CN103041247A - 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

A kind of colpitic Chinese medicine suppository and preparation method thereof for the treatment of

Technical field

The present invention relates to contain the medicinal preparation that derives from plant, animal or mineral component, particularly a kind of colpitic Chinese medicine suppository and preparation method thereof for the treatment of.

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, the variation of matter abnormal.Pudendum, pruritus of vagina can't bear, and very then 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, the 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 is made humidogene heat, the pudendum of making a bet; Or overstrain impairing the spleen, insufficiency of the spleen resulting in production of dampness, turbid damp accumulate to be held back, for a long time and heat-transformation, and damp and hot fumigating in lower; Or dampness-heat of the liver is made a bet; Or infect damp and hot foully, and losing in health, turbid damp is made a bet, and sends out to be leukorrhagia." Yizong Jinjian gynecological heart method gist " said " how married woman's pudendal pruritus is because of parasite caused by accumulation of damp-heat in the body " namely is this meaning.Obviously, cause colpitic former in belonging to the latter.Because the pudendal pruritus, the leukorrhagia person that infect due to the sick worm of damp show as dampness-heat of the liver more, thereby treatment should be take removing damp-heat, killing parasites for relieving itching as principle.The western medicine medicine is a lot, and antibacterials such as metronidazole, ciprofloxacin etc. are arranged, microecologic cure preparation such as lactobacillus, Bacillus licheniformis.Texts is very undesirable under the various genitourinary system inflammations of antibiotic therapy gynecological and the TONGJINGDAI, with 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 the Chinese physician with disease foreign side, and some Chinese medicine lotions, but therapeutic effect is all not satisfactory, exists to 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 there are 10% women and 30% anemia of pregnant woman to be band mycete person, but without any clinical symptoms.Because Candida albicans is the most suitable growth in about 5.5 the vaginal environment at pH value, and on the normal situation of vagina ducrey bacillus, the pH value of vagina is 4 ~ 4.5, and is also irreproducible even mycete exists.Such as 3% soda solution lavation vagina, or the menstrual phase pH value all surpasses 5.5 with alkaline disinfectant, and colpitis mycotica all can alleviate.

On dissecting, women's pudendum is in the state of a Natural closure, guarantees that the vagina discord external world communicates.Vaginal wall also is closed state at front and rear wall at ordinary times, and cervix uteri also is a closure state.In addition in addition, the mediate contact infection also is 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, when the vulvoaginal candidiasis of infected person reached some, mycotic vulvovaginitis can occur.Other can cause colpitic behavior antibiotics, antibiotic medicine is that the chief-criminal takes in a large number antibiotics and also can cause vaginitis.As long as to have used antibiotic be oral or the lactobacillus that all can suppress vagina of having an injection is upset the balance of nature of vagina, changed the microenvironment of vagina, pathogenic antibacterial source of disease body just may be bred, and finally causes local monilial vaginitis to show effect.So do not take in a large number generally speaking the 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, Mycosporin bolt or the tablet for the treatment of colpitis mycotica arranged, clindamycin for the treatment of nonspecific vaginitis etc. is arranged, also have some Chinese patent medicines, these medicines all have his own strong points, and take effect slowly but all exist, and curative effect is not remarkable, treat not thorough, perhaps side effect is larger, causes the repeatedly shortcoming such as outbreak or obstinate, and when treatment vaginitis disease certain limitation is arranged, can't 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, and antibacterials such as metronidazole, ciprofloxacin etc. are arranged, microecologic cure preparation such as lactobacillus, Bacillus licheniformis.Texts is very undesirable under the various genitourinary system inflammations of antibiotic therapy gynecological and the TONGJINGDAI, with 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 the 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, the treatment vaginitis.

