CN108553605A - A kind of Chinese herbal granules and its preparation process for treating chronic pelvic inflammatory disease - Google Patents

A kind of Chinese herbal granules and its preparation process for treating chronic pelvic inflammatory disease Download PDF

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Publication number
CN108553605A
CN108553605A CN201810373731.9A CN201810373731A CN108553605A CN 108553605 A CN108553605 A CN 108553605A CN 201810373731 A CN201810373731 A CN 201810373731A CN 108553605 A CN108553605 A CN 108553605A
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parts
radix
powder
added
water
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孙臻
周玉海
高华宏
汪杰
黄敏
张影
薛中峰
黎俊禹
黄祖光
陈明聪
陈焕擂
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Sanya Maternal And Child Health Care Hospital (sanya Women And Children's Hospital)
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Sanya Maternal And Child Health Care Hospital (sanya Women And Children's Hospital)
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Priority to CN201810373731.9A priority Critical patent/CN108553605A/en
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    • A61K36/185—Magnoliopsida (dicotyledons)
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    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
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Abstract

The present invention relates to a kind of Chinese herbal granules and its preparation process for treating chronic pelvic inflammatory disease.The Chinese medicine is prepared from the following materials：Radix Astragali, Radix Codonopsis, Fructus meliae toosendan, Radix Glycyrrhizae, Radix Angelicae Sinensis, radix paeoniae rubra, Sargent gloryvine, field pennycress, rhizoma cyperi, motherwort, Radix Salviae Miltiorrhizae, trigone.The present invention also provides the preparation method of this Chinese herbal granules, which uses dry granulation, is substantially reduced with supplementary product consumption, product quality is stable, the high and low cost of production efficiency, low power consuming, it is highly practical the features such as.

Description

A kind of Chinese herbal granules and its preparation process for treating chronic pelvic inflammatory disease
Technical field
The present invention relates to field of traditional Chinese, and in particular to a kind of Chinese herbal granules that treating chronic pelvic inflammatory disease and its preparation Technique.
Background technology
Chronic pelvic inflammatory disease (chronic pelvic inflammatory disease, CPID) refer to female sex organ, The chronic inflammation that surrounding connective tissue and loquacious peritonaeum are occurred, mostly acute pelvitis of pelvic cavity fail thoroughly to treat or patient's constitution It is poor, caused by protracted inflammation.Clinic thickens with abdominal pain, with lower exception, pelvic tissue, adhesion, mass are formed as main feature. Inflammation can be confined to a position, can also involve several positions simultaneously, usually recurrent exerbation, touching refractory, be to cause ectopic pregnancy And infertile one of common cause.In recent years, the morbidity of chronic pelvic inflammatory disease is in the trend increased year by year, it has also become a kind of common , multiple gynecological disease.
Western medicine thinks pelvic infecton mostly because after postpartum, intrauterine surgical operation, menstrual hygiene is unclean, property is infected by contact etc. causes The intrusion of pathogen causes.Traditional Chinese medicine thinks that this disease belongs to chronic refractory disease, belongs to caused by long-term disease and evil delays more, is divided into wet The cards types such as hot stasis type, cold and damp stagnation type, Qi deficiency blood stasis type, qi stagnation and blood stasis type.
Pelvic infecton therapy includes being controlled using anti-inflammatory drug, Pelvic Cavity Administration perfusion therapy, physical therapy and operation at present It treats.But it is not good enough for the therapeutic effect of chronic pelvic inflammatory disease, while the vaginal dysbacteriosis that is caused by the abuse of antibiotic and immune Underactivity, such as candidal vaginitis side effect is induced, more come to chronic pelvic inflammatory disease treatment zone difficult.It also allows in this way TCM therapy for Chronic Pelvic Inflammation protrudes its superiority, and Chinese medicine has the effect of promoting blood circulation and removing blood stasis, to remove adhesions between tissues, has Drug the organized renewing of hyperplasia can also be made to soften, be treat chronic pelvic inflammatory disease effective ways.
Chinese herbal granules are a kind of existing new formulations that grows up on the basis of traditional Chinese medicine decoction, are treated retaining decoction On the basis of effect, have the characteristics that taking dose is small, oral absorption is fast, easy to carry, is the weight for modernizing oral preparation of Chinese traditional medicinal Want component part.
