CN100581568C - Production of slow-releasing capsule in treatment of pelvic inflammatory disease - Google Patents

Abstract

The invention is concerned with the method of preparation of the capsule for pelvic inflamatroy disease therapy that is in dry cream form extracts from leatherleaf milletia, creat, leatherleaf mahonia, prickly ash, Qianjin Stubbs, and cherry-kan by ethanol or water, adds into 0.5-5% spermaceti wax or other retarder dressing and separates into 2,4,6,8 hours releasing pills with different identify colors and mixes into empty capsule, pack the pilles into boxes to get the final products.

Description

A kind of production method for the treatment of the slow releasing capsule of pelvic inflammatory disease

The application is the dividing an application of patent application of application number 200510055523.7, and 200510055523.7 patent application days were on March 16th, 2005, and denomination of invention is a kind of medicine and production method thereof for the treatment of pelvic inflammatory disease.

Technical field

The present invention relates to a kind of medicine for the treatment of pelvic inflammatory disease, particularly relate to and treat medicine and the production method thereof that endometritis, adnexitis belong to syndrome of dampness-heat diffusing downward.

Background technology

Pelvic inflammatory disease refers to the inflammation that female internal genital organs and connective tissue on every side thereof, pelvic peritoneum take place, can be divided into acute and chronic two classes, clinical its pathological change of acute and chronic pelvic inflammatory disease comprises endometritis, myometritis, adnexitis, inflammation of pelvic connective tissue and pelvioperitonitis, wherein adnexitis is the most common, when body's immunity descends, endocrine changes or exogenous pathogenic bacterium are invaded, all can cause the generation of inflammation.To be pathogen invade through the placental separation face endometritis, is diffused into the uterine decidua layer and the inflammation that causes, and pilosity is born in intrauterine surgical, miscarriage and puerperal; Adnexitis claims adnexitis again, for perioophoritis takes place for the fimbriated extremity of fallopian adhesion of ovary and inflammation.Above inflammation is everlasting after fatigue, the sexual intercourse, increase the weight of during defecation and menstruation before and after increase the weight of.

China tradition traditional Chinese medical science has a lot of treatises to the treatment of pelvic inflammatory disease, has also put down in writing the Chinese medicinal formulae of many treatment pelvic inflammatory disease, and these prescriptions are one of China's pools of traditional Chinese medicine important compositions according to the different syndromes of pelvic inflammatory disease and different.The ancient Chinese medicine theory is fully being summed up, excavating and utilized to the modern Chinese medicine theory also, and many science treatises have also proposed the method and the medicine of a large amount of Chinese traditional treatment pelvic inflammatory disease, and the Chinese traditional treatment pelvic inflammatory disease has been played directive function preferably.Some pharmaceutical factories and Chinese medicine institute department have also released the Chinese patent medicine of some treatment pelvic inflammatory disease over the years, but the price that these Chinese patent medicines have is higher, and patient is difficult to accept, and the specific aim that has is not strong, and curative effect only plays the auxiliary treatment effect not as people's will.

Applicant Lingfeng Pharmaceutical Co., Ltd., Guangxi, from motherland's traditional medical theory, through research for many years, screen tens kinds of Chinese medicinal formulaes, compared repeatedly, therefrom chosen some medicines and prescription, pharmacodynamics, pharmacology and research experiment such as clinical have been carried out, produced by Chinese medicines such as Radix Rosae Laevigatae, Caulis Spatholobi, Caulis Mahoniae, Radix Zanthoxyli, Radix Flemingiae Philippinensis, Herba Andrographis and formed, had the invigorate blood circulation JINJI PIAN of effect of heat-clearing and toxic substances removing, spleen invigorating dehumidifying, collateral dredging, as gynecological's anti-inflammatory agent commonly used.This JINJI PIAN is carried out clinical trial in several years ago offering more domestic hospitals, has received effect preferably.These hospitals have also delivered some articles on technical journal, as 1, [autograph] Chinese general family medicine .2003 of oral JINJI PIAN treatment chronic endometritis 80 routine observation of curative effect [author] Qi Gang [mechanism] the People's Hospital of Linyi City, Shandong Province department ofs Chinese medicine [periodical name] when selecting, 6 (2) .-157-157.2, the Shandong journal of Chinese medicine .1999 of best medicine time of [author] Qi Gang Wei Xuan [mechanism] the Linyi City the People's Hospital of [autograph] JINJI PIAN treatment chronic endometritis [periodical name], 18 (4) .-157-158[digests] treatment organizes 40 examples, only took JINJI PIAN on the 1st of menstrual onset the day, other times are not obeyed, each 6, day 3 times, take 1-3 menstrual cycle, matched group 20 examples all can be taken at ordinary times any time, each 6, days 3 times, logotype 10d, result: treatment group 40 examples of fully recovering, total effective rate 100%, effective 12 examples of matched group, invalid 8 examples, total effective rate 60%, two groups of curative effects are learned processing by statistics, have significant differences (P＜0.01 〉.

But the above-mentioned article of publishing just discloses the part ingredient, does not disclose the preparation method of content and medicine, that is to say the not full disclosure on document of the drug products of treatment pelvic inflammatory disease of the present invention and preparation method.

Summary of the invention

The purpose of this invention is to provide a kind of to pelvic inflammatory disease is with strong points, evident in efficacy, prescription is uncomplicated, moderate Chinese patent medicine and production method thereof.

The inventor is in secular medical practice; original national Chinese medicine protection kind JINJI PIAN has been carried out the dosage form improvement; processing technology is also reformed; be prepared into capsule; and pharmacodynamics, pharmacology and research experiment such as clinical have been carried out again; finally invented a kind of good effect, medicine source extensively, moderate, production technology advanced feasible, use Chinese patent medicine more easily; the medicine of this treatment pelvic inflammatory disease is made by raw material of Chinese medicine Radix Rosae Laevigatae, Caulis Spatholobi, Caulis Mahoniae, Radix Zanthoxyli, Radix Flemingiae Philippinensis, Herba Andrographis, and its composition and mass fraction are as follows:

10～30 parts of Radix Rosae Laevigataes, 20～40 parts of Caulis Spatholobis, 10～30 parts of Radix Flemingiae Philippinensiss, 10～30 parts of Caulis Mahoniaes, 3～15 parts of Radix Zanthoxylis, 1～15 part of Herba Andrographis.

Above-mentioned Chinese medicine can be from " finding its another name, latin name and the place of production, usage Chinese pharmacopoeia and other Chinese medicine handbook, in order to understand the mechanism that the present invention treats disease, now respectively distinguish the flavor of in the prescription effect of Chinese medicine and the effect in prescription thereof are described below: Caulis Spatholobi is enriched blood, invigorate blood circulation, collateral dredging is monarch drug; The Radix Rosae Laevigatae reinforcing the kidney and controlling nocturnal emission; The Radix Flemingiae Philippinensis wind-damp dispelling, strong waist knee joint; The Caulis Mahoniae heat clearing and damp drying, eliminating fire and detoxication is ministerial drug altogether; The Radix Zanthoxyli promoting the circulation of QI to relieve pain, blood circulation promoting and blood stasis dispelling, dispelling wind and removing obstruction in the collateral; The Herba Andrographis heat-clearing and toxic substances removing, removing heat from blood, detumescence is adjuvant altogether.

Chinese medicine composition best in quality umber content of the present invention is:

15～20 parts of Radix Rosae Laevigataes, 30～35 parts of Caulis Spatholobis, 16～20 parts of Radix Flemingiae Philippinensiss, 16～20 parts of Caulis Mahoniaes,

5～8 parts of Radix Zanthoxylis, 4～7 parts of Herba Andrographis.

The composition of Chinese medicine composition of the present invention and content the best in quality also can adopt following proportioning (weight portion):

Radix Rosae Laevigatae 8; Caulis Spatholobi 15; Radix Flemingiae Philippinensis 8; Caulis Mahoniae 8; Radix Zanthoxyli 3; Herba Andrographis 2.5.