For solving the problems of the technologies described above, the invention provides a kind of colpitic Chinese medicine suppository for the treatment of, the parts by weight of various crude drug are in the described suppository: 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, 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 in its described suppository, 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, the parts by weight of various crude drug also can be 10～20 parts of the Radixs Stemonae, 10～20 parts of Cortex Phellodendris, 10～20 parts of Radix Sophorae Flavescentiss in its described suppository, 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 the pulverizer grinding and sieving,

B. the rear remaining particulate matter that will sieve is put into the ethanol heating and refluxing extraction 2 times;

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

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

Among the described step a, described crude drug can be put into and cross 100 order dusting covers after pulverizer is pulverized, 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.

Among the described step b, the rear remaining particulate matter that sieves can be put into the ethanol reflux and carry 2 times, each 1～2 hour, 2 extracting solution merging be left standstill;

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

In the described steps d, above-mentioned two kinds of extracting solution can be merged, 1.37 filtrate when the concentrating under reduced pressure relative density is 80 ℃, Recycled ethanol, gained filtrate is adjusted proportion to 1.06, stir evenly behind the fine powder that adding is sieved, pour in the substrate, 50 ℃～60 ℃ 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: with described crude drug except Pseudobulbus Bletillae (Rhizoma Bletillae) and Herba Menthae, all the other were soaked 30 minutes to 1 hour, heated and boiled 30～40 minutes, filter filtrate for later use; Filtering residue adds water, and heating was boiled 30～40 minutes for the second time, filters filtrate for later use; Filtering residue adds water again, and heated and boiled is 30～40 minutes for the third time, filters; Three filtrates are combined, and heating is concentrated into paste, Pseudobulbus Bletillae (Rhizoma Bletillae), Herba Menthae is extracted with steam distillation again, gets crystal, is mixed in the ointment obtained above; Choose 50 ℃～60 ℃ heating and melting of substrate, add ointment cooling and shaping obtained above and make class warhead shape suppository, the ultraviolet virus killing.

Treat the preparation method of colpitic Chinese medicine suppository, the used substrate of its described suppository can be selected from: one or more in semi-synthetic fatty acid glyceride, poloxamer, Polyethylene Glycol, the lanoline; Described substrate is heating and melting under ℃ condition of temperature 50 C～60, adds the fine drug powder that described preparation method makes, and stirring in water bath is even, is mixed into the liquid of thickness, is poured in the 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 that afterbody is with the tampon of cotton thread.

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

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

The specific embodiment

Vaginitis belongs to TCM Gynecology miscellaneous diseases pudendal pruritus and leukorrhagia category, and both normal mutually companions see.Pudendal pruritus and leukorrhagia two reasons are arranged: on the one hand and endogenous cause of ill: the liver,kidney,spleen malfunction closes, and the liver pulse is around external genitals, and main store blood is viscus attriguted to wind and wood again; 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 given birth to wet, damp and hot heresy is pented up external genitals so pudendal pruritus with through making a bet; Or deficiency of the liver and kindey, blood and essence asthenia is given birth to air slaking dry, and the 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 " how married woman's pudendal pruritus is because of parasite caused by accumulation of damp-heat in the body " namely 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 the endogenous cause of ill take oral medicine, and because of person due to the exterior syndrome worm or be aided with external treatment or take external treatment as Main Means.

Because the pudendal pruritus, the leukorrhagia person that infect due to the sick worm of damp show as dampness-heat of the liver more, thereby treatment should be take removing damp-heat, killing parasites for relieving itching as principle.Primary disease mainly is because of damp-heat accumulation, in worm-eaten the moon due to damp and hot heresy have inside and outside minute.Cause damp and invade outward as occupying 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, then be that interior life is damp and hot.Damp-heat accumulation, ligament are not solid, and then leukorrhagia increases, yellow skin.Damp-heat in lower-JIAO, the excellent then concurrent stranguria of failing to keep an appointment of wing; With the passing of time the damp contamination becomes poison, or infects the pyretic toxicity pathogen, and as seen the absurd row of intenseness of heat forcing blood, or noxious dampness corrosion skin then are with defecation with blood and pus, or are seen " 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 then in worm-eaten the moon, though the causalgia primary disease is sick at external genitals in the moon, whenever relevant with the internal organs such as liver spleen.Be disease because of damp how.Obviously, cause the former in belonging to the latter of infective vaginitis.

