CN1628765A

CN1628765A - Cherokee rose root formulation for treating gynecological disease and its preparation process

Info

Publication number: CN1628765A
Application number: CN 200410040502
Authority: CN
Inventors: 于文风
Original assignee: Yunyanxichuang Medicinal Science And Technology Development Co Ltd Guiyang C
Current assignee: Yunyanxichuang Medicinal Science And Technology Development Co Ltd Guiyang C
Priority date: 2004-08-19
Filing date: 2004-08-19
Publication date: 2005-06-22

Abstract

The invention provides a cherokee rose root formulation for treating gynecological disease and its preparation process, wherein the formulation is prepared from root of Fructus Rosae Laevigatae, spatholobus stem, Moghania philippinensis, mahonia stem and is made into dispersible tablet, soft capsule, mini-pill or dripping pill.

Description

Jinji preparation of treatment gynaecopathia and preparation method thereof

Technical field: the present invention is a kind of Jinji preparation for the treatment of gynaecopathia and preparation method thereof, belongs to technical field of Chinese medicine.

Technical background: gynaecopathia such as pelvic inflammatory disease, endometritis, cervicitis etc. all are to threaten the able-bodied common disease of women in the world today, brought great misery for numerous women, traditional Therapeutic Method mostly is antibiotic or physical therapy, the life-time service antibiotic, can make the patient that drug resistance takes place and easily cause double infection, physical therapy then makes most of patients not adhere to and therapy discontinued for a long time.Prevent and treat purpose in order to reach, a large amount of research has been done by many inventors and medicine enterprise, and the product of some treatments also is provided; As: JINJI JIAONANG, JINJI PIAN, these three kinds of products of JINJI KELI are this type of disease of treatment and develop, but, technology preparation is unexposed in these three kinds of products, do not people also know what is key technologies such as its concrete prescription, formula proportion and preparation method? so can not be directly used in the guidance of production; And the dosage form of existing Jinji preparation falls behind, and product quality is not ideal enough: the poor performance of its disintegration of tablet, capsule are store the benefit bonding for a long time and the granule dose is big, and the Herba Andrographis taste is extremely bitter, needs to add the correctives that has no therapeutical effect in a large number; The dosage form kind of existing product is abundant inadequately, be suitable for crowd's narrow range, the product bioavailability is low, medicine stability is undesirable, and especially not high, the mouthfeel extreme difference of the bioavailability of its water-insoluble effective ingredient andrographolide is unfavorable for the absorption by human body utilization; In view of such circumstances, seek a kind of therapeutic effect ideal, the thing that effective medicine preparation stable and controllable for quality has just become people to be badly in need of solving.

Summary of the invention: the objective of the invention is to: a kind of Jinji preparation for the treatment of gynaecopathia and preparation method thereof is provided; The present invention is directed to the problem that prior art exists, a kind of good effect, adaptation is wide, preparation method is scientific and reasonable Chinese medicine preparation are provided; This preparation has reasonable therapeutic effect for gynaecopathia such as pelvic inflammatory disease, endometritis, cervicitis etc.; The applicant has carried out deep research to existing Jinji preparation; Micropill provided by the invention, dispersible tablet formulation, disintegrative are good, and the bioavailability height is particularly suitable for the old people and swallow tablet or the inconvenient patient of capsule take; Soft capsule provided by the invention, dropping pill formulation solved medicine and met damp and hot problem of unstable, can also cover Herba Andrographis poor taste, abnormal smells from the patient, can play the effect that increases stability, improves bioavailability.

The present invention constitutes like this: calculate according to components by weight percent, it mainly is to be made by 9～20 parts of Radix Rosae Laevigataes, 18～40 parts of Caulis Spatholobis, 9～20 parts of Radix Flemingiae Philippinensiss, 9～20 parts of Caulis Mahoniaes, 4～8 parts of Radix Zanthoxylis, 3～7 parts of Herba Andrographis or their extract of corresponding weight portion.Say accurately: calculate according to components by weight percent, it mainly is to be made by 16 parts of Radix Rosae Laevigataes, 30 parts of Caulis Spatholobis, 16 parts of Radix Flemingiae Philippinensiss, 16 parts of Caulis Mahoniaes, 6 parts of Radix Zanthoxylis, 5 parts of Herba Andrographis or their extract of corresponding weight portion.Preparation of the present invention comprises: injection comprises: all acceptable dosage forms on injection, powder pin, freeze-dried powder, tablet, dispersible tablet, effervescent tablet, capsule, soft capsule, microcapsule, granule, pill, micropill, powder, drop pill, slow releasing preparation, controlled release preparation, gel, suppository, oral liquid, soft extract, extractum and the membrane pharmaceutics.Say accurately: described preparation is dispersible tablet, soft capsule, micropill or dropping pill formulation.

