CN104352910A

CN104352910A - Traditional Chinese medicine external suppository for treating women morbid leucorrhea and preparation method thereof

Info

Publication number: CN104352910A
Application number: CN201410619372.2A
Authority: CN
Inventors: 不公告发明人
Original assignee: Qingdao Hengbo Instrument Co Ltd
Current assignee: Qingdao Hengbo Instrument Co Ltd
Priority date: 2014-11-05
Filing date: 2014-11-05
Publication date: 2015-02-18

Abstract

The invention provides a traditional Chinese medicine external suppository for treating women morbid leucorrhea. The suppository comprises the following crude drugs in parts by weight: 10-20 parts of rhizoma smilacis glabrae, 10-20 parts of semen plantaginis, 10-20 parts of salviae miltiorrhizae, 10-20 parts of notopterygium root, 10-20 parts of scutellaria baicalensis, 10-20 parts of rhizoma atractylodis, 10-20 parts of fructus forsythia, 10-20 parts of fructus cnidii, 10-20 parts of cortex phellodendri, 10-20 parts of radix angelicae, 10-20 parts of radix sophorae flavescentis, 10-20 parts of oldenlandia diffusa, 10-20 parts of myrrh, 10-20 parts of radix stemonae, 10-20 parts of teasel root and 10-20 parts of red peony root. The traditional Chinese medicine external suppository has the efficacies of clearing heat and promoting dieresis, and tonifying qi and resolving stagnation, and is used for treating the symptoms such as hypogastralgia, leukorrhagia, yellow and thick leucorrhea, lumbosacral pain and fatigue caused by damp and hot retardation. The external suppository is carefully developed by adopting a modern processing method on the basis of traditional medicine; and effective components of the raw material medicines are scientific in compatibility. Compared with an oral preparation, relatively few drugs are absorbed by the whole body; and the drugs are mainly focused on local parts to play a role of treatment, so that the side effects are relatively few.

Description

A kind of Chinese medicine external suppository for the treatment of women's leukorrhagia and preparation method thereof

Technical field

The present invention relates to the medicinal preparation containing deriving from plant composition, particularly a kind of Chinese medicine external suppository for the treatment of women's leukorrhagia and preparation method thereof.

Background technology

Leukorrhagia refers to woman vagina secretions showed increased, the symptom of color, matter, abnormal smells from the patient exception.Cold-damp or damp invasion of lower energizer, or pyretic toxicity contamination, or abnormal under the normal visible band such as spleen kidney yang gas virtual loss.Leukorrhagia generally sees the evil poison of cysthus local infection, or the pathological changes of uterus etc., is most commonly in leukorrheal diseases.But Sheng person's also visible profuse leukorrhea in physical weakness or phlegm-damp.

Normal woman is from pubarche, and kidney qi fills Sheng, the strong fortune of temper, and conception vessel is logical to be adjusted, dai channel is strong solid, and namely intravaginal has the viscous liquid of a small amount of white or water white transparency odorless, particularly before and after menstrual period, midcycle and trimester of pregnancy amount increase, with moist vaginal orifice, defence exopathogen, this makes a living under rational band.The amount showed increased of leukorrhagia, color, matter, abnormal smells from the patient occur abnormal, or accompany whole body, local symptom person, are called " leukorrheal diseases ", also known as " leukorrhea ", " flowing dirty thing ".Be equivalent to the leukorrhagia that the diseases such as the vaginitis of western medicine, cervicitis, pelvic inflammatory disease, gynecological tumor cause increase.

Draw Wang Mengying as " Shen Shi female section summary " to say: " leukorrhagia, woman is raw and namely have, and Jin Jinchang moistens, and this non-disease also.If " leukorrhagia amount showed increased, or color, matter, abnormal smells from the patient exception, be leukorrheal diseases." female section card controls about purport " is said: " if diseases caused by exogenous pathogenic factor six climate exopathogens, internal damage by the excessive seven emotions, ferments into disease, and cause the vertical relaxation of dai channel, can not retrain all pulse classics, so have thing in the moon, dripping decline, constantly continuous, namely so-called leukorrhagia also.Mainly function is not normal for this pathogenetic etiology and pathogenesis, wet from interior life; Or lower cloudy direct infection noxious dampness worm is evil, causes damp to be damaged and appoint band, make conception vessel not solid, dai channel is failed to keep an appointment, and in foul leukorrhea bet born of the same parents, slime flux, in yin orifice, is sent out as leukorrheal diseases.

Clear famous gynecological classical Chinese medicine works "Fu Qingzhu works on obstetric" is thought, leukorrheal diseases mainly dai channel are hurt, reason is deficiency-weakness of spleen-QI, irritability is smouldered, and thus dampness intrusion and steam think that leukorrheal diseases are damp syndrome mostly caused by suddenly forcing, damp and hot intrusion uterus, external genitals, involve conception vessel and dai channel, conception vessel is lost solid, and dai channel is failed to keep an appointment and caused women to fall ill.Show that the sick position of leukorrheal diseases is in office, be with two arteries and veins thus, dirty in close relations with spleen, kidney two.Spleen is Central Region the foundation of acquired constitution, likes dry evil and wets.As because of eating and drinking without temperance, work mistakes degree, or pondering over depression, to cause the soil wood that declines strongly fragrant, essence of water and grain loses in strong fortune, stops poly-ly forming the wet evil dirty Liver and kidney of water, and leaching and rushing times to cause dai channel and loses its constraint and then become primary disease.Moreover kidney is congenital root, the middle residence gate of vitality is mutually fiery, is the residence of vigour.All because of congenital defect, kidney qi element is empty, or exhaustion due to sexual indulgence fecund to injure lower unit be that cloudy liquid slippage is wandered away in lower orifices and also can be led to leukorrheal diseases.

Leukorrheal diseases are not account for very important illness in gynecological, but very general very thorny, be difficult to the disease that twines, every women was almost once perplexed.The radical cure of leukorrheal diseases is not so difficult, and Traditional Chinese Medicine is generally with the five internal organs endogenous cause of ill determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs; And doctor trained in Western medicine is generally sick with bacterium, inflammation is set about.Due to the patient of leukorrheal diseases, be usually the sick inflammation of bacterium, accompany by the five internal organs endogenous cause of ill body void and cause a disease.So should focus on during treatment to hold concurrently in anti-inflammation and sterilization to consolidate with tonify deficiency, to treating both the principal and secondary aspects of a disease, otherwise the generation easily causing leukorrheal diseases infertile.Therapeutic modality best is at present the method adopting traditional Chinese medical science conditioning and treating.Chinese traditional treatment effectively can solve the surface symptoms of disease, can solve pathogenic basic factor thoroughly again.Patient can also be suitable as the case may be selection physiotherapy.But patient will note must not at will medication, will carry out under the guidance of expert.For physiotherapy, also limited, can not be excessive, be unfavorable for the state of an illness excessively on the contrary, damage the health of patient.

Motherland's medical science thinks that this disease is many by hollow through row vessels of the uterus in puerperal, invades uterus in affection of exogenous damp pyretic toxicity; Or spleen is suffered from a deficiency of the kidney damage, retention of water-damp in the body is heat-transformation with the passing of time; Or surfeit delicious food savoury, interior life is damp and hot, bet uterus; Or fire caused by depression of liver-QI, phlegm-fire multiple abscess uterus, cause pelvic cavity viscera inner membrance QI-blood circulation not smooth, damp pyretic toxicity, phlegm-fire blood stasis are tied mutually, suppuration, infringement pelvic tissue.Control or wrong treatment owing to losing, cause recurrent exerbation, protracted course of disease, organ-tissue adhesion, hypertrophy form abdominal mass enclosed mass.This sick simulataneous insufficiency and excessive, the wet hot phlegm stasis of blood are suffered from mutually each other, and spleen damage of suffering from a deficiency of the kidney is it, and wet hot phlegm stasis blocking is stagnant is its mark.

Patient's mostly recurrent exerbation of leukorrhagia, touching difficulty more, affects quality of life.Though most patient seeks medical advice in many ways, general all poor effect, cause anxiety, depression, and then further increase the weight of the state of an illness, have a strong impact on work and quality of life.