Pseudobulbus Bletillae (Rhizoma Bletillae) is bitter, sweet, puckery, is slightly cold.Return lung, liver, stomach warp.Function cures mainly astringing to arrest bleeding, detumescence and promoting granulation.Be used for hemoptysis and spit blood traumatic hemorrhage, sore swollen toxin, chapped skin; The pulmonary tuberculosis hemoptysis, ulcer haemorrhage.Shennong's Herbal: " main carbuncle, malignant boil, lose cellulitis, the dead flesh of impairment of YIN, pathogen in the 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.Be used for difficulty and pain in micturition, pudendal pruritus leukorrhagia, rubella, eczema, skin pruritus." property of medicine opinion ": " with the same clothes of Actinolitum, main husband's impotence does not rise, QI invigorating benefit power; Control cloudy ovum Huang disease, the wind that reduces phlegm and internal heat can be made soup and take a shower." Fructus Kochiae decoct 2g/kg is to the rabbit gavage, and urine chloride increases by 127.1%～131.6% in 6 hours, but total volume of urine is unchanged. and have report to point out, the Fructus Kochiae is discharged all influential to Urine of Rats amount and urine sodium.

The Cortex Phellodendri heat clearing and damp drying, pathogenic fire purging is except steaming, and skin ulcer is treated in detoxifcation.Be used 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.The stir-baked CORTEX PHELLODENDRI with salt solution nourishing YIN to lower pathogenic fire.Be used for hyperactivity of fire caused by deficiency of YIN, the night sweat hectic fever due to YIN-deficiency." Chinese pharmacopoeia is carried the power of Cortex Phellodendri heat clearing and damp drying, and is similar to Radix Scutellariae, Rhizoma Coptidis, but damp and hot as good take except the part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels.

Radix Sophorae Flavescentis is bitter, and is cold.GUIXIN, liver, stomach, large intestine, urinary bladder channel heat clearing and damp drying, parasite killing, diuresis.Be used 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; The external treatment colpitis mycotica often is 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.Be used for new chronic cough and cough pulmonary tuberculosis cough, pertussis; Outer head louse, body louse, enterobiasis, the pudendum Pruritus of being used for.

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

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

Rhizoma Smilacis Glabrae nature and flavor: sweet light, flat.Gui Jing: Liver Channel; The stomach warp; Spleen channel.Function: detoxifcation, dehumidifying, sharp joint.Cure mainly: control syphilis, stranguria with turbid discharge, the 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 hot cold sweating antipyretic medicine, controls influenza, headache, conjunctival congestion, fever of the body, throat, the dental bed disease such as swell and ache.But place's training the mind dysmenorrhoea, skin pruritus, erythra and eczema etc.All herbal medicine, suffering, cold.Return lung, Liver Channel, the wind heat of dispersing is arranged, clearing throat, the rash detoxifcation, 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 diseases such as colic, dysentery and scrofula, external has slight analgesic effect, is used for neuralgia etc.

Radix Angelicae Sinensis, its sweet in the mouth and weighing, therefore specially can enrich blood, its gas is light and hot, thus again can promoting the circulation of blood, invigorating middle warmer has, in the row benefit is arranged, really the gas medicine in the blood, the also panacea in the blood.About mending to mend then of assistant, thus can support nutrition blood, the QI invigorating spermatogenesis, settling five organs, body by force, beneficial mind, all tangible deficient diseases, nothing is unsuitable.Assistant logical to attack then, therefore the pain relieving constipation of dispelling, relieving rigidity of muscles and joints is controlled 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 the person, and help with Radix Et Rhizoma Rhei and so on, again can consolidating superficial resistance.Precisely because gas Xin Erdong, therefore want its quiet person when keeping away it, the sliding benefaction of property is defecated and is not consolidated the 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 antibiotic not worse than Rhizoma Coptidis, and does not develop immunity to drugs.We are used in the fungal culture miscellaneous bacteria and infect special severity by the strong characteristics of broad-spectrum antibacterial action, and are fine with 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 wins 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 is also analysed it, then all diseases are from recover.Bitter cold can be except damp and hot, thus small intestinal profit and water from pursuing, the source is clearly then 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, then Ying Qi is clearly and voluntarily also.Malignant boil cellulitis erosion person, heat in blood is then stayed knot, and is that carbuncle stain is mashed also: the acute scleritis person, the fire of moxibustion blood trouble also, the removing heat from blood heat extraction, then 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, to passive general allergy and the Cavia porcellus passivity skin allergic reaction of Cavia porcellus and mice, 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 because under the effect of glucuronidase, and baicalin decomposites glucuronic acid, and with due to multiple poisonous substance is combined.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.

The 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, the controlling nocturnal emission with astringent drugs reducing urination makes eye bright.Observation index is made in vaginal smear and inner membrance section with rat, rabbit, and Fructus Rubi seemingly has estrogen-like effects.Bacteriostasis 100% decoct has inhibitory action with the flat board method that burrows to staphylococcus, and vibrio cholera is also had 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.

The Herba Leonuri acrid in the mouth is bitter, cool.Invigorate blood circulation, dispel silt, regulating menstruation, water disappears.The treatment menoxenia, vaginal bleeding during pregnancy difficult labour, retention of placenta, puerperal blood faints, abdominal pain due to blood stasis, metrorrhagia and metrostaxis, rushes down blood, the carbuncle skin infection at hematuria.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 when higher concentration.Leonurine infusion tube dilution method 1: 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 the 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.Be used for acute appendicitis, lung abscess and sore and toxic, the breast abdomen pain due to the excess-heat stasis of blood stagnates, the stagnant stomachache of the stasis of blood in puerperal waits disease.

Fructus Toosendan is cold in nature, and bitter in the mouth is a kind of of qi-activating drug.Mainly enter Liver Channel, the 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.Be used for the breast side of body, abdominal distention, colic, abdominal pain due to worm stagnation." herbal classic ": " main warm disease, typhoid fever are too hot tired mad, kill three scabies and steal the 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 the blood also, and the nourishing YIN victory very, be stamped and keep and walk alone, in the married woman side multiplex what." Nanning City's medicine will ": the merit of eliminating inflammation and expelling toxin, hemostasis and pain-relieving, evacuation of pus granulation promoting is arranged, control red Hakuri.

Caulis Spatholobi property is bitter, sweet, temperature.Return liver, kidney channel, enrich blood, invigorate blood circulation, collateral dredging.Be used 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 carry it can cure numb hand and foot; Quadriplegia; Rheumatic arthralgia; Flos Campsis, Caulis Spatholobi is for oral administration to be that the treatment blood stasis is not loose, the good medicine that nourishing blood silt is invigorated blood circulation.

The Herba Ecliptae all herbal medicine.Nature and flavor are sweet, sour, cool, and the effect of removing heat from blood, hemostasis, nourishing the liver and kidney, heat-clearing and toxic substances removing is arranged.Herb contains volatile oil, tannin and Saponin, bosom moral endoenzyme, demethyl Huai Denei vinegar, α-three Ping thiophene phenol methanol and nicotinamide, vitamin A sample material.Bacteriostasis: with 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, the detoxifcation rash.Be used for that the heat in blood poison is contained, purple black, the measles without adequate eruption of macule, skin infection, dermatomycosis, burn due to hot liquid or fire.Clearing away heat and cooling blood is used for measles, the calentura skin eruption, and dermatomycosis, hematuria, stranguria with blood, dysentery, skin infection is separated erysipelas." book on Chinese herbal medicine justice " carries: Radix Arnebiae (Radix Lithospermi), and the abnormal smells from the patient bitter cold, and the color purple enters blood, therefore the heat of cleaning blood system.Ancient to control the accumulation of heat of internal organs, the descendant is special treatment of smallpox infections then, 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: with Radix Stemonae 1000g, and 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, further pulverizes, cross 100 mesh sieves, the fine powder amount that enable pass is crossed 100 mesh sieves is reaching 30%, and the fine powder of collecting by 100 mesh sieves gets fine powder a; Can not drop into multi-function extractor by the coarse powder of 100 mesh sieves again and extract twice, and add 8-10 for the first time and doubly measure ethanol decoction 1-2 hour, and add 4-8 times of water gaging for the second time and decocted 1-2 hour, merge decocting liquid twice, filter to get filtrate; Heating is concentrated into pasty state, again with 50 ℃～60 ℃ 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 the plastic shape-forming pipe, and cooling and shaping is made class warhead shape suppository; Use behind the ultraviolet radiation for sterilizing and disinfecting.Then get the substrate heating and melting, temperature 50 C～60 ℃ add the fine powder that the present invention makes, and stirring in water bath is even, is mixed into the liquid of thickness, is poured in the plastic shape-forming pipe, inserts tampon, and cooling and shaping is made similar bullet-shaped suppository.General used substrate 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 that the tampon of cotton thread is arranged.The detailed directions of described suppository is as follows: after menstrual phase, drug suppository of the present invention is removed cabinet, take out stype, pull out the afterbody cotton thread, include stype in the vagina deep, cotton thread is stayed external, 1 every night, rise morning next day and pull out tampon, continuous use 7 days was a course for the treatment of.

