CN103041247B - Traditional Chinese medicine suppository for curing colpitis and preparation method thereof - Google Patents

Abstract

The invention provides a traditional Chinese medicine suppository for curing colpitis, and bulk drugs in the suppository in part by weight are as follows: 10-20 parts of radix stemonae, 10-20 parts of golden cypress, 10-20 parts of radix sophorae flavescentis, 10-20 parts of fructus kochiae, 10-20 parts of dittany bark, 10-20 parts of angelica sinensis, 10-20 parts of szechwan Chinaberry fruit, 10-20 parts of smoked plum, 10-20 parts of rhizoma smilacis glabrae, 10-20 parts of Chinese trumpet creeper, 10-20 parts of mentha haplocalyx, 10-20 parts of lithospermum, 10-20 parts of rhizoma bletillae, 10-20 parts of motherwort, 10-20 parts of raspberry, 10-20 parts of caulis spatholobi, 10-20 parts of eclipta alba and 10-20 parts of patrinia scabiosaefolia fisch. The suppository adopts the integral technology of stype and tampon, and compensates deficiency of the common suppository that the common suppository cannot be delivered to the deep of vagina; the invention solves the difficult problem, the prepared suppository brings the drug therapeutic effect into full play, has the advantages of excellent safety and feasibility, reaches the focus of infection to ward off disease, and has the advantages of quickly relieving itching, completely sterilizing, being strong in antiphlogosis and deinsectization, convenient for administration and low in cost and the realization of easily-manufactured drug compared with the prior art.

Description

One is treated colpitic Chinese medicine suppository and preparation method thereof

Technical field

The present invention relates to contain the medicinal preparation that derives from plant, animal or mineral component, particularly one is treated colpitic Chinese medicine suppository and preparation method thereof.

Background technology

Vaginitis is a kind of common gynecological disease, frequently-occurring disease, is often perplexing many women, and severe patient can affect patient's study, work and women's all one's life.Clinical main manifestations colpitis mycotica, trichomonal vaginitis, bacterial vaginitis.This disease belongs to traditional Chinese medical science leukorrhagia, pudendal pruritus category.Main clinical manifestation is profuse leukorrhea, color, matter generation ANOMALOUS VARIATIONS.Pudendum, pruritus of vagina can't bear, and very itch pain unbearably, uneasy in either sitting or lying.This disease cause of disease is a lot of, shows differently, but blanket pathogeny is how relevant with damp invasion of lower energizer.Modern Chinese medicine thinks, primary disease morbidity by, because plain body is insufficiency of the spleen, can not transmitting and distributing the fluids; Or the pungent delicious food drinks of luxurious food, impairing the spleen and stomach, makes humidogene heat, bet pudendum; Or overstrain impairing the spleen, insufficiency of the spleen resulting in production of dampness, turbid damp accumulates to be held back, for a long time and heat-transformation, damp and hot fumigate under; Or dampness-heat of the liver bet; Or infect damp and hot foully, and to lose in health, turbid damp bet, sends out as leukorrhagia." Yizong Jinjian gynecological heart method gist " said " married woman's pudendal pruritus, how because of parasite caused by accumulation of damp-heat in the body " is this meaning.Obviously, cause colpitic former in response to belong to the latter.Because pudendal pruritus, leukorrhagia person due to the sick worm of infection damp show as dampness-heat of the liver more, thereby treatment should be taking removing damp-heat, killing parasites for relieving itching as principle.Western medicine medicine is a lot, has antibacterials as metronidazole, ciprofloxacin etc., and microecologic cure preparation is as lactobacillus, Bacillus licheniformis.Under the various genitourinary system inflammations of antibiotic therapy gynecological and TONGJINGDAI, texts is very undesirable, by this type of gynaecopathia of western medicine, and not only weak curative effect, easily recurrence, and also side effect is large, does not have again specific Chinese patent medicine.Clinically make decoction oral with Chinese physician with disease foreign side, and some Chinese medicine lotions, but therapeutic effect is all not satisfactory, exists and can bring out the deficiencies such as drug resistance, relapse rate is high, medication is inconvenient, preparation is difficult.And be used for the treatment of publicly at present colpitic medicine, and as: " grace prestige board " JIEERYIN XIYE, still can not reach desirable antiinflammatory, antipruritic effect.Although also have clinically some to treat colpitic medicine for external use, curative effect is all not ideal.Many patients urgently wish to have a kind of external used medicine easy to use and effective, are used for the treatment of various types of vaginitiss, can reach treating both the principal and secondary aspects of a disease, outside interior supporting, and have no side effect, and easy to use, healing time is short, are difficult for the preparation of recurrence after curing.

Because vagina has self-defense ability and vagina ducrey bacillus inhibitory action, approximately having the anemia of pregnant woman of 10% women and 30% is band mycete person, but without any clinical symptoms.Because Candida albicans is the most suitable growth in the vaginal environment of 5.5 left and right at pH value, and in the normal situation of vagina ducrey bacillus, the pH value of vagina is 4 ~ 4.5, also irreproducible even if mycete exists.By alkaline disinfectant, as 3% soda solution lavation vagina, or menstrual phase pH value all exceedes 5.5, and colpitis mycotica all can alleviate.

From dissecting, the state of women's pudendum in a Natural closure, ensures that the vagina discord external world communicates.Vaginal wall is also closed state at front and rear wall at ordinary times, and cervix uteri is also a closure state.In addition in addition, mediate contact infection is also a route of transmission of colpitis mycotica.Contacting which article may contact by the toilet seat in mycete patient infection's common lavatory, bathtub, bathing pool seat, towel by infected vaginitis, use unclean toilet paper, can cause propagation, in the time that the vulvoaginal candidiasis of infected person reaches some, can there is mycotic vulvovaginitis.Other can cause colpitic behavior antibiotics, antibiotic medicine is that chief-criminal takes in a large number antibiotics and also can cause vaginitis.Be oral or the balance of nature of the lactobacillus upset vagina that all can suppress vagina of having an injection as long as used antibiotic, changed the microenvironment of vagina, pathogenic antibacterial source of disease body just may be bred, and finally causes local monilial vaginitis outbreak.So generally do not take in a large number Antibiotics medicine.

At present, the medicine that is used for the treatment of gynecological inflammation is a lot, route of administration has external and oral, pharmaceutical dosage form has lotion, suppository, gel, tablet, capsule, powder etc., if any the metronidazole for the treatment of trichomonal vaginitis, there are Mycosporin bolt or the tablet for the treatment of colpitis mycotica, there is clindamycin for the treatment of nonspecific vaginitis etc., also have some Chinese patent medicines, these medicines all have his own strong points, take effect slowly but all exist, curative effect is not remarkable, treat not thorough, or side effect is larger, cause the shortcoming such as outbreak or obstinate repeatedly, and in the time for the treatment of vaginitis disease, there is certain limitation, cannot treat all sidedly vaginitis, clinical effectiveness is all unsatisfactory.

Summary of the invention

Technical problem to be solved by this invention is, primary disease western medicine medicine is a lot, has antibacterials as metronidazole, ciprofloxacin etc., and microecologic cure preparation is as lactobacillus, Bacillus licheniformis.Under the various genitourinary system inflammations of antibiotic therapy gynecological and TONGJINGDAI, texts is very undesirable, by this type of gynaecopathia of western medicine, not only weak curative effect, easily recurrence, and side effect is large, do not have again specific Chinese patent medicine, clinically make decoction oral with Chinese physician with disease foreign side, and some Chinese medicine lotions, but therapeutic effect is all not satisfactory, exists and can bring out the deficiencies such as drug resistance, relapse rate is high, medication is inconvenient, preparation is difficult.Now in the urgent need to a kind of instant effect is provided, side effect is little, biocidal property is strong, Anti-Puritic and insecticidal effect preparation rapidly, can efficient solution except patient's misery, treatment vaginitis.

For solving the problems of the technologies described above, the invention provides one and treat colpitic Chinese medicine suppository, in described suppository, the parts by weight of various crude drug are: 10～20 parts of the Radixs Stemonae, 10～20 parts of Cortex Phellodendris, 10～20 parts of Radix Sophorae Flavescentiss, 10～20 parts of the Fructus Kochiae, 10～20 parts of Cortex Dictamnis, 10～20 parts of Radix Angelicae Sinensis, 10～20 parts of Fructus Toosendans, 10～20 parts of Fructus Mumes, 10～20 parts of Rhizoma Smilacis Glabraes, 10～20 parts of Flos Campsiss, 10～20 parts of Herba Menthaes, 10～20 parts of Radix Arnebiae (Radix Lithospermi)s, 10～20 parts of Pseudobulbus Bletillae (Rhizoma Bletillae), 10～20 parts of Herba Leonuris, 10～20 parts of Fructus Rubies, 10～20 parts of Caulis Spatholobis, 10～20 parts of Herba Ecliptaes, 10～20 parts of Patrinia scabiosaefolia Fisch grass, 10～20 parts of Radix Scutellariaes.

