of Chinese medicine of example and adjuvant and proportioning thereof are:
Fructus Gardeniae 971g
Rhizoma Smilacis Glabrae 971g
Flos Lonicerae 454g
Radix Gentianae 324g
Beta-schardinger dextrin-adds to 300g.
Its preparation technology is undertaken by the preparation technology of capsule of the present invention.Every heavy 0.3g, every gram contains raw material of Chinese medicine 9.067g.
With production oral liquid product of the present invention 1000mL is that the used raw material of Chinese medicine of example and adjuvant and weight proportion thereof are:
Fructus Gardeniae 291g
Rhizoma Smilacis Glabrae 291g
Flos Lonicerae 136g
Radix Gentianae 98g
Sucrose 400g
Distilled water adds to 1000mL.
Its preparation technology is undertaken by the preparation technology of oral liquid of the present invention.Every bottle of 10mL, every milliliter contains raw material of Chinese medicine 0.816g.
In the proportioning of present embodiment, the weight portion of each component of raw material of Chinese medicine is:
15 parts of 15 parts of Rhizoma Smilacis Glabraes of Fructus Gardeniae
5 parts of 7 parts of Radix Gentianae of Flos Lonicerae
Embodiment 3
With production medicinal granule product of the present invention 1000 grams is that the used raw material of Chinese medicine of example and adjuvant and proportioning thereof are:
Fructus Gardeniae 408g
Rhizoma Smilacis Glabrae 408g
Flos Lonicerae 245g
Radix Gentianae 163g
Sucrose 400g
Dextrin adds to 1000g.
Its preparation technology is identical with the preparation technology of embodiment 1 granule.Every bag heavy 10g, every gram contains raw material of Chinese medicine 1.224g.
With 1000 of production medicinal tablet products of the present invention is that the used raw material of Chinese medicine of example and adjuvant and proportioning thereof are:
Fructus Gardeniae 1360g
Rhizoma Smilacis Glabrae 1360g
Flos Lonicerae 816g
Radix Gentianae 544g
Starch adds to 400g.
Its preparation technology is undertaken by the preparation technology of tablet of the present invention.Every heavy 0.4g, every gram contains raw material of Chinese medicine 10.2g.
With 1000 of production medicine capsule products of the present invention is that the used raw material of Chinese medicine of example and adjuvant and proportioning thereof are:
Fructus Gardeniae 907g
Rhizoma Smilacis Glabrae 907g
Flos Lonicerae 544g
Radix Gentianae 362g
Beta-schardinger dextrin-adds to 300g.
Its preparation technology is undertaken by the preparation technology of capsule of the present invention.Every heavy 0.3g, every gram contains raw material of Chinese medicine 9.067g.
With production oral liquid product of the present invention 1000mL is that the used raw material of Chinese medicine of example and adjuvant and weight proportion thereof are:
Fructus Gardeniae 272g
Rhizoma Smilacis Glabrae 272g
Flos Lonicerae 163g
Radix Gentianae 109g
Sucrose 400g
Distilled water adds to 1000mL.
Its preparation technology is undertaken by the preparation technology of oral liquid of the present invention.Every bottle of 10mL, every milliliter contains raw material of Chinese medicine 0.816g.
In the proportioning of present embodiment, the weight portion of each component of raw material of Chinese medicine is:
25 parts of 25 parts of Rhizoma Smilacis Glabraes of Fructus Gardeniae
10 parts of 15 parts of Radix Gentianae of Flos Lonicerae
In order to verify the therapeutic effect of medicine of the present invention to skin infection, the applicant adopts the medicinal granule of the present invention (name is called refreshing Cape jasmine FUKANG granule during test) of the embodiment of the invention 1 proportioning preparation to entrust the ShanXi Chinese Medicine Academy institute of materia medica to carry out pharmacodynamics test, and various test situation are as follows:
Test objective: adopt the whole animal test, observe the effect of medicine of the present invention to candidiasis induced mice, rat colpitis mycotica model, and the test of antiinflammatory, diuresis, immunologic function (promoting leukocytic phagocytic function), aspect such as antipruritic, for clinical trial provides theoretical foundation.