Summary of the invention

Technical problem to be solved by this invention is, doctor trained in Western medicine uses antibiotic therapy for the general great majority of this disease, as penicillin, streptomycin, erythromycin, gentamycin etc., easily repeatedly.Due to the patient of leukorrheal diseases, be usually the sick inflammation of bacterium, accompany by the five internal organs endogenous cause of ill body void and cause a disease.So should focus on during treatment to hold concurrently in anti-inflammation and sterilization to consolidate with tonify deficiency, to treating both the principal and secondary aspects of a disease, otherwise the generation easily causing leukorrheal diseases infertile.But the traditional Chinese medical science is particular about and is suited the remedy to the case, individual variation is obvious, will carry out under the guidance of doctor.The present invention combines clinical experience for many years on the basis of traditional medicine, modern processing method is adopted meticulously to develop external suppository, to each effective ingredient scientific compatibility of raw material medicine, the through focus of energy, and the preparation that the side effect of instant effect, non-oral administration is little, biocidal property is strong, energy efficient solution, except the misery of patient, reaches the object of dispelling disease.Compared with oral formulations, systemic Absorption is less, and drug main will concentrate on local and play therapeutical effect, and therefore untoward reaction is also less.

For solving above-mentioned technical barrier, the invention provides a kind of Chinese medicine external suppository for the treatment of women's leukorrhagia, the parts by weight of the crude drug of suppository described in it can be: Rhizoma Smilacis Glabrae 10 ~ 20 parts, Semen Plantaginis 10 ~ 20 parts, Radix Salviae Miltiorrhizae 10 ~ 20 parts, Rhizoma Et Radix Notopterygii 10 ~ 20 parts, Radix Scutellariae 10 ~ 20 parts, Rhizoma Atractylodis 10 ~ 20 parts, Fructus Forsythiae 10 ~ 20 parts, Fructus Cnidii 10 ~ 20 parts, Cortex Phellodendri 10 ~ 20 parts, the Radix Angelicae Dahuricae 10 ~ 20 parts, Radix Sophorae Flavescentis 10 ~ 20 parts, Herba Hedyotidis Diffusae 10 ~ 20 parts, Myrrha 10 ~ 20 parts, the Radix Stemonae 10 ~ 20 parts, interrupted 10 ~ 20 parts, Radix Paeoniae Rubra 10 ~ 20 parts.

The Chinese medicine external suppository of described treatment women leukorrhagia, the parts by weight of the crude drug of suppository described in it can also be: Rhizoma Smilacis Glabrae 10 ~ 15 parts, Semen Plantaginis 10 ~ 15 parts, Radix Salviae Miltiorrhizae 10 ~ 15 parts, Rhizoma Et Radix Notopterygii 10 ~ 15 parts, Radix Scutellariae 10 ~ 15 parts, Rhizoma Atractylodis 10 ~ 15 parts, Fructus Forsythiae 10 ~ 15 parts, Fructus Cnidii 10 ~ 15 parts, Cortex Phellodendri 10 ~ 20 parts, the Radix Angelicae Dahuricae 10 ~ 20 parts, Radix Sophorae Flavescentis 10 ~ 20 parts, Herba Hedyotidis Diffusae 10 ~ 20 parts, Myrrha 10 ~ 20 parts, the Radix Stemonae 10 ~ 20 parts, interrupted 10 ~ 20 parts, Radix Paeoniae Rubra 10 ~ 20 parts.

The Chinese medicine external suppository of described treatment women leukorrhagia, the parts by weight of the crude drug of suppository described in it also can be: Rhizoma Smilacis Glabrae 10 ~ 20 parts, Semen Plantaginis 10 ~ 20 parts, Radix Salviae Miltiorrhizae 10 ~ 20 parts, Rhizoma Et Radix Notopterygii 10 ~ 20 parts, Radix Scutellariae 10 ~ 20 parts, Rhizoma Atractylodis 10 ~ 20 parts, Fructus Forsythiae 10 ~ 20 parts, Fructus Cnidii 10 ~ 20 parts, Cortex Phellodendri 10 ~ 15 parts, the Radix Angelicae Dahuricae 10 ~ 15 parts, Radix Sophorae Flavescentis 10 ~ 15 parts, Herba Hedyotidis Diffusae 10 ~ 15 parts, Myrrha 10 ~ 15 parts, the Radix Stemonae 10 ~ 15 parts, interrupted 10 ~ 15 parts, Radix Paeoniae Rubra 10 ~ 15 parts.

For solving the problems of the technologies described above, the present invention also provides a kind of preparation method for the treatment of the Chinese medicine external suppository of women's leukorrhagia, and described in it, the preparation process of suppository comprises:

A, get Rhizoma Atractylodis, the Radix Angelicae Dahuricae, Myrrha and the Rhizoma Et Radix Notopterygii way of distillation and be vaporized into crystallization;

Medicinal residues after b, distillation add all the other crude drug and put into ethanol and soak, and heat is extracted, and is component 1;

C, medicinal residues extracting in water again, thickening filtration is component 2;

D, will distill the crystallization that obtains, add in above-mentioned two kinds of extracting solution, substrate Mixer pot sets type, and ultraviolet is killed virus;

In described step a, Rhizoma Atractylodis, the Radix Angelicae Dahuricae, Myrrha and the Rhizoma Et Radix Notopterygii way of distillation can be got and be vaporized into crystallization, after pulverizing, cross 100-120 mesh sieve, become fine powder for subsequent use.

In described step b, medicinal residues after distillation can be added the ethanol that all the other crude drug put into 5-10 times amount and soak 1-2 hour, heating extraction 2 times, each 1-2 hour, merge extractive liquid, supernatant is removed after leaving standstill, then 100-120 order filters, then is the ultrafiltration post ultrafiltration of 5000-10000 through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.36 extractum, stand for standby use, becomes component 1.

In described step c, the medicinal residues of the crude drug above-mentioned ethanol extraction can crossed add 10 times of water gagings, heating and refluxing extraction 2 times, each 1 ~ 2 hour, merged by 2 extracting solution and leave standstill, then 100-120 order filtered, be the ultrafiltration post ultrafiltration of 5000-10000 again through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.36 extractum, stand for standby use, becomes component 2.

In described steps d, can by the merging of component 1 and component 2, then put into concentrating under reduced pressure tank, decompression recycling ethanol, being concentrated into liquor strength is 0.6g crude drug/mL, when sucking filtration to the relative density of filtrate is 20 DEG C 1.06; Above-mentioned filtrate, after the macroporous adsorptive resins absorption that volume is 10L, with deionized water or the distilled water eluting of 10 times of resin column volumes, then is used 95% ethanol elution of 5 times of resin column volumes, is collected ethanol elution, remove solvent, obtain medicated powder; The crystalline powder that mixing above-mentioned steps obtains, pour in substrate, 50 DEG C ~ 60 DEG C heating and melting, cooling and shaping makes class warhead shape suppository, and 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.

Described 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, adds the medicine mastic that described preparation method is obtained, and stirring in water bath is even, is mixed into the liquid of thickness, is poured in plastic shape-forming pipe, and insert tampon, cooling and shaping makes bullet-shaped suppository; Described tampon is the tampon of afterbody with cotton thread.

For solving the problems of the technologies described above, the present invention also provides a kind of preparation method for the treatment of the Chinese medicine external suppository of women's leukorrhagia, the preparation process of described suppository can also comprise: by described crude drug except Rhizoma Atractylodis, the Radix Angelicae Dahuricae, Myrrha and Rhizoma Et Radix Notopterygii, all the other soak 30 minutes to 1 hour, heated and boiled 30 ~ 40 minutes, filter, filtrate is for subsequent use; Filtering residue adds water, and second time heating, boils 30 ~ 40 minutes, and filter, filtrate is for subsequent use; Filtering residue adds water again, for the third time heated and boiled 30 ~ 40 minutes, filters; Three filtrates be combined, heating is concentrated into paste, then Rhizoma Atractylodis, the Radix Angelicae Dahuricae, Myrrha and Rhizoma Et Radix Notopterygii steam distillation is extracted, and obtains crystal, is mixed in ointment obtained above; Choose substrate 50 DEG C ~ 60 DEG C heating and melting, add ointment cooling and shaping obtained above and make class warhead shape suppository, ultraviolet is killed virus.

Using method of the present invention: first with singly referring to bring fingerstall, suppository of the present invention is broken into two with one's hands taking-up from plastics afterbody, after powder is stained with water, puts into intravaginal gently.Put inwards as far as possible.Finally, removed by tampon plastic sheeting, of band wire is put into vaginal orifice outwardly just can complete operation overall process.Within second day, early taken out gently by tampon, medicine has been absorbed by tissue thawing and cannot have taken out.Seance can be completed.The present invention adopts stype and tampon integrated technique, compensate for the deficiency of ordinary suppository, and ordinary suppository effectively can not be delivered to the depths of vagina.Due to the self purification of vagina, when there being foreign body to exist, can increase liquid secretion, got rid of by medicine external at short notice, both reduced curative effect, and extended the course for the treatment of again, increase expense pollutes underwear again.And the present invention overcomes this technical barrier, the suppository made can give full play to curative effect of medication, has safety good, the advantage that feasibility is good, and focus of going directly, reaches the object that gets rid of illness.

Compared with oral formulations, the present invention absorbs comparatively slow, and peak concentration is lower, and absorbtivity is less, and point out this medicine general action less, untoward reaction is also less, and Local residues more being conducive to plays therapeutical effect.And the present invention has convenient drug administration, the advantages such as medicament is easy to manufacture, with low cost.The present invention has effect of blood circulation promoting and blood stasis dispelling, eliminating damp-heat, is used for the treatment of that lower abdominal pain, leucorrhoea grow in quantity and yellow skin matter that damp and hot retardance causes are thick, the symptom such as lumbosacral aching pain and spiritlessness and weakness; Combination is mended clearly in each taste medication of the present invention, QI and blood is ruled together, and finally reaches the object promoting QI and blood and tune, endometrium reparation and improve immunity of organisms.The merit of parasite killing removing toxic substances of the present invention, eliminating dampness and arresting leucorrhea, and have immediate effect.The present invention combines clinical experience for many years on the basis of traditional medicine, modern processing method is adopted meticulously to develop external effervescent tablet, to each effective ingredient scientific compatibility of raw material medicine, the through focus of energy, and instant effect, side effect is little, biocidal property is strong preparation, energy efficient solution, except the misery of patient, reaches the object of dispelling disease.

Detailed description of the invention

Leukorrhagia refers to woman vagina secretions showed increased, the symptom of color, matter, abnormal smells from the patient exception.Cold-damp or damp invasion of lower energizer, or pyretic toxicity contamination, or abnormal under the normal visible band such as spleen kidney yang gas virtual loss.Leukorrhagia generally sees the evil poison of cysthus local infection, or the pathological changes of uterus etc., is most commonly in leukorrheal diseases.But Sheng person's also visible profuse leukorrhea in physical weakness or phlegm-damp.Primary symptom is that the thick liquid that vagina flows out increases, if tears are as pus.Doublely see leucorrhea with yellow discharge, sticky, if pus is as tears, gas is dirty smelly, pruritus in the moon, and lower abdomen is had a pain, oliguria with reddish urine, fever of the body, bitter taste in the mouth and dry throat, red tongue, yellow fur, slippery and rapid pulse person, is damp invasion of lower energizer; Leukorrhagia color is white or yellowish, odorless, matter thickness, without stop, shallow complexion, anorexia and loose stool, spiritlessness and weakness, light red tongue, and tongue is greasy in vain, soft pulse weak person, for insufficiency of the spleen; Leukorrhagia color is white, and amount is many, and matter is rare clearly, constantly continuous, and lower abdomen is cold and cool, and waist is ached, and frequent micturition is long clearly, and more so large loose stool was thin, light red tongue, white and thin fur, deep pulse person, for suffering from a deficiency of the kidney night.

Mainly function is not normal for this pathogenetic etiology and pathogenesis, wet from interior life; Or lower cloudy direct infection noxious dampness worm is evil, causes damp to be damaged and appoint band, make conception vessel not solid, dai channel is failed to keep an appointment, and in foul leukorrhea bet born of the same parents, slime flux, in yin orifice, is sent out as leukorrheal diseases.Leukorrhagia color is white or yellowish, matter thickness, without foul smell, constantly continuous, pale complexion, extremity are not warm, mental weariness, anorexia loose stool, pale tongue, tongue is greasy in vain, moderate pulse.The dialectical of leukorrheal diseases has dividing of deficiency and excess.Clinical more with excess syndrome, especially merge pudendal pruritus person more common.General profuse leukorrhea, color are white, the clear odorless person of matter, belong to empty; Profuse leukorrhea, color, matter are abnormal smelly person, true.The treatment of primary disease is based on damp eliminating.Person with Spleen Deficiency, invigorating the spleen and benefiting QI, yang invigorating dehumidifies; Person who suffer from deficiency of kidney Yang, the kidney invigorating is astringent or styptic treatment for spontaneous sweating, helps and dehumidifies with spleen invigorating; Damp and hot person, clearing away heat-damp and promoting diuresis; Noxious dampness person, clearing heat, detoxicating, dispelling dampness; Sense worm pudendal pruritus loses rotten person, must coordinate vaginadouche and the external treatmenies such as medicine of receiving.With profuse leukorrhea, or color, matter, abnormal smells from the patient to occur abnormal be that the common gynecological disease of main manifestations is demonstrate,proved.

Clinical is common with leucorrhea, fulminant leucorrhagia with yellowish discharge, red and white leukorrhea, often with whole body or local symptom.Leukorrhagia is many by eating and drinking without temperance, overstrain, or it is depressed to be worried, damage temper, or sexual overstrain, old prolonged illness, damage kidney qi, spleen kidney can not transmitting and distributing the fluids, and dai channel is failed to keep an appointment, and throws off restraint food savoury and make raw damp and hot, or feelings will is smooth, stagnation of liver-QI with deficiency of the spleen, damp invasion of lower energizer, or experience noxious dampness, cold-damp etc. and cause.

Herba Hedyotidis Diffusae is again Herba Hedyotidis Diffusae, two leaves, Herba Commelinae Bengalensis, Chinese Lobelia.Mildly bitter flavor, sweet, cold.Enter stomach, large intestine, small intestine meridian, clearing up internal heat by using drugs of bitter in taste and cold in nature detoxifies, and sweet cold eliminating damp-heat, has stronger removing toxicity for eliminating carbuncles effect to carbuncle, pharyngalgia, snakebite etc.Be generally used for treatment sore, laryngopharynx swelling and pain, abdominalgia with intestinal abscess, venom, also for the puckery pain of pyretic stranguria, dysuria.The good medicine of damp eliminating of drawing out pus by applying a plaster to the affected part.

Rhizoma Smilacis Glabrae, its acrid in the mouth, becomes, cold, slightly poisonous, and external has effect such as removing toxic substances parasite killing, removing toxic substances and promoting tissue regeneration etc., can treat carbuncle, fester, the disease such as incised wound is hemorrhage, aphtha; Radix Salviae Miltiorrhizae, its sweet in the mouth, cold, dispel liver-fire, blood circulation promoting and blood stasis dispelling curative effect.Radix Sophorae Flavescentis is sweet, becomes, cool, has the effects such as heat-clearing and toxic substances removing, parasite killing are anticorrosion; Herba Hedyotidis Diffusae nature and flavor are pungent, and hardship is slightly cold, and have the effect of reducing swelling and alleviating pain, and all medicines share and are combined with directly treatment and cause pudendum redness because leucorrhea abnormal dipping, or the effect of the double disease such as pain.Compared with oral formulations, the present invention absorbs comparatively slow, and peak concentration is lower, and absorbtivity is less, and point out this medicine general action less, untoward reaction is also less, and Local residues more being conducive to plays therapeutical effect.The present invention to each effective ingredient scientific compatibility of raw material medicine, focus of going directly, and instant effect, side effect is little, biocidal property is strong preparation, can efficient solution except the misery of patient, reach the object of dispelling disease.

Rhizoma Smilacis Glabrae is 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, treat furuncle, carbuncle, scrofula, syphilis and the limbs contracture caused by mercurialism, bones and muscles pain." book on Chinese herbal medicine justice ": Rhizoma Smilacis Glabrae, dampness removing reduces phlegm and internal heat, and can enter network, searches to pick and damp and hot accumulates poison.It separates d hydrargyrum, Calomelas poison person, and it is up that receive poison with ascending, and this leads as business under oozing profit, therefore specially control Fructus Myricae rubrae skin infection, gos deep into hundred networks, arthralgia, even rotten, and poison fire is up again, and throat pain is burst, and all dislike disease.