The colpitic Chinese medicine suppository of described treatment, described in it, in suppository, the parts by weight of various crude drug can also be: 10～15 parts of the Radixs Stemonae, 10～15 parts of Cortex Phellodendris, 10～15 parts of Radix Sophorae Flavescentiss, 10～15 parts of the Fructus Kochiae, 10～15 parts of Cortex Dictamnis, 10～15 parts of Radix Angelicae Sinensis, 10～15 parts of Fructus Toosendans, 10～15 parts of Fructus Mumes, 10～15 parts of Rhizoma Smilacis Glabraes, 10～20 parts of Flos Campsiss, 10～20 parts of Herba Menthaes, 10～20 parts of Radix Arnebiae (Radix Lithospermi)s, 10～20 parts of Pseudobulbus Bletillae (Rhizoma Bletillae), 10～20 parts of Herba Leonuris, 10～20 parts of Fructus Rubies, 10～20 parts of Caulis Spatholobis, 10～20 parts of Herba Ecliptaes, 10～20 parts of Patrinia scabiosaefolia Fisch grass, 10～20 parts of Radix Scutellariaes.

The colpitic Chinese medicine suppository of described treatment, described in it, in suppository, the parts by weight of various crude drug can be also: 10～20 parts of the Radixs Stemonae, 10～20 parts of Cortex Phellodendris, 10～20 parts of Radix Sophorae Flavescentiss, 10～20 parts of the Fructus Kochiae, 10～20 parts of Cortex Dictamnis, 10～20 parts of Radix Angelicae Sinensis, 10～20 parts of Fructus Toosendans, 10～20 parts of Fructus Mumes, 10～20 parts of Rhizoma Smilacis Glabraes, 10～15 parts of Flos Campsiss, 10～15 parts of Herba Menthaes, 10～15 parts of Radix Arnebiae (Radix Lithospermi)s, 10～15 parts of Pseudobulbus Bletillae (Rhizoma Bletillae), 10～15 parts of Herba Leonuris, 10～15 parts of Fructus Rubies, 10～15 parts of Caulis Spatholobis, 10～15 parts of Herba Ecliptaes, 10～15 parts of Patrinia scabiosaefolia Fisch grass, 10～15 parts of Radix Scutellariaes.

For solving the problems of the technologies described above, the present invention also provides a kind of preparation method for the treatment of colpitic Chinese medicine suppository, and the preparation process of described suppository comprises:

A. described crude drug is put into pulverizer grinding and sieving,

B. particulate matter remaining after sieving is put into ethanol heating and refluxing extraction 2 times;

C. get again the medicinal residues after above-mentioned ethanol extraction, the heating and refluxing extraction that adds water 2 times;

D. above-mentioned two kinds of extracting solution are merged, add substrate Mixer pot and set type, ultraviolet virus killing.

In described step a, described crude drug can be put into after pulverizer is pulverized and cross 100 order dusting covers, the fine powder amount that enable pass is crossed 100 mesh sieves is reaching 30%, collects by the raw material fine powder of 100 mesh sieves for subsequent use.

In described step b, particulate matter remaining after sieving can be put into ethanol reflux and carry 2 times, each 1～2 hour, 2 extracting solution be merged and left standstill;

In described step c, the medicinal residues that above-mentioned ethanol extraction can be crossed add 10 times of water gaging heating and refluxing extraction 2 times, each 1～2 hour, 2 extracting solution are merged and are left standstill.

In described steps d, above-mentioned two kinds of extracting solution can be merged, 1.37 filtrate when concentrating under reduced pressure relative density is 80 DEG C, reclaim ethanol, gained filtrate is adjusted to proportion to 1.06, stir evenly after adding the fine powder sieving, pour in substrate, 50 DEG C～60 DEG C heating and melting, cooling and shaping is made class warhead shape suppository.

For solving the problems of the technologies described above, the present invention provides a kind of preparation method for the treatment of colpitic Chinese medicine suppository again, the preparation process of described suppository further comprises: by described crude drug except Pseudobulbus Bletillae (Rhizoma Bletillae) and Herba Menthae, all the other are soaked 30 minutes to 1 hour, heated and boiled 30～40 minutes, filter, filtrate is for subsequent use; Filtering residue adds water, and heating, boils 30～40 minutes for the second time, filters, and filtrate is for subsequent use; Filtering residue adds water again, and heated and boiled 30～40 minutes is for the third time filtered; Three filtrates are combined, and heating is concentrated into paste, then Pseudobulbus Bletillae (Rhizoma Bletillae), Herba Menthae are extracted with steam distillation, obtains crystal, is mixed in ointment obtained above; Choose 50 DEG C～60 DEG C heating and melting of substrate, add ointment cooling and shaping obtained above to make class warhead shape suppository, ultraviolet virus killing.

Treat the preparation method of colpitic Chinese medicine suppository, described in it, suppository substrate used can be selected from: one or more in semi-synthetic fatty acid glyceride, poloxamer, Polyethylene Glycol, lanoline; Described substrate is heating and melting under DEG C condition of temperature 50 C～60, the fine drug powder that adds described preparation method to make, and stirring in water bath is even, is mixed into the liquid of thickness, is poured in plastic shape-forming pipe, inserts tampon, and cooling and shaping is made bullet-shaped suppository; The proportioning of described powder Chinese patent medicine and substrate is 1: 2～1: 4; Described tampon is the tampon of afterbody with cotton thread.

The present invention adopts stype and tampon integrated technique, has made up the deficiency of ordinary suppository, and ordinary suppository can not effectively be delivered to the depths of vagina.Due to the self purification of vagina, in the time having foreign body to exist, can increase liquid secretion, at short notice medicine is got rid of externally, both reduced curative effect, extend again the course for the treatment of, increase expense is polluted again underwear.And the present invention's value of overcoming is with a difficult problem, the suppository of making can be given full play to curative effect of medication, has safety good, the advantage that feasibility is good, and the focus of going directly, reaches the object that gets rid of illness.

Compared with prior art religion, the present invention has the antipruritic advantages such as sterilization is thorough rapidly, and antiinflammatory deinsectization effect is strong, and convenient drug administration, and medicament is easy to manufacture, with low cost.And safety, toxic and side effects is little, easy to use, and healing time is short, after curing, is difficult for recurrence.Can create good social value and economic interests.

Detailed description of the invention

Vaginitis belongs to TCM Gynecology miscellaneous diseases pudendal pruritus and leukorrhagia category, and both normal companions mutually see.Pudendal pruritus and leukorrhagia have two reasons: on the one hand and endogenous cause of ill: liver,kidney,spleen malfunction closes, and the liver pulse is around external genitals, and main store blood again, is viscus attriguted to wind and wood; Kidney controlling essence storage, main reproduction, Yu Eryin has one's ideas straightened out; The spleen has the function to transport and transform nutrients, and water is wet.If dampness-heat of the liver or stagnation of liver-QI with deficiency of the spleen fire-transformation are raw wet, damp and hot heresy, with through bet, is pented up external genitals so pudendal pruritus; Or deficiency of the liver and kindey, blood and essence asthenia, raw air slaking are dry, and pudendum failure of skin and muscle to be nourished is flourish and itch; Relevant with the sick worm of exopathogenic factor infection damp on the one hand in addition, careless because taking the photograph body, cause the sick worm of damp and invade, worm disturbs pudendum, and sending out is pudendal pruritus." Yizong Jinjian gynecological heart method gist " said " married woman's pudendal pruritus, how because of parasite caused by accumulation of damp-heat in the body " is this meaning.Obviously, cause the former in belonging to the latter of infective vaginitis.According to Traditional Chinese medical theory, adjust function as main by person due to endogenous cause of ill taking oral medicine, and because of person due to exterior syndrome worm or be aided with external treatment or taking external treatment as Main Means.

