CN101732662B - Chinese medicinal composition for treating pelvic inflammatory disease and preparation method thereof - Google Patents

Abstract

The invention relates to a Chinese medicinal composition for treating a pelvic inflammatory disease and a preparation method thereof, and belongs to the field of Chinese medicaments. The Chinese medicinal composition is prepared from the following 13 Chinese medicaments: Chinese angelica, red paeony root, common burreed rhizome, zedoary, Szechwan chinaberry fruit, nutgrass galingale rhizome, rhizoma corydalis, swordlike atractylodes rhizome, cinnamomvine, amur corktree bark, glabrous greenbrier rhizome, moghania root and chinaroot greenbrier. The Chinese medicinal composition has the effects of regulating vital energy, dissolving stasis, relieving pain, drying damp and strengthening spleen, has obvious effects of activating blood, dissolving stasis and killing pain, and has obvious antibacterial activity. The Chinese medicinal composition is mainly used for hypogastric swollerpain, or sharp pain or lumbosacral portion psychroalgia, abnormal leucorrhea and the like caused by acute and chronic pelvic inflammatory diseases, appendagitis, endometritis, chronic cervicitis and the like. Compared with the prior art, the Chinese medicinal composition has the advantages of reasonable formula, obvious curative effect, no toxic or side effects and portability and is favorable for clinical application.

Description

A kind of Chinese medicine composition for the treatment of pelvic inflammatory disease and preparation method thereof

Technical field

The present invention relates to a kind of Chinese medicine composition for the treatment of pelvic inflammatory disease, is the preparation of feedstock production with Chinese medicine specifically, belongs to technical field of Chinese medicines, the invention still further relates to the preparation method of this Chinese medicine composition.

Background technology

Pelvic inflammatory disease is the pelvic cavity internal reproductive organ, the general name of inflammatory lesion takes place for connective tissue and pelvic peritoneum etc. on every side, is divided into acute and chronic two kinds.Many because the up infection of pathogenic microorganism, or puerperal, cut open palace puerperal and gynecologic surgery antibacterial and enter traumatic infection and fall ill.Chronic pelvic inflammatory disease be acute pelvic inflammatory disease treatment thoroughly or patient's body constitution is relatively poor, due to the course of disease delay, the part chronic pelvic inflammatory disease is the pathological change that acute pelvic inflammatory disease is left over, and pathogen-free domestic.Though do not have the chronic pelvic inflammatory disease name of disease in the traditional Chinese medical science doctor nationality,, can belong to ancient Chinese medicine doctor to " married woman's stomachache ", “ mass in the abdomen according to its clinical symptoms and sign ", in the argumentation of diseases such as " menoxenia ", " infertility ", " leukorrheal diseases ".Chronic pelvic inflammatory disease is commonly encountered diseases, the frequently-occurring disease of gynecological, has characteristics such as the course of disease is long, the state of an illness is touching, relapse rate height.

For the treatment of pelvic inflammatory disease, western modern medicine mainly is that to select antibiotic therapy for use according to clinical experience or drug sensitive experiment be main, to the determined curative effect of killing of pathogen; But for chronic pelvic inflammation, owing to tissue adhesion's fibrosis, local circulation obstacle, antibiotic is difficult to infiltrate the part and plays a role, and the weak effect of the inflammation of fibrous tissue and connective tissue is soaked in elimination, and antibiotic does not possess the adhesion of releasing and analgesic effect; The life-time service antibiotic also causes alteration of intestinal flora easily and can produce drug resistance.At this disease, Traditional Chinese Medicine experts have accumulated rich experience in long-term clinical practice, combine with treatment based on differentiation of disease with determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, Chinese medicine for oral administration cooperates external treatmenies such as coloclysis, external application and iontophoresis, is preventing the chronic pelvic inflammatory disease recurrence, alleviates pelvic pain, is dwindling or aspect such as dissipation inflammatory masses of pelvic cavity has definite curative effect and significant advantage.

It mainly is owing to invade in the heresy of damp and hot, cold-damp that primary disease takes place, and treat untimelyly or not thorough, damp is lingered on do not go, and forms the stasis of blood with the vessels of the uterus QI and blood knot of fighting, and the stagnation of QI-blood of vessels of the uterus, collaterals of the uterus move not freely, cause dashing, times, dai channel damages; With the passing of time course of disease delay causes healthy energy further impaired, visceral dysfunction, and spleen kidney two deficiency of five ZANG-organs decrease; Thereby produce distention and pain in the lower abdomen, lumbosacral aching pain, menoxenia, leucorrhea or a series of clinical symptoms such as fulminant leucorrhagia with yellowish discharge increases, spiritlessness and weakness, low grade fever.

For acute pelvic inflammatory disease, the traditional Chinese medical science thinks many and shows as the master with wet, heat, poison, the stasis of blood that seize the opportunity at this moment and carry out regular treatment, big multipotency is thoroughly cured.But,, formed positive QI-insufficiency and pathological characteristic that pathogen is delaied because the course of disease is longer for chronic pelvic inflammatory disease, symptom often shows as hypogastralgia, meets Lao Zefa, likes warm pain relieved by pressing, the lower abdomen tenesmus, the waist sacrum is aching and limp, spiritlessness and weakness, and big loose stool is thin, menorrhagia, very then Mian Se Koushi is white, and cold extremities is not warm, the light red tongue weak pulse.This stage pathogenesis has been main by wet, heat, poison, the stasis of blood, changes into based on empty, cold, wet, the stasis of blood; The sick dirty spleen kidney that reaches by liver.Still use the method for heat-clearing and toxic substances removing dampness this moment merely, often is difficult to prove effective, and should pay attention to strengthening the method for warm Tonghua stasis of blood.Clinical main Chinese patent medicine commonly used has: FUKE QIANJIN PIAN: have removing damp-heat, benefiting vital QI and blood; The leukorrhagia that is used for due to the chronic pelvic inflammatory disease belongs to damp invasion of lower energizer, insufficiency of vital energy and blood disease.JINJI JIAONANG: have heat-clearing and toxic substances removing, the spleen invigorating dehumidifying, collateral dredging is invigorated blood circulation; Be used for profuse leukorrhea and chronic pelvic inflammatory disease that damp invasion of lower energizer causes and see above symptom.HUAHONG PIAN: clearing away heat-damp and promoting diuresis, stasis-dispelling and pain-killing; Be used for few or companion's dysmenorrhea of women's leukorrhagia, the menstrual blood volume of damp-heat type and chronic pelvic inflammatory disease and see above-mentioned patient.GUIZHI FULING JIAONANG: have invigorate blood circulation, blood stasis dispelling, Xiao Disorder effect, focus on the warming the meridian blood stasis-eliminating and stagnation-dissipating; The person that is applicable to the inflammatory masses of pelvic cavity.Health woman's antiinflammatory bolt (rectally): have heat-clearing and toxic substances removing, dampness removing eliminating stagnation, killing parasites for relieving itching effect; Be used for damp and hot, the lumbago due to the noxious dampness, lower abdominal pain, leukorrheal diseases, pudendal pruritus, the erosion of the vulva.

As can be seen from the above analysis, have the Chinese patent medicine kind of the treatment chronic pelvic inflammatory disease of certain influence power in the market, majority be damp and hot accumulate the poison the pathogenesis theoretical direction under the side of sending select medicine, the treatment more than based on methods such as heat-clearing and toxic substances removing dampness removings.In fact, this mainly still is subjected to the influence of doctor trained in Western medicine thinking, the new Chinese medicine of exploitation treatment chronic pelvic inflammatory disease under the theoretical direction of doctor trained in Western medicine anti-inflammation, fail to jump out " doctor trained in Western medicine thinking " this stereotype, when causing treating acute pelvic inflammatory disease clinically, Chinese patent medicine also needs to be used with antibiotic, can only play the effect of auxiliary treatment, can only play second; And when the treatment chronic pelvic inflammatory disease, Chinese patent medicine should have be the leading role, but curative effect is undesirable.In a word, treated the Chinese patent medicine of chronic pelvic inflammatory disease why curative effect is not good enough in the past, and key is that the power of clearing up internal heat by using drugs of bitter in taste and cold in nature has a surplus, and warm Tonghua stasis of blood strength deficiency; Too pay attention to the removing damp-heat detoxifcation, and ignore the logical regulating the flow of QI to dissipate blood stasis of temperature.

