CN1879799A - Menstruation-regulating preparation with asiabell and cassia bark and method for preparing same - Google Patents

Menstruation-regulating preparation with asiabell and cassia bark and method for preparing same Download PDF

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Publication number
CN1879799A
CN1879799A CN 200610081148 CN200610081148A CN1879799A CN 1879799 A CN1879799 A CN 1879799A CN 200610081148 CN200610081148 CN 200610081148 CN 200610081148 A CN200610081148 A CN 200610081148A CN 1879799 A CN1879799 A CN 1879799A
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preparation
parts
active component
radix
extract
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刘露
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Beijing Fukangren Bio Pharm Tech Co Ltd
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Beijing Fukangren Bio Pharm Tech Co Ltd
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Abstract

The invention relates to a Chinese medicinal composition and preparing process thereof, especially a composition for treating abnormal menstruation, abdominal pain due to enterositosis, and excessive menstruation. The preferred dosage type for the preparation includes drop pills and soft capsules.

Description

Ginseng osmanthus menstruation-regulating preparation and new preparation method
Technical field:
The present invention relates to a kind of Chinese medicine composition and preparation technology thereof, particularly a kind ofly be used for menoxenia, through the front and back asthenia cold lumbago, menorrheal prescription and preparation technology thereof.
Background technology:
Menoxenia, through the front and back asthenia cold lumbago, menorrhagia is clinically to see that symptom, the traditional Chinese medical science often take the means of warming the meridian and activating blood circulation that it is treated more, and evident in efficacy.Ginseng osmanthus regulating menstruation ball is that it represents medicine.But in the practice, because this medicine is medical material to be beaten powder be used as medicine in preparation, cause impurity many, shortcoming such as dosage is big has a strong impact on its clinical practice.
The preparation of process extraction process preparation of the present invention is easy to dissolving and absorption than elite and thick putting that ordinary pill more can collect medicine, and curative effect is fast, and administration time is short, and therefore, curative effect is better.
The purpose of this invention is to provide a kind of therapeutic domain wide, easily accept, easily absorb, the preparation technology of efficient, low dosage, the Chinese medicine dripping pills that has no side effect, soft capsule, granule, chewable tablet, its pill that makes can be used for curing mainly and is used for menoxenia, through front and back asthenia cold lumbago, menorrhagia.
Summary of the invention:
The present invention relates to a kind of prescription and preparation technology thereof of Chinese medicine preparation, it is characterized in that, the preparation of per 1000 dosage units is prepared from by following proportion raw material:
10~24 parts of Radix Codonopsis (processing) 10~24 portions of Radix Paeoniae Albas of 40~96 parts of Cortex Moutans (stir-fry)
10~24 parts of 10~24 parts of Radix Angelicae Sinensis of 10~24 parts of Fructus Evodiaes of Rhizoma Chuanxiong (system)
20~48 parts of 10~24 parts of Rhizoma Pinelliaes of 10~24 portions of Cortex Cinnamomis of Radix Glycyrrhizae (processing)
Radix Ophiopogonis, 20~48 parts of Colla Corii Asini were 20~48 parts.
Preferably:
10 parts of Radix Codonopsis (processing) 10 portions of Radix Paeoniae Albas of 40 parts of Cortex Moutans (stir-fry)
10 parts of 10 parts of Radix Angelicae Sinensis of 10 parts of Fructus Evodiaes of Rhizoma Chuanxiong (system)
20 parts of 10 parts of Rhizoma Pinelliaes of 10 portions of Cortex Cinnamomis of Radix Glycyrrhizae (processing)
Radix Ophiopogonis, 20 parts of Colla Corii Asini were 20 parts.
In more than forming, the weight of medicine is calculated with crude drug, and per 1 part can be 1 gram, also can be kilogram or ton, if be unit with gram, this prescription composition can be made into 1000 doses of pharmaceutical preparatioies.Described 1000 doses of fingers, the final drug preparation of making, as make 1000 of soft capsule preparations, drop pill 1000 balls, granule 1000g etc., also can make big packing as granule, as 100~500 bags, specifically can be 100 bags, 125 bags, 200 bags, 250 bags, 500 bags etc., every bag can be used as taking dose 1 time.