Because pudendal pruritus, leukorrhagia person due to the sick worm of infection damp show as dampness-heat of the liver more, thereby treatment should be taking removing damp-heat, killing parasites for relieving itching as principle.Primary disease is mainly because of damp-heat accumulation, in worm-eaten the moon due to damp and hot heresy have inside and outside point.Cause damp and invade outward as occupied for a long time wetland etc., strongly fragrant and heat-transformation, or menstrual period, puerperal, damp and hot evil poison is taken advantage of a weak point, and this is that diseases caused by exogenous pathogenic factor are damp and hot.If plain body deficiency-weakness of spleen-QI, or depression of liver-QI, wood gram spleen soil, dysfunction of the spleen in transportation, stays in water is wet, stops pouring down Jiao, accumulate and heat-transformation, be that interior life is damp and hot.Damp-heat accumulation, ligament is not solid, and leukorrhagia increases, yellow skin.Damp-heat in lower-JIAO, the excellent concurrent stranguria of failing to keep an appointment of wing; With the passing of time damp contamination becomes poison, or infects pyretic toxicity pathogen, and the absurd row of intenseness of heat forcing blood, or noxious dampness corrosion skin, be with as seen defecation with blood and pus, or see " erosion of the vulva ", " erosion of vulva ".Web rot is infested, or health preserving is careless, the evil straight external genitals of violating of worm, and pudendal pruritus in worm-eaten the moon, though causalgia primary disease is sick at external genitals in the moon, often relevant with the internal organs such as liver spleen.How because damp is disease.Obviously, cause the former in belonging to the latter of infective vaginitis.

Pseudobulbus Bletillae (Rhizoma Bletillae) hardship, sweet, puckery, is slightly cold.Return lung, liver, stomach warp.Function cures mainly astringing to arrest bleeding, detumescence and promoting granulation.Spit blood for hemoptysis, traumatic hemorrhage, sore swollen toxin, chapped skin; Pulmonary tuberculosis hemoptysis, ulcer haemorrhage.Shennong's Herbal: " main carbuncle, malignant boil, lose cellulitis, the dead flesh of impairment of YIN, pathogen in stomach "; Compendium of Material Medica: " abnormal smells from the patient (root) is bitter, flat, nontoxic.

Fructus Kochiae clearing away heat-damp and promoting diuresis, dispelling wind for relieving itching.For difficulty and pain in micturition, pudendal pruritus leukorrhagia, rubella, eczema, skin pruritus." property of medicine opinion ": " with clothes, main husband's impotence does not rise with Actinolitum, QI invigorating benefit power; Control cloudy ovum Huang disease, the wind that reduces phlegm and internal heat, can make soup and take a shower." Fructus Kochiae decoct 2g/kg is to rabbit gavage, and in 6 hours, urine chloride increases by 127.1%～131.6%, but total volume of urine is unchanged. and have report to point out, the Fructus Kochiae is discharged and is all had impact Urine of Rats amount and urine sodium.

Cortex Phellodendri heat clearing and damp drying, pathogenic fire purging is except steaming, detoxification sore treatment.For damp-heat dysentery, jaundice, leukorrhagia, pyretic stranguria, beriberi, flaccidity is warded off, hectic fever due to YIN-deficiency consumptive fever, night sweat, seminal emission, sore swollen toxin, eczema pruritus.Stir-baked CORTEX PHELLODENDRI with salt solution nourishing YIN to lower pathogenic fire.For hyperactivity of fire caused by deficiency of YIN, night sweat hectic fever due to YIN-deficiency." Chinese Pharmacopoeia " carries the power of Cortex Phellodendri heat clearing and damp drying, similar to Radix Scutellariae, Rhizoma Coptidis, but damp and hot as good taking except the part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels.

Radix Sophorae Flavescentis hardship, cold.GUIXIN, liver, stomach, large intestine, urinary bladder channel heat clearing and damp drying, parasite killing, diuresis.For hematodiarrhoea, have blood in stool, jaundice urine retention, leucorrhea with red and white discharge, swelling of the vulva pudendal pruritus, eczema, eczema, skin pruritus, scabies leprosy; External treatment colpitis mycotica, is often combined with Cortex Phellodendri, is the colpitic external use gynaecological good medicine for the treatment of.

Radix Stemonae nature and flavor sweetness and bitterness, tepor." not Lu ": tepor." property of medicine opinion ": sweet in the mouth is nontoxic." Japan hanako materia medica ": bitter in the mouth is nontoxic.Nature and flavor are sweet, bitter, tepor.Return lung meridian.Function cures mainly] nourishing the lung to keep the adverse QI downward cough-relieving, parasite killing.Cough for new chronic cough, pulmonary tuberculosis cough, pertussis; Outward for head louse, body louse, enterobiasis, pudendum Pruritus.

Fructus Mume, sour and astringent and warm, seemingly have class in Fructus Chaenomelis, but this enters lung and receives, enter intestinal puckery, enter muscle and bone soft, enter worm and lie prostrate, enter dead flesh, dislike meat, dislike nevus and remove, worm obtains sour volt, and worm volt is only itched.The good medicine of killing parasites for relieving itching.

Cortex Dictamni dispels the wind, dampness, heat clearing away, removing toxic substances.Control wind heat sore, scabies, itchy skin eruption, rheumatic arthralgia, jaundice." herbal classic ": main wind syndrome of head, jaundice, cough with dyspnea, drenches drop, in woman's the moon, swells and ache, the dead flesh of arthralgia chiefly caused by damp pathogen, unable to flex and stretch the extremities, start-stop, row step.

Rhizoma Smilacis Glabrae nature and flavor: sweet light, flat.Gui Jing: Liver Channel; Stomach warp; Spleen channel.Function: removing toxic substances, dehumidifying, sharp joint.Cure mainly: control syphilis, stranguria with turbid discharge, muscles and bones spasm and pain, beriberi, furuncle is treated skin ulcer, carbuncle, scrofula.

Herba Menthae is one of Chinese conventional Chinese medicine.It is pungent cool property sweating antipyretic medicine, controls influenza, headache, conjunctival congestion, fever of the body, throat, the dental bed disease such as swell and ache.Place with can training the mind dysmenorrhoea, skin pruritus, erythra and eczema etc.All herbal medicine, pungent, cool.Return lung, Liver Channel, there is the wind heat of dispersing, clearing throat, rash removing toxic substances, dispersing the stagnated live-QI to relieve the stagnation of QI and the effect such as antipruritic, be applicable to that cold, fever, headache, laryngopharynx swelling and pain, lossless, wind-fire acute conjunctivitis, rubella, skin are itched, the disease such as colic, dysentery and scrofula, external has slight analgesic effect, for neuralgia etc.

Radix Angelicae Sinensis, its sweet in the mouth and weighing, therefore specially can enrich blood, its gas is light and pungent, thus again can promoting the circulation of blood, invigorating middle warmer has, in row, has benefit, the really gas medicine in blood, the also panacea in blood.Approximately mending to mend of assistant, thus can support nutrition blood, QI invigorating spermatogenesis, settling five organs, strong body, beneficial mind, all tangible deficient diseases, unsuitable without institute.Assistant logical to attack, therefore the pain relieving constipation of dispelling, relieving rigidity of muscles and joints, controls contracture, paralysis, the card such as dry, puckery.Nutrient QI being deficient and exterior syndrome being not relieved person, assistant is with agent such as bavin, Pueraria lobota, fiber crops, osmanthus, the Biao Weire that can fall apart greatly, and show not hold back person, and help with Radix Et Rhizoma Rhei and so on, again can consolidating superficial resistance.Precisely because gas Xin Erdong, thus want its quiet person when keeping away it, the sliding benefaction of property, stool is not consolidated person when keeping away it.All cloudy moderate heat Sheng persons, the active blood of Radix Angelicae Sinensis, also non-institute is suitable, cloudy deficiency of YANG of middle-JIAO person, Radix Angelicae Sinensis can nourish blood, and is indispensable.

