CN1824114A - Blood quickening pain relieving medicinal preparation and its new preparation method - Google Patents

Blood quickening pain relieving medicinal preparation and its new preparation method Download PDF

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Publication number
CN1824114A
CN1824114A CN 200510134434 CN200510134434A CN1824114A CN 1824114 A CN1824114 A CN 1824114A CN 200510134434 CN200510134434 CN 200510134434 CN 200510134434 A CN200510134434 A CN 200510134434A CN 1824114 A CN1824114 A CN 1824114A
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preparation
active component
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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

A composite Chinese medicine in the form of dripping pill and soft capsule for treating obstruction of blood vessels, lumbocrural pain, rheumatic numbness, joint sore, etc, and its preparing process are disclosed.

Description

Blood quickening pain relieving medicinal 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 blood vessels that are used for stagnate lumbago and skelalgia, rheumatic numbness, joint aches, the prescription of walking hardship and preparation technology thereof.
Background technology:
Blood vessels stagnate, lumbago and skelalgia, and rheumatic numbness, joint aches, walking hardship are clinically to see symptom more, the traditional Chinese medical science is often taked strengthening bone and muscle, the arteries and veins of invigorating blood circulation, the means of expelling wind and removing dampness are treated it, and evident in efficacy.The blood quickening pain relieving medicinal 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, mixture, its pill that makes can be used for curing mainly blood vessels and stagnates, lumbago and skelalgia, rheumatic numbness, joint aches, walking hardship.
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:
18~90 parts of 96~480 parts of 180~900 parts of Myrrhas of Rhizoma Cyperi (vinegar system) (vinegar system) of Rhizoma Cibotii (stir-baking in sand unhairing)
48~240 parts of 132~660 parts of Radix Clematidis of 36~180 parts of Pericarpium Citri Reticulataes of Radix Aconiti Kusnezoffii Preparata
144~720 parts of Rhizoma Atractylodis (rice-washed water system)
Preferably:
45 parts of 240 parts of 450 parts of Myrrhas of Rhizoma Cyperi (vinegar system) (vinegar system) of Rhizoma Cibotii (stir-baking in sand unhairing)
120 parts of 330 parts of Radix Clematidis of 90 parts of Pericarpium Citri Reticulataes of Radix Aconiti Kusnezoffii Preparata
360 parts of Rhizoma Atractylodis (rice-washed water 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, capsule, granule, tablet, mixture, soft extract, fluid extract and extractum, emplastrum, powder.
The above new technology of the present invention may further comprise the steps:
Method a:(technology 1.)
(1) gets Rhizoma Cibotii, Rhizoma Cyperi, Rhizoma Atractylodis three flavor medical materials, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 2.0~5.0h 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 ∏) 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 Radix Aconiti Kusnezoffii Preparata, decoct with water 2~5 times, each 0.5~2.5 hour, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract;
(3) get residue after residue medical material and the extraction, with 50~95% ethanol immersion earlier 30~60 minutes, reheat reflux, extract, 2~5 times, each 0.5~3 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby.
Above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) get Myrrha, the Radix Aconiti Kusnezoffii Preparata medical material is beaten powder and is used as medicine;
(2) prescription residue medical material is handled the same;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing the various preparations except that drop pill and soft capsule 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; 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, pharmacological research
1.1 on Carrageenan causes the inhibitory action of pedal swelling
40 of extracting male Wistar rats, body weight 140~160g is divided into 4 groups at random by body weight, 10 every group.Be respectively 1. extractum group (0.07g/kg) of technology, technology is extractum group (0.10g/kg) 2., rheumatism panacea group 0.5g/kg, matched group (with the capacity normal saline).Measure every rat right hind leg normal foot sole of the foot volume with the glass container method, adopt gastric infusion, behind the administration 30min, cause inflammation at every the right back glue foot of rat plantar subcutaneous injection 1% carrageenin 0.1ml respectively, 1h, 2h, 4h, 6h measure every rat paw volume as stated above subsequently.And calculate swelling rate (%) and suppression ratio (%) respectively by following formula.
Figure A20051013443400081
Figure A20051013443400082
Experimental result sees Table 1.
The influence of the pedal swelling that table 1 on Carrageenan causes (x ± s, n=10)
Group Dosage (g/kg) Cause scorching back different time swelling rate (%)
1h 2h 4h 6h
Matched group technology is 2. extractum group rheumatism panacea group of extractum group technology 1. - 0.07 0.10 0.5 29.7±8.1 13.2±7.3 **(55.6) 16.2±6.2 **(45.5) 19.4±5.7 **(34.7) 70.2±9.4 26.1±10.2 **(62.8) 29.7±6.6 **(57.7) 38.6±10.3 **(45.0) 68.8±7.5 39.4±6.9 **(42.7) 43.2±7.9 **(37.2) 49.4±5.9 **(28.2) 64.3±7.7 48.2±4.6 **(25.0) 51.1±6.7 **(20.5) 52.9±5.6 **(17.7)
Annotate: experimental group and matched group are relatively *In P<0.01, bracket is suppression ratio
1.2 promoting blood circulation to remove obstruction in the collateral effect (to the influence of granuloma induced by implantation of cotton pellets formation)
Get 30 of Wistar rats, body weight 140~160g is divided into 5 groups at random, and 6 every group, be respectively matched group (with the capacity normal saline), technology is the extractum group 1., and technology is the extractum group 2., rheumatism panacea group (0.5g/kg).With pentobarbital sodium 30g/kg intraperitoneal injection of anesthesia animal, the rat knee with iodine tincture and 75% alcohol disinfecting after, cut the osculum of about 1cm, put into from otch with the ophthalmology tweezers of the sterilization autoclaving cotton balls that 20mg is heavy (soak dry with penicillin and streptomycin mixed liquor 0.2ml) subcutaneous, skin suture immediately.Each group all adopts gastric infusion, continuous use 7d.Opened former otch on the 8th day, cotton balls is taken out together with connective tissue, put in the baking oven 70 ℃ of oven dry, weigh.With claim weight deduct cotton balls weight and be granuloma weight.Each experimental group and matched group relatively and carry out t check, experimental result sees Table 2.
The bullate influence of table 2 pair rat granuloma (x ± s)
Group Dosage (g/kg) Number of animals Granuloma dry weight (mg)
Matched group technology is 2. extractum group rheumatism panacea group of extractum group technology 1. - 0.07 0.10 0.5 6 6 6 6 97.8±4.7 73.5±2.1 ** 76.1±1.7 ** 82.4±2.6 **
Table 2 explanation, the effect that extractum group and rheumatism panacea group have the obvious suppression granuloma induced by implantation of cotton pellets to increase is with matched group comparing difference highly significant (P<0.01).
2, 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 that a kind of good treatment blood vessels stagnate, lumbago and skelalgia, rheumatic numbness, joint aches, the medicine of walking hardship, and change preparation technology, can obviously strengthen its strengthening bone and muscle, the arteries and veins of invigorating blood circulation, clinical efficacies such as expelling wind and removing dampness, 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:
Rhizoma Cibotii (stir-baking in sand unhairing) 96g Rhizoma Cyperi (vinegar system) 180g Myrrha (vinegar system) 18g
Radix Aconiti Kusnezoffii Preparata 36g Pericarpium Citri Reticulatae 132g Radix Clematidis 48g
Rhizoma Atractylodis (rice-washed water system) 144g
PEG4000 100g
Make 1000 balls
Preparation method:
(1) gets Rhizoma Cibotii, Rhizoma Cyperi, Rhizoma Atractylodis three flavor medical materials, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 3.0h 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 ∏) 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 40min gets clathrate;
(2) get Radix Aconiti Kusnezoffii Preparata, decoct with water 2 times, each 1.5 hours, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract;
(3) get residue after residue medical material and the extraction, with 85% ethanol immersion earlier 30 minutes, reheat reflux, extract, 3 times, each 1 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(4) 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:
Rhizoma Cibotii (stir-baking in sand unhairing) 288g Rhizoma Cyperi (vinegar system) 540g Myrrha (vinegar system) 54g
Radix Aconiti Kusnezoffii Preparata 108g Pericarpium Citri Reticulatae 396g Radix Clematidis 144g
Rhizoma Atractylodis (rice-washed water system) 432g
PEG400 360g
Make 1000
Preparation method:
(1) gets Rhizoma Cibotii, Rhizoma Cyperi, Rhizoma Atractylodis three flavor medical materials, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 3.0h 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 ∏) 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 40min gets clathrate;
(2) get Radix Aconiti Kusnezoffii Preparata, decoct with water 2 times, each 1.5 hours, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract;
(3) get residue after residue medical material and the extraction, with 85% ethanol immersion earlier 30 minutes, reheat reflux, extract, 3 times, each 1 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(4) 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:
Rhizoma Cibotii (stir-baking in sand unhairing) 480g Rhizoma Cyperi (vinegar system) 900g Myrrha (vinegar system) 90g
Radix Aconiti Kusnezoffii Preparata 180g Pericarpium Citri Reticulatae 660g Radix Clematidis 240g
Rhizoma Atractylodis (rice-washed water system) 720g
Make 1000g
Preparation method:
(1) get Myrrha, the Radix Aconiti Kusnezoffii Preparata medical material is beaten powder and is used as medicine;
(2) get Rhizoma Cibotii, Rhizoma Cyperi, Rhizoma Atractylodis three flavor medical materials, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 3.0h 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 ∏) 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 40min gets clathrate;
(3) get residue after residue medical material and the extraction, with 85% ethanol immersion earlier 30 minutes, reheat reflux, extract, 3 times, each 1 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(4) above active component is merged, add aspartame 5.0g, dextrin 220.0g, granulate, drying sprays into essence 5.0g, promptly gets granule 1000g.
Embodiment 4:
The preparation method of chewable tablet of the present invention:
Prescription:
Rhizoma Cibotii (stir-baking in sand unhairing) 312g Rhizoma Cyperi (vinegar system) 585g Myrrha (vinegar system) 58.5g
Radix Aconiti Kusnezoffii Preparata 117g Pericarpium Citri Reticulatae 429g Radix Clematidis 156g
Rhizoma Atractylodis (rice-washed water system) 468g
Make 1000
Preparation method:
(1) get Myrrha, the Radix Aconiti Kusnezoffii Preparata medical material is beaten powder and is used as medicine;
(2) get Rhizoma Cibotii, Rhizoma Cyperi, Rhizoma Atractylodis three flavor medical materials, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 3.0h 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 ∏) 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 40min gets clathrate;
(3) get residue after residue medical material and the extraction, with 85% ethanol immersion earlier 30 minutes, reheat reflux, extract, 3 times, each 1 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby;
(4) 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:
18~90 parts of 96~480 parts of 180~900 parts of Myrrhas of Rhizoma Cyperi (vinegar system) (vinegar system) of Rhizoma Cibotii (stir-baking in sand unhairing)
48~240 parts of 132~660 parts of Radix Clematidis of 36~180 parts of Pericarpium Citri Reticulataes of Radix Aconiti Kusnezoffii Preparata
144~720 parts of Rhizoma Atractylodis (rice-washed water 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:
45 parts of 240 parts of 450 parts of Myrrhas of Rhizoma Cyperi (vinegar system) (vinegar system) of Rhizoma Cibotii (stir-baking in sand unhairing)
120 parts of 330 parts of Radix Clematidis of 90 parts of Pericarpium Citri Reticulataes of Radix Aconiti Kusnezoffii Preparata
360 parts of Rhizoma Atractylodis (rice-washed water system).
3, claim 1 or any one Chinese medicine preparation of 2 are drop pill, capsule, granule, tablet, mixture, soft extract, fluid extract and extractum, emplastrum, powder.
4, the Chinese medicine preparation of claim 3 through described raw material is extracted processing, obtains active component, adds suitable adjuvant as required and makes.
5, the Chinese medicine preparation of claim 4 is characterized in that, described active component prepares through following steps:
Method a:(technology 1.)
(1) gets Rhizoma Cibotii, Rhizoma Cyperi, Rhizoma Atractylodis three flavor medical materials, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 2.0~5.0h 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: 4~6 with β-CD ratio, and ultrasonic 30~70min gets clathrate;
(2) get Radix Aconiti Kusnezoffii Preparata, decoct with water 2~5 times, each 0.5~2.5 hour, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract;
(3) get residue after residue medical material and the extraction, with 50~95% ethanol immersion earlier 30~60 minutes, reheat reflux, extract, 2~5 times, each 0.5~3 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby.
Above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) get Myrrha, the Radix Aconiti Kusnezoffii Preparata medical material is beaten powder and is used as medicine;
(2) prescription residue medical material is handled the same;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing the various preparations except that drop pill and soft capsule 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 Rhizoma Cibotii, Rhizoma Cyperi, Rhizoma Atractylodis three flavor medical materials, adopt supercritical extraction (or steam distillation): in the supercritical extraction jar of packing into, be that 20MPa, temperature are to extract 2.0~5.0h 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: 4~6 with β-CD ratio, and ultrasonic 30~70min gets clathrate;
(2) get Radix Aconiti Kusnezoffii Preparata, decoct with water 2~5 times, each 0.5~2.5 hour, collecting decoction filtered, and filtrate is condensed into thick paste, promptