CN1775276A - Fushu Preparation and new preparing method - Google Patents

Fushu Preparation and new preparing method Download PDF

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Publication number
CN1775276A
CN1775276A CNA2005101159868A CN200510115986A CN1775276A CN 1775276 A CN1775276 A CN 1775276A CN A2005101159868 A CNA2005101159868 A CN A2005101159868A CN 200510115986 A CN200510115986 A CN 200510115986A CN 1775276 A CN1775276 A CN 1775276A
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parts
preparation
radix
active component
rhizoma
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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 present invention relates to a Chinese medicine composition and its preparation method. In particular, it relates to a Chinese medicine prescription for curing the diseases of stagnation of qi and blood, uterine cold, irregular menstruation, dysmenorrhea, red flooding and white discharge, prolonged menstruation, smaller-abdomen sagging and no thought of food and drink and its preparation process. Said invention can be made into dripping pills and soft capsule preparation.

Description

Fushu 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 of treatment coagulation of QI-blood, cold uterus, menoxenia, dysmenorrhea redly collapses leucorrhea, and menstrual period are touching, lower abdomen tenesmus, the prescription of anorexia and preparation technology thereof.
Background technology:
Coagulation of QI-blood, cold uterus, menoxenia, dysmenorrhea redly collapses leucorrhea, and menstrual period are touching, the lower abdomen tenesmus, anorexia is the gynecological clinic common sympton, and the traditional Chinese medical science is often taked benefiting qi and nourishing blood, and the means of adjusting meridian and stopping leukorrhea are treated it, and evident in efficacy.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, capsule, tablet, its pill that makes can be used for curing mainly coagulation of QI-blood, cold uterus, menoxenia, dysmenorrhea redly collapses leucorrhea, and menstrual period are touching, the lower abdomen tenesmus, anorexia.
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:
20~280 parts of 20~280 parts of Radix Codonopsis of 20~280 parts of Rhizoma Chuanxiongs of Radix Angelicae Sinensis
20~280 parts of 20~280 portions of Rhizoma Cyperis of 20~280 parts of Radix Rehmanniae Preparata of the Rhizoma Atractylodis Macrocephalae (parched with bran) (salt vinegar system)
20~280 parts in 5~70 parts of Poria of 20~280 parts of Radix Scutellariaes of the Radix Paeoniae Alba (processed with wine)
20~280 parts of 5~70 portions of Radix Cynanchi Atratis of 20~280 parts of Pericarpium Citri Reticulataes of Cortex Moutan
20~280 parts of 10~140 parts of Cortexs Eucommiae of 10~140 parts of Radix Dipsacis of Radix Glycyrrhizae (processed with wine) (processed with salt)
5~70 parts of Semen Cuscutae (processed with salt) 20~280 parts of Fructus Amomis of 20~280 parts of Herba Taxillis (processed with salt)
20~280 parts in 20~280 parts of Colla Corii Asini of 20~280 portions of Cortex Cinnamomis of Rhizoma Corydalis (vinegar system) (Pulvis concha Mactrae scalds)
10~140 parts of 10~140 portions of Folium Artemisiae Argyis of Herba Schizonepetae (vinegar system) (vinegar system)
Preferably:
40 parts of 40 parts of Radix Codonopsis of 40 parts of Rhizoma Chuanxiongs of Radix Angelicae Sinensis
40 parts of 40 portions of Rhizoma Cyperis of 40 parts of Radix Rehmanniae Preparata of the Rhizoma Atractylodis Macrocephalae (parched with bran) (salt vinegar system)
40 parts in 10 parts of Poria of 40 parts of Radix Scutellariaes of the Radix Paeoniae Alba (processed with wine)
40 parts of 10 portions of Radix Cynanchi Atratis of 40 parts of Pericarpium Citri Reticulataes of Cortex Moutan
40 parts of 20 parts of Cortexs Eucommiae of 20 parts of Radix Dipsacis of Radix Glycyrrhizae (processed with wine) (processed with salt)
10 parts of Semen Cuscutae (processed with salt) 40 parts of Fructus Amomis of 40 parts of Herba Taxillis (processed with salt)
40 parts in 40 parts of Colla Corii Asini of 40 portions of Cortex Cinnamomis of Rhizoma Corydalis (vinegar system) (Pulvis concha Mactrae scalds)
20 parts of 20 portions of Folium Artemisiae Argyis of Herba Schizonepetae (vinegar system) (vinegar system)
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, soft capsule, granule, chewable tablet, tablet, capsule.
The above new technology of the present invention may further comprise the steps:
Method a:(technology 1.)
(1) gets eight flavor medical materials such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Rhizoma Atractylodis Macrocephalae, Rhizoma Cyperi, Pericarpium Citri Reticulatae, Cortex Cinnamomi, Herba Schizonepetae, Folium Artemisiae Argyi, adopt supercritical extraction (or steam distillation), 70 ℃ of extracting pressure 27MPa, extraction temperature; Resolve I pressure 9MPa, resolve 60 ℃ of I temperature.Get extract; β-CDBao He, optimised process is: β-CD is 1: 6~10 with the water ratio, and oil is 1: 4~6 with β-CD ratio, and ultrasonic 30~70min gets clathrate;
(2) get prescription residue medical material, soaked 30~60 minutes earlier with 50~85% ethanol, reheat reflux, extract, three times, each 0.5~2 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) alcohol extract and clathrate lump together the active constituents of medicine into preparation of the present invention.
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) it is the same to contain the medicinal material extract of volatile oil;
(2) surplus medicinal 6~15 times water extraction is 2~4 times, and each 0.5~2.5 hour, merge extractive liquid, filtered, and the extractum of reclaim under reduced pressure is standby;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing various preparations such as drop pill of the present invention and soft 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 violent mitigation of shrinking of rat uterus due to the oxytocin
Get 40 of SD rats, body weight 200~250g, female, by body weight at random equilibrium be divided into 4 groups, each organize rat continuous subcutaneous injection (SC) estradiol 10d (the 1st, 10d be 0.5mg/ only, other times are 0.2mg/), beginning administration in the 8th day of SC estradiol, successive administration 3d.Ip oxytocin 4u/ only behind end SC estradiol, the administration 45min, write down the rat dysmenorrhea writhing response number of animals in the 30min and turn round the body number of times, with writhing response (rat abdomen shrinks indent, and trunk and hind leg stretch, a buttocks and a side limbs inward turning) is the index of uterine contraction (dysmenorrhea).Experimental result shows, two extractum groups all can the antagonism oxytocin due to the violent contraction of rat uterus.The results are shown in Table 1.
The violent mitigation of shrinking of rat uterus due to the table 1 pair oxytocin (x ± s)
Group Dosage (g/kg) Turn round the body number of animals Turn round the body number of times in the 30min
Model group technology is 2. extractum group YUEYUESHU CHONGJI of extractum group technology 1. - 0.20 0.25 5 10 9 9 6 21.8±14.0 9.2±5.3 *9.3±4.2 *6.0±3.9 **
Compare with model group *P<0.05, *P<0.01
2, the effect that uterine smooth muscle due to the mice oxytocin is shunk
Get 32 of healthy no pregnant female Kunming mouses, body weight 25~30g is divided into 4 groups at random by body weight, 10 every group.The continuous ig administration of each extractum group 7d, in the experiment before continuous two days, 1 estradiol benzoate 0.2ml/ of lumbar injection every day only, with pentobarbital sodium 40mg/kg intraperitoneal injection of anesthesia, cut otch about 1cm at hypogastric region, open the abdominal cavity, find out a side cornua uteri, peel off surrounding tissue gently, clamp gently with the frog heart clip that is connected with cotton thread therein, be connected on the tonotransducer, trace line with desk-top balance recorder, after treating that curve is stable, on the uterus, drip oxytocin 1ml, observe the influence of medicine uterine smooth muscle.Experimental result shows that each extractum group is compared the uterine smooth muscle shrinkage amplitude and descended with model group, significant difference (P<0.05) is arranged, and all the contraction of energy antagonism oxytocin induced mice uterine smooth muscle the results are shown in Table 2.