Radix Scutellariae has heat clearing and damp drying, and removing heat from blood is antiabortive, detoxicating functions.Cure mainly the diseases such as epidemic febrile disease, upper respiratory tract infection, cough due to lung-heat, damp and hot jaundice, pneumonia, dysentery, hemoptysis, conjunctival congestion, frequent fetal movement, hypertension, carbuncle furuncle.The clinical practice of Radix Scutellariae is antibacterial not worse than Rhizoma Coptidis, and does not develop immunity to drugs.We are used in fungal culture miscellaneous bacteria and infect special severity by the strong feature of broad-spectrum antibacterial action, fine by Radix Scutellariae extracting solution effect." Bencao Jingshu ": Radix Scutellariae, its property is respectful clearly, so evil removing: so bitter in the mouth dampness; So YIN-cold victory heat, therefore main all heat.All hot persons, pathogenic heat with all over heat also, jaundice, intestinal be out-of-the-way, let out dysentery, the disease of all damp and hot victory also, is analysed it, all diseases are from recover.Bitter cold can be except damp and hot, thus small intestinal profit and water from by, source is clearly flowed also clean.The blood person of closing, excess-heat is at blood system, and amenorrhea is made us obstructed in instant heating human blood chamber, damp and hot solution, Ying Qi is clearly and voluntarily also.Malignant boil cellulitis erosion person, heat in blood is stayed knot, and is that carbuncle stain is also rotten: acute scleritis person, fire of moxibustion blood trouble also, removing heat from blood heat extraction, spontaneous recovery also.Radix Scutellariae has antiallergic action and antiinflammatory action: the contained baicalin of Radix Scutellariae and baicalin can obviously suppress the anaphylaxis contractile response that sensitized guinea pig rat small intestine in vitro and isolated tracheal produce antigen, passive general allergy to Cavia porcellus and mice and Cavia porcellus passivity skin allergic reaction, baicalin and baicalin also have inhibitory action.Radix Scutellariae has refrigeration function, most evidences, and the active ingredient baicaligenin of Radix Scutellariae has refrigeration function.Radix Scutellariae has Detoxication, and baicalin has obvious Detoxication, and this may be that baicalin decomposites glucuronic acid due under the effect of glucuronidase, and due to being combined with multiple poisonous substance.10 milligrams of LD50 that can improve strychnine of baicalin reach 2.5 times, and the hepatic glycogen content of carbon tetrachloride poisoning mice is increased.

Fructus Rubi plant can be used as medicine, and has multi-medicament to be worth, and its fruit has the effect of kidney invigorating and YANG supporting.Raspberry seed oil belongs to unsaturated fatty acid, can promote the severe that of prostate secretion to cover.Effect: the liver and the kidney tonifying, controlling nocturnal emission with astringent drugs reducing urination, improving eyesight.Observation index is made in vaginal smear and inner membrance section with rat, rabbit, and Fructus Rubi seemingly has estrogen-like effects.The flat board method that burrows for bacteriostasis 100% decoct, has inhibitory action to staphylococcus, and vibrio cholera is also had to inhibitory action.The indexs such as the vaginal smear of estrogen-like effects rat, rabbit and inner membrance section show, Fructus Rubi seemingly has estrogen-like effects.

Herba Leonuri acrid in the mouth hardship, cool.Invigorate blood circulation, dispel silt, regulating menstruation, water disappears.Treatment menoxenia, vaginal bleeding during pregnancy difficult labour, retention of placenta, puerperal blood faints, abdominal pain due to blood stasis, metrorrhagia and metrostaxis, hematuria, rushes down blood, carbuncle skin infection.Herba Leonuri alkalescence subcutaneous injection has central inhibitory action, and MLD is 0.4-0.6g/kg.Intravenous rabbit injection leonurine 1mg/kg, visible urine amount significantly increases.Leonurine can make Sanguis Leporis seu oryctolagi suspension generation haemolysis in the time of higher concentration.Tube dilution method 1 for leonurine infusion: 13-1: 10, to achorion schoenleinii, Pilus Caprae seu Ovis sample sporidiole bacteria, epidermophyton rubrum, starlike nocadia all have inhibitory action.The dull and stereotyped paper disk method of Herba Leonuri decoct, has inhibitory action to escherichia coli, dysentery bacterium.Herba Leonuri can remove the tissue regeneration promoting that becomes silted up, and promoting blood flow to regulate menstruation contains the various trace elements such as selenium, manganese, and energy antioxidation, anti-aging has pretty good beneficial face beauty treatment, anti-ageing anti-old effect.

Patrinia scabiosaefolia Fisch grass nature and flavor are bitter flat, have effect of heat-clearing and toxic substances removing, evacuation of pus removing blood stasis with potent drugs.Can cure acute appendicitis, dysentery, leucorrhea with red and white discharge, the stagnant stomachache of the stasis of blood in puerperal, conjunctival congestion and swelling pain.Enter stomach, large intestine, Liver Channel.Cure mainly heat-clearing and toxic substances removing, eliminating carbuncle evacuation of pus, blood circulation promoting competent silt.For acute appendicitis, lung abscess and sore and toxic, the breast abdomen pain due to the excess-heat stasis of blood is stagnant, the diseases such as the stagnant stomachache of the stasis of blood in puerperal.

Fructus Toosendan is cold in nature, and bitter in the mouth is the one of qi-activating drug.Mainly enter Liver Channel, catharsis liver-heat, promoting the circulation of QI to relieve pain, have the function except damp and hot, clearing away liver-fire, pain relieving, parasite killing.Function cures mainly soothing liver-QI, promoting the circulation of QI to relieve pain, anthelmintic.For the breast side of body, abdominal distention, colic, abdominal pain due to worm stagnation." herbal classic ": " main temperature disease, typhoid fever are too hot tired mad, kill three scabies and steal, diuresis water channel

A kind of Chinese medicine material of Flos Campsis, has promoting the circulation of blood blood stasis removing, cooling blood, expelling wind dampness removing, heat-clearing and toxic substances removing, and acrid in the mouth acid, cold nature is returned liver, pericardium channel, function promoting blood circulation to remove blood stasis, cooling blood, expelling wind.Cure mainly menoxenia, amenorrhea lump in the abdomen, puerperal swelling of the breast, skin pruritus. " Amplification on Materia Medica addendum ": Flos Campsis, control the key medicine of pain in blood also, and nourishing YIN victory very, be stamped and keep and walk alone, in married woman side multiplex what." Nanning City's medicine will ": have the merit of eliminating inflammation and expelling toxin, hemostasis and pain-relieving, evacuation of pus granulation promoting, control red Hakuri.

Caulis Spatholobi property hardship, sweet, temperature.Return liver, kidney channel, enrich blood, invigorate blood circulation, dredging collateral.For menoxenia, blood deficiency and yellow complexion, paralysis and numbness, rheumatic arthralgia relaxing muscles and tendons to promote blood circulation; Nourishing blood for regulating menstruation, supplementary Amplifications of the Compendium of Materia Medica carries it can cure numb hand and foot; Quadriplegia; Rheumatic arthralgia; Flos Campsis, Caulis Spatholobi is for oral administration is that treatment blood stasis is loose, the nourishing blood good medicine of invigorating blood circulation that becomes silted up.

Herba Ecliptae all herbal medicine.Nature and flavor are sweet, sour, cool, have the effect of removing heat from blood, hemostasis, nourishing the liver and kidney, heat-clearing and toxic substances removing.Herb is containing volatile oil, tannin and Saponin, bosom moral endoenzyme, demethyl Huai Denei vinegar, α-tri-Ping thiophene phenol methanol and nicotinamide, vitamin A sample material.Bacteriostasis: by the flat board method that burrows, prove that Herba Ecliptae has bacteriostasis to staphylococcus aureus, typhoid fever stalk bacterium, Song's Shigella flexneri, bacillus pyocyaneus.

Radix Arnebiae (Radix Lithospermi) is cold in nature, sweet in the mouth, salty.GUIXIN, Liver Channel.Cure mainly removing heat from blood, invigorate blood circulation, removing toxic substances rash.For heat in blood poison contain, macule purple is black, measles without adequate eruption, skin infection, dermatomycosis, burn due to hot liquid or fire.Clearing away heat and cooling blood, for measles, calentura skin eruption, dermatomycosis, hematuria, stranguria with blood, dysentery, skin infection, separates erysipelas." book on Chinese herbal medicine justice " carries: Radix Arnebiae (Radix Lithospermi), and abnormal smells from the patient bitter cold, and color purple enters blood, therefore the heat of cleaning blood system.Ancient to control the accumulation of heat of internal organs, descendant is special treatment of smallpox infections, treats skin eruption, all positive purport of heat clearing and blood cooling and hold concurrently.