More than form, can be made into the preparation of 50~1000 taking doses,, make 125 bags, take 1~2 bag at every turn, can take altogether 62.5~125 times as granule.
More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or be unit with the ton, small-scale production can be unit with the milligram also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The raw material of Chinese medicine of said ratio extracts processing through new technology of the present invention, obtain the active constituents of medicine of preparation of the present invention, add suitable excipient as required and make suitable medicinal any dosage form, said preparation can be drop pill, capsule, granule, tablet, mixture, fluid extract and extractum, soft extract, powder.
The above new technology of the present invention may further comprise the steps:
Method a:(technology 1.)
(1) get Radix Codonopsis, Fructus Evodiae, the Rhizoma Pinelliae, the Radix Paeoniae Alba, Radix Ophiopogonis and add ethanol and carry out reflux, extract, 2~4 times, the alcohol solvent consumption is 4~10 times of medical material amount, and concentration of alcohol is 50~90%, return time 0.5~2.0 hour.The ethanol extract concentrating under reduced pressure gets ethanol extraction;
(2) get Cortex Moutan, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Cortex Cinnamomi and add water distillation and extraction volatile oil, amount of water is 4~10 times, and extraction time is 2.0~10 hours, the volatile oil that must extract;
(3) with medicinal residues and Radix Glycyrrhizae behind medicinal residues behind the above ethanol extraction and the extraction volatile oil, extracting in water 2~4 times, amount of water are 4~10 times, each extraction time is 0.5~3 hour, and merge extractive liquid, filters, filtrate decompression is concentrated into the clear paste of relative density 1.18~1.22 (50 ℃ of surveys), put coldly, add ethanol and make and contain alcohol amount and reach 50~80%, stir evenly, left standstill 8~48 hours, get supernatant and reclaim ethanol to be concentrated into relative density be 1.15~1.30 (50), drying, water extract;
(4) get Colla Corii Asini, the fusing back adds in the said extracted thing.
Above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) extracting liquorice, Colla Corii Asini medical material break into fine powder, and be standby;
(2) prescription residue medical material is handled the same;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as tablet of the present invention and capsule.
The active constituents of medicine of the preparation of the present invention that above method obtains can be prepared into preparation of the present invention through further processing.
Preparation of the present invention, different dosage form method difference below is the preparation method of several preferred dosage form.
(1) preparation of drop pill
Drop pill of the present invention, wherein the ratio of active component and adjuvant is 1: 0.5~10, and preferred ratio is 1: 2~4, and most preferred ratio is 1: 3.The above adjuvant be specially molecular weight polyethylene glycol between 400 to 10000 Polyethylene Glycol and their mixture, as PEG400 (PEG400), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture or other suitable other auxiliary elements of making drop pill, as glycerol, gelatin or stearic acid sodium etc.
Following steps are taked in the preparation of drop pill of the present invention:
1. be ready to following raw material: active component, adjuvant and/or other inactive ingredients;
2. with the above-mentioned raw materials mix homogeneously;
3. add the transconversion into heat material, move into the drip irrigation of drop pill machine, medicinal liquid splashes in the liquid sub liquid paraffin by water dropper, removes liquid paraffin, selects ball, promptly.
(2) preparation of soft capsule
Soft capsule preparation of the present invention is that active component and pharmaceutically useful organic solvent and the material of making soft capsule shell are formed.Organic solvent wherein is selected from PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, the material of wherein making soft capsule shell is gelatin or arabic gum, water, plasticizer and antiseptic, the weight ratio of gelatin or arabic gum and plasticizer is 1.0: 0.4~1.0 in the soft capsule shell, and the weight ratio of gelatin and water is 1.0: 0.8~1.2; The content of active component is 50mg~500mg in every soft capsule.