It pelletizes two kinds currently, Chinese herbal granules granulating process is mainly traditional wet granulation and new dry process.Wet method system Grain is easy to operate, it is low to require appointed condition, but there is various defects, as supplementary product consumption is excessive, mechanization degree It is low, multi-process handling, the preparation of softwood is higher to the experience and skill set requirements of operating personnel, granular mass is unstable, microorganism The shortcomings of easily exceeded.Dry granulation technology is developed afterwards after " boiling granulating " used by joining stilbene Fukang granules moulding process A kind of novel method of granulating come, its advantage is that preparation process is not required to be substantially reduced by hydro-thermal variation, supplementary product consumption, produce Flow is short etc., the preparation particularly suitable for the Chinese herbal granules to damp and hot sensitivity.At the same time it can also be greatly lowered Chinese medicine preparation Taking dose, so that content of dispersion is increased, improve patient's oral dose, be conducive to the performance of drug effect, it is special to meet modern medicines preparations Point.It is not required to compared with wet granulation, in dry granulation process plus binder, mixing softwood is omitted, drying, whole grain waited Journey, used device is few, maintenance cost is low, floor space is few, therefore production cost is low；Simple for process, intermediate link is few, both controllably Dust from flying processed can reduce powder waste, while non-exhaust emission again, reduce environmental pollution.The maximum advantage of dry granulation It is low energy consumption, because dry granulation is without humidifying re-dry, without adding any binder；Some drugs (antibiotics, temperature-sensitive Property is strong) and Chinese medical extract proportion do not reach requirement, and binder cannot be added, it is necessary to complete by dry granulation process；System The epigranular of finished product, stable quality, bulk density dramatically increase after grain, and mobility improves and controllable disintegration, unit bodies Long-pending capsule or granule weight increase, and improve dose loading amount, reduce drug oral volume, conveniently take, carry, store.
Chinese medicine compound prescription is the principal mode of tcm clinical practice medication, and the research to compound is the base of entire Chinese medicine preparation research Plinth.The research of Chinese medicine compound prescription basis and mechanism of action comes particularly noticeable this year.In the compound of the mutual attenuation synergistic of multicomponent Medicine formulation development is just becoming the new hot spot of future world medical market, the treatment chronic pelvic inflammatory disease drug product listed at this stage Kind is various, but is not all effective to all patients.
Invention content
The purpose of the present invention is being directed to chronic pelvic inflammatory disease clinical treatment present situation, existing western medicine antibiotics treatment side effect is overcome Greatly, be used for a long time be also easy to produce drug resistance the shortcomings that, under guidance of traditional Chinese medicine theory, provide one kind meet tcm clinical practice treatment Characteristic and the Chinese herbal granules with quick-acting, high-efficiency low-toxicity the treatment chronic pelvic inflammatory diseases of Modern preparations
A kind of Chinese herbal granules for treating chronic pelvic inflammatory disease provided by the invention, preparation process include the following steps：
1) medicinal material of following parts by weight is taken：20-40 parts of Radix Astragali, 10-30 parts of Radix Codonopsis, 5-20 parts of Radix Angelicae Sinensis, 5-20 parts of radix paeoniae rubra, 10-25 parts of Sargent gloryvine, 10-25 parts of field pennycress, 5-15 parts of Fructus meliae toosendan, 5-15 parts of rhizoma cyperi, 10-25 parts of motherwort, 5-20 parts of Radix Salviae Miltiorrhizae, 5-20 parts of trigone, 3-10 parts of Radix Glycyrrhizae；
2) Radix Astragali, Radix Codonopsis, Fructus meliae toosendan, Radix Glycyrrhizae crush 30-60 mesh sieve, obtain coarse powder, and 2-4 times of water of four kinds of medicinal material total amounts is added to impregnate 1-2h is placed in 55 DEG C of water-bath, with the salt acid for adjusting pH of 1mol/L to 4, weighs the fiber for the quality 3-8% that water is added Plain enzyme is added in the supernatant of adjusted good pH, is digested 100-120 minutes, and enzyme deactivation in 100 DEG C of water-bath, 4000r/ are moved into Min centrifuges 10-15min, and precipitation is washed 2 times with absolute ethyl alcohol, and 50-70 DEG C of baking oven is dried to permanent quality, and get dry extract A；
3) remaining pulverizing medicinal materials crosses 30-60 mesh sieve, and mixing obtains coarse powder.4-6 times of water heating extracting of weight three is added in coarse powder Secondary, each extraction time distinguishes 2h, 1h, 1h, and extraction for the first time adjusts pH2.0, second, third secondary use with 1mol/L hydrochloric acid The sodium hydroxide tune pH7.5 of 1mol/L, 9.0, are filtered, merging filtrate is concentrated to give thick paste respectively；By thick paste in 50-70 DEG C of condition Lower vacuum drying 10-15 hours makes moisture control 5% hereinafter, the B that gets dry extract；
4) dried cream powder A and dried cream powder B are broken into fine powder, mixed, it is solvable that dried cream powder-superfine silica gel powder-is added by weight proportion Property starch-maltodextrin 70-85：2-5：3-10：10-18 is uniformly mixed, in 20-30 DEG C of room temperature, 40-60% relative humidity Under, dry granulation obtains granule, packing to get.
Preferably, preparation process includes the following steps：
1) medicinal material of following parts by weight is taken：25-35 parts of Radix Astragali, 15-25 parts of Radix Codonopsis, 8-15 parts of Radix Angelicae Sinensis, 8-15 parts of radix paeoniae rubra, 12-20 parts of Sargent gloryvine, 12-20 parts of field pennycress, 7-10 parts of Fructus meliae toosendan, 7-10 parts of rhizoma cyperi, 12-20 parts of motherwort, 8-15 parts of Radix Salviae Miltiorrhizae, 8-15 parts of trigone, 5-8 parts of Radix Glycyrrhizae；
2) Radix Astragali, Radix Codonopsis, Fructus meliae toosendan, Radix Glycyrrhizae crushed 30-60 mesh sieve, obtain coarse powder, add the 2-3 times of water logging of four kinds of medicinal material total amounts 1-2h is steeped, is placed in 55 DEG C of water-bath, with the salt acid for adjusting pH of 1mol/L to 4, weighs the fibre for the quality 4-6% that water is added The plain enzyme of dimension, is added in the supernatant of adjusted good pH, digests 100-120 minutes, move into enzyme deactivation in 100 DEG C of water-bath, 4000r/min centrifuges 12min, and precipitation is washed 2 times with absolute ethyl alcohol, and 60 DEG C of baking ovens are dried to permanent quality, and get dry extract A；
3) remaining pulverizing medicinal materials crosses 30-60 mesh sieve, and mixing obtains coarse powder.5 times of water heating extractings of weight are added three times in coarse powder, Each extraction time distinguishes 2h, 1h, 1h, and extraction for the first time adjusts pH2.0 with 1mol/L hydrochloric acid, and 1mol/L is used in second, third time Sodium hydroxide tune pH7.5,9.0, filter respectively, merging filtrate is concentrated to give thick paste；By thick paste, vacuum is done under the conditions of 60 DEG C Dry 12 hours, make moisture control 5% hereinafter, the B that gets dry extract；
4) dried cream powder A and dried cream powder B are broken into fine powder, mixed, it is solvable that dried cream powder-superfine silica gel powder-is added by weight proportion Property starch-maltodextrin 75-80：3-4：5-8：12-13 is uniformly mixed, under 25 DEG C of room temperatures, 50% relative humidity, dry method system Grain, obtains granule, packing to get.
In above method, the dry granulation condition described in step 4) is squeeze pressure 10-15kg/cm3, side seal pressure 12-17kg/cm3, frequency 20-25HZ is squeezed, pelletize frequency 50-55HZ, feeding frequency 15-25HZ.
Preferably, the dry granulation condition described in step 4) is squeeze pressure 12kg/cm3, side seal pressure 14kg/cm3, squeeze Voltage-frequency rate 22HZ, pelletize frequency 52HZ, feeding frequency 19HZ.
A kind of Chinese herbal granules for treating chronic pelvic inflammatory disease provided by the invention have the following advantages：
1, granule provided by the present application is the product that traditional Chinese medicine theory is combined with modern medicines preparation technique, To improving compound of Chinese herbal medicine chronic pelvic inflammatory disease curative effect, promote form of Chinese drug modernization that there is realistic meaning.
2, replace traditional wet granulation technique to prepare granule with dry granulation technology, there is supplementary product consumption significantly to subtract It is few, product quality is stable, the high and low cost of production efficiency, low power consuming, it is highly practical the features such as, be dry granulation technology it is middle at Extensive use in medicine production provides solid test basis.
3, the effective ingredient in Radix Astragali, Radix Codonopsis, Fructus meliae toosendan, Radix Glycyrrhizae is extracted with cellulase, yield is carried better than direct water It takes；Remaining medicinal material uses semi-bionic extraction, and soda acid adjustment PH is added in extraction process, and extraction process meets Chinese medicine compatibility And the characteristics of clinical application and oral drugs are the characteristics of gastrointestinal transit absorbs.
Specific implementation mode
It is further illustrated the present invention below by embodiment.It should be understood that the embodiment of the present invention is for illustrating The present invention is rather than limiting the invention.The simple modifications that essence according to the present invention carries out the present invention belong to this hair Bright claimed range.Unless otherwise indicated, the percentage of the amount of alcohol in the present invention is percentage by volume, and v/v indicates molten The volume ratio of liquid.