Table 2 pair mice oxytocin causes the effect that uterine smooth muscle shrinks (x ± s)
Group Dosage (g/kg) Number of animals Shrinkage amplitude (m/g) Contraction inhibiting rate (%)
Model group technology is the extractum group 1. - 0.40 8 8 0.84±0.14 0.67±0.07 * - 20.24
Technology is extractum group salbutamol sulfate 2. 0.50 0.002 8 8 0.69±0.07 * 0.55±0.15 ** 17.86 34.52
Compare with model group *P<0.05, *P<0.01
3, to the influence of blood stasis due to the rat cold coagulation
Get 40 of SD rats, body weight 250~300g, ♀ Dual-purpose, by body weight at random equilibrium be divided into 5 groups, 8 every group, compound Salviae Miltiorrhizae group and the continuous ig administration of each extractum group 7d.In the 7th day, model group, compound Salviae Miltiorrhizae group, each extractum group subcutaneous injection adrenalin hydrochloride 0.08mg/100g, totally 2 times.Two minor tick 4h, at the 1st injection back 2h with rat people frozen water 5min, fasting then, the Yu Cichen detection that experimentizes.The result shows, two extractum groups and model group specific energy mutually reduce whole blood contrast viscosity, and plasma viscosity and packed cell volume have significant difference (P<0.05), show that it has the effect of the hemorheology of improvement.The results are shown in Table 3.
The hemorheology effect of the table 3 pair rat cold coagulation hyperamization stasis of blood (x ± s)
Group Dosage (g/kg) Whole blood contrast viscosity Plasma viscosity 120s -1 The erythrocyte blood pressure
8s -1 60s -1 150s -1
Normal group model group technology is 2. extractum group compound Salviae Miltiorrhizae group of extractum group technology 1. - - 0.20 0.25 3 11.8±1.5 ** 15.6±1.6 14.0±0.9 * 13.5±1.8 * 9.4±4.0 ** 6.2±0.4 **7.1±0.6 6.4±0.5 *6.3±0.7 *5.2±1.5 ** 4.9±0.3 ** 5.6±0.4 5.1±0.5 5.2±0.5 4.2±1.2 * 1.16±0.05 ** 1.26±0.05 1.18±0.06 * 1.19±0.06 * 1.05±0.16 ** 40.9±3.1 ** 46.0±3.1 41.1±2.9 ** 42.3±2.4 39.0±4.7 **
Compare with model group *P<0.05, *P<0.01
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 coagulation of QI-blood, cold uterus, menoxenia, dysmenorrhea, redly collapse leucorrhea, menstrual period are touching, the lower abdomen tenesmus, the medicine of anorexia, and change preparation technology, can obviously strengthen its benefiting qi and nourishing blood, clinical efficacies such as adjusting meridian and stopping leukorrhea, 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 Angelicae Sinensis 52g Rhizoma Chuanxiong 52g Radix Codonopsis 52g
The Rhizoma Atractylodis Macrocephalae (parched with bran) 52g Radix Rehmanniae Preparata 52g Rhizoma Cyperi (salt vinegar system) 52g
Radix Paeoniae Alba 52g Radix Scutellariae (processed with wine) 13g Poria 52g
Cortex Moutan 52g Pericarpium Citri Reticulatae 13g Radix Cynanchi Atrati 52g
Radix Glycyrrhizae 26g Radix Dipsaci (processed with wine) the 26g Cortex Eucommiae (processed with salt) 52g
Semen Cuscutae (processed with salt) 52g Herba Taxilli 52g Fructus Amomi (processed with salt) 13g
Rhizoma Corydalis (vinegar system) 52g Cortex Cinnamomi 52g Colla Corii Asini (Pulvis concha Mactrae scalds) 52g
Herba Schizonepetae (vinegar system) 26g Folium Artemisiae Argyi (vinegar system) 26g
PEG4000 100g
Make 1000 balls
Preparation method:
(1) gets eight flavor medical materials such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Rhizoma Atractylodis Macrocephalae, Rhizoma Cyperi, Pericarpium Citri Reticulatae, Cortex Cinnamomi, Herba Schizonepetae, Folium Artemisiae Argyi, adopt supercritical extraction (or steam distillation), 70 ℃ of extracting pressure 27MPa, extraction temperature; Resolve I pressure 9MPa, resolve 60 ℃ of I temperature.Get extract; β-CDBao He, optimised process is: β-CD is 1: 8 with the water ratio, and oil is 1: 5 with β-CD ratio, and ultrasonic 30min gets clathrate;