Summary of the invention

The object of the present invention is to provide a kind of Chinese medicine composition for the treatment of pelvic inflammatory disease, overcome the deficiency of above-mentioned all kinds, be made up of pure Chinese medicine and provide a kind of, treating both the exterior and interior reaches better regulating the flow of QI to dissipate blood stasis pain relieving, drying damp and strengthening spleen effect; This medicament can be prepared into different dosage form at needs of patients in addition, is convenient to take safety, effective and easy to carry.

The object of the invention to solve the technical problems realizes by the following technical solutions.According to a kind of Chinese medicine composition for the treatment of pelvic inflammatory disease that the present invention proposes, this Chinese medicine composition is to be prepared from by following raw materials in weight portion:

Radix Angelicae Sinensis 50-300 Radix Paeoniae Rubra 100-600 rhizoma sparganic 50-300

Rhizoma Curcumae 50-300 Fructus Toosendan 50-300 Rhizoma Cyperi 25-200

Rhizoma Corydalis 50-300 Rhizoma Atractylodis 50-300 Rhizoma Dioscoreae 100-600

Cortex Phellodendri 50-300 Rhizoma Smilacis Glabrae 80-500 Radix Flemingiae Philippinensis 80-500

Rhizoma Smilacis Chinensis 80-500.

According to the Chinese medicine composition of the treatment pelvic inflammatory disease of the embodiment of the invention, the weight portion proportioning of described each raw material is:

Radix Angelicae Sinensis 150 Radix Paeoniae Rubra 300 rhizoma sparganic 150

Rhizoma Curcumae 150 Fructus Toosendans 150 Rhizoma Cyperis 100

Rhizoma Corydalis 150 Rhizoma Atractylodis 150 Rhizoma Dioscoreaes 300

Cortex Phellodendri 150 Rhizoma Smilacis Glabraes 250 Radix Flemingiae Philippinensiss 250

Rhizoma Smilacis Chinensis 250.

Chinese medicine composition according to the treatment pelvic inflammatory disease of the embodiment of the invention, described Chinese medicine composition can add adjuvant and make any dosage form of accepting on the pharmaceutics, and described dosage form can be capsule, tablet, granule, pill, powder, unguentum, suppository, oral liquid, injection, lotion, liniment, aerosol, spray, injectable powder, enema.

In addition, the invention allows for a kind of preparation method for the treatment of the Chinese medicine composition of pelvic inflammatory disease, get Radix Angelicae Sinensis 50-300, Radix Paeoniae Rubra 100-600, rhizoma sparganic 50-300, Rhizoma Curcumae 50-300, Fructus Toosendan 50-300, Rhizoma Cyperi 25-200, Rhizoma Corydalis 50-300, Rhizoma Atractylodis 50-300, Rhizoma Dioscoreae 100-600, Cortex Phellodendri 50-300, Rhizoma Smilacis Glabrae 80-500, Radix Flemingiae Philippinensis 80-500, Rhizoma Smilacis Chinensis 80-500, adopt supercritical carbon dioxide extraction, 70%～95% ethanol extraction, any 1～3 kind of technology in three kinds of extraction processes of water extraction makes up extraction, and extracting solution concentrates the back and carries out molding by the different dosage form requirement.

Preparation method according to the Chinese medicine composition of the treatment pelvic inflammatory disease of the embodiment of the invention comprises step:

1) Rhizoma Curcumae, Radix Angelicae Sinensis, Rhizoma Atractylodis, Rhizoma Cyperi are ground into coarse powder, use supercritical carbon dioxide extraction, extracting parameter is extracting pressure 22-26MPa, extraction temperature 45-55 ℃, resolve pressure 5～6MPa, resolution temperature 45-60 ℃, 0.5-2.5 hour extraction time, the gained extract is standby;

2) Cortex Phellodendri, Rhizoma Corydalis are ground into coarse powder, add ethanol extraction with the medicinal residues behind the supercritical extraction, extraction conditions is that concentration of alcohol is 60-90%, add ethanol extraction 1-3 time, the 4-12 that adds amount of alcohol and be Rhizoma Curcumae, Radix Angelicae Sinensis, Rhizoma Atractylodis, Rhizoma Cyperi, Cortex Phellodendri, Rhizoma Corydalis 6 flavor medical material mixture doubly each 0.5-2 hour, decocts temperature and is controlled at 70 ℃ to boiling, extracting solution filters, and relative density is 1.05～1.15 concentrated solution during filtrate vacuum concentration to 60 ℃;

3) Radix Paeoniae Rubra, Rhizoma Dioscoreae, Rhizoma Smilacis Chinensis, Rhizoma Smilacis Glabrae, Radix Flemingiae Philippinensis, rhizoma sparganic, Fructus Toosendan, decoct with water, extraction conditions is for decocting with water 1-3 time, amount of water be Radix Paeoniae Rubra, Rhizoma Dioscoreae, Rhizoma Smilacis Chinensis, Rhizoma Smilacis Glabrae, Radix Flemingiae Philippinensis, rhizoma sparganic, Fructus Toosendan 7 flavor medical material mixture 4-12 doubly, each 0.5-2 hour, decoct temperature and be controlled at 80 ℃ to boiling, extracting solution filters, the concentrated solution of filtrate vacuum concentration to 60 ℃ relative density 1.05～1.15;

4) with step 2) and the mixing of step 3) gained concentrated solution, the thick paste of relative density 1.35～1.45 when being concentrated into 55 ℃;

5) adopt vacuum microwave drying to carry out drying step 4) gained thick paste, drying parameter is: thick paste/microwave power ratio is 1.0～1.6Kg/KW, vacuum-0.08～-0.09MPa, 60-90 ℃ of dry run ceiling temperature, 3 ℃ of return difference temperature, dry terminal point is that material does not have obvious foaming back 10min, and institute gets dry extract standby.

Preparation method according to the Chinese medicine composition of the treatment pelvic inflammatory disease of the embodiment of the invention, with get dry extract, pulverize, add carboxymethyl starch sodium, sucrose, dextrin, stevioside, starch, Pulvis Talci at least a adjuvant wherein, with supercritical extract, mixing, supplementary product consumption is a Radix Angelicae Sinensis, Radix Paeoniae Rubra, rhizoma sparganic, Rhizoma Curcumae, Fructus Toosendan, Rhizoma Cyperi, Rhizoma Corydalis, Rhizoma Atractylodis, Rhizoma Dioscoreae, Cortex Phellodendri, Rhizoma Smilacis Glabrae, Radix Flemingiae Philippinensis, the 2.5-4.0% of Rhizoma Smilacis Chinensis 13 flavor medical material mixture amounts, wherein, the adjuvant carboxymethyl starch sodium, sucrose, dextrin, stevioside, starch, talcous weight portion proportioning is any ratio, and dry-pressing is granulated.Dry-pressing makes capsule after granulating and dressing up capsule; Or tabletting makes tablet; Or packing makes granule.

According to the preparation method of the Chinese medicine composition of the treatment pelvic inflammatory disease of the embodiment of the invention, it comprises step:

1) Rhizoma Curcumae, Radix Angelicae Sinensis, Rhizoma Atractylodis, Rhizoma Cyperi are ground into coarse powder, use supercritical carbon dioxide extraction, extracting parameter is extracting pressure 22-26MPa, extraction temperature 45-55 ℃, resolve pressure 5～6MPa, resolution temperature 45-60 ℃, 0.5-2.5 hour extraction time, the gained extract is standby;

2) Cortex Phellodendri, Rhizoma Corydalis are ground into coarse powder, add ethanol extraction with the medicinal residues behind the supercritical extraction, extraction conditions is that concentration of alcohol is 60-90%, add ethanol extraction 1-3 time, the 4-12 that adds amount of alcohol and be Rhizoma Curcumae, Radix Angelicae Sinensis, Rhizoma Atractylodis, Rhizoma Cyperi, Cortex Phellodendri, Rhizoma Corydalis 6 flavor medical material mixture doubly each 0.5-2 hour, decocts temperature and is controlled at 70 ℃ to boiling, extracting solution filters, and relative density is 1.05～1.15 concentrated solution during filtrate vacuum concentration to 60 ℃;

3) Radix Paeoniae Rubra, Rhizoma Dioscoreae, Rhizoma Smilacis Chinensis, Rhizoma Smilacis Glabrae, Radix Flemingiae Philippinensis, rhizoma sparganic, Fructus Toosendan, decoct with water, extraction conditions is for decocting with water 1-3 time, amount of water be Radix Paeoniae Rubra, Rhizoma Dioscoreae, Rhizoma Smilacis Chinensis, Rhizoma Smilacis Glabrae, Radix Flemingiae Philippinensis, rhizoma sparganic, Fructus Toosendan 7 flavor medical material mixture 4-12 doubly, each 0.5-2 hour, decoct temperature and be controlled at 80 ℃ to boiling, extracting solution filters, the concentrated solution of filtrate vacuum concentration to 60 ℃ relative density 1.05～1.15;

4) to step 2) and step 3) gained concentrated solution in add the 2-5g sodium benzoate, add water, stir evenly, fill makes oral liquid.