Embodiment 1
A kind of Chinese herbal granules for treating chronic pelvic inflammatory disease, preparation process include the following steps：
1) medicinal material of following parts by weight is taken：Radix Astragali 2kg, it Radix Codonopsis 1kg, Radix Angelicae Sinensis 0.5kg, radix paeoniae rubra 0.5kg, Sargent gloryvine 1kg, loses Sauce grass 1kg, Fructus meliae toosendan 0.5kg, rhizoma cyperi 0.5kg, motherwort 1kg, Radix Salviae Miltiorrhizae 0.5kg, trigone 0.5kg, Radix Glycyrrhizae 0.3kg；
2) Radix Astragali, Radix Codonopsis, Fructus meliae toosendan, Radix Glycyrrhizae crushed 60 mesh sieve, obtain coarse powder, and four kinds of medicinal material total amounts, 2 times of water is added to impregnate 1h, It is placed in 55 DEG C of water-bath, with the salt acid for adjusting pH of 1mol/L to 4, weighs the cellulase for the quality 3% that water is added, add Enter into the supernatant of adjusted good pH, digest 100 minutes, moves into enzyme deactivation in 100 DEG C of water-bath, 4000r/min centrifugations 10min, precipitation are washed 2 times with absolute ethyl alcohol, and 50 DEG C of baking ovens are dried to permanent quality, and get dry extract A；
3) remaining pulverizing medicinal materials crosses 30 mesh sieve, and mixing obtains coarse powder.4 times of water heating extractings of weight are added three times in coarse powder, every time Extraction time distinguishes 2h, 1h, 1h, and extraction for the first time adjusts pH2.0 with 1mol/L hydrochloric acid, the hydrogen of second, third time 1mol/L Sodium oxide molybdena tune pH7.5,9.0, are filtered respectively, and merging filtrate is concentrated to give thick paste；Thick paste is dried in vacuo 15 under the conditions of 50 DEG C Hour, make moisture control 5% hereinafter, the B that gets dry extract；
4) dried cream powder A and dried cream powder B are broken into fine powder, mixed, it is solvable that dried cream powder-superfine silica gel powder-is added by weight proportion Property starch-maltodextrin 70：5：10：18, it is uniformly mixed, under 20 DEG C of room temperatures, 40% relative humidity, squeeze pressure 10kg/ cm3, side seal pressure 12kg/cm3, frequency 20HZ is squeezed, pelletize frequency 50HZ, and under the conditions of feeding frequency 15HZ, dry granulation obtains Granule, packing to get.
Embodiment 2
A kind of Chinese herbal granules for treating chronic pelvic inflammatory disease, preparation process include the following steps：
1) medicinal material of following parts by weight is taken：Radix Astragali 4kg, Radix Codonopsis 3kg, Radix Angelicae Sinensis 2kg, radix paeoniae rubra 2kg, Sargent gloryvine 2.5kg, Patrinia scaniosaefolia Careless 2.5kg, Fructus meliae toosendan 1.5kg, rhizoma cyperi 1.5kg, motherwort 2.5kg, Radix Salviae Miltiorrhizae 2kg, trigone 2kg, Radix Glycyrrhizae 1kg；
2) Radix Astragali, Radix Codonopsis, Fructus meliae toosendan, Radix Glycyrrhizae crushed 30 mesh sieve, obtain coarse powder, and four kinds of medicinal material total amounts, 4 times of water is added to impregnate 1h, It is placed in 55 DEG C of water-bath, with the salt acid for adjusting pH of 1mol/L to 4, weighs the cellulase for the quality 8% that water is added, add Enter into the supernatant of adjusted good pH, digest 120 minutes, moves into enzyme deactivation in 100 DEG C of water-bath, 4000r/min centrifugations 15min, precipitation are washed 2 times with absolute ethyl alcohol, and 70 DEG C of baking ovens are dried to permanent quality, and get dry extract A；
3) remaining pulverizing medicinal materials crosses 60 mesh sieve, and mixing obtains coarse powder.6 times of water heating extractings of weight are added three times in coarse powder, every time Extraction time distinguishes 2h, 1h, 1h, and extraction for the first time adjusts pH2.0 with 1mol/L hydrochloric acid, the hydrogen of second, third time 1mol/L Sodium oxide molybdena tune pH7.5,9.0, are filtered respectively, and merging filtrate is concentrated to give thick paste；Thick paste is dried in vacuo 10 under the conditions of 70 DEG C Hour, make moisture control 5% hereinafter, the B that gets dry extract；
4) dried cream powder A and dried cream powder B are broken into fine powder, mixed, it is solvable that dried cream powder-superfine silica gel powder-is added by weight proportion Property starch-maltodextrin 85：2：3：10, it is uniformly mixed, under 30 DEG C of room temperatures, 60% relative humidity, squeeze pressure 15kg/ cm3, side seal pressure 117kg/cm3, frequency 25HZ is squeezed, pelletize frequency 55HZ, under the conditions of feeding frequency 25HZ, dry granulation, Granule, packing to get.
Embodiment 3
A kind of Chinese herbal granules for treating chronic pelvic inflammatory disease, preparation process include the following steps：
1) medicinal material of following parts by weight is taken：Radix Astragali 2.5kg, Radix Codonopsis 1.5kg, Radix Angelicae Sinensis 0.8kg, radix paeoniae rubra 0.8kg, Sargent gloryvine 1.2kg, field pennycress 1.2kg, Fructus meliae toosendan 0.7kg, rhizoma cyperi 0.7kg, motherwort 1.2kg, Radix Salviae Miltiorrhizae 0.8kg, trigone 0.8kg, Radix Glycyrrhizae 0.5kg；
2) Radix Astragali, Radix Codonopsis, Fructus meliae toosendan, Radix Glycyrrhizae crushed 40 mesh sieve, obtain coarse powder, and four kinds of medicinal material total amounts, 2 times of water is added to impregnate 1h, It is placed in 55 DEG C of water-bath, with the salt acid for adjusting pH of 1mol/L to 4, weighs the cellulase for the quality 4% that water is added, add Enter into the supernatant of adjusted good pH, digest 110 minutes, moves into enzyme deactivation in 100 DEG C of water-bath, 4000r/min centrifugations 12min, precipitation are washed 2 times with absolute ethyl alcohol, and 60 DEG C of baking ovens are dried to permanent quality, and get dry extract A；
3) remaining pulverizing medicinal materials crosses 40 mesh sieve, and mixing obtains coarse powder.5 times of water heating extractings of weight are added three times in coarse powder, every time Extraction time distinguishes 2h, 1h, 1h, and extraction for the first time adjusts pH2.0 with 1mol/L hydrochloric acid, the hydrogen of second, third time 1mol/L Sodium oxide molybdena tune pH7.5,9.0, are filtered respectively, and merging filtrate is concentrated to give thick paste；Thick paste is dried in vacuo 12 under the conditions of 60 DEG C Hour, make moisture control 5% hereinafter, the B that gets dry extract；
4) dried cream powder A and dried cream powder B are broken into fine powder, mixed, it is solvable that dried cream powder-superfine silica gel powder-is added by weight proportion Property starch-maltodextrin 75：4：8：13, it is uniformly mixed, under 25 DEG C of room temperatures, 50% relative humidity, squeeze pressure 11kg/ cm3, side seal pressure 14kg/cm3, frequency 23HZ is squeezed, pelletize frequency 53HZ, and under the conditions of feeding frequency 18HZ, dry granulation obtains Granule, packing to get.
Embodiment 4
A kind of Chinese herbal granules for treating chronic pelvic inflammatory disease, preparation process include the following steps：
1) medicinal material of following parts by weight is taken：Radix Astragali 3.5kg, Radix Codonopsis 2.5kg, Radix Angelicae Sinensis 1.5kg, radix paeoniae rubra 1.5kg, Sargent gloryvine 2kg, Field pennycress 2kg, Fructus meliae toosendan 1kg, rhizoma cyperi 1kg, motherwort 2kg, Radix Salviae Miltiorrhizae 1.5kg, trigone 1.5g, Radix Glycyrrhizae 0.8kg；
2) Radix Astragali, Radix Codonopsis, Fructus meliae toosendan, Radix Glycyrrhizae crushed 50 mesh sieve, obtain coarse powder, and four kinds of medicinal material total amounts, 3 times of water is added to impregnate 2h, It is placed in 55 DEG C of water-bath, with the salt acid for adjusting pH of 1mol/L to 4, weighs the cellulase for the quality 6% that water is added, add Enter into the supernatant of adjusted good pH, digest 115 minutes, moves into enzyme deactivation in 100 DEG C of water-bath, 4000r/min centrifugations 12min, precipitation are washed 2 times with absolute ethyl alcohol, and 60 DEG C of baking ovens are dried to permanent quality, and get dry extract A；
3) remaining pulverizing medicinal materials crosses 50 mesh sieve, and mixing obtains coarse powder.5 times of water heating extractings of weight are added three times in coarse powder, every time Extraction time distinguishes 2h, 1h, 1h, and extraction for the first time adjusts pH2.0 with 1mol/L hydrochloric acid, the hydrogen of second, third time 1mol/L Sodium oxide molybdena tune pH7.5,9.0, are filtered respectively, and merging filtrate is concentrated to give thick paste；Thick paste is dried in vacuo 12 under the conditions of 60 DEG C Hour, make moisture control 5% hereinafter, the B that gets dry extract；
4) dried cream powder A and dried cream powder B are broken into fine powder, mixed, it is solvable that dried cream powder-superfine silica gel powder-is added by weight proportion Property starch-maltodextrin 80：3：5：12, it is uniformly mixed, under 25 DEG C of room temperatures, 50% relative humidity, squeeze pressure 13kg/ cm3, side seal pressure 15kg/cm3, frequency 21HZ is squeezed, pelletize frequency 54HZ, and under the conditions of feeding frequency 22HZ, dry granulation obtains Granule, packing to get.