(2) get prescription residue medical material, soaked 30 minutes earlier with 75% ethanol, reheat reflux, extract, three times, each 1 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) 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 Angelicae Sinensis 172g Rhizoma Chuanxiong 172g Radix Codonopsis 172g
The Rhizoma Atractylodis Macrocephalae (parched with bran) 172g Radix Rehmanniae Preparata 172g Rhizoma Cyperi (salt vinegar system) 172g
Radix Paeoniae Alba 172g Radix Scutellariae (processed with wine) 43g Poria 172g
Cortex Moutan 172g Pericarpium Citri Reticulatae 43g Radix Cynanchi Atrati 172g
Radix Glycyrrhizae 86g Radix Dipsaci (processed with wine) the 86g Cortex Eucommiae (processed with salt) 172g
Semen Cuscutae (processed with salt) 172g Herba Taxilli 172g Fructus Amomi (processed with salt) 43g
Rhizoma Corydalis (vinegar system) 172g Cortex Cinnamomi 172g Colla Corii Asini (Pulvis concha Mactrae scalds) 172g
Herba Schizonepetae (vinegar system) 86g Folium Artemisiae Argyi (vinegar system) 86g
PEG400 370g
Make 1000
Preparation method:
(1) gets eight flavor medical materials such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Rhizoma Atractylodis Macrocephalae, Rhizoma Cyperi, Pericarpium Citri Reticulatae, Cortex Cinnamomi, Herba Schizonepetae, Folium Artemisiae Argyi, adopt supercritical extraction (or steam distillation), 70 ℃ of extracting pressure 27MPa, extraction temperature; Resolve I pressure 9MPa, resolve 60 ℃ of I temperature.Get extract; β-CDBao He, optimised process is: β-CD is 1: 8 with the water ratio, and oil is 1: 5 with β-CD ratio, and ultrasonic 30min gets clathrate;
(2) get prescription residue medical material, soaked 30 minutes earlier with 75% ethanol, reheat reflux, extract, three times, each 1 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) 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 Angelicae Sinensis 280g Rhizoma Chuanxiong 280g Radix Codonopsis 280g
The Rhizoma Atractylodis Macrocephalae (parched with bran) 280g Radix Rehmanniae Preparata 280g Rhizoma Cyperi (salt vinegar system) 280g
Radix Paeoniae Alba 280g Radix Scutellariae (processed with wine) 70g Poria 280g
Cortex Moutan 280g Pericarpium Citri Reticulatae 70g Radix Cynanchi Atrati 280g
Radix Glycyrrhizae 140g Radix Dipsaci (processed with wine) the 140g Cortex Eucommiae (processed with salt) 280g
Semen Cuscutae (processed with salt) 280g Herba Taxilli 280g Fructus Amomi (processed with salt) 70g
Rhizoma Corydalis (vinegar system) 280g Cortex Cinnamomi 280g Colla Corii Asini (Pulvis concha Mactrae scalds) 280g
Herba Schizonepetae (vinegar system) 140g Folium Artemisiae Argyi (vinegar system) 140g
Make 1000g
Preparation method:
(1) it is the same to contain the medicinal material extract of volatile oil;
(2) surplus medicinal 12 times water extraction is 3 times, and each 1 hour, merge extractive liquid, filtered, and the extractum of reclaim under reduced pressure is standby;
(3) above-mentioned active component is merged, add aspartame 5.0g, dextrin 350.0g, 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 Angelicae Sinensis 172g Rhizoma Chuanxiong 172g Radix Codonopsis 172g
The Rhizoma Atractylodis Macrocephalae (parched with bran) 172g Radix Rehmanniae Preparata 172g Rhizoma Cyperi (salt vinegar system) 172g
Radix Paeoniae Alba 172g Radix Scutellariae (processed with wine) 43g Poria 172g
Cortex Moutan 172g Pericarpium Citri Reticulatae 43g Radix Cynanchi Atrati 172g
Radix Glycyrrhizae 86g Radix Dipsaci (processed with wine) the 86g Cortex Eucommiae (processed with salt) 172g
Semen Cuscutae (processed with salt) 172g Herba Taxilli 172g Fructus Amomi (processed with salt) 43g
Rhizoma Corydalis (vinegar system) 172g Cortex Cinnamomi 172g Colla Corii Asini (Pulvis concha Mactrae scalds) 172g
Herba Schizonepetae (vinegar system) 86g Folium Artemisiae Argyi (vinegar system) 86g
Make 1000
Preparation method:
(1) it is the same to contain the medicinal material extract of volatile oil;
(2) surplus medicinal 12 times water extraction is 3 times, and each 1 hour, merge extractive liquid, filtered, and the extractum of reclaim under reduced pressure is standby;
(3) above-mentioned active component is merged, add aspartame 3.0g, mannitol 100.0g, 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:
20~280 parts of 20~280 parts of Radix Codonopsis of 20~280 parts of Rhizoma Chuanxiongs of Radix Angelicae Sinensis
20~280 parts of 20~280 portions of Rhizoma Cyperis of 20~280 parts of Radix Rehmanniae Preparata of the Rhizoma Atractylodis Macrocephalae (parched with bran) (salt vinegar system)
20~280 parts in 5~70 parts of Poria of 20~280 parts of Radix Scutellariaes of the Radix Paeoniae Alba (processed with wine)
20~280 parts of 5~70 portions of Radix Cynanchi Atratis of 20~280 parts of Pericarpium Citri Reticulataes of Cortex Moutan
20~280 parts of 10~140 parts of Cortexs Eucommiae of 10~140 parts of Radix Dipsacis of Radix Glycyrrhizae (processed with wine) (processed with salt)
5~70 parts of Semen Cuscutae (processed with salt) 20~80 parts of Fructus Amomis of 20~280 parts of Herba Taxillis (processed with salt)
20~280 parts in 20~280 parts of Colla Corii Asini of 20~280 portions of Cortex Cinnamomis of Rhizoma Corydalis (vinegar system) (Pulvis concha Mactrae scalds)
10~140 parts of 10~140 portions of Folium Artemisiae Argyis of Herba Schizonepetae (vinegar system) (vinegar system).
2, the compound preparation of claim 1 is characterized in that, per 1000 dosage units are made by the following weight proportion raw material:
40 parts of 40 parts of Radix Codonopsis of 40 parts of Rhizoma Chuanxiongs of Radix Angelicae Sinensis
40 parts of 40 portions of Rhizoma Cyperis of 40 parts of Radix Rehmanniae Preparata of the Rhizoma Atractylodis Macrocephalae (parched with bran) (salt vinegar system)
40 parts in 10 parts of Poria of 40 parts of Radix Scutellariaes of the Radix Paeoniae Alba (processed with wine)
40 parts of 10 portions of Radix Cynanchi Atratis of 40 parts of Pericarpium Citri Reticulataes of Cortex Moutan
40 parts of 20 parts of Cortexs Eucommiae of 20 parts of Radix Dipsacis of Radix Glycyrrhizae (processed with wine) (processed with salt)
10 parts of Semen Cuscutae (processed with salt) 40 parts of Fructus Amomis of 40 parts of Herba Taxillis (processed with salt)
40 parts in 40 parts of Colla Corii Asini of 40 portions of Cortex Cinnamomis of Rhizoma Corydalis (vinegar system) (Pulvis concha Mactrae scalds)
20 parts of 20 portions of Folium Artemisiae Argyis of Herba Schizonepetae (vinegar system) (vinegar system).
3, claim 1 or any one Chinese medicine preparation of 2 are drop pill, soft capsule, granule, chewable tablet, tablet, capsule.
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) gets eight flavor medical materials such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Rhizoma Atractylodis Macrocephalae, Rhizoma Cyperi, Pericarpium Citri Reticulatae, Cortex Cinnamomi, Herba Schizonepetae, Folium Artemisiae Argyi, adopt supercritical extraction (or steam distillation), 70 ℃ of extracting pressure 27MPa, extraction temperature; Resolve I pressure 9MPa, resolve 60 ℃ of I temperature.Get extract; β-CDBao He, optimised process is: β-CD is 1: 6~10 with the water ratio, and oil is 1: 4~6 with β-CD ratio, and ultrasonic 30~70min gets clathrate;
(2) get prescription residue medical material, soaked 30~60 minutes earlier with 50~85% ethanol, reheat reflux, extract, three times, each 0.5~2 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) alcohol extract and clathrate lump together the active constituents of medicine into preparation of the present invention.
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) it is the same to contain the medicinal material extract of volatile oil;
(2) surplus medicinal 6~15 times water extraction is 2~4 times, and each 0.5~2.5 hour, merge extractive liquid, filtered, and the extractum of reclaim under reduced pressure is standby;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
6, the Chinese medicine preparation of claim 5, it 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) gets eight flavor medical materials such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Rhizoma Atractylodis Macrocephalae, Rhizoma Cyperi, Pericarpium Citri Reticulatae, Cortex Cinnamomi, Herba Schizonepetae, Folium Artemisiae Argyi, adopt supercritical extraction (or steam distillation), 70 ℃ of extracting pressure 27MPa, extraction temperature; Resolve I pressure 9MPa, resolve 60 ℃ of I temperature.Get extract; β-CDBao He, optimised process is: β-CD is 1: 6~10 with the water ratio, and oil is 1: 4~6 with β-CD ratio, and ultrasonic 30~70min gets clathrate;
(2) get prescription residue medical material, soaked 30~60 minutes earlier with 50~85% ethanol, reheat reflux, extract, three times, each 0.5~2 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(3) alcohol extract and clathrate lump together the active constituents of medicine into preparation of the present invention.
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) it is the same to contain the medicinal material extract of volatile oil;
(2) surplus medicinal 6~15 times water extraction is 2~4 times, and each 0.5~2.5 hour, merge extractive liquid, filtered, and the extractum of reclaim under reduced pressure is standby;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention.
This active component is suitable for preparing various preparations such as drop pill of the present invention and soft 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.
CNA2005101159868A 2005-11-18 2005-11-18 Fushu Preparation and new preparing method Pending CN1775276A (en)

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102429925A (en) * 2011-11-29 2012-05-02 山东福胶集团有限公司 Donkey-hide gelatin dripping pill and preparation method thereof
CN102488875A (en) * 2011-12-15 2012-06-13 于燕 Traditional Chinese medicine for treating acquired dysmenorrhea
CN102885979A (en) * 2012-10-30 2013-01-23 信璐 Traditional Chinese medicine preparation for treating metrorrhagia and metrostaxis
CN103611054A (en) * 2013-11-24 2014-03-05 唐建红 Traditional Chinese medicine for treating white vaginal discharge
CN103705869A (en) * 2014-01-09 2014-04-09 孙胜波 Traditional Chinese medicine composition for treating edema during menstruation
CN103720986A (en) * 2014-01-09 2014-04-16 孙胜波 Traditional Chinese medicine composition for treating leukorrhea
CN103720996A (en) * 2014-01-07 2014-04-16 董艳丽 Traditional Chinese medicinal composition for treating dysmenorrhea
CN104096179A (en) * 2014-07-15 2014-10-15 张桂萍 Chinese materia medica preparation for treating dysmenorrhea

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102429925A (en) * 2011-11-29 2012-05-02 山东福胶集团有限公司 Donkey-hide gelatin dripping pill and preparation method thereof
CN102429925B (en) * 2011-11-29 2013-05-29 山东福胶集团有限公司 Preparation method of donkey-hide gelatin dripping pill
CN102488875A (en) * 2011-12-15 2012-06-13 于燕 Traditional Chinese medicine for treating acquired dysmenorrhea
CN102885979A (en) * 2012-10-30 2013-01-23 信璐 Traditional Chinese medicine preparation for treating metrorrhagia and metrostaxis
CN103611054A (en) * 2013-11-24 2014-03-05 唐建红 Traditional Chinese medicine for treating white vaginal discharge
CN103611054B (en) * 2013-11-24 2016-06-01 唐建红 One treats leukorrhea Chinese medicine
CN103720996A (en) * 2014-01-07 2014-04-16 董艳丽 Traditional Chinese medicinal composition for treating dysmenorrhea
CN103705869A (en) * 2014-01-09 2014-04-09 孙胜波 Traditional Chinese medicine composition for treating edema during menstruation
CN103720986A (en) * 2014-01-09 2014-04-16 孙胜波 Traditional Chinese medicine composition for treating leukorrhea
CN104096179A (en) * 2014-07-15 2014-10-15 张桂萍 Chinese materia medica preparation for treating dysmenorrhea

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