Cortex Phellodendri heat clearing and damp drying, eliminating fire and detoxication, except hectic fever due to YIN-deficiency clearind deficient heat.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." Bencao Jingshu ": Cortex Phellodendri, stagnation of pathogenic heat in main the five internal organs the intestines and stomach.Lid deficiency of YIN, then heat begins to tie in the intestines and stomach; Though jaundice is by damp and hot, the people in kidney-YIN being deficient so must be sent out; Perianal abscess is leaked, also caused by all damp and hot blood trouble; Let out dysentery person, dysentery also, the also damp and hot disease offending the intestines and stomach; Woman's whitish metrorrhagia, acute vulva ulcer, all damp and hot deficiency of YIN stream visitor bottom of taking advantage of forms; Red of skin heat, the hot swelling pain aphtha of order, all YinXuXueRe disease of viscera connecting with this channel also.With the gas of Zhiyin, mend the deficiency of Zhiyin, deficiency syndrome should be treated by tonifying method, with class from, therefore cloudy backheat solution, wet dry and all card oneself remove.Be the key medicine of kidney meridian, specially control all cards of the raw interior-heat of bright void, achievements very big, very medicine is also comparable.

Semen Plantaginis is sweet; Light; Cold nature.Gui Jing: return lung meridian; Liver Channel; Kidney channel; Urinary bladder channel.Function: clearing away heat and promoting diuresis; Eliminating dampness by diuresis antidiarrheal; Improving eyesight; Eliminate the phlegm.Cure mainly: main dysuria; Stranguria with turbid discharge leukorrhagia; Edema distension; Heat-damp in summer dysentery; Conjunctival congestion is hidden from view; Expectorant heat syndrome cough is breathed heavily.Collective Notes to the Canon of Materia medica: main asthenia." property of medicine is fallen ": can remove pathogenic wind toxic, the liver affected by pathogenic wind heat, malicious wind dotting punch order, swelling pain is hidden from view, and headache lacrimation, removes irritable feverish sensation of chest and heart." Japan hanako materia medica ": diuresis drenches puckery, tonifying YANG.Control de-essence, vexed.The therapeutic method to keep the adverse QI flowing downwards.

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 by the strong feature of broad-spectrum antibacterial action, are used in fungal culture miscellaneous bacteria and infect special severe, fine by Radix Scutellariae extracting solution effect." Bencao Jingshu ": Radix Scutellariae, its property is respectful clearly, so evil removing: bitter in the mouth is so dampness; YIN-cold is so 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, and the disease of all damp and hot victory also, analyses it, then all diseases are from recover.

Fructus Cnidii is pungent, bitter, temperature; Slightly poisonous.Return kidney channel.Cure mainly warming the kidney to invigorate YANG, dampness, dispel the wind, parasite killing.For sexual impotence, cold womb, cold-damp leukorrhagia, arthralgia chiefly caused by damp pathogen lumbago; External treatment vulval eczema, married woman's pudendal pruritus; Trichomonal vaginitis is gynecological external use good medicine." Bencao Jingshu " carries: Fructus Cnidii, and bitter in the mouth is put down; " not Lu " be pungent sweet nontoxic; Modern its abnormal smells from the patient in detail, when warm-dryness syndrome of must holding concurrently, sun also.Therefore swell and ache in housewife people's the moon, man's impotence pruritus due to damp pathogen, except stagnated QI, sharp joint, malignant boil." not Lu " warming the middle warmer and descending qi, makes married woman's Zifu heat, and man is cloudy strong, has made us son.Lid can dehumidify with tongue, and temperature can cold expelling, pungently can moisten kidney, sweet energy strengthening the spleen, therefore can remove all deficiency and coldness of married woman man and to wet disease of viscera connecting with this channel.Cold-damp was both removed, then disease is gone, performance Yiyang, therefore can disease, and had tonification also.

The Radix Angelicae Dahuricae: meridian distribution of property and flavor: pungent, temperature.Attach to the lung and stomach meridians.Expelling wind and cold, understand things pain-stopping, detumescence and apocenosis, dampness leukorrhagia stopping.For wind-damp dispelling, evacuation of pus of invigorating blood circulation, granulation promoting pain relieving.For headache, toothache, nasal sinusitis, hemorrhoidal hamorrhage anal fistula, leucorrhea with red and white discharge, ulcer sores, skin pruritus." Japan hanako materia medica ": control conjunctival congestion bulbar conjunctiva polyp, and tire patching leaks landing, broken stagnated blood, mend fresh blood, acute mastitis, carbuncle on the back, scrofula, hemorrhoidal hamorrhage, hemorrhoid complicated by anal fistula, evacuation of pus, desolation, scabies, pain relieving granulation promoting, goes face Shao-defect scar.

Radix Sophorae Flavescentis is bitter, 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 Dipsaci Chinese medicine name.For the root of Dipsacaceae herbaceos perennial Radix Dipsaci, gain the name because of energy " synthetism of continuous folding ".Autumn excavates, and removing root head and fibrous root, be dried to half-dried with low baking temperature, when bank up " diaphoresis " is to inner virescence, then dries." the southern regions of the Yunnan Province book on Chinese herbal medicine ": " meridians determine in tonifying liver, bone and muscle strengthening, and only in warp, (muscles and bones) is ached, and antiabortive, control married woman leucorrhea, tissue regeneration promoting blood, removing blood stasis with potent drugs blood, fall stillborn fetus, and cough-relieving is coughed hemoptysis, controls red white turbid urine.”

Rhizoma Et Radix Notopterygii Chinese medicine title, cures mainly: warming the kidney to activate YANG, improving inspiration by invigorating kidney-QI, antidiarrheal.For impotence and seminal emission, enuresis frequent micturition, chills and pain of the waist and kness, suffers from a deficiency of the kidney and breathes heavily, Diarrhoea; External curing vitiligo, speckle is bald; Affection of exogenous wind-cold, have a headache lossless, mimeograph cold-damp numbness, edema due to wind pathogen edema, sore swollen toxin.Loose exterior cold; Wind-damp dispelling; Profit joint; Pain relieving.Main affection of exogenous wind-cold; Have a headache lossless; Edema due to wind pathogen edema; Sore swollen toxin.For impotence and seminal emission, enuresis frequent micturition, chills and pain of the waist and kness, suffers from a deficiency of the kidney and breathes heavily, Diarrhoea; External curing vitiligo, alopecia areata.Induce sweat cold expelling, expelling wind and dampness, pain relieving." Japan hanako materia medica ": " control a wind cutting and gas, muscles and bones fist contraction, extremity are thin bad, and head revolves the red pain of eyes and fullness in the epigastrium especially referring to the abcess of the abdomen in ancient times aqueous vapor, five kinds of strain and seven kinds of impairment, deficient cold air, joint ache, tonneau the five internal organs.

Rhizoma Atractylodis are pungent, bitter, temperature.Return spleen, stomach, Liver Channel.The transporting imbalance that the spleen being blocked by dampness causes, inappetence, vomiting is unhappy, and abdominal distention is had loose bowels, arthralgia.For dampness taste, distension and fullness in the abdomen, cold-damp leucorrhea, damp-warm diseases and damp invasion of lower energizer, foot swelling and pain in knee, flaccidity are soft unable.Control dampness taste, and see the thick disease such as turbid of distension and fullness in the abdomen, inappetence, fatigue and weakness, white and greasy fur, the normal and compatibility such as Cortex Magnoliae Officinalis, Pericarpium Citri Reticulatae is applied; Controlling cold-damp leucorrhea, the Radix Angelicae Dahuricae can being joined with using.As damp and hot leucorrhea, the Rhizoma Anemarrhenae, Radix Sophorae Flavescentis, Radix Patriniae heterophyllae can be joined again; Damp invasion of lower energizer, foot swelling and pain in knee, flaccidity are soft unable, can join Cortex Phellodendri, Radix Achyranthis Bidentatae, the equivalent use of Semen Coicis; Hygropyrexia disease can join Gypsum Fibrosum, the Rhizoma Anemarrhenae is equivalent uses.Rhizoma Atractylodis have drying damp and strengthening spleen, effect of wind-damp dispelling.Cure mainly retention of dampness in middle-JIAO, anemofrigid-damp arthralgia, foot swelling and pain in knee, flaccidity is soft unable, nyctalopia nyctalopia." pearl sac " day: " stomach invigorating can pacify spleen, non-this of all damp-edema can not remove." Compendium of Material Medica says: " control damp-phlegm prolonged fluid-retention ... and spleen wets dirty, turbid drop leukorrhagia, slidingly rush down hemorrhoidal hamorrhage." " Newly Revised Canon of Materia Medica " claim it can " diuresis ".

Myrrha promoting blood circulation to remove blood stasis, analgesic therapy, hemostasia and promoting granulation, sore.Control treating swelling and pain by traumatic injury, ecchymoma due to internal injury; Continuous bleeding due to traumatic injury, scrofula, ecthyma unhealed for long time.Tang Materia Medica: main the five internal organs pathogen, leukorrhagia, pain relieving, removing mass blood, gold creation meat.