Embodiment 1: the manufacturing process of suppository of the present invention is: by Radix Stemonae 1000g, Cortex Phellodendri 1000g, Radix Sophorae Flavescentis 1000g, Fructus Kochiae 1000g, Cortex Dictamni 1000g, Radix Angelicae Sinensis 1000g, Fructus Toosendan 1000g, Fructus Mume 1000g, Rhizoma Smilacis Glabrae 1000g, Flos Campsis 1000g, Herba Menthae 1000g, Radix Arnebiae (Radix Lithospermi) 1000g, Pseudobulbus Bletillae (Rhizoma Bletillae) 1000g, Herba Leonuri 1000g, Fructus Rubi 1000g, Caulis Spatholobi 1000g, Herba Ecliptae 1000g, Patrinia scabiosaefolia Fisch grass 1000g, Radix Scutellariae 1000g.First described crude drug is ground into coarse powder, more further pulverizes, cross 100 mesh sieves, the fine powder amount that enable pass is crossed 100 mesh sieves is reaching 30%, collects and obtains fine powder a by the fine powder of 100 mesh sieves; Can not drop into multi-function extractor by the coarse powder of 100 mesh sieves again and extract twice, and add for the first time 8-10 and doubly measure ethanol decoction 1-2 hour, and add for the second time 4-8 times of water gaging and decoct 1-2 hour, merge twice decocting liquid, filter to get filtrate; Heating is concentrated into pasty state, then by 50 DEG C～60 DEG C heating and melting of substrate, adds fine powder a and the coarse granule extracting solution b of preparation, and stirring in water bath is even, is mixed into the liquid of thickness, is poured in plastic shape-forming pipe, and cooling and shaping is made class warhead shape suppository; After ultraviolet radiation for sterilizing and disinfecting, use.Get substrate heating and melting, temperature 50 C～60 DEG C, the fine powder that adds the present invention to make, stirring in water bath is even, is mixed into the liquid of thickness, is poured in plastic shape-forming pipe, inserts tampon, and cooling and shaping is made similar bullet-shaped suppository.General substrate used can be: semi-synthetic fatty acid glyceride, lanoline, Polyethylene Glycol, the proportioning of medicine fine powder and substrate is 1: 2～1: 4, be preferably 1: 3, or adopt poloxamer poloxamer as substrate, it has been widely used as the hydrophilic matrix of suppository, have the following advantages: the dissolubility than other substrate is soft, quick, and drug loading is also higher.For easy to use, tampon can select the foot section brought to have the tampon of cotton thread.The detailed directions of described suppository is as follows: after menstrual phase, drug suppository of the present invention is removed to cabinet, take out stype, pull-out afterbody cotton thread, includes stype in vagina deep, and cotton thread is stayed external, 1 every night, play pull-out tampon morning next day, continuous use 7 days is a course for the treatment of.

Embodiment 2: the manufacturing process of suppository of the present invention can also be: by Radix Stemonae 1500g, Cortex Phellodendri 1500g, Radix Sophorae Flavescentis 1500g, Fructus Kochiae 1500g, Cortex Dictamni 1500g, Radix Angelicae Sinensis 1500g, Fructus Toosendan 1500g, Fructus Mume 1500g, Rhizoma Smilacis Glabrae 1500g, Flos Campsis 1000g, Radix Arnebiae (Radix Lithospermi) 1000g, Herba Leonuri 1000g, Fructus Rubi 1000g, Caulis Spatholobi 1000g, Herba Ecliptae 1000g, Patrinia scabiosaefolia Fisch grass 1000g, Radix Scutellariae 1000g.Mix, chopping, soaks.Just soaked crude drug heating and refluxing extraction 2 times, each 1～2 hour, merges 2 extracting solution to leave standstill.The medicinal residues of more above-mentioned water extraction being crossed add 5～8 times of amount 60～70% alcohol heating reflux and extract 2 times, each 1～2 hour, 2 extracting solution are merged and are left standstill.Above-mentioned two kinds of extracting solution are merged, and concentrating under reduced pressure relative density is the filtrate of 1.35 (80 DEG C), reclaims ethanol, gained filtrate is adjusted to proportion to 1.06, the extractum that reduces pressure to obtain, by Herba Menthae 1000g, the Pseudobulbus Bletillae (Rhizoma Bletillae) 1000g way of distillation is vaporized into white crystalline powder, again by 50 DEG C～60 DEG C heating and melting of substrate, add the extractum and the white powder that prepare, stirring in water bath is even, is mixed into the liquid of thickness, be poured in plastic shape-forming pipe, cooling and shaping is made class warhead shape suppository; After ultraviolet radiation for sterilizing and disinfecting, use.

Embodiment 3: the preparation method of suppository of the present invention can be also: by Radix Stemonae 1000g, Cortex Phellodendri 1000g, Radix Sophorae Flavescentis 1000g, Fructus Kochiae 1000g, Cortex Dictamni 1000g, Radix Angelicae Sinensis 1000g, Fructus Toosendan 1000g, Fructus Mume 1000g, Rhizoma Smilacis Glabrae 1000g, Flos Campsis 1500g, Herba Menthae 1500g, Radix Arnebiae (Radix Lithospermi) 1500g, Pseudobulbus Bletillae (Rhizoma Bletillae) 1500g, Herba Leonuri 1500g, Fructus Rubi 1500g, Caulis Spatholobi 1500g, Herba Ecliptae 1500g, Patrinia scabiosaefolia Fisch grass 1500g, Radix Scutellariae 1500g, the water soaking 1-2 hour that adds 5-10 doubly to measure, extracts 2 times; Heating extraction 1-2 hour, is concentrated into extractum shape, becomes component 1; Residue medicinal residues add 60-90% soak with ethanol 0.5-1.5 hour, extract twice, each 1-2 hour, merge extractive liquid,, filters, concentrated, 80-160 order filters, and the 6000-10000 rev/min of supernatant after centrifugal, is the ultrafiltration post ultrafiltration of 5000-10000 through the molecular weight that dams, ultrafiltrate concentrating under reduced pressure relative density is the extractum of 1.35 (80 DEG C), heating and refluxing extraction 2 times, each 30 minutes～45 minutes, extracts active ingredient, 2 extracting solution are merged and are settled into extractum shape, as component 2.By 50 DEG C～60 DEG C heating and melting of substrate, add the extractum preparing again, stirring in water bath is even, is mixed into the liquid of thickness, is poured in plastic shape-forming pipe, and cooling and shaping is made class warhead shape suppository; After ultraviolet radiation for sterilizing and disinfecting, use.

The preparation method of suppository of the present invention: get substrate heating and melting, temperature 50 C～60 DEG C, the fine powder that adds the present invention to make, stirring in water bath is even, is mixed into the liquid of thickness, is poured in plastic shape-forming pipe, insert tampon, cooling and shaping is made similar bullet-shaped suppository.General substrate used can be: semi-synthetic fatty acid glyceride, lanoline, Polyethylene Glycol, the proportioning of medicine fine powder and substrate is 1: 2～1: 4, be preferably 1: 3, or adopt poloxamer poloxamer as substrate, it has been widely used as the hydrophilic matrix of suppository, have the following advantages: the dissolubility than other substrate is soft, quick, and drug loading is also higher.

For easy to use, tampon can select the foot section brought to have the tampon of cotton thread.The detailed directions of described suppository is as follows: after menstrual phase, drug suppository of the present invention is removed to cabinet, take out stype, pull-out afterbody cotton thread, includes stype in vagina deep, and cotton thread is stayed external, 1 every night, play pull-out tampon morning next day, continuous use 7 days is a course for the treatment of.

Toxicology test:

1 skin irritation test

1.1 skin anaphylactic tests: 40 Cavia porcelluss are equally divided into 4 groups: 1. matched group, 2. 3. 4. cydiodine group (1% sensitization concentration and 0.1% excite concentration) of metronidazole group of suppository group of the present invention.

1.2 sensitization contact: before test, 24h, in guinea pig back both sides, carefully cuts the unhairing district of 3cm × 3cm.Get tested material 0.2ml, be coated in depilation district, animal left side, with one deck oilpaper and two layers of gauzes covering, then with non-stimulated adhesive plaster sealing, fixing, keep 6h.The 7th day and the 14th day, in kind respectively repeat 1 time, amount to 3 times.Blank group and positive drug matched group method the same (the sensitization concentration of cydiodine and metronidazole 1% for positive sensitizer, matched group is coated with the normal saline that gives equivalent).

1.3 excite contact: after last administration tested material sensitization 14 days, tested material 0.2ml is applied to depilation district, Cavia porcellus right side, positive control 0.1% metronidazole, after 6h, remove tested material, at once observe, then in 24,48, again observe skin allergy situation after 72h, by the scoring of table 1 standard, and evaluate sensitization degree.

Table 1 skin allergy degree standards of grading

1.4 skin anaphylactic test results

With medicament suppository of the present invention be example, induce and excite contact test, viewing test mice after 24 hours and 48 hours, all loseing skin has the phenomenon such as erythema and edema, with negative control group zero difference.Result shows, this liniment is bordering on zero to dermoreaction intensity, without skin allergic reaction.The present invention is wiped containing agent and smears mouse vagina, induce and excite contact test, viewing test mouse vagina after 24 hours and 48 hours, all loseing skin has the phenomenon such as erythema and edema, with negative control group zero difference.Result shows, this suppository is bordering on zero to dermoreaction intensity.