By technique scheme, the advantage that the present invention has is: this Chinese medicine composition has the regulating the flow of QI to dissipate blood stasis pain relieving, drying damp and strengthening spleen effect, have tangible blood circulation promoting and blood stasis dispelling and analgesic activity, also have significant antibacterial activity, be mainly used in hypogastric region distending pain or twinge or lumbosacral region cold type of pain, leucorrhea abnormal etc. that urgent chronic pelvic inflammatory disease, adnexitis, endometritis, chronic cervicitis etc. cause; Compared with prior art, the reasonable recipe of this medicine, obvious toxic-side effects evident in efficacy, no, easy to carry, be beneficial to clinical practice; Technology Chinese medicine composition of the present invention can be made capsule, tablet, granule, pill, powder, unguentum, suppository, oral liquid, injection, lotion, liniment, aerosol, spray, injectable powder, enema routinely; Its most preferred dosage form is a capsule.

The specific embodiment

For curative effect of the present invention is described, the applicant carries out pharmacodynamics test to it, and the result is as follows:

Experiment purpose:, observe the power of its pharmacological action by capsule of the present invention and FUKE QIANJIN PIAN are compared.

Trial drug:

Capsule group of the present invention:

Raw material: Radix Angelicae Sinensis 150, Radix Paeoniae Rubra 300, rhizoma sparganic 150, Rhizoma Curcumae 150, Fructus Toosendan 150, Rhizoma Cyperi 100, Rhizoma Corydalis 150, Rhizoma Atractylodis 150, Rhizoma Dioscoreae 300, Cortex Phellodendri 150, Rhizoma Smilacis Glabrae 250, Radix Flemingiae Philippinensis 250, Rhizoma Smilacis Chinensis 250.

Method for making: Rhizoma Curcumae, Radix Angelicae Sinensis, Rhizoma Atractylodis, Rhizoma Cyperi are ground into coarse powder, with supercritical carbon dioxide (SFE-CO ₂) extract, extracting parameter is extracting pressure 24MPa, 45 ℃ of extraction temperature are resolved pressure 5～6MPa, and 50 ℃ of resolution temperatures, 2 hours extraction time, the gained extract is put in the clean container, and is standby.Cortex Phellodendri, Rhizoma Corydalis are ground into coarse powder, add 70% alcohol reflux 2 times with medicinal residues behind the supercritical extraction, for the first time 8 times of amounts, 6 times of amounts for the second time, each 1 hour, filter merging filtrate, vacuum concentration, vacuum-0.05～-0.06Mpa, to relative density 1.05～1.15 (60 ℃), standby.Radix Paeoniae Rubra, Rhizoma Dioscoreae, Rhizoma Smilacis Chinensis, Rhizoma Smilacis Glabrae, Radix Flemingiae Philippinensis, rhizoma sparganic cut into thin slice, Fructus Toosendan half-and-half cuts into two lobes, decoct with water 2 times, for the first time 10 times of amounts, 8 times of amounts for the second time, each 1 hour, filter merging filtrate, vacuum concentration, vacuum-0.06～-0.09Mpa, to relative density 1.05～1.15 (60 ℃); Water concentration solution mixes with the alcohol extraction concentrated solution, vacuum concentration, and vacuum-0.08～-0.09MPa, to relative density 1.35～1.45 (55 ℃), thick paste vacuum microwave drying, drying parameter are that thick paste/microwave power ratio is 1.2～1.4Kg/KW, vacuum-0.08～-0.09MPa, 90 ℃ of dry run ceiling temperatures, 3 ℃ of return difference temperature, dry terminal point is that material does not have obvious foaming back 10min, dry extract is pulverized, cross 80 orders, dry extract is put in the clean container, and is standby.Get supercritical extract, dry extract, add 5% carboxymethyl starch sodium mixing, pulverize, cross 60 orders, adding starch is an amount of, mixing, and dry-pressing is granulated, and fills the 0# capsule.

FUKE QIANJIN PIAN: for Zhuzhou Qianjin Pharmacy Co., Ltd produces, lot number: 200505094,200612004

One, antiinflammatory test

1, the influence of xylol induced mice auricle edema

(1), test material

Medicine: FUKE QIANJIN PIAN 0.32g/ sheet, large, medium and small three the dosage group 0.52g/ grains of capsule of the present invention; Medicine disposes with distilled water before experiment, gastric infusion.

Animal: Kunming female mice, body weight 18-20g

(2), test method and result

Select for use body weight 50 of 20 ± 2g female mices, be divided into 5 groups at random: FUKE QIANJIN PIAN group 1.92g medicated powder/kg, Capsules group 0.52g medicated powder/kg of the present invention, 1.04g medicated powder/kg, 1.56g medicated powder/kg, the blank group gives the isometric(al) distilled water, each organizes continuous gastric infusion 3 days, every day 1 time.After the last administration 30 minutes, every Mus auris dextra was coated with dimethylbenzene 0.02ml.Put to death animal behind the 30min, cut ears, lay auricle in same area, weigh, as the swelling degree, adopt SPSS 10.0 statistical softwares to carry out One-Way-ANOVA and analyze, the results are shown in Table 1 with the weight differential value with card punch.

The influence of table 1 xylol induced mice ear swelling (x ± s)

Annotate: compare * P＜0.05, * * P＜0.01 with the blank group; Compare #P＜0.05, ##P＜0.01 with the FUKE QIANJIN PIAN group.

The result shows: compare with the blank group, the ear swelling of each medicine group xylol induced mice all has significant inhibitory effect (p＜0.01).Compare with the FUKE QIANJIN PIAN group, the inhibitory action of Capsules group height of the present invention, middle dosage group is significantly increased (p＜0.01), and the low dose group action intensity is suitable (p＞0.05) with it.Point out Capsules group of the present invention to have antiinflammatory action, and the Capsules group antiinflammatory action of the present invention of identical clinical dosage is better than FUKE QIANJIN PIAN.

2, the influence of rat paw edema due to the on Carrageenan

(1), test material

Medicine: FUKE QIANJIN PIAN 0.32g/ sheet, large, medium and small three the dosage group 0.52g/ grains of capsule of the present invention; Medicine disposes with distilled water before experiment, gastric infusion.

Animal: Wistar female rats, body weight 180-200g

(2), test method and result

Getting body weight is 60 of 180～200g female rats, be divided into 5 groups at random: FUKE QIANJIN PIAN group 0.96g medicated powder/kg, Capsules group 0.26g medicated powder/kg of the present invention, 0.52g medicated powder/kg, 1.04g medicated powder/kg, the blank group gives the isometric(al) distilled water, each organizes continuous gastric infusion 7 days, every day 1 time.Measure and respectively organize the right back sufficient normal volume of rat (under sufficient front, making a clear graticule), at the subcutaneous injection of right back toes 0.1ml carrageenin (0.2%), measure and cause inflammation back 1h, 2h, the right back sufficient volume of 3h, 4h after the last administration, calculate rat toes swelling rate.Relatively the difference of each administration group toes swelling rate and distilled water matched group toes swelling rate adopts SPSS 10.0 statistical softwares to carry out One-Way-ANOVA and analyzes, and the results are shown in Table 3.

The influence of table 2 pair rat toes swelling rate (x ± s)

Annotate: compare * P＜0.01 with the blank group; Compare #P＜0.01 with the FUKE QIANJIN PIAN group; Compare ▲ P＜0.01 with the traditional handicraft sample sets

The result shows, compares with the blank group, and swelling all has obvious inhibitory action (P＜0.01) to each medicine group to the rat toes at each time point.Compare with the FUKE QIANJIN PIAN group, all there were significant differences at each time point (P＜0.01) for Capsules group height of the present invention, middle dosage group, and the low dose group action intensity is suitable (p＞0.05) with it.Point out Capsules group of the present invention to have antiinflammatory action, and the Capsules group antiinflammatory action of the present invention of identical clinical dosage is better than FUKE QIANJIN PIAN.