The preparation method of preparation of the present invention, the process following steps:
A. get gelatin, glycerol, pure water adds thermosol, adds an amount of antiseptic, preparation rubber;
B. get active component and be dissolved in organic solvent, add suitable quantity of water, be prepared into soft capsule through encapsulating machine.
(3) preparation process of granule is as follows: with the gained active component, add a certain amount of correctives, filler, lubricant, granulate, promptly get granule.
(4) preparation method of chewable tablet is as follows: with the gained active component, add a certain amount of correctives, filler, lubricant, granulate, and drying, tabletting promptly gets chewable tablet.
Filler described in the preparation of granule, chewable tablet is selected from one or more the mixture in lactose, sucrose, dextrin, starch, microcrystalline Cellulose, mannitol, pregelatinized Starch, sorbitol, the xylitol etc.;
Described correctives one of is selected from Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, Fructus Fragariae Ananssae, Fructus Musae, Fructus Ananadis comosi, honey peach essence, maltose alcohol, saccharin sodium, protein sugar, sucrose, aspartame, the stevioside or wherein several mixture;
Suitable lubricant comprises wherein one or more such as magnesium stearate, Pulvis Talci, micropowder silica gel.
Following data declaration beneficial effect of the present invention by experiment:
In order to prove the Clinical feasibility that changes after the technology, we have carried out its main pharmacodynamics, toxicologic study to this medicine, observe its therapeutical effect, and the clinical experimental basis that provides is provided.
1, to the influence of Mouse Uterus, the development of ovary
Get 40 of ♀ ICR mices, body weight (11 ± 1) g is divided into 4 groups at random, normal saline group, diethylstilbestrol group and technology 1., 2. extractum group, except that diethylstilbestrol group sc, other respectively organizes equal ig administration, successive administration 14d, after weighing, the 15d animal puts to death, cut open and get uterus and ovary, peel off clean its connective tissue on every side, use scales/electronic balance weighing, and be converted into organ coefficient, the results are shown in Table 1.
The influence that table 1 pair Mouse Uterus is grown (x ± s, n=10)
Group Dosage (gkg -1) Uterus (mg10g -1) Ovary (mg10g -1)
Matched group diethylstilbestrol group technology is 2. extractum group of extractum group technology 1. - 0.001 0.21 0.25 26.1±4.8 47.8±7.6 ** 48.1±6.5 ** 44.3±8.0 ** 11.8±4.2 18.7±5.3 ** 12.2±3.2 12.1±3.3
Annotate: compare with matched group, *P<0.05, *P<0.01 (down together)
By table 1 as seen, medicine can significantly increase mouse uterine weight, and weightening finish does not have influence to ovary.
2, xylol causes the bullate influence of mouse ear
Get 40 of ICR mices, ♀
Figure A20061008114800081
Half and half, body weight (20 ± 2) g is divided into 4 groups at random, normal saline group, aspirin group and technology 1., 2. extractum group, each organizes equal ig administration, dosage 0.3mL10g -1Every day 1 time, successive administration 7d, last 1 administration 30min is applied to mouse right ear with 50 μ L dimethylbenzene, left side ear is coated with normal saline 50 μ L, put to death behind the 15min, along the punching of left and right sides auricle same area, the both sides auricle is weighed respectively with the 6mm card punch, as the swelling degree, the results are shown in Table 2 with two auricle weight differences.
Table 2 xylol cause the bullate influence of mouse ear (x ± s, n=10)
Group Dosage (gkg -1) Two auricle weight differences (mg)
Matched group aspirin group technology is 2. extractum group of extractum group technology 1. - 0.2 0.21 0.25 7.28±2.16 2.39±1.01 ** 3.15±1.87 * 4.23±2.07
By table 2 as seen, technology 1. extractum group xylol induced mice ear swelling the obvious suppression effect is arranged.
3, to the influence of rat writhing response due to the oxytocin
Get 40 of ♀ SD rats, body weight (200 ± 20) g is divided into 4 groups at random, continuous sc diethylstilbestrol 10d, (first day 0.8mg of every day 1 time -1, the 2nd to the 9th 0.4mg only -1, 0.8mg on the 10th only -1), the rat of sc diethylstilbestrol began to being subjected to reagent on the 5th, continuously ig7d (aspirin administration 3d).After last is given diethylstilbestrol 24h, give and once test medicine, ip oxytocin 2 μ only behind the 40min -1, the writhing response number of times that rat is taken place in the oxytocin 30min (rat abdomen shrinks indent, and trunk and hind leg stretch, and arm and side limbs inward turning are the index of dysmenorrhea for uterine contraction) given in record, the results are shown in Table 3.
The influence of rat writhing response due to the table 3 pair oxytocin (x ± s, n=10)
Group Dosage (gkg -1) Turn round the body number of times
Matched group aspirin group technology is 2. extractum group of extractum group technology 1. - 0.1 0.10 0.12 16.7±2.1 2.3±0.8 ** 3.0±1.6 ** 5.2±2.1 *
By table 3 as seen, medicine can obviously reduce rat writhing response number of times.
4, toxicological study
Acute toxicity test shows that rat oral gavage extract of the present invention fails to measure LD 50
Long term toxicity test: rat grouping, extract of the present invention is irritated stomach, every day three times, connect and annotate 90d, the result, administration group rat and control rats movable, search for food, drinking-water, body weight and multinomial observation indexs such as substantial viscera pathologic finding and histopathology detect, result of the test is not all found any toxicity; Hemogram and hepatic and renal function index and the equal no significant difference of matched group.
The blood vessel irritation of this medicine, allergy and hemolytic test all are negative.
In sum, preparation of the present invention, dropping pill formulation particularly of the present invention and soft capsule preparation are a kind of good treatment menoxenias, through front and back asthenia cold lumbago, the medicine of diseases such as menorrhagia, and change preparation technology, can obviously strengthen clinical efficacies such as its warming the meridian and activating blood circulation, its hypotoxicity in addition, prolonged application safety, therefore, be worth clinical application.
The specific embodiment:
Further specify the present invention by the following examples, include but not limited to the following example.
Embodiment 1:
The preparation method of drop pill of the present invention:
Prescription:
Radix Codonopsis (processing) the 96g Cortex Moutan 24g Radix Paeoniae Alba (stir-fry) 24g
Rhizoma Chuanxiong (system) 24g Fructus Evodiae 24g Radix Angelicae Sinensis 24g
Radix Glycyrrhizae (processing) 24g Cortex Cinnamomi 24g Rhizoma Pinelliae 48g
Radix Ophiopogonis 48g Colla Corii Asini 48g
PEG4000 100g
Make 1000 balls
Preparation method:
(1) get Radix Codonopsis, Fructus Evodiae, the Rhizoma Pinelliae, the Radix Paeoniae Alba, Radix Ophiopogonis and add ethanol and carry out reflux, extract, 3 times, the alcohol solvent consumption is 8 times of medical material amount, and concentration of alcohol is 80%, return time 1.0 hours.The ethanol extract concentrating under reduced pressure gets ethanol extraction;
(2) get Cortex Moutan, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Cortex Cinnamomi and add water distillation and extraction volatile oil, amount of water is 6 times, and extraction time is 8 hours, the volatile oil that must extract;
(3) with medicinal residues and Radix Glycyrrhizae behind medicinal residues behind the above ethanol extraction and the extraction volatile oil, extracting in water 2 times, amount of water are 8 times, each extraction time is 1.5 hours, and merge extractive liquid, filters, filtrate decompression is concentrated into the clear paste of relative density 1.18~1.22 (50 ℃ of surveys), put coldly, add ethanol and make and contain alcohol amount and reach 50~80%, stir evenly, left standstill 24 hours, get supernatant and reclaim ethanol to be concentrated into relative density be 1.15~1.30 (50), drying, water extract;
(4) get Colla Corii Asini, the fusing back adds in the said extracted thing.
(5) with above-mentioned extract obtained, the PEG4000 that adds recipe quantity puts into the vessel in heating dissolving, and jolting makes and dissolves into uniform solution, inserts in the fluid reservoir.Keep 80 ℃ the system of dripping temperature, and a control speed, condensed fluid is a liquid paraffin, drips system promptly.
Embodiment 2:
Preparation of soft capsule method of the present invention:
Prescription:
Radix Codonopsis (processing) the 480g Cortex Moutan 120g Radix Paeoniae Alba (stir-fry) 120g
Rhizoma Chuanxiong (system) 120g Fructus Evodiae 120g Radix Angelicae Sinensis 120g
Radix Glycyrrhizae (processing) 120g Cortex Cinnamomi 120g Rhizoma Pinelliae 240g
Radix Ophiopogonis 240g Colla Corii Asini 240g
PEG400 500g
Make 1000
Preparation method:
(1) get Radix Codonopsis, Fructus Evodiae, the Rhizoma Pinelliae, the Radix Paeoniae Alba, Radix Ophiopogonis and add ethanol and carry out reflux, extract, 3 times, the alcohol solvent consumption is 8 times of medical material amount, and concentration of alcohol is 80%, return time 1.0 hours.The ethanol extract concentrating under reduced pressure gets ethanol extraction;
(2) get Cortex Moutan, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Cortex Cinnamomi and add water distillation and extraction volatile oil, amount of water is 6 times, and extraction time is 8 hours, the volatile oil that must extract;
(3) with medicinal residues and Radix Glycyrrhizae behind medicinal residues behind the above ethanol extraction and the extraction volatile oil, extracting in water 2 times, amount of water are 8 times, each extraction time is 1.5 hours, and merge extractive liquid, filters, filtrate decompression is concentrated into the clear paste of relative density 1.18~1.22 (50 ℃ of surveys), put coldly, add ethanol and make and contain alcohol amount and reach 50~80%, stir evenly, left standstill 24 hours, get supernatant and reclaim ethanol to be concentrated into relative density be 1.15~1.30 (50), drying, water extract;
(4) get Colla Corii Asini, the fusing back adds in the said extracted thing.
(5) with above-mentioned extract obtained, add an amount of PEG400 and mix and mixing, add the PEG400 of surplus then, promptly get medicinal liquid.It is standby in addition to join gelatin solution by certain prescription.The condition that control is suitable is regulated content weight, obtains soft capsule in the soft capsule machine.
Embodiment 3:
The preparation method of granule of the present invention:
Prescription:
Radix Codonopsis (processing) the 600g Cortex Moutan 150g Radix Paeoniae Alba (stir-fry) 150g
Rhizoma Chuanxiong (system) 150g Fructus Evodiae 150g Radix Angelicae Sinensis 150g
Radix Glycyrrhizae (processing) 150g Cortex Cinnamomi 150g Rhizoma Pinelliae 300g
Radix Ophiopogonis 300g Colla Corii Asini 300g
Make 1000g
Preparation method:
(1) get Colla Corii Asini, licorice medicinal materials breaks into fine powder, and is standby;
(2) get Radix Codonopsis, Fructus Evodiae, the Rhizoma Pinelliae, the Radix Paeoniae Alba, Radix Ophiopogonis and add ethanol and carry out reflux, extract, 3 times, the alcohol solvent consumption is 8 times of medical material amount, and concentration of alcohol is 80%, return time 1.0 hours.The ethanol extract concentrating under reduced pressure gets ethanol extraction;
(3) get Cortex Moutan, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Cortex Cinnamomi and add water distillation and extraction volatile oil, amount of water is 6 times, and extraction time is 8 hours, the volatile oil that must extract;
(4) with the medicinal residues behind medicinal residues behind the above ethanol extraction and the extraction volatile oil, extracting in water 2 times, amount of water are 8 times, each extraction time is 1.5 hours, and merge extractive liquid, filters, filtrate decompression is concentrated into the clear paste of relative density 1.18~1.22 (50 ℃ of surveys), put coldly, add ethanol and make and contain alcohol amount and reach 70%, stir evenly, left standstill 24 hours, get supernatant and reclaim ethanol to be concentrated into relative density be 1.15~1.30 (50), drying, water extract.
(5) above active component is merged, add aspartame 5.0g, dextrin 250.0g, granulate, drying sprays into essence 5.0g, promptly gets granule 1000g.
Embodiment 4:
The preparation method of chewable tablet of the present invention:
Prescription:
Radix Codonopsis (processing) the 320g Cortex Moutan 80g Radix Paeoniae Alba (stir-fry) 80g
Rhizoma Chuanxiong (system) 80g Fructus Evodiae 80g Radix Angelicae Sinensis 80g
Radix Glycyrrhizae (processing) 80g Cortex Cinnamomi 80g Rhizoma Pinelliae 160g
Radix Ophiopogonis 160g Colla Corii Asini 160g
Make 1000
Preparation method:
(1) get Colla Corii Asini, licorice medicinal materials breaks into fine powder, and is standby;
(2) get Radix Codonopsis, Fructus Evodiae, the Rhizoma Pinelliae, the Radix Paeoniae Alba, Radix Ophiopogonis and add ethanol and carry out reflux, extract, 3 times, the alcohol solvent consumption is 8 times of medical material amount, and concentration of alcohol is 80%, return time 1.0 hours.The ethanol extract concentrating under reduced pressure gets ethanol extraction;
(3) get Cortex Moutan, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Cortex Cinnamomi and add water distillation and extraction volatile oil, amount of water is 6 times, and extraction time is 8 hours, the volatile oil that must extract;
(4) with the medicinal residues behind medicinal residues behind the above ethanol extraction and the extraction volatile oil, extracting in water 2 times, amount of water are 8 times, each extraction time is 1.5 hours, and merge extractive liquid, filters, filtrate decompression is concentrated into the clear paste of relative density 1.18~1.22 (50 ℃ of surveys), put coldly, add ethanol and make and contain alcohol amount and reach 70%, stir evenly, left standstill 24 hours, get supernatant and reclaim ethanol to be concentrated into relative density be 1.15~1.30 (50), drying, water extract.
(5) above active component is merged, add aspartame 3.0g, mannitol 200.0g, granulation, drying adds magnesium stearate 3.0g, mixing, and tabletting promptly gets 1000 of chewable tablet.

Claims (10)

1, a kind of Chinese medicine preparation is characterized in that per 1000 dosage units are made by the following weight proportion raw material:
10~24 parts of Radix Codonopsis (processing) 10~24 portions of Radix Paeoniae Albas of 40~96 parts of Cortex Moutans (stir-fry)
10~24 parts of 10~24 parts of Radix Angelicae Sinensis of 10~24 parts of Fructus Evodiaes of Rhizoma Chuanxiong (system)
20~48 parts of 10~24 parts of Rhizoma Pinelliaes of 10~24 portions of Cortex Cinnamomis of Radix Glycyrrhizae (processing)
Radix Ophiopogonis, 20~48 parts of Colla Corii Asini were 20~48 parts.
2, the compound preparation of claim 1 is characterized in that, per 1000 dosage units are made by the following weight proportion raw material:
10 parts of Radix Codonopsis (processing) 10 portions of Radix Paeoniae Albas of 40 parts of Cortex Moutans (stir-fry)
10 parts of 10 parts of Radix Angelicae Sinensis of 10 parts of Fructus Evodiaes of Rhizoma Chuanxiong (system)
20 parts of 10 parts of Rhizoma Pinelliaes of 10 portions of Cortex Cinnamomis of Radix Glycyrrhizae (processing)
Radix Ophiopogonis, 20 parts of Colla Corii Asini were 20 parts.
3, claim 1 or any one Chinese medicine preparation of 2 are drop pill, capsule, granule, tablet, mixture, fluid extract and extractum, soft extract, powder.