2 long term toxicity test data

2.1, experimental technique

Become 4 groups, 15 every group by random Cavia porcellus part.In guinea pig back spinal column both sides, depilatory is evenly coated, made approximately 40 square centimeters of its depilation scopes.Clean depilatory, observe every group of Cavia porcellus after 24 hours and be coated with respectively suppository 0.2,0.4 of the present invention and 0.8ml, respectively containing crude drug 92,184 and 368mg, another group is coated with the every twice-daily of solvent 0.8ml, continuous 30 days, observe the ordinary circumstance of Cavia porcellus, experiment finishes rear execution animal and carries out hematology, blood biochemical and pathological examination.

2.2 result

Above-mentioned three groups of medication Cavia porcellus trunk unhairing districts, having no local skin has edema, hyperemia, erythema, petechia and ulcer.Medication group and control animals chroma of hair, ingest, the matched group no significant difference such as extremity activity, blood biochemistry checking, medication group and matched group are all in normal range.Histopathologic examination, tests each group of heart, liver, kidney and local skin and is showed no obvious pathological changes.Prompting, Chinese medicine preparation long-term prescription of the present invention is showed no obvious toxic action to local skin and whole body important organ.Result of the test shows: Chinese medicine preparation experiment safety of the present invention.

The present invention is 1: 150 to group B streptococcus, staphylococcus aureus, colibacillary minimal inhibitory concentration, gonococcus is 1: 150, Candida albicans is 1: 300, the time of killing during to 1: 20 dilution factor of vagina mycete is 5 minutes, it within 1: 50 o'clock, is 10 minutes, within 1: 100 o'clock, being 20 minutes, 1: 200 o'clock is 40 minutes, within 1: 400 o'clock, is 8 hours.

Pharmacodynamics test

1. the impact of medicine dialogue beads vaginitis model mice vagina of the present invention

Laboratory animal: 50 of ICR mices, all female, body weight 18g-22g.

Trial drug: preparation of the present invention (embodiment 2 method therefor preparations); Contrast groups: JIEERYIN XIYE, commercially available.

Modeling: get 70 of healthy mices, female, body weight 18-22g, wherein 10 mices are as Normal 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 liquid-tight degree of bacterium of inoculation is 9 × 108/ml, every 20 μ L, once a day, totally three times, after modeling 10 days, within the 11st day, observe modeling result, method is to rinse mouse vagina with aseptic PBS (phosphate buffer), collect irrigating solution, smear, dyeing, microscopy, main pseudohypha of looking under the microscope Candida albicans, because the pseudohypha of Candida albicans just has the ability of the vaginal mucosa of settling down, thereby cause colpitis, modeling result is more successful.In 60 modeling mices, selecting 50 more mices of pseudohypha tests.Grouping administration: first group of Normal group, gavage deionized water 10ml/kg, get 50 successful mices of modeling and be divided at random 5 groups, every group 10, be second group of vaginitis model control group, every day gavage deionized water 10ml/kg, the 3rd group of positive controls, the scorching clean washing liquid of woman's every day is rinsed mouse vagina 22.5mg/kg (quite 9 times of people's consumptions), six groups of four-are that medicine of the present invention is large, in, small dose group, fill in respectively mouse vagina 6.0g/kg every day, 3.0g/kg, 1.5g/kg (is equivalent to 18 times of clinical people's consumption, 9 times, 4.5 times), administration volume is 10ml/kg, successive administration 7 days.

Detect: last administration, after 8 hours, starts to rinse mouse vagina, every 20 μ L with aseptic PBS liquid, collect irrigating solution, wherein 10 μ L smears, dyeing, microscopy, observes spore, pseudohypha, pseudohypha group's formational situation and its amount is carried out to classification, to judge the infection order of severity.The criteria for classifying is: whole smear has no pseudohypha and be 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 the > 1 of pseudohypha group is designated as 4; Remain 10 μ L and add in the aseptic PBS liquid of 1ml and dilute, then in diluent, get 50 μ L, be inoculated in the culture medium of husky fort, cultivate 48 hours, carry out CFU counting (being colony-forming units, with bacterium colony number/L) for 30 DEG C.After every mouse vagina irrigating solution is got, put to death, get mice monilial infection vagina tissue, fix through 10% formalin, draw materials, routine paraffin wax embedding, serial section, thickness 5 μ m, HE dyeing, observes with LEICA biological microscope.The criteria for classifying of index: inflammatory infiltration :+interstitial is dispersed in neutrophilic leukocyte or lymphocyte; ++ neutrophilic leukocyte is showed increased around blood vessel; +++ in most visuals field, there is more inflammatory cell, but without obviously necrosis and calcification; The obvious abscess of ++++have or calcification.Mycelia: the visible Candida albicans mycelia of+vaginal canal.Submucous tissue edema :+Mild edema had; ++ edema is obvious; +++ edema involves muscle shallow-layer; ++++edema involves muscle deep layer.The pseudohypha amount of model group, apparently higher than Normal group (P < 0.01), illustrates that the scorching model of mouse vagina becomes.With model group comparison, medicine 6.0g/kg of the present invention, 3.0g/kg, 1.5g/kg dosage and positive drug JIEERYIN group, can make the pseudohypha in mouse vagina irrigating solution significantly reduce (P < 0.01, P < 0.05).

2. In vitro Bactericidal Experiments

Culture medium: broth bouillon, broth agar culture medium, blood plate, chocolate flat board; Strain:

Select the strains such as escherichia coli, bacillus pyocyaneus, staphylococcus aureus, Candida albicans, Bacillus proteus, gonococcus, γ-streptococcus, micrococcus catarrhalis; Method: dilution method, by high, medium and low preparation of the present invention dosage with meat soup from 1: 5,1:50 to 1: 100 make doubling dilution, every pipe is containing medicinal liquid 2ml, the 9th pipe, for without medicine contrast, adds 1 of dilution bacterium liquid in every pipe, hatch 18h for 37 DEG C, perusal result, pastille least concentration is still the minimal inhibitory concentration (MIC) that obvious haze-free pipe is this medicine.Gonococcus is undergrowth in meat soup, uses chocolate plate dilution method instead and surveys minimal inhibitory concentration.As following table:

Bacterial strain	Minimum inhibitory concentration (MIC) (mg/ml)
		Candida albicans	4.135
Gonococcus	11.8
		γ-streptococcus	27
Bacillus pyocyaneus	5.95
		Escherichia coli	51
Micrococcus catarrhalis	23
		Staphylococcus aureus	6.18

Result shows that suppository of the present invention is all 5mg/ml to the minimal inhibitory concentration of escherichia coli, bacillus pyocyaneus, staphylococcus aureus, Candida albicans, Bacillus proteus, micrococcus catarrhalis, γ-streptococcus, and gonococcus is 10mg/ml.Escherichia coli, bacillus pyocyaneus, staphylococcus aureus, Candida albicans, Bacillus proteus, micrococcus catarrhalis, γ-streptococcus, gonococcus are all had to obvious bacteriostasis.

3. anti-vagina mould test

Culture medium is prepared in proportion, and 4 bottles of subpackages, are respectively charged into etc. and hold normal saline (blank group), 0.5%, 1%, 2% suppository solution of the present invention, are sub-packed in sterility test pipe the about 2ml of every pipe.Getting fresh microscopy proves the specimen 0.2ml of the mycete positive, add above-mentioned 7 heterogeneities in vitro, sending into immediately 37 DEG C of incubators puts 24～48 hours, after taking-up, observe liquid muddiness, without membranoid substance, minimum precipitation, then draw the upper, middle and lower layer observed result of every test tube with aseptic long sucking pipe.Result shows that the present invention has very strong killing action to mycete.

4. antiinflammatory action test

Inhibitory action to rat pedal swelling due to Ovum Gallus domesticus album: select experiment with rat, 220～300g, half and half, 10/group of male and female, left ankle subcutaneous injection 100% egg clear liquid 0.03ml/ only causes inflammation.A joint girth of each measurement after 1h, 2h, 4h, 6h.Obtaining each times two joints of foot girth poor is swelling, and amalgamation result, carries out the comparison of inflammation suppression ratio between each group.As following table:

Result shows the inhibitory action that rat paw edema is had to highly significant of the present invention.To sum up result shows, the present invention has obvious antiinflammatory action.

