CN101167842A

CN101167842A - Medicinal preparation for treating gynecologic inflammation and hysteromyoma and its preparation method

Info

Publication number: CN101167842A
Application number: CNA2007102023722A
Authority: CN
Inventors: 周强; 王利平; 李世禄; 皮海燕; 王井洪
Original assignee: GUIYANG CHUNKE PHARMACY GROUP TECHNICAL RESEARCH Co Ltd
Current assignee: GUIYANG CHUNKE PHARMACY GROUP TECHNICAL RESEARCH Co Ltd
Priority date: 2007-11-05
Filing date: 2007-11-05
Publication date: 2008-04-30
Anticipated expiration: 2027-11-05
Also published as: CN101167842B

Abstract

The invention provides a Miao national herb combination for treating gynecological inflammation and tumor and process for preparation, which is mainly prepared by raw materials of bittersweet herb, oldenlandia diffusa, and melastoma dodecandrum lour, or is used by the compatibility of part or all of clusiaceae, herb emilia, herb centellae, goldenrod, king melon seed, bidens. Compared with the prior art, the invention has the effects of clearing away heat and toxic materials, dissipating blood stasis and resolving mass, eliminating carbuncle and relieving pain, has favorable efficacy for gynecological inflammation caused by damp-heat and damp-toxin and phlegm-dampness stasis accumulation, hysteromyoma, cervical cancer, ovarian cyst, and pelvic inflammation mass, and has no toxic and side effects and drug-resistance. The invention is new Chinese medicine, which has the advantages of safety, efficiency, and controllable quality, worthwhile clinic application, favorable social and economic values.

Description

A kind of pharmaceutical preparation for the treatment of gynecological inflammation and hysteromyoma and preparation method thereof

Technical field

The present invention relates to a kind of pharmaceutical preparation for the treatment of gynecological inflammation and hysteromyoma and preparation method thereof, belong to technical field of Chinese medicines.

Background technology

Gynecological inflammation is meant that female genital system infects caused disease.Because the particularity of female sex organ, gynecological inflammation is adult female's common, a frequently-occurring disease, its clinical manifestation is also varied, clinical common gynecologic inflammation has vaginitis, cervicitis, pelvic inflammatory disease, endometritis etc., and the cause of disease is complicated and often with multiple severe complication, does not often prolongedly heal, live and work to the women has a significant impact, influence quality of life and love life, and can cause infertile, induced tumor etc., have endless trouble.Gynecological inflammation has become a big disease of puzzlement modern female.Gynecological inflammation is disease or a symptom common in the gynaecopathia, all is very high in China or even global sickness rate.Adult female's infection in various degree in the whole world about 87% gynecological inflammation.The sickness rate of China's gynaecological inflammation disease is also quite high, and according to the investigation of World Health Organization (WHO) to Chinese women: China women at reproduction age is about 1.5～200,000,000, and wherein about 41% women suffers from gynecological inflammation in various degree, and married women's sickness rate is more up to 70%.According to southern medication economics institute the geographic Epidemiological study result in part is calculated that China married woman's gynaecopathia prevalence is 46.1%, wherein, rural women's gynecological inflammation prevalence reaches 48.85%, is higher than the prevalence in city 41.26%.According to the market survey analysis, gynecological inflammation medication market scale was about 52.8 hundred million yuan in 2004, increased by 16.84% than 2003, from the growth trend of whole market, the gynecological inflammation medication increases stable, it is predicted that gynecological inflammation market scale in 2008 will be up to 77.55 hundred million yuan.Because its higher sickness rate makes that China's gynecological inflammation medication market demand is huge.

Hysteromyoma is a modal benign tumor in the female sex organ, also is one of tumor common in the human body.Hysteromyoma is mainly formed by uterine smooth muscle hyperplasia.Wherein there is a small amount of connective fiber only to exist as a kind of supporting tissue.The cardinal symptom of general hysteromyoma has: menoxenia, abdominal mass, pressure symptom, pain, leucorrhoea grow in quantity, sterile, blood circulation symptom etc.Except hysteromyoma itself causes very the grieved evil of bodice numerous women, clinical practice confirms that the usually concurrent oviduct oophoropathy of hysteromyoma also very easily exists with adenocarcinoma of corpus uteri and cervical cancer simultaneously.Hysteromyoma is the modal a kind of benign tumors of female sex organs, discovers, and the women of age between 30～50 years old, about 20% suffers from hysteromyoma, and according to director Li Guoying of gynecological of Shanghai kindheartedness hospital introduction, this disease has the trend of increasing in recent years.Though hysteromyoma is a benign tumor, most of symptoms are not obvious, as find untimelyly, and a plurality of organs of entail dangers to health also can cause infertilely, and therefore early anti-early controlling is very necessary.Hysteromyoma is a harm women able-bodied kinds of tumor, perfect along with diagnostic means (B ultrasonic, magnetic resonance etc.), and period of duration women sickness rate can be up to 20～30%.But seldom cancerate, most of patients are also asymptomatic.Because of its from smooth muscle cell, so claim leiomyoma of uterus, relevant because of its morbidity again with estrogen (estrogen, progestogen), so the attribute hormone-dependent tumor.Hysteromyoma is more common in 30～50 years old women, and is rare below 30 years old, seldom sees below 20 years old, the highest with 40～50 years old incidence rate, accounts for 51.2～60.9.If muscular tumor is grown up after the menopause, general expression has degeneration, and especially watching out for has the muscular tumor degeneration.

At present to the treatment of gynecological inflammation mainly based on medicine for external use, as lotion, suppository, effervescent tablet, foam, gel etc., mostly such preparation is to cure the symptoms, not the disease, carry, use all inconvenient, and most of gynecological medicine still contains metronidazole, clotrimazole class antibiotic, too much use the direct result of this quasi drugs to make pathogenic bacteria produce drug resistance exactly, destroy the restricting relation between vaginal microbial flora, cause conk vigorous, treatment cycle constantly prolongs, constantly increase drug dose, disease can not get effective treatment, and for acute inflammation, doctor trained in Western medicine is fast, but in chronic phase, doctor trained in Western medicine is powerless.The western medical treatment hysteromyoma has two kinds of methods at present: the one, and adopt the gonadal hormone medicine to reduce estrogen level by force, alleviate the hysteromyoma symptom, but too much use hormone medicine unfavorable human body, may lead self dysequilibrium.The 2nd, for big tumor body, doctor trained in Western medicine is advocated operative treatment, adopts myomatectomy or uterectomy.The advantage of operative treatment is that produce effects is very fast, if but this basic pathogenesis of endocrine disturbance fail to change, the probability of hysteromyoma recurrence is very big, performs the operation simultaneously patient is brought very big misery, influences the integrity and the fertility of organ.Suffered from hysteromyoma when the patient makes a definite diagnosis, doctor says to such an extent that operate on or must hysterectomize the time, and most patients think and just can endure very.Chinese medicine is to set about from QI and blood regulating, change silt eliminating stagnation, replenishing CHONG and REN meridians by supplementing the essence and blood to the treatment of hysteromyoma, by comprehensive each organ function of conditioning women, adjusts endocrine, and microcirculation improvement is removed alluvial in the body, thereby reaches the purpose of elimination hysteromyoma.Have advantages such as safe, that toxic and side effects is little, be difficult for recurrence after the radical cure.

In order to develop the Chinese medicine that can effectively treat inflammation of woman genetic system, hysteromyoma, cervical cancer, ovarian cyst, inflammatory masses of pelvic cavity etc., the applicant has carried out a large amount of explorations and research.

Summary of the invention

Technical problem to be solved by this invention provides a kind of pharmaceutical preparation for the treatment of gynecological inflammation and hysteromyoma and preparation method thereof.Pharmaceutical preparation of the present invention has heat-clearing and toxic substances removing, blood stasis-eliminating and stagnation-dissipating, and eliminating carbuncle analgesic effect is a kind of safe, effective, the quality controllable treatment gynecological inflammation and the new Chinese medicine of hysteromyoma.

In order to solve the problems of the technologies described above, the present invention adopts following technical scheme:

The pharmaceutical preparation of treatment gynecological inflammation and hysteromyoma mainly is to be made by the crude drug of following weight ratio example: Herba Solani Lyrati 20%～50%, Herba Hedyotidis Diffusae 20%～50% and Herba Melastomatis dodecandri 15～40%.

The part by weight of above-mentioned raw materials medicine is preferably: Herba Solani Lyrati 35.7%, Herba Hedyotidis Diffusae 35.7% and Herba Melastomatis dodecandri 28.6%.

The preparation method of the pharmaceutical preparation of aforementioned therapies gynecological inflammation and hysteromyoma: get Herba Solani Lyrati, Herba Hedyotidis Diffusae and Herba Melastomatis dodecandri, adding 6～10 times of water gagings decocts 1～4 time, the each decoction 1～4 hour, filter, it is 1.25 extractum that filtrate is concentrated into 60 ℃ of relative densities, promptly gets the active component of medicine of the present invention.

In order to make pharmaceutical preparation of the present invention reach better therapeutic effect, can also add crude drug Herba Hyperici Japonici, Herba Duchesneae Indicae and Herba Centellae, wherein the part by weight of each crude drug is: Herba Solani Lyrati 15%～35%, Herba Hedyotidis Diffusae 15%～35%, Herba Melastomatis dodecandri 10～30%, Herba Hyperici Japonici 5%～15%, Herba Duchesneae Indicae 10～30% and Herba Centellae 5%～15%.

The part by weight of each crude drug is preferably: Herba Solani Lyrati 23.2%, Herba Hedyotidis Diffusae 23.2%, Herba Melastomatis dodecandri 18.6%, Herba Hyperici Japonici 7.8%, Herba Duchesneae Indicae 19.4% and Herba Centellae 7.8%.

If also add place grass, Herba Duchesneae Indicae and Herba Centellae in the pharmaceutical preparation of the present invention, then its preparation method is: get Herba Solani Lyrati, Herba Hedyotidis Diffusae, Herba Hyperici Japonici, Herba Duchesneae Indicae and Herba Centellae, adding 6～10 times of water gagings decocts 1～4 time, the each decoction 1～4 hour, filter, it is 1.25 extractum that filtrate is concentrated into 60 ℃ of relative densities, promptly gets the active component of medicine of the present invention.

In order to reach best therapeutic effect, can also add Herba Solidaginis, Semen Trichosanthis Cucumeroidis and Herba Bidentis Bipinnatae in the pharmaceutical preparation of the present invention, wherein the part by weight of each crude drug is: Herba Solani Lyrati 10%～30%, Herba Hedyotidis Diffusae 10%～30%, Herba Melastomatis dodecandri 10～25%, Herba Duchesneae Indicae 5%～20%, Herba Hyperici Japonici 5～10%, Herba Centellae 5～10%, Herba Solidaginis 5～10%, Semen Trichosanthis Cucumeroidis 5～10% and Herba Bidentis Bipinnatae 5～10%.

The consumption of each crude drug is preferably: Herba Solani Lyrati 19.5%, Herba Hedyotidis Diffusae 19.5%, Herba Melastomatis dodecandri 15.5%, Herba Duchesneae Indicae 13%, Herba Hyperici Japonici 6.5%, Herba Centellae 6.5%, Herba Solidaginis 6.5%, Semen Trichosanthis Cucumeroidis 6.5% and Herba Bidentis Bipinnatae 6.5%.

If also add Herba Solidaginis, Semen Trichosanthis Cucumeroidis and Herba Bidentis Bipinnatae in the crude drug, then the preparation method of pharmaceutical preparation of the present invention is: get Herba Solani Lyrati, Herba Hedyotidis Diffusae, Herba Melastomatis dodecandri, Herba Hyperici Japonici, Herba Duchesneae Indicae, Herba Centellae, Herba Solidaginis, Semen Trichosanthis Cucumeroidis, Herba Bidentis Bipinnatae, adding 6～10 times of water gagings decocts 1～4 time, the each decoction 1～3 hour, filter, it is 1.25 extractum that filtrate is concentrated into 60 ℃ of relative densities, promptly gets the active component of medicine of the present invention.

Aforesaid pharmaceutical preparation can be decoction, granule, powder, oral liquid, syrup, soft extract, pill, tablet, capsule.

Required conventional adjuvant was made the various dosage forms on the pharmaceutics meaning when active component of medicine of the present invention can add the preparation different dosage form.