Embodiment 5
A kind of Chinese herbal granules for treating chronic pelvic inflammatory disease, preparation process include the following steps：
1) medicinal material of following parts by weight is taken：Radix Astragali 3kg, Radix Codonopsis 2kg, Radix Angelicae Sinensis 1kg, radix paeoniae rubra 1kg, Sargent gloryvine 1.5kg, Patrinia scaniosaefolia Careless 1.5kg, Fructus meliae toosendan 0.8kg, rhizoma cyperi 0.8kg, motherwort 1.5kg, Radix Salviae Miltiorrhizae 1kg, trigone 1g, Radix Glycyrrhizae 0.6kg；
2) Radix Astragali, Radix Codonopsis, Fructus meliae toosendan, Radix Glycyrrhizae crushed 40 mesh sieve, obtain coarse powder, and four kinds of medicinal material total amounts, 3 times of water is added to impregnate 1h, It is placed in 55 DEG C of water-bath, with the salt acid for adjusting pH of 1mol/L to 4, weighs the cellulase for the quality 5% that water is added, add Enter into the supernatant of adjusted good pH, digest 105 minutes, moves into enzyme deactivation in 100 DEG C of water-bath, 4000r/min centrifugations 12min, precipitation are washed 2 times with absolute ethyl alcohol, and 60 DEG C of baking ovens are dried to permanent quality, and get dry extract A；
3) remaining pulverizing medicinal materials crosses 40 mesh sieve, and mixing obtains coarse powder.5 times of water heating extractings of weight are added three times in coarse powder, every time Extraction time distinguishes 2h, 1h, 1h, and extraction for the first time adjusts pH2.0 with 1mol/L hydrochloric acid, the hydrogen of second, third time 1mol/L Sodium oxide molybdena tune pH7.5,9.0, are filtered respectively, and merging filtrate is concentrated to give thick paste；Thick paste is dried in vacuo 12 under the conditions of 60 DEG C Hour, make moisture control 5% hereinafter, the B that gets dry extract；
4) dried cream powder A and dried cream powder B are broken into fine powder, mixed, it is solvable that dried cream powder-superfine silica gel powder-is added by weight proportion Property starch-maltodextrin 77.5：2.5：5：15, it is uniformly mixed, under 20 DEG C of room temperatures, 50% relative humidity, squeeze pressure 12kg/cm3, side seal pressure 14kg/cm3, frequency 22HZ is squeezed, pelletize frequency 52HZ, under the conditions of feeding frequency 19HZ, dry method system Grain, obtains granule, packing to get.
Comparative example 1：
After identical prescription water boiling and extraction, using wet granulation, it is dried in vacuo into granule.Steps are as follows：
1) medicinal material of following parts by weight is taken：Radix Astragali 3kg, Radix Codonopsis 2kg, Radix Angelicae Sinensis 1kg, radix paeoniae rubra 1kg, Sargent gloryvine 1.5kg, Patrinia scaniosaefolia Careless 1.5kg, Fructus meliae toosendan 0.8kg, rhizoma cyperi 0.8kg, motherwort 1.5kg, Radix Salviae Miltiorrhizae 1kg, trigone 1g, Radix Glycyrrhizae 0.6kg；
2) the above pulverizing medicinal materials cross 40 mesh sieve, and mixing obtains coarse powder.5 times of water heating extractings of weight are added three times in coarse powder, every time Extraction time distinguishes 2h, 1h, 1h, filters respectively, merging filtrate is concentrated to give medicinal extract；
3) starch slurry for taking soluble starch that water is added to be made 6%, is added medicinal extract obtained by step 2), granulation, and gained particle is set 70 DEG C of dryings of vacuum shelf dryer to get.
Pharmacodynamics test of the present invention
The influence of rat chronic pelvic infecton model is caused to mixed bacteria liquid
1 test medicine and animal：
1.1 test medicine：
Particle, the 1 gained granule of comparative example of the preparation of the embodiment of the present invention 5
1.2 animal：SD rats, 180-220g, female are provided by Guangxi University of Chinese Medicine's animal center.
1.3 mixed bacteria liquid：It provided, prepared by Microbiological Lab of Guangxi University of Chinese Medicine.
Escherichia coli:Staphylococcus aureus:Beta hemolysis type streptococcus presses 2:1:1 ratio, is dissolved in sterile saline In, it is made into the bacterial population of 3,000,000,000/mL.
2 modelings and grouping：SD rats 60,180-220g, female, are randomly divided into 6 groups, every group 10.