Preparation method of the present invention is: it is an amount of to get Herba Andrographis, is ground into fine powder, sieves; Residue Herba Andrographis and Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli decoct with water, and collecting decoction filters, and filtrate is condensed into the thick paste shape, adds above-mentioned Herba Andrographis fine powder, and mixing is made different preparations then respectively; Preparation method of the present invention can also be: get Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli, Herba Andrographis, decoct with water, collecting decoction filters, and filtrate is condensed into the thick paste shape, makes different preparations then respectively.

Dispersible tablet in the preparation of the present invention prepares like this: it is an amount of to get Herba Andrographis, is ground into fine powder, sieves; Residue Herba Andrographis and Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli decoct with water 2 times, and each 2 hours, collecting decoction, filter, filtrate is condensed into the thick paste shape, adds Herba Andrographis fine powder, 3%CMS-Na, with concentration is that 10% starch slurry is a binding agent, and the system soft material is crossed 20 mesh sieves and granulated, 60 ℃ of oven dry, 20 order granulate add 4%CMS-Na, 3% Pulvis Talci, 2% micropowder silica gel, mix homogeneously, one-shot formula tablet machine, 2 grades of compression force tablettings, promptly.

Pellet in the preparation of the present invention prepares like this: get Radix Rosae Laevigatae; Caulis Spatholobi; Radix Flemingiae Philippinensis; Caulis Mahoniae; Radix Zanthoxyli; Herba Andrographis; decoct with water 2 times; each 2 hours; collecting decoction; filter; filtrate is condensed into the thick paste shape, and drying is pulverized; get extract powder; with extract powder and microcrystalline Cellulose mixed by 5: 2, put in the comminutor, be binding agent with 1%L-HPC solution; with water is wetting agent; at engine speed 250r/min; spray pump rotating speed 20r/min; for powder machine rotating speed 25r/min; jet flow 15L/min; whiff pressure 0.5Mpa; air blast flux 10 * 20L/min; whitewashing time 5min; round as a ball time 4min, pill, promptly.

Soft capsule in the preparation of the present invention prepares like this: it is an amount of to get Herba Andrographis, is ground into fine powder, sieves; Residue Herba Andrographis and Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli decoct with water 2 times, and each 2 hours, collecting decoction, filter, filtrate is condensed into the thick paste shape, adds the Herba Andrographis fine powder, mixing, promptly get medicated powder, press medicated powder again: substrate=1: 1.2, the mixed-matrix of adding soybean oil, yellow beeswax, soybean lecithin, heating and melting, mixing gets soft capsule content; The preparation of glue: with gelatin: glycerol: water=1: 0.4: 0.7, get gelatin and add an amount of distilled water and make its imbibition, glycerol and remaining water are put be heated to 70-80 ℃ in the glue pot in addition, mix homogeneously adds expansible gelatin and stirs, and makes it to dissolve into uniform glue, in 70 ℃ of insulations 1-2 hour, leave standstill, remove the come-up foam, filter with cloth bag, in encapsulating machine, be pressed into soft capsule, be pressed into soft capsule, put in the drum drying machine and finalize the design, whole ball, drying, promptly.

Drop pill in the preparation of the present invention prepares like this: get Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli, Herba Andrographis, decoct with water 2 times, each 2 hours, collecting decoction, filter, filtrate is condensed into the thick paste shape, is substrate with PEG4000, adds thick paste, drug quality: substrate volume=3: 7, stir, airtight, insulation, with internal diameter 4.5mm, external diameter 5.5mm dropper, speed with 40～50 of per minutes splashes into methyl-silicone oil: in the mixing liquid coolant of liquid paraffin=3: 1, and the high 120cm of cooling column, rotating speed 15rmin ^-1, promptly.

Among the present invention, Radix Rosae Laevigatae clearing away heat and eliminating dampness leukorrhagia stopping is a monarch drug, Radix Flemingiae Philippinensis clearing away heat-damp and promoting diuresis, detoxifcation, and the Caulis Spatholobi promoting the circulation of blood of enriching blood, the Caulis Mahoniae clearing away heat and cooling blood is monarch drug altogether; Herba Andrographis heat-clearing and toxic substances removing, Radix Zanthoxyli promoting blood circulation and detoxication, reducing swelling and alleviating pain are adjuvant drug altogether, and all medicines are harmonious, and play the effect of damp-clearing pain-relieving, menstruction regulating and pain relieving altogether.

Compared with prior art, micropill, dispersible tablet formulation, the disintegrative of the present invention's preparation are good, the bioavailability height, be particularly suitable for the old people and swallow tablet or the inconvenient patient of capsule take, dispersible tablet meet water rapidly disintegrate form the water dispersion tablet of uniform sticky suspension, solved the not high problem of bioavailability of water-insoluble effective ingredient andrographolide; Soft capsule provided by the invention, dropping pill formulation have solved medicine and have met damp and hot problem of unstable, can also cover poor taste, the abnormal smells from the patient of Herba Andrographis, can play the effect that increases stability, improves bioavailability.The applicant finds in development process, dispersible tablet needs disintegrate fully in the 3min in 19 ℃～21 ℃ water, the micropill roundness is inhomogeneous, the drop pill ratio of briquetting is low, it is the key issue of this product that the soft capsule disintegrate is transfinited, by a large amount of influence factors such as adjuvant, process conditions have been carried out experiment screening, make the functional of product.Certainly, other preparation process condition is also feasible reluctantly, and is the most simple with process conditions provided by the invention but we find; The preparation that obtains has reasonable prevention effect for gynaecopathia such as pelvic inflammatory disease, endometritis, cervicitis etc.; But low production cost, be convenient to improve the quality of products, carry out the control and the little patients life-time service of preparation untoward reaction provided by the invention of the quality of production.

The applicant has carried out a series of experiments, with the supplementary product kind of the preparation technology that selects pharmaceutical preparation provided by the invention, use and consumption, ratio etc.; Guarantee its science, reasonable, feasible; The preparation that obtains has effective therapeutic effect.

Experimental example 1: Study on extraction

Group decocts number of times (inferior) decocting time (h) andrographolide %

1 1 1 0.42

2 1 2 0.39

3 1 3 0.38

4 2 1 0.44

5 2 2 0.65

6 2 3 0.60

7 3 1 0.52

8 3 2 0.56

9 3 3 0.31

The result shows that extraction process of the present invention is rationally feasible.

Experimental example 2: Study on Forming

Measure angle of repose: adopt the fixed funnel method, funnel is fixed on the graph paper of horizontal positioned, the funnel end opening is 3cm apart from the distance of graph paper, pour the difference pill of writing out a prescription into funnel respectively, below the cone tip that forms up to the bottom touches till the bell mouth, measure the diameter of conical base, calculate angle of repose, the bright mobility of particle of novel angle of repose is good.

Check disintegration: adopting changes the basket method, and lift disintegration tester, tablet or capsule are got 6 slices/, observes the situation by screen cloth.Percent of pass height then disintegrative is good, more pleasant bulk absorption.

Melting is checked: get granule 10g, add 20 times of hot water, stirred 5 minutes, observe immediately.

The mensuration of tablet tensile strength: behind the tabletting tablet is placed 12h,, calculate the tensile strength of tablet with the radially crushing force of tablet four-function instrument mensuration tablet.

Homogeneity be the ball between the 18-40 order heavy/total ball is heavy by * 100%, yield P%=W1/W * 100% (wherein the weight W 1 of 18-24 order ball, the gross weight that feeds intake W)

Friability: tablet four-function instrument, the radially crushing force and the friability of mensuration tablet.

1, dispersible tablet Study on Forming

Dispersible tablet meet water rapidly disintegrate form the water dispersion tablet of uniform sticky suspension, it is poor to have solved former dosage form disintegrative, stripping is shortcoming slowly, and the dispersible tablet that the applicant makes is disintegrate fully in the 3min in 19 ℃～21 ℃ water, and suspension ability is good, bioavailability is high, dispersed homogeneous degree.

1. adjuvant screening: the bigger factor (as disintegrating agent, binder concn) of dispersible tablet preparation technology influence of the present invention is carried out orthogonal test, determine best prescription.

Group CMS-Na (in add) % CMS-Na (adding) % starch slurry concentration % disintegration time (s)

1 1 4 8 115

2 1 3 10 58

3 1 2 12 120

4 2 4 12 89

5 2 3 8 87

6 2 2 10 55

7 3 4 10 30

8 3 3 12 45

9 3 2 8 64

2. compression force:

Compression force/shelves friability %

3 0.56

2 0.31

1 0.42

The result shows that optimum process condition is that 10% starch slurry is a binding agent for adding 3%CMS-Na with concentration, the system soft material, cross 20 mesh sieves and granulate, 60 ℃ of oven dry, 20 order granulate add 4%CMS-Na, 3% Pulvis Talci, 2% micropowder silica gel, mix homogeneously, one-shot formula tablet machine, 2 grades of pressure tablettings.

2, pellet Study on Forming

The micropill diameter is less than 2.5mm, and class is in particle properties, the bioavailability height, and the applicant is when development product micropill of the present invention, and maximum difficulty is exactly that hygroscopicity is strong and mobile poor, and poor plasticity is difficult to molding.

1. diluent ratio

Diluent extract powder: diluent angle of repose

- - 45°

34 ° of starch 6: 2

5∶2 35°

4∶2 40°

3∶2 42°

30 ° of microcrystalline Cellulose 6: 2

5∶2 25°

4∶2 29°

3∶2 28°

2. binder concn

Binder concn % angle of repose

HPMC 1 42°

2 35°

3 38°

L-HPC 1 25°

2 30°

3 29°

3. engine speed

Rotating speed (r/min) particle size distribution

100 a large amount of aggregation block and powder

200 a large amount of aggregation block and powder

250 aggregation block fragmentations, particle diameter diminishes

300 aggregation block fragmentations, particle diameter diminishes

The result shows that the selection engine speed is 250r/min.

4. the round as a ball time: this experiment is the optimization screening that index is carried out process conditions with the roundness (critical angle φ represents with the plane) and 18～24 purpose yields (f) of micropill.The mensuration of roundness: a certain amount of micropill is put on the flat board, a dull and stereotyped side is lifted, measure at micropill begin the to roll angle (φ) of top rake plane and horizontal plane, this angle is more little, and the roundness of micropill is good more.

(min) 2 φ of round as a ball time/° f/%

4 30.2 87.2

6 31.2 54.2

8 33.4 65.4

10 32.5 84.5

12 35.7 85.7

5. become the ball parameters Optimization

At fixing jet flow 15L/min, on the basis of whiff pressure 0.5Mpa, air blast flux 10 * 20L/min, be two factors with the spray revolution speed with for powder machine rotating speed, carry out uniform Design, the screening technology condition.

Spray revolution speed (r/min) is for powder machine rotating speed (r/min) f/%

5 10 80.4

10 15 77.3

15 20 79.5

20 25 88.0

25 30 84.2

The result shows; with extract powder and microcrystalline Cellulose mixed by 5: 2; put in the comminutor; with 1%L-HPC solution is binding agent; with water is wetting agent, is optimum process condition at engine speed 250r/min, spray pump rotating speed 20r/min, for powder machine rotating speed 25r/min, jet flow 15L/min, whiff pressure 0.5Mpa, air blast flux 10 * 20L/min, whitewashing time 5min, round as a ball time 4min.

3, soft capsule Study on Forming

1. the adsorbing base rate is investigated

Medicated powder: substrate suspension situation

1: 1.0 inhomogeneous suspension

1: 1.2 even suspension

1: 1.5 even suspension

2. adjuvant is to the influence of composition:

Group andrographolide (mg/g)

Medicated powder 6.05

Add after the substrate 6.00

The result shows that optimum process condition is for pressing medicated powder: substrate=1: 1.2, andrographolide content did not have significant change after medicated powder added substrate.

4, drop pill Study on Forming

1. different substrates and coolant are to the influence of drop pill molding

Group substrate and medicine amalgamation coolant drip system situation molding situation

1 PEG4000 easily melts liquid paraffin oil droplet shape mutually and oozes fast, oblate spheroid, and the chain pearl,

The too fast ball that sinks is less

2 PEG4000 easily melt methyl-silicone oil oil droplet shape mutually and ooze fast, oblate spheroid, and the chain pearl,

The slow ball that sank is less

3 PEG4000 easily melt methyl-silicone oil mutually: liquid paraffin oil droplet shape oozes fast, and spheroidal is no stingy

3: 1 moderate holes of sinking, ball is less

4 PEG6000 melt liquid paraffin mutually than difficulty, and to drip speed slower, and oblate spheroid appears in water dropper, the chain pearl,

Stop up, the too fast ball that sinks is bigger

5 PEG6000 melt methyl-silicone oil mutually than difficulty, and to drip speed slower, water dropper oblate spheroid, chain pearl

Occur stopping up, the slow ball that sank is bigger

6 PEG6000 melt methyl-silicone oil mutually than difficulty: liquid paraffin drips that speed is slower, and oblate spheroid appears in water dropper, no spilehole

Stop up at 3: 1, the moderate ball that sinks is bigger

2. different pharmaceutical adding mode and ratio are to the influence of drop pill molding

Group substrate medicine: substrate (g: ml) medicine deployment conditions molding situation in substrate

1 PEG4000 is difficult to be uniformly dispersed rough at 3: 5, and irregular colour is even

The 2 PEG4000 spheroidal that is uniformly dispersed at 3: 7, smooth, color even, quality is better

The 3 PEG4000 spheroidal that is uniformly dispersed at 2: 4, smooth, color even, quality is harder

The 4 PEG4000 smooth surface that is uniformly dispersed at 2: 5, irregular colour is even

The 5 PEG4000 spheroidal that is uniformly dispersed at 1: 3, smooth, color is not too even, and quality is softer

3. cool off liquid-column height, rotating speed and drip fast selection

Group cooling column height (cm) rotating speed (rmin ^-1) a speed (min ^-1) drop pill ratio of briquetting (%)