Above-mentioned composition can be used as the prescription of institute of traditional Chinese medicine's treatment pelvic inflammatory disease, and patients is fried in shallow oil soup and taken; Be more suitable for modern pharmaceutical enterprise and extract its effective ingredient, make capsule, slow releasing capsule, soft capsule, drop pill, oral liquid, soft extract, perhaps make any dosage form on the pharmaceutics, concrete production method is as follows:

1, the production method of capsule:

(1) get the 1/25-10/25 of Herba Andrographis total amount, it be ground into fine powder with superfine communication technique, with 100～120 ℃ of high pressure steam sterilization 30-60 minutes, intermediate products A;

(2) get remaining Herba Andrographis with the soak with ethanol of volumetric concentration 60-80% 1 hour, the alcohol extraction that refluxes, the later solution of alcohol extraction reclaims ethanol, alcohol extraction part B;

(3) Caulis Mahoniae, Radix Zanthoxyli decoct twice, and each 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, concentrated to such an extent that water is put forward portion C;

(4) with Radix Rosae Laevigatae, Caulis Spatholobi, after-filtration of Radix Flemingiae Philippinensis decocting in water, with the later medicinal residues decocting in water of alcohol extraction, each equal 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, concentrated to such an extent that water is carried part D with the medicinal residues after the filter;

(5) merge above-mentioned B, C, D thick paste mixing, merge with A, drying is ground into fine powder, gets intermediate products dried cream powder E;

(6) get intermediate products dried cream powder E mixing, granulate, encapsulated with the appropriate amount of auxiliary materials mixing, In Aluminium Foil Packing, packing gets the finished capsule product agent.

Also can adopt following method to prepare capsule:

(1) 1/25-10/25 that gets the Herba Andrographis total amount is ground into fine powder, with 100～120 ℃ of high pressure steam sterilization 30-60 minutes, intermediate products A;

(2) get remaining Herba Andrographis and add 5～8 times of water gagings with whole Radix Rosae Laevigataes, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli, soaked 1 hour, decoct twice, each 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, got water and carried part B;

(3) B is concentrated, get thick paste, merge mixing with A, drying is ground into fine powder, gets intermediate products dried cream powder E;

(4) get intermediate products dried cream powder mixing, granulate, encapsulated with the appropriate amount of auxiliary materials mixing, In Aluminium Foil Packing, packing gets the finished capsule product agent.

Above-described adjuvant is a magnesium stearate, or meets other adjuvant of international and national Specification, and addition is the 0.3-1% of dried cream powder.

2, the production method of slow releasing capsule:

(1) get Herba Andrographis, Caulis Mahoniae with the soak with ethanol of volumetric concentration 60-80% 1 hour, the alcohol extraction that refluxes, the later solution of alcohol extraction reclaims ethanol, the alcohol extraction part A;

(2) Radix Rosae Laevigatae, Radix Zanthoxyli, Radix Flemingiae Philippinensis decoct twice, and each 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, concentrated to such an extent that water is carried part B;

(3) with Caulis Spatholobi decocting in water secondary, each 2～3 hours, merge twice leach cooking liquid and filter, filtrate is concentrated into relative density 1.05-1.20/55-60 ℃, add ethanol then and make and contain the alcohol amount and reach 80%, leave standstill, get supernatant concentration and get intermediate products C;

(4) merge above-mentioned A, B, C thick paste mixing, drying is ground into fine powder, gets intermediate products dried cream powder D;

(5) according to the total amount of intermediate products dried cream powder, add spermaceti or other blocker coating of 0.5-5%, make 2,4,6,8 hours slow-release pills respectively, every kind of piller is distinguished with different color and lusters, pack into behind the mix homogeneously in the capsulae vacuus, be packaged into box or hot pressing war aluminium-plastic panel and obtain product.

3, the production method of soft capsule:

(1) get Herba Andrographis, Caulis Mahoniae with the soak with ethanol of volumetric concentration 60-80% 1 hour, the alcohol extraction that refluxes, the later solution of alcohol extraction reclaims ethanol, the alcohol extraction part A;

(2) Radix Rosae Laevigatae, Radix Zanthoxyli, Radix Flemingiae Philippinensis decoct twice, and each 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, concentrated to such an extent that water is carried part B;

(3) with Caulis Spatholobi decocting in water secondary, each 2～3 hours, merge twice leach cooking liquid and filter, filtrate is concentrated into relative density 1.05-1.20/55-60 ℃, add ethanol then and make and contain the alcohol amount and reach 80%, leave standstill, get supernatant concentration and get intermediate products C;

(4) merge above-mentioned A, B, C thick paste mixing, drying is ground into fine powder, gets intermediate products dried cream powder D;

(5) get intermediate products dry extract D, vegetable oil, Cera Flava by making suspended matter at 1: 1: 0.02, with gelatin: glycerol: water is that 1: 0.35: 0.9 ratio prepares rubber, then the suspended matter fill is pressed into soft capsule, typing below 25 ℃, with ethanol flush away soft capsule appearance oil reservoir, in dry below 25 ℃, take out the soft capsule that gets product.

4, the production method of drop pill:

With the polyethylene glycol 6000 heating and melting, get the intermediate products dried cream powder again and add, stir evenly, be transferred on the drop pill device, 86 ℃ of airtight insulations are made coolant with 10 ℃ of-15 ℃ of liquid paraffin, and with the 50/component velocity system of dripping, drop pill gets product.

5, the production method of oral liquid:

(1) get Herba Andrographis with the soak with ethanol of volumetric concentration 60-80% 1 hour, the alcohol extraction that refluxes, the later solution of alcohol extraction reclaims ethanol, the alcohol extraction part A;

(2) Caulis Mahoniae, Radix Zanthoxyli decoct twice, and each 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, concentrated to such an extent that water is carried part B;

(3) with Radix Rosae Laevigatae, Caulis Spatholobi, after-filtration of Radix Flemingiae Philippinensis decocting in water, with the later after-filtration of medicinal residues decocting in water of alcohol extraction, each equal 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, concentrated to such an extent that water is put forward portion C with the medicinal residues after the filter;

(4) merge above-mentioned A, B, three kinds of clear paste of C, mixing concentrates, and gets relative density 1.05-1.20/55-60 ℃ intermediate products fluid extract D;

(5) get intermediate products D and an amount of syrup or Mel mixing, sterilization, fill gets the finished product oral liquid.

6, the production method of soft extract:

(1) get Herba Andrographis with the soak with ethanol of volumetric concentration 60-80% 1 hour, the alcohol extraction that refluxes, the later solution of alcohol extraction reclaims ethanol, the alcohol extraction part A;

(2) Caulis Mahoniae, Radix Zanthoxyli decoct twice, and each 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, concentrated to such an extent that water is carried part B;

(3) with Radix Rosae Laevigatae, Caulis Spatholobi, after-filtration of Radix Flemingiae Philippinensis decocting in water, with the later after-filtration of medicinal residues decocting in water of alcohol extraction, each equal 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, concentrated to such an extent that water is put forward portion C with the medicinal residues after the filter;

(4) merge above-mentioned A, B, three kinds of clear paste of C, mixing concentrates, and gets relative density 1.15-1.25/55-60 ℃ intermediate products fluid extract D;

(5) get intermediate products D and an amount of syrup and Mel mixing, sterilization, fill gets the finished product soft extract.

Other dosage form such as pill, Film coated tablets, buccal tablet etc. can carry out with reference to pharmacopeia or Chinese medicinal preparation method.

The extracting method of above-mentioned Chinese medicine composition has provided alcohol extraction+water and has carried, except carrying with alcohol extraction+water, can also adopt the extracting method of microwave, ultrasonic extraction, carbon dioxide supercritical fluid extraction or other Chinese medicine preparation, these extracting method have had report in scientific and technical literature, pharmacy corporation can adopt extracting method according to concrete practical situation, its objective is extracts active ingredients with Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli, Herba Andrographis, make any dosage form pharmaceutically, just can provide to dose a patient with.

Instructions of taking:

Capsule, oral, one time 4,3 times on the one, every 0.35 the gram.

Slow releasing capsule, oral, one time 5,1-2 time on the one, every 0.5 the gram.

Soft capsule, oral, one time 4,3 times on the one;

Drop pill, oral, one time 4,3 times on the one;

Oral liquid, every day 3 times, each 10ml.

Soft extract, every day 3 times, each 10ml.

The present invention compared with the prior art, its outstanding substantive distinguishing features and obvious improvement is:

The present invention is preferred above-mentioned Chinese medicine under Chinese medical theory instructs, science compatibility, making in addition, make each medicine cooperatively interact, can guarantee to greatest extent the group effect and the pharmaceutically-active performance of this product reasonable formula, all medicines share, play the effect that heat-clearing and toxic substances removing, spleen invigorating dehumidifying, collateral dredging are invigorated blood circulation altogether, can effectively treat gynecology pelvic inflammatory disease.

1, proves through animal experiment, that the present invention has is antibiotic, antiinflammatory, analgesic activity: 0.31% drug level has inhibitory action to staphylococcus aureus, 2.5% drug level has inhibitory action to beta hemolytic streptococcus, and 5% drug level has inhibitory action to escherichia coli; To white mice foot swelling due to the Oleum Tiglii have rat ear swelling inhibitory action due to obvious suppression effect, the on Carrageenan obviously, to the inhibitory action of white mice granulation tissue hyperplasia due to the cotton balls very obviously, can suppress the increase of intraperitoneal mouse capillary permeability due to the acetic acid; Can significantly suppress due to the acetic acid white mice turns round the body number of times, can significantly improve the white mice hot plate reaction threshold of pain after administration; The intraperitoneal mouse of enhancing macrophage phagocytic function is arranged, promote that PHA induces the LT effect of white mice.

2, the medicine of this treatment pelvic inflammatory disease is on the basis of original tablet, makes through change dosage form and improvement production technology.

3, raw material is easy to get, the prescription science, and moderate product price is fit to suitability for industrialized production.

4, production technology adopts pulverizing, water to mention corresponding sterilizing methods, and increased alcohol extraction step (extracting the alkaloid, tannin of the active ingredient esters etc. of Herba Andrographis, the flavonoid of Caulis Spatholobi etc., Caulis Mahoniae etc.) according to practical situation, difference extractive technique (guaranteeing that alkaloid in the merit Radix Zanthoxyli, tannin propose), thereby product active constituent content height, the bioavailability height, and not perishable, long shelf-life.

5, production technology advanced person, workable, according to each flavor Effective Components of Chinese Herb character and preparation requirement, successively adopt international advanced pharmaceutical technology and equipment such as superfine communication technique, multiple-effect decompression technology, spray drying technology, three-dimensional hybrid technology in the production.

6, the result of product studies on acute toxicity of the present invention and long term toxicity research shows, is safe by intending with using the daily dose and the course of treatment product of the present invention.

7, several capsule preparations of the present invention compared with the advantage of existing tablet is:

(1) good absorbing effect, some patients reflection, it is very fast to take capsular produce effects, just produces effect in second day.From the angle of medical science, capsular disintegration rate is faster compared with tablet.

(2) diabetics is taken coated tablet taboo, does not just have this phenomenon and take capsule.

(3) capsule simple grain content is higher, thus take negligible amounts, as tablet need one time 6, and capsule only need one time 4.

The specific embodiment

Below be embodiments of the invention:

Embodiment 1

Take by weighing following Chinese medicine ingredients (unit: g)

Radix Rosae Laevigatae 18.8; Caulis Spatholobi 32.7; Radix Flemingiae Philippinensis 18.1; Caulis Mahoniae 18.3; Radix Zanthoxyli 7.5; Herba Andrographis 6.60;

Its production stage is:

(1) get the 2.1g of Herba Andrographis total amount, it be ground into fine powder with superfine communication technique, with 100～120 ℃ of high pressure steam sterilization 30-60 minutes, intermediate products A;

(2) get remaining Herba Andrographis 4.5g with the soak with ethanol of volumetric concentration 60-80% 1 hour, the alcohol extraction that refluxes, the later solution of alcohol extraction reclaims ethanol, alcohol extraction part B;

(3) Caulis Mahoniae, Radix Zanthoxyli decoct twice, and each 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, concentrated to such an extent that water is put forward portion C;

(4) with Radix Rosae Laevigatae, Caulis Spatholobi, after-filtration of Radix Flemingiae Philippinensis decocting in water, with the later medicinal residues decocting in water of alcohol extraction, each equal 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, concentrated to such an extent that water is carried part D with the medicinal residues after the filter;

(5) merge above-mentioned B, C, D thick paste mixing, drying is ground into fine powder, gets intermediate products dried cream powder E;

(6) get intermediate products dried cream powder E and A and merge mixing, granulate, encapsulated with the appropriate amount of auxiliary materials mixing, In Aluminium Foil Packing, packing gets finished product, and name of product is " JINJI JIAONANG ".

Embodiment 2

Take by weighing following Chinese medicine ingredients (unit: g)

Radix Rosae Laevigatae 8, Caulis Spatholobi 15, Radix Flemingiae Philippinensis 8, Caulis Mahoniae 8, Radix Zanthoxyli 3, Herba Andrographis 2.5;

Its production stage is:

(1) get the 0.8g of Herba Andrographis total amount, it be ground into fine powder with superfine communication technique, with 100～120 ℃ of high pressure steam sterilization 30-60 minutes, intermediate products A;

(2) get remaining Herba Andrographis 1.7 weight portions with the soak with ethanol of volumetric concentration 60-80% 1 hour, the alcohol extraction that refluxes, the later solution of alcohol extraction reclaims ethanol, alcohol extraction part B;

(3) Caulis Mahoniae, Radix Zanthoxyli decoct twice, and each 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, concentrated to such an extent that water is put forward portion C;

(4) with Radix Rosae Laevigatae, Caulis Spatholobi, after-filtration of Radix Flemingiae Philippinensis decocting in water, with the later medicinal residues decocting in water of alcohol extraction, each equal 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, concentrated to such an extent that water is carried part D with the medicinal residues after the filter;

(5) merge above-mentioned B, C, D thick paste mixing, drying is ground into fine powder, gets intermediate products dried cream powder E;

(6) get intermediate products A and E and merge, granulate, encapsulated with the appropriate amount of auxiliary materials mixing, In Aluminium Foil Packing, packing gets finished product, and name of product is " JINJI JIAONANG ".

Embodiment 3

Take by weighing following Chinese medicine ingredients (unit: g)

Radix Rosae Laevigatae 23.4; Caulis Spatholobi 38.8; Radix Flemingiae Philippinensis 22.9; Caulis Mahoniae 23.2; Radix Zanthoxyli 8.8; Herba Andrographis 8.1;

Its production stage is:

(1) get the 3g of Herba Andrographis total amount, be ground into fine powder, with 100～120 ℃ of high pressure steam sterilization 30-60 minutes, intermediate products A;

(2) get remaining Herba Andrographis 5.1g with the Radix Rosae Laevigatae that weighs up, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli, add 5～8 times of water gagings, decoct twice, each 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, got water and carried part B;

(3) B is concentrated, drying is ground into fine powder, gets intermediate products dried cream powder C;

(4) get intermediate products A and C mixing, granulate, encapsulated with the appropriate amount of auxiliary materials mixing, In Aluminium Foil Packing, packing gets finished product, and name of product is " JINJI JIAONANG ".

Embodiment 4

Take by weighing following Chinese medicine ingredients (unit: g)

Radix Rosae Laevigatae 16, Caulis Spatholobi 30, Radix Flemingiae Philippinensis 16, Caulis Mahoniae 16, Radix Zanthoxyli 6, Herba Andrographis 5.

Its production stage is:

(1) get the 2g of Herba Andrographis total amount, be ground into fine powder, with 100～120 ℃ of high pressure steam sterilization 30-60 minutes, intermediate products A;

(2) get remaining Herba Andrographis 3g and add 5～8 times of water gagings with the Radix Rosae Laevigatae that weighs up, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli, soaked 1 hour, decoct twice, each 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, got water and carried part B;

(3) B is concentrated, get thick paste, drying is ground into fine powder, gets intermediate products dried cream powder C;

(4) get intermediate products A and C mixing, granulate, encapsulated with the appropriate amount of auxiliary materials mixing, In Aluminium Foil Packing, packing gets finished product, and name of product is " JINJI JIAONANG ".

Embodiment 5

Take by weighing following Chinese medicine ingredients (unit: g)

Radix Rosae Laevigatae 20, Caulis Spatholobi 35, Radix Flemingiae Philippinensis 20, Caulis Mahoniae 20, Radix Zanthoxyli 8, Herba Andrographis 7.

Its production stage is:

(1) get the 3g of Herba Andrographis total amount, it be ground into fine powder with superfine communication technique, with 100～120 ℃ of high pressure steam sterilization 30-60 minutes, intermediate products A;

(2) get remaining Herba Andrographis 4g and add 5～8 times of water gagings with the Radix Rosae Laevigatae that weighs up, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli, soaked 1 hour, decoct twice, each 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, got water and carried part B;

(3) B is concentrated, get thick paste, drying is ground into fine powder, gets intermediate products dried cream powder C;

(4) get intermediate products A and C mixing, granulate, encapsulated with the appropriate amount of auxiliary materials mixing, In Aluminium Foil Packing, packing gets finished product, and name of product is " JINJI JIAONANG ".

Embodiment 6

Take by weighing following Chinese medicine ingredients (unit: g)

Radix Rosae Laevigatae 18, Caulis Spatholobi 33.7, Radix Flemingiae Philippinensis 18, Caulis Mahoniae 18, Radix Zanthoxyli 6.7, Herba Andrographis 5.6.

Its production stage is:

(1) get the 2.1g of Herba Andrographis total amount, be ground into fine powder, with 100～120 ℃ of high pressure steam sterilization 30-60 minutes, intermediate products A;

(2) get remaining Herba Andrographis 3.5g and add 5～8 times of water gagings with the Radix Rosae Laevigatae that weighs up, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli, soaked 1 hour, decoct twice, each 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, got water and carried part B;

(3) B is concentrated, get thick paste, drying is ground into fine powder, gets intermediate products dried cream powder C;

(4) get intermediate products A and C mixing, granulate, encapsulated with the appropriate amount of auxiliary materials mixing, In Aluminium Foil Packing, packing gets finished product, and name of product is " JINJI JIAONANG ".

Embodiment 7

Take by weighing following Chinese medicine ingredients (unit: g)

Radix Rosae Laevigatae 18, Caulis Spatholobi 33.7, Radix Flemingiae Philippinensis 18, Caulis Mahoniae 18, Radix Zanthoxyli 6.7, Herba Andrographis 5.6.

Its production stage is:

(1) get the 2.6g of Herba Andrographis total amount, be ground into fine powder, with 100～120 ℃ of high pressure steam sterilization 30-60 minutes, intermediate products A;

(2) get remaining Herba Andrographis 3g with the soak with ethanol of volumetric concentration 60-80% 1 hour, the alcohol extraction that refluxes, the later solution of alcohol extraction reclaims ethanol, alcohol extraction part B;

(3) Caulis Mahoniae, Radix Zanthoxyli decoct twice, and each 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, concentrated to such an extent that water is put forward portion C;

(4) with Radix Rosae Laevigatae, Caulis Spatholobi, after-filtration of Radix Flemingiae Philippinensis decocting in water, with the later medicinal residues decocting in water of alcohol extraction, each equal 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, concentrated to such an extent that water is carried part D with the medicinal residues after the filter;

(5) merge above-mentioned B, C, D thick paste mixing, drying is ground into fine powder, gets intermediate products dried cream powder E;

(6) according to the total amount of intermediate products A and E, the spermaceti or other blocker coating that add 0.5-5%, make 2,4,6,8 hours slow-release pills respectively, every kind of piller is distinguished with different color and lusters, pack into behind the mix homogeneously in the capsulae vacuus, be packaged into box or be hot pressed into aluminium-plastic panel and obtain product, name of product is " a slow release JINJI JIAONANG ".

Embodiment 8

Take by weighing following Chinese medicine ingredients (unit: g)

Radix Rosae Laevigatae 21, Caulis Spatholobi 34, Radix Flemingiae Philippinensis 19, Caulis Mahoniae 19, Radix Zanthoxyli 7, Herba Andrographis 6.

Its production stage is:

(1) get the 2g of Herba Andrographis total amount, be ground into fine powder, with 100～120 ℃ of high pressure steam sterilization 30-60 minutes, intermediate products A;

(2) get remaining Herba Andrographis 4g and add 5～8 times of water gagings with the Radix Rosae Laevigatae that weighs up, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli, soaked 1 hour, decoct twice, each 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, got water and carried part B;

(3) B is concentrated, get thick paste, drying is ground into fine powder, gets intermediate products dried cream powder C;

(4) according to the total amount of intermediate products A and C, add spermaceti or other blocker coating of 0.5-5%, make 2,4,6,8 hours slow-release pills respectively, every kind of piller is distinguished with different color and lusters, pack into behind the mix homogeneously in the capsulae vacuus, be packaged into box or be hot pressed into aluminium-plastic panel and obtain product.Name of product is " a slow release JINJI JIAONANG ".

Embodiment 9

Take by weighing following Chinese medicine ingredients (unit: g)

Radix Rosae Laevigatae 10.8, Caulis Spatholobi 18, Radix Flemingiae Philippinensis 11, Caulis Mahoniae 10.3, Radix Zanthoxyli 4.5, Herba Andrographis 3.5.

Its technological process of production is:

(1) get above-mentioned 6 flavor medicines and add 5～8 times of water gagings, soaked 1 hour, decoct twice, each 2～3 hours, collecting decoction got water and puies forward part A;

(2) A is filtered, filtrate concentrates after drying, promptly gets intermediate products dry extract B.

(3) get intermediate products dry extract B, vegetable oil, Cera Flava by making suspended matter C at 1: 1: 0.02, with gelatin: glycerol: water is that 1: 0.35: 0.9 ratio prepares rubber, then suspended matter C fill is pressed into soft capsule, typing below 25 ℃, with ethanol flush away soft capsule appearance oil reservoir, in dry below 25 ℃, take out and promptly obtain product, name of product is " a golden pheasant soft capsule ".

Embodiment 10

Take by weighing following Chinese medicine ingredients (unit: g)

Radix Rosae Laevigatae 8, Caulis Spatholobi 15, Radix Flemingiae Philippinensis 8, Caulis Mahoniae 8, Radix Zanthoxyli 3, Herba Andrographis 2.5.

Its technological process of production is:

(1) get Herba Andrographis with the soak with ethanol of volumetric concentration 60-80% 1 hour, the alcohol extraction that refluxes, the later solution of alcohol extraction reclaims ethanol, the alcohol extraction part A;

(2) Caulis Mahoniae, Radix Zanthoxyli decoct twice, and each 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, concentrated to such an extent that water is carried part B;

(3) with Radix Rosae Laevigatae, Caulis Spatholobi, after-filtration of Radix Flemingiae Philippinensis decocting in water, with the later medicinal residues decocting in water of alcohol extraction, each equal 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, concentrated to such an extent that water is put forward portion C with the medicinal residues after the filter;

(4) merge above-mentioned A, B, C thick paste mixing, drying is ground into fine powder, gets intermediate products dried cream powder D;

(5) get intermediate products dry extract D, vegetable oil, Cera Flava by making suspended matter at 1: 1: 0.02, with gelatin: glycerol: water is that 1: 0.35: 0.9 ratio prepares rubber, then the suspended matter fill is pressed into soft capsule, typing below 25 ℃, with ethanol flush away soft capsule appearance oil reservoir, in dry below 25 ℃, take out and promptly obtain product, name of product is " a golden pheasant soft capsule ".

Embodiment 11

Take by weighing following Chinese medicine ingredients (unit: g)

Radix Rosae Laevigatae 18, Caulis Spatholobi 33, Radix Flemingiae Philippinensis 16, Caulis Mahoniae 16.2, Radix Zanthoxyli 6.1, Herba Andrographis 4.8.

Its technological process of production is:

(1) get Herba Andrographis, Caulis Mahoniae with the soak with ethanol of volumetric concentration 60-80% 1 hour, the alcohol extraction that refluxes, the later solution of alcohol extraction reclaims ethanol, the alcohol extraction part A;

(2) Radix Zanthoxyli decocts twice, and each 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, concentrated to such an extent that water is carried part B;

(3) with Radix Rosae Laevigatae, Caulis Spatholobi, after-filtration of Radix Flemingiae Philippinensis decocting in water, with the later medicinal residues decocting in water of alcohol extraction, each equal 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, concentrated to such an extent that water is put forward portion C with the medicinal residues after the filter;

(4) merge above-mentioned A, B, C thick paste mixing, drying is ground into fine powder, gets intermediate products dried cream powder D;

(5) get intermediate products dry extract D, vegetable oil, Cera Flava by making suspended matter at 1: 1: 0.02, with gelatin: glycerol: water is that 1: 0.35: 0.9 ratio prepares rubber, then the suspended matter fill is pressed into soft capsule, typing below 25 ℃, with ethanol flush away soft capsule appearance oil reservoir, in dry below 25 ℃, take out and promptly obtain product, name of product is " a golden pheasant soft capsule ".

Embodiment 12

Take by weighing following Chinese medicine ingredients (unit: g)

Radix Rosae Laevigatae 19, Caulis Spatholobi 31, Radix Flemingiae Philippinensis 17, Caulis Mahoniae 17.2, Radix Zanthoxyli 6.1, Herba Andrographis 4.8.

Its technological process of production is:

(1) get Herba Andrographis, Caulis Mahoniae with the soak with ethanol of volumetric concentration 60-80% 1 hour, the alcohol extraction that refluxes, the later solution of alcohol extraction reclaims ethanol, the alcohol extraction part A;

(2) Radix Rosae Laevigatae, Radix Zanthoxyli, Radix Flemingiae Philippinensis decoct twice, and each 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, concentrated to such an extent that water is carried part B;

(3) with Caulis Spatholobi decocting in water secondary, each 2～3 hours, merge twice leach cooking liquid and filter, filtrate is concentrated into relative density 1.05-1.20/55-60 ℃, add ethanol then and make and contain the alcohol amount and reach 80%, leave standstill, get supernatant concentration and get intermediate products C;

(4) merge above-mentioned A, B, C thick paste mixing, drying is ground into fine powder, gets intermediate products dried cream powder D;

(5) get intermediate products dry extract D, vegetable oil, Cera Flava by making suspended matter at 1: 1: 0.02, with gelatin: glycerol: water is that 1: 0.35: 0.9 ratio prepares rubber, then the suspended matter fill is pressed into soft capsule, typing below 25 ℃, with ethanol flush away soft capsule appearance oil reservoir, in dry below 25 ℃, take out and promptly obtain product, name of product is " a golden pheasant soft capsule ".

Embodiment 13

Take by weighing following Chinese medicine ingredients (unit: g)

Radix Rosae Laevigatae 20, Caulis Spatholobi 35, Radix Flemingiae Philippinensis 18, Caulis Mahoniae 18.2, Radix Zanthoxyli 8.1, Herba Andrographis 6.8.

Its technological process of production is:

(1) get Herba Andrographis, Caulis Mahoniae with the soak with ethanol of volumetric concentration 60-80% 1 hour, the alcohol extraction that refluxes, the later solution of alcohol extraction reclaims ethanol, the alcohol extraction part A;

(2) Radix Rosae Laevigatae, Radix Zanthoxyli, Radix Flemingiae Philippinensis decoct twice, and each 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, concentrated to such an extent that water is carried part B;

(3) with Caulis Spatholobi with the soak with ethanol of volumetric concentration 60-80% 1 hour, the alcohol extraction that refluxes, the later solution of alcohol extraction reclaims ethanol, and is concentrated into relative density 1.05-1.20/55-60 ℃, add 2 times of water gagings stirrings then and leave standstill, get supernatant concentration and get intermediate products C;

(4) merge above-mentioned A, B, C thick paste mixing, drying is ground into fine powder, gets intermediate products dried cream powder D;

(5) get intermediate products dry extract D, vegetable oil, Cera Flava by making suspended matter at 1: 1: 0.02, with gelatin: glycerol: water is that 1: 0.35: 0.9 ratio prepares rubber, then the suspended matter fill is pressed into soft capsule, typing below 25 ℃, with ethanol flush away soft capsule appearance oil reservoir, in dry below 25 ℃, take out and promptly obtain product, name of product is " a golden pheasant soft capsule ".

Embodiment 14

Take by weighing following Chinese medicine ingredients (unit: g)

Radix Rosae Laevigatae 13.8, Caulis Spatholobi 21, Radix Flemingiae Philippinensis 14, Caulis Mahoniae 13.3, Radix Zanthoxyli 7.5, Herba Andrographis 5.5.

Its technological process of production is:

(1) get above-mentioned 6 flavors with the soak with ethanol of volumetric concentration 60-80% 1 hour, the alcohol extraction that refluxes, the later solution of alcohol extraction reclaims ethanol, the alcohol extraction part A;

(2) A is filtered, after filtrate concentrated, drying was ground into fine powder, promptly gets intermediate products dry extract B.

(3) get intermediate products dry extract B, vegetable oil, Cera Flava by making suspended matter C at 1: 1: 0.02, with gelatin: glycerol: water is that 1: 0.35: 0.9 ratio prepares rubber, then suspended matter C fill is pressed into soft capsule, typing below 25 ℃, with ethanol flush away soft capsule appearance oil reservoir,, take out in dry below 25 ℃, promptly obtain product, name of product is " a golden pheasant soft capsule ".

Embodiment 15

Take by weighing following Chinese medicine ingredients (unit: g)

Radix Rosae Laevigatae 20, Caulis Spatholobi 30, Radix Flemingiae Philippinensis 16, Caulis Mahoniae 16, Radix Zanthoxyli 9, Herba Andrographis 8.

Its technological process of production is:

(1) get Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli, Herba Andrographis and add 5～8 times of water gagings, soaked 1 hour, decoct twice, each 2～3 hours, collecting decoction, water be carried part B;

(2) with B ₂Filter, after filtrate concentrated, drying was ground into fine powder, promptly gets intermediate products dry extract C.

(3) with the polyethylene glycol 6000 heating and melting, get intermediate products dry extract C again and add, stir molten, be transferred on the drop pill device, 86 ℃ of airtight insulations are made coolant with 10 ℃ of-15 ℃ of liquid paraffin, with the 50/component velocity system of dripping, promptly obtain product, name of product is " a golden pheasant drop pill ".

Embodiment 16

Take by weighing following Chinese medicine ingredients (unit: g)

Radix Rosae Laevigatae 8, Caulis Spatholobi 15, Radix Flemingiae Philippinensis 8, Caulis Mahoniae 8, Radix Zanthoxyli 3, Herba Andrographis 2.5.

Its technological process of production is:

(1) get Herba Andrographis with the soak with ethanol of volumetric concentration 60-80% 1 hour, the alcohol extraction that refluxes, the later solution of alcohol extraction reclaims ethanol, the alcohol extraction part A;

(2) Caulis Mahoniae, Radix Zanthoxyli decoct twice, and each 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, concentrated to such an extent that water is carried part B;

(3) with Radix Rosae Laevigatae, Caulis Spatholobi, after-filtration of Radix Flemingiae Philippinensis decocting in water, with the later medicinal residues decocting in water of alcohol extraction, each equal 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, concentrated to such an extent that water is put forward portion C with the medicinal residues after the filter;

(4) merge above-mentioned A, B, C thick paste mixing, drying is ground into fine powder, gets intermediate products dried cream powder D;

(5) get intermediate products dried cream powder D mixing, with the polyethylene glycol 6000 heating and melting, add dried cream powder D again, stir evenly, be transferred on the drop pill device, 86 ℃ of airtight insulations, make coolant with 10 ℃ of-15 ℃ of liquid paraffin, with the 50/component velocity system of dripping, promptly obtain product, name of product is " a golden pheasant drop pill ".

Embodiment 17

Take by weighing following Chinese medicine ingredients (unit: g)

Radix Rosae Laevigatae 20, Caulis Spatholobi 35, Radix Flemingiae Philippinensis 19, Caulis Mahoniae 19.5, Radix Zanthoxyli 7, Herba Andrographis 6.

Its technological process of production is:

(1) get Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli, Herba Andrographis and add 5～8 times of water gagings, soaked 1 hour, decoct twice, each 2～3 hours, collecting decoction, water be carried part B;

(2) with B ₂Filter, after filtrate concentrated, drying was ground into fine powder, promptly gets intermediate products dry extract C.

(3) with the polyethylene glycol 6000 heating and melting, get intermediate products dry extract C again and add, stir evenly, be transferred on the drop pill device, 86 ℃ of airtight insulations are made coolant with 10 ℃ of-15 ℃ of liquid paraffin, with the 50/component velocity system of dripping, promptly obtain product, name of product is " a golden pheasant drop pill ".

Embodiment 18

Take by weighing following Chinese medicine ingredients (unit: g)

Radix Rosae Laevigatae 16.4, Caulis Spatholobi 34.2, Radix Flemingiae Philippinensis 16.1, Caulis Mahoniae 17, Radix Zanthoxyli 9, Herba Andrographis 7.

Its technological process of production is:

(1) get Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli, Herba Andrographis and add 5～8 times of water gagings, soaked 1 hour, decoct twice, each 2～3 hours, collecting decoction filtered, water be carried part B;

(2) water is carried part B and concentrated, get relative density 1.05-1.20/55-60 ℃ intermediate products fluid extract E;

(3) get intermediate products E and an amount of syrup or Mel mixing, sterilization, fill obtains product, and name of product is " a golden pheasant oral liquid ".

Embodiment 19

Take by weighing following Chinese medicine ingredients (unit: g)

Radix Rosae Laevigatae 8, Caulis Spatholobi 15, Radix Flemingiae Philippinensis 8, Caulis Mahoniae 8, Radix Zanthoxyli 3, Herba Andrographis 2.5.

Its technological process of production is:

(1) get Herba Andrographis with the soak with ethanol of volumetric concentration 60-80% 1 hour, the alcohol extraction that refluxes, the later solution of alcohol extraction reclaims ethanol, the alcohol extraction part A;

(2) Caulis Mahoniae, Radix Zanthoxyli decoct twice, and each 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, concentrated to such an extent that water is carried part B;

(3) with Radix Rosae Laevigatae, Caulis Spatholobi, after-filtration of Radix Flemingiae Philippinensis decocting in water, with the later after-filtration of medicinal residues decocting in water of alcohol extraction, each equal 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, concentrated to such an extent that water is put forward portion C with the medicinal residues after the filter;

(4) merge above-mentioned A, B, three kinds of clear paste of C, mixing concentrates, and gets relative density 1.05-1.20/55-60 ℃ intermediate products fluid extract D

(5) get intermediate products D and an amount of syrup or Mel mixing, sterilization, fill gets finished product, and name of product is " a golden pheasant oral liquid ".

Embodiment 20

Take by weighing following Chinese medicine ingredients (unit: g)

Radix Rosae Laevigatae 14, Caulis Spatholobi 28, Radix Flemingiae Philippinensis 13, Caulis Mahoniae 13, Radix Zanthoxyli 6, Herba Andrographis 5.

Its technological process of production is:

(1) get Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli, Herba Andrographis and add 5～8 times of water gagings, soaked 1 hour, decoct twice, each 2～3 hours, collecting decoction filtered, water be carried part B;

(2) water is carried part B and concentrated, get relative density 1.15-1.25/55-60 ℃ intermediate products fluid extract E;

(3) get intermediate products E and an amount of syrup and Mel mixing, sterilization, fill obtains product, and name of product is " a golden pheasant cream ".

Embodiment 21

Take by weighing following Chinese medicine ingredients (unit: g)

Radix Rosae Laevigatae 8, Caulis Spatholobi 15, Radix Flemingiae Philippinensis 8, Caulis Mahoniae 8, Radix Zanthoxyli 3, Herba Andrographis 2.5.

Its technological process of production is:

(1) get Herba Andrographis with the soak with ethanol of volumetric concentration 60-80% 1 hour, the alcohol extraction that refluxes, the later solution of alcohol extraction reclaims ethanol, the alcohol extraction part A;

(2) Caulis Mahoniae, Radix Zanthoxyli decoct twice, and each 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, concentrated to such an extent that water is carried part B;

(3) with Radix Rosae Laevigatae, Caulis Spatholobi, after-filtration of Radix Flemingiae Philippinensis decocting in water, with the later after-filtration of medicinal residues decocting in water of alcohol extraction, each equal 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, concentrated to such an extent that water is put forward portion C with the medicinal residues after the filter;

(4) merge above-mentioned A, B, three kinds of clear paste of C, mixing concentrates, and gets relative density 1.15-1.25/55-60 ℃ intermediate products fluid extract D

(5) get intermediate products D and an amount of syrup and Mel mixing, sterilization, fill gets finished product, and name of product is " a golden pheasant cream ".

Below be clinical research report of the present invention:

Medicine of the present invention entrusts Guangxi city-level three tame hospitals to carry out clinical verification, and job step and experimental result are as follows:

Clinical data:

One, diagnostic criteria

(1) under the tcm diagnosis index zone (syndrome of dampness-heat diffusing downward):

(1) profuse leukorrhea, yellow skin or HUANGBAI(sic) are alternate, and matter thickness such as bean dregs shape have foul smell.

(2) lower abdomen weighs down the pain that expands.

(3) bitter taste in the mouth and dry throat

(4) oliguria with reddish urine.

(5) red tongue, yellow and greasy fur or thick greasy.

(6) soft and thready pulse omits number or sliding number.

More than (1) must possess, have all the other in every 3 concurrently, promptly diagnosable.

(2) Western medicine diagnose standard:

1, chronic endometritis:

(1) pilosity is born in intrauterine surgical, miscarriage and puerperal.

(2) leucorrhoea grow in quantity and (or) menorrhagia and lower abdomen weigh down pain etc., gynecologial examination can be no abnormal, or slight uterus tenderness is only arranged, the other tissue in palace has thickening and touches a tender spot.

2, chronic adnexitis:

(1) lower abdomen and lumbago, lower abdomen weigh down to expand, and lumbosacral region is ached, increase the weight of after the fatigue of being everlasting, the sexual intercourse, during defecation and menstruation before and after increase the weight of.Can be with low grade fever, menorrhagia and leucorrhoea grow in quantity.

(2) uterus often is the position, back, and active receiving restriction or adhesion are fixed, and uterus one side or bilateral can touch streak thing, and mild tenderness is arranged; During the inflammation of pelvic cavity sheath, uterus one side or bilateral have lamellar to thicken tenderness, or touch enclosed mass in the pelvic cavity one or both sides.

Two, case is selected:

(1) include standard in:

1, Western medicine diagnose meets chronic pelvic inflammatory disease (chronic endometritis or chronic adnexitis).

2, Chinese medical discrimination belongs to leukorrhagia (syndrome of dampness-heat diffusing downward).

(2) exclusion standard:

1, confirms on inspection by gynecological tumor and sexually transmitted disease (STD) causer.

2, gestation or women breast-feeding their children are to this medicine allergy sufferers under-18s or over-65s person the age.

3, be associated with serious primary disease such as cardiovascular, liver, kidney and hemopoietic system, psychotic.

4, do not meet the standard of including in, not medication in accordance with regulations can't be judged that curative effect or data are not congruent to affect the treatment or safety judgement person.

Three, observational technique: adopt district's group at random, contrast, non-blind method observe.

1, grouping: observe 421 examples altogether, wherein 201 examples are organized in treatment, matched group 120 examples, open treatment group 100 examples.Look into the random digit permutation table, treatment group and matched group were by 2: 1,3: 2 and 5: 3 district's group random packet.

2, consumption and medication:

(1) treatment group and open treatment group: JINJI JIAONANG, oral, each 4, every day 3 times.

(2) matched group: FUYANJING JIAONANG (production of the Guangxi XX city pharmaceutical factory of traditional Chinese medicine), each 3, every day 3 times.

3, the course of treatment: 4 weeks.

4, viewing duration is withdrawn the Chinese and western drugs that affects the treatment in principle.

Four, observation standard:

1, safety observation:

(1) general physical examination project.

(2) blood, urine, just routine examination.

(3) heart, liver, kidney function test.

2, health giving quality observation:

(1) related symptoms and sign.

(2) variation of leukorrhagia and menstrual blood volume, color, matter.

(3) gynecologial examination.

(4) ultrasound diagnosis.

Five, efficacy assessment standard:

(1) degrees of symptoms grade scale and scoring method:

1, leukorrhagia increases: remember 0,2,4,6 fen respectively by nothing, I level, II level, III level.

The I level: vaginal secretions is many slightly

The II level: posterior fornix of vagina has accumulation secretions, and amount is many

The III level: full vagina has secretions and flows out outside the vaginal orifice

2, vagina cleanness degree: remember 0,2,4 fen respectively by I °, II °, III °.