Radix Salviae Miltiorrhizae is bitter, is slightly cold.GUIXIN, Liver Channel.Stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, clear away heart-fire relieving restlessness.For menoxenia, amenorrhea dysmenorrhea, lump in the abdomen, breast ventral spine pain, pyretic arthralgia pain, skin infection swells and ache, dysphoria and insomnia.For costa sternales hypochondriac pain, rheumatic arthralgia, lump in the abdomen lumps, and skin infection swells and ache, and tumbling down is grieved, menoxenia, amenorrhea dysmenorrhea, puerperal stasis of blood pain etc.Treatment costa sternales pain, lump in the abdomen caking, and menoxenia, amenorrhea dysmenorrhoea have good effect." detailed outline " carries: Radix Salviae Miltiorrhizae, and by " the sensible opinion of married woman " cloud, SIWU TANG controls gynecopathy, pays no attention to antenatal puerperal, how many through water, all can be general, and only taste Radix Salviae Miltiorrhizae falls apart, and cures mainly identical with it.Lid Radix Salviae Miltiorrhizae can break stagnated blood, and mend fresh blood, peaceful tire, fall stillborn fetus, only metrorrhagia dysentery, regulating menstruation arteries and veins.Main Compositions of Radix Salviae Miltiorrhizae TANSHINONES has blood vessel dilating, improves circulation, removes the effects such as intravascular coagulation, has effect of invigorating blood circulation trace, and can promote that liver blood circulates, be beneficial to liver cell regeneration.

Fructus Forsythiae is bitter, is slightly cold.Return lung, the heart, gallbladder meridian.Fructus Forsythiae has broad-spectrum antibacterial action, has very strong inhibitory action to staphylococcus aureus, Hayes dysentery bacterium, has certain inhibitory action to other pathogenic bacterium, influenza virus, fungus.There is antiinflammatory action.Oleanolic acid contained by this product has heart tonifying, diuresis and hypotensive activity, and Citrin can reduce vascular permeability and fragility, prevents haemolysis.Decoct has the town effect of telling, anti-liver injury effect.Heat-clearing and toxic substances removing, dispersing swelling and dissipating binds, dispelling wind and heat pathogens.Cure mainly carbuncle sore tumefacting virus, sucutaneous nodule scrofula, affection due to external wind and heat, epidemic febrile disease is from the beginning of, puckery pain of pyretic stranguria etc.The pharmacological action such as have antibacterial, heart tonifying, diuresis, town to tell, the diseases such as the conventional acute anemopyretic cold of forsythia fruit for treating, carbuncle sore tumefacting virus, tuberculous lymphadenitis, urinary tract infection are the primary raw material of the Chinese medicine preparation such as SHUANGHUANGLIAN KOUFUYE, SHUANGHUANGLIAN FENZHENJI, QINGRE JIEDU KOUFUYE, even careless antipyretic oral liquid, flos ionicerae and fructus forsythiae infusion for detoxication.

Radix Stemonae nature and flavor are sweet, bitter, tepor.Return lung meridian.Cure mainly nourishing the lung to keep the adverse QI downward cough-relieving, parasite killing.Cough for new chronic cough, pulmonary tuberculosis cough, pertussis; Outer for head louse, body louse, enterobiasis, pudendum Pruritus.Honey Radix Stemonae nourishing the lung to arrest cough.For deficiency of YIN chronic cough.In vitro tests shows: Radix Stemonae decoct and alcohol preserved material are to streptococcus pneumoniae, beta hemolytic streptococcus, meningococcus, staphylococcus aureus, Staphylococcus albus, dysentery bacterium, Bacillus typhi, Salmonella paratyphi, escherichia coli, Bacillus proteus, diphtheria corynebacterium, pneumobacillus, bacillus pestis, anthrax bacillus, bacillus subtilis and vibrio cholera, Bacillus tuberculosis etc. all have inhibitory action in various degree. and Radix stemonae japonicae infusion has certain inhibitory action to some pathomycete in vitro. and Radix Stemonae decoct can reduce the pathogenicity of Asia influenza A virus to mice, also therapeutical effect is had to the mice infected. show with the Newcastle virus test of chick embryo culture: the Radix Stemonae can extend 36 hours Embryo Gallus domesticus life-spans. the infusion of insecticidal action Radix stemonae japonicae and other kind Radixs Stemonae and ethanol immersion, to mosquitos and flies larva, head louse, clothing louse and Cimex bedbug etc. all have killing action, alcohol preserved material is large compared with the effect of water logging agent. 50% distilled water suspension contact pubic louse number minute of Radix Stemonae ethanol soluble extraction can be killed, and infusion is then invalid. the alcohol leaching liquid with 70% behead louse and pubic louse effect than DDT and Pyrethrum strong. the high concentration Radix Stemonae has the effect of killing Mus pinworm in vitro.

Radix Paeoniae Rubra bitter in the mouth, is slightly cold.Return Liver Channel.Function cures mainly clearing away heat and cooling blood, eliminating stasis to stop pain.For maculae caused by violent heat pathogen, hematemesis and epistaxis, conjunctival congestion and swelling pain, hypochondriac pain due to stagnation of liverQI, amenorrhea dysmenorrhea, lump in the abdomen is suffered from abdominal pain, injury from falling down, carbuncle skin infection.Radix Paeoniae Rubra can purify the blood a point excess-heat, and dissipating blood stasis blood is detained.This product function is close with Cortex Moutan, therefore normal and Cortex Moutan mutual reinforcement between is for use.But the effect of Cortex Moutan clearing away heat and cooling blood is better, can purify the blood a point excess-heat, can control fever due to yin deficiency again; And Radix Paeoniae Rubra can only be used for blood system excess-heat, be good at promoting blood circulation to remove blood stasis.

The preparation method 1 of suppository of the present invention: get Radix Angelicae Dahuricae 1500g, Myrrha 1500g, Rhizoma Atractylodis 1500g and the Rhizoma Et Radix Notopterygii 1500g way of distillation and be vaporized into crystallization, after pulverizing, crosses 100-120 mesh sieve, becomes fine powder for subsequent use.Medicinal residues are added Rhizoma Smilacis Glabrae 1500g, Semen Plantaginis 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Scutellariae 1500g, Fructus Forsythiae 1500g, Herba Hedyotidis Diffusae 1500g, Fructus Cnidii 1500g, Cortex Phellodendri 1500g, Radix Sophorae Flavescentis 1500g, Radix Stemonae 1500g, interrupted 1500g, Radix Paeoniae Rubra 1500g are cut into coarse grain, to be then soaked in ethanol 2 hours.Then heating extraction 2 times, each 1-2 hour, merge extractive liquid, remove supernatant after leaving standstill, then 100-120 order filters, then is the ultrafiltration post ultrafiltration of 5000-10000 through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.36 extractum, stand for standby use, becomes component 1.The medicinal residues of the crude drug crossed by above-mentioned ethanol extraction again add 10 times of water gagings, heating and refluxing extraction 2 times, each 1 ~ 2 hour, merged by 2 extracting solution and leave standstill, remove supernatant, then 100-120 order filters, be the ultrafiltration post ultrafiltration of 5000-10000 again through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.36 extractum, stand for standby use, becomes component 2.By the merging of component 1 and component 2, then put into concentrating under reduced pressure tank, decompression recycling ethanol, being concentrated into liquor strength is 0.6g crude drug/mL, when sucking filtration to the relative density of filtrate is 20 DEG C 1.06; Above-mentioned filtrate, after the macroporous adsorptive resins absorption that volume is 10L, with deionized water or the distilled water eluting of 10 times of resin column volumes, then is used 95% ethanol elution of 5 times of resin column volumes, is collected ethanol elution, remove solvent, obtain medicated powder.To distill the crystalline powder obtained, add the drug powder of above-mentioned preparation, pour in substrate, 50 DEG C ~ 60 DEG C heating and melting, cooling and shaping makes class warhead shape suppository, and the proportioning of described powder Chinese patent medicine and substrate is 1: 2 ~ 1: 4; Described tampon is the suppository of afterbody with cotton thread.

Get substrate heating and melting, temperature 50 C ~ 60 DEG C, add medicine fine powder of the present invention, stirring in water bath is even, is mixed into the liquid of thickness, is poured in plastic shape-forming pipe, and insert tampon, cooling and shaping makes 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: softer than the dissolubility of other substrate, quick, drug loading is also higher.