Experimental apparatus: single single face superpurgative working table, specifications and models are SW-CJ-IFD, are numbered 0408210, are produced by Purifying Equipment Co., Ltd., Suzhou; Biological microscope, specifications and models are E-220LDE, are numbered 669017, are produced by Mike Audi company limited; Air dry oven, specifications and models are DHG-9140A, are numbered 048344, by Shanghai one permanent company limited production; The water isolation type constant incubator, specifications and models are GHP-9080, are numbered 0503104, by Shanghai one permanent company limited production; Seat formula automatic control pressure steam sterilizer, specifications and models are ZDX-35B, are numbered 0014526, are produced by Shenan Medical Appliances Factory, Shanghai; Electronic balance, model are AL104, and degree of accuracy is 0.1mg, are produced by Shanghai prunus mume (sieb.) sieb.et zucc. Teller-Tuo benefit Instr Ltd.; Spectrophotometer, model are 721, are produced by Shanghai lake-light scientific instrument company; 5～40 μ L micropipettors are produced by French GILSON company; TGL20M desk type high speed refrigerated centrifuger is produced by Changsha Ke Wei Industrial Co., Ltd..
Strain: Candida albicans, reference culture, bacterial strain number are ATCC90028, are provided by Xijing hospital laboratory Bacteriology Room.
Reagent: estradiol benzoate injection, to produce by Tianjin gold credit aminoacid company limited, specification is that ml*10 props up 1mg/1ml; Injection liquid of gentamicin is produced by Shanxi Jin Xin Double-Crane Pharmaceutical Co., Ltd company limited, and specification is that 2ml*10 props up, 40,000 units/1ml; Ampicillin for inj sodium, by HARBIN PHARMACEUTICAL GROUP CO., LTD. General Pharm. Factory production, specification is the 0.5g/ bottle; India ink is sincerely believed in meticulous preparation factory by Beijing and is produced, and specification is the 100ml/ bottle; Dimethylbenzene, lot number are 040405, and analytical pure is produced by Chinese Shishou chemical reagent factory; Yi Wensilan;
Positive drug: the fluconazol sheet, to produce by Shijiazhuang Siyao Co., Ltd, treatment is the property read vaginitis in vain, and adult's single dose 0.15 gram is once taken; Indometacin tablets, specification 25mg is produced by Linfen Qi Lin pharmaceutcal corporation, Ltd; FUSAIMI PIAN is produced by Tianjin Lisheng Pharmaceutical Co., Ltd., every day consumption 60-120mg/kg, average 90mg/kg, body weight for humans is by 60kg, i.e. 1.5mg/kg, 10 times of consumption 15mg/kg; Polysaccharide-peptide capsule, Shanghai Xinkang Pharmaceutical Factory produces, and specification is the 0.34g/ grain, and clinical consumption is every day 3 times, and each 3, body weight for humans is 0.051g/kg by 60kg; Chlorate (chlorphenamine) is produced by Linfen, Shaanxi Province pharmaceutical factory, and specification is the 4mg/ sheet, clinical consumption 1-3 time on the one, and a slice of being grown up a time, body weight for humans are by 60kg, and every day, 0.2mg/kg measured 2mg/kg for 10 times.
Animal: the ICR white mice, the SD rat is provided by Xi'an Jiaotong University Medical College's Experimental Animal Center, and credit number is SCXK (Shan) 2007-001; Cavia porcellus stays village laboratory animal plant to provide by the Xi'an Changan District.
Be subjected to the reagent thing: medicinal granule of the present invention, provide by Shenmu County's Chinese medicine institute, lot number is 080301, every bag heavy 10g, clinical people's consumption: obey every day 2 times, each 1 bag, obey 20g every day.Every gram is equivalent to crude drug in whole 1.224g.Body weight for humans is by 60kg, per kilogram of body weight dosage 1/3g.
Preparation: medicinal granule of the present invention is made into suitable suspension with deionized water, and it is stand-by to put into 4 ℃ of refrigerators.
Administering mode: adopt gastric infusion.
Dosage is provided with: the large, medium and small dosage of mice is 6.0g/kg, 3.0g/kg, 1.5g/kg, 18 times, 9 times, 4.5 times of quite clinical people's consumption respectively; The large, medium and small dosage of rat is 4.6g/kg, 2.3g/kg, 1.2g/kg, 14 times, 7 times, 3.5 times of quite clinical people's consumption respectively; The large, medium and small dosage of Cavia porcellus is 4g/kg, 2g/kg, 1g/kg, 12 times, 6 times, 3 times of quite clinical people's consumption respectively.