By above-mentioned pharmacodynamics test, confirm that suppository of the present invention all has obvious bacteriostasis to escherichia coli, bacillus pyocyaneus, staphylococcus aureus, Candida albicans, Bacillus proteus, micrococcus catarrhalis, γ-streptococcus, gonococcus; Mycete is had to killing action; Topical has resist inflammation on repercussive function to Ovum Gallus domesticus album rat paw edema, and can significantly improve itch-threshold value, for the effectiveness of suppository of the present invention provides reliable foundation.

Clinical data

1 data and method

1.1 physical data

Collect the medical history information of 240 routine vaginitis patients of diagnosis and treatment between Wo Yuan gynecological year May in May, 2009 to 2012,20 years old 12 example of age distribution: <, 20～29 years old 23 examples, 30～39 years old 39 examples, 40～49 years old 59 examples, 50～59 years old 70 example, 60～69 years old 24 example, >=70 years old 13 examples, wherein patients with mild example 73 examples, moderate patient's 127 examples, severe patient's 40 examples.

1.2 specimen materials

By clinical gynecologist before not using antibiotic, the vaginal wall that gathers female reproductive system under sterile working spills liquid and the epithelial cell coming off, the secretions such as cervix uteri mucus, endometrium liquid, fallopian tube and ovarian secretion liquid.

1.3 method

The vagina collecting and cervical secretions specimen smear immediately, being coated with a diameter at 1/3 place of slide China and foreign countries is the large small circular specimen of 1cm layer, should not be too thick; After natural drying, then smear is fixed for three times through alcohol burner flame flame envelope; The leucorrhea disease treatment smear rapid dye liquor dyeing of producing with Shanghai Saifu Biotechnology Co., Ltd. after fixed preparation, first drips A liquid, and cover and be all coated with lamella, dyeing 30s, slide tilts 45 °, with distilled water flushing, rear dropping B liquid, dyeing 30s, water rinses; Be positioned over specimen holder natural drying; Finally add 100 times of oily mirror microscopies for cedar oil.The scope of examination mainly comprises: antibacterial, virus, fungus and parasite check, pathological cells, blood cell inspection and counting, and the pathogen of emphasis inspection is candida albicans bacterium, Diplococcus gonorrhoeae, the Gartner coccobacillus, clues cell.There is the pathological examination technician who is familiar with grasp colpocytology and bacteriology's specialty relevant knowledge to carry out inspection.

2 results

In 240 routine vaginitis patients, all kinds of pathogen detect totally 226 examples, and recall rate is 94.16%, wherein bacterial vaginitis 95 examples account for 39.58%, and colpitis mycotica 70 examples account for 29.17%, and trichomonal vaginitis 55 examples account for 22.92%, infusorian and fungus concurrent infection vaginitis 6 examples, ratio is 2.5%.The pathogenic infection situation of age groups is in table 1.

The routine vaginitis Pathogen constituents of table 1226 is than (%)

3 Therapeutic Method

Matched group is with the treatment of compound recipe first nitre vaginal suppository, and vagina administration, starts medication in menstruation after clean 2 one 3 days, and each 1 piece, (menstrual phase is forbidden medication) 7 days is a course for the treatment of.Treatment group is with the prepared suppository of the embodiment of the present invention 2, and vagina administration, starts medication in menstruation after clean 2 one 3 days, and each 1 piece, (menstrual phase is forbidden medication) 7 days is a course for the treatment of.

3 criterions of therapeutical effect and therapeutic outcome

3.1 criterions of therapeutical effect are cured: clinical symptoms, sign disappear completely or obviously, and secretions plate coating checking infusorian feminine gender, cleannes are I degree.Effective: symptom, sign alleviate, secretions plate coating checking infusorian feminine gender, cleannes are for taking a turn for the better.Invalid: symptom, sign are without change, the secretions plate coating checking infusorian positive, and cleannes are without change.

The check after treatment first course for the treatment of (7 days) of 3.2 therapeutic outcomes, judges therapeutic effect.In table 1.

Table 1 curative effect of the present invention

4 discuss

Vaginitis is a kind of taking the change of leucorrhea character, pruritus vulvae, pudendum causalgia, sexual anhedonia as main clinical manifestation, the diseases associated with inflammation that women is common, can levy frequent micturition, urgent micturition, dysurea with bladder irritation, severe patient can occur that vagina is hemorrhage on a small quantity, course of disease elder's anemia that can occur together, the symptoms such as appearance headache, dizzy, asthenia is unable, insomnia Yi Xing are a kind of gynecological common diseases of puzzlement women's health.Women vaginitis is the most common is clinically bacterial vaginitis, colpitis mycotica, trichomonal vaginitis, senile vaginitis.By to the routine vaginitis Etiology analysis of this city 240, discovery bacterial vaginitis is maximum, account for 39.58%, secondly being colpitis mycotica, accounting for 29.17%, is trichomonal vaginitis again, account for 22.92%, the mixed infection of many pathogen is relatively rare, infusorian and fungus concurrent infection vaginitis 6 examples, and shared ratio is only 2.5%.

According to the observation of curative effect of this group case and summary, prove that vaginal suppository of the present invention all has good therapeutic effect to senile vaginitis, trichomonal vaginitis and nonspecific vaginitis.

The main pathogenic factor of senile vaginitis is: ovarian function decline after women's amenorrhea, estrogen level reduces, vaginal mucosa attenuation, elasticity attenuation or disappearance, azoamyly in epithelial cell, intravaginal pH value rises, local lower for the resistance, cause pathogenic bacteria invasion to be infected and produce inflammation, this disease is estrogen and the antibiotic therapies of adopting in the past more, due to long-time medication, dosage is difficult to grasp, and long-time application also can produce more serious side effect, and vaginal suppository of the present invention is not containing estrogen, include various Chinese medicine, mainly contain antibacterial, kill infusorian, anti-inflammatory analgetic, promote wound healing, improve body Effects on local immunological functions, the vaginal mucosa of attenuation is thickened, can make ability of Lactobacillus in human vagina increase, fundamentally change intravaginal environment, senile positive antiinflammatory is treated thoroughly.

But in vaginitis treatment prevention, also can be subject to the impact of many factors, common influence factor has: 1. medication is lack of standardization, treats not thorough; 2. drug withdrawal without authorization, does not focus on checking after medication; 3. not treatment in time of spouse, causes cross infection repeatedly.4. abuse of antibiotics, the not protopathy such as active treatment diabetes, increases the morbidity chance of vaginal candidiasis; 5. bad health habit, as underwear and other medicated clothings shuffle, dry in the sun is at the stuffy place of darkness, increases vaginitis chance of occurrence repeatedly.Therefore, prevent vaginitis recurrence, should follow the doctor's advice, the medication course for the treatment of in accordance with regulations, companion rules together, and reason element is removed in not abuse of antibiotics, cultivates good health habits, and notes public places sanitary, must guard against excessively and cleans, and avoids unclean sexual life.

Specific embodiment 1: Pan, 31 years old, readme is pruritus vulvae often, readme had abortion history 2 times, vagina is scorching hot, leucorrhea abnormal, frequent micturition, urgent micturition, lower part of the body falling inflation, be diagnosed as colpitis mycotica through doctor, outbreak repeatedly, to our hospital, use suppository of the present invention, Fang Yong: Radix Stemonae 10g, Cortex Phellodendri 12g, Radix Sophorae Flavescentis 13g, Fructus Kochiae 11g, Cortex Dictamni 10g, Radix Angelicae Sinensis 10g, Fructus Toosendan 12g, Fructus Mume 11g, Rhizoma Smilacis Glabrae 12g, Flos Campsis 10g, Herba Menthae 10g, Radix Arnebiae (Radix Lithospermi) 13g, Pseudobulbus Bletillae (Rhizoma Bletillae) 11g, Herba Leonuri 12g, Fructus Rubi 13g, Caulis Spatholobi 13g, Herba Ecliptae 13g, Patrinia scabiosaefolia Fisch grass 11g, Radix Scutellariae 10g, make suppository, after 1 course for the treatment of, pruritus disappears, after two courses for the treatment of, vagina is without burning sensation, leucorrhea is normal, urine is normal, so far not recurrence.