The detailed directions of described suppository is as follows: by drug suppository removing cabinet of the present invention, take out stype, pull-out afterbody cotton thread, stype is included in vagina deep, cotton thread is stayed external, and 1 every night, morning next day plays pull-out tampon, and continuous use 10 days is a course for the treatment of.

The preparation method 2 of suppository of the present invention: by Rhizoma Smilacis Glabrae 1200g, Semen Plantaginis 1300g, Radix Salviae Miltiorrhizae 1200g, Radix Scutellariae 1300g, Fructus Forsythiae 1200g, Herba Hedyotidis Diffusae 1200g, Fructus Cnidii 1200g, Cortex Phellodendri 1300g, Radix Sophorae Flavescentis 1300g, Radix Stemonae 1200g, interrupted 1200g, Radix Paeoniae Rubra 1200g, soak 30 minutes to 45 minutes by described raw material, heating boils 30 ~ 40 minutes, filter, filtrate is for subsequent use; The second time that adds water filtering residue heats, and boils 30 ~ 40 minutes, and filter, filtrate is for subsequent use; Filtering residue adds water again, for the third time heated and boiled 40 ~ 50 minutes, filters; Merge the decoction liquor of three times, be concentrated into the concentrated solution that relative density is 1.08.Put into drying machine and be dried to powder; Get Radix Angelicae Dahuricae 1200g, Myrrha 1300g, Rhizoma Atractylodis 1300g and the Rhizoma Et Radix Notopterygii 1300g way of distillation and be vaporized into crystallization, distill crystallization of vaporizing to obtain, be dried to powder; By distilling the crystalline powder obtained, adding the drug powder of above-mentioned preparation, calling in substrate; First by substrate heating and melting, temperature 50 C ~ 60 DEG C, add medicine fine powder of the present invention, and stirring in water bath is even, is mixed into the liquid of thickness, is poured in plastic shape-forming pipe, and insert tampon, cooling and shaping makes 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: softer than the dissolubility of other substrate, quick, drug loading is also higher.

Toxicology test:

Test example 1: acute toxicity test of the present invention

One, test material:

Animal: Kunming mouse, body weight 21-24g, male and female half and half, Shandong University's biology laboratory breeding.Medicine: suppository of the present invention.

Two, method:

1, LD50 calculates: adopt improvement karber's method, mice is divided into 5 groups at random, often organize 10, male and female half and half, dissolve suppository, are made into Cmax, by the administration of mice maximum permission capacity, institute is followed successively by 18,14.4 to dosage by crude drug amount, 11.5,9.2,7.4 (g.kg-1), in animal fasting (can't help water) after 18 hours, administration at twice in one day (interval half an hour), each 0.5ml, observes animal dead situation.

2, maximum tolerated dose measures (MTD value): get mice 20, each 10 of male and female.Suppository adding distil water is dissolved, is made into maximum concentration, by the maximum tolerated dose of animal, feed device and can twitch to inject to fill with and be as the criterion.In animal fasting (can't help water) after 18 hours, administration at twice in one day (interval half an hour), each 0.5ml (every ml containing crude drug 0.36g), total dose is 18g crude drug/kg.d, 300 times of quite clinical adult 50Kg body weight consumption.Continuous Observation 7 days after administration.

Three, result of the test:

In LD50 calculates when giving mice with maximum acceptable concentration and maximum permission capacity (18g/Kg.d), have no dead mouse, namely LD50 is not measured, ask maximum tolerated dose only, in 7 day observation period, its appetite of animal, activity, hair color, the mental status etc. are all normal, grow normal, there are no death.Namely select the 300 times of doses being equivalent to clinical dosage, and have no adverse reaction, show that acute toxicity is minimum, MTD > 18g/Kg.d.

Test example 2: acute skin irritation test report of the present invention

1, experiment purpose: detect suppository to the stimulation/corrosiveness of laboratory animal skin and intensity

2, materials and methods:

2.1. tested material: title: the present invention washes suppository (embodiment method obtains)

2.2. laboratory animal: one grade of large ear white race rabbit, 10, female, body weight 2.1-2.3kg; Thered is provided by Affiliated Hospital of Qingdao University biology department Experimental Animal Center;

2.3. test method:

Its spinal column both sides, back are cut by hair in test by the healthy rabbits selecting skin intact 10 for first 24 hours, the left and right each about 4cm × 4cm of unhairing area.Get tested material 0.2ml during test to be applied on two layers of gauze of 2.5cm × 2.5cm, be applied to skin of unhairing surface, side, oilpaper covers, immobilization with adhesive tape.Opposite side skin is as blank.Close after 4 hours, dismantle, and go residual tested material with warm water cleaning, within 1,24 and 48 hour after removing tested material, observe and smear position dermoreaction, and mark.

3, experimental result: any erythema does not appear in laboratory animal skin, red and swollen, inflammation phenomenon.

4, brief summary: judge according to skin wound repair standards of grading in " disinfection technology standard " (1999), ointment of the present invention belongs to nonirritant to animal skin stimulus intensity.

Embodiment 3: vaginal mucomembranous irritant test result

1. test method:

After laboratory animal is quarantined 3 days, select 18 above-mentioned healthy rabbits, be divided into three groups at random, often organize each 6, be respectively: blank, excipient control, suppository group of the present invention (by application liquid 5 times of concentration).Be placed in excipient control group and the intravaginal of tested material treated animal with the sterilizing cotton sliver leaching of suitable size with sterile saline and tested material respectively, contact 6 hours with vaginal mucosa, after 24 hours, put to death animal.Taking-up topical vaginal tissue, observes pathological changes situation.

2, result of the test: vaginal mucomembranous irritant test result

Embodiment 4: skin anaphylactic test result

Use suppository of the present invention, carry out inducing and exciting 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 suppository is bordering on zero, namely without skin allergic reaction to dermoreaction intensity.

Embodiment 5: long term toxicity test data

1, experimental technique

Random for Cavia porcellus part is become 4 groups, often organizes 15.In guinea pig back spinal column both sides, depilatory is evenly coated, make its scope about 40 square centimeters of losing hair or feathers.Clean depilatory, observe and often organize Cavia porcellus after 24 hours and be coated with suppository solution 0.2,0.4 of the present invention and 0.8ml respectively, 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 terminates rear execution animal and carries out hematology, blood biochemical and pathological examination.

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 are movable, 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 suppository 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 suppository experiment safety of the present invention.This medicine is 1: 150 to group B streptococcus, staphylococcus aureus, colibacillary minimal inhibitory concentration, gonococcus is 1: 150, Candida albicans is 1: 300, it is 5 minutes to the time of killing during 1: 20 dilution factor, be 10 minutes when 1: 50, being 20 minutes when 1: 100, is 40 minutes when 1: 200, is 8 hours when 1: 400.

Pharmacodynamics test

Test 1, medicine of the present invention are on the impact of mouse peritoneal inflammation

Experimental technique: get some healthy male mices, body weight is between 18 ~ 22 grams, be divided into 6 groups at random, be respectively high, medium and low three the dosage groups of suppository of the present invention, ten thousand logical XIAOMI SHUAN, the accurate word Z20025663 of traditional Chinese medicines, Tonghua Wan Tong Pharmaceutical pharmaceutical Co. Ltd, is dissolved in ethanol, hydrocortisone matched group and Normal group.Except hydrocortisone group intraperitoneal administration, all the other are the equal vagina administration of group respectively, after each group of administration 40 minutes, with the blue 4.0mg/kg tail vein injection of 1% she Wen, and simultaneously lumbar injection 0.25% acetic acid 0.4ml/10g, sacrificed by decapitation after 30 minutes, blood-letting, cut open the belly, by sagging for every animal abdominal part, repeatedly abdominal cavity is rinsed with appropriate distilled water, collect washing liquid and adjust to 10ml, move into scale in vitro, centrifugal 2500 revs/min, precipitate is discarded after 10 minutes, supernatant adds 0.1N sodium peroxide 0.1ml, its optical density is surveyed with spectrophotometer 590nm, the seepage discharge of she Wen is obtained by standard curve.Experimental result is in table 1.

Note: compare with Normal group, ※ p < 0.05, ※ ※ p < 0.01; Compare with the present invention, Δ p < 0.05, Δ Δ p < 0.01.From upper table result, each administration group is compared with matched group, (p < 0.05 or p < 0.01, with hydrocortisone group for the best, is secondly each dosage group of the present invention all to have obvious inhibitory action to the seepage discharge of her Wen orchid.The present invention's each dosage group is compared with ten thousand logical XIAOMI SHUAN also has obvious diversity, and illustrate that her the oozing out of Wen orchid of mice that suppository Dichlorodiphenyl Acetate of the present invention causes has obvious inhibitory action, logical XIAOMI SHUAN is strong than ten thousand for its effect, but not as good as hydrocortisone group.