Embodiment 2: the manufacturing process of suppository of the present invention can also for: with 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 is soaked.Just soaked crude drug heating and refluxing extraction 2 times each 1～2 hour, leaves standstill 2 extracting solution merging.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 merging are left standstill.Above-mentioned two kinds of extracting solution are merged, and the concentrating under reduced pressure relative density is the filtrate of 1.35 (80 ℃), Recycled ethanol, gained filtrate is adjusted proportion to 1.06, the extractum that reduces pressure to get, with Herba Menthae 1000g, the Pseudobulbus Bletillae (Rhizoma Bletillae) 1000g way of distillation is vaporized into white crystalline powder, again with 50 ℃～60 ℃ 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 the plastic shape-forming pipe, cooling and shaping is made class warhead shape suppository; Use behind the ultraviolet radiation for sterilizing and disinfecting.

Embodiment 3: the preparation method of suppository of the present invention also can for: with 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 added water soaking 1-2 hour that 5-10 doubly measures, and extracted 2 times; Heating extraction 1-2 hour, be concentrated into the extractum shape, become component 1; The residue medicinal residues added the 60-90% soak with ethanol 0.5-1.5 hour, extracted twice, each 1-2 hour, merge extractive liquid, filters, and is concentrated, the 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 ℃), heating and refluxing extraction 2 times each 30 minutes～45 minutes, is extracted active ingredient, 2 extracting solution merging are settled into the extractum shape, as component 2.With 50 ℃～60 ℃ heating and melting of substrate, add the extractum for preparing again, stirring in water bath is even, is mixed into the liquid of thickness, is poured in the plastic shape-forming pipe, and cooling and shaping is made class warhead shape suppository; Use behind the ultraviolet radiation for sterilizing and disinfecting.

The preparation method of suppository of the present invention: then get the substrate heating and melting, temperature 50 C～60 ℃ add the fine powder that the present invention makes, stirring in water bath is even, is mixed into the liquid of thickness, is poured in the plastic shape-forming pipe, insert tampon, cooling and shaping is made similar bullet-shaped suppository.General used substrate 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 that the tampon of cotton thread is arranged.The detailed directions of described suppository is as follows: after menstrual phase, drug suppository of the present invention is removed cabinet, take out stype, pull out the afterbody cotton thread, include stype in the vagina deep, cotton thread is stayed external, 1 every night, rise morning next day and pull out tampon, continuous use 7 days was a course for the treatment of.

Toxicology test:

The test of 1 skin irritation

1.1 skin anaphylactic test: 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: 24h carefully cuts the unhairing district of 3cm * 3cm in the guinea pig back both sides before the test.Get tested material 0.2ml, be coated in depilation district, animal left side, cover with one deck oilpaper and two layers of gauze, with non-stimulated adhesive plaster sealing, fixing, keep 6h again.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 positive sensitizer sensitization concentration of cydiodine and metronidazole 1%, 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, remove tested material behind the 6h, at once observe, then in 24,48, again observe the skin allergy situation behind the 72h, press the scoring of table 1 standard, and estimate the sensitization degree.