1. the influence of medicine dialogue beads vaginitis model mice vagina of the present invention
Laboratory animal: 50 of ICR mices, the male and female dual-purpose, body weight 18g-22g is provided by Xi'an Jiaotong University Medical College's Experimental Animal Center, and credit number is SCXK (Shan) 2007-001.
Modeling: get 70 of healthy mices, ♀, body weight 18-22g, wherein 10 mices are as the normal control group, all the other 60 equal subcutaneous injection estradiol benzoate 5mg/kg, every other day once, totally 3 times, the 6th day mouse vagina inoculation Candida albicans, the bacterium liquid density of inoculation is 9 * 10
8Individual/ml, every 20 μ L, once a day, totally three times, modeling is after 10 days, observes the modeling result on the 11st day, method is with aseptic PBS (phosphate buffer) flushing mouse vagina, collects irrigating solution, smear, dyeing, microscopy, main pseudohypha of looking for Candida albicans at microscopically is because the pseudohypha of Candida albicans just has the ability of the vaginal mucosa of settling down, thereby cause colpitis, the modeling result is more successful.Selecting 50 more mices of pseudohypha in 60 modeling mices tests.
Grouping administration: first group of normal control group, irritate stomach deionized water 10ml/kg, the mice of getting 50 modeling successes is divided into 5 groups at random, every group 10, be second group of vaginitis model control group, irritate stomach deionized water 10ml/kg every day, the 3rd group of positive controls, irritate stomach fluconazol sheet 22.5mg/kg (quite people's consumption is 9 times), six groups of the 4th-Di are big for medicine of the present invention, in, small dose group, irritate stomach 6.0g/kg respectively every day, 3.0g/kg, 1.5g/kg (be equivalent to 18 times of clinical people's consumption, 9 times, 4.5 doubly), the administration volume is 10ml/kg, successive administration 7 days.
Detect: the last administration began with aseptic PBS liquid flushing mouse vagina, every 20 μ L after 1 hour, collect irrigating solution, wherein 10 μ L smears, dyeing, microscopy are observed spore, pseudohypha, pseudohypha group's formation situation and its amount are carried out classification, infect the order of severity to judge.The criteria for classifying is: whole smear do not see that pseudohypha is designated as 0, and pseudohypha amount＜10 is designated as 1, is designated as 2 between 10-30, has a pseudohypha group to be designated as 3, and pseudohypha group＞1 is designated as 4; Remain 10 μ L and add in the aseptic PBS liquid of 1ml and dilute, get 50 μ L again in diluent, be inoculated in the husky fort culture medium, cultivated 48 hours for 30 ℃, carrying out the CFU counting (is colony-forming units, with bacterium colony number/L).After every mouse vagina irrigating solution is got, put to death, get mice monilial infection vagina tissue,, draw materials through 10% formalin fixed, the routine paraffin wax embedding, serial section, thickness 5 μ m, HE dyeing is observed with the LEICA biological microscope.The criteria for classifying of index: inflammatory infiltration :+a matter is dispersed in neutrophilic leukocyte or lymphocyte; ++ neutrophilic leukocyte is showed increased around blood vessel; +++most have more inflammatory cell in the visual field, but do not have obvious necrosis and calcification; ++ ++ tangible abscess or calcification are arranged.Mycelia: the visible Candida albicans mycelia of+vaginal canal.The submucous tissue edema :+Mild edema arranged; ++ edema is obvious; +++edema involves the muscle shallow-layer; ++ ++ edema involves the muscle deep layer.
The results are shown in Table 1, table 2, table 3, between table 1, table 2 group relatively, the t check, between table 3 group relatively, rank test.
Table 1 medicine of the present invention is to the influence of microscopy pseudohypha in the mouse vagina irrigating solution (X ± S)
Annotate: compare △ P＜0.01 with matched group; Compare * P＜0.05 * * P＜0.01 with model control group
The result: as seen from Table 1, the pseudohypha of model group is measured apparently higher than normal control group (P＜0.01), illustrates that the scorching model of mouse vagina becomes.Compare with model group, medicine 6.0g/kg of the present invention, 3.0g/kg, 1.5g/kg dosage and positive drug fluconazol sheet can make the pseudohypha in the mouse vagina irrigating solution significantly reduce (P＜0.01, P＜0.05).
Table 2 medicine of the present invention carries the influence (X ± S) of bacterium amount to the mouse vagina irrigating solution
Annotate: compare △ P＜0.01 with matched group; Compare * P＜0.05 * * P＜0.01 with model control group.
As seen from Table 2: the bacterium amount of carrying of model group illustrates that apparently higher than normal control group (P＜0.01) the scorching model of mouse vagina becomes.Compare with model group, medicine 6.0,3.0 of the present invention, 1.5g/kg dosage group and positive drug fluconazol sheet can significantly reduce the bacterium amount (P＜0.01, P＜0.05) of carrying.
Table 3 medicine of the present invention is to the influence of mouse vagina pathological tissue
Annotate: tissue edema: compare with ※, ◎, △ respectively organize equal P＜0.01, ☆, ▲ respectively organizing equal P＜0.05, ★ organizes P＞0.05.
Mycelia: compare with ※, ◎, △ respectively organize equal P＜0.01, ▲ group P＜0.05, and ☆, ★ respectively organize equal P＞0.05.
Inflammatory infiltration: compare with ※, △ organizes P＜0.01, ▲, ☆ respectively organizes equal P＜0.05, ◎, ★ respectively organize equal P＞0.05.
As seen from Table 3, tissue edema: the edema degree of model group is apparently higher than matched group (P＜0.01).Compare with model group, positive controls can significantly reduce edema (P＜0.01), and medicine 6.0 of the present invention, 3.0g/kg dosage can significantly reduce edema (P＜0.05); Mycelia: the hyphae content of model group is apparently higher than matched group (P＜0.01).Compare with model group, positive controls can significantly reduce hyphae content (P＜0.01), and medicine 6.0g/k group significance of the present invention reduces hyphae content (P＜0.05); Inflammatory infiltration: the inflammatory infiltration of model group is apparently higher than matched group (P＜0.01).Compare with model group, positive controls can significantly reduce inflammatory infiltration (P＜0.01), and inflammatory infiltration (P＜0.05) falls in medicine 6.0g/kg group significance of the present invention.
This shows that medicine of the present invention has anti-candida albicans to infect the effect of vagina.Can reduce the pseudohypha quantity in the mouse vagina irrigating solution and carry the bacterium amount, alleviate tissue edema, inflammatory infiltration and mycelia.Onset dosage is 1.5g/kg.
2. the influence of medicine dialogue beads vaginitis rat model vagina of the present invention
Modeling: get 70 of healthy rats, ♀, body weight 180-220g, wherein 10 rats are as the normal control group, all use gentamycin 400,000/ml, ampicillin 40,000/ml for all the other 60, each 0.1ml splashes into rat vagina, be administered once every day, behind the successive administration 8 days, remove antibacterial in the rat vagina (microscopy mirror under aseptic) as a result, next day, No. 8 syringe needles with buckle stretch into the clockwise cut of rat vagina (hemorrhage), with the bacterium liquid (9 * 10 of Candida albicans
14CFU/ml) 50 μ L inject vagina, once a day, and vaccinization 3 days, after 3 days, observe the modeling result, method is with aseptic PBS (phosphate buffer) flushing rat vagina, collects irrigating solution, smear, dyeing (Gram staining method), microscopy, the mainly pseudohypha of looking for Candida albicans at microscopically, because the pseudohypha of Candida albicans just has the ability of the vaginal mucosa of settling down, thereby cause beads colpitis model.Selecting 50 more rats of pseudohypha in 60 modeling rats tests.
Grouping and administration: first group of normal control group, irritate stomach deionized water 10ml/kg; The rat of 50 modeling successes is divided into 5 groups at random, 10 every group, be second group of vaginitis model control group, irritate stomach deionized water 10ml/kg every day; The 3rd group of positive controls, irritate stomach fluconazol sheet 17.5mg/kg (quite people's consumption is 7 times), the 4th-Di is the large, medium and small dosage group of medicine of the present invention for six groups, irritate stomach 4.6g/kg, 2.3g/kg, 1.2g/kg (be equivalent to clinical people's consumption 14,9,4.5 times) respectively every day, the administration volume is 10ml/kg.Successive administration 7 days.