4, the Chinese medicine preparation of claim 3 through described raw material is extracted processing, obtains active component, adds suitable adjuvant as required and makes.
5, the Chinese medicine preparation of claim 4 is characterized in that, described active component prepares through following steps:
Method a:(technology 1.)
(1) get Radix Codonopsis, Fructus Evodiae, the Rhizoma Pinelliae, the Radix Paeoniae Alba, Radix Ophiopogonis and add ethanol and carry out reflux, extract, 2~4 times, the alcohol solvent consumption is 4~10 times of medical material amount, and concentration of alcohol is 50~90%, return time 0.5~2.0 hour.The ethanol extract concentrating under reduced pressure gets ethanol extraction;
(2) get Cortex Moutan, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Cortex Cinnamomi and add water distillation and extraction volatile oil, amount of water is 4~10 times, and extraction time is 2.0~10 hours, the volatile oil that must extract;
(3) with medicinal residues and Radix Glycyrrhizae behind medicinal residues behind the above ethanol extraction and the extraction volatile oil, extracting in water 2~4 times, amount of water are 4~10 times, each extraction time is 0.5~3 hour, and merge extractive liquid, filters, filtrate decompression is concentrated into the clear paste of relative density 1.18~1.22 (50 ℃ of surveys), put coldly, add ethanol and make and contain alcohol amount and reach 50~80%, stir evenly, left standstill 8~48 hours, get supernatant and reclaim ethanol to be concentrated into relative density be 1.15~1.30 (50), drying, water extract;
(4) get Colla Corii Asini, the fusing back adds in the said extracted thing.
Above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) extracting liquorice, Colla Corii Asini medical material break into fine powder, and be standby;
(2) prescription residue medical material is handled the same;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as tablet of the present invention and capsule.
6, the Chinese medicine preparation of claim 5 is characterized in that:
Described drop pill, wherein the ratio of active component and adjuvant is 1: 0.5~10, described adjuvant be molecular weight between 400 to 10000 Polyethylene Glycol and their mixture, be selected from PEG400 (or 600), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture.
Its preparation method is: active constituents of medicine and proper auxiliary materials behind 60~115 ℃ of mix homogeneously, are regulated the water dropper size with control drop pill weight, are that the coolant system of dripping forms with dimethicone or liquid paraffin, and coolant temperature is-10~5 ℃.
7, the Chinese medicine preparation of claim 5 is characterized in that:
Described soft capsule, its content is made up of active component and suitable substrate, and wherein the content of active component is 50mg~500mg in every soft capsule; Substrate wherein is selected from wherein one or more of PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, animal wet goods.
Its preparation method is: with active constituents of medicine and proper auxiliary materials mix homogeneously, obtain uniform suspension and/or solution, regulate content weight, compacting, dry getting final product.
8, the Chinese medicine preparation of claim 5 is characterized in that:
The preparation process of described granule is as follows: with above-mentioned extract obtained, add a certain amount of filler, correctives, lubricant, granulate, promptly get granule;
The preparation method of chewable tablet is as follows: with above-mentioned extract obtained, adds a certain amount of filler, correctives, lubricant, granulates, and drying, tabletting promptly gets chewable tablet.
9, the Chinese medicine preparation of claim 8 is characterized in that:
Described filler is selected from one or more the mixture in lactose, sucrose, dextrin, starch, microcrystalline Cellulose, mannitol, pregelatinized Starch, sorbitol, the xylitol etc.;
Described correctives one of is selected from Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, Fructus Fragariae Ananssae, Fructus Musae, Fructus Ananadis comosi, honey peach essence, maltose alcohol, saccharin sodium, protein sugar, sucrose, aspartame, the stevioside or wherein several mixture;
Suitable lubricant comprises wherein one or more such as magnesium stearate, Pulvis Talci, micropowder silica gel.
10, the preparation method of any one Chinese medicine preparation of claim 1~9 is characterized in that, the process following steps:
Described raw material of Chinese medicine is extracted processing, obtain active component, add suitable adjuvant and make; Wherein said active component prepares through following steps:
Method a:(technology 1.)
(1) get Radix Codonopsis, Fructus Evodiae, the Rhizoma Pinelliae, the Radix Paeoniae Alba, Radix Ophiopogonis and add ethanol and carry out reflux, extract, 2~4 times, the alcohol solvent consumption is 4~10 times of medical material amount, and concentration of alcohol is 50~90%, return time 0.5~2.0 hour.The ethanol extract concentrating under reduced pressure gets ethanol extraction;
(2) get Cortex Moutan, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Cortex Cinnamomi and add water distillation and extraction volatile oil, amount of water is 4~10 times, and extraction time is 2.0~10 hours, the volatile oil that must extract;
(3) with medicinal residues and Radix Glycyrrhizae behind medicinal residues behind the above ethanol extraction and the extraction volatile oil, extracting in water 2~4 times, amount of water are 4~10 times, each extraction time is 0.5~3 hour, and merge extractive liquid, filters, filtrate decompression is concentrated into the clear paste of relative density 1.18~1.22 (50 ℃ of surveys), put coldly, add ethanol and make and contain alcohol amount and reach 50~80%, stir evenly, left standstill 8~48 hours, get supernatant and reclaim ethanol to be concentrated into relative density be 1.15~1.30 (50), drying, water extract;
(4) get Colla Corii Asini, the fusing back adds in the said extracted thing.
Above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) extracting liquorice, Colla Corii Asini medical material break into fine powder, and be standby;
(2) prescription residue medical material is handled the same;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as tablet of the present invention and capsule.
Described drop pill, wherein the ratio of active component and adjuvant is 1: 0.5~10, described adjuvant be molecular weight between 400 to 10000 Polyethylene Glycol and their mixture, be selected from PEG400 (or 600), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture.
Its preparation method is: active constituents of medicine and proper auxiliary materials behind 60~115 ℃ of mix homogeneously, are regulated the water dropper size with control drop pill weight, are that the coolant system of dripping forms with dimethicone or liquid paraffin, and coolant temperature is-10~5 ℃.
Described soft capsule, its content is made up of active component and suitable substrate, and wherein the content of active component is 50mg~500mg in every soft capsule; Substrate wherein is selected from wherein one or more of PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, animal wet goods.
Its preparation method is: active constituents of medicine is mixed with proper auxiliary materials, obtain uniform suspension and/or solution, regulate content weight, compacting, dry getting final product.
CN 200610081148 2006-05-18 2006-05-18 Menstruation-regulating preparation with asiabell and cassia bark and method for preparing same Pending CN1879799A (en)

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103919955A (en) * 2014-05-09 2014-07-16 苏玉琴 Traditional Chinese medicine formula for treating female menstrual period pain
CN103933522A (en) * 2014-04-23 2014-07-23 卢亮峰 Traditional Chinese medicine preparation for treating dysmenorrhea
CN104189326A (en) * 2014-09-29 2014-12-10 洛阳御平国生物科技有限公司 Traditional Chinese medicine formula for treating dysmenorrhea
CN106177082A (en) * 2016-08-26 2016-12-07 山东汉方制药有限公司 A kind of preparation method and application of compound phellodendron bark liquid varnish

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103933522A (en) * 2014-04-23 2014-07-23 卢亮峰 Traditional Chinese medicine preparation for treating dysmenorrhea
CN103919955A (en) * 2014-05-09 2014-07-16 苏玉琴 Traditional Chinese medicine formula for treating female menstrual period pain
CN104189326A (en) * 2014-09-29 2014-12-10 洛阳御平国生物科技有限公司 Traditional Chinese medicine formula for treating dysmenorrhea
CN106177082A (en) * 2016-08-26 2016-12-07 山东汉方制药有限公司 A kind of preparation method and application of compound phellodendron bark liquid varnish
CN106177082B (en) * 2016-08-26 2020-01-10 山东汉方制药有限公司 Preparation method and application of compound phellodendron bark liquid liniment

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