Table 1 skin allergy degree standards of grading

1.4 skin anaphylactic test result

Be example with medicament suppository of the present invention, induce and excite contact test, viewing test mice after 24 hours and 48 hours, all loseing skin has the phenomenons such as erythema and edema, with the negative control group zero difference.The result shows, this liniment is bordering on zero to dermoreaction intensity, namely without skin allergic reaction.The present invention's wiping is contained agent smear mouse vagina, induce and excite contact test, viewing test mouse vagina after 24 hours and 48 hours, all loseing skin has the phenomenons such as erythema and edema, with the negative control group zero difference.The result shows, this suppository is bordering on zero to dermoreaction intensity.

2 long term toxicity test data

2.1, experimental technique

Random part of Cavia porcellus is become 4 groups, 15 every group.In guinea pig back spinal column both sides depilatory is evenly coated, made approximately 40 square centimeters of its depilation scopes.Clean depilatory, observe after 24 hours every group of Cavia porcellus and be coated with respectively suppository 0.2 of the present invention, 0.4 and 0.8ml, contain respectively 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, put to death animal after experiment finishes and carry 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, experiment is respectively organized the 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, 1: 50 o'clock is 10 minutes, 1: 100 o'clock is 20 minutes, and 1: 200 o'clock is 40 minutes, and 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 (preparation of embodiment 2 method therefors); 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 the bacterium of inoculation is 9 * 108/ml, every 20 μ L, once a day, totally three times, modeling is after 10 days, observed the modeling result on the 11st day, method is with aseptic PBS (phosphate buffer) flushing mouse vagina, collects irrigating solution, smear, dyeing, microscopy, the pseudohypha of mainly 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 group, gavage 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, every day gavage deionized water 10ml/kg, the 3rd group of positive controls, the scorching clean washing liquid flushing mouse vagina 22.5mg/kg of woman every day (quite people's consumption is 9 times), six groups of the 4th-Di 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 (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 8 hours, collect irrigating solution, wherein 10 μ L smears, dyeing, microscopy are observed spore, pseudohypha, pseudohypha group's formational situation and its amount are carried out classification, infect the order of severity to judge.The criteria for classifying is: whole smear has no pseudohypha and is designated as 0, and pseudohypha amount＜10 are 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, fix through 10% formalin, draw materials, 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 without obviously necrosis and calcification; ++ ++ obvious 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 pseudohypha amount of model group illustrates that apparently higher than Normal group (P＜0.01) 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 JIEERYIN group can make the pseudohypha in the 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, with the high, medium and low dosage of preparation of the present invention with meat soup from 1: 5,1:50 to 1: 100 make doubling dilution, every pipe contains medicinal liquid 2ml, the 9th pipe adds 1 of dilution bacterium liquid for without the medicine contrast in every pipe, hatch 18h for 37 ℃, the perusal result, the pastille least concentration still is obvious haze-free pipe and is the minimal inhibitory concentration (MIC) of this medicine.Gonococcus is undergrowth in meat soup, uses the chocolate plate dilution method instead and surveys minimal inhibitory concentration.Such 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

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

3. anti-vagina mould test

Culture medium is prepared in proportion, and 4 bottles of packing 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 the sterility test pipe, and every pipe is 2ml approximately.Get the specimen 0.2ml of the fresh microscopy proof mycete positive, add above-mentioned 7 heterogeneities in vitro, sending into immediately 37 ℃ of incubators put 24～48 hours, observe the liquid muddiness after the taking-up, without membranoid substance, minimum precipitation, then draw the upper, middle and lower layer observed result of every test tube with aseptic long sucking pipe.The 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 the Ovum Gallus domesticus album: select experiment use rat, 220～300g, half and half, 10 of male and female/organize, left ankle subcutaneous injection 100% egg clear liquid 0.03ml/ only causes inflammation.Respectively measure the joint girth behind 1h, 2h, 4h, the 6h one time.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.Such as following table:

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

By above-mentioned pharmacodynamics test, confirmed 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 there is killing action; Topical has resist inflammation on repercussive function to the Ovum Gallus domesticus album rat paw edema, and can significantly improve the 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 240 routine vaginitis patients' of diagnosis and treatment between year May in May, 2009 to 2012 of my gynecological of institute medical history information, age distribution:＜20 years old 12 example, 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 material

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

1.3 method

The vagina that collects and cervical secretions specimen be smear immediately, and being coated with a diameter at 1/3 place, slide China and foreign countries is the large small circular specimen of 1cm layer, should not be too thick; Behind the natural drying, again smear is passed alcohol burner flame flame envelope and fixed for three times; Inspire confidence in the leucorrhea disease treatment smear rapid dye liquor dyeing that bio tech ltd is produced with the Shanghai plug behind the fixed preparation, drip first A liquid, cover and all be coated with lamella, dyeing 30s, slide tilts 45 °, uses distilled water flushing, rear dropping B liquid, dyeing 30s, water flushing; Be positioned over the specimen holder natural drying; Add at last cedar oil with 100 times of oily mirror microscopies.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

Among the 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 sees 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 begins medication in menstruation after clean 2 one 3 days, and each 1 piece, (menstrual phase is forbidden medication) 7 days was a course for the treatment of.Treatment group is with the embodiment of the invention 2 prepared suppositorys, and vagina administration begins medication in menstruation after clean 2 one 3 days, and each 1 piece, (menstrual phase is forbidden medication) 7 days was a course for the treatment of.

3 criterions of therapeutical effect and therapeutic outcome

3.1 criterion of therapeutical effect is cured: clinical symptoms, sign disappear fully or obviously, and secretions plate coating checking infusorian is negative, cleannes are the I degree.Effectively: symptom, sign alleviate, and secretions plate coating checking infusorian is negative, and 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.

3.2 therapeutic effect is judged in therapeutic outcome check after treatment first course for the treatment of (7 days).See Table 1.

Table 1 curative effect of the present invention

4 discuss

Vaginitis is a kind of take the change of leucorrhea character, pruritus vulvae, pudendum causalgia, sexual anhedonia as main clinical manifestation, the diseases associated with inflammation that the women is common, can levy frequent micturition, urgent micturition, dysurea with bladder irritation, it is hemorrhage on a small quantity that vagina can appear in severe patient, 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 clinically to be bacterial vaginitis, colpitis mycotica, trichomonal vaginitis, senile vaginitis.By to this city 240 routine vaginitis Etiology analysis, the 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 only is 2.5%.

According to observation of curative effect and the summary of this group case, 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, the vaginal mucosa attenuation, elasticity attenuation or disappearance, azoamyly in the epithelial cell, the intravaginal pH value rises, local lower for the resistance, cause the pathogenic bacteria invasion to be infected and the generation inflammation, this disease is estrogen and the antibiotic therapies of adopting in the past more, because 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 does not contain estrogen, include various Chinese medicines, mainly contain antibiotic, kill infusorian, anti-inflammatory analgetic, promote wound healing, improve the body Effects on local immunological functions, the vaginal mucosa of attenuation is thickened, ability of Lactobacillus in human vagina is increased; Fundamentally changed the intravaginal environment, senile positive antiinflammatory is treated thoroughly.

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

Specific embodiment 1: Pan, 31 years old, readme is pruritus vulvae often, and readme had abortion history 2 times, vagina is scorching hot, leucorrhea abnormal, frequent micturition, urgent micturition, lower part of the body pendant is swollen, is diagnosed as colpitis mycotica through the doctor, repeatedly outbreak, to our hospital, use suppository of the present invention, the side uses: 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, pruritus disappears after 1 course for the treatment of, and vagina is without burning sensation after two courses for the treatment of, leucorrhea is normal, and 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 cervix uteri, endometrium, fallopian tube even abdominal cavity, and delay is difficult to radical cure repeatedly.Marry and do not give birth in 4 years, use preparation of the present invention: the side uses: 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, pruritus disappears after 7 days, leucorrhea is normal, and vagina is normal without burning sensation, urine after 14 days, consolidate 3 courses for the treatment of, now successfully become pregnant.