Detect: the last administration began with aseptic PBS liquid flushing rat vagina, every 100 μ L after 1 hour, collect irrigating solution, wherein 50 μ L smears, dyeing, microscopy are observed spore, pseudohypha, pseudohypha group's formation situation and its amount are carried out classification, infect the order of severity to judge.Whole smear do not see that pseudohypha is designated as 0, and pseudohypha amount＜10 is designated as 1, is designated as 2 between 10-30, has a pseudohypha group to be designated as 3, and pseudohypha group＞1 is designated as 4; Remain 50 μ L and add in the aseptic PBS liquid of 1ml and dilute, get 50 μ L again in diluent, be inoculated in the husky fort culture medium, cultivated 48 hours for 30 ℃, carrying out the CFU counting (is colony-forming units, with bacterium colony number/L); After every rat vagina irrigating solution is got, put to death, get rat monilial infection vagina tissue,, draw materials through 10% formalin fixed, the routine paraffin wax embedding, serial section, thickness 5 μ m, HE dyeing is observed with the LEICA biological microscope.The criteria for classifying of index is: inflammatory infiltration, and+a matter is dispersed in neutrophilic leukocyte or lymphocyte, ++ neutrophilic leukocyte is showed increased around blood vessel; +++most have more inflammatory cell in the visual field, but do not have obvious necrosis and calcification; ++ ++ tangible abscess or calcification are arranged.Mycelia: the visible Candida albicans mycelia of+vaginal canal.The submucous tissue edema :+Mild edema arranged; ++ edema is obvious; +++edema involves the muscle shallow-layer; ++ ++ edema involves the muscle deep layer.
The results are shown in Table 4, table 5, table 6, between table 4, table 5 group relatively, the t check, between table 6 group relatively, rank test.
Table 4 medicine of the present invention is to the influence of microscopy pseudohypha in the rat vagina irrigating solution (X ± S)
Annotate: compare Δ P＜0.01 with matched group; Compare * P＜0.05**P＜0.01 with model control group.
As seen from Table 4, the pseudohypha of model group is measured apparently higher than normal control group (P＜0.01), illustrates that the scorching model of rat vagina becomes.Compare with model group, medicine 4.6g/kg of the present invention, 2.3g/kg, 1.2g/kg dosage and positive drug fluconazol sheet can make the pseudohypha in the rat vagina irrigating solution significantly reduce (P＜0.01, P＜0.05).
Table 5 medicine of the present invention carries the influence (X ± S) of bacterium amount to the rat vagina irrigating solution
Annotate: compare Δ P＜0.01 with matched group; Compare * P＜0.05 * * P＜0.01 with model control group.
As seen from Table 5: the bacterium amount of carrying of model group illustrates that apparently higher than normal control group (P＜0.01) the scorching model of rat vagina becomes.Compare with model group, medicine 4.6g/kg of the present invention, 2.3g/kg, 1.2g/kg dosage group and positive drug fluconazol sheet can significantly reduce the bacterium amount (P＜0.01, P＜0.05) of carrying.
Table 6 medicine of the present invention is to the influence of mouse vagina pathological tissue
Annotate: tissue edema: compare with ※, ◎, △, ▲, ☆ respectively organizes equal P＜0.05, ★ organizes equal P＞0.05.
Mycelia: compare with ※, ◎, △, ▲, ☆, ★ organize equal P＞0.05.
Inflammatory infiltration: compare with ※, △, ▲, ☆ respectively organizes equal P＜0.01, ◎, ★ organize P＜0.05.
As seen from Table 6, tissue edema: the edema degree of model group is apparently higher than matched group (P＜0.05), compare with model group, positive controls can significantly reduce edema (P＜0.05), and medicine 4.6g/kg of the present invention, 2.3g/kg dosage group can significantly reduce edema (P＜0.05); Mycelia: there was no significant difference between each group of the mycelia on the vagina tissue; Inflammatory infiltration: the inflammatory infiltration of model group is apparently higher than matched group (P＜0.01), compare with model group, positive controls can significantly reduce inflammatory infiltration (P＜0.01), medicine 4.6g/kg of the present invention, 2.3g/kg, 1.2g/kg dosage group significantly reduce inflammatory infiltration (P＜0.01, P＜0.05).
