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CN1748783A - Dismenorrhea preparation and new preparing method - Google Patents

Dismenorrhea preparation and new preparing method Download PDF

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Publication number
CN1748783A
CN1748783A CNA2005101091916A CN200510109191A CN1748783A CN 1748783 A CN1748783 A CN 1748783A CN A2005101091916 A CNA2005101091916 A CN A2005101091916A CN 200510109191 A CN200510109191 A CN 200510109191A CN 1748783 A CN1748783 A CN 1748783A
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preparation
parts
active component
rhizoma
medicine
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Chinese (zh)
Inventor
刘露
严轶东
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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 especially a kind of Chinese medicine composition for treating blood stagnation caused by cold evil and abdominal pain during menstrual period and its preparation process. The Chinese medicine composition is preferably prepared into dripping pill and soft capsule.

Description

Dismenorrhea preparation and new preparation method
Technical field:
The present invention relates to a kind of Chinese medicine composition and preparation technology thereof, the stasis of particularly a kind of treatment cold coagulation, the prescription of menalgia and preparation technology thereof.
Background technology:
Menoxenia, dysmenorrhea are gynecological's common symptons, and the traditional Chinese medical science thinks that dysmenorrhea is many because of QI-blood circulation due to the smooth or deficiency of qi and blood.Clinical common have qi depression to blood stasis, cold coagulation uterus, deficient qi and blood, diseases such as damp invasion of lower energizer.The traditional Chinese medical science is often taked the cold expelling of invigorating blood circulation, and the means of menstruction regulating and pain relieving are treated it, and evident in efficacy, and TONGJING WAN is that it represents medicine.But in the practice, because this medicine is directly medical material to be beaten powder to be used as medicine in preparation process, impurity is many, and dosage is big, is again ordinary pill, has a strong impact on giving full play to of its curative effect.
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 cold coagulation stasis, menalgia.
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:
18.5~187.5 parts of 25~250 parts of Rhizoma Chuanxiongs of 37.5~375 portions of Radix Paeoniae Albas of Radix Angelicae Sinensis
6~62.5 parts of 37.5~375 parts of Radix Aucklandiae of 50~500 portions of Rhizoma Cyperis of Radix Rehmanniae Preparata (vinegar system)
25~250 parts of 37.5~375 parts of Rhizoma Corydalis of 6~62.5 portions of Fructus Crataegis of Pericarpium Citri Reticulatae Viride (charcoal)
6~62.5 parts of Radix Salviae Miltiorrhizaes 37.5~375 of 6~62.5 portions of Cortex Cinnamomis of Rhizoma Zingiberis Preparatum
150~1500 parts of 12~125 parts of Herba Leonuris of 12~125 parts of Flos Carthamis of Fructus Leonuri
25~250 parts of Oletum Trogopteroris (vinegar stir-fry)
Preferably:
100 parts of 37.5 parts of Radix Rehmanniae Preparata of 50 parts of Rhizoma Chuanxiongs of 75 portions of Radix Paeoniae Albas of Radix Angelicae Sinensis
75 parts of Rhizoma Cyperi (vinegar system) 75 parts of Radix Aucklandiae, 12.5 portions of Fructus Crataegis of 12.5 parts of Pericarpium Citri Reticulatae Virides (charcoal)
75 parts of 12.5 parts of Radix Salviae Miltiorrhizaes of 12.5 portions of Cortex Cinnamomis of 50 portions of Rhizoma Zingiberis Preparatums of Rhizoma Corydalis
50 parts of 300 parts of Oletum Trogopteroris of 25 parts of Herba Leonuris of 25 parts of Flos Carthamis of Fructus Leonuri (vinegar stir-fry)
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 the 100-500 bag, 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 Radix Angelicae Sinensis, Rhizoma Cyperi, the Radix Aucklandiae, Rhizoma Zingiberis Preparatum, Rhizoma Chuanxiong, Pericarpium Citri Reticulatae Viride, Cortex Cinnamomi seven flavor medicine material, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 4h under 40 ℃, the condition of flow 20L/h with pressure; With pressure is 5.5MPa, and temperature is 34.5 ℃ (separating III), and 34.8 ℃ (separating m) 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 (Flos Carthami is carried in addition), 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) Flos Carthami is ground into fine powder and is used as medicine; Surplus medicinal 6~15 times water extraction 2~4 times, 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.
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.Wherein the weight proportion between active component and the pharmaceutically useful organic solvent is: 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 writes down the rat dysmenorrhea writhing response number of animals in the 30min and turns round the body number of times behind end SC estradiol, the administration 45min.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. - 0.28 0.39 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 2. extractum group of extractum group technology 1. - 0.55 0.77 8 8 8 0.84±0.14 0.67±0.07 * 0.69±0.07 * - 20.24 17.86
Salbutamol sulfate 0.002 8 0.55±0.15 ** 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, ♀
Figure A20051010919100091
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 120 s -1 The erythrocyte blood pressure
8 s -1 60 s -1 150 s -1
2. normal group mould punishment group technology 1. soaking technology soak compound Salviae Miltiorrhizae - - 0.28 0.39 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 cold coagulation stasis, the medicine of menalgia, and change preparation technology, can obviously strengthen clinical efficacies such as its cold expelling of invigorating blood circulation, menstruction regulating and pain relieving, 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:
Radix Angelicae Sinensis 65g Radix Paeoniae Alba 44g Rhizoma Chuanxiong 33g Radix Rehmanniae Preparata 87g
Rhizoma Cyperi (vinegar system) 65g Radix Aucklandiae 11g Pericarpium Citri Reticulatae Viride 11g Fructus Crataegi (charcoal) 65g
Rhizoma Corydalis 44g Rhizoma Zingiberis Preparatum 11g Cortex Cinnamomi 11g Radix Salviae Miltiorrhizae 65g
Fructus Leonuri 22g Flos Carthami 22g Herba Leonuri 261g Oletum Trogopterori (vinegar stir-fry) 44g
PEG4000 100g
Make 1000 balls
Preparation method:
(1) gets Radix Angelicae Sinensis, Rhizoma Cyperi, the Radix Aucklandiae, Rhizoma Zingiberis Preparatum, Rhizoma Chuanxiong, Pericarpium Citri Reticulatae Viride, Cortex Cinnamomi seven flavor medicine material, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 4h under 40 ℃, the condition of flow 20L/h with pressure; With pressure is 5.5MPa, and temperature is 34.5 ℃ (separating III), and 34.8 ℃ (separating m) resolve, and 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 (Flos Carthami is carried in addition), soaked 40 minutes earlier with 75% ethanol, reheat reflux, extract, three times, each 1.0 hours, 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 326g Radix Paeoniae Alba 218g Rhizoma Chuanxiong 163g Radix Rehmanniae Preparata 435g
Rhizoma Cyperi (vinegar system) 326g Radix Aucklandiae 54g Pericarpium Citri Reticulatae Viride 54g Fructus Crataegi (charcoal) 326g
Rhizoma Corydalis 218g Rhizoma Zingiberis Preparatum 54g Cortex Cinnamomi 54g Radix Salviae Miltiorrhizae 326g
Fructus Leonuri 109g Flos Carthami 109g Herba Leonuri 1305g Oletum Trogopterori (vinegar stir-fry) 218g
PEG400 500g
Make 1000
Preparation method:
(1) gets Radix Angelicae Sinensis, Rhizoma Cyperi, the Radix Aucklandiae, Rhizoma Zingiberis Preparatum, Rhizoma Chuanxiong, Pericarpium Citri Reticulatae Viride, Cortex Cinnamomi seven flavor medicine material, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 4h under 40 ℃, the condition of flow 20L/h with pressure; With pressure is 5.5MPa, and temperature is 34.5 ℃ (separating III), and 34.8 ℃ (separating m) resolve, and 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 (Flos Carthami is carried in addition), soaked 40 minutes earlier with 75% ethanol, reheat reflux, extract, three times, each 1.0 hours, 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 375g Radix Paeoniae Alba 250g Rhizoma Chuanxiong 188g Radix Rehmanniae Preparata 500g
Rhizoma Cyperi (vinegar system) 375g Radix Aucklandiae 63g Pericarpium Citri Reticulatae Viride 63g Fructus Crataegi (charcoal) 375g
Rhizoma Corydalis 250g Rhizoma Zingiberis Preparatum 63g Cortex Cinnamomi 63g Radix Salviae Miltiorrhizae 375g
Fructus Leonuri 125g Flos Carthami 125g Herba Leonuri 1500g Oletum Trogopterori (vinegar stir-fry) 250g
Make 1000g
Preparation method:
(1) it is the same to contain the medicinal material extract of volatile oil;
(2) Flos Carthami is ground into fine powder and is used as medicine; Surplus medicinal 12 times water extraction 3 times, each 1 hour, merge extractive liquid, filtered, and the extractum of reclaim under reduced pressure is standby;
(3) merge above active component, add aspartame 5.0g, dextrin 200.0g, 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 143g Radix Paeoniae Alba 95g Rhizoma Chuanxiong 71g Radix Rehmanniae Preparata 190g
Rhizoma Cyperi (vinegar system) 143g Radix Aucklandiae 24g Pericarpium Citri Reticulatae Viride 24g Fructus Crataegi (charcoal) 143g
Rhizoma Corydalis 95g Rhizoma Zingiberis Preparatum 24g Cortex Cinnamomi 24g Radix Salviae Miltiorrhizae 143g
Fructus Leonuri 48g Flos Carthami 48g Herba Leonuri 570g Oletum Trogopterori (vinegar stir-fry) 95g
Make 1000
Preparation method:
(1) it is the same to contain the medicinal material extract of volatile oil;
(2) Flos Carthami is ground into fine powder and is used as medicine; Surplus medicinal 12 times water extraction 3 times, each 1 hour, merge extractive liquid, filtered, and the extractum of reclaim under reduced pressure is standby;
(3) merge above active component, 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:
18.5~187.5 parts of 25~250 parts of Rhizoma Chuanxiongs of 37.5~375 portions of Radix Paeoniae Albas of Radix Angelicae Sinensis
6~62.5 parts of 37.5~375 parts of Radix Aucklandiae of 50~500 portions of Rhizoma Cyperis of Radix Rehmanniae Preparata (vinegar system)
25~250 parts of 37.5~375 parts of Rhizoma Corydalis of 6~62.5 portions of Fructus Crataegis of Pericarpium Citri Reticulatae Viride (charcoal)
6~62.5 parts of Radix Salviae Miltiorrhizaes 37.5~375 of 6~62.5 portions of Cortex Cinnamomis of Rhizoma Zingiberis Preparatum
150~1500 parts of 12~125 parts of Herba Leonuris of 12~125 parts of Flos Carthamis of Fructus Leonuri
25~250 parts of Oletum Trogopteroris (vinegar stir-fry)
2, the compound preparation of claim 1 is characterized in that, per 1000 dosage units are made by the following weight proportion raw material:
100 parts of 37.5 parts of Radix Rehmanniae Preparata of 50 parts of Rhizoma Chuanxiongs of 75 portions of Radix Paeoniae Albas of Radix Angelicae Sinensis
75 parts of Rhizoma Cyperi (vinegar system) 75 parts of Radix Aucklandiae, 12.5 portions of Fructus Crataegis of 12.5 parts of Pericarpium Citri Reticulatae Virides (charcoal)
75 parts of 12.5 parts of Radix Salviae Miltiorrhizaes of 12.5 portions of Cortex Cinnamomis of 50 portions of Rhizoma Zingiberis Preparatums of Rhizoma Corydalis
50 parts of 300 parts of Oletum Trogopteroris of 25 parts of Herba Leonuris of 25 parts of Flos Carthamis of Fructus Leonuri (vinegar stir-fry)
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 Radix Angelicae Sinensis, Rhizoma Cyperi, the Radix Aucklandiae, Rhizoma Zingiberis Preparatum, Rhizoma Chuanxiong, Pericarpium Citri Reticulatae Viride, Cortex Cinnamomi seven flavor medicine material, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 4h under 40 ℃, the condition of flow 20L/h with pressure; With pressure is 5.5MPa, and temperature is 34.5 ℃ (separating III), and 34.8 ℃ (separating m) 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 (Flos Carthami is carried in addition), 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) Flos Carthami is ground into fine powder and is used as medicine; Surplus medicinal 6~15 times water extraction 2~4 times, 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 other dosage forms except that drop pill and soft capsule preparation of the present invention.
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 Radix Angelicae Sinensis, Rhizoma Cyperi, the Radix Aucklandiae, Rhizoma Zingiberis Preparatum, Rhizoma Chuanxiong, Pericarpium Citri Reticulatae Viride, Cortex Cinnamomi seven flavor medicine material, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 4h under 40 ℃, the condition of flow 20L/h with pressure; With pressure is 5.5MPa, and temperature is 34.5 ℃ (separating III), and 34.8 ℃ (separating m) 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 (Flos Carthami is carried in addition), 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) Flos Carthami is ground into fine powder and is used as medicine; Surplus medicinal 6~15 times water extraction 2~4 times, 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.
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: with active constituents of medicine and proper auxiliary materials mix homogeneously, obtain uniform suspension and territory solution, regulate content weight, compacting, dry getting final product.
CNA2005101091916A 2005-10-20 2005-10-20 Dismenorrhea preparation and new preparing method Pending CN1748783A (en)

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101143177B (en) * 2007-08-16 2010-06-23 河南花花牛奶牛育种科技有限公司 Medicine for preventing and treating postpartum disease of cow
CN101411859B (en) * 2008-11-22 2010-12-15 宋爱民 Chinese medicine preparation for treating dysmenorrhea
CN104127781A (en) * 2014-07-16 2014-11-05 太仓思瑞生物科技有限公司 Traditional Chinese medicine patch for treating dysmenorrhoea
CN104147478A (en) * 2014-07-16 2014-11-19 太仓思瑞生物科技有限公司 Applications of traditional Chinese medicine in externally treating dysmenorrhea
CN105031551A (en) * 2015-09-11 2015-11-11 孔春灵 Traditional Chinese medicine composition for treating dysmenorrhea
CN108704050A (en) * 2018-08-23 2018-10-26 高玉梅 A kind of benefit rubber master batch capsule and preparation method thereof
CN111214639A (en) * 2020-03-27 2020-06-02 朱秀华 A pharmaceutical composition for regulating menstruation and removing dampness, and its preparation method

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101143177B (en) * 2007-08-16 2010-06-23 河南花花牛奶牛育种科技有限公司 Medicine for preventing and treating postpartum disease of cow
CN101411859B (en) * 2008-11-22 2010-12-15 宋爱民 Chinese medicine preparation for treating dysmenorrhea
CN104127781A (en) * 2014-07-16 2014-11-05 太仓思瑞生物科技有限公司 Traditional Chinese medicine patch for treating dysmenorrhoea
CN104147478A (en) * 2014-07-16 2014-11-19 太仓思瑞生物科技有限公司 Applications of traditional Chinese medicine in externally treating dysmenorrhea
CN105031551A (en) * 2015-09-11 2015-11-11 孔春灵 Traditional Chinese medicine composition for treating dysmenorrhea
CN108704050A (en) * 2018-08-23 2018-10-26 高玉梅 A kind of benefit rubber master batch capsule and preparation method thereof
CN111214639A (en) * 2020-03-27 2020-06-02 朱秀华 A pharmaceutical composition for regulating menstruation and removing dampness, and its preparation method

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