Test 2. In vitro Bactericidal Experiments

Culture medium: broth bouillon, broth agar culture medium, blood plate, chocolate are dull and stereotyped; 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 for suppository solution of the present invention dosage meat soup from 1: 5, make doubling dilution at 1: 50 to 1: 100, often pipe is containing medicinal liquid 2ml, 9th pipe, for contrasting without medicine, often adds dilution bacterium liquid 1, hatches 18h for 37 DEG C in pipe, visual results, pastille least concentration is still the minimal inhibitory concentration (MIC) of this medicine in obvious haze-free pipe.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 washing liquid 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.Obvious bacteriostasis is all had to escherichia coli, bacillus pyocyaneus, staphylococcus aureus, Candida albicans, Bacillus proteus, micrococcus catarrhalis, γ-streptococcus, gonococcus.

3. anti-vagina mould test

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

Clinical trial:

Compared with oral formulations, the present invention absorbs comparatively slow, and peak concentration is lower, and absorbtivity is less, and point out this medicine general action less, untoward reaction is also less, and Local residues more being conducive to plays therapeutical effect.Inventor's application on the basis of learning Chinese medicine ancient books and forefathers' experience is fallen from intending external suppository treatment leukorrheal diseases 160, achieves good curative effect.Now sum up report as follows.

1 clinical data: this group peasant 43 example, white collar 32 falls, student 26 example, workman 37 example, individual 22 examples; Age 19-55 year, average 32.56 years old, less than 20 years old 2 example, 20 ~ 29 years old 38 example, 30 ~ 39 years old 53 example, 40 ~ 49 years old 42 gal, 50 ~ 55 years old 25 example, wherein have Western medicine diagnose in 121 examples: cervical erosion and cervicitis person 32 example, acute pelvic inflammatory disease person 33 example; Acute vaginitis person 5 example; Light 34 examples of trichomonas vagina; Colpitis mycotica 16 is fallen.

Symptom; Leukorrhagia secretions is that yellow person 42 is sorrowful, color white person 66 example, HUANGBAI(sic) alternate person 39 example. redly to fall from alternate person 13. and smelly person 45 example of leukorrhagia heat; Soreness of waist person 73 example, abdominal distention person 55 falls, and dizzy person 25 falls, and heart-throb person 34 is out-of-the-way, and heating person 24 example, inappetence person 27 falls.

160 examples are all female outpatient patient, are divided into two groups at random.Often organize 80 people, the state of an illness, the age indifference opposite sex.Treatment group 80 example (suppository of the present invention) age reckling 21 years old, the maximum 55 years old; The shortest person of the state of an illness falls ill 3, most elder 9 years; In leucorrhea, inspection has infusorian person 43 example.Matched group 80 example (ten thousand logical XIAOMI SHUAN, the accurate word Z20025663 of traditional Chinese medicines, Tonghua Wan Tong Pharmaceutical pharmaceutical Co. Ltd) wherein age reckling 20 years old, the maximum 55 years old; The state of an illness is the shortest 5 days, and most elder falls ill 7 years; In leucorrhea, inspection has infusorian person 45 example.

2 Therapeutic Method

2.1 contrast groups: get ten thousand logical XIAOMI SHUAN, fill in vagina deep 1 day 1 time, menstrual phase is stopped using, and 10 days is 1 course for the treatment of.Use vaginal speculum vaginal dilation by medical worker, clean vaginal secretions, medicine is placed in vagina. then take out vaginal speculum.During medication, every day cleans pudendum, forbids sexual intercourse, drug withdrawal in menstrual period.

2.2 treatment groups: suppository of the present invention, Fang Yong: Rhizoma Smilacis Glabrae 12g, Semen Plantaginis 14g, Radix Salviae Miltiorrhizae 13g, Rhizoma Et Radix Notopterygii 13g, Radix Scutellariae 13g, Rhizoma Atractylodis 14g, Fructus Forsythiae 13g, Fructus Cnidii 13g, Cortex Phellodendri 12g, Radix Angelicae Dahuricae 13g, Radix Sophorae Flavescentis 14g, Herba Hedyotidis Diffusae 14g, Myrrha 12g, Radix Stemonae 11g, interrupted 13g, Radix Paeoniae Rubra 12g, make suppository by embodiment 1.Each 1,1 time on the 1st, fill in vagina deep, 10 days was 1 course for the treatment of, and menstrual phase is stopped using.Use vaginal speculum vaginal dilation by medical worker, clean vaginal secretions, medicine is placed in vagina. then take out vaginal speculum.During medication, every day cleans pudendum, forbids sexual intercourse, drug withdrawal in menstrual period.

3 criterion of therapeutical effect recoveries from illness: leukorrhagia secretions disappears, other transference cures. antisecosis, gynaecological examination inflammation is eliminated.Effective: leukorrhagia secretions significantly reduces, other symptoms obviously alleviate, and gynecologial examination inflammation disappears substantially.Take a turn for the better: leukorrhagia fractional distillation association reduces, other symptoms comparatively before also have and alleviate, alleviate before gynecological inflammation religion treatment.Invalid: the identical and gynecologial examination of symptom for the treatment of front and back there is no obvious change.

4 therapeutic outcomes are in table 1.

Two groups of Comparison of therapeutic (%)

Note P < 0.001, two groups has comparability.

5 discuss: leukorrheal diseases are gynecological's common diseases. have leucorrhea, fulminant leucorrhagia with yellowish discharge and leucorrhea with bloody discharge, leukorrhagia with greenish discharge. black vaginal discharge, multicolored vaginal discharge point, but the most common be leucorrhea, fulminant leucorrhagia with yellowish discharge and leucorrhea with bloody discharge.The traditional Chinese medical science is more to leukorrheal diseases classification class, and medication is numerous and diverse, but the most common be divided into insufficiency of the spleen, suffer from a deficiency of the kidney, the three major types such as noxious dampness.Clear famous gynecological classical Chinese medicine works "Fu Qingzhu works on obstetric" is thought, leukorrheal diseases mainly dai channel are hurt, reason is deficiency-weakness of spleen-QI, irritability is smouldered, and thus dampness intrusion and steam think that leukorrheal diseases are damp syndrome mostly caused by suddenly forcing, damp and hot intrusion uterus, external genitals, involve conception vessel and dai channel, conception vessel is lost solid, and dai channel is failed to keep an appointment and caused women to fall ill.Show that the sick position of leukorrheal diseases is in office, be with two arteries and veins thus, dirty in close relations with spleen, kidney two.Spleen is Central Region the foundation of acquired constitution, likes dry evil and wets.As because of eating and drinking without temperance, work mistakes degree, or pondering over depression, to cause the soil wood that declines strongly fragrant, essence of water and grain loses in strong fortune, stops poly-ly forming the wet evil dirty Liver and kidney of water, and leaching and rushing times to cause dai channel and loses its constraint and then become primary disease.Moreover kidney is congenital root, the middle residence gate of vitality is mutually fiery, is the residence of vigour.All because of congenital defect, kidney qi element is empty, or exhaustion due to sexual indulgence fecund to injure lower unit be that cloudy liquid slippage is wandered away in lower orifices and also can be led to leukorrheal diseases.Compared with oral formulations, the present invention absorbs comparatively slow, and peak concentration is lower, and absorbtivity is less, and point out this medicine general action less, untoward reaction is also less, and Local residues more being conducive to plays therapeutical effect.