This shows that medicine of the present invention has anti-candida albicans to infect the effect of vagina, can reduce the pseudohypha quantity in the rat vagina irrigating solution and carry the bacterium amount, alleviates tissue edema, inflammatory infiltration.Onset dosage is 1.2g/kg.
3. medicine xylol of the present invention causes the influence of mice auricle swelling
Experimental technique: get 50 of mices, the male and female dual-purpose is divided into 5 groups at random, 10 every group.Be respectively matched group, positive group (indomethacin 25mg/kg), the heavy dose of group of medicine of the present invention 6g/kg, middle dosage group 3g/kg, small dose group 1.5g/kg, successive administration 5 days, the test of positive group indomethacin was administered once the same day.After the test administration on the same day, be coated with the about 20 μ l modelings of dimethylbenzene for two sides, mouse right ear front and back, left ear is done normal control.After 30 minutes, draw neck to put to death mice, cut two ears, lay round auricle at the corresponding same position of two ears, weigh, calculate swelling degree and inhibitory rate of intumesce (%) with analytical balance with card punch along the auricle baseline.
Swelling degree=auris dextra weight-left ear weight;
Swelling degree suppression ratio (%)=(matched group swelling degree-administration group swelling degree)/matched group swelling degree * 100%.Relatively T check the results are shown in Table 7 between group.
Table 7 medicine of the present invention is to the bullate influence of the mouse ear (n=10 of X ± SD)
Annotate: compare * P＜0.05, * * P＜0.01 with matched group.
Table 7 as can be seen, medicine 6g/kg of the present invention, 3g/kg, 1.5g/kg dosage group and matched group relatively, it is swollen all obviously to suppress dimethylbenzene induced mice ear.
4. medicine of the present invention is to the influence of mouse peritoneal capillary permeability
Experimental technique: get 50 of white mice, ♂ ♀ half and half is divided into five groups at random, 10 every group.Be respectively matched group, positive group, the large, medium and small dosage group of medicine of the present invention, successive administration 5 days, the test of positive group indomethacin was administered once the same day.After the test administration on the same day, inject 0.8% glacial acetic acid 0.2ml, give mouse tail vein injection Yi Wensilan 0.1ml/10g then at once to mouse peritoneal, take off cervical vertebra after 30 minutes and put to death mice, cut open the belly with the azovan blue in normal saline washing abdominal cavity each 3ml, totally twice, collect washing liquid 6ml.Use the spectrophotometer colorimetric, wavelength 610nm returns to zero with distilled water.In case of collecting the liquid muddiness, then need centrifugal 10 minutes (3000 rev/mins), colorimetrics again.According to the 0D value, relatively T check between group.The results are shown in Table 8.
Table 8 medicine of the present invention is to the influence of mouse peritoneal capillary permeability (X ± SD)
As seen from Table 8, medicine 6,3 of the present invention, 1.5g/kg dosage group OD value are starkly lower than matched group, show that this product suppresses the seepage discharge of mouse peritoneal Yi Wensilan, promptly obviously suppresses capillary permeability.
5. medicine of the present invention is to the influence of rat urine amount
Experimental technique: get 60 of SD male rats, body weight 80-120g at first selects rat healthy, that be fit to diuretic test.The other male rat of unisexuality is adopted in this experiment, and reaching what pour into the water yield with the urine amount of collecting in 2 hours is qualified standard 40% or more.Get 50 of above-mentioned qualified rats, be divided into five groups at random, matched group, positive group FUSAIMI PIAN, the large, medium and small dosage group of medicine of the present invention.Medicine of the present invention is administered once every day, successive administration 5 days; Matched group is irritated the stomach normal saline; Positive group was irritated the stomach normal saline in 1-4 days, and experiment irritated the long-pending 1ml/100g that is of body of stomach for FUSAIMI PIAN 15mg/kg, each group the same day.Before experiment the rat fasting be can't help water 12 hours, carry out for rat oral normal saline feedwater load and last administration simultaneously with administration by gavage, every of total capacity is all by 2.5ml/100g.When beginning to survey urine, gently press the rat hypogastric region to drain surplus urine.Put into metabolic cage and collect 5 hours urines, per hour amount is urinated once, and the urine amount is only represented with ml/.Calculate urine amount meansigma methods and the standard deviation of respectively organizing certain hour accumulative total, relatively t check between group.