3, to the bullate influence of rat granuloma

(1), test material

Medicine: FUKE QIANJIN PIAN 0.32g/ sheet, large, medium and small three the dosage group 0.52g/ grains of capsule of the present invention; Medicine disposes with distilled water before experiment, gastric infusion.

Animal: Wistar female rats, body weight 180-200g

(2), test method and result

Getting body weight is 60 of 180～200g female rats, is divided into 5 groups at random: FUKE QIANJIN PIAN group 0.96g medicated powder/kg, and Capsules group 0.26g medicated powder/kg of the present invention, 0.52g medicated powder/kg, 1.04g medicated powder/kg, the blank group gives the isometric(al) distilled water.Claim the degreasing cotton of 20mg to make the roughly the same cotton balls of shape earlier, standby behind the autoclaving.Every rats by intraperitoneal injection pentobarbital sodium (30mg/kg) is anaesthetized, and it is subcutaneous that 1 cotton balls is implanted rat axillary region.Second day after operation begins gastric infusion, successive administration 7 days, and rat is put to death in dislocation in the 8th day, takes out cotton balls, rejects fatty tissue, puts 60 ℃ of baking boxs and dries to constant weight, and deducts the raw cotton ball weight and is granuloma weight.Granuloma weight compares each administration group granuloma and blank group granuloma weight differential with mg (granuloma) expression, and adopts SPSS 10.0 statistical softwares to carry out One-Way-ANOVA and analyze, and the results are shown in Table 3.

The bullate influence of table 3 pair rat granuloma (x ± s)

Annotate: compare * P＜0.01 with the blank group; Compare #P＜0.01 with the FUKE QIANJIN PIAN group; Compare ▲ P＜0.01 with the traditional handicraft sample

The result shows, compares with the blank group, and each medicine group all can significantly alleviate granulation tissue weight (P＜0.01), points out each medicine that subchronic inflammation disease is all had the obvious suppression effect.Compare with the FUKE QIANJIN PIAN group, all there were significant differences for the inhibitory action of the high, medium and low dosage group of Capsules group of the present invention (P＜0.01), points out Capsules group of the present invention to have antiinflammatory action, and the Capsules group effect of the present invention of identical clinical dosage is better than FUKE QIANJIN PIAN.

Two, analgesic test (writhing method, hot plate method)

1, the influence of Dichlorodiphenyl Acetate induced mice pain (writhing method)

(1), test material

Medicine: FUKE QIANJIN PIAN 0.32g/ sheet, large, medium and small three the dosage group 0.52g/ grains of capsule of the present invention; Medicine disposes with distilled water before experiment, gastric infusion.

Animal: Kunming female mice, body weight 18-20g

(2), test method and result

Choose body weight and be 50 of the female mices of 18～22g, be divided into 5 groups at random: FUKE QIANJIN PIAN group 1.92g medicated powder/kg, Capsules group 0.52g medicated powder/kg of the present invention, 1.04g medicated powder/kg, 1.56g medicated powder/kg, the blank group gives the isometric(al) distilled water, each organizes continuous gastric infusion 3 days, every day 1 time.Fasting 12 hours, after the last administration 0.5 hour lumbar injection 0.8% acetic acid normal saline solution 0.2ml/ only, in the observed and recorded 20 minutes mice turn round the body number of times, respectively organize difference, and adopt SPSS 10.0 statistical softwares to carry out One-Way-ANOVA and analyze, the results are shown in Table 4.

The influence of table 4 Dichlorodiphenyl Acetate induced mice pain (x ± s)

Annotate: compare * P＜0.01 with the blank group; Compare #P＜0.01 with the FUKE QIANJIN PIAN group

The result shows: compare with the blank group, each medicine all can significantly reduce mouse writhing number of times (p＜0.01), points out each medicine that the effect that suppresses acetic acid induced mice pain is all arranged; Compare with the FUKE QIANJIN PIAN group, the inhibitory action of the high, medium and low dosage group of Capsules group of the present invention is significantly increased (p＜0.01), points out Capsules group of the present invention to have analgesic activity, and the Capsules group effect of the present invention of identical clinical dosage is better than FUKE QIANJIN PIAN.

2, to the influence (hot plate method) of thermostimulation induced mice pain

(1), test material

Medicine: FUKE QIANJIN PIAN 0.32g/ sheet, large, medium and small three the dosage group 0.52g/ grains of capsule of the present invention; Medicine disposes with distilled water before experiment, gastric infusion.

Animal: NiH female mice, body weight 18-20g

(2), test method and result

Female mice placed on 55 ℃ ± 0.5 ℃ the metallic plate, licking metapedes with mice is the pain reaction signal, with pain reaction incubation period be threshold of pain index, twice of administration before measurement (5min at interval), with its average as the basic threshold of pain, select pain threshold 50 of 5～30 seconds mices, be divided into 5 groups at random: FUKE QIANJIN PIAN group 1.92g medicated powder/kg, Capsules group 0.52g medicated powder/kg of the present invention, 1.04g medicated powder/kg, 1.56g medicated powder/kg, the blank group gives the isometric(al) distilled water, each organizes continuous gastric infusion 3 days, every day 1 time.After the last administration, surveyed pain threshold twice (5min at interval) in 1 hour, average, calculate the threshold of pain and improve percentage rate.Adopt SPSS 10.0 statistical softwares to carry out One-Way-ANOVA and analyze, as a result 5.

The influence of table 5 pair hot plate method induced mice pain (x ± s)

Annotate: compare * P＜0.01 with the blank group; Compare #P＜0.05, ##P＜0.01 with the FUKE QIANJIN PIAN group

The result shows: compare with the blank group, each medicine group all can significantly improve the threshold of pain of mice and improve percentage rate (P＜0.01), points out each medicine that the effect that suppresses hot plate induced mice pain is all arranged.Compare with the FUKE QIANJIN PIAN group, the inhibitory action of Capsules group height of the present invention, middle dosage group be significantly increased (P＜0.01, P＜0.05), the low dose group action intensity is suitable (p＞0.05) with it, point out Capsules group of the present invention to have analgesic activity, and the Capsules group effect of the present invention of identical clinical dosage is better than FUKE QIANJIN PIAN.

Three, immunity test (experiment of mice reticuloendothelial system carbon clearance)

(1), test material

Medicine: FUKE QIANJIN PIAN 0.32g/ sheet, large, medium and small three the dosage group 0.52g/ grains of capsule of the present invention; Medicine disposes with distilled water before experiment, gastric infusion.

Animal: NiH female mice, body weight 18-20g

(2), test method and result

Select for use body weight 60 of 20 ± 2g female mices, be divided into 5 groups at random: FUKE QIANJIN PIAN group 1.92g medicated powder/kg, Capsules group 0.52g medicated powder/kg of the present invention, 1.04g medicated powder/kg, 1.56g medicated powder/kg, the blank group gives the isometric(al) distilled water, successive administration 6 days, every day 1 time.After the last administration 0.5 hour, inject dilution prepared Chinese ink (dilute 4 times) 0.1ml/10g in the tail vein, 2min and 12min after injecting prepared Chinese ink get blood with glass capillary from the mouse orbit rear vein beard, and accurate rapidly absorption 20 μ l are blown into 0.1%Na at once ₂CO ₃Among the solution 10ml, in this liquid, suck urgency with suction pipe and fully wash out the blood that the suction pipe wall adheres to for several times, with 0.1%Na ₂CO ₃Trap (A) value is measured in solution school zero in the 576nm place, 12min puts to death mice after injecting prepared Chinese ink, wins thymus and spleen, calculates phagocytic index K, proofreaies and correct and clean up index α.Adopt SPSS 10.0 statistical softwares to carry out One-Way-ANOVA and analyze, the results are shown in Table 6.