Side of the present invention separates: the Herba Solani Lyrati hardship, and cold, the function heat-clearing and toxic substances removing, expelling wind and removing dampness, blood stasis dispelling cures mainly jaundice due to damp-heat, headache due to pathogenic wind-heat, leukorrhagia, rheumatic arthritis, edema, gonorrhea, erysipelas is treated skin ulcer.The Herba Hedyotidis Diffusae nature and flavor are sweet, light, cold, and function: heat-clearing and toxic substances removing, promoting blood circulation and stopping pain, promoting urination to remove dampness, anti-cancer and detumescence cures mainly acute appendicitis (appendicitis), furuncle toxic swelling, jaundice due to damp-heat, diseases such as dysuria; The furuncle carbuncle is controlled in external, venom, the modern clinical diseases such as malignant tumor, appendicitis, hepatitis, bacillary dysentery, bronchitis, tonsillitis, laryngitis, urinary system infection, pelvic inflammatory disease, adnexitis that are used for.The Herba Melastomatis dodecandri nature and flavor are sweet, puckery, and are flat, function: heat-clearing and toxic substances removing, and expelling wind and removing dampness, tonifying blood and arresting bleeding cures mainly enteritis, dysentery, lung abscess, pelvic inflammatory disease, metrorrhagia, anemia, leucorrhea, lumbago and skelalgia, rheumatic ostalgia, traumatic hemorrhage, venom etc. can be prevented epidemic cerebrospinal meningitis.Herba Hyperici Japonici nature and flavor hardship, sweet, cold, return liver, gallbladder meridian, function: the dampness removing jaundice eliminating, heat-clearing and toxic substances removing, promoting blood circulation and detumescence cures mainly infectious hepatitis, dysentery, infantile convulsion, infantile malnutrition, throat moth, acute appendicitis, furuncle and phyma, venom.Herba Duchesneae Indicae nature and flavor hardship, cold, function: heat-clearing and toxic substances removing, antiinflammatory, diuresis, dissipating blood stasis for subsidence of swelling cures mainly upper respiratory tract infection, laryngopharynx swelling and pain, oral ulcer, conjunctivitis, pneumonia, acute enteritis, bacillary dysentery, urinary system infection, orchitis, mastitis, furuncle and phyma skin infection, skin eczema, osteopatia sprain etc.Herba Centellae nature and flavor hardship, suffering, cold, function: removing damp-heat, the detoxifcation diuresis cures mainly jaundice due to damp-heat, heatstroke diarrhoea, sand Stranguria stranguria with blood, carbuncle sore tumefacting virus, injury from falling down.The Herba Solidaginis nature and flavor are arduous, and function: wind and heat dispersing, subduing swelling and detoxicating cures mainly headache due to common cold, laryngopharynx swelling and pain, jaundice, pertussis, infantile convulsion, traumatic injury, carbuncle carbuncle on the back, fungal infection of hand and foot.Semen Trichosanthis Cucumeroidis's nature and flavor are bitter, and are flat, function: clearing away heat-damp and promoting diuresis, and cooling blood for hemostasis, the Shujin emesis cures mainly and controls the consumptive lung disease haematemesis, jaundice, dysentery, discharging fresh blood stool, the muscles and bones spasm and pain, food is told in regurgitation.Herba Bidentis Bipinnatae nature and flavor hardship, suffering, cold, function: removing damp-heat, the detoxifcation diuresis cures mainly and is used for jaundice due to damp-heat, heatstroke diarrhoea, sand Stranguria stranguria with blood, carbuncle sore tumefacting virus, injury from falling down.

We's institute main symptom type system is risen by damp and hot noxious dampness, phlegm-damp stasis of blood knot, and the clinical syndrome differentiation main points are many through the row amount, menostaxis, and profuse leukorrhea, yellow skin or be purulence, the matter thickness has dirty stink, or leukorrhagia color white matter glues, and is the bean dregs sample, pruritus vulvae; Abdominal mass, lower abdomen is had a pain, and burning pain rises and falls, and the pain of touching is acute, connects the waist sacrum bitterly, doublely sees that fever of the body is thirsty, and is vexed not peaceful, or the bitter taste greasy taste in the mouth, uncomfortable in chest indigestion and loss of appetite, constipation, yellowish or reddish urine; Red tongue, or dim red, ecchymosis is arranged, yellow and greasy fur, slippery and rapid pulse.From the pathogen and pathology of tcm analysis as seen, damp and hot noxious dampness, phlegm-damp stasis of blood knot all may cause gynecological inflammation, hysteromyoma, ovarian cyst, inflammatory masses of pelvic cavity, presses differentiation of tcm, when with clearing away heat-damp and promoting diuresis, and heat-clearing and toxic substances removing, circulation of qi promoting is invigorated blood circulation, and blood stasis dispelling is main method.The core that we cure mainly function is heat clearing away, dampness removing, detoxifcation, blood circulation promoting and blood stasis dispelling, hard masses softening and resolving, and the prescription opinion is controlled rationally, and is consistent with the differentiation of tcm principle.Though gynecological inflammation, hysteromyoma, ovarian cyst, inflammatory masses of pelvic cavity adhere to the traditional Chinese medical science " leukorrhagia ", “ mass in the abdomen separately " category; if differentiation of symptoms and signs for classification of syndrome belongs to damp and hot noxious dampness, phlegm-damp stasis of blood knot type person; due to illness machine is identical, and the determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs principle by traditional Chinese medical science treating different diseases with the same therapeutic principle all can adopt we to rule together.

Damp and hot noxious dampness, phlegm-damp stasis of blood knot all may cause gynecological inflammation, hysteromyoma, ovarian cyst, inflammatory masses of pelvic cavity, in the side with Herba Solani Lyrati, Herba Solidaginis, Herba Duchesneae Indicae heat-clearing and toxic substances removing; With Herba Hedyotidis Diffusae, Herba Melastomatis dodecandri, Herba Hyperici Japonici blood circulation promoting and blood stasis dispelling, hard masses softening and resolving; With Semen Trichosanthis Cucumeroidis, Herba Bidentis Bipinnatae, Herba Centellae, dehumidifying diuresis, all medicines share, receive heat clearing away, dampness removing, detoxifcation, blood circulation promoting and blood stasis dispelling altogether, the merit of hard masses softening and resolving can make hot clearly, wet as to dispel, malicious must separating, hard must disappearing tied diffusingly, and all diseases of gynecological inflammation, hysteromyoma, ovarian cyst, inflammatory masses of pelvic cavity of damp and hot noxious dampness, phlegm-damp stasis of blood knot must be controlled.

Function of the present invention cures mainly: medicine of the present invention has heat-clearing and toxic substances removing, blood stasis-eliminating and stagnation-dissipating, and the effect of eliminating carbuncle pain relieving is used for the gynecological inflammation due to damp and hot noxious dampness, the phlegm-damp stasis of blood knot, hysteromyoma, cervical cancer, ovarian cyst, inflammatory masses of pelvic cavity etc.; Disease is seen leucorrhea with red and white discharge, and menorrhagia accompanies big or small clot, menostaxis, or stomachache etc. is arranged.

In order to verify that medicine of the present invention has excellent curative, the applicant has carried out series of experimental research, and is specific as follows:

One, preliminary pharmacodynamics test

Test unit: pharmacology teaching and research room of Zunyi Medical College, basis, Guizhou Province pharmacology key lab, entrusted by the present patent application people, adopt rat vagina, cervicitis model and external bacteriostasis method that medicine of the present invention has been carried out preliminary pharmacodynamic experiment and observe, now its experimental result is reported as follows:

(1) experiment material

1, medicine and reagent: be subjected to reagent: pharmaceutical preparation of the present invention, lot number: do not have specification: the 50g/ bag, the dark brown powdery, face the time spent take by weighing aequum with distilled water diluting to finite concentration; Liquid phenol is Shantou Xilong Chemical Factory, a Guangdong product, lot number: 0402041; Arabic plastic powder is a Tianjin section close europeanized reagent development centre product, lot number: 20020728.

2, laboratory animal: the SD rat, female, body weight 220 ± 20g is provided by big level ground hospital of Third Military Medical University Experimental Animal Center, the quality certification number: SCXK (Chongqing): 2002003.

3, key instrument: BS110S precise electronic balance (Beijing Sai Duolisi joint-stock company), SHA-C temperature controlled water bath oscillator (all over the country industrial corporation in Shenzhen).

(2) experimental technique

1, medicine of the present invention is to the therapeutical effect of rat vagina inflammation and cervicitis model

1.1 modelling: by taper venotomy pin, 25% phenol rubber cement 0.5ml/ is only injected in the vagina deep, makes rat vagina and cervicitis model.

1.2 grouping and administration: 32 of molding rats are divided into 4 groups at random: normal control group, model control group, medicine of the present invention low (0.8g/kg), medicine high dose group of the present invention (4.0g/kg), 8 every group.8 of rats in normal control group, not molding.All the other respectively organize the 7th day beginning gastric infusion 10ml/kg after the molding, once a day, and continuous 14 days.Model group and normal control group give with the volume distilled water.

1.3 observation item: successive administration with 3% pentobarbital sodium intraperitoneal injection of anesthesia, was dissected taking-up tissue behind vagina and the uterus: 1. observe and write down finding of naked eye with rat after 14 days.2. with the vagina and the uterus subangle place tissue that take out, place 10% formalin fixing, will organize from the center line longitudinal incision after 3 days, do the routine paraffin wax section, HE dyeing, mirror is observed vagina and uterine cancer cell morphological change down.

2, medicine in-vitro antibacterial experiment of the present invention

2.1 select the different liquids culture medium for use according to different strain, by coubling dilution with drug dilution of the present invention become 125,62.5,31.25,15.625,7.6125,3.90625,1.953125mg/ml concentration.

2.2 the cultivation according to different strain requires to cultivate with different cultural methods and incubation time.Cultivate and finish, measure the muddy situation of culture in vitro with the Maxwell than turbid instrument, MIC represents the medicine minimum inhibitory concentration.

2.3 get more than the MIC terminal point long bacterium respectively manage culture fluid respectively subcultivation on the solid medium that does not contain this medicine, cultivate, the medicine least concentration of asepsis growth is with MBC (minimum bactericidal concentration) expression.

(3) result

The therapeutical effect of the 1 pair of rat vagina inflammation and cervicitis model

1.1 perusal: model group rat vagina collar extension is obviously red and swollen, and secretions is many, and is movable few.Medicine of the present invention is low, the rarely seen vagina redness of high dose group rat is lighter, and the vagina collar extension has a small amount of secretions.

1.2 tectology is observed: the expansion of normal control group blood vessels of vagina, the cervical tissue cell shows no obvious abnormalities.Model group rat vagina, cervix uteri vasodilation hyperemia, special mess shape covering epithelium disappears, comes off the body of gland phosphatization, the mucosa hyperplasia of squamous epithelium, the visible columnar epitheliumization of cervix uteri squama post intersection is given birth to, and epithelial erosion, a matter mucosa are seen chronic inflammatory cell and oxyphil cell's infiltration.Compare with model group, medicine 0.8g/kg rat vagina of the present invention, the slight dilatation and congestion of cervix uteri blood vessel are seen the mucosa hyperplasia of squamous epithelium individually, and a small amount of lymphocyte and oxyphil cell are soaked into.4.0/kg the group pathological changes obviously alleviates than model group, the squamous epithelial cancer form is similar to normal group, and inflammatory cell infiltration obviously reduces, and the covering epithelium organizational structure exists, and does not see obvious disappearance.

2. in-vitro antibacterial result

Table 1 in-vitro antibacterial result

(4) conclusion

1, medicine 4.0g/kg of the present invention can produce therapeutical effect to experimental vaginitis, cervicitis, can reduce inflammatory reaction, and the pathology that cause that reduce inflammation change.Vaginitis, cervicitis therapeutical effect are not as good as the 4.0g/kg group due to the medicine 0.8g/kg Pyrogentisinic Acid rubber cement of the present invention.

2, medicine of the present invention is in the in-vitro antibacterial experiment, to the female genital tract common pathogen, as golden Portugal bacterium, escherichia coli, Pseudomonas aeruginosa, group B streptococcus, Candida albicans, novel candidiasis etc. antibacterial action is arranged all, point out medicine of the present invention may produce preventive and therapeutic effect reproductive tract infection due to the above-mentioned pathogenic bacterium.

Two, prescription compatibility of medicines screening test

Adopt zoopery, in-vitro antibacterial, the antiinflammatory action of different formulations of the present invention carried out the contrast experiment.

1, experiment material

1.1 laboratory animal: Kunming mouse, female, cleaning level, body weight 18-22g.

1.2 medicine and reagent:

Be subjected to reagent:

The present invention fills a prescription 1: Herba Solani Lyrati 30g, Herba Hedyotidis Diffusae 30g, Herba Melastomatis dodecandri 24g;

The present invention fills a prescription 2: Herba Solani Lyrati 30g, Herba Hedyotidis Diffusae 30g, Herba Melastomatis dodecandri 24g, Herba Hyperici Japonici 10g, Herba Duchesneae Indicae 25g, Herba Centellae 10g;

The present invention fills a prescription 3: Herba Solani Lyrati 30g, Herba Hedyotidis Diffusae 30g, Herba Melastomatis dodecandri 24g, Herba Duchesneae Indicae 20g, Herba Hyperici Japonici 10g, Herba Centellae 10g, Herba Solidaginis 10g, the 10g of Semen Trichosanthis Cucumeroidis, Herba Bidentis Bipinnatae 10g.

Above three parts is water extract, and facing the time spent, to be made into suspension with distilled water standby; Dimethylbenzene.

1.3 experiment equipment: BS110S precise electronic balance, SHA-C temperature controlled water bath oscillator, timer.

2, method and result

2.1 in-vitro antibacterial test

2.1.1 method: adopt the in-vitro antibacterial test, measure the different formulations extract to staphylococcus aureus, escherichia coli, Pseudomonas aeruginosa, group B streptococcus, Candida albicans, novel oidiomycetic lowest concentration of antimicrobial (MIC) and minimum bactericidal concentration (MBC).

2.1.2 result: extracorporeal bacteria inhibitor test shows that various combination prescription of the present invention all has bacteriostasis to staphylococcus aureus, aerobacteria, Bacillus proteus, escherichia coli, streptococcus faecalis.The test comparing result show, the prescription 3 be better than filling a prescription 1 and the prescription 2, the result sees Table 2～table 7 respectively.