Experimental result sees Table 9.
Table 9 medicine of the present invention is to the influence of rat urine amount (ml X ± S)
Compare with the normal control group:
*P＜0.05;
*P＜0.01.
As can be seen from Table 9, furosemide group and medicine of the present invention 4.6,2.3g/kg dosage group obviously increase than blank group rat urine amount, prove that medicine of the present invention has certain diuresis to normal rat.
6. medicine of the present invention is to the influence of Turnover of Mouse Peritoneal Macrophages phagocytic function
Experimental technique: get 60 of mices, body weight 18～22g, be divided into 5 groups at random, every group 12, be respectively blank group (pure water 0.1ml/10g), positive controls (Polysaccharide-peptide capsule 0.51g/kg, 10 times of clinical consumptions) and medicine of the present invention 6,3,1.5g/kg (18,9,4.5 times of clinical consumptions) dosage group.Gastric infusion, every day 1 time, successive administration 7 days.After the last administration 30 minutes, claim the mice body weight, the tail vein injects the india ink 0.1ml/10g of 10% dilution.When injecting 2 minutes and 12 minutes, get blood 20 μ l with micropipettor from mice angular vein clump respectively, join the 2ml weight concentration at once and be 0.1% Na
2CO
3In the aqueous solution, shake up.After the off-test, read OD at spectrophotometer
680nmValue is got Mouse Liver, spleen is weighed simultaneously, calculates phagocytic index κ and correction index α value.
The result sees table 10 for details.
Table 10 medicine of the present invention is to the influence of Turnover of Mouse Peritoneal Macrophages phagocytic function
| Group | Dosage | Liver spleen heavy (g) | Phagocytic index (κ) | Engulf coefficient (α) |
| Matched group | - | 2.381±0.225 | 0.0130±0.0066 | 2.838±0.536 |
| Polysaccharide-peptide | 0.51g/kg | 2.454±0.317 | 0.0377±0.0099 ** | 3.915±0.460 ** |
| The heavy dose of group of medicine of the present invention | 6.0g/kg | 2.251±0.457 | 0.0387±0.0106 ** | 4.400±0.475 ** |
| Dosage group in the medicine of the present invention | 3.0g/kg | 2.393±0.354 | 0.0313±0.0068 ** | 3.785±0.566 * |
| Medicine small dose group of the present invention | 1.5g/kg | 2.209±0.231 | 0.0222±0.0128 * | 3.449±0.728 |
By table 10 result as seen, the phagocytic index of medicine 6.0g/kg of the present invention, 3.0g/kg, 1.5g/kg dosage group and Polysaccharide-peptide capsule group all is significantly higher than matched group; Medicine 6.0 of the present invention, 3.0g/kg dosage group and Polysaccharide-peptide capsule dosage group engulf coefficient all apparently higher than matched group.Show that medicine of the present invention can significantly improve the carbon clearance ability of mice, point out medicine of the present invention can obviously strengthen the phagocytic function of mice reticuloendothelial system.
7. antipruritic test
Experimental technique: choose 50 of healthy guinea pigs, body weight 300-350g is divided into 5 groups, and 10 every, ♀ ♂ dual-purpose.The 1st group of matched group irritated stomach deionized water 10ml/kg, continuous 7 days; The 2nd group of positive group only fed 2mg/kg of Chlorate on the 7th day, 1-6 days, irritated stomach deionized water 10ml/kg; The 3-5 group is the heavy dose of group of medicine of the present invention 4.0/kg, middle dosage group 2.0/kg, small dose group 1.0g/kg, continuous 7 days.Began to measure itch-threshold after the administration in the 7th day in 0.5 hour.Before the mensuration, cut the hair on right back instep earlier, then with coarse sandpaper scratch, the about 1cm of area
2During mensuration, only be coated with 0.01% 0.05ml/ of histamine phosphate at wound face, the progressive concentration at double every 3 minutes later on, each all 0.05ml/ only later lick metapedes until Cavia porcellus occurring, at this moment the histamine phosphate's total amount that is given is itch-threshold (mg), itch-threshold is high more, and itching-relieving action is strong more, calculates the average itch-threshold of every treated animal, relatively, t checks between group.The results are shown in Table 11.