$K=\frac{\log 0D_1-\log 0D_2}{t2-t1}$

The influence of table 6 pair mice reticuloendothelial system phagocytic function (x ± s)

Annotate: compare * P＜0.01 with the blank group; Compare #P＜0.01 with the FUKE QIANJIN PIAN group; Compare ▲ P＜0.01 with the traditional handicraft sample

The result shows, with the blank group relatively, the phagocytic index K of each test group, proofread and correct and clean up index α significant difference (P＜0.01) is all arranged, show that each medicine all has the effect that strengthens phagocytic function.Compare with the FUKE QIANJIN PIAN group, index α is cleaned up in the phagocytic index K of Capsules group height of the present invention, middle dosage group and correction, and all there were significant differences (P＜0.01), there were significant differences for the phagocytic index K of Capsules group low dose group of the present invention (P＜0.01), the immunological enhancement of pointing out identical clinical dosage Capsules group of the present invention is greater than FUKE QIANJIN PIAN, point out Capsules group of the present invention to have the enhancing phagocytic function, improve immunization, and the Capsules group effect of the present invention of identical clinical dosage is better than FUKE QIANJIN PIAN.

Four, microcirculation test

(1), test material

Medicine: FUKE QIANJIN PIAN 0.32g/ sheet, large, medium and small three the dosage group 0.52g/ grains of capsule of the present invention; Medicine disposes with distilled water before experiment, gastric infusion.

Animal: Kunming female mice, body weight 18-20g

(2), test method and result

Get body weight 40 of the female mices of 20 ± 2g, be divided into 5 groups at random: FUKE QIANJIN PIAN group 1.92g medicated powder/kg, Capsules group 0.52g medicated powder/kg of the present invention, 1.04g medicated powder/kg, 1.56g medicated powder/kg, the blank group gives the isometric(al) distilled water.Before the administration, each treated animal is with 20% urethane (1.4gkg ^-1) intramuscular anesthesia, gently draw with the light subsides of medical proof fabric and to remove the auricle hair, mice ventrad is fixed on the observation platform down, the auricle surface drips a little liquid paraffin.Observation platform is placed on the anatomic microscope object stage, under transillumination,, and measure the venule bore at same position with micro-micrometer with 15 * 5 times of sem observation auricles, labelling.

Dosage by table 7 gavages administration, and the blank group gives the isometric(al) distilled water, for three days on end.After the last administration 0.5 hour, with method anesthesia and measure the venule bore at labelling position.Analyze the situation of change of the preceding capillary tube bore of administration, the front and back difference is represented with x ± s, adopts SPSS 10.0 statistical softwares to carry out One-Way-ANOVA and analyzes, and the results are shown in Table 7.

The influence (x ± s, μ m) of table 7 pair Mice Auricle venule bore

Annotate: compare with the normal control group: * P＜0.01; Compare with the FUKE QIANJIN PIAN group: #P＜0.01.

The result shows, compares with the blank group, and the auricle venule external caliber of FUKE QIANJIN PIAN group and the high, medium and low dosage group of Capsules group of the present invention mice all enlarges markedly (P＜0.01); Compare with the FUKE QIANJIN PIAN group, Capsules group height of the present invention, middle dosage group all variant (P＜0.01), the low dose group effect is suitable (P＞0.01) with it.Point out Capsules group height of the present invention, middle dosage group expansion Mice Auricle capillary action to be better than the FUKE QIANJIN PIAN group.The effect of pointing out Capsules group of the present invention to have microcirculation improvement, and the Capsules group effect of the present invention of identical clinical dosage is better than FUKE QIANJIN PIAN.

Five, the pharmacodynamics test relevant with pelvic inflammatory disease

1, to the inhibitory action of the bacillary intestinal adhesion of rat

(1), test material

Medicine: FUKE QIANJIN PIAN 0.32g/ sheet, large, medium and small three the dosage group 0.52g/ grains of capsule of the present invention; Medicine disposes with distilled water before experiment, gastric infusion.

Animal: SD female rats, body weight 180-200g

Strain: staphylococcus aureus (GIM1.221=CMCC26003)

(2), test method and result

Getting body weight is 180～200g female rats, and fasting is after 12 hours, with 3% pentobarbital sodium (30mg/Kg) intraperitoneal injection of anesthesia.Anesthetized rat is fixed on the operation plate, carries out abdominal under aseptic condition, get about the about 2cm in small intestinal stage casing, getting concentration is 1 * 10 ⁶The staphylococcus aureus liquid 0.5ml of/ml injects enteral, and with syringe needle shallow puncture intestinal wall (about 10 pins), with little bloodstain degree of being that oozes out.After finishing the inside and outside bacterial infection operation of intestinal segment, intestinal tube is resetted the layer-by-layer suture wound.Fasting on the same day recovered normal and raises on the 1st.Survival rats is divided into 5 groups at random: FUKE QIANJIN PIAN group 0.96g medicated powder/kg, Capsules group 0.26g medicated powder/kg of the present invention, 0.52g medicated powder/kg, 1.04g medicated powder/kg, the blank group gives the isometric(al) distilled water, put to death all animals on the 6th day, cut open inspection, by following criterion the situation that each treated animal forms abscess, adhesion and abdominal cavity inflammation is compared, adopt SPSS 10.0 statistical softwares to carry out the rank test of completely random design, the results are shown in Table 8.

Adhesion grading criterion:

"-" expression intraperitoneal does not have obvious inflammation, and the place does not have the vestige of infection to bacterium.

"+" expression infection place has redness or adhesion is arranged slightly.

" ++ " expression infection place has lump to form, and with the surrounding tissue adhesion, but easily peels off.

" +++" the swollen thing of expression infection place formation agglomerate, with surrounding tissue adhesion, intestinal wall, fat or the adhesion of abdominal operation position, be difficult for peeling off.

The inhibitory action of the table 8 pair bacillary intestinal adhesion of rat

Annotate: compare * P＜0.05, * * P＜0.01 with the blank group; Compare with the FUKE QIANJIN PIAN group: #/＜0.05

The result shows, compares with the blank group, and intestinal adhesion, the intestinal abscess degree of FUKE QIANJIN PIAN group and the high, medium and low dosage group of Capsules group of the present invention rat obviously alleviate (P＜0.01 or P＜0.05).Compare with the FUKE QIANJIN PIAN group, the high, medium and low dosage group of Capsules group of the present invention action intensity does not all have significant difference (P＞0.05), but the equal intestinal adhesion incidence rate of each dosage of Capsules group of the present invention all decreases.

Rat intestine adhesion, the phleboedesis of pointing out Capsules group of the present invention that staphylococcus aureus is caused expand and have the obvious suppression effect.

2, to the therapeutical effect of the pelvic inflammatory disease model of bacteria-induction

(1), test material

Medicine: FUKE QIANJIN PIAN 0.32g/ sheet, large, medium and small three the dosage group 0.52g/ grains of capsule of the present invention; Medicine disposes with distilled water before experiment, gastric infusion.

Animal: Wistar female rats, body weight 180-200g

Strain: staphylococcus aureus (GIM1.221=CMCC26003), escherichia coli (GIM1.223=CMCC44102), beta hemolytic streptococcus (GIM1.143=CMCC32210)

(2), test method and result

Getting body weight is 180～200 gram female rats, feeds after 5 days, is divided into 6 groups at random, and in the beginning administration of the 3rd week of modeling, in 5 weeks of successive administration, each is organized dosage and sees Table 9.Wherein, model group, the FUKE QIANJIN PIAN group, the basic, normal, high dosage treated animal of Capsules group of the present invention, behind the fasting 12h,, get the about 0.8～1cm of rat median incision of lower abdomen under the aseptic condition with 3% pentobarbital sodium (30mg/Kg) intraperitoneal injection of anesthesia, open and expose behind the abdomen and fixing uterus, (escherichia coli, staphylococcus aureus, beta hemolytic streptococcus are dissolved in physiological saline solution with 2: 1: 1 ratio, and to be made into concentration be 3 * 10 with 1ml syringe extraction 0.2ml mixed cell suspension ⁹The mixed cell suspension of/ml), before injecting bacterium liquid,, injects bacterium liquid then to the bilateral of uterus, sew up the incision with syringe mechanical damage endometrial tissue.The blank group extracts the 0.2ml normal saline with the 1ml syringe after opening abdomen by the above-mentioned steps operation, injects in the bilateral of uterus, sews up the incision.

Each organizes rat (water is can't help in fasting) behind last administration 12h, abdominal aortic blood test section hemorheology index, and the result adopts SPSS 10.0 statistical softwares to carry out One-Way-ANOVA and analyzes, and sees Table 9,10.Put to death rat, get uterus, fallopian tube, ovary, put in 10% formaldehyde and fix, the routine paraffin wax embedded section, HE dyeing, light microscopic is observed pathological change down, and the result sees the pathology photo (annotate: the used title of this medicine is transient name in the pathologic finding) of attached sheet for details.According to the amount of inflammatory cell and the degree that sticks together with the inflammation situation be divided into normally, 4 grades of slight, moderate and severes, represent with "-", "+", " ++ ", " +++".Wherein, "-" basic NIP cellular infiltration; A spot of inflammatory cell infiltration appears in "+"; A large amount of inflammatory cell infiltrations appears in " ++ " expression, and a small amount of adhesion is arranged; " +++" a large amount of inflammatory cell infiltration of expression appearance, and a large amount of adhesions are arranged.Carry out the rank test that completely random designs with SPSS 10.0 statistical softwares, the results are shown in Table 9.

Table 9 part hemorheology index measurement result (x ± s)

Annotate: compare with the blank group:: * P＜0.01; Compare #P＜0.05, ##P＜0.01 with model control group

Table 10 part hemorheology index measurement result (x ± s)

Annotate: compare with the blank group:: * P＜0.05, * * P＜0.01; Compare #P＜0.01 with model control group

The statistics in various degree of each treated animal inflammation of uterus of table 11

Annotate: compare with the blank group: * P＜0.01; Compare #P＜0.05 with model control group

Table 9,10 results show, compare with the blank group, model control group whole blood viscosity (high, medium and low cutting), Kazon viscosity, erythrocyte electrophoretic time be significantly rising (P＜0.01) all, show escherichia coli, staphylococcus aureus, when beta hemolytic streptococcus (2: 1: 1) causes the rat chronic pelvic inflammatory disease, have the blood stasis state to exist in the animal body.Compare with model control group, the blood stasis state of each administration group makes moderate progress, every indexs such as whole blood viscosity (high, medium and low cutting), Kazon viscosity, erythrocyte electrophoretic time are significantly decline (P＜0.05 or P＜0.01) all, and plasma viscosity, erythrocyte aggregation index all do not have significant difference (P＞0.05), but from its numerical value, trend all significantly decreases.Compare with the FUKE QIANJIN PIAN group, high, medium and low each index of dosage group of Capsules group of the present invention does not all have significant difference (P＞0.05), but the average of part index numbers such as whole blood viscosity, plasma viscosity, erythrocyte aggregation index is less than the FUKE QIANJIN PIAN group.Point out Capsules group of the present invention to have function of promoting blood circulation to disperse blood clots.

Table 12 is the result show, compare with the blank group, 1 routine hyperphlogosis, 3 routine moderate inflammations, 6 routine mild inflammations appear in model control group, show and adopt escherichia coli, staphylococcus aureus, beta hemolytic streptococcus (2: 1: 1) to carry out modeling, can make rat uterus obvious inflammation (P＜0.05) occur; Compare with model control group, the inflammation of uterus degree of each administration group rat all significantly reduces (P＜0.05), but does not see significant difference (P＞0.05) between each group.Point out Capsules group of the present invention to have to suppress the effect of rat endometrium inflammation due to the antibacterial.The fallopian tube of each treated animal, ovary pathological examination results are not seen tangible salpingitis and oophoritis.

Pathological examination shows, censorship blank group, model group, the high, medium and low dosage group of Capsules group of the present invention, FUKE QIANJIN PIAN group ovary, fallopian tube no abnormality seen.The model group endometrium is slightly-the severe cell infiltration, and the high, medium and low dosage group of Capsules group of the present invention, FUKE QIANJIN PIAN group endometrium are slight cell infiltration, show that the high, medium and low dosage of Capsules group of the present invention, FUKE QIANJIN PIAN all have therapeutical effect to endometritis, but curative effect does not have significant difference between each is organized on the pathomorphism, and the result sees the pathologic finding report (annotate: the used title of this medicine is transient name in the pathologic finding) of attached sheet for details.

Above experimental result points out Capsules group of the present invention to have the effect of stronger blood circulation promoting and blood stasis dispelling and inhibition rat endometrium inflammation.

Six, antibacterial tests

1, in-vitro antibacterial test

(1), test material

Medicine: FUKE QIANJIN PIAN 0.32g/ sheet, large, medium and small three the dosage group 0.52g/ grains of capsule of the present invention; Medicine disposes with distilled water before experiment, gastric infusion.

Strain: staphylococcus aureus (GIM1.221=CMCC26003), staphylococcus epidermidis (GIM1.143=ATCC12228), escherichia coli (GIM1.223=CMCC44102), Pseudomonas aeruginosa (GIM1.220=CMCC10104), beta hemolytic streptococcus (GIM1.143=CMCC32210), Candida albicans (GIM2.169=ATCC10231), proteus mirabilis (GIM1.240=CMCC49005)

Culture medium: nutrient broth medium, meat infusion broth, husky Bao Shi culture medium, all preparation according to a conventional method.

(2), test method and result

Capsules group medicated powder of the present invention is prepared with nutrient broth medium, and a times amount is diluted to every 1ml and contains medication amount 0.2g, 0.1g, 0.05g, 0.025g, 0.0125g, 6.25 * 10 ^-3G, 3.125 * 10 ^-3G, 1.0625 * 10 ^-3G, totally 8 drug level, every pipe total amount 1ml, 0.22 μ m microporous filter membrane filter, sterilization.The meat infusion broth preparating liquid is then used in test to beta hemolytic streptococcus, and husky Bao Shi culture medium preparating liquid is then used in oidiomycetic test to white.

Contrast: the strain contrast adds test organisms for the culture medium that does not contain medicine, and the medicine contrast is not for adding the medicinal liquid of test organisms.

The test organisms liquid 0.1ml that each concentration pipe of every row's medicinal liquid and strain control tube add 1: 2000 respectively cultivates 24 hours observed results for 36 ℃.To the oidiomycetic test of white, medicinal liquid adds behind the bacterium liquid 28 ℃ and cultivates 48 hours observed results.With the turbidity is that each pipe of index naked-eye observation has asepsis growth.

Judge that minimal inhibitory concentration (MIC): MIC is meant the minimum drug level that complete inhibition test growth is contained.The results are shown in Table 13.

Table 13 Capsules group vitro antibacterial activity of the present invention

Annotate: it is normal that strain contrasts each bacteria growing, medicine contrast asepsis growth.

Table 15 is the result show, Capsules group of the present invention is to all having antibacterial action in various degree for examination strain (mainly being encountered pathogenic bacteria and conditioned pathogen in the gynecological inflammation), to the MIC of each bacterium between 6.25 * 10 ^-3～0.1gml ^-1Between.Point out Capsules group of the present invention that most of test strains are all had certain inhibitory action, the strongest to staphylococcus aureus, staphylococcus epidermidis, beta hemolytic streptococcus, escherichia coli, Candida albicans effect.

2, antibacterial tests in the body

(1), to the protective effect of coli-infection mouse death rate

1., test material

Medicine: FUKE QIANJIN PIAN 0.32g/ sheet, large, medium and small three the dosage group 0.52g/ grains of capsule of the present invention; Amoxicillin Capsules is for federalism pharmaceutical factory, Hong Kong company limited is produced lot number: 16453;

Medicine disposes with distilled water before experiment, gastric infusion.

Strain: escherichia coli (GIM1.223=CMCC44102)

Animal: Kunming female mice, body weight 18-20g

2., test method and result

Get 90 of body weight 18～22g female mices, be divided into 6 groups at random: blank group, amoxicillin group, FUKE QIANJIN PIAN group 1.92g medicated powder/kg, Capsules group 0.52g medicated powder/kg of the present invention, 1.04g medicated powder/kg, 1.56g medicated powder/kg, the blank group gives the isometric(al) distilled water.Gastric infusion is 1 day in advance, and the upper and lower noon each 1 time, getting concentration in the 2nd day is 10 ⁹Ml ^-1Only to each group mouse peritoneal injection, in injecting the back the 1st, 6 hour, once observed continuously 7 days by each gastric infusion with 0.5ml/ for the escherichia coli suspension, and the death toll of record mice every day is calculated and respectively organized mouse death rate, relatively each group difference.Carry out the rank test that completely random designs with SPSS 10.0 statistical softwares, the results are shown in Table 14.