1 80 10 40～50 90.24

2 80 15 50～60 89.51

3 80 20 60～70 78.59

4 100 10 50～60 42.87

5 100 15 60～70 68.32

6 100 20 40～50 55.98

7 120 10 60～70 60.34

8 120 15 40～50 94.01

9 120 20 50～60 88.02

The result shows, optimum process condition is for being substrate with PEG4000, add thick paste, medicine: substrate=3: 7 stirs, airtight, insulation with internal diameter 4.5mm, external diameter 5.5mm dropper, splashes into methyl-silicone oil with the speed of 40～50 of per minutes: in the mixing liquid coolant of liquid paraffin=3: 1, the high 120cm of cooling column, rotating speed 15rmin ^-1

Experimental example 3: contrast experiment

1. dissolution is investigated: adopt the little slurry method of cuvette to measure dissolution in vitro, get in the little stripping rotor of 0.05mol/L phosphate sodium dihydrogen buffer solution that 12 in tablet is equipped with 37 ℃ ± 0.5 ℃ of 100ml, put 2 for every glass, totally 6 glasss of (micropills, drop pill then every glass put 1 ball), start little slurry immediately and pick up counting, rotating speed is 50 rev/mins, respectively at 5min, 10min, 30min, 45min, the 60min sampling, sampling amount 10ml (replenishing 10ml37 ℃ ± 0.5 ℃ 0.05mol/L phosphate sodium dihydrogen buffer solution after each sampling simultaneously), and through the 0.45um membrane filtration, inject high performance liquid chromatograph, measure the content of andrographolide.

Average stripping quantity (%)

Time (min) conventional tablet drop pill pellet

5 21.0 45.2 56.2

10 52.5 85.7 87.4

30 82.0 99.2 99.9

45 88.0 99.8 100.0

60 90.9 100.0 97.5

2. disintegration time is investigated

The group disintegration time

Capsule 30min

Soft capsule 25min

Dispersible tablet 30sec

Experimental example 4: antiinflammatory action pharmacological research

1.1 the influence of xylol induced mice auricle edema

Experimental technique faces with preceding that dispersible tablet of the present invention, micropill, soft capsule, micropill are mixed with the 0.10g/ml suspension with 0.5% Carboxymethyl cellulose sodium (CMC-Na) is standby, and animal is used healthy Kunming mouse, body weight 20 grams.With mice random packet (matched group normal saline), irritate the long-pending 20ml/kg of being of body of stomach, two weeks of continuous irrigation stomach, once a day, the last administration after 30 minutes with microsyringe only with 0.05ml/, dimethylbenzene is applied to mouse right ear, put to death mice after 15 minutes, cut two ears, dash with the 8mm diameter steel and lay round auricle in left and right sides auricle same area respectively along the auricle baseline, torsion balance claims two auricle weight in wet bases, with two auricle weight differences as the swelling level index.Inhibitory rate of intumesce equals the difference of average swelling degree of matched group and the average swelling degree of administration group and takes advantage of 100% again divided by the average swelling degree of matched group.

Average swelling degree (mg) suppression ratio (%) of group dosage (g/kg) animal (only)

Matched group 20ml/kg 8 24.21 ± 4.60

Hydrocortisone group 0.04 8 7.25 ± 2.03 69.10

JINJI PIAN group 2.0 8 16.34 ± 0.24 30.10

JINJI KELI group 2.0 8 17.12 ± 2.25 30.02

JINJI JIAONANG group 2.0 8 16.13 ± 4.15 31.17

Micropill group 2.0 8 14.57 of the present invention ± 5.09 34.24

Drop pill group 2.0 8 14.92 of the present invention ± 3.08 33.72

Dispersible tablet group 2.0 8 14.30 of the present invention ± 8.70 32.16

Soft capsule group 2.0 8 15.51 of the present invention ± 0.34 33.34

2.2 influence to the rat uterus inflammation

Experimental technique: animal is selected the female rat of SD kind for use, about 200 grams of body weight.The animal grouping, each treated animal under etherization, cut off the hypogastric region hair, long mouthful of 2cm is cut in the sterilization back in the abdomen center, expose the uterus, make a kerf in the place along 1cm on the left hand corner of uterus, one plastic hoop (caliber 12mm, long 0.5cm, alcohol disinfecting) is positioned over intrauterine, with the uterine incision sutured, postoperative beginning in 2 hours administration, once a day, the administration volume is the 20ml/kg body weight, put to death animal after 7 days, take out the uterus, both sides, remove fat, analytical balance is weighed, left side, every Mus uterus is inflammation swelling degree with the difference on right side, calculates the swelling rate and the suppression ratio of administration group.The swelling rate equals to cause scorching uterus average weight and not multiply by 100% with the difference that does not cause scorching uterus average weight divided by causing scorching uterus average weight, and the difference that suppression ratio equals average swelling rate in matched group uterus and the average swelling rate in administration group uterus multiply by 100% divided by the average swelling rate in matched group uterus.

Group dosage (g/kg) animal (only) swelling rate (%) suppression ratio (%)

Matched group 20ml/kg 10 210.40

Hydrocortisone group 0.04 10 6.72 96.57

JINJI PIAN group 2.0 10 17.91 91.30

JINJI KELI group 2.0 10 18.02 91.72

JINJI JIAONANG group 2.0 10 18.36 91.35

Drop pill group 2.0 10 15.08 92.75 of the present invention

Micropill group 2.0 10 15.37 92.19 of the present invention

Soft capsule group 2.0 10 15.81 92.16 of the present invention

Dispersible tablet group 2.0 10 15.23 91.06 of the present invention

The result shows that preparation of the present invention has good anti-inflammation of uterus effect, and effect is not less than in JINJI PIAN, JINJI JIAONANG, JINJI KELI.

Concrete embodiment:

Embodiments of the invention 1: 9 parts of Radix Rosae Laevigataes, 18 parts of Caulis Spatholobis, 9 parts of Radix Flemingiae Philippinensiss, 9 parts of Caulis Mahoniaes, 4 parts of Radix Zanthoxylis, 3 parts of Herba Andrographis, get 1 part of Herba Andrographis, be ground into fine powder, sieve; Remain 2 parts of Herba Andrographis and Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli decocts with water 2 times, each 2 hours, collecting decoction, filter, filtrate is condensed into the thick paste shape, adds Herba Andrographis fine powder, 3%CMS-Na, is that 10% starch slurry is a binding agent with concentration, the system soft material, cross 20 mesh sieves and granulate 60 ℃ of oven dry, 20 order granulate, add 4%CMS-Na, 3% Pulvis Talci, 2% micropowder silica gel, mix homogeneously, one-shot formula tablet machine, 2 grades of compression force tablettings, promptly get dispersible tablet, this product oral, three times on the one, each 2.

Embodiments of the invention 2: 20 parts of Radix Rosae Laevigataes; 40 parts of Caulis Spatholobis; 20 parts of Radix Flemingiae Philippinensiss; 20 parts of Caulis Mahoniaes; 8 parts of Radix Zanthoxylis; 7 parts of Herba Andrographis; get Radix Rosae Laevigatae; Caulis Spatholobi; Radix Flemingiae Philippinensis; Caulis Mahoniae; Radix Zanthoxyli; Herba Andrographis; decoct with water 2 times; each 2 hours; collecting decoction; filter; filtrate is condensed into the thick paste shape; dry; pulverize, extract powder, extract powder and microcrystalline Cellulose pressed 5: 2 mixed; put in the comminutor; with 1%L-HPC solution is binding agent, is wetting agent with water, at engine speed 250r/min; spray pump rotating speed 20r/min; for powder machine rotating speed 25r/min; jet flow 15L/min; whiff pressure 0.5Mpa; air blast flux 10 * 20L/min; whitewashing time 5min; round as a ball time 4min; pill promptly gets micropill.

Embodiments of the invention 3: 16 parts of Radix Rosae Laevigataes, 30 parts of Caulis Spatholobis, 16 parts of Radix Flemingiae Philippinensiss, 16 parts of Caulis Mahoniaes, 6 parts of Radix Zanthoxylis, 5 parts of Herba Andrographis, get 3 parts of Herba Andrographis, be ground into fine powder, sieve; Remain 2 parts of Herba Andrographis and Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli decocts with water 2 times, each 2 hours, collecting decoction, filter, filtrate is condensed into the thick paste shape, adds the Herba Andrographis fine powder, mixing, promptly get medicated powder, press medicated powder again: substrate=1: 1.2, the mixed-matrix of adding soybean oil, yellow beeswax, soybean lecithin, heating and melting, mixing gets soft capsule content; The preparation of glue: with gelatin: glycerol: water=1: 0.4: 0.7, get gelatin and add an amount of distilled water and make its imbibition, glycerol and remaining water are put be heated to 70-80 ℃ in the glue pot in addition, mix homogeneously adds expansible gelatin and stirs, and makes it to dissolve into uniform glue, in 70 ℃ of insulations 1-2 hour, leave standstill, remove the come-up foam, filter with cloth bag, in encapsulating machine, be pressed into soft capsule, be pressed into soft capsule, put in the drum drying machine and finalize the design, whole ball, drying promptly gets soft capsule.

Embodiments of the invention 4: 16 parts of Radix Rosae Laevigataes, 30 parts of Caulis Spatholobis, 16 parts of Radix Flemingiae Philippinensiss, 16 parts of Caulis Mahoniaes, 6 parts of Radix Zanthoxylis, 5 parts of Herba Andrographis, get Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli, Herba Andrographis, decoct with water 2 times, each 2 hours, collecting decoction filters, and filtrate is condensed into the thick paste shape, with PEG4000 is substrate, add thick paste, drug quality: substrate volume=3: 7 stirs, airtight, internal diameter 4.5mm is used in insulation, external diameter 5.5mm dropper splashes into methyl-silicone oil with the speed of 40～50 of per minutes: in the mixing liquid coolant of liquid paraffin=3: 1, the high 120cm of cooling column, rotating speed 15rmin ^-1, promptly get drop pill.