Table 11 medicine of the present invention is to the influence of Cavia porcellus itch-threshold
| Group | Dosage | Number of animals | Itch-threshold (mg) | The P value |
| Matched group | - | 10 | 34.00±19.26 | |
| The chlorphenamine group | 2.0mg/kg | 10 | 107.50±51.22 | ＜0.01 |
| Medicine group of the present invention | 4.0g/kg | 10 | 75.50±33.20 | ＜0.01 |
| Medicine group of the present invention | 2.0g/kg | 10 | 59.00±23.31 | ＜0.05 |
| Medicine group of the present invention | 1.0g/kg | 10 | 54.00±21.83 | ＜0.05 |
As seen from Table 11, medicine 4.0/kg of the present invention, 2.0/kg, 1.0g/ dosage group and chlorphenamine group obviously improve the Cavia porcellus itch-threshold, show that medicine of the present invention has itching-relieving action.
More than test shows, medicine of the present invention has anti-candida albicans to infect the effect of vagina.Can reduce the pseudohypha quantity in mice, the rat vagina irrigating solution and carry the bacterium amount, alleviate tissue edema, inflammatory infiltration and mycelia.And have antiinflammatory, strengthen the phagocytic function and the itching-relieving action of mice reticuloendothelial system.Mice onset dosage is 1.5g/kg (amounting to crude drug 1.836g/kg), and rat onset dosage is 1.2g/kg (amounting to crude drug 1.4688g/kg).Medicine of the present invention can enter clinical observation.
The function of medicine of the present invention with cure mainly: heat clearing and damp drying, killing parasites for relieving itching cures mainly the colpitis mycotica damp-heat syndrome.
The specification of medicine of the present invention: every bag heavy 10g of medicinal granule of the present invention, every gram contains raw material of Chinese medicine 1.22g; Every heavy 0.4g of medicinal tablet of the present invention, every gram contains crude drug 10.2g; Every heavy 0.3g of medicine capsule of the present invention, every gram contains raw material of Chinese medicine 9.067g; Every bottle of 10mL of medicine oral liquid of the present invention, every milliliter contains raw material of Chinese medicine 0.816g.
The usage of medicine of the present invention and consumption: oral medicinal granule of the present invention, boiled water is taken after mixing it with water, one time one bag, each 1 time sooner or later; Oral medicinal tablet of the present invention, one time 2,3 times on the one; Oral medicine capsule of the present invention, one time 3,3 times on the one; Oral medicine oral liquid of the present invention, one time 1 bottle, 3 times on the one.
Claims (4)
1, the colpitic oral drugs of a kind of treatment is characterized in that it is by the following weight parts Chinese medicinal raw materials medicinal preparation for oral administration of formulation method preparation routinely:
15～25 parts of 15～25 parts of Rhizoma Smilacis Glabraes of Fructus Gardeniae
5～10 parts of 7～15 parts of Radix Gentianae of Flos Lonicerae.
2,, it is characterized in that wherein the weight portion proportioning of each raw material of Chinese medicine is according to the colpitic oral drugs of the described treatment of claim 1:
15～20 parts of 15～20 parts of Rhizoma Smilacis Glabraes of Fructus Gardeniae
5～8 parts of 7～12 parts of Radix Gentianae of Flos Lonicerae.
3,, it is characterized in that wherein the weight portion proportioning of each raw material of Chinese medicine is according to the colpitic oral drugs of the described treatment of claim 1:
18 parts of 18 parts of Rhizoma Smilacis Glabraes of Fructus Gardeniae
6 parts of 9 parts of Radix Gentianae of Flos Lonicerae.
4, according to the colpitic oral drugs of the described treatment of claim 1, it is characterized in that: said medicinal preparation for oral administration is said capsule or tablet or granule or an oral liquid on the galenic pharmacy.
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