Blank group：Operative control group opens abdominal cavity, does sham-operation under etherization.
Other 5 groups under etherization, opens abdominal cavity, and exposure uterus scratches rat endometrium, and right uterine injection is mixed Combined bacteria suspension 0.1mL, rejecting uterus has inflammation and injects resistant rat, and abdominal cavity is closed in layering.Normal raising 10 days.It will Rat after modeling is divided into 5 groups again：Model group, experimental group 1, experimental group 2, experimental group 3, positive group.
3 administrations：By following grouping gastric infusion 20 days, 1 time a day.
Experimental group 1：Embodiment 5 is given, by crude drug gauge 0.60g/kg；
Experimental group 2：Embodiment 5 is given, by crude drug gauge 1.20g/kg；
Experimental group 3：Embodiment 5 is given, by crude drug gauge 2.40g/kg；
Control group：Comparative example 1 is given, by crude drug gauge 2.40g/kg；
Model group：Give the distilled water of 1mL；
Operative control group：Give the distilled water of 1mL；
4 detection methods
After 4.1 administrations 20 days, rat uterus ovary is fixed with 10% formalin, HE dyeing, successively to uterine wall It carries out observation and does histopathologic examination.
Pathological observation index and scoring criteria are：
4.1.1 Asherman's syndrom occlusion or expansion："-" remembers 0 point without lesion：“+”<1/3 lesion remembers 1 point；" ++ " 1/3~2/3 Lesion remembers 2 points；" +++ " 2/3 or more lesion remembers 3 points；
4.1.2 cavity wall structural lesions：Often note O divides each layer structure card of "-"；"+" proper mucous membrane body of gland knot, which disappears, remembers 1 point； " ++ " muscle layer and unclear 2 points of the note of mucous layer boundary；Unclear 3 points of the note of " +++ " layered structure；
4.1.3 epithelial cell degeneration necrosis："-" simple columnar epithelium remembers O points；"+" epithelial cell is flat or falls off<1/3 1 point of note；" ++ " epithelial cell is flat or 1/3~2/3 lesion that falls off remembers 2 points；" +++ " holostrome epithelial cell degeneration necrosis note 3 Point；
4.1.4 chronic inflammatory cell, which is invaded, dries up："-" remembers 0 point without chronic inflammation cell invasion；"+" decimal is dispersed in or stove and only exists 1 point of note in proper mucous membrane；" ++ " be dispersed in or stove but go deep into muscle layer remember 2 points；" +++ " majority is dispersed in or stratiform infiltrates and tires out And holostrome remembers 3 points；
4.1.5 inner membrance congestion and edema："-" remembers 0 point without inner membrance congestion and edema；The slight congestion and edema of "+" tunica propria remembers 1 point； " ++ " apparent congestion and edema remembers 2 points；" +++ " holostrome congestion and edema remembers 3 points.
5 results：Statistical method：Data are indicated with x- ± s, with the significance of difference between t inspections or correction t ' inspection comparative groups.
5.1 uterus pathology histological indications are shown in Table 1：
The testing result (x- ± s) of 1 uterus pathological change (appraisal result) of table
Note：Compared with blank group, ##P ＜ 0.01；Compared with model group, * ＜ 0.05, * * P ＜ 0.01.
1 result of table is shown：Modeling success (P ＜ 0.01)；Experimental group can obviously improve uterus items pathology with control group Compared with the control group, dosage is identical for symptom, wherein experimental group 3, but experimental group 3 is better than control group.
Although above having used general explanation, specific implementation mode and experiment, the present invention is made to retouch in detail It states, but on the basis of the present invention, it can be made some modifications or improvements, this is aobvious and easy to those skilled in the art See.Therefore, these modifications or improvements without departing from theon the basis of the spirit of the present invention, belong to that the present invention claims guarantors The range of shield.