Embodiments of the invention 5: 9 parts of Radix Rosae Laevigataes, 18 parts of Caulis Spatholobis, 9 parts of Radix Flemingiae Philippinensiss, 9 parts of Caulis Mahoniaes, 4 parts of Radix Zanthoxylis, 3 parts of Herba Andrographis, get 2 parts of Herba Andrographis, be ground into fine powder, sieve; Remain 1 part of Herba Andrographis and Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli decocts with water 2 times, each 2 hours, collecting decoction filtered, filtrate is condensed into the thick paste shape, adds the Herba Andrographis fine powder, granulates, tabletting promptly gets tablet.

Embodiments of the invention 6: 20 parts of Radix Rosae Laevigataes, 40 parts of Caulis Spatholobis, 20 parts of Radix Flemingiae Philippinensiss, 20 parts of Caulis Mahoniaes, 8 parts of Radix Zanthoxylis, 7 parts of Herba Andrographis, get Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli, Herba Andrographis, decoct with water 2 times, each 2 hours, collecting decoction, filter, filtrate is condensed into thick paste shape, drying, pulverize, get extract powder, add alcohol granulation, promptly get granule.

Embodiments of the invention 7: 16 parts of Radix Rosae Laevigataes, 30 parts of Caulis Spatholobis, 16 parts of Radix Flemingiae Philippinensiss, 16 parts of Caulis Mahoniaes, 6 parts of Radix Zanthoxylis, 5 parts of Herba Andrographis, get 4 parts of Herba Andrographis, be ground into fine powder, sieve; Remain 1 part of Herba Andrographis and Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli decocts with water 2 times, each 2 hours, collecting decoction filtered, filtrate is condensed into the thick paste shape, adds the Herba Andrographis fine powder, mixing adds alcohol granulation, and is encapsulated, promptly gets capsule.

Embodiments of the invention 8: 16 parts of Radix Rosae Laevigataes, 30 parts of Caulis Spatholobis, 16 parts of Radix Flemingiae Philippinensiss, 16 parts of Caulis Mahoniaes, 6 parts of Radix Zanthoxylis, 5 parts of Herba Andrographis, get Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli, Herba Andrographis, decoct with water 2 times, each 2 hours, collecting decoction filters, and filtrate is condensed into the thick paste shape, add syrup, promptly get oral liquid.

Embodiments of the invention 9: 16 parts of Radix Rosae Laevigataes, 30 parts of Caulis Spatholobis, 16 parts of Radix Flemingiae Philippinensiss, 16 parts of Caulis Mahoniaes, 6 parts of Radix Zanthoxylis, 5 parts of Herba Andrographis, get Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli, Herba Andrographis, decoct with water 1 time, each 3 hours, collecting decoction filtered, filtrate is condensed into the thick paste shape, add carbomer, stir evenly, promptly get gel.

Embodiments of the invention 10: 16 parts of Radix Rosae Laevigataes, 30 parts of Caulis Spatholobis, 16 parts of Radix Flemingiae Philippinensiss, 16 parts of Caulis Mahoniaes, 6 parts of Radix Zanthoxylis, 5 parts of Herba Andrographis, get Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli, Herba Andrographis, decoct with water 1 time, each 3 hours, collecting decoction, filter, filtrate is condensed into the thick paste shape, adds microcrystalline Cellulose, granulates, tabletting promptly gets oral cavity disintegration tablet.

Claims

1, a kind of Jinji preparation for the treatment of gynaecopathia, it is characterized in that: calculate according to components by weight percent, it mainly is to be made by 9～20 parts of Radix Rosae Laevigataes, 18～40 parts of Caulis Spatholobis, 9～20 parts of Radix Flemingiae Philippinensiss, 9～20 parts of Caulis Mahoniaes, 4～8 parts of Radix Zanthoxylis, 3～7 parts of Herba Andrographis or their extract of corresponding weight portion.

2, according to the Jinji preparation of the described treatment gynaecopathia of claim 1, it is characterized in that: calculate according to components by weight percent, it mainly is to be made by 16 parts of Radix Rosae Laevigataes, 30 parts of Caulis Spatholobis, 16 parts of Radix Flemingiae Philippinensiss, 16 parts of Caulis Mahoniaes, 6 parts of Radix Zanthoxylis, 5 parts of Herba Andrographis or their extract of corresponding weight portion.