Table 2 different formulations of the present invention is to the bacteriostasis of staphylococcus aureus

Table 3 different formulations of the present invention is to colibacillary bacteriostasis

Table 4 different formulations of the present invention is to the bacteriostasis of Pseudomonas aeruginosa

Table 5 different formulations of the present invention is to the bacteriostasis of group B streptococcus

Table 6 different formulations of the present invention is to the oidiomycetic bacteriostasis of white

Table 7 different formulations of the present invention is to the bacteriostasis of Cryptococcus histolyticus

2.2 the influence of different formulations xylol induced mice ear swelling

2.2.1 method is got 30 of mices, body weight is 20～22g, is divided into 3 groups at random, 10 every group, respectively to the present invention fill a prescription 1, the extract of prescription 2, prescription 3.Irritate stomach and give normal saline, administration concentration is subjected to reagent to be 1.5g/kg for 3 groups, administration volume 10ml/kg, and successive administration 5d once a day, behind the last administration 1h, only is coated with dimethylbenzene 0.02ml/ with two sides before and after the animal auris dextra, and left ear is left intact.Behind the 4h the disconnected vertebra of animal is put to death, cut ears, lay round auricle at same position respectively with 9mm diameter card punch, the precise electronic balance is weighed, and it is the swelling degree that every Mus auris dextra weight deducts left ear weight, and by formula calculates inhibitory rate of intumesce.Result of the test represents that with the meansigma methods standard deviation result adopts the t check, and P＜0.05 shows to have significance.

2.2.2 the result is as shown in table 8, each group relatively, prescription 1 of the present invention and prescription 2 xylol cause mice ear all certain inhibitory action, but the present invention fills a prescription and 3 is better than filling a prescription 1 and prescription 2.

2.3 different formulations is to the bullate influence of rat granuloma

2.3.1 30 of experimental technique and animal grouping female rats, grouping and medication are with 2.2.After the rat 3% pentobarbital sodium intraperitoneal anesthesia, routine disinfection skin, abdominal part side otch, it is subcutaneous that two sterilization cotton balls (40mg, autoclaving respectively add ampicillin 1mg/0.1ml, 50 ℃ of stove-dryings) are implanted rat both sides groin respectively.Began gastric infusion the same day in postoperative, successive administration 7 days, once a day, 1h after the last administration puts to death animal, takes out cotton balls, after 60 ℃ of baking boxs are placed 12h, use scales/electronic balance weighing, by formula calculate granuloma weight (the cotton balls weight-raw cotton ball weight of granuloma weight=taking-up).

3.2 the result is as shown in table 9, each group relatively, 2 pairs of rat granulomas of prescription 1 of the present invention and prescription are swollen all certain inhibitory action, but the present invention fills a prescription and 3 is better than filling a prescription 1 and prescription 2.

Table 8 different formulations xylol of the present invention causes the influence of mice ear

Group	Dosage (g/kg)	Swelling degree (mg)	Inhibitory rate of intumesce (%)
Group	Dosage (g/kg)	Swelling degree (mg)	Inhibitory rate of intumesce (%)	Prescription 1	1.5	0.26±1.74	73.6
Prescription 2	1.5	0.22±1.67	89.7	Prescription 1	1.5	0.26±1.74	73.6
Prescription 2	1.5	0.22±1.67	89.7	Prescription 3	1.5	0.17±1.58	96.2

Table 9 different formulations of the present invention is to the bullate influence of rat granuloma

Group	Dosage (g/kg)	Number of animals (only)	Granulation tissue (mg)
Group	Dosage (g/kg)	Number of animals (only)	Granulation tissue (mg)	Prescription 1	1	10	46.2±22.4
Prescription 2	1	10	48.4±21.2	Prescription 1	1	10	46.2±22.4
Prescription 2	1	10	48.4±21.2	Prescription 3	1	10	51.1±21.3

3, conclusion

3.1 various combination prescription of the present invention is in the in-vitro antibacterial contrast experiment, each combination formula is all to common pathogens such as gynaecologic reproductive system inflammation: staphylococcus aureus, escherichia coli, Pseudomonas aeruginosa, group B streptococcus, Candida albicans, novel candidiasis has antibacterial action, but experimental result prompting prescription 3 (Herba Solani Lyratis 19.5%, Herba Hedyotidis Diffusae 19.5%, Herba Melastomatis dodecandri 15.5%, Herba Duchesneae Indicae 13%, Herba Hyperici Japonici 6.5%, Herba Centellae 6.5%, Herba Solidaginis 6.5%, Semen Trichosanthis Cucumeroidis 6.5% and Herba Bidentis Bipinnatae 6.5%) can produce better preventive and therapeutic effect to urinary tract infection due to the above-mentioned pathogenic bacterium etc.

3.2 various combination prescription of the present invention is in xylol induced mice ear swelling and the bullate influence experiment of rat granuloma, each makes up equal xylol induced mice auricle edema and the certain inhibitory action of the swollen generation of rat granuloma, but experimental result shows prescription 3 (Herba Solani Lyrati 30g, Herba Hedyotidis Diffusae 30g, Herba Melastomatis dodecandri 24g, Herba Duchesneae Indicae 20g, Herba Hyperici Japonici 10g, Herba Centellae 10g, Herba Solidaginis 10g, the 10g of Semen Trichosanthis Cucumeroidis, Herba Bidentis Bipinnatae 10g) xylol induced mice auricle edema and rat granuloma are swollen produces than the obvious suppression effect, points out this combination formula to have antiinflammatory action preferably.

Three, Pharmacodynamic test of active extract

(1) to the pharmacodynamics test of genital organ inflammation

Medicine and reagent: be subjected to reagent: capsule of the present invention by the Kweiyang spring section's Pharmaceutical technical research company lot number is provided: 2006001, specification is the 0.3g/ grain.Be subjected to reagent to face the time spent and make 2.5%, 5%, 10% concentration with distilled water; The positive control drug KANGFUYAN JIAONANG is the long-range pharmaceutical Co. Ltd in a Guizhou product, lot number: 20061120; Liquid phenol is Shantou Xilong Chemical Factory, a Guangdong product, lot number: 0402041; Gum arabic powder is a Tianjin section close europeanized reagent development centre product, lot number: 20020728.

Laboratory animal: SD rat, body weight 220 ± 20g; Provide the quality certification number by big level ground hospital of Third Military Medical University Experimental Animal Center: SCXK (Chongqing) 2002003; Kunming kind female mice, body weight 18～22g is provided by Animal Experimental Study chamber, Chongqing Institute of Chinese Medicine, the quality certification number: SCXK (Chongqing) 20020004.

1, capsule of the present invention is to the influence of rat vagina inflammation and cervicitis

1.1 modelling is by taper venotomy pin, 25% phenol rubber cement 1.5ml/ is only injected in the vagina deep, makes rat vagina and cervicitis model.

1.2 grouping and 50 of administration molding rats are divided into 5 groups at random: model control group, capsule height of the present invention (1.2g/kg), in (0.6g/kg), low (0.3g/kg) dosage group and the scorching Capsules group (1.4g/kg) of antagonism woman, 10 every group.10 of rats in normal control group, not molding.The 7th day beginning gastric infusion 10ml/kg after the molding, once a day, continuous 14 days.Model group and normal control group give with the volume distilled water.

1.3 the observation item successive administration is put to death each treated animal after 14 days, dissect taking-up tissue behind vagina and the uterus: 1. observe and write down finding of naked eye.2. with the vagina and the uterus subangle place tissue that take out, place 10% formalin fixing, will organize from the center line longitudinal incision after 3 days, do the routine paraffin wax section, vagina and uterine cancer cell morphological change are observed in HE dyeing, mirror down: matter inflammatory activity between observing under mucosa, the mucosa.The judgement of inflammation degree :-do not change for having; + be MC; ++ for moderate changes; +++for severe changes, result such as table 10.

1.4 result

1.4.1 the rat vagina collar extension is obviously red and swollen after the perusal molding, secretions is many, and rat flocks together, and is movable few.Each administration group of capsule of the present invention, the rarely seen vagina of KANGFUYAN JIAONANG group rat are slightly red and swollen, and the vagina collar extension has a small amount of secretions.

1.4.2 tectology is observed model group rat vagina mucosa squamous epithelial cancer level and thickened, the visible columnar epitheliumization of cervix uteri squama post intersection is given birth to, epithelial erosion, and the visible mucosal ulcer of minority, tela submucosa telangiectasis hyperemia, inflammatory cell infiltration is obvious.Medicine height of the present invention, middle dosage group and model group compare, and pathological changes all obviously alleviates, and the squamous epithelial cancer form is similar to normal group, and inflammatory cell infiltration obviously reduces than model group under the mucosa.

Table 10 capsule of the present invention is to the influence of rat vagina and cervicitis

2, capsule of the present invention is to the influence of rat uterus inflammation

2.1 model prepares rat 3% pentobarbital sodium 30mg/kg intraperitoneal anesthesia, the abdominal part routine disinfection, median abdominal incision 2cm exposes the uterus, in the uterus, left side apart from dividing and 1cm place incision one osculum, with a plastics tubule (long 2mm, diameter 0.5mm, heavy 2mg, alcohol disinfecting) put into intrauterine, and with the uterine incision sutured, with anti-slip.Wound splash into ampicillin 0.1mg (0.05%, 0.2ml) in case infect, close abdomen, the sterile surgical district.

2.2 grouping and administration are divided into model group at random with 50 of 3 days rats of modeling, capsule low dose group of the present invention (0.3g/kg), middle dosage group (0.6g/kg), high dose group (1.2g/kg), KANGFUYAN JIAONANG matched group (1.4g/kg), 10 every group.10 of normal rat matched groups, not modeling.Gastric infusion 10ml/kg, once a day, in continuous 2 weeks, model group and normal control group give with the volume distilled water.

2.3 after 2 weeks of observation index administration with animal with 3% pentobarbital sodium 30mg/kg intraperitoneal anesthesia, take out the uterus, left side, be stained with the liquid of dehematizing gently with filter paper, precision balance is weighed, calculate inflammation of uterus swelling degree (left and right sides uterus weight is poor), and calculate swelling rate and inhibitory rate of intumesce (%) by following formula.

Swelling rate (%)=(Vt-Vn)/Vn * 100%; (Vt in the formula :) for causing scorching uterus weight, Vn: do not cause scorching uterus weight; Inhibitory rate of intumesce (%)=(a-b)/a * 100%; A: the average swelling rate of model group, b: the average swelling rate of administration group

2.4 the result shows that model group and normal control group compare, uterus swelling degree obviously increases.Each administration group of capsule of the present invention and model group compare, and swelling degree in uterus obviously alleviates (table 11).

Table 11 capsule of the present invention is to the influence of rat uterus inflammation

3, medicament capsule of the present invention is to the influence of chronic salpingitis

3.1 model prepares rat 3% pentobarbital sodium (30mg/kg) intraperitoneal anesthesia, the abdominal part routine disinfection, median abdominal incision exposes the uterus, finds the bilateral fallopian tube along the uterus, at the nearly fallopian tube of cornua uteri place inserting needle, to fallopian tube-ovary direction, inject the 0.05ml mixed bacteria liquid in the fallopian tube, annotate and finish, abdomen is closed in layering, the sterile surgical district, sub-cage rearing.

3.2 grouping and 80 of female modeling rats of administration are divided into model group at random, capsule height of the present invention (1.2g/kg), in (0.6g/kg), low (0.3g/kg) dosage group and positive drug contrast medicine KANGFUYAN JIAONANG group (1.4g/kg), 16 every group.16 of rats in normal control group, not molding.Second day beginning gastric infusion after the molding, once a day, continuous 21 days, model group and normal control group gave with the volume distilled water.

3.3 the index observing administration after 21 days with animal with 3% pentobarbital sodium (30mg/kg) intraperitoneal anesthesia, the perusal fallopian tube changes, and cutting fallopian tube, to put into 4% formalin fixing, is used as histopathologic examination.Every check index by pathological change be divided into normally, slight, moderate and severe, use respectively-,+, ++, +++represent."-" do not have obvious degeneration, inflammatory cell infiltration, pathological changes such as hamartoplasia; "+" showed cell is become cubic by column, cilium disappears, a small amount of connective tissue proliferation, a small amount of inflammatory infiltration; " ++ " expression cell becomes flat by column, connective tissue proliferation, part inflammatory cell infiltration, tube chamber adhesion; +++expression cell epithelium and cilium complete obiteration, a large amount of hyperplasias and inflammatory cell infiltration, the tube chamber adhesion is serious.Adopt the check of grade preface value method, analyze the pathological examination of each sample.

3.4 result

3.4.1 perusal: normal rats fallopian tube outward appearance even thickness, smooth mellow and full, color and luster is ruddy, and high resilience does not have adhesion with surrounding tissue, no edema phenomenon.The rat model fallopian tube increases slightly, the color and luster deepening, and with peripheral part adhesion, visible hydrops of minority or abscess.Medicament capsule height of the present invention, middle dosage group and positive drug group have in various degree improvement (table 12) than model group.

Table 12 medicament capsule of the present invention is to the influence of chronic salpingitis

3.4.2 histological examination HE dyeing light microscopic is observed down, rats in normal control group tubal wall organizational structure is clear, and tube chamber is unobstructed, and the far-end cilium is abundant, and the near-end tube wall is clear, and cilium is less.The boundary of rat model tubal wall structure is unclear, cilium and the connective tissue proliferation of flesh layer, mucomembranous epithelial cell structural deterioration, be column or oval, the cell engrain concentrates, the collagen fiber hypertrophy, between the obvious edema of matter, inflammatory cell infiltration is obvious, part tube chamber severe obstruction.Capsule height of the present invention and middle dosage group and model group compare, and pathological changes obviously alleviates, and the connective tissue proliferation of flesh layer is lighter, and tube chamber blocks less, and inflammatory cell obviously reduces (table 12) than model group under the serous coat.

4, the capsular antiinflammatory of the present invention, analgesia, refrigeration function

4.1 the influence of capsule xylol induced mice ear swelling of the present invention

4.1.1 50 of experimental technique and animal grouping female mices, be divided into 5 groups at random: medicament capsule of the present invention low (0.3g/kg), in (0.6g/kg), high dose (1.2g/kg) group, the scorching matched group (1.4g/kg) of anti-woman, normal saline matched group (with the capacity normal saline).Gastric infusion, successive administration 7 days once a day, behind the last administration 1h, only is coated with dimethylbenzene 0.02ml/ with two sides before and after the animal auris dextra, and left ear is left intact.Behind the 4h the disconnected vertebra of animal is put to death, cut ears, lay round auricle at same position respectively with 9mm diameter card punch, scales/electronic balance weighing, it is the swelling degree that every Mus auris dextra weight deducts left ear weight.Each parameter judges between administration group and normal saline matched group that with the t check there was no significant difference is arranged.

4.1.2 capsule in high dose xylol induced mice auricle edema of the present invention as a result has obvious inhibitory action, though in, low dose group has the trend that alleviates mice ear, difference does not have significance (table 13).

Table 13 medicament capsule of the present invention is to the influence of mice ear

4.2 medicament capsule of the present invention is to the influence of mouse peritoneal capillary permeability

Female unpregnancy mice is 50 4.2.1 experimental technique and animal divide into groups, and group technology is with 1.1.Gastric infusion, successive administration 3 days, once a day, and 1h after the last administration, each caudal vein injection azovan blue normal saline 0.1ml/10g, lumbar injection 0.6% acetic acid 0.2ml/ is only immediately.The mice dislocation is put to death behind the 20min, cut the abdominal cavity open, wash for several times the abdominal cavity with 6ml normal saline (NS), collection also merges flushing liquor in centrifuge tube, adds NS as for 10ml, with 3000 rev/mins, centrifugal 15min, take out supernatant in 721 type spectrophotometer 590nm wavelength place colorimetrics, represent the azovan blue seepage discharge, judge its significance with the t check with absorbance.

4.2.2 the result shows, compares with the normal saline group, high, medium and low three the dosage groups of medicament capsule of the present invention all can obviously suppress increasing of acetic acid induced mice abdominal cavity capillary permeability, reduce to ooze out (table 14).

Table 14 medicament capsule of the present invention is to the influence of capillary permeability due to the mice HAC

4.3 capsule of the present invention is to the bullate influence of rat granuloma

4.3.1 50 of experimental technique and animal grouping female rats, grouping and medication are with 1.1.After the rat 3% pentobarbital sodium intraperitoneal anesthesia, routine disinfection skin, abdominal part side otch, it is subcutaneous that two sterilization cotton balls (40mg, autoclaving respectively add ampicillin 1mg/0.1ml, 50 ℃ of stove-dryings) are implanted rat both sides groin respectively.Began gastric infusion the same day in postoperative, successive administration 7 days, once a day, 1h after the last administration puts to death animal, takes out cotton balls, after 60 ℃ of baking boxs are placed 12h, use scales/electronic balance weighing, by formula calculate granuloma weight (the cotton balls weight-raw cotton ball weight of granuloma weight=taking-up).

4.3.2 the middle and high dosage of capsule of the present invention as a result can significantly suppress granulation tissue hyperplasia, low dose group alleviates the effect not obvious (p＞0.05) of granuloma induced by implantation of cotton pellets; The positive control drug FUYANKANG can obviously suppress granulation tissue hyperplasia (table 15).

Table 15 medicament capsule of the present invention is to the bullate influence of rat granuloma

4.4 the capsular analgesic experiment of the present invention

4.4.1 50 of female mices are got in the experiment of mice hot plate method, grouping and medication 1.1.Mice is placed on 55 ℃ of metallic plates, licks metapedes or hopping response incubation period is a threshold of pain index, be recorded in the time that stops on the metallic plate with mice.The result shows, mice pain does not have obvious difference incubation period before and after the administration of normal saline matched group.Medicine height of the present invention, middle dosage all can obviously prolong pain incubation period, compare significant difference (table 16) with the normal saline matched group.

Table 16 capsule of the present invention is to the influence of hot plate method induced mice pain

4.4.2 50 of mices are got in the mouse writhing method experiment, and are female, grouping is with 1.1.Gastric infusion, 1 time/day, for three days on end, behind the last administration 1h, lumbar injection 0.6% acetic acid 0.2ml/ only, observe take place in the mice 15min turn round the body number of times, and calculate suppression ratio.Suppression ratio (%)=(the normal saline group is turned round body number of times-reagent group and turned round the body number of times)/normal saline group is turned round the body number of times.The result shows that medicine height of the present invention, middle dosage and positive drug FUYANKANG all can obviously reduce the acetic acid induced mice and turn round the body number of times, medicine low dosage of the present invention effect not obvious (table 17).

The influence of table 17 medicament capsule Dichlorodiphenyl Acetate of the present invention induced mice pain

4.5. medicament capsule of the present invention is to 2, the influence of rat fever due to the 2, 4-dinitrophenol

4.5.1 50 of experimental technique and animal grouping rats, grouping and administration are with 1.1.1h after the last administration, after mensuration was respectively organized rat anus temperature, every Corium Mus is injection 2 down, 2, 4-dinitrophenol 15mg/kg (1.5mg/ml, 1ml/100g body weight) causes and raises rat temperature (body temperature 20min promptly raises, and reaches the peak to 1h, continue more than 3 hours), measure every group of rat temperature behind the 1h and change.

4.5.2 medicament capsule high dose group of the present invention as a result is to 2, rat fever has certain influence due to the 2, 4-dinitrophenol, in, low dose group do not have obvious influence.

5, medicament capsule in-vitro antibacterial experiment of the present invention

5.1 test method

(1) select the different liquids culture medium for use according to different strain, by coubling dilution with medicament capsule of the present invention be diluted to 125,62.5,31.25,15.625,7.6125,3.90625,1.953125mg/ml concentration.

(2) cultivation according to different strain requires to cultivate with different cultural methods and incubation time.Cultivate and finish, measure the muddy situation of culture in vitro with the Maxwell than turbid instrument, MIC represents the medicine minimum inhibitory concentration.

(3) get more than the MIC terminal point long bacterium respectively manage culture fluid respectively subcultivation on the solid medium that does not contain this medicine, cultivate, the medicine least concentration of asepsis growth is with MBC (minimum bactericidal concentration) expression.

5.2 result of the test

The outer antibacterial experiment result of table 18 capsule body of the present invention

5, conclusion

5.1 capsule 0.6g/kg of the present invention, 1.2g/kg produces the obvious treatment effect to experimental vaginitis, cervicitis and salpingitis, can reduce inflammatory reaction, and the pathology that cause that reduce inflammation change.

5.2 capsule of the present invention is in the in-vitro antibacterial experiment, to the female genital tract common pathogen, as golden Portugal bacterium, escherichia coli, Pseudomonas aeruginosa, group B streptococcus, novel candidiasis, Candida albicans etc. antibacterial action is arranged, point out medicament capsule of the present invention may produce preventive and therapeutic effect reproductive tract infection due to the above-mentioned pathogenic bacterium.

5.3 capsule 0.6g/kg of the present invention, 1.2g/kg xylol induced mice auricle edema and rat granuloma all produce the obvious suppression effect, and can reduce capillary permeability, reduce inflammation and ooze out, and show that medicament capsule of the present invention has tangible antiinflammatory action.

5.4 capsule 0.6g/kg of the present invention and 1.2g/kg have the obvious suppression effect to hot plate method and acetic acid induced mice pain, point out medicament capsule of the present invention that the pain that inflammation causes is had mitigation.

In sum, capsule of the present invention produces the obvious treatment effect to experimental vaginitis, cervicitis and salpingitis, for its clinical experiment and use provide experimental basis.

(2) to the pharmacodynamics test of genital organ tumor

1, experiment material

1.1 laboratory animal (1) Kunming KM mice: 6～8 ages in week, body weight 20 ± 2g.(2) S180 tumor strain.

1.2 medicine is with (one).Contrast medicine: palace tumor capsule for eliminating.

2, experimental technique

2.1 animal model prepares aseptic the 7th day Mus metastatic carcinoma S180 ascites of getting, and uses normal saline 1: 3 (1 * 10 ⁷/ ml) dilution is got the 0.2ml diluent, right axil subcutaneous injection KM mice.

2.2 administering mode and dosage (1) normal control group: 10 Kunming KM mices, irritate stomach 14d with normal saline.(2) lotus tumor matched group (model group): 10 Kunming KM mices, irritate stomach 14d with normal saline.(3) medicament capsule treatment group of the present invention (experimental group): 30 Kunming KM mices, use respectively medicament capsule of the present invention low (0.3g/kg), in (0.6g/kg), high dose (1.2g/kg) group irritate stomach 14d.(4) contrast medicine palace tumor capsule for eliminating: 10 Kunming KM mices, irritate stomach 14d with palace tumor capsule for eliminating (2.0g/kg).

Above model group and experimental group are all being irritated stomach modeling in the 7th day.

Tumor is tested in experiment and was got lotus tumor matched group and each 10 dislocation of cervical vertebra methods execution of medicament capsule treatment group mice of the present invention on the 15th day 2.3 the mice body is interior, peels off the tumor body, and the survey tumor weighs, and calculates tumour inhibiting rate.

Tumour inhibiting rate (the %)=average tumor of (it is heavy that average tumor is organized in the average tumor weight-treatment of matched group)/matched group heavy * 100%

2.4 the mensuration of increase in life span record normal control group, lotus tumor matched group, medicament capsule treatment group of the present invention low (0.3g/kg), in (0.6g/kg), high dose (1.2g/kg) and palace tumor capsule for eliminating matched group (2.0g/kg) natural law of the existence of 10 mices respectively, observe the animation of tumor-bearing mice, calculate increase in life span.

Increase in life span=(the average natural law of the medication group-average natural law of He tumor the matched group)/average natural law of lotus tumor matched group * 100%

3, experimental result

3.1 medicament capsule of the present invention is lower than model group (P＜0.05) to the inhibitory action medication group shown in table 19 tumor representation work of S180 sarcoma growth in the mice body, illustrates that medicament capsule of the present invention has the effect that suppresses tumor growth.From experiment, observe the many flexible movements of taking food of medication group mice in addition.And lotus tumor control group mice weight increase is slower,, few moving, feed is few.Show that medication group mice upgrowth situation quality of life is better than lotus tumor matched group.

The inhibition effect of table 19 medicament capsule of the present invention to growing in the S180 tumor cell body

3.2 medicament capsule of the present invention is shown in table 20 to the influence of tumor-bearing mice increase in life span, medication group and the lotus tumor matched group natural law of relatively surviving obviously prolongs, both have significant difference (P＜0.01) learn to handle the back by statistics, show that medicament capsule of the present invention can prolong tumor-bearing mice life cycle.In addition, medication group survival condition also is better than lotus tumor matched group.

Table 20 medicament capsule of the present invention is to the influence of tumor-bearing mice increase in life span

4, conclusion medicament capsule of the present invention has a good restraining effect to what grow in the experimental S180 tumor cell body, can prolong tumor-bearing mice life cycle, for its clinical experiment and use provide experimental basis.

Four, acute toxicity testing

Summary is observed the acute toxicity of medicine of the present invention to mice.Mice single gastric infusion does not have death, can't obtain median lethal dose(LD 50), adopts maximum dosage-feeding 80g/kg.d (three times on the 1st filling stomaches) to observe continuously 14 days, do not see dead mouse, generally in order, no abnormal discovery shows that medicine of the present invention is very low to chmice acute toxicity.

1. experiment material

1.1 the animal Kunming mouse, body weight 18～22g.Provide the quality certification number by Animal Experimental Study chamber, Chongqing Institute of Chinese Medicine: SCXK (Chongqing) 20020004.

1.2 medicine medicated powder of the present invention.Wear into fine powder with mortar before the experiment, it is standby to be mixed with suspension with distilled water.

2, method

2.1 measure median lethal dose(LD 50) (LD ₅₀): 40 of female mices, body weight 18～22g is divided into 4 groups (10/group): be respectively medicine 20g/kg.d of the present invention at random ^-1, 22g/kg.d ^-1, 24g/kg.d ^-1, 26g/kg.d ^-1(maximum suspendible concentration), fasting (can't help water) single gastric infusion after 12 hours, each 0.4ml/10g, ordinary circumstance (body weight change, diet, fur, behavior, secretions, Excreta etc.) of observation mice and poisoning, death condition were observed 14 days continuously.

2.2 maximum dosage-feeding experiment: 20 of female mices, body weight 18～22g, administration volume 0.4ml/10g, 80g/kg.d divide gastric infusion three times, observe general activity situation and the death toll of mice, observe continuously 14 days.

3, result

3.1 medicine of the present invention is not seen death during respectively organizing mouse test, (body weight, diet, fur, behavior, secretions, Excreta etc.) can't obtain LD generally in order ₅₀

3.2 adopt maximum dosage-feeding 80g/kg.d (be equivalent to approximately clinical every day of dosage 250 times) to irritate stomach, duration of test mice body weight all increases (seeing Table 21), diet and movable normal, fur is smooth, no abnormality seen secretions such as mouth, nose, eye, only be the brown soft stool after the administration on the 1st day, the urine no abnormality seen.

4. the experiment of conclusion maximum dosage-feeding shows that medicine of the present invention is very low to chmice acute toxicity.

The comparison of table 21 medicine maximum dosage-feeding of the present invention experiment mice body weight

Grouping	Number of animals (only)	Before the administration (g)	1 week (g) after the administration	2 weeks (g) after the administration
Grouping	Number of animals (only)	Before the administration (g)	1 week (g) after the administration	2 weeks (g) after the administration	Preparation of the present invention (80g/kg.d)	20	20.2±1.6	22.8±1.3	24.8±1.2

Five, long term toxicity test

SD rat continuous irrigation stomach gives individual month of capsule 1.94g/kg of the present invention, 9.7g/kg, 19.4g/kg6, observes during the administration and the toxicity in drug withdrawal 2 weeks of convalescent period.Observe diet, activity, body weight, the food ration of rat after the administration every day.In administration 6 months and 2 weeks of drug withdrawal (convalescent period) the results of regular determination animal hematology, serum biochemistry learn, and cut open inspection and histopathological examination.The result shows, medicament capsule 1.94g/kg of the present invention, 9.7g/kg, 19.4g/kg gastric infusion 3 months do not have tangible toxicity to rat.

(1) animal: the SD rat (quality certification number: SCXK (Chongqing): 2002003), rank: cleaning level.Number of animals and sex: 80 of SD rats, female.Body weight: the weight range 220 ± 20g in preceding 1 week of administration.Health status: in preceding 1 week of administration, observe the general situation of rat, no abnormality seen.The raising condition: cleaning level Animal House, 22 ± 3 ℃ of temperature, every cage is raised 5 rats.Feedstuff: cobalt ⁶⁰The radiosterilization rat is used the pellet feeding: freely ingest every day.Drinking water: tap water is after sterilization, and animal freely absorbs from the drinking-water bottle.

(2) grouping and administration: grouping: be divided into 4 groups by 80 rats of body weight, be respectively matched group, capsule of the present invention (high dose group, middle dosage group, low dose group), 20 every group.Group technology: by the balanced grouping of body weight.The administration phase: 6 days weekly, successive administration 6 months.Administering mode: gastric infusion, 20ml/kg, (point in mornings 8) once a day.Convalescent period: after stopping administration, observe once every day, continuous 2 weeks.

(3) dosage: dosage group: low dose group 1.94g/kg (being equivalent to 5 times of clinical consumptions), in dosage group 9.7g/kg (be equivalent to clinical consumption 25 times), high dose group 19.4g/kg (be equivalent to clinical consumption 50 times), the blank group gives with the volume distilled water.Design considerations: capsule mouse stomach of the present invention is not measured mice LD ₅₀, adopt the maximum volume administration.Capsule of the present invention is 0.6g/kg to the effective dose of rat effect.The clinical people who provides according to the developer intends dosage and is 3.6g for each person every day, is calculated as 0.0375g/kg/d by kg body weight.3 months long term toxicity dosages of capsule of the present invention calculate: according to the body surface area conversion, rat dosage is 1.94g/kg, 9.7g/kg, 19.4g/kg, is respectively 5,25,50 times of clinical administration amount.

(4) observed content

The observation of general state: play drug withdrawal convalescent period animal day and finish from buying, observe once every day usually, but during the administration every day observe 2～3 times.The forward and backward whole laboratory animals of administration.

Body weight determination: before the administration, administration begins to finish until drug withdrawal convalescent period, measures body weight weekly 1 time.In addition, before dissection, measure the body weight of animal earlier.All animals before the administration and after the administration.

Food ration is measured: preceding 1 week of administration, administration begin, and until drug withdrawal convalescent period end, measure food ration (24 hours food consumption quantities) 1 time weekly.At 9 o'clock in the morning feedstuff of every cage (5 rats) is taken out on every Tuesdays, and put into 500 gram feedstuffs.Take out every cage (5 rats) residual feed at 9 o'clock in morning Wednesday, and weighing is also calculated average every rat food ration (g/rat/d) every day.All animals before the administration and after the administration.

Blood sampling and sample preparations: 6 months and convalescent period finish after the administration plucks simple eye ball method blood sampling before cuing open inspection at every turn, carries out sample preparations and inspections such as clotting time, hematology, serum biochemistry.

Hematological examination: carry out 11 indexs, leukocyte, erythrocyte, hemoglobin, platelet, reticulocyte, lymphocyte, neutrophil cell, eosinophilic granulocyte, basophilic granulocyte, mononuclear cell, clotting time, hemocyte inspection.

Serum biochemistry is checked: adopt whole blood through centrifugal gained serum, carry out 11 biochemical indicators (AST, ALT, ALP, GLU, BUN, TCHO, TBIL, CRE, TP, ALB, mensuration A/G).

The postmortem test: all experimental group animal (comprising the experimental session dead animal) is cutd open inspection.The postmortem test is carried out during 2 weeks in administration 3 months and drug withdrawal, adopts and cuts off carotid artery sacrificed by exsanguination rat.

Dissect macroscopy and claim organ weights: the when dissected naked eyes examine the ANOMALOUS VARIATIONS of each internal organs and tissue.The organ of weighing: heart, liver, spleen, lung, kidney, brain, adrenal gland, thymus, thyroid (containing parathyroid gland), uterus, ovary, and calculate organ weights coefficient (internal organs weight/body weight * 100%).

Fixing of tissue and organ: fixed histoorgan is as follows: brain, the heart, liver, spleen, lung, kidney, pancreas, adrenal gland, ovary, uterus, thyroid, thymus, lymph node, bladder, breastbone, spinal cord, optic nerve, hypophysis cerebri, esophagus, stomach, duodenum, jejunum, ileum and colon and diseased region etc.

Histopathological examination: internal organs and tissue are through formalin fixed after 12 hours, renew formalin and continue to fix 48 hours, gastric tissue is repaiied piece for repair 4～6 tissues that about 2cm is long respectively along the lesser gastric curvature stringer, comprises cardia, lesser gastric curvature, greater gastric curvature, pylorus, duodenum and glandular stomach.Tissue dewaters through routine, and paraffin embedding is cut 5 μ M thin slices, HE dyeing, light microscopy checking.

(5) result of the test

1. general situation: matched group: in the experimentation of 6 wheat harvesting periods, 20 rats eatings of matched group and activity situation are normal, no abnormal phenomenon.Low dose group (1.94g/kg): in entire test, 20 rats eatings and activity situation are normal, do not find abnormal phenomenas such as breathing, vomiting, sialorrhea, diarrhoea.Middle dosage group (9.7g/kg): only No. 4 rats are found the red secretions of nose during 6 weeks, recover normally voluntarily after three days, and all the other rats are no abnormal.High dose group (19.4g/kg): No. 1 rat the 2nd week after administration is found diarrhoea, recovers normal after two days voluntarily, and other does not all occur unusual.

2. body weight: in entire test, the body weight gain of each administration group rat is all normal.Compare with matched group, do not see notable difference, find the body weight change relevant with medicine.

3. food ration: in entire test, food ration of rat and matched group are not relatively seen notable difference, find the food ration variation relevant with medicine.

4. to hematological influence

Administration hematological examination in 6 months: administration 11 indexs of 6 months hematologys (leukocyte, erythrocyte, hemoglobin, platelet, reticulocyte, lymphocyte, eosinophilic granulocyte, neutrophil cell, basophilic granulocyte, mononuclear cell and clotting time) check result.

Total white blood cells: medicament capsule high dose group total white blood cells of the present invention is 4.68 * 10 ⁹/ L is than matched group 5.67 * 10 ⁹/ L reduces to some extent, but does not have significant difference.

PLT: the platelet count of medicament capsule high dose group of the present invention is 989.64 * 10 ⁹/ L is than matched group 1018.23 * 10 ⁹/ L reduces to some extent, but does not have significant difference; Middle dosage, low dose group and matched group relatively do not have obvious statistical significance.

Other hematological indices, administration group and matched group are not seen obvious significant difference.

Drug withdrawal convalescent period hematological examination: stop 2 weeks after the administration, above-mentioned 11 the index check results of hematology.Administration group and matched group are not seen the difference of statistical significance.

5. to the influence of serum biochemistry

6 months serum biochemistries of administration change: and 11 indexs of 6 months (24 week) of administration inspection serum biochemistry (AST, ALT, ALP, GLU, BUN, TCHO, TBIL, CRE, TP, ALB, A/G).

Na ⁺: the serum N a of medicament capsule high dose of the present invention (19.4g/kg) group ⁺Na for 155.46mmol/L, middle dosage (9.7g/kg) group ⁺Be 152.17mmol/L, increase to some extent than matched group 148.27mmol/L, but do not have significant difference, low dose group and matched group relatively do not have obvious significant difference.

TBLL: the total bilirubin of medicament capsule high dose group of the present invention (19.4g/kg) is 2.47 μ mol/L, is starkly lower than matched group (5.84 μ mol/L, P＜0.05); In, low dose group and matched group no significant difference relatively.

GLU: the blood glucose of medicament capsule low dose group of the present invention (1.94g/kg) is 7.78mmol/L, and apparently higher than matched group 5.86mmol/L (P＜0.05), but middle and high dosage group is not seen significant change.

Other serum biochemistry index, administration group and matched group are not seen notable difference.

The biochemical procuratorial work of drug withdrawal convalescent serum: stop 2 weeks after the administration, check 11 indexs of serum biochemistry (AST, ALT, ALP, GLU, BUN, TCHO, TBIL, CRE, TP, ALB, A/G).

TBLL: medicament capsule high dose group TBLL of the present invention is 6.55 ± 0.93, middle dosage group is 5.51 ± 0.82, all apparently higher than 3.32 ± 0.93 (P＜0.05) than matched group.

TG: medicament capsule high dose group TG content of the present invention is that 1.12mmol/L, middle dosage group are 1.03mmol/L, all a little more than matched group (0.77mmol/L), but does not have significant difference (P＞0.05).

6. system becomes celestial: the tissue of all animals in each stage of when dissected macroscopy (6 months, convalescent period), the abnormal conditions of organ.

6 months systems of administration become celestial:

Matched group: 12 rats are smooth by hair, head organ, perineal position there is no unusually, and macroscopic pathological changes is not all found in the heart, liver, spleen, lung, kidney, adrenal gland, brain, testis, epididymis, prostate, ovary, uterus, thyroid, thymus, mesenteric lymph node, bladder, breastbone, spinal cord, optic nerve, hypophysis cerebri, trachea, stomach, duodenum, jejunum, ileum, colon, thoracic cavity and abdominal cavity.

The blank group: 1 animal sees hepatic cyst in 12 rats, all the other no abnormality seens

High dose group (19.4g/kg): in 12 rats only outside 1 splenomegaly, all the other each internal organs and organize no abnormality seen.

In dosage group (9.7g/kg): in 12 rats outside 2 splenomegalies, all the other each internal organs and organize no abnormality seen.

Low dose group (1.94g/kg): in 12 rats outside the two cyst of kidney of 1 animal, all the other each internal organs and organize no abnormality seen.

Convalescent period, system became celestial

Matched group: 8 rats are smooth by hair, head organ, perineal position there is no unusually, and macroscopic pathological changes is not all found in the heart, liver, spleen, lung, kidney, adrenal gland, brain, ovary, uterus, thyroid, thymus, mesenteric lymph node, bladder, breastbone, spinal cord, optic nerve, hypophysis cerebri, trachea, stomach, duodenum, jejunum, ileum, colon, thoracic cavity and abdominal cavity.

High dose group (19.4g/kg): 8 rats are smooth by hair, head organ, perineal position there is no unusually, and macroscopic pathological changes is not all found in the heart, liver, spleen, lung, kidney, adrenal gland, brain, ovary, uterus, thyroid, thymus, mesenteric lymph node, bladder, breastbone, spinal cord, optic nerve, hypophysis cerebri, trachea, stomach, duodenum, jejunum, ileum, colon, thoracic cavity and abdominal cavity.

Middle dosage group (9.7g/kg): 1 example sees that thymus is less in 8 rats.8 rats are smooth by hair, head organ, perineal position there is no unusually, and the heart, liver, spleen, lung, kidney, adrenal gland, brain, ovary, uterus, thyroid, thymus, mesenteric lymph node, bladder, breastbone, spinal cord, optic nerve, hypophysis cerebri, trachea, duodenum, jejunum, ileum, colon, thoracic cavity and abdominal cavity there is no the naked eyes pathological changes.

Low dose group (1.94g/kg): 8 rats are smooth by hair, head organ, perineal position there is no unusually, and the heart, liver, spleen, lung, kidney, adrenal gland, brain, ovary, uterus, thyroid, thymus, mesenteric lymph node, bladder, breastbone, spinal cord, optic nerve, hypophysis cerebri, trachea, stomach, duodenum, jejunum, ileum, colon, thoracic cavity and abdominal cavity there is no the naked eyes pathological changes.

