CN1318054C - Prepn process of medicine for treating gynecopathy - Google Patents
Prepn process of medicine for treating gynecopathy Download PDFInfo
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Abstract
The present invention discloses a preparation method of a medicine for treating gynecopathy, in particular to a preparation method of traditional Chinese medicines. Compared with the prior art, the method of the present invention is characterized in that an alcohol extracting step, a water extracting step, a spray drying step, etc. are carried out to reduce content uniformity and reduce patient's dosage as much as possible. The production practice proves that the method of the present invention has strong practicability, and is favorable for popularization.
Description
Technical field
The present invention relates to a kind of preparation method of medicine, especially a kind of preparation method of Chinese medicine for the treatment of gynaecopathia belongs to the field of Chinese medicines.
Background technology
The 18th Chinese patent medicine kind---FUKE QIANJIN PIAN of recording of " Drug Standard of Ministry of Public Health of the Peoples Republic of China " (Chinese traditional patent formulation preparation), effect with removing damp-heat, benefiting vital QI and blood, be used for the treatment of leukorrhagia, damp invasion of lower energizer, gynaecopathias such as the pelvic inflammatory disease of insufficiency of vital energy and blood disease, endometritis, cervicitis, be widely used in clinically, comparatively ideal effect has been arranged.But also there is following deficiency:
1, medicament contg inaccuracy, it is bigger to fluctuate;
2, the refining degree of medicine is low, causes dose big, needs every day and takes 18.
Through consulting document, in CN1251763A, clearly provide this drug prescription and the weight ratio of medical material of respectively distinguishing the flavor of is: Radix Angelicae Sinensis, Radix Codonopsis, Herba Andrographis and Fructus Zanthoxyli Dissiti respectively account for 9%, and Radix Rosae Laevigatae, Caulis Spatholobi, Mahonia fortunei (Lindl.) Fedde and Radix Flemingiae Philippinensis respectively account for 16%.Simultaneously, also disclose the preparation technology of this tablet, stayed powder, part medical material water to carry and realizing by the part medical material.Therefrom as can be seen, medical material stays powder and extraction process by water because of refining degree is low, all can cause dose bigger; Simultaneously, medical material stays powder also can bring the big consequence of drug loading fluctuation.Therefore, address these problems, just must design a kind of new technical process, former prescription be made with extra care, and made corresponding dosage forms.Preparation technology with the prescription capsule is all disclosed in the file of CN1158087C, CN1298731A and CN1298730A, but all there is certain defective in the disclosed technical scheme of these documents, as having used the lower percolation technology of extraction efficiency among the CN1298730A; Then occur the technical process that repeats to extract among CN1158087C, the CN1298731A, increased power consumption.In addition, the also all unexposed concrete technological parameter of above document technology, as want to obtain gratifying extraction effect, still need do further experimentation.
Summary of the invention
In conjunction with existing result of study, technical problem to be solved by this invention is the new technical process of design one cover, select solvent preferably and extracting mode for use, prescription is done further made with extra care, to reach the purpose that increases drug loading, improves refining degree, makes things convenient for the patient to take.
At the aforementioned technical problem that will solve, bright people designed following technical scheme:
(1). get Caulis Spatholobi, Caulis Mahoniae, Herba Andrographis, Fructus Zanthoxyli Dissiti and Radix Angelicae Sinensis, add 60%～80% ethanol of 6～10 times of amounts, extract 2～3 times, each 1～2 hour, filter, merging filtrate reclaims ethanol to there not being the alcohol flavor, leaves standstill, and filters, and is standby;
(2). get Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis, add 6～10 times of water gagings and decoct 2～3 times, each 1～2 hour, collecting decoction filtered, and concentrates;
(3). (1) extraction concentrated solution with (2) is merged, and relative density is 1.10～1.20 clear paste when continuing to be concentrated into 60 ℃;
(4). with above-mentioned clear paste drying, make fine powder.
By above-mentioned technical process extract refining after, final the rate of extract is 6～8%; And contrast experiment simultaneously shows, extracts purified the rate of extract nearly 20% by former process.As seen, the process of the present invention's design has certain advance than former process, can obviously reduce to make total amount, thereby also reduce dose, has made things convenient for patient's use.Through inventor's further research, make the optimum process scheme:
(1). get Caulis Spatholobi, Caulis Mahoniae, Herba Andrographis, Fructus Zanthoxyli Dissiti and Radix Angelicae Sinensis, add 70% ethanol of 8 times of amounts, extract 3 times, each 2 hours, filter, merging filtrate reclaims ethanol to there not being the alcohol flavor, leaves standstill, and filters, and is standby;
(2). get Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis, add 8 times of water gagings and decoct 2 times, each 2 hours, collecting decoction filtered, and concentrates;
(3). (1) extraction concentrated solution with (2) is merged, and relative density is 1.15～1.20 clear paste when continuing to be concentrated into 60 ℃;
(4). above-mentioned clear paste is spray dried to fine powder.
Through the pilot scale checking, above technical process is pratical and feasible, has reached inventor's initial purpose substantially.And use this cover process, and combine with modern preparation technique, just can make clinical required various dosage forms, as: add disintegrating agent, binding agent and lubricant etc. in medicated powder, compacting is in flakes; To dress up capsule after the medicated powder granulation; In medicated powder, add correctives, granulate, make granule etc.In order to cover the adverse drug abnormal smells from the patient, improve the accuracy of medicine stability and drug loading, the inventor preferably makes soft capsule.
Whether soft capsule stability is good, closely related with the kind and the addition of suspensoid, and the inventor has selected for use the mixture of suspending agent and vegetable oil as suspensoid after after deliberation.The suspending agent here can be one or more the mixture in Cera Flava, lecithin, aluminum monostearate, the ethyl cellulose etc., be preferably Cera Flava, and vegetable oil can be one or more the mixture in soybean oil, Oleum Arachidis hypogaeae semen, Oleum Brassicae campestris, Oleum Helianthi, Oleum Gossypii semen, rapeseed oil and other edible plants oil, in view of big, the stay in grade of cheap, output of soybean oil, so be decided to be optimum selection.
According to universal law, the amount of suspensoid is big more, and the stability of suspension is just good more, yet in actual production, the amount of suspensoid is too big, can cause the increase of cost again, also make troubles for production process, therefore must on the basis that can reach stablizing effect, reduce the suspensoid consumption as far as possible, the inventor gropes through experiment, determined that medicated powder and soybean oil, mellisic optimum weight ratio are 1: 1.4: 0.1, can satisfy the requirement of stability so fully, saved the consumption of suspensoid again.
After finishing the foregoing invention content, the product of the original relatively technology of resulting product, more refining, the unit formulation drug loading increases, and content of dispersion is accurate, does not have bad abnormal smells from the patient, patient's taking convenience has overcome the various drawbacks of original technical products substantially, has reached purpose of the present invention.It is emphasized that this technologic progress is not making the cost that is reduced to of pharmaceutical effectiveness, illustrate by technical solution of the present invention below by animal pharmacodynamics contrast experiment to make the curative effect of product and uninfluenced.Used medicine in the experiment " gynecological's a thousand pieces of gold soft capsule " makes by optimised process of the present invention, and FUKE QIANJIN PIAN is that Zhuzhou Qianjin Pharmacy Co., Ltd produces.
Experiment purpose: observe medicine Pyrogentisinic Acid mucilage and cause the therapeutical effect of rat chronic pelvic inflammatory disease to observe:
Experimental technique
1. grouping is used 60 of rats with the administration experiment, be divided into 6 groups at random, 10 every group, i.e. normal control group, model control group, FUKE QIANJIN PIAN treatment group (press the conversion of raw medicinal herbs amount, be equivalent to 20 times of human dosage, down together), gynecological's a thousand pieces of gold soft capsule treatment group, be divided into small dose group, middle dosage group, heavy dose of group, be equivalent to 5 times of human dosage respectively, 10 times and 20 times.The 3rd day beginning successive administration after the modeling observed 12 days altogether first.