Claims (4)

1. a kind of Chinese herbal granules for treating chronic pelvic inflammatory disease, it is characterised in that its preparation process includes the following steps：
1）Take the medicinal material of following parts by weight：20-40 parts of Radix Astragali, 10-30 parts of Radix Codonopsis, 5-20 parts of Radix Angelicae Sinensis, 5-20 parts of radix paeoniae rubra, Sargent gloryvine 10-25 parts, 10-25 parts of field pennycress, 5-15 parts of Fructus meliae toosendan, 5-15 parts of rhizoma cyperi, 10-25 parts of motherwort, 5-20 parts of Radix Salviae Miltiorrhizae, trigone 5- 20 parts, 3-10 parts of Radix Glycyrrhizae；
2）Radix Astragali, Radix Codonopsis, Fructus meliae toosendan, Radix Glycyrrhizae crushed 30-60 mesh sieve, obtain coarse powder, and 2-4 times of water of four kinds of medicinal material total amounts is added to impregnate 1- 2h is placed in 55 DEG C of water-bath, with the salt acid for adjusting pH of 1mol/L to 4, weighs the cellulase for the quality 3-8% that water is added, Be added in the supernatant of adjusted good pH, digest 100-120 minute, enzyme deactivation in 100 DEG C of water-bath of immigration, 4000r/min from Heart 10-15min, precipitation are washed 2 times with absolute ethyl alcohol, and 50-70 DEG C of baking oven is dried to permanent quality, and get dry extract A；
3）Remaining pulverizing medicinal materials crosses 30-60 mesh sieve, and mixing obtains coarse powder；
4-6 times of water heating extracting of weight is added three times in coarse powder, and each extraction time distinguishes 2h, 1h, 1h, and extraction for the first time is used 1mol/L hydrochloric acid adjusts pH2.0, the sodium hydroxide tune pH7.5 of second, third time 1mol/L, 9.0 filter, merge filter respectively Liquid is concentrated to give thick paste；Thick paste is dried in vacuo 10-15 hours under the conditions of 50-70 DEG C, makes moisture control 5% hereinafter, must do Cream B；
4）Dried cream powder A and dried cream powder B are broken into fine powder, mixed, dried cream powder-superfine silica gel powder-solubility is added by weight proportion and forms sediment Powder-maltodextrin 70-85：2-5：3-10：10-18 is uniformly mixed, under 20-30 DEG C of room temperature, 40-60% relative humidity, dry method Granulation, obtains granule, packing to get.
2. as described in claim 1 treatment chronic pelvic inflammatory disease Chinese herbal granules, it is characterised in that its preparation process include with Lower step：
1）Take the medicinal material of following parts by weight：25-35 parts of Radix Astragali, 15-25 parts of Radix Codonopsis, 8-15 parts of Radix Angelicae Sinensis, 8-15 parts of radix paeoniae rubra, Sargent gloryvine 12-20 parts, 12-20 parts of field pennycress, 7-10 parts of Fructus meliae toosendan, 7-10 parts of rhizoma cyperi, 12-20 parts of motherwort, 8-15 parts of Radix Salviae Miltiorrhizae, trigone 8- 15 parts, 5-8 parts of Radix Glycyrrhizae；
2）Radix Astragali, Radix Codonopsis, Fructus meliae toosendan, Radix Glycyrrhizae crushed 30-60 mesh sieve, obtain coarse powder, and 2-3 times of water of four kinds of medicinal material total amounts is added to impregnate 1- 2h is placed in 55 DEG C of water-bath, with the salt acid for adjusting pH of 1mol/L to 4, weighs the cellulase for the quality 4-6% that water is added, Be added in the supernatant of adjusted good pH, digest 100-120 minute, enzyme deactivation in 100 DEG C of water-bath of immigration, 4000r/min from Heart 12min, precipitation are washed 2 times with absolute ethyl alcohol, and 60 DEG C of baking ovens are dried to permanent quality, and get dry extract A；
3）Remaining pulverizing medicinal materials crosses 30-60 mesh sieve, and mixing obtains coarse powder；
5 times of water heating extractings of weight are added three times in coarse powder, and each extraction time distinguishes 2h, 1h, 1h, the 1mol/L of extraction for the first time Hydrochloric acid adjusts pH2.0, the sodium hydroxide tune pH7.5 of second, third time 1mol/L, 9.0 are filtered, merging filtrate, concentrated respectively Obtain thick paste；Thick paste is dried in vacuo 12 hours under the conditions of 60 DEG C, makes moisture control 5% hereinafter, the B that gets dry extract；
4）Dried cream powder A and dried cream powder B are broken into fine powder, mixed, dried cream powder-superfine silica gel powder-solubility is added by weight proportion and forms sediment Powder-maltodextrin 75-80：3-4：5-8：12-13 is uniformly mixed, and under 25 DEG C of room temperatures, 50% relative humidity, dry granulation obtains Granule, packing to get.
3. the Chinese herbal granules for the treatment of chronic pelvic inflammatory disease as claimed in claim 1 or 2, it is characterised in that step 4）Described Dry granulation condition is squeeze pressure 10-15kg/cm3, side seal pressure 12-17kg/cm3, squeeze frequency 20-25HZ, granulation frequency Rate 50-55HZ, feeding frequency 15-25HZ.
4. the Chinese herbal granules for the treatment of chronic pelvic inflammatory disease as claimed in claim 3, it is characterised in that step 4）Described is dry Method granulation conditions are squeeze pressure 12kg/cm3, side seal pressure 14kg/cm3, frequency 22HZ is squeezed, pelletize frequency 52HZ, feeding Frequency 19HZ.
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