7. to the influence of organ weights

6 months organ weights of administration change

Spleen: the average spleen weight of dosage group (9.7g/kg) is 1.35 ± 0.69 (g) in the medicament capsule of the present invention, obviously increases (P＜0.05) than matched group 0.63 ± 0.13 (g); High dose group, low dose group and matched group be no significant difference relatively.

Thymus: the average thymic weight of dosage group in the medicament capsule of the present invention (9.7g/kg group) is 0.18g, obviously reduces (P＜0.05) than matched group (0.24g).

Each group of administration is to other internal organs (heart, lung, brain, liver, kidney, adrenal gland, thyroid, uterus, ovary) weight and matched group no significant difference.

Table 22 medicament capsule rat of the present invention long term toxication 12 all organ weights coefficients (Mean ± SD)

The detection of drug withdrawal convalescent period organ weights: 2 weeks of drug withdrawal are respectively organized in medicament capsule administration of the present invention, Rats Organs and Tissues weight and matched group no significant difference.

Table 23 medicament capsule rat long term toxication convalescent period organ weights of the present invention and organ coefficient (Mean ± SD)

(6) 6 months toxic actions of medicine medication of the present invention to the SD rat

1. to the influence of food ration and body weight gain: rat was irritated stomach medicament capsule 1.94g/kg of the present invention, 9.7g/kg, 19.4g/kg respectively continuous 6 months, its body weight gain rate and food ration and blank group relatively there is no notable difference, illustrate medicament capsule of the present invention in 1.94g～19.4g/kg scope to ingest and body weight gain do not have obvious influence.

2. to hematological influence: in 11 indexs of hematology (leukocyte, erythrocyte, hemoglobin, platelet, reticulocyte, lymphocyte, neutrophil cell, eosinophilic granulocyte, basophilic granulocyte, mononuclear cell and clotting time) check result of administration 6 months (24 week) be analyzed as follows:

3. to serological influence: GLU: in 24 weeks of administration, the blood glucose of medicament capsule low dose group of the present invention is 7.78mmol/L, obviously raises than matched group 5.86mmol/L; And medicament capsule high dose group of the present invention, middle dosage group and the equal no significant difference of blank infer that the rising of low dose group blood glucose may be excessive relevant with individual animal appetite, and do not see rising in drug withdrawal convalescent period, so the non-drug-induced of supposition.

4. to the influence of organ weights: in 24 weeks of administration, the weight 1.35g of dosage group spleen obviously increases than matched group 0.63g in the medicament capsule of the present invention; The weight of thymus internal organs is 0.18g, obviously reduce than matched group 0.24g, but high dose group spleen and thymus is not found significant change.Convalescent period each administration group and the blank group relatively, each organ index there is no significant difference.Prompting, the toxicity of the variation of dosage group spleen and thymic weight and medicine relation is little in the medicament capsule of the present invention.

5. to histopathologic influence: medication 6 months, high, middle dosage group as seen: a little steatosis of hepatic tissue and hydropic degeneration take place in A, minority animal, see the chronic inflammation cellular infiltration between hepatic tissue in the matter.The slight chronic inflammatory disease of trachea, bronchial mucosa and alveolar takes place and changes in B, minority animal.C, individual animal lymph node, intestinal mucosa, cervix uteri and bladder have inflammatory activity.These changes are similar to matched group, all belong to the common pathological changes of secondary animal, and are little with the toxicity relation of medicine.Convalescent period is not seen special change.

(7) conclusion: rat oral gavage gives medicament capsule 1.94g/kg of the present invention, 9.7g/kg and 19.4g/kg, (be equivalent to respectively clinical consumption 5,25,50 times), continuous 6 months toxicity research result shows that this product is not seen overt toxicity to major organs with organizing.

Six, clinical data

(1) clinical practice of decoction

1, is used for gynecological inflammation

(1) physical data: decoction of the present invention is tried out among the people, and through compiling with these prescription therapeutic gynecological inflammation 60 examples, wherein minimal ages is 20 years old, maximum 65 years old age; Disease time is the shortest 3 days, and is the longest 5 years; Vaginitis 24 examples wherein, cervicitis 14 examples, pelvic inflammatory disease 16 examples, adnexitis 6 examples, wherein sick urine retention 3 examples, secondary prostate the infected 6 examples sent out.

(2) Therapeutic Method: this organizes 60 examples is main formula with decoct of the present invention all.Prescription is formed: Herba Solani Lyrati 15g, Herba Hedyotidis Diffusae 15g, Herba Melastomatis dodecandri 12g, Herba Hyperici Japonici 10g, Herba Duchesneae Indicae 10g, Herba Centellae 10g, Herba Solidaginis 15g, the 10g of Semen Trichosanthis Cucumeroidis, Herba Bidentis Bipinnatae 10g.Usage is a decocting, divides clothes 3 times 1 dose of every day, takes for 2 weeks continuously.

(3) therapeutic outcome: among the 60 routine patients, cure 16, produce effects 22 examples, effective 18 examples, invalid 4 examples.This treatment total effective rate is 93.3%, and curative effect is comparatively satisfied, illustrates that prescription of the present invention has good exploitation and is worth.

2, be used for gynecological's reproductive tract tumor

(1) physical data: decoction of the present invention is tried out among the people, and through compiling with these prescription therapeutic gynecological reproductive tract tumor 24 examples, wherein minimal ages is 32 years old, maximum 65 years old age; Disease time is the shortest 1 year, and is the longest 8 years; Hysteromyoma 10 examples wherein, cervical cancer 5 examples, inflammatory masses of pelvic cavity 9 examples.

(2) Therapeutic Method: this organizes 24 examples is main formula with decoct of the present invention all.Herba Solani Lyrati 30g, Herba Hedyotidis Diffusae 30g, Herba Melastomatis dodecandri 24g, Herba Duchesneae Indicae 20g, Herba Hyperici Japonici 10g, Herba Centellae 10g, Herba Solidaginis 10g, the 10g of Semen Trichosanthis Cucumeroidis, Herba Bidentis Bipinnatae 10g.Usage is a decocting, divides clothes 3 times 1 dose of every day, takes continuously 1 month.

(3) therapeutic outcome: among the 24 routine patients, cure 4, produce effects 7 examples, effective 10 examples, invalid 3 examples.This treatment total effective rate is 87.5%, and curative effect is comparatively satisfied, illustrates that prescription of the present invention has good exploitation and is worth.

(2) preparation clinical practice

1, medicine of the present invention is in the clinical practice of gynecological inflammation

1.1 the clinical data selection of clinical is diagnosed as women genitals inflammation, has the case such as leukorrheal diseases, menoxenia, dysmenorrhea, mass in the abdomen of TCM Gynecology again.

1.1.1 case situation: observe clinical 100 routine patients, wherein pelvic inflammatory disease 28 examples, adnexitis 18 examples, endometritis 12 examples, cervicitis 10 examples, the other cellulites in palace 10 examples, vaginitis 22 examples; By traditional Chinese medical science typing is to invade type 26 examples, noxious dampness stasis of blood junction type 38 examples, ascites of liver meridian damp-heat type 20 examples, Liver and kidney deficiency 16 examples in damp and hot; Minimum 20 years old of patient, maximum 65 years old, 48 examples (accounting for 48%) were arranged in 25～35 years old, less than 16 examples (accounting for 16%) were arranged in 25 years old, 36 examples (accounting for 36%) are arranged greater than 35 years old, as seen, women's internal reproductive organ inflammation frequently-occurring disease is between 25～35 years old.

1.1.2 the course of disease: the shortest 1 day, the longest 10 years, some months occupied the majority to several years, do not do the special for treating except that 44 examples in the case, all the other 56 examples were all done treatment, were that main treatment person and treatment by Chinese herbs are main person approximately each half with Western medicine wherein, groups of people are effective, but the relapse rate height.

1.1.3 clinical symptoms: 100 routine patients all have tangible clinical symptoms and sign.

1.2 diagnostic criteria and tcm syndrome differentiation and typing

There is the leucorrhea with red and white discharge amount many 1.2.1 diagnostic criteria (1) is all, the pruritus vulvae redness, hypogastric region one or both sides pain, companion's lumbago or Yao Di Acid weigh down symptoms such as pain, and increase the weight of after be everlasting fatigue or the sexual intercourse and before and after the menstruation; Or menoxenia; Or with the infertility history.(2) 1. adnexitis of gynecologial examination: the one or both sides adnexa increases thick thickening, and tenderness is arranged.2. the other cellulites in palace: bilateral adnexa and uterus are no abnormal, only are that other connective tissue one side in uterus or two sides thicken or streakly increase thick and tenderness is arranged.3. pelvic inflammatory disease: uterus position is the position, back mostly, and limitation of activity or fixing, both sides adnexa increase thick or be streak, and tenderness is arranged.4. endometritis: miscarriage history or BH are arranged, and there is tenderness in the uterus during inspection, and limitation of activity.5. cervicitis: visible cervix uteri has rotten to the corn district of shiny red fine grained and neck tube secretion mycopus sample leucorrhea, the contrafluxion of then cervix uteri, the hypertrophy that have.6. vaginitis: the visible down a small amount of epithelial cell of mirror mainly is outward pus cell and assorted bacterium.

Invade type in 1.2.2 tcm syndrome differentiation and typing (1) is damp and hot: this type has hypogastralgia, or expands, or full, profuse leukorrhea, and thick, the frowziness of yellow skin matter, or preceeded menorrhea, the amount polychrome is scarlet, dysmenorrhea etc., yellowish or reddish urine or heating is arranged, red tongue greasy fur Huang, slippery and rapid pulse.(2) noxious dampness stasis of blood junction type: this type has few abdomen and waist and sacrum pain and expands, and few abdomen has enclosed mass, and profuse leukorrhea, yellow skin are smelt dirty or companion's menorrhagia, menostaxis, dysmenorrhea etc., yellowish or reddish urine, red tongue thick, yellow and greasy fur, arteries and veins flood or sliding number.(3) ascites of liver meridian damp-heat type: this type has few abdomen one or both sides distending pain, does not with the passing of time heal, and time ends when sending out, and is obvious with midcycle or premenstrua distending pain, companion's menstruation irregularly successively, how many amounts differs, through the fore udder distending pain etc., wiry and frequent pulse.(4) Liver and kidney deficiency: this type has the stomachache soreness of waist, and the rare color of leukorrhagia matter in vain, is not with the passing of time not breathed hard a little less than the companion body, and is dizzy refreshing tired, anorexia loose stool, clear urine in large amounts, soreness of the loins and weakness of the limbs, deep and weak pulse.

1.3 the oral medicament capsule of the present invention of Therapeutic Method, usage be one time 2～4,3 times on the one.To take medicine 7 is a course of treatment, serve on 2～3 courses of treatment in case of necessity.

1.4 curative effect judging standard

1.4.1 clinical cure: clinical symptoms all disappears, gynecological's pelvioscopy (as tenderness, adnexa thicken, metrosynizesis fixes the inflammation enclosed mass) all disappear.

1.4.2 produce effects: clinical symptoms is obviously improved, gynecological's pelvioscopy (as tenderness, adnexa thicken, metrosynizesis fixes the inflammation enclosed mass) obviously improve or dwindle.

1.4.3 effectively: clinical symptoms has improvement, gynecological's pelvioscopy (as tenderness, adnexa thicken, metrosynizesis fixes the inflammation enclosed mass) make moderate progress or dwindle.

1.4.4 invalid: clinical symptoms and sign all do not have the changer.

1.5 therapeutic outcome result: 24 examples of fully recovering, produce effects 38 examples, effective 32 examples, invalid 6 examples, total effective rate 94.0%.

1.5.1 invade type 26 examples in Chinese medical discrimination typing and therapeutic effect relationship are damp and hot: 6 examples of fully recovering, produce effects 11 examples, effective 8 examples, invalid 1 example, total effective rate 100%.Noxious dampness stasis of blood junction type 38 examples: 11 examples of fully recovering, produce effects 18 examples, effective 9 examples, invalid 0 example, total effective rate 100%.Ascites of liver meridian damp-heat type 20 examples: 5 examples of fully recovering, produce effects 7 examples, effective 7 examples, invalid 1 example, total effective rate 91.7%.Liver and kidney deficiency 16 examples: 2 examples of fully recovering, produce effects 2 examples, effective 8 examples, invalid 4 examples, total effective rate 87.5%.

Table 25 traditional Chinese medical science typing efficacy result

1.5.2 inflammation is sick plant with curative effect concern adnexitis 18 examples: 5 examples of fully recovering, produce effects 7 examples, effective 5 examples, invalid 1 example, total effective rate 94.4%.The other cellulites in palace 10 examples: 4 examples of fully recovering, produce effects 4 examples, effective 2 examples, invalid 0 example, total effective rate 100%.Pelvic inflammatory disease 28 examples: 7 examples of fully recovering, produce effects 12 examples, effective 8 examples, invalid 1 example, total effective rate 96.4%.Endometritis 12 examples: 4 examples of fully recovering, produce effects 4 examples, effective 4 examples, invalid 0 example, total effective rate 100%.Cervicitis 10 examples: 2 examples of fully recovering, produce effects 3 examples, effective 4 examples, invalid 1 example, total effective rate 90.0%.Vaginitis 22 examples: 2 examples of fully recovering, produce effects 8 examples, effective 9 examples, invalid 3 examples, total effective rate 86.4%.