Specific embodiment 2: Lin, 29 years old, symptom had purulent leukorrhea, vaginal mucosa redness, with urgent micturition, frequent micturition, dysurea etc., be diagnosed as gonococcal vaginitis, gonococcal vaginitis is easily invaded even abdominal cavity of cervix uteri, endometrium, fallopian tube, and delay is difficult to radical cure repeatedly.Marry and do not give birth to for 4 years, use preparation of the present invention: Fang Yong: Radix Stemonae 11g, Cortex Phellodendri 13g, Radix Sophorae Flavescentis 13g, Fructus Kochiae 11g, Cortex Dictamni 10g, Radix Angelicae Sinensis 10g, Fructus Toosendan 12g, Fructus Mume 11g, Rhizoma Smilacis Glabrae 12g, Flos Campsis 11g, Herba Menthae 10g, Radix Arnebiae (Radix Lithospermi) 12g, Pseudobulbus Bletillae (Rhizoma Bletillae) 12g, Herba Leonuri 12g, Fructus Rubi 13g, Caulis Spatholobi 13g, Herba Ecliptae 13g, Patrinia scabiosaefolia Fisch grass 11g, Radix Scutellariae 10g, make suppository, after 7 days, pruritus disappears, leucorrhea is normal, and after 14 days, vagina is normal without burning sensation, urine, consolidate 3 courses for the treatment of, now successfully become pregnant.

Specific embodiment 3: Lee, 48 years old, 2009 Nian Lai the courts, emaciation and sallow complexion, readme often through first three day start and menstrual period lower abdomen pain with tenderness more than 10 years, angina abdominis under paroxysm, abdominal part is scorching hot, waist distending pain, time have nausea and vomiting, be in a cold sweat, hands and feet coolness, dim red through color, matter is thick piece, and leukorrhagia is sticky and yellow at ordinary times, foul smelling.Gynecologial examination symptom: vaginal secretions increases, is yellow green cystose, frowziness and matter is rare.Pruritus vulvae, scorching hot, vaginal mucosa and cervix uteri are " Fructus Fragariae Ananssae sample " outward appearance, and rear arched roof has a large amount of yellow green cystose secretions.Diagnosis trichomonal vaginitis, uses preparation of the present invention: Fang Yong: Radix Stemonae 11g, Cortex Phellodendri 13g, Radix Sophorae Flavescentis 13g, Fructus Kochiae 11g, Cortex Dictamni 10g, Radix Angelicae Sinensis 10g, Fructus Toosendan 12g, Fructus Mume 11g, Rhizoma Smilacis Glabrae 12g, Flos Campsis 11g, Herba Menthae 10g, Radix Arnebiae (Radix Lithospermi) 12g, Pseudobulbus Bletillae (Rhizoma Bletillae) 12g, Herba Leonuri 12g, Fructus Rubi 13g, Caulis Spatholobi 13g, Herba Ecliptae 13g, Patrinia scabiosaefolia Fisch grass 11g, Radix Scutellariae 12g, makes suppository, after finish the 3rd course for the treatment of, transference cure, leucorrhea is normal, and abnormal flavour disappears, and pruritus stops.After using 4 courses for the treatment of after consolidating, cure, follow up a case by regular visits to 3 years without recurrence.

Claims (5)

1. the colpitic Chinese medicine suppository for the treatment of, it is characterized in that, described suppository is made up of the crude drug of following parts by weight: 10～20 parts of the Radixs Stemonae, 10～20 parts of Cortex Phellodendris, 10～20 parts of Radix Sophorae Flavescentiss, 10～20 parts of the Fructus Kochiae, 10～20 parts of Cortex Dictamnis, 10～20 parts of Radix Angelicae Sinensis, 10～20 parts of Fructus Toosendans, 10～20 parts of Fructus Mumes, 10～20 parts of Rhizoma Smilacis Glabraes, 10～20 parts of Flos Campsiss, 10～20 parts of Herba Menthaes, 10～20 parts of Radix Arnebiae (Radix Lithospermi)s, 10～20 parts of Pseudobulbus Bletillae (Rhizoma Bletillae), 10～20 parts of Herba Leonuris, 10～20 parts of Fructus Rubies, 10～20 parts of Caulis Spatholobis, 10～20 parts of Herba Ecliptaes, 10～20 parts of Patrinia scabiosaefolia Fisch grass, 10～20 parts of Radix Scutellariaes.

2. treat according to claim 1 colpitic Chinese medicine suppository, it is characterized in that, described suppository is made up of the crude drug of following parts by weight: 10～15 parts of the Radixs Stemonae, 10～15 parts of Cortex Phellodendris, 10～15 parts of Radix Sophorae Flavescentiss, 10～15 parts of the Fructus Kochiae, 10～15 parts of Cortex Dictamnis, 10～15 parts of Radix Angelicae Sinensis, 10～15 parts of Fructus Toosendans, 10～15 parts of Fructus Mumes, 10～15 parts of Rhizoma Smilacis Glabraes, 10～20 parts of Flos Campsiss, 10～20 parts of Herba Menthaes, 10～20 parts of Radix Arnebiae (Radix Lithospermi)s, 10～20 parts of Pseudobulbus Bletillae (Rhizoma Bletillae), 10～20 parts of Herba Leonuris, 10～20 parts of Fructus Rubies, 10～20 parts of Caulis Spatholobis, 10～20 parts of Herba Ecliptaes, 10～20 parts of Patrinia scabiosaefolia Fisch grass, 10～20 parts of Radix Scutellariaes.

3. treat according to claim 1 colpitic Chinese medicine suppository, it is characterized in that, described suppository is made up of the crude drug of following parts by weight: 10～20 parts of the Radixs Stemonae, 10～20 parts of Cortex Phellodendris, 10～20 parts of Radix Sophorae Flavescentiss, 10～20 parts of the Fructus Kochiae, 10～20 parts of Cortex Dictamnis, 10～20 parts of Radix Angelicae Sinensis, 10～20 parts of Fructus Toosendans, 10～20 parts of Fructus Mumes, 10～20 parts of Rhizoma Smilacis Glabraes, 10～15 parts of Flos Campsiss, 10～15 parts of Herba Menthaes, 10～15 parts of Radix Arnebiae (Radix Lithospermi)s, 10～15 parts of Pseudobulbus Bletillae (Rhizoma Bletillae), 10～15 parts of Herba Leonuris, 10～15 parts of Fructus Rubies, 10～15 parts of Caulis Spatholobis, 10～15 parts of Herba Ecliptaes, 10～15 parts of Patrinia scabiosaefolia Fisch grass, 10～15 parts of Radix Scutellariaes.

4. a preparation method for the treatment of colpitic Chinese medicine suppository as described in any one in claim 1～3, is characterized in that, the preparation process of described suppository comprises:

A. described crude drug is put into pulverizer grinding and sieving,

B. particulate matter remaining after sieving is put into ethanol heating and refluxing extraction 2 times;

C. get again the medicinal residues after above-mentioned ethanol extraction, the heating and refluxing extraction that adds water 2 times;

D. above-mentioned two kinds of extracting solution are merged, add substrate mediation fill sizing, ultraviolet virus killing;

In described step a, described crude drug is put into after pulverizer is pulverized and crossed 100 order dusting covers, the fine powder amount that enable pass is crossed 100 mesh sieves reaches 30%, collects by the raw material fine powder of 100 mesh sieves for subsequent use;

In described step b, particulate matter remaining after sieving is put into ethanol heating and refluxing extraction 2 times, each 1～2 hour, 2 extracting solution are merged and left standstill;

In described step c, the medicinal residues that above-mentioned ethanol extraction is crossed add 10 times of water gaging heating and refluxing extraction 2 times, each 1～2 hour, 2 extracting solution are merged and are left standstill;

In described steps d, above-mentioned two kinds of extracting solution are merged, 1.37 filtrate when concentrating under reduced pressure relative density is 80 DEG C, reclaims ethanol, gained filtrate is adjusted to proportion to 1.06, stir evenly after adding the fine powder sieving, pour in substrate, 50 DEG C～60 DEG C heating and melting, cooling and shaping is made class warhead shape suppository.

5. as described in any one in claim 1～3, treat the preparation method of colpitic Chinese medicine suppository for one kind, it is characterized in that, the preparation process of described suppository comprises: by described crude drug except Pseudobulbus Bletillae (Rhizoma Bletillae) and Herba Menthae, all the other are soaked 30 minutes to 1 hour, heated and boiled 30～40 minutes, filter, filtrate is for subsequent use; Filtering residue adds water, and heating, boils 30～40 minutes for the second time, filters, and filtrate is for subsequent use; Filtering residue adds water again, and heated and boiled 30～40 minutes is for the third time filtered; Three filtrates are combined, and heating is concentrated into paste, then Pseudobulbus Bletillae (Rhizoma Bletillae), Herba Menthae are extracted with steam distillation, obtains crystal, is mixed in the ointment obtaining; Choose 50 DEG C～60 DEG C heating and melting of substrate, add ointment cooling and shaping obtained above to make class warhead shape suppository, ultraviolet virus killing.