2. modelling: except that normal group, all the other animals are made vagina and cervix uteri inflammatory model with 25% phenol rubber cement, with taper venotomy pin, enter the vagina deep and inject phenol rubber cement, every 0.3ml, per 3 days 1 time, totally 3 times.
Observation index
(1) hemorheology detects index: whole blood viscosity, blood plasma viscosity and packed cell volume.
(2) histopathologic examination 12 days execution rats after administration.Get uterus, bladder, ovary, vagina, fix, gradient ethanol dehydration, paraffin embedding, the tissue slice of cutting preparation 2-3mm, HE dyeing, neutral gum mounting, tissues observed pathological change under the optical microscope with 10% neutral formalin solution.
(3) statistical method: (X ± SD) expression, group difference relatively adopts the independent sample t check to all measurement datas, is finished by the SPSS11.0 of statistical software with mean ± standard deviation.
Experimental result
(1) Pyrogentisinic Acid's mucilage causes the influence of chronic pelvic inflammatory disease hemorheology of rat index: we have observed administration hemorheology of rat index after 12 days, the results are shown in Table one.By table one as seen, in administration after 12 days, the whole blood viscosity of positive drug treatment group and the big or middle dosage group of gynecological's a thousand pieces of gold soft capsule is starkly lower than model group, have significant statistical significance (P＜0.05), gynecological's a thousand pieces of gold soft capsule small dose group does not then have statistical significance to the influence of whole blood viscosity.
(2) histopathology result:
1. perusal
The normal control group: the uterus color, hardness is normal, and swelling, hyperemia are seen in the cervix uteri end, the ovary no abnormality seen.
Model control group: part uterus darker in color is red, the obvious swelling of cervix uteri, hyperemia, and the slight adhesion in individual animal abdominal cavity, ovary shows no obvious abnormalities.
All administrations each group (positive drug, the large, medium and small dosage of gynecological's a thousand pieces of gold soft capsule) cervix uteri swelling, hyperemia have in various degree and alleviate; Ovary shows no obvious abnormalities.
2. observed result under the mirror
The normal control group: endometrium does not see obviously and thickens that the intimal surface epithelium is normal or slight hypertrophy is arranged, and body of gland is not seen pathological changes, does not see obvious lymphocytic infiltration, and ovary is not seen obvious pathological changes.
Model control group: the obvious hypertrophy of endometrium, thicken, the intimal surface epithelial proliferation, karyokinesis is mutually more to be seen, between epithelial cell, the time see apoptotic body and visible more fragment.Between in the matter visible in to the severe cell infiltration, go up subcutaneous being dispersed in or kitchen range shape lymphocyte, neutrophil infiltration.Sometimes see that cell infiltration is in around the inner membrance body of gland or in the lumen of gland.Bilateral ovaries is not seen obvious pathological changes.
Positive drug control group: visible slight hypertrophy of endometrium glandular epithelium and inflammatory cell infiltration.The visible inflammation of individual animal endometrium, but obviously alleviate than model control group.Ovary is not seen obvious pathological changes.
The heavy dose of group of gynecological a thousand pieces of gold soft capsule endometrium slightly thickens, and indivedual uterine cavities expansions, thicken part endometrial surface epithelium hypertrophy.Go up subcutaneous have mild inflammation cellular infiltration, the visible fragment of individual animal hyperplastic epithelium cell, interior intermembranous matter has light to moderate intiltration of acidophilic leukocyte.Bilateral ovaries is not seen obvious pathological changes.
Dosage group endometrium slightly thickens in gynecological's a thousand pieces of gold soft capsule, and endometrial surface epithelium has accidental fragment between hypertrophy, hyperplastic epithelium in various degree.Go up the subcutaneous mild inflammation cellular infiltration that only has, ovary is not seen obvious pathological changes.
Gynecological's a thousand pieces of gold soft capsule small dose group endometrial hyperplasia, thicken, the expansion of part uterine cavity, epithelial cell has hypertrophy in various degree, goes up the subcutaneous slight lymphocytic infiltration that has, and indivedual visible kitchen range shapes soak into, and ovary is not seen obvious pathological changes.
Conclusion: in gynecological's a thousand pieces of gold soft capsule, heavy dose of group is suitable to the therapeutic effect and the FUKE QIANJIN PIAN of chronic pelvic.
The specific embodiment:
Below further specify technical process of the present invention by specific embodiment:
Embodiment one:
Prescription: Radix Flemingiae Philippinensis 16kg Radix Rosae Laevigatae 16kg Radix Codonopsis 9kg
Caulis Spatholobi 16kg Fructus Zanthoxyli Dissiti 9kg Herba Andrographis 9kg
Caulis Mahoniae 16kg Radix Angelicae Sinensis 9kg
Method for making: above eight flavors, get Caulis Spatholobi, Caulis Mahoniae, Herba Andrographis, Fructus Zanthoxyli Dissiti and Radix Angelicae Sinensis add 60% ethanol of 6 times of amounts, extract secondary, and each 1 hour, filter, merging filtrate reclaims ethanol to there not being the alcohol flavor, leaves standstill, and filters, and is standby.All the other Radix Rosae Laevigataes, Radix Flemingiae Philippinensis and Radix Codonopsis three flavors, the decocting that adds 6 times of amounts boils secondary, each 1 hour, collecting decoction, filter, filtrate concentrates, and merges with aforementioned ethanol extract, mixing, continue to be concentrated into the clear paste that relative density is 1.10 ~ 1.15 (60 ℃), drying under reduced pressure is ground into fine powder, add appropriate amount of starch, make capsule.
Embodiment two:
Prescription: Radix Flemingiae Philippinensis 16kg Radix Rosae Laevigatae 16kg Radix Codonopsis 9kg
Caulis Spatholobi 16kg Fructus Zanthoxyli Dissiti 9kg Herba Andrographis 9kg
Caulis Mahoniae 16kg Radix Angelicae Sinensis 9kg
Method for making: above eight flavors, get Caulis Spatholobi, Caulis Mahoniae, Herba Andrographis, Fructus Zanthoxyli Dissiti and Radix Angelicae Sinensis add 80% ethanol of 10 times of amounts, extract three times, each 2 hours, filter, merging filtrate reclaims ethanol to there not being the alcohol flavor, leaves standstill, filtration, standby.All the other Radix Rosae Laevigataes, Radix Flemingiae Philippinensis and Radix Codonopsis three flavors, the decocting that adds 10 times of amounts boils three times, each 2 hours, collecting decoction filters, and filtrate concentrates, merge with aforementioned ethanol extract, mixing continues to be concentrated into the clear paste that relative density is 1.15 ~ 1.20 (60 ℃), be spray dried to fine powder, add carboxymethylstach sodium 120g, microcrystalline Cellulose 300g, with alcohol granulation, it is an amount of to add starch again, mixing, and compacting is in flakes.
Embodiment three:
Prescription: Radix Flemingiae Philippinensis 16kg Radix Rosae Laevigatae 16kg Radix Codonopsis 9kg
Caulis Spatholobi 16kg Fructus Zanthoxyli Dissiti 9kg Herba Andrographis 9kg
Caulis Mahoniae 16kg Radix Angelicae Sinensis 9kg
Method for making: above eight flavors, get Caulis Spatholobi, Caulis Mahoniae, Herba Andrographis, Fructus Zanthoxyli Dissiti and Radix Angelicae Sinensis add 70% ethanol of 8 times of amounts, extract three times, each 2 hours, filter, merging filtrate reclaims ethanol to there not being the alcohol flavor, leaves standstill, filtration, standby.All the other Radix Rosae Laevigataes, Radix Flemingiae Philippinensis and Radix Codonopsis three flavors, the decocting that adds 8 times of amounts boils secondary, each 2 hours, collecting decoction, filter, filtrate concentrates, and merges with aforementioned ethanol extract, mixing, continue to be concentrated into the clear paste that relative density is 1.15 ~ 1.20 (60 ℃), be spray dried to fine powder, add 1.4 times of soybean oils and 0.1 times of Cera Flava, suspendible is even, is pressed into soft capsule.
Embodiment four:
Prescription: Radix Flemingiae Philippinensis 16kg Radix Rosae Laevigatae 16kg Radix Codonopsis 9kg
Caulis Spatholobi 16kg Fructus Zanthoxyli Dissiti 9kg Herba Andrographis 9kg
Caulis Mahoniae 16kg Radix Angelicae Sinensis 9kg
Method for making: above eight flavors, get Caulis Spatholobi, Caulis Mahoniae, Herba Andrographis, Fructus Zanthoxyli Dissiti and Radix Angelicae Sinensis add 75% ethanol of 8 times of amounts, extract three times, each 1.5 hours, filter, merging filtrate reclaims ethanol to there not being the alcohol flavor, leaves standstill, filtration, standby.All the other Radix Rosae Laevigataes, Radix Flemingiae Philippinensis and Radix Codonopsis three flavors, the decocting that adds 8 times of amounts boils secondary, and each 1 hour, collecting decoction, filter, filtrate concentrates, and merges mixing with aforementioned ethanol extract, continue to be concentrated into the clear paste that relative density is 1.10 ~ 1.15 (60 ℃), be spray dried to fine powder, add the Cera Flava of 1.6 times of Oleum Gossypii semens and 0.08 times, be pressed into soft capsule.
Table one medicine Pyrogentisinic Acid mucilage causes the influence (X ± SD) of chronic pelvic inflammatory disease hemorheology of rat index
| Whole blood viscosity | The blood plasma viscosity | Packed cell volume | ||
| Height is cut | Low cutting | |||
| The normal group model group The positive drug groupDosage group small dose group in heavy dose of group | 4.21±0.46 ** 5.11±0.53 4.69±0.36 * 4.51±0.34 * 4.54±0.38 * 5.09±0.42 | 8.88±1.46 *** 12.67±1.55 11.32±1.32 * 11.05±1.32 * 11.06±1.02 * 12.18±1.09 | 37.5±1.12 37.3±1.35 36.6±1.74 37.7±1.42 37.2±2.09 37.2±2.56 | 1.09±0.04 1.14±0.06 1.07±0.19 1.08±0.27 1.03±0.27 1.15±0.23 |
Annotate: compare with model control group
*P＜0.05,
*P＜0.01,
* *P＜0.001.
Claims (7)
1. preparation method for the treatment of the medicine of gynaecopathia, the prescription of this medicine is made up of the Radix Angelicae Sinensis, Radix Codonopsis, Herba Andrographis, the Fructus Zanthoxyli Dissiti that account for prescription medical material gross weight 9% respectively and the Radix Rosae Laevigatae, Caulis Spatholobi, Mahonia fortunei (Lindl.) Fedde, the Radix Flemingiae Philippinensis that account for prescription medical material gross weight 16% respectively, it is characterized in that this preparation method comprises following processing step:
A. get Caulis Spatholobi, Caulis Mahoniae, Herba Andrographis, Fructus Zanthoxyli Dissiti and Radix Angelicae Sinensis, add 60%～80% ethanol of 6～10 times of amounts, extract 2～3 times, each 1～2 hour, filter, merging filtrate reclaims ethanol to there not being the alcohol flavor, leaves standstill, and filters, and is standby;
B. get Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis, add 6～10 times of water gagings and decoct 2～3 times, each 1～2 hour, collecting decoction filtered, and concentrates;
C. the extraction concentrated solution with a and b merges, and relative density is 1.10～1.20 clear paste when continuing to be concentrated into 60 ℃;