I °: mainly be vaginal epithelial cell and bacterium vaginae in the smear.

II °: mainly be outside vaginal epithelial cell and the bacterium vaginae in the smear, visible leukocyte and other assorted bacterium.

III °: remove vaginal epithelial cell and bacterium vaginae in the smear seldom, other assorted bacterium and leukocyte are more; Or have only leukocyte and other assorted bacterium.

3, abdominal pain during menstruation: by do not have, slight, moderate, severe remember 0,2,4,6 fen respectively.

Slightly: lower abdomen pain is obvious before and after menstrual period or menstrual period, but does not have General Symptoms, can adhere to work.

Moderate: lower abdomen pain accompanies waist to ache unbearably before and after menstrual period or menstrual period, and nausea and vomiting, extremity are not warm.

Severe: lower abdomen pain is felt restless unbearably before and after menstrual period or menstrual period, has a strong impact on work, study and daily life.

4, limited, the tenderness of uterine activity: by do not have, slight, moderate, severe remember 0,2,4,6 fen respectively

Slightly: uterine activity is slightly limited, tenderness is not obvious.

Moderate: the uterine activity moderate is limited, tenderness is heavier.

Severe: uterine activity is obviously limited, tenderness heavy.

5, fallopian tube is streak, tenderness: by do not have, slight, moderate, severe remember 0,2,4,6 fen respectively

Slightly: fallopian tube is streak, tenderness is not obvious.

Moderate: fallopian tube is streak, tenderness is heavier.

Severe: fallopian tube is streak, tenderness heavy.

6, one or both sides, uterus lamellar thicken, tenderness:

Slightly: one or both sides, uterus lamellar thickens, tenderness is not obvious.

Moderate: one or both sides, uterus lamellar thickens, tenderness is heavier.

Severe: one or both sides, uterus lamellar thickens, tenderness heavy.

7, the lower abdomen waist tenesmus of aching:

Slightly: idol has slight lower abdomen to weigh down the pain that expands.

Moderate: lower abdomen weighs down pain more very, happens occasionally.

Severe: it is heavy that lower abdomen weighs down pain, unbearably, and outbreak repeatedly.

8, heating:

Slightly: 37.1～37.5 ℃.

Moderate: 37.6～38 ℃.

Severe: more than 38.1 ℃.

9, bitter taste in the mouth and dry throat:

Slightly: light, amount of drinking water increases 1/2.

Moderate: more very, amount of drinking water increases 1/2～1 times.

Severe: heavy, amount of drinking water increases more than 1 times.

10, oliguria with reddish urine:

Slightly: urinate every day below 10 times, each＞50ml, the urine color is yellow slightly.

Moderate: urinate each 30～50ml, urine color depth Huang every day 10～15 times.

Severe: urinate every day more than 15 times, each＜30ml, the urine yellow skin is red.

11, body of the tongue: the red partially note of body of the tongue 2 minutes, red tongue note 4 minutes, deep red tongue note 6 minutes.

12, tongue fur: thin and greasy fur note 2 minutes, yellowish fur note 4 minutes, yellow fur, thick greasy note 6 minutes.

13, pulse condition: soft pulse omited number scale 2 minutes, soft pulse number scale 4 minutes, rolling pulse number scale 6 minutes.

(2); Efficacy assessment standard:

1, recovery from illness: symptom, sign note check and all recover normal that integration is 0 minute.

2, produce effects: transference cure, gynecologial examination has clear improvement, and the treatment back reduces more than 2/3 than the preceding integration of treatment.

3, effective: symptom, sign note are checked all to have and are alleviated, and reduce more than 1/3 than integration before the treatment after the treatment.

4, do not reach above standard person.

Six, statistical procedures: ranked data Ridit analytic process; Enumeration data X ²Method of inspection; Measurement data t (U) method of inspection.

Seven, therapeutic outcome:

1, to the influence of various symptoms, sign: see Table 1.From table, can find out that two kinds of medicines all have therapeutical effect to chronic endometritis, the comparison of treatment group and matched group, except that leukorrhagia increase and the abdominal pain during menstruation item, no significant difference; See Table 2.Two kinds of medicines all have therapeutical effect to chronic adnexitis, and treatment group and matched group compare, except that leukorrhagia increases, and no significant difference.

2, compare before and after patient's physico-chemical examination treatment: see Table 3.From table, can find out that every inspection there is no unusually, not find obvious adverse reaction and toxic and side effects.

3, treatment group and matched group curative effect compare: can find out chronic endometritis patient treatment group 91 examples from table, total effective rate is 91.2%, open treatment group 100 examples, total effective rate is 88.0%, matched group 50 examples, total effective rate is 82.0%, and treatment group and matched group total effects difference do not have significance meaning (P＞0.05), see Table 4.Chronic adnexitis patient treatment group 110 examples, total effective rate 88.2%, matched group 70 examples, total effective rate 88.6%.Treatment group and matched group total effects difference do not have significance meaning (P＞0.05), see Table 5.

Side effect

Two groups of patients all do not find obvious adverse reaction and toxic and side effects at viewing duration.

Model case

Example 1, trick XX, woman, 35 years old.

The patient goes to a doctor because of " it is surplus that hypogastric region distending pain, vaginal secretions increase half a year ".Private prosecution hypogastric region distending pain closely over the past half year shows effect repeatedly, and with the lumbosacral region distending pain, leucorrhoea grow in quantity is through preceding or work postemphasis.Bitter taste in the mouth and dry throat, short urination is red, and stool is normal.Menstrual history: $14=\frac{4~6}{27~30}$ 2000.9.16, through color, the amount all normal.Obsterical history: married in 22 years old, pregnant 3 produce 1 artificial abortion 2.Acute pelvic inflammatory disease and other specific disease histories have been denied.Check: ordinary circumstance is fair, and vital sign is normal.Cardiopulmonary are checked no abnormal.Abdomen is flat soft, hypogastric region tenderness, no rebound tenderness.The hepatic dullness exists.Do not touch under the liver spleen rib, do not lay one's hand on and the interior obviously enclosed mass of abdomen.Borborygmus is normal.Gynecologial examination: pudendum is normal, and vagina is smooth unobstructed, and vaginal secretions is many, and yellow skin matter is thick.Retroposition of uterus, normal big in the matter, obvious tenderness, limitation of activity.Left side attachment is normal, and the right side attachment area thickens, tenderness.Red tongue, yellow and greasy fur, rolling pulse is number slightly.B ultrasonic shows: retroposition of uterus, and often big, flesh wall echo is even, and the uterine cavity line is clear, sees one 5.2 * 4.4cm opaque dark area of fluid in the right back, uterus, and the boundary is clear, wall thickness, interior entrant sound is good, and left ovary shows clear, size 2.4 * 2.2cm, right ovary demonstration is owed clearly.Impression: 1, basin piece fluidity.2, the uterus is often big.Laboratory examination: routine blood test: RBC 4.98 * 1012/L, HB 128g/L, WBC 8.8 * 10 ⁹/ L.ALT?12u/L，BCr?102μmol/L，BUN?4.2mmol/L。Routine urinalysis (-), stool routine examination (-).Electrocardioscopy is normal.Tcm diagnosis: leukorrhagia (syndrome of dampness-heat diffusing downward).Western medicine diagnose: endometritis, chronic pelvic inflammatory disease.Give the JINJI JIAONANG treatment, oral, each 4, every day 3 times, serve on for 4 weeks.2 all back hypogastric region distending pains and the lumbosacral region distending pain of taking medicine alleviates, and bitter taste in the mouth and dry throat obviously alleviates.The 4 all backs hypogastric region of taking medicine weigh down pain and the lumbosacral region distending pain all obviously alleviates, and bitter taste in the mouth and dry throat disappears, and two is just normal.B ultrasonic shows: retroposition of uterus, and normal big, flesh wall echo is even, and the uterine cavity line is clear, and the both sides adnexa shows no obvious abnormalities.Laboratory examination: routine blood test: RBC 4.9 * 10 ¹²/ L, HB 114g/L, WBC 6.2 * 10 ⁹/ L.ALT?10u/L，BCr?98μmol/L，BUN?4.0mmol/L。Routine urinalysis (-), stool routine examination (-).Electrocardioscopy is normal.Efficacy evaluation: produce effects.