Table 26 disease efficacy result

1.6 untoward reaction 100 routine patient's period in a medicine all find no any toxic reaction or side effect, illustrate that medicament capsule of the present invention is treatment women genitals inflammation safe and effective medicine, the no obvious toxic-side effects patient's period in a medicine of safety all finds no any toxic reaction or side effect.

2, medicine of the present invention is in the clinical practice of gynecological's genital organ tumor

2.1 clinical data 30 routine patients, 26～51 years old age, average 34 years old, unmarried's 6 examples, the married's 24 examples are the course of disease the shortest half a year, the longest 5 years.

2.2 diagnostic criteria is with reference to " guideline of treatment by Chinese herbs hysteromyoma ", the diagnostic criteria of lump in the abdomen in relevant female reproductive system tumor and " Gynecology of Chinese Medicine " the 6th edition in " obstetrics and gynecology " the 5th edition.

2.2.1 Western medicine diagnose standard: comprehensive clinical symptoms, gynecologial examination and more than twice, the B ultrasonic clinical diagnosis is uterus intermural myoma or Subserous myoma.

2.2.2 Chinese medical discrimination standard: the hypogastric region enclosed mass, to fix and do not move, lower abdomen waist sacrum weighs down the dull pain that expands, leucorrhoea grow in quantity, yellow skin has abnormal flavour, menorrhagia or menostaxis, scarlet or dark red through color, abdominal pain in menstruation increases the weight of, yellowish urine, dimly red tongue, there is the ecchymosis point on the limit, the Sublingual meridians increase thick growth, and tongue is white thick or yellow greasy, rapid pulse or sliding number.

2.3 the oral medicament capsule of the present invention of Therapeutic Method, each 2～grain, every day 3 times.To take medicine 30 days is a course of treatment, serve on 2～3 courses of treatment in case of necessity.

2.4 observation index:

2.4.1 symptom: observe the bob of lower abdomen sacrum by integration method and expand, lower abdomen dull pain, menorrhagia, menostaxis, the leucorrhea yellow skin, Sublingual meridians etc. are respectively at the change situation that observes the symptoms before and after the treatment.

2.4.2B over-extraction is decided the machine method with deciding the people: measure muscular tumor size and uterine volume in clean 1 week of menstruation, all by irregular oval calculating, multiple myomata calculates by a plurality of muscular tumor volume sums for both.

2.4.3 lab testing; Measure blood, routine urinalysis before and after the treatment, liver, renal function, gonadal hormone, hemorheology, indexs such as insulin like growth factor, minute all carried out in the clean back of menstruation on the 3rd～5 day.

2.4.4 untoward reaction: patient's untoward reaction and persistent period etc. during the observation medication.

2.5, curative effect determinate standard:

Symptom integral changes: recovery from illness: transference cure, and menstruation (amount, cycle) recovers normal: produce effects: symptom integral descends＞2/3 before the treatment; Effectively: symptom integral descends 1/3～2/3 before the treatment; Invalid: symptom integral descends less than 1/3 before the treatment

Tumor body size variation: recovery from illness: the ultrasound diagnosis muscular tumor disappears, and the uterus size recovers normal; Produce effects: ultrasound diagnosis muscular tumor volume-diminished is more than 1/2; Effectively: ultrasound diagnosis muscular tumor volume-diminished 1/4～1/2; Invalid: ultrasound diagnosis muscular tumor volume-diminished, less than 1/4

Improve clinical symptoms: adopt the symptom integral method to collect the clinicing symptom observation sagging distention in the smaller abdomen, lower abdomen dull pain, menorrhagia, menostaxis, leucorrhea yellow skin, the light and heavy degree of Sublingual meridians etc., symptom obviously and longer duration influence the meter 3 minutes of work, and the meter 2 minutes of work is lacked and do not influenced to the persistent period, the lighter meter of symptom 1 minute, the doing well,improving situation of observing observation group and matched group before and after the treatment.

2.6 therapeutic outcome:

Result: treat 30 examples, 4 examples of wherein fully recovering, produce effects 12 examples, effective 10 examples, invalid 4 examples, total effective rate 86.7%.

The clinical total effects result of table 27 medicament capsule of the present invention

2.6.1 the improvement of tcm symptom is more obvious.

Menostaxis 9 examples, aldehyde is 3 examples more, produce effects 2 examples, effective 3 examples, invalid 1 example, total effective rate 88.9%; Menorrhagia 12 examples, aldehyde is 5 examples more, produce effects 4 examples, effective 1 example, invalid 2 examples, total effective rate 83.3%; Sagging distention in the smaller abdomen 5 examples, aldehyde is 2 examples more, produce effects 1 example, effective 1 example, invalid 1 example, total effective rate 80.0%; Lower abdomen dull pain 12 examples, aldehyde is 2 examples more, produce effects 4 examples, effective 2 examples, invalid 4 examples, total effective rate 66.7%; Leucorrhea yellow skin 20 examples, aldehyde is 9 examples more, produce effects 6 examples, effective 2 examples, invalid 3 examples, total effective rate 85.0%; Sublingual meridians 19 examples, aldehyde is 7 examples more, produce effects 5 examples, effective 3 examples, invalid 4 examples, total effective rate 79.0%;

Table 28 treatment back tcm symptom curative effect compares:

Tcm symptom	Menostaxis	Menorrhagia	Sagging distention in the smaller abdomen	Lower abdomen dull pain	The leucorrhea yellow skin	The Sublingual meridians
Tcm symptom	Menostaxis	Menorrhagia	Sagging distention in the smaller abdomen	Lower abdomen dull pain	The leucorrhea yellow skin	The Sublingual meridians	The example number	9 examples	12 examples	5 examples	12 examples	20 examples	19 examples
Recovery from illness	3 examples (33.3%)	5 examples (41.7%)	2 examples (40.0%)	2 examples (16.7%)	9 examples (45.0%)	7 examples (36.8%)	The example number	9 examples	12 examples	5 examples	12 examples	20 examples	19 examples
Recovery from illness	3 examples (33.3%)	5 examples (41.7%)	2 examples (40.0%)	2 examples (16.7%)	9 examples (45.0%)	7 examples (36.8%)	Produce effects	2 examples (22.2%)	4 examples (33.3%)	1 example (20.0%)	4 examples (33.3%)	6 examples (30.0%)	5 examples (26.3%)
Effectively	3 examples (33.3%)	1 example (8.3%)	1 example (20.0%)	2 examples (16.7%)	2 examples (10.0%)	3 examples (15.8%)	Produce effects	2 examples (22.2%)	4 examples (33.3%)	1 example (20.0%)	4 examples (33.3%)	6 examples (30.0%)	5 examples (26.3%)
Effectively	3 examples (33.3%)	1 example (8.3%)	1 example (20.0%)	2 examples (16.7%)	2 examples (10.0%)	3 examples (15.8%)	Invalid	1 example (11.1%)	2 examples (16.7%)	1 example (20.0%)	4 examples (33.3%)	3 examples (15.0%)	4 examples (21.1%)
Total effective rate	8 examples (88.9%)	10 examples (83.3%)	4 examples (80.0%)	8 examples (66.7%)	17 examples (85.0%)	15 examples (79.0%)	Invalid	1 example (11.1%)	2 examples (16.7%)	1 example (20.0%)	4 examples (33.3%)	3 examples (15.0%)	4 examples (21.1%)

2.6.2 the efficacy analysis to hysteromyoma: check muscular tumor size and body of uterus volume in clean 1 week of menstruation, the result shows that this product has obvious effect to dwindling the muscular tumor volume.Treat 30 examples, 4 examples of wherein fully recovering, produce effects 12 examples, effective 10 examples, invalid 4 examples, total effective rate 86.7%.

Tumor body size variation before and after table 29 treatment

	The example number	Muscular tumor size (cm)	Uterine volume
	The example number	Muscular tumor size (cm)	Uterine volume	Before the treatment	30 examples	4.33±0.78	18.42±1.13
After the treatment	30 examples	2.42±0.39	14.48±0.86	Before the treatment	30 examples	4.33±0.78	18.42±1.13

2.6.3 the influence to hemorheology: the state dense, that glue, gather, coagulate slow, blood of blood flow is to cause thrombotic principal element in the blood vessel.That the traditional Chinese medical science is thought is damp and hot, the stagnation of QI all can cause blood stasis.This product can be improved the microcirculation of the damp and hot stasis of blood junction type of hysteromyoma, improves hemorheology and learns, and alleviates the blood adhesive aggregation state, thereby muscular tumor is dwindled.

The hemorheology index changes before and after table 30 treatment

Hemorheology is learned index	Before the treatment	After the treatment
Hemorheology is learned index	Before the treatment	After the treatment	The low value of cutting whole blood viscosity ratio	8.36±1.46	7.13±1.08
The high value of cutting whole blood viscosity ratio	6.12±0.86	5.56±0.63	The low value of cutting whole blood viscosity ratio	8.36±1.46	7.13±1.08
The high value of cutting whole blood viscosity ratio	6.12±0.86	5.56±0.63	The plasma viscosity ratio	1.86±0.68	1.81±0.58
The hemocyte aggregate index	1.48±0.21	1.34±0.15	The plasma viscosity ratio	1.86±0.68	1.81±0.58
The hemocyte aggregate index	1.48±0.21	1.34±0.15	Packed cell volume	0.44±0.12	0.41±0.08

2.7 untoward reaction 30 routine patient's period in a medicine all find no any toxic reaction or side effect, illustrate that medicament capsule of the present invention is treatment women genitals inflammation safe and effective medicine, the no obvious toxic-side effects patient's period in a medicine of safety all finds no any toxic reaction or side effect.

3, conclusion

3.1 medicine of the present invention is a principal agent with Miao ethnic group's traditional herbal medicine Herba Solani Lyrati, Herba Hedyotidis Diffusae etc., and utilization modern science means are extracted refining forming.Have heat-clearing and toxic substances removing, blood stasis-eliminating and stagnation-dissipating, eliminating carbuncle pain relieving effect.

3.2 pharmacodynamic experiment proves this medicine to the female genital tract common pathogen, as golden Portugal bacterium, escherichia coli, Pseudomonas aeruginosa, group B streptococcus, novel candidiasis, Candida albicans etc. antibacterial action is arranged.Clinical have better therapeutic effect to acute bladder class, urinary tract infection, urgent, chronic nephropyeltis, urethritis, prostatitis.

3.3 this medicine decoction is cured produce effects totally 38 examples after being used for 60 example urine gynecological inflammation patient treatments, accounts for 63.3%; Effective 18 examples account for 30%, and total effective rate reaches 93.3%.Illustrate that medicine of the present invention is the medicine that the treatment gynecological inflammation has good result.

3.4 this medicine decoction is cured produce effects totally 11 examples after being used for the reproductive tract tumor patient treatment of 24 routine gynecological, accounts for 45.8%; Effective 10 examples account for 41.7%, and total effective rate reaches 87.5%.Illustrate that medicine of the present invention is the medicine that treatment gynecological reproductive tract tumor has good result.

3.5 with medicine of the present invention (capsule) treatment 100 routine gynecological inflammation patients, the result: the recovery from illness produce effects is totally 62 examples, accounts for 62.0%, and effective 32 examples account for 32.0%, total effective rate 94.0%.Illustrate that medicine of the present invention has good effect to the treatment gynecological inflammation, compare that clinical efficacy is close, no significant difference with decoction.

3.6 with medicine of the present invention (capsule) treatment 30 routine hysteromyoma of gynecology patients, the result: the recovery from illness produce effects is totally 16 examples, accounts for 53.3%, and effective 10 examples account for 33.3%, total effective rate 86.7%.Illustrate that medicine of the present invention has good effect to the treatment hysteromyoma of gynecology, compare that clinical efficacy is close, no significant difference with decoction.

3.7 this medicine all has no adverse reaction in treatment 214 routine patients, illustrates that this medicine is safe.

3.8 medicine of the present invention is the active drug of treatment gynecological's section's genital disease and urncus tumor, especially better to female pelvic inflammation, adnexitis, endometritis, the other cellulites in palace, hysteromyoma and inflammatory masses of pelvic cavity curative effect, simultaneously cervicitis, vaginitis and ovarian cyst, cervical cancer etc. also there is certain curative effect, and take safety, have no side effect, utilization is worthy to be popularized.

Compared with prior art, medicine of the present invention has heat-clearing and toxic substances removing, blood stasis-eliminating and stagnation-dissipating, eliminating carbuncle analgesic effect, gynecological inflammation due to not only damp and hot noxious dampness, the phlegm-damp stasis of blood being tied, hysteromyoma, cervical cancer, ovarian cyst, inflammatory masses of pelvic cavity etc. have good curative effect, and can prevent that it from showing effect repeatedly, no obvious toxic-side effects can not produce drug resistance, be a kind of safe, effective, quality controllable new Chinese medicine, have good social value and economic worth.

The specific embodiment

Embodiment 1: Herba Solani Lyrati 300g, Herba Hedyotidis Diffusae 300g, Herba Melastomatis dodecandri 240g, Herba Duchesneae Indicae 200g, Herba Hyperici Japonici 100g, Herba Centellae 100g, Herba Solidaginis 100g, the 100g of Semen Trichosanthis Cucumeroidis, Herba Bidentis Bipinnatae 100g.

Get above nine flavor medical materials, add 2 times of water gagings and decoct 2 times, decocted 2 hours at every turn, merge medicinal liquid, left standstill 24 hours, filter, filtrate is concentrated into the extractum that relative density is 1.25 (60 ℃), adds starch 100g, mixing, dry (60 ℃), pulverize, cross 40 mesh sieves, incapsulate, make 1000, promptly get capsule.Specification: every dress 0.3g; Usage and dosage: oral, one time 2～4,3 times on the one.

Embodiment 2: Herba Solani Lyrati 450g, Herba Hedyotidis Diffusae 450g, Herba Melastomatis dodecandri 360g.

Get above three flavor medical materials, decoct with water 3 times, decocted 2 hours at every turn, merge medicinal liquid, left standstill 24 hours, filter, filtrate is concentrated into the extractum that relative density is 1.25 (60 ℃), adds starch 100g and dextrin 50g, mixing, granulate 60 ℃ of dryings, granulate, add magnesium stearate 5g, mixing is pressed into 1000, the bag film-coat promptly gets tablet.Specification: every heavy 0.3g; Usage and dosage: oral, one time 2～4,3 times on the one.

Embodiment 3: Herba Solani Lyrati 300g, Herba Hedyotidis Diffusae 300g, Herba Melastomatis dodecandri 240g, Herba Hyperici Japonici 100g, Herba Duchesneae Indicae 250g, Herba Centellae 100g.

Get above six and hide medical material, decoct with water 4 times, decocted 1 hour at every turn, merge medicinal liquid, left standstill 24 hours, and filtered, filtrate is concentrated into the extractum that relative density is 1.25 (60 ℃), adds dextrin 850g (or dextrin 250g, sucrose 600g), mixing is made granule 1000g, and drying promptly gets granule.Specification: every packed 5g; Usage and dosage: oral, one time 1 bag, 3 times on the one.

Embodiment 4: Herba Solani Lyrati 400g, Herba Hedyotidis Diffusae 400g, Herba Melastomatis dodecandri 240g, Herba Duchesneae Indicae 100g, Herba Hyperici Japonici 80g, Herba Centellae 80g, Herba Solidaginis 80g, the 80g of Semen Trichosanthis Cucumeroidis, Herba Bidentis Bipinnatae 80g.

Get above nine flavor medical materials, decoct with water 3 hours, medicinal liquid left standstill 24 hours, filtered, and filtrate is concentrated into the extractum that relative density is 1.25 (60 ℃), and dry (60 ℃) are pulverized, and cross 120 mesh sieves, extract powder.Other gets soybean oil 144g and Cera Flava 6g, in 80 ℃ of heating and meltings, be chilled to room temperature after, add above-mentioned extract powder, through the colloid mill mix homogeneously, 1000 soft capsules are made in fill, the setting, drying promptly gets soft capsule of the present invention.Specification: every dress 0.3g; Usage and dosage: oral, one time 2～4,3 times on the one.

Embodiment 5: Herba Solani Lyrati 150g, Herba Hedyotidis Diffusae 150g, Herba Melastomatis dodecandri 120g, Herba Hyperici Japonici 100g, Herba Duchesneae Indicae 100g, Herba Centellae 100g.

Get above Six-element medical material, decoct with water 3 times, decocted 1 hour at every turn, filter, filtrate is concentrated into the extractum that relative density is 1.25 (60 ℃), adds ethanol and makes and contain the alcohol amount and reach 50%, shake up, left standstill 24 hours, filter, filtrate recycling ethanol also is concentrated into about 900ml, filters, and adds simple syrup 100g, aspartame 1g, sodium benzoate 2g, essence 2ml, add water to 1000ml, stir evenly, filter, fill promptly gets oral agents of the present invention.Specification: every bottled 10ml; Usage and dosage: oral, a 10ml, 3 times on the one.

Embodiment 6: Herba Solani Lyrati 400g, Herba Hedyotidis Diffusae 400g, Herba Melastomatis dodecandri 460g.

Get above three flavor medical materials, decoct with water 2 times, decocted 3 hours at every turn, filter, filtrate is concentrated into the extractum that relative density is 1.25 (60 ℃), add starch 150g, mixing, vacuum (60 ℃) drying is pulverized, cross 40 mesh sieves, incapsulate, make 1000, promptly get capsule of the present invention.Specification: every dress 0.3g; Usage and dosage: oral, one time 2～4,3 times on the one.

Embodiment 7: Herba Solani Lyrati 35g, Herba Hedyotidis Diffusae 35g, Herba Melastomatis dodecandri 14g

Get above three flavor medical materials, add decocting according to a conventional method and become decoction to take.Usage and dosage: 1 dose of every day, divide clothes 3 times.

Embodiment 8: Herba Solani Lyrati 20g, Herba Hedyotidis Diffusae 20g, Herba Melastomatis dodecandri 18g, Herba Duchesneae Indicae 15g, Herba Hyperici Japonici 10g, Herba Centellae 10g.

Get above Six-element medical material, add decocting according to a conventional method and become decoction to take.Usage and dosage: 1 dose of every day, divide clothes 3 times.

Embodiment 9: Herba Solani Lyrati 15g, Herba Hedyotidis Diffusae 15g, Herba Melastomatis dodecandri 12g, Herba Duchesneae Indicae 10g, Herba Hyperici Japonici 10g, Herba Centellae 10g, Herba Solidaginis 15g, the 10g of Semen Trichosanthis Cucumeroidis, Herba Bidentis Bipinnatae 10g.

Get above nine flavor medical materials, add decocting according to a conventional method and become decoction to take.Usage and dosage: 1 dose of every day, divide clothes 3 times.

Embodiment 10: Herba Solani Lyrati 120g, Herba Hedyotidis Diffusae 120g, Herba Melastomatis dodecandri 96g

Get above three flavor medical materials, decoct with water 3 times, decocted 1 hour at every turn, filter, filtrate is concentrated into the extractum that relative density is 1.25 (60 ℃), adds ethanol and makes and contain the alcohol amount and reach 60%, shakes up, and leaves standstill 48 hours, get supernatant and reclaim ethanol and be concentrated in right amount, be cooled to 70 ℃, standby; Taking polyethylene glycol (6000) 800g heat fused is cooled to 70 ℃ in addition.Above-mentioned medicinal liquid is slowly added in the Polyethylene Glycol (6000), and mixing splashes into molding in the dimethicone, removes surperficial oil stain, makes 1000, promptly gets drop pill of the present invention.Specification: the heavy 50mg of every ball; Usage and dosage: oral, one time 10,3 times on the one.

Embodiment 11: Herba Solani Lyrati 360g, Herba Hedyotidis Diffusae 360g, Herba Melastomatis dodecandri 288g, Herba Duchesneae Indicae 240g, Herba Hyperici Japonici 120g, Herba Centellae 120g, Herba Solidaginis 120g, the 120g of Semen Trichosanthis Cucumeroidis, Herba Bidentis Bipinnatae 120g.

Get above nine flavor medical materials, decoct with water 2 times, decocted 2 hours at every turn, merge medicinal liquid, left standstill 24 hours, filter, filtrate is concentrated into the extractum that relative density is 1.25 (60 ℃), adds starch 100g, mixing, dry (60 ℃), pulverize, cross 40 mesh sieves, incapsulate, make 1000, promptly get capsule of the present invention.Specification: every dress 0.4g; Usage and dosage: oral, one time 3,3 times on the one.

Embodiment 12: Herba Solani Lyrati 600g, Herba Hedyotidis Diffusae 600g, Herba Melastomatis dodecandri 480g, Herba Duchesneae Indicae 400g, Herba Hyperici Japonici 200g, Herba Centellae 200g, Herba Solidaginis 200g, the 200g of Semen Trichosanthis Cucumeroidis, Herba Bidentis Bipinnatae 200g.

Get above nine flavor medical materials, decoct with water 3 times, decocted 1 hour at every turn, filter, filtrate is concentrated into the extractum that relative density is 1.25 (60 ℃), adds ethanol and makes and contain the alcohol amount and reach 60%, shake up, left standstill 48 hours, and filtered, get supernatant and reclaim ethanol and be concentrated into the extractum that relative density is 1.25 (60 ℃), dry (60 ℃), pulverize, cross 120 mesh sieves, get extract powder.Other gets soybean oil 290g and Cera Flava 10g, in 80 ℃ of heating and meltings, be chilled to room temperature after, add above-mentioned extract powder, through the colloid mill mix homogeneously, 1000 soft capsules are made in fill, the setting, drying promptly gets soft capsule of the present invention.Specification: every dress 0.5g; Usage and dosage: oral, one time 2,3 times on the one.

Claims

1. pharmaceutical preparation for the treatment of gynecological inflammation and hysteromyoma is characterized in that: it mainly is to be made by the crude drug of following weight ratio example: Herba Solani Lyrati 20%～50%, Herba Hedyotidis Diffusae 20%～50% and Herba Melastomatis dodecandri 15～40%.

2. according to the pharmaceutical preparation of described treatment gynecological inflammation of claim 1 and hysteromyoma, it is characterized in that: the part by weight of described crude drug is: Herba Solani Lyrati 35.7%, Herba Hedyotidis Diffusae 35.7% and Herba Melastomatis dodecandri 28.6%.

3. treat the preparation method of the pharmaceutical preparation of gynecological inflammation and hysteromyoma as claimed in claim 1 or 2, it is characterized in that: get Herba Solani Lyrati, Herba Hedyotidis Diffusae and Herba Melastomatis dodecandri, adding 6～10 times of water gagings decocts 1～4 time, the each decoction 1～4 hour, filter, it is 1.25 extractum that filtrate is concentrated into 60 ℃ of relative densities, promptly gets the active component of medicine of the present invention.

4. according to the pharmaceutical preparation of described treatment gynecological inflammation of claim 1 and hysteromyoma, it is characterized in that: wherein crude drug also has Herba Hyperici Japonici, Herba Duchesneae Indicae and Herba Centellae, and the part by weight of each crude drug is: Herba Solani Lyrati 15%～35%, Herba Hedyotidis Diffusae 15%～35%, Herba Melastomatis dodecandri 10～30%, Herba Hyperici Japonici 5%～15%, Herba Duchesneae Indicae 10～30% and Herba Centellae 5%～15%.

5. according to the pharmaceutical preparation of described treatment gynecological inflammation of claim 4 and hysteromyoma, it is characterized in that: the part by weight of described crude drug is: Herba Solani Lyrati 23.2%, Herba Hedyotidis Diffusae 23.2%, Herba Melastomatis dodecandri 18.6%, Herba Hyperici Japonici 7.8%, Herba Duchesneae Indicae 19.4% and Herba Centellae 7.8%.

6. as the preparation method of the pharmaceutical preparation of treatment gynecological inflammation as described in claim 4 or 5 and hysteromyoma, it is characterized in that: get Herba Solani Lyrati, Herba Hedyotidis Diffusae, Herba Hyperici Japonici, Herba Duchesneae Indicae and Herba Centellae, adding 6～10 times of water gagings decocts 1～4 time, the each decoction 1～4 hour, filter, it is 1.25 extractum that filtrate is concentrated into 60 ℃ of relative densities, promptly gets the active component of medicine of the present invention.

7. according to the pharmaceutical preparation of described treatment gynecological inflammation of claim 4 and hysteromyoma, it is characterized in that: wherein crude drug also has Herba Solidaginis, Semen Trichosanthis Cucumeroidis and Herba Bidentis Bipinnatae, and the part by weight of each crude drug is: Herba Solani Lyrati 10%～30%, Herba Hedyotidis Diffusae 10%～30%, Herba Melastomatis dodecandri 10～25%, Herba Duchesneae Indicae 5%～20%, Herba Hyperici Japonici 5～10%, Herba Centellae 5～10%, Herba Solidaginis 5～10%, Semen Trichosanthis Cucumeroidis 5～10% and Herba Bidentis Bipinnatae 5～10%.

8. according to the medicine of described treatment gynecological inflammation of claim 7 and hysteromyoma, it is characterized in that: the consumption of each crude drug is: Herba Solani Lyrati 19.5%, Herba Hedyotidis Diffusae 19.5%, Herba Melastomatis dodecandri 15.5%, Herba Duchesneae Indicae 13%, Herba Hyperici Japonici 6.5%, Herba Centellae 6.5%, Herba Solidaginis 6.5%, Semen Trichosanthis Cucumeroidis 6.5% and Herba Bidentis Bipinnatae 6.5%.

9. as the preparation method of the medicine of treatment gynecological inflammation as described in claim 7 or 8 and hysteromyoma, it is characterized in that: get Herba Solani Lyrati, Herba Hedyotidis Diffusae, Herba Melastomatis dodecandri, Herba Hyperici Japonici, Herba Duchesneae Indicae, Herba Centellae, Herba Solidaginis, Semen Trichosanthis Cucumeroidis, Herba Bidentis Bipinnatae, adding 6～10 times of water gagings decocts 1～4 time, the each decoction 1～3 hour, filter, it is 1.25 extractum that filtrate is concentrated into 60 ℃ of relative densities, promptly gets the active component of medicine of the present invention.

10. according to the medicine of claim 1,4 or 7 arbitrary described treatment gynecological inflammations and hysteromyoma, it is characterized in that: described pharmaceutical preparation is decoction, granule, powder, oral liquid, syrup, soft extract, pill, tablet, capsule.