3, according to the Jinji preparation of claim 1 or 2 described treatment gynaecopathias, it is characterized in that: described preparation comprises: injection comprises: all acceptable dosage forms on injection, powder pin, freeze-dried powder, tablet, dispersible tablet, effervescent tablet, capsule, soft capsule, microcapsule, granule, pill, micropill, powder, drop pill, slow releasing preparation, controlled release preparation, gel, suppository, oral liquid, soft extract, extractum and the membrane pharmaceutics.

4, according to the Jinji preparation of claim 1,2 or 3 described treatment gynaecopathias, it is characterized in that: described preparation is dispersible tablet, soft capsule, micropill or dropping pill formulation.

5, as the preparation method of the Jinji preparation of any described treatment gynaecopathia in the claim 1～4, it is characterized in that: it is an amount of to get Herba Andrographis, is ground into fine powder, sieves; Residue Herba Andrographis and Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli decoct with water, and collecting decoction filters, and filtrate is condensed into the thick paste shape, adds above-mentioned Herba Andrographis fine powder, and mixing is made different preparations then respectively; Can also be: get Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli, Herba Andrographis, decoct with water, collecting decoction filters, and filtrate is condensed into the thick paste shape, makes different preparations then respectively.

6, according to the preparation method of the Jinji preparation of the described treatment gynaecopathia of claim 5, it is characterized in that: the dispersible tablet in the described preparation prepares like this: it is an amount of to get Herba Andrographis, is ground into fine powder, sieves; Residue Herba Andrographis and Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli decoct with water 2 times, and each 2 hours, collecting decoction, filter, filtrate is condensed into the thick paste shape, adds Herba Andrographis fine powder, 3%CMS-Na, with concentration is that 10% starch slurry is a binding agent, and the system soft material is crossed 20 mesh sieves and granulated, 60 ℃ of oven dry, 20 order granulate add 4%CMS-Na, 3% Pulvis Talci, 2% micropowder silica gel, mix homogeneously, one-shot formula tablet machine, 2 grades of compression force tablettings, promptly.

7; preparation method according to the Jinji preparation of the described treatment gynaecopathia of claim 5; it is characterized in that: the pellet in the described preparation prepares like this: get Radix Rosae Laevigatae; Caulis Spatholobi; Radix Flemingiae Philippinensis; Caulis Mahoniae; Radix Zanthoxyli; Herba Andrographis; decoct with water 2 times; each 2 hours; collecting decoction; filter; filtrate is condensed into the thick paste shape; dry; pulverize, extract powder, extract powder and microcrystalline Cellulose pressed 5: 2 mixed; put in the comminutor; with 1%L-HPC solution is binding agent, is wetting agent with water, at engine speed 250r/min; spray pump rotating speed 20r/min; for powder machine rotating speed 25r/min; jet flow 15L/min; whiff pressure 0.5Mpa; air blast flux 10 * 20L/min; whitewashing time 5min; round as a ball time 4min; pill, promptly.

8, according to the preparation method of the Jinji preparation of the described treatment gynaecopathia of claim 5, it is characterized in that: the soft capsule in the described preparation prepares like this: it is an amount of to get Herba Andrographis, is ground into fine powder, sieves; Residue Herba Andrographis and Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli decoct with water 2 times, and each 2 hours, collecting decoction, filter, filtrate is condensed into the thick paste shape, adds the Herba Andrographis fine powder, mixing, promptly get medicated powder, press medicated powder again: substrate=1: 1.2, the mixed-matrix of adding soybean oil, yellow beeswax, soybean lecithin, heating and melting, mixing gets soft capsule content; The preparation of glue: with gelatin: glycerol: water=1: 0.4: 0.7, get gelatin and add an amount of distilled water and make its imbibition, glycerol and remaining water are put be heated to 70-80 ℃ in the glue pot in addition, mix homogeneously adds expansible gelatin and stirs, and makes it to dissolve into uniform glue, in 70 ℃ of insulations 1-2 hour, leave standstill, remove the come-up foam, filter with cloth bag, in encapsulating machine, be pressed into soft capsule, be pressed into soft capsule, put in the drum drying machine and finalize the design, whole ball, drying, promptly.

9, preparation method according to the Jinji preparation of the described treatment gynaecopathia of claim 5, it is characterized in that: the drop pill in the described preparation prepares like this: get Radix Rosae Laevigatae, Caulis Spatholobi, Radix Flemingiae Philippinensis, Caulis Mahoniae, Radix Zanthoxyli, Herba Andrographis, decoct with water 2 times, each 2 hours, collecting decoction filters, and filtrate is condensed into the thick paste shape, with PEG4000 is substrate, add thick paste, drug quality: substrate volume=3: 7 stirs, airtight, internal diameter 4.5mm is used in insulation, external diameter 5.5mm dropper splashes into methyl-silicone oil with the speed of 40～50 of per minutes: in the mixing liquid coolant of liquid paraffin=3: 1, the high 120cm of cooling column, rotating speed 15rmin ^-1, promptly.