Model case Liu, 32 years old, white collar.Married, do not educate.Sufferer to be chief complaint first visit on March 15th, 2010 with leukorrhagia heat smelly yellow skin February, with few abdomen dull pain, and the diseases such as the soreness of waist.Gynecologial examination is that acute pelvic inflammatory disease companion's vaginitis 1 DEG C of cervix uteri elk is rotten.With crossing XIAOMI SHUAN, FUKE QIANJIN PIAN, effect is undesirable, off and on, drips and draws.Use suppository of the present invention, Fang Yong: Rhizoma Smilacis Glabrae 12g, Semen Plantaginis 14g, Radix Salviae Miltiorrhizae 13g, Rhizoma Et Radix Notopterygii 13g, Radix Scutellariae 13g, Rhizoma Atractylodis 14g, Fructus Forsythiae 13g, Fructus Cnidii 13g, Cortex Phellodendri 12g, Radix Angelicae Dahuricae 13g, Radix Sophorae Flavescentis 14g, Herba Hedyotidis Diffusae 14g, Myrrha 12g, Radix Stemonae 11g, interrupted 13g, Radix Paeoniae Rubra 12g, make suppository by embodiment 1.Each 1,1 time on the 1st, fill in vagina deep, 10 days was 1 course for the treatment of, and menstrual phase is stopped using.First with singly referring to bring fingerstall, suppository of the present invention being broken into two with one's hands taking-up from plastics afterbody, after powder is stained with water, putting into intravaginal gently.Put inwards as far as possible.Finally, removed by tampon plastic sheeting, of band wire is put into vaginal orifice outwardly just can complete operation overall process.Within second day, early taken out gently by tampon, medicine has been absorbed by tissue thawing and cannot have taken out.Seance can be completed.Continuous use 10 days, sensation secretions reduces, and stench disappears, and lumbago alleviates, and continues use 10 days, the rotten recovery from illness of cervix uteri elk.Leukorrhagia is normal.Follow up a case by regular visits to and do not recur.

Claims

1. treat a Chinese medicine external suppository for women's leukorrhagia, it is characterized in that, the parts by weight of the crude drug of described suppository comprise: Rhizoma Smilacis Glabrae 10 ~ 20 parts, Semen Plantaginis 10 ~ 20 parts, Radix Salviae Miltiorrhizae 10 ~ 20 parts, Rhizoma Et Radix Notopterygii 10 ~ 20 parts, Radix Scutellariae 10 ~ 20 parts, Rhizoma Atractylodis 10 ~ 20 parts, Fructus Forsythiae 10 ~ 20 parts, Fructus Cnidii 10 ~ 20 parts, Cortex Phellodendri 10 ~ 20 parts, the Radix Angelicae Dahuricae 10 ~ 20 parts, Radix Sophorae Flavescentis 10 ~ 20 parts, Herba Hedyotidis Diffusae 10 ~ 20 parts, Myrrha 10 ~ 20 parts, the Radix Stemonae 10 ~ 20 parts, interrupted 10 ~ 20 parts, Radix Paeoniae Rubra 10 ~ 20 parts.

2. treat the Chinese medicine external suppository of women's leukorrhagia according to claim 1, it is characterized in that, the parts by weight of the crude drug of described suppository comprise: Rhizoma Smilacis Glabrae 10 ~ 15 parts, Semen Plantaginis 10 ~ 15 parts, Radix Salviae Miltiorrhizae 10 ~ 15 parts, Rhizoma Et Radix Notopterygii 10 ~ 15 parts, Radix Scutellariae 10 ~ 15 parts, Rhizoma Atractylodis 10 ~ 15 parts, Fructus Forsythiae 10 ~ 15 parts, Fructus Cnidii 10 ~ 15 parts, Cortex Phellodendri 10 ~ 20 parts, the Radix Angelicae Dahuricae 10 ~ 20 parts, Radix Sophorae Flavescentis 10 ~ 20 parts, Herba Hedyotidis Diffusae 10 ~ 20 parts, Myrrha 10 ~ 20 parts, the Radix Stemonae 10 ~ 20 parts, interrupted 10 ~ 20 parts, Radix Paeoniae Rubra 10 ~ 20 parts.

3. treat the Chinese medicine external suppository of women's leukorrhagia according to claim 1, it is characterized in that, the parts by weight of the crude drug of described suppository comprise: Rhizoma Smilacis Glabrae 10 ~ 20 parts, Semen Plantaginis 10 ~ 20 parts, Radix Salviae Miltiorrhizae 10 ~ 20 parts, Rhizoma Et Radix Notopterygii 10 ~ 20 parts, Radix Scutellariae 10 ~ 20 parts, Rhizoma Atractylodis 10 ~ 20 parts, Fructus Forsythiae 10 ~ 20 parts, Fructus Cnidii 10 ~ 20 parts, Cortex Phellodendri 10 ~ 15 parts, the Radix Angelicae Dahuricae 10 ~ 15 parts, Radix Sophorae Flavescentis 10 ~ 15 parts, Herba Hedyotidis Diffusae 10 ~ 15 parts, Myrrha 10 ~ 15 parts, the Radix Stemonae 10 ~ 15 parts, interrupted 10 ~ 15 parts, Radix Paeoniae Rubra 10 ~ 15 parts.

4. according to any one of claims 1 to 3, treat a preparation method for the Chinese medicine external suppository of women's leukorrhagia, it is characterized in that, the preparation process of described suppository comprises:

D, will distill the crystallization that obtains, add in above-mentioned two kinds of extracting solution, substrate Mixer pot sets type, and ultraviolet is killed virus.

5. treat the preparation method of the Chinese medicine external suppository of women's leukorrhagia according to claim 4, it is characterized in that, in described step a, get Rhizoma Atractylodis, the Radix Angelicae Dahuricae, Myrrha and the Rhizoma Et Radix Notopterygii way of distillation and be vaporized into crystallization, after pulverizing, cross 100-120 mesh sieve, become fine powder for subsequent use.

6. treat the preparation method of the Chinese medicine external suppository of women's leukorrhagia according to claim 4, it is characterized in that, in described step b, medicinal residues after distillation are added the ethanol that all the other crude drug put into 5-10 times amount and soak 1-2 hour, heating extraction 2 times, each 1-2 hour, merge extractive liquid, supernatant is removed after leaving standstill, then 100-120 order filters, then is the ultrafiltration post ultrafiltration of 5000-10000 through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.36 extractum, stand for standby use, becomes component 1.

7. treat the preparation method of the Chinese medicine external suppository of women's leukorrhagia according to claim 4, it is characterized in that, in described step c, the medicinal residues of the crude drug that above-mentioned ethanol extraction is crossed add 10 times of water gagings, heating and refluxing extraction 2 times, each 1 ~ 2 hour, merged by 2 extracting solution and leave standstill, then 100-120 order filtered, be the ultrafiltration post ultrafiltration of 5000-10000 again through the molecular weight that dams, when ultrafiltrate concentrating under reduced pressure relative density is 80 DEG C 1.36 extractum, stand for standby use, becomes component 2.

8. treat the preparation method of the Chinese medicine external suppository of women's leukorrhagia according to claim 4, it is characterized in that, in described steps d, by the merging of component 1 and component 2, then concentrating under reduced pressure tank is put into, decompression recycling ethanol, being concentrated into liquor strength is 0.6g crude drug/mL, when sucking filtration to the relative density of filtrate is 20 DEG C 1.06; Above-mentioned filtrate, after the macroporous adsorptive resins absorption that volume is 10L, with deionized water or the distilled water eluting of 10 times of resin column volumes, then is used 95% ethanol elution of 5 times of resin column volumes, is collected ethanol elution, remove solvent, obtain medicated powder; The crystalline powder that mixing above-mentioned steps obtains, pour in substrate, 50 DEG C ~ 60 DEG C heating and melting, cooling and shaping makes class warhead shape suppository, and 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.

9. treat the preparation method of the Chinese medicine external suppository of women leukorrhagia according to claim 4, it is characterized in that, described suppository substrate used is 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, adds the medicine mastic that described preparation method is obtained, and stirring in water bath is even, is mixed into the liquid of thickness, is poured in plastic shape-forming pipe, and insert tampon, cooling and shaping makes bullet-shaped suppository; Described tampon is the tampon of afterbody with cotton thread.

10. according to any one of claims 1 to 3, treat the preparation method of the Chinese medicine external suppository of women's leukorrhagia for one kind, it is characterized in that, the preparation process of described suppository can also comprise: by described crude drug except Rhizoma Atractylodis, the Radix Angelicae Dahuricae, Myrrha and Rhizoma Et Radix Notopterygii, all the other soak 30 minutes to 1 hour, heated and boiled 30 ~ 40 minutes, filter, filtrate is for subsequent use; Filtering residue adds water, and second time heating, boils 30 ~ 40 minutes, and filter, filtrate is for subsequent use; Filtering residue adds water again, for the third time heated and boiled 30 ~ 40 minutes, filters; Three filtrates be combined, heating is concentrated into paste, then Rhizoma Atractylodis, the Radix Angelicae Dahuricae, Myrrha and Rhizoma Et Radix Notopterygii steam distillation is extracted, and obtains crystal, is mixed in ointment obtained above; Choose substrate 50 DEG C ~ 60 DEG C heating and melting, add ointment cooling and shaping obtained above and make class warhead shape suppository, ultraviolet is killed virus.