Table 14 pair coli-infection dead mouse protective effect

Annotate: compare * P＜0.01 with the blank group

The result shows, compares with the blank group, and the amoxicillin group has significant difference (P＜0.01), and Capsules group high dose group of the present invention variant (P＜0.05) shows that Capsules group high dose of the present invention causes dead mouse to escherichia coli certain protective role is arranged; With the FUKE QIANJIN PIAN group relatively, each dosage group of Capsules group of the present invention there are no significant difference (P＞0.05), but the mouse death rate of ehec infection is all had reduction trend (mortality rate is all less than 73.3%).Point out Capsules group of the present invention that the ehec infection dead mouse is had the certain protection effect.

(2), to the protective effect of infection of staphylococcus aureus mouse death rate

1., test material

Medicine: FUKE QIANJIN PIAN 0.32g/ sheet, large, medium and small three the dosage group 0.52g/ grains of capsule of the present invention; Amoxicillin Capsules is for federalism pharmaceutical factory, Hong Kong company limited is produced lot number: 16453;

Medicine disposes with distilled water before experiment, gastric infusion.

Strain: staphylococcus aureus (GIM1.221=CMCC26003)

Animal: Kunming female mice, body weight 18-20g

2., test method and result

Get 90 of body weight 18～22g female mices, be divided into 6 groups at random: blank group, amoxicillin group, FUKE QIANJIN PIAN group 1.92g medicated powder/kg, Capsules group 0.52g medicated powder/kg of the present invention, 1.04g medicated powder/kg, 1.56g medicated powder/kg, the blank group gives the isometric(al) distilled water.Gastric infusion is 1 day in advance, and the upper and lower noon each 1 time, getting concentration in the 2nd day is 10 ⁹Ml ^-1Only to each group mouse peritoneal injection, in injecting the back the 1st, 6 hour, once observed continuously 7 days by each gastric infusion with 0.5ml/ for the staphylococcus aureus suspension, and the death toll of record mice every day is calculated and respectively organized mouse death rate, relatively each group difference.Carry out the rank test that completely random designs with SPSS 10.0 statistical softwares, the results are shown in Table 15.

Table 15 pair infection of staphylococcus aureus dead mouse protective effect

Annotate: compare * * P＜0.05 with the blank group; * P＜0.01

The result shows, compares with the blank group, and the amoxicillin group has significant difference (P＜0.01), the equal no difference of science of statistics of the high, medium and low dosage group of FUKE QIANJIN PIAN group and Capsules group of the present invention; With the FUKE QIANJIN PIAN group relatively, the high, medium and low dosage group of Capsules group of the present invention there are no significant difference (P＞0.05), but the mouse death rate that infects staphylococcus aureus is had reduction trend (mortality rate is all less than 80%).Point out Capsules group of the present invention to have and reduce the trend that infects the staphylococcus aureus mouse death rate.

(3), to the protective effect of beta hemolytic streptococcus infecting mouse mortality rate

1., test material

Medicine: FUKE QIANJIN PIAN 0.32g/ sheet, large, medium and small three the dosage group 0.52g/ grains of capsule of the present invention; Amoxicillin Capsules is for federalism pharmaceutical factory, Hong Kong company limited is produced lot number: 16453;

Medicine disposes with distilled water before experiment, gastric infusion.

Strain: beta hemolytic streptococcus (GIM1.143=CMCC32210)

Animal: Kunming female mice, body weight 18-20g

2., test method and result

Get 90 of female mices, body weight 18～22g is divided into 6 groups at random, the blank group, amoxicillin group, FUKE QIANJIN PIAN group 1.92g medicated powder/kg, Capsules group 0.52g medicated powder/kg of the present invention, 1.04g medicated powder/kg, 1.56g medicated powder/kg, the blank group gives the isometric(al) distilled water.Gastric infusion is 1 day in advance, and the upper and lower noon each 1 time, getting concentration in the 2nd day is 10 ⁹Ml ^-1Only to each group mouse peritoneal injection, in injecting the back the 1st, 6 hour, once observed continuously 7 days by each gastric infusion with 0.5ml/ for the beta hemolytic streptococcus suspension, and the death toll of record mice every day is calculated and respectively organized mouse death rate, relatively each group difference.Carry out the rank test that completely random designs with SPSS 10.0 statistical softwares, the results are shown in Table 16.

The dead protective effect of table 16 pair beta hemolytic streptococcus infecting mouse

Annotate: compare * P＜0.01 with the blank group

The result shows, compares with the blank group, and the amoxicillin group has significant difference (P＜0.01), and the high, medium and low dosage group of FUKE QIANJIN PIAN group and Capsules group of the present invention does not all have significant difference (P＜0.05); With the FUKE QIANJIN PIAN group relatively, each dosage group of Capsules group of the present invention there are no significant difference (P＞0.05), but the mouse death rate that infects beta hemolytic streptococcus is had reduction trend (mortality rate is all less than 93.3%).Point out Capsules group of the present invention to have and reduce the trend that infects the beta hemolytic streptococcus mouse death rate.

Seven, conclusion

Result of the test shows: capsule group of the present invention obviously resists the granuloma that rat toes swelling due to dimethylbenzene induced mice auricle edema, the carrageenin, cotton balls cause; Dichlorodiphenyl Acetate lumbar injection and thermostimulation induced mice pain all have significant analgesia role; Has the phagocytosis that strengthens mice reticuloendothelial system carbon clearance; Obviously expansion Mice Auricle vein blood vessel bore has the microcirculation improvement effect; Rat intestine adhesion due to the escherichia coli had remarkable inhibitory action; Rat pelvic inflammatory disease model has certain inhibitory action due to the pathogenic bacterium (escherichia coli, staphylococcus aureus, beta hemolytic streptococcus) to mixing; Suppress the effect of seven kinds of common gynecological inflammation pathogenic bacterium such as staphylococcus aureus, staphylococcus epidermidis, escherichia coli, Pseudomonas aeruginosa, beta hemolytic streptococcus, Candida albicans, proteus mirabilis, wherein stronger to staphylococcus aureus, beta hemolytic streptococcus, colibacillary bacteriostasis; Bacteriostatic test shows in the body, can significantly reduce injection staphylococcus aureus, beta hemolytic streptococcus, escherichia coli mortality of mice, demonstrates antibacterial action preferably.

Acute toxicity testing is the result show: the LD of capsule of the present invention is not measured in trial test ₅₀Carried out the maximum dosage-feeding experiment of capsule of the present invention, promptly with the tolerant heap(ed) capacity of white mice (40mL/kg body weight) be subjected to the Cmax (gastric infusion of 0.85g medicated powder/mL) 1 time of reagent, dosage reaches 34g medicated powder/kg body weight (163g crude drug/kg body weight), is equivalent to 654 times of Coming-of-Age Day consumption.Observed for two weeks none death of animal, no abnormality seen reaction continuously.Show that this capsule does not have acute toxic reaction.

Long term toxicity test is the result show: select the Wistar rat for use, every group 20, give respectively distilled water or variable concentrations (7.8,5.2, the capsule of the present invention of 2.6g medicated powder/kg), be equivalent to 150,100,50 times of clinical dosage, gastric infusion is 6 times weekly, continuous 6 months, respectively organized 10 animals extremely that live in 24 hours after the last administration, all the other 10 animals continuation observation 2 all backs are extremely alive.Result of the test shows: in June after the administration, each treated animal generally in order; Three dosage groups and matched group hematological examination, blood biochemical are learned, the urine biochemical analysis is all in normal range, do not have significant difference between group; System dissects, the also no abnormal pathological change of organ coefficient and histopathological examination.The These parameters drug withdrawal is not seen change after 2 weeks yet.Capsule of the present invention is not found overt toxicity reaction and delayed toxicity reaction in long term toxicity test.Point out capsule non-toxic reaction of the present invention, long-term prescription is safe and reliable.

Clinical trial

Clinical observation patient 134 examples of the present invention are used for hypogastric region distending pain or twinge or lumbosacral region cold type of pain, leucorrhea abnormal etc. that pelvic inflammatory disease, adnexitis, endometritis, chronic cervicitis etc. cause.Clinical observation shows: after the patient uses the present invention, can alleviate clinical symptoms at short notice, patient stomachache, lumbosacral aching pain alleviates or disappear; Leukorrhagia turns to normally gradually, and the patient is continuously after the treatment, fully recovers on inspection or is clearly better, and total effective rate of the present invention is 97.9%, and the regulating the flow of QI to dissipate blood stasis pain relieving is described, drying damp and strengthening spleen exact efficacy.In clinical chicken coop process, do not find that the patient has untoward reaction and anaphylaxis, illustrate that this product is safe and effective.

The above, it only is preferred embodiment of the present invention, be not that the present invention is done any pro forma restriction, though the present invention discloses as above with preferred embodiment, yet be not in order to limit the present invention, any those skilled in the art, in not breaking away from the technical solution of the present invention scope, when the technology contents that can utilize above-mentioned announcement is made a little change or is modified to the equivalent embodiment of equivalent variations, in every case be not break away from the technical solution of the present invention content, according to technical spirit of the present invention to any simple modification that above embodiment did, equivalent variations and modification all still belong in the scope of technical solution of the present invention.

Claims (9)

1. Chinese medicine composition for the treatment of pelvic inflammatory disease, it is characterized in that: this Chinese medicine composition is to be prepared from by following raw materials in weight portion:

2. the Chinese medicine composition of treatment pelvic inflammatory disease according to claim 1 is characterized in that: this Chinese medicine composition can add adjuvant and make any dosage form of accepting on the pharmaceutics.

3. the Chinese medicine composition of treatment pelvic inflammatory disease according to claim 2 is characterized in that: described dosage form can be capsule, tablet, granule, pill, powder, unguentum, suppository, oral liquid, injection, lotion, liniment, aerosol, spray, enema.

4. the Chinese medicine composition of treatment pelvic inflammatory disease according to claim 3 is characterized in that: described injection is an injectable powder.

5. preparation method for the treatment of the Chinese medicine composition of pelvic inflammatory disease, it is characterized in that: get Radix Angelicae Sinensis 150 weight portions, Radix Paeoniae Rubra 300 weight portions, rhizoma sparganic 150 weight portions, Rhizoma Curcumae 150 weight portions, Fructus Toosendan 150 weight portions, Rhizoma Cyperi 100 weight portions, Rhizoma Corydalis 150 weight portions, Rhizoma Atractylodis 150 weight portions, Rhizoma Dioscoreae 300 weight portions, Cortex Phellodendri 150 weight portions, Rhizoma Smilacis Glabrae 250 weight portions, Radix Flemingiae Philippinensis 250 weight portions, Rhizoma Smilacis Chinensis 250 weight portions, adopt supercritical carbon dioxide extraction, 70%～95% ethanol extraction, any 1～3 kind of technology in three kinds of extraction processes of water extraction makes up extraction, and extracting solution concentrates the back and carries out molding by the different dosage form requirement.

6. the preparation method of the Chinese medicine composition of treatment pelvic inflammatory disease according to claim 5 is characterized in that it comprises step:

1) Rhizoma Curcumae, Radix Angelicae Sinensis, Rhizoma Atractylodis, Rhizoma Cyperi are ground into coarse powder, use supercritical carbon dioxide extraction, extracting parameter is extracting pressure 22-26MPa, extraction temperature 45-55 ℃, resolve pressure 5～6MPa, resolution temperature 45-60 ℃, 0.5-2.5 hour extraction time, the gained extract is standby;

2) Cortex Phellodendri, Rhizoma Corydalis are ground into coarse powder, add ethanol extraction with the medicinal residues behind the supercritical extraction, extraction conditions is that concentration of alcohol is 60-90%, add ethanol extraction 1-3 time, the 4-12 that adds amount of alcohol and be Rhizoma Curcumae, Radix Angelicae Sinensis, Rhizoma Atractylodis, Rhizoma Cyperi, Cortex Phellodendri, Rhizoma Corydalis 6 flavor medical material mixture doubly each 0.5-2 hour, decocts temperature and is controlled at 70 ℃ to boiling, extracting solution filters, and relative density is 1.05～1.15 concentrated solution during filtrate vacuum concentration to 60 ℃;

3) Radix Paeoniae Rubra, Rhizoma Dioscoreae, Rhizoma Smilacis Chinensis, Rhizoma Smilacis Glabrae, Radix Flemingiae Philippinensis, rhizoma sparganic, Fructus Toosendan, decoct with water, extraction conditions is for decocting with water 1-3 time, amount of water be Radix Paeoniae Rubra, Rhizoma Dioscoreae, Rhizoma Smilacis Chinensis, Rhizoma Smilacis Glabrae, Radix Flemingiae Philippinensis, rhizoma sparganic, Fructus Toosendan 7 flavor medical material mixture 4-12 doubly, each 0.5-2 hour, decoct temperature and be controlled at 80 ℃ to boiling, extracting solution filters, the concentrated solution of filtrate vacuum concentration to 60 ℃ relative density 1.05～1.15;

4) with step 2) and the mixing of step 3) gained concentrated solution, the thick paste of relative density 1.35～1.45 when being concentrated into 55 ℃;

5) adopt vacuum microwave drying to carry out drying step 4) gained thick paste, drying parameter is: thick paste/microwave power ratio is 1.0～1.6Kg/KW, vacuum-0.08～-0.09MPa, 60-90 ℃ of dry run ceiling temperature, 3 ℃ of return difference temperature, dry terminal point is that material does not have obvious foaming back 10min, and institute gets dry extract standby.

7. the preparation method of the Chinese medicine composition of treatment pelvic inflammatory disease according to claim 6, it is characterized in that: with get dry extract, pulverize, add carboxymethyl starch sodium, sucrose, dextrin, stevioside, starch, Pulvis Talci at least a adjuvant wherein, with supercritical extract, mixing, supplementary product consumption is a Radix Angelicae Sinensis, Radix Paeoniae Rubra, rhizoma sparganic, Rhizoma Curcumae, Fructus Toosendan, Rhizoma Cyperi, Rhizoma Corydalis, Rhizoma Atractylodis, Rhizoma Dioscoreae, Cortex Phellodendri, Rhizoma Smilacis Glabrae, Radix Flemingiae Philippinensis, the 2.5-4.0% of Rhizoma Smilacis Chinensis 13 flavor medical material mixture amounts, wherein, the adjuvant carboxymethyl starch sodium, sucrose, dextrin, stevioside, starch, talcous weight portion proportioning is any ratio, and dry-pressing is granulated.

8. the preparation method of the Chinese medicine composition of treatment pelvic inflammatory disease according to claim 7 is characterized in that: above-mentioned dry-pressing makes capsule after granulating and dressing up capsule; Or tabletting makes tablet; Or packing makes granule.

9. the preparation method of the Chinese medicine composition of treatment pelvic inflammatory disease according to claim 5 is characterized in that it comprises step:

1) Rhizoma Curcumae, Radix Angelicae Sinensis, Rhizoma Atractylodis, Rhizoma Cyperi are ground into coarse powder, use supercritical carbon dioxide extraction, extracting parameter is extracting pressure 22-26MPa, extraction temperature 45-55 ℃, resolve pressure 5～6MPa, resolution temperature 45-60 ℃, 0.5-2.5 hour extraction time, the gained extract is standby;

2) Cortex Phellodendri, Rhizoma Corydalis are ground into coarse powder, add ethanol extraction with the medicinal residues behind the supercritical extraction, extraction conditions is that concentration of alcohol is 60-90%, add ethanol extraction 1-3 time, the 4-12 that adds amount of alcohol and be Rhizoma Curcumae, Radix Angelicae Sinensis, Rhizoma Atractylodis, Rhizoma Cyperi, Cortex Phellodendri, Rhizoma Corydalis 6 flavor medical material mixture doubly each 0.5-2 hour, decocts temperature and is controlled at 70 ℃ to boiling, extracting solution filters, and relative density is 1.05～1.15 concentrated solution during filtrate vacuum concentration to 60 ℃;

3) Radix Paeoniae Rubra, Rhizoma Dioscoreae, Rhizoma Smilacis Chinensis, Rhizoma Smilacis Glabrae, Radix Flemingiae Philippinensis, rhizoma sparganic, Fructus Toosendan, decoct with water, extraction conditions is for decocting with water 1-3 time, amount of water be Radix Paeoniae Rubra, Rhizoma Dioscoreae, Rhizoma Smilacis Chinensis, Rhizoma Smilacis Glabrae, Radix Flemingiae Philippinensis, rhizoma sparganic, Fructus Toosendan 7 flavor medical material mixture 4-12 doubly, each 0.5-2 hour, decoct temperature and be controlled at 80 ℃ to boiling, extracting solution filters, the concentrated solution of filtrate vacuum concentration to 60 ℃ relative density 1.05～1.15;

4) to step 2) and step 3) gained concentrated solution in add the 2-5g sodium benzoate, add water, stir evenly, fill makes oral liquid.