D. with above-mentioned clear paste drying, make fine powder.
2. the preparation method of medicine according to claim 1 is characterized in that this preparation method comprises following processing step:
A. get Caulis Spatholobi, Caulis Mahoniae, Herba Andrographis, Fructus Zanthoxyli Dissiti and Radix Angelicae Sinensis, add 70% ethanol of 8 times of amounts, extract 3 times, each 2 hours, filter, merging filtrate reclaims ethanol to there not being the alcohol flavor, leaves standstill, and filters, and is standby;
B. get Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis, add 8 times of water gagings and decoct 2 times, each 2 hours, collecting decoction filtered, and concentrates;
C. the extraction concentrated solution with a and b merges, and relative density is 1.15～1.20 clear paste when continuing to be concentrated into 60 ℃;
D. above-mentioned clear paste is spray dried to fine powder.
3. as the preparation method of medicine as described in the claim 2, it is characterized in that fine powder with the steps d gained adds suitable adjuvant and makes clinical required dosage form.
4. as the preparation method of medicine as described in the claim 3, it is characterized in that in steps d gained fine powder, adding the vegetable oil of its 1.2～1.6 times of weight and the suspending agent of 0.08～0.12 times of weight, make suspendible even, make soft capsule.
5. as the preparation method of medicine as described in the claim 4, it is characterized in that described vegetable oil is meant one or more the mixture in soybean oil, Oleum Arachidis hypogaeae semen, Oleum Brassicae campestris, Oleum Helianthi, Oleum Gossypii semen, rapeseed oil and other edible plants oil.
6. as the preparation method of medicine as described in the claim 4, it is characterized in that described suspending agent can be one or more the mixture in Cera Flava, lecithin, aluminum monostearate, the ethyl cellulose etc.
7. as the preparation method of medicine as described in the claim 4, the weight ratio that it is characterized in that described fine powder, soybean oil and Cera Flava three is 1: 1.4: 0.1.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2004101555028A CN1318054C (en) | 2004-08-26 | 2004-12-03 | Prepn process of medicine for treating gynecopathy |
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| CNB2004101555028A CN1318054C (en) | 2004-08-26 | 2004-12-03 | Prepn process of medicine for treating gynecopathy |
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| CN1318054C true CN1318054C (en) | 2007-05-30 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106138375A (en) * | 2016-08-12 | 2016-11-23 | 株洲千金药业股份有限公司 | The application in terms of preparation treatment hysteropathy medicine of the Chinese medicine composition combined with antibiotic |
| CN106266149A (en) * | 2016-08-12 | 2017-01-04 | 株洲千金药业股份有限公司 | The application in terms of preparation suppression inflammatory factor medicine of the heat clearing Chinese medicine compositions combined with antibiotic |
| CN106421071A (en) * | 2016-08-12 | 2017-02-22 | 株洲千金药业股份有限公司 | Application of combination of heat-clearing traditional Chinese medicinal composition and antibiotic in preparation of uterus disease treatment drugs |
| CN106389621A (en) * | 2016-08-12 | 2017-02-15 | 株洲千金药业股份有限公司 | Application of combination of traditional Chinese medicinal composition and antibiotic in aspect of preparing medicines for inhibiting inflammatory factors |
| CN106138374A (en) * | 2016-08-12 | 2016-11-23 | 株洲千金药业股份有限公司 | The application in terms of preparation treatment disease of thymus gland medicine of gynecological's prescriptions worth thousand gold compositions combined with antibiotic |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1298730A (en) * | 1999-12-07 | 2001-06-13 | 株洲千金药业股份有限公司 | Process for preparing 'Qianjin' capsule to treat genopathy |
| CN1298731A (en) * | 1999-12-07 | 2001-06-13 | 株洲千金药业股份有限公司 | Process for preparing 'Qianjin' capsule to treat ganopathy |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1298730A (en) * | 1999-12-07 | 2001-06-13 | 株洲千金药业股份有限公司 | Process for preparing 'Qianjin' capsule to treat genopathy |
| CN1298731A (en) * | 1999-12-07 | 2001-06-13 | 株洲千金药业股份有限公司 | Process for preparing 'Qianjin' capsule to treat ganopathy |
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