Example 2, surplus XX, woman, 29 years old.

The patient goes to a doctor because of " two hypogastric region swelling and pains, leukorrhagia increase 1 year surplus ".The hypogastric region swelling and pain is often felt in private prosecution closely one year over, tired postemphasis.With bitter taste in the mouth and dry throat, yellowish urine.The leukorrhagia amount increases, and yellow skin matter is thick, and is smelly dirty.Menstrual history: $13=\frac{4~6}{28~32}$ 2000.10.14, through color, the amount all normal.Obsterical history: married in 21 years old, pregnant 2 produce 1 artificial abortion 1.Acute pelvic inflammatory disease and other specific disease histories have been denied.Check: ordinary circumstance is fair, and vital sign is normal.Cardiopulmonary are checked no abnormal.Abdomen is flat soft, hypogastric region both sides tenderness, no rebound tenderness.The hepatic dullness exists.Do not touch under the liver spleen rib, do not lay one's hand on and the interior obviously enclosed mass of abdomen.Borborygmus is normal.Gynecologial examination: pudendum is normal, and vagina is smooth unobstructed, and vaginal secretions is many, and yellow skin matter is thick smelly dirty.Retroposition of uterus, normal big in the matter, obvious tenderness, limitation of activity.Each can touch about 6 * 8cm capsule enclosed mass the both sides, uterus, and is movable poor, tenderness.Red tongue, yellow and greasy fur, rolling pulse is number slightly.Does B ultrasonic show: bilateral basin piece no echo area (inflammatory mass?) laboratory examination: routine blood test: RBC 4.2 * 10 ¹²/ L, HB 130g/L, WBC 8.9 * 10 ⁹/ L.BCr?110μmol/L，BUN?4.0mmol/L。Routine urinalysis (-), stool routine examination (-).Electrocardioscopy is normal.Tcm diagnosis: mass in the abdomen (syndrome of dampness-heat diffusing downward).Western medicine diagnose: chronic pelvic inflammatory disease (adnexitis).Give the JINJI JIAONANG treatment, oral, each 4, every day 3 times, serve on for 4 weeks.The diseases such as 2 week back hypogastric region swelling and pains and bitter taste in the mouth and dry throat of taking medicine all have and alleviate, and leukorrhagia reduces.The diseases such as 3 all back hypogastric region swelling and pains and bitter taste in the mouth and dry throat of taking medicine obviously alleviate, and leukorrhagia is normal.The diseases such as 4 all back hypogastric region swelling and pains and bitter taste in the mouth and dry throat of taking medicine disappear.Gynecologial examination: uterus left-hand bar pallial siphuncle 4 * 2cm, the streak thing 3 * 2cm in right side, tenderness is not obvious.The check B ultrasonic shows: left ovary 3.5 * 2.2cm, right ovary 2.5 * 2.2cm.Laboratory examination: routine blood test: RBC 4.2 * 10 ¹²/ L, HB 128g/L, WBC 6.0 * 10 ⁹/ L.BCr?98μmol/L，BUN?4.4mmol/L。Urine RBC (-), Pro (-).FOB(-)。Electrocardioscopy is normal.Efficacy evaluation: produce effects.

Below be to adopt the curative effect of " JINJI JIAONANG " of the embodiment of the invention to compare:

Table 1 chronic endometritis patient clinical symptoms curative effect is (Ridit analysis) relatively

Annotate: the U value compares for the Ridit of treatment group and matched group.*P＜0.05，**P＜0.01。

After chronic endometritis was respectively organized patient treatment, each witness all took an evident turn for the better; Treatment group and matched group relatively, except that leukorrhagia increase and the abdominal pain during menstruation item, each witness P all＞0.05, difference does not have clear meaning

Table 2 chronic adnexitis patient clinical symptoms curative effect is (Ridit analysis) relatively

Annotate: the U value compares for the Ridit of treatment group and matched group.**P＜0.01。After chronic adnexitis was respectively organized patient treatment, each witness all took an evident turn for the better; Treatment group and matched group relatively, except that leukorrhagia increases item, each witness P all＞0.05, difference does not have clear meaning.

Compare before and after the table 3 physico-chemical examination treatment

Table 4 chronic endometritis curative effect is (Ridit analysis) relatively

Grouping	The example number	Recovery from illness (%)	Produce effects (%)	Effectively (%)	Invalid (%)	Total effectively (%)
							The treatment group	91	4(4.4)	18(19.8)	61(67.0)	8(8.8)	83(91.2)
Matched group	50	2(4.0)	14(28.0)	25(50.0)	9(18.0)	41(82.0)
							The open treatment group	100	8(8.0)	27(27.0)	53(53.0)	12(12.0)	88(88.0)

Annotate: chronic endometritis treatment group and matched group total effects compare, U=0.03, and P＞0.05, difference does not have the significance meaning.

Table 5 chronic adnexitis curative effect is (Ridit analysis) relatively

Grouping	The example number	Recovery from illness (%)	Produce effects (%)	Effectively (%)	Invalid (%)	Total effectively (%)
							The treatment group	110	16(14.6)	29(26.4)	52(47.3)	13(11.8)	97(88.2)
Matched group	70	13(18.6)	22(31.4)	27(38.6)	8(11.4)	62(88.6)

Annotate: chronic endometritis treatment group and matched group total effects compare, U=0.97, and P＞0.05, difference does not have the significance meaning.

Brief summary

Above clinical data discloses:

1, medicine of the present invention has the effect that heat-clearing and toxic substances removing, spleen invigorating dehumidifying, collateral dredging are invigorated blood circulation, and the pelvic inflammatory disease (chronic endometritis, chronic adnexitis) due to the damp invasion of lower energizer is had therapeutical effect.

2, medicine JINJI JIAONANG treatment chronic endometritis patient 191 examples of the present invention, effective percentage is 89.6%; Treatment chronic adnexitis patient 110 examples, effective percentage is 88.2%; To sum up, this Drug therapy pelvic inflammatory disease total effective rate is 88.9%.

3, the capsule disintegrate is faster than tablet, and consumption is few than tablet, and taking convenience is welcome by patient and clinician deeply.

4, this product is safe and reliable, and 301 examples are not all found obvious adverse reaction and toxic and side effects at viewing duration.

Claims (2)

1, a kind of production method for the treatment of the slow releasing capsule of pelvic inflammatory disease is characterized in that: this medicine is that raw material of Chinese medicine Radix Rosae Laevigatae, Caulis Spatholobi, Caulis Mahoniae, Radix Zanthoxyli, Radix Flemingiae Philippinensis, Herba Andrographis are made slow releasing capsule, and its raw materials quality umber is as follows:

10～30 parts of Radix Rosae Laevigataes; 20～40 parts of Caulis Spatholobis; 10～30 parts of Radix Flemingiae Philippinensiss;

10～30 parts of Caulis Mahoniaes; 3～15 parts of Radix Zanthoxylis; 1～15 part of Herba Andrographis;

Its production method is:

(1) get 1/25～10/25 of Herba Andrographis total amount and be ground into fine powder, with 100～120 ℃ of high pressure steam sterilizations 30～60 minutes, intermediate products A;

(2) get remaining Herba Andrographis and add 5～8 times of water gagings with whole Radix Rosae Laevigataes, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli, soaked 1 hour, decoct twice, each 2～3 hours, medicinal liquid filtered, and merges leach cooking liquid twice, got water and carried part B;

(3) B is concentrated, get thick paste, drying is ground into fine powder, gets intermediate products dried cream powder C;

(4) according to the total amount of intermediate products A and C, spermaceti or other blocker coating of adding 0.5～5% are made 2,4,6,8 hours slow-release pills respectively, and every kind of piller is distinguished with different color and lusters, pack into behind the mix homogeneously in the capsulae vacuus, be packaged into box or be hot pressed into aluminium-plastic panel and obtain product.

2, the production method of the slow releasing capsule of treatment pelvic inflammatory disease according to claim 1 is characterized in that: the raw materials quality umber of Chinese medicine composition of making slow releasing capsule is as follows:

Radix Rosae Laevigatae 8; Caulis Spatholobi 15; Radix Flemingiae Philippinensis 8; Caulis Mahoniae 8; Radix Zanthoxyli 3; Herba Andrographis 2.5.