Specific embodiment 3: Lee, 48 years old, the court over 2009, emaciation and sallow complexion, readme often begin through first three sky and menstrual period lower abdomen pain with tenderness more than 10 years, angina abdominis under the paroxysm, abdominal part is scorching hot, the waist distending pain, the time nausea and vomiting is arranged, 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.The gynecologial examination symptom: vaginal secretions increases, and is the 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, use preparation of the present invention: the side uses: 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.Cure after using 4 courses for the treatment of after consolidating, follow up a case by regular visits to 3 years without recurrence.

Claims (10)

1. the colpitic Chinese medicine suppository for the treatment of is characterized in that, the parts by weight of various crude drug are in the described suppository: 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. the colpitic Chinese medicine suppository of described treatment according to claim 1 is characterized in that, the parts by weight of various crude drug are in the described suppository: 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. the colpitic Chinese medicine suppository of described treatment according to claim 1 is characterized in that, the parts by weight of various crude drug are in the described suppository: 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. one kind such as the preparation method of the colpitic Chinese medicine suppository for the treatment of as described in each in the claim 1～3, it is characterized in that, the preparation process of described suppository comprises:

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

B. the rear remaining particulate matter that will sieve is put into the ethanol heating and refluxing extraction 2 times;

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

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

5. the preparation method of described suppository according to claim 4, it is characterized in that, among the described step a, described crude drug is put into pulverizer pulverize the rear 100 order dusting covers of crossing, 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.

6. the preparation method of described suppository according to claim 4 is characterized in that, among the described step b, the rear remaining particulate matter that sieves is put into the ethanol heating and refluxing extraction 2 times, each 1～2 hour, 2 extracting solution is merged leave standstill.

7. the preparation method of described suppository according to claim 4 is characterized in that, among the 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 is merged leave standstill.

8. the preparation method of described suppository according to claim 4, it is characterized in that, in the described steps d above-mentioned two kinds of extracting solution are merged, 1.37 filtrate when the concentrating under reduced pressure relative density is 80 ℃, Recycled ethanol is adjusted proportion to 1.06 with gained filtrate, stir evenly after adding the fine powder that sieves, pour in the substrate, 50 ℃～60 ℃ heating and melting, cooling and shaping is made class warhead shape suppository.

9. one kind such as the preparation method of the colpitic Chinese medicine suppository for the treatment of as described in each in the claim 4～8, it is characterized in that, the preparation process of described suppository can also comprise: with described crude drug except Pseudobulbus Bletillae (Rhizoma Bletillae) and Herba Menthae, all the other were soaked 30 minutes to 1 hour, heated and boiled 30～40 minutes, filter filtrate for later use; Filtering residue adds water, and heating was boiled 30～40 minutes for the second time, filters filtrate for later use; Filtering residue adds water again, and heated and boiled is 30～40 minutes for the third time, filters; Three filtrates are combined, and heating is concentrated into paste, Pseudobulbus Bletillae (Rhizoma Bletillae), Herba Menthae is extracted with steam distillation again, gets crystal, is mixed in the ointment obtained above; Choose 50 ℃～60 ℃ heating and melting of substrate, add ointment cooling and shaping obtained above and make class warhead shape suppository, the ultraviolet virus killing.

10. the preparation method of the colpitic Chinese medicine suppository of each described treatment is characterized in that according to claim 4～9, and the used substrate of described suppository is selected from: one or more in semi-synthetic fatty acid glyceride, poloxamer, Polyethylene Glycol, the lanoline; Described substrate is heating and melting under ℃ condition of temperature 50 C～60, adds the fine drug powder that described preparation method makes, and stirring in water bath is even, is mixed into the liquid of thickness, is poured in the 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 that afterbody is with the tampon of cotton thread.