CN1775279A - Gynaecologic formulation and new preparing method - Google Patents

Gynaecologic formulation and new preparing method Download PDF

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Publication number
CN1775279A
CN1775279A CNA2005101159923A CN200510115992A CN1775279A CN 1775279 A CN1775279 A CN 1775279A CN A2005101159923 A CNA2005101159923 A CN A2005101159923A CN 200510115992 A CN200510115992 A CN 200510115992A CN 1775279 A CN1775279 A CN 1775279A
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parts
rhizoma
radix
preparation
processed
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Chinese (zh)
Inventor
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 process in particular, it relates to a Chinese medicine prescription for curing the diseases of postpartum deficiency of qi and blood, deficiency complicated with blood stasis, abdominal pain, persistent lochia, constipation and scant breast milk, etc. and its preparation process. It can be made into dripping pills and soft capsule preparation.

Description

'Fukang ' 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 insufficiency of vital energy and blood in puerperal, the apoplexy due to deficiency folder stasis of blood, the flank distending pain of coldheat complex, stomachache, head-body-pain, lochia, the bruise stupor, constipation, the prescription of diseases such as agalactia and preparation technology thereof.
Background technology:
Puerperal insufficiency of vital energy and blood, the apoplexy due to deficiency folder stasis of blood, the flank distending pain of coldheat complex, stomachache, head-body-pain, lochia, bruise stupor, constipation, diseases such as agalactia are clinical common symptons, and the traditional Chinese medical science is often taked benefiting QI and nourishing blood, and the means of regulating qi to disperse stagnation are treated it, and evident in efficacy, the FUKANG 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 the insufficiency of vital energy and blood in puerperal, the apoplexy due to deficiency folder stasis of blood, the flank distending pain of coldheat complex, stomachache, head-body-pain, lochia, the bruise stupor, constipation, diseases such as agalactia.
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:
6~30 parts in 6~30 parts of Poria of 6~30 parts of Radix Codonopsis of the Rhizoma Atractylodis Macrocephalae (parching with earth)
6~30 parts of 6~30 parts of Radix Rehmanniae Preparata of 6~30 parts of Rhizoma Chuanxiongs of Rhizoma Atractylodis (Mi Ganshui processs) (wine is processed)
6~30 parts of 6~30 portions of Rhizoma Cyperis of 6~30 parts of Pollen Typhaes of Radix Cyathulae
6~30 parts of Olibanum (parched with bran) 6~30 parts of Rhizoma Corydalis of 6~30 portions of Fructus Chaenomeliss (processed with vinegar)
6~30 parts of 6~30 parts of Pericarpium Citri Reticulatae Viride (process with vinegar) of 6~30 parts of Myrrhas of Rhizoma Alpiniae Officinarum (parched with bran)
6~30 parts of 14~70 parts of Radixs Linderae of 14~70 parts of Radix Angelicae Sinensis of Radix Sanguisorbae (charcoal) (wine is processed) (processed with vinegar)
14~70 parts of 6~30 parts of Herba Leonuris of 14~70 parts of Semen Persicaes of the Radix Paeoniae Alba (wine is processed) (the peeling point is fried)
14~70 parts of 14~70 parts of rhizoma sparganic of 14~70 parts of Fructus Corni of Rhizoma Et Radix Notopterygii (steaming) (processed with vinegar)
14~70 parts of the Radix Aucklandiae 14~70 parts of Oletum Trogopteroris of 14~70 parts of Pericarpium Citri Reticulataes (processed with vinegar)
750~3750 parts of 14~70 parts of Radix Et Rhizoma Rhei of Radix Glycyrrhizae (system)
Preferably:
12 parts in 12 parts of Poria of 12 parts of Radix Codonopsis of the Rhizoma Atractylodis Macrocephalae (parching with earth)
12 parts of 12 parts of Radix Rehmanniae Preparata of 12 parts of Rhizoma Chuanxiongs of Rhizoma Atractylodis (Mi Ganshui processs) (wine is processed)
12 parts of 12 portions of Rhizoma Cyperis of 12 parts of Pollen Typhaes of Radix Cyathulae
12 parts of Olibanum (parched with bran) 12 parts of Rhizoma Corydalis of 12 portions of Fructus Chaenomeliss (processed with vinegar)
12 parts of 12 parts of Pericarpium Citri Reticulatae Viride (process with vinegar) of 12 parts of Myrrhas of Rhizoma Alpiniae Officinarum (parched with bran)
12 parts of 28 parts of Radixs Linderae of 28 parts of Radix Angelicae Sinensis of Radix Sanguisorbae (charcoal) (wine is processed) (processed with vinegar)
28 parts of 12 parts of Herba Leonuris of 28 parts of Semen Persicaes of the Radix Paeoniae Alba (wine is processed) (the peeling point is fried)
28 parts of 28 parts of rhizoma sparganic of 28 parts of Fructus Corni of Rhizoma Et Radix Notopterygii (steaming) (processed with vinegar)
28 parts of the Radix Aucklandiae 28 parts of Oletum Trogopteroris of 28 parts of Pericarpium Citri Reticulataes (processed with vinegar)
1500 parts of 28 parts of Radix Et Rhizoma Rhei of Radix Glycyrrhizae (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.
The above new technology of the present invention may further comprise the steps:
Method a:(technology 1.)
(1) gets nine flavor medical materials such as the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Atractylodis, Olibanum, Myrrha, Rhizoma Cyperi, Rhizoma Et Radix Notopterygii, the Radix Aucklandiae, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 3.0~4.0h under 40 ℃, the condition of flow 20L/h with pressure; With pressure is 5.5MPa, and temperature is 34.5 ℃ (separating I), and 34.8 ℃ (separating II) resolve, and get extract; β-CDBao He, optimised process is: β-CD is 1: 6~10 with the water ratio, and oil is 1: 46 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) 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.
Method b:(technology 2.)
(1) it is the same to contain the medicinal material extract of volatile oil;
(2) get the residue medical material, decoct with water 2~4 times, each 0.5~2.5 hour, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract;
(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 influence of white mice developing womb
Get the female white mice of Kunming kind, body weight 18~22g, 40, every group 10, blank group (equivalent distilled water), technology is 2. extractum group (0.49g/kg), NVJINDAN PIAN (12g/kg) of extractum group (0.41g/kg), technology 1., gastric infusion, once a day, continuous 15 days, weigh in the 16th day animal, put to death.Win the uterus and ovary is weighed at ten thousand/balance rapidly, and be converted into organ index, observe of the influence of this extractum Mouse Uterus and ovary.
The influence of table 1 pair white mice developing womb (x ± s)
Group Dosage (g/kg) Number of animals (only) Uterus/body weight (mg/10g) Ovary/body weight (mg/10g)
Matched group technology is 2. extractum group NVJINDAN PIAN of extractum group technology 1. - 0.41 0.49 12 10 10 10 10 12.0±2.6 10.8±2.0 10.5±2.7 11.2±1.9 5.1±1.2 5.9±1.7 4.9±1.8 5.4±1.4
Data show in the table, and this extractum and blank group and positive controls compare, difference that there are no significant.
2, to the analgesic activity of white mice
Getting body weight is female 40 of 18~22g Kunming kind white mice, is divided into 4 groups at random, and 10 every group, grouping and medication are the same.Every day gastric infusion once, continuous five days, after last administration 30 minutes lumbar injection 0.05% antimony tartrate potassium solution 0.2ml/ only, each treated animal is turned round the body number of times by what antimony potassium tartrate caused in the observed and recorded 30 minutes.Result of the test sees Table 2.
The analgesic activity of table 2 pair white mice (x ± s)
Group Dosage (g/kg) Number of animals (only) Turn round the body number of times The P value
Matched group technology is the extractum group 1. - 0.41 10 10 27.8±8.1 11.8±9.6 - <0.01
Technology is extractum group NVJINDAN PIAN 2. 0.49 12 10 10 10.6±4.1 12.5±9.4 <0.01 <0.01
The result shows that this extractum group and positive controls can obviously reduce white mice and turn round the body number of times, and the effect of obvious suppression pain is arranged.
3, 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 insufficiency of vital energy and bloods in puerperal, the apoplexy due to deficiency folder stasis of blood, the flank distending pain of coldheat complex, stomachache, head-body-pain, lochia, bruise stupor, constipation, the medicine of diseases such as agalactia, and change preparation technology, can obviously strengthen its benefiting QI and nourishing blood, clinical efficacies such as regulating qi to disperse stagnation, its hypotoxicity in addition, therefore prolonged application safety, 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:
The Rhizoma Atractylodis Macrocephalae (parching with earth) 4g Radix Codonopsis 4g Poria 4g
Rhizoma Atractylodis (Mi Ganshui processs) 4g Rhizoma Chuanxiongs (wine is processed) 4g Radix Rehmanniae Preparata 4g
Radix Cyathulae 4g Pollen Typhae 4g Rhizoma Cyperi 4g
Olibanum (parched with bran) 4g Fructus Chaenomelis 4g Rhizoma Corydalis (processed with vinegar) 4g
Rhizoma Alpiniae Officinarum 4g Myrrha (parched with bran) 4g Pericarpium Citri Reticulatae Viride (process with vinegar) 4g
Radix Sanguisorbae (charcoal) 10g Radix Angelicae Sinensis (wine is processed) the 10g Radix Linderae (processed with vinegar) 4g
The Radix Paeoniae Alba (wine is processed) 10g Semen Persicae (the peeling point is fried) 4g Herba Leonuri 10g
Rhizoma Et Radix Notopterygii 10g Fructus Corni (steaming) 10g rhizoma sparganic (processed with vinegar) 10g
Radix Aucklandiae 10g Pericarpium Citri Reticulatae 10g Oletum Trogopterori (processed with vinegar) 10g
Radix Glycyrrhizae 10g Radix Et Rhizoma Rhei (system) 540g
PEG4000 100g
Make 1000 balls
Preparation method:
(1) gets nine flavor medical materials such as the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Atractylodis, Olibanum, Myrrha, Rhizoma Cyperi, Rhizoma Et Radix Notopterygii, the Radix Aucklandiae, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 4.0h under 40 ℃, the condition of flow 20L/h with pressure; With pressure is 5.5MPa, and temperature is 34.5 ℃ (separating I), and 34.8 ℃ (separating II) resolve, and get extract; β-CDBao He, optimised process is: β-CD is 1: 6 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:
The Rhizoma Atractylodis Macrocephalae (parching with earth) 21.5g Radix Codonopsis 21.5g Poria 21.5g
Rhizoma Atractylodis (Mi Ganshui processs) 21.5g Rhizoma Chuanxiongs (wine is processed) 21.5g Radix Rehmanniae Preparata 21.5g
Radix Cyathulae 21.5g Pollen Typhae 21.5g Rhizoma Cyperi 21.5g
Olibanum (parched with bran) 21.5g Fructus Chaenomelis 21.5g Rhizoma Corydalis (processed with vinegar) 21.5g
Rhizoma Alpiniae Officinarum 21.5g Myrrha (parched with bran) 21.5g Pericarpium Citri Reticulatae Viride (process with vinegar) 21.5g
Radix Sanguisorbae (charcoal) 50g Radix Angelicae Sinensis (wine is processed) the 50g Radix Linderae (processed with vinegar) 21.5g
The Radix Paeoniae Alba (wine is processed) 50g Semen Persicae (the peeling point is fried) 21.5g Herba Leonuri 50g
Rhizoma Et Radix Notopterygii 50g Fructus Corni (steaming) 50g rhizoma sparganic (processed with vinegar) 50g
Radix Aucklandiae 50g Pericarpium Citri Reticulatae 50g Oletum Trogopterori (processed with vinegar) 50g
Radix Glycyrrhizae 50g Radix Et Rhizoma Rhei (system) 2685g
PEG400 600g
Make 1000
Preparation method:
(1) gets nine flavor medical materials such as the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Atractylodis, Olibanum, Myrrha, Rhizoma Cyperi, Rhizoma Et Radix Notopterygii, the Radix Aucklandiae, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 4.0h under 40 ℃, the condition of flow 20L/h with pressure; With pressure is 5.5MPa, and temperature is 34.5 ℃ (separating I), and 34.8 ℃ (separating II) resolve, and get extract; β-CDBao He, optimised process is: β-CD is 1: 6 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:
The Rhizoma Atractylodis Macrocephalae (parching with earth) 30g Radix Codonopsis 30g Poria 30g
Rhizoma Atractylodis (Mi Ganshui processs) 30g Rhizoma Chuanxiongs (wine is processed) 30g Radix Rehmanniae Preparata 30g
Radix Cyathulae 30g Pollen Typhae 30g Rhizoma Cyperi 30g
Olibanum (parched with bran) 30g Fructus Chaenomelis 30g Rhizoma Corydalis (processed with vinegar) 30g
Rhizoma Alpiniae Officinarum 30g Myrrha (parched with bran) 30g Pericarpium Citri Reticulatae Viride (process with vinegar) 30g
Radix Sanguisorbae (charcoal) 70g Radix Angelicae Sinensis (wine is processed) the 70g Radix Linderae (processed with vinegar) 30g
The Radix Paeoniae Alba (wine is processed) 70g Semen Persicae (the peeling point is fried) 30g Herba Leonuri 70g
Rhizoma Et Radix Notopterygii 70g Fructus Corni (steaming) 70g rhizoma sparganic (processed with vinegar) 70g
Radix Aucklandiae 70g Pericarpium Citri Reticulatae 70g Oletum Trogopterori (processed with vinegar) 70g
Radix Glycyrrhizae 70g Radix Et Rhizoma Rhei (system) 3750g
Make 1000g
Preparation method:
(1) it is the same to contain the medicinal material extract of volatile oil;
(2) get the residue medical material, decoct with water 3 times, each 1.0 hours, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract;
(3) above active component is merged, add aspartame 5.0g, dextrin 160.0g, granulate, drying sprays into essence 5.0g, promptly gets granule 1000g.
Embodiment 4:
The preparation method of chewable tablet of the present invention:
Prescription:
The Rhizoma Atractylodis Macrocephalae (parching with earth) 11g Radix Codonopsis 11g Poria 11g
Rhizoma Atractylodis (Mi Ganshui processs) 11g Rhizoma Chuanxiongs (wine is processed) 11g Radix Rehmanniae Preparata 11g
Radix Cyathulae 11g Pollen Typhae 11g Rhizoma Cyperi 11g
Olibanum (parched with bran) 11g Fructus Chaenomelis 11g Rhizoma Corydalis (processed with vinegar) 11g
Rhizoma Alpiniae Officinarum 11g Myrrha (parched with bran) 11g Pericarpium Citri Reticulatae Viride (process with vinegar) 11g
Radix Sanguisorbae (charcoal) 25g Radix Angelicae Sinensis (wine is processed) the 25g Radix Linderae (processed with vinegar) 11g
The Radix Paeoniae Alba (wine is processed) 25g Semen Persicae (the peeling point is fried) 11g Herba Leonuri 25g
Rhizoma Et Radix Notopterygii 25g Fructus Corni (steaming) 25g rhizoma sparganic (processed with vinegar) 25g
Radix Aucklandiae 25g Pericarpium Citri Reticulatae 25g Oletum Trogopterori (processed with vinegar) 25g
Radix Glycyrrhizae 25g Radix Et Rhizoma Rhei (system) 1335g
Make 1000
Preparation method:
(1) it is the same to contain the medicinal material extract of volatile oil;
(2) get the residue medical material, decoct with water 3 times, each 1.0 hours, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract.
(3) 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:
6~30 parts in 6~30 parts of Poria of 6~30 parts of Radix Codonopsis of the Rhizoma Atractylodis Macrocephalae (parching with earth)
6~30 parts of 6~30 parts of Radix Rehmanniae Preparata of 6~30 parts of Rhizoma Chuanxiongs of Rhizoma Atractylodis (Mi Ganshui processs) (wine is processed)
6~30 parts of 6~30 portions of Rhizoma Cyperis of 6~30 parts of Pollen Typhaes of Radix Cyathulae
6~30 parts of Olibanum (parched with bran) 6~30 parts of Rhizoma Corydalis of 6~30 portions of Fructus Chaenomeliss (processed with vinegar)
6~30 parts of 6~30 parts of Pericarpium Citri Reticulatae Viride (process with vinegar) of 6~30 parts of Myrrhas of Rhizoma Alpiniae Officinarum (parched with bran)
6~30 parts of 14~70 parts of Radixs Linderae of 14~70 parts of Radix Angelicae Sinensis of Radix Sanguisorbae (charcoal) (wine is processed) (processed with vinegar)
14~70 parts of 6~30 parts of Herba Leonuris of 14~70 parts of Semen Persicaes of the Radix Paeoniae Alba (wine is processed) (the peeling point is fried)
14~70 parts of 14~70 parts of rhizoma sparganic of 14~70 parts of Fructus Corni of Rhizoma Et Radix Notopterygii (steaming) (processed with vinegar)
14~70 parts of the Radix Aucklandiae 14~70 parts of Oletum Trogopteroris of 14~70 parts of Pericarpium Citri Reticulataes (processed with vinegar)
750~3750 parts of 14~70 parts of Radix Et Rhizoma Rhei of Radix Glycyrrhizae (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:
12 parts in 12 parts of Poria of 12 parts of Radix Codonopsis of the Rhizoma Atractylodis Macrocephalae (parching with earth)
12 parts of 12 parts of Radix Rehmanniae Preparata of 12 parts of Rhizoma Chuanxiongs of Rhizoma Atractylodis (Mi Ganshui processs) (wine is processed)
12 parts of 12 portions of Rhizoma Cyperis of 12 parts of Pollen Typhaes of Radix Cyathulae
12 parts of Olibanum (parched with bran) 12 parts of Rhizoma Corydalis of 12 portions of Fructus Chaenomeliss (processed with vinegar)
12 parts of 12 parts of Pericarpium Citri Reticulatae Viride (process with vinegar) of 12 parts of Myrrhas of Rhizoma Alpiniae Officinarum (parched with bran)
12 parts of 28 parts of Radixs Linderae of 28 parts of Radix Angelicae Sinensis of Radix Sanguisorbae (charcoal) (wine is processed) (processed with vinegar)
28 parts of 12 parts of Herba Leonuris of 28 parts of Semen Persicaes of the Radix Paeoniae Alba (wine is processed) (the peeling point is fried)
28 parts of 28 parts of rhizoma sparganic of 28 parts of Fructus Corni of Rhizoma Et Radix Notopterygii (steaming) (processed with vinegar)
28 parts of the Radix Aucklandiae 28 parts of Oletum Trogopteroris of 28 parts of Pericarpium Citri Reticulataes (processed with vinegar)
1500 parts of 28 parts of Radix Et Rhizoma Rhei of Radix Glycyrrhizae (system).
3, claim 1 or any one Chinese medicine preparation of 2 are drop pill, soft capsule, granule, chewable tablet.
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 nine flavor medical materials such as the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Atractylodis, Olibanum, Myrrha, Rhizoma Cyperi, Rhizoma Et Radix Notopterygii, the Radix Aucklandiae, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 3.0~4.0h under 40 ℃, the condition of flow 20L/h with pressure; With pressure is 5.5MPa, and temperature is 34.5 ℃ (separating I), and 34.8 ℃ (separating П) resolve, and 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) 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.
Method b:(technology 2.)
(1) it is the same to contain the medicinal material extract of volatile oil;
(2) get the residue medical material, decoct with water 2~4 times, each 0.5~2.5 hour, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract;
(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 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 nine flavor medical materials such as the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Atractylodis, Olibanum, Myrrha, Rhizoma Cyperi, Rhizoma Et Radix Notopterygii, the Radix Aucklandiae, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 3.0~4.0h under 40 ℃, the condition of flow 20L/h with pressure; With pressure is 5.5MPa, and temperature is 34.5 ℃ (separating I), and 34.8 ℃ (separating П) resolve, and 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) 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.
Method b:(technology 2.)
(1) it is the same to contain the medicinal material extract of volatile oil;
(2) get the residue medical material, decoct with water 2~4 times, each 0.5~2.5 hour, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract;
(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.
CNA2005101159923A 2005-11-18 2005-11-18 Gynaecologic formulation and new preparing method Pending CN1775279A (en)

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102114188A (en) * 2011-02-23 2011-07-06 施维群 Enema Chinese medicine for treating hepatic encephalopathy in prodromal period
CN102423393A (en) * 2011-11-24 2012-04-25 张秀艳 Traditional Chinese medicinal composition for treating qi stagnation and blood stasis type primary dysmenorrhea
CN102526675A (en) * 2012-01-16 2012-07-04 王海荣 Soup for treating primary dysmenorrhea
CN102688338A (en) * 2012-06-12 2012-09-26 赵国藏 Chinese medicament composition for treating constipation
CN103127460A (en) * 2013-02-16 2013-06-05 河南科技大学 Traditional Chinese medicine composition for curing gynecologic inflammation and preparation method thereof
CN103638511A (en) * 2013-12-22 2014-03-19 林凡友 Postpartum stasis removing particles

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102114188A (en) * 2011-02-23 2011-07-06 施维群 Enema Chinese medicine for treating hepatic encephalopathy in prodromal period
CN102423393A (en) * 2011-11-24 2012-04-25 张秀艳 Traditional Chinese medicinal composition for treating qi stagnation and blood stasis type primary dysmenorrhea
CN102423393B (en) * 2011-11-24 2012-11-28 张秀艳 Traditional Chinese medicinal composition for treating qi stagnation and blood stasis type primary dysmenorrhea
CN102526675A (en) * 2012-01-16 2012-07-04 王海荣 Soup for treating primary dysmenorrhea
CN102526675B (en) * 2012-01-16 2013-08-21 王海荣 Soup for treating primary dysmenorrhea
CN102688338A (en) * 2012-06-12 2012-09-26 赵国藏 Chinese medicament composition for treating constipation
CN103127460A (en) * 2013-02-16 2013-06-05 河南科技大学 Traditional Chinese medicine composition for curing gynecologic inflammation and preparation method thereof
CN103127460B (en) * 2013-02-16 2014-12-10 河南科技大学 Traditional Chinese medicine composition for curing gynecologic inflammation and preparation method thereof
CN103638511A (en) * 2013-12-22 2014-03-19 林凡友 Postpartum stasis removing particles
CN103638511B (en) * 2013-12-22 2015-08-19 翔宇药业股份有限公司 Puerperal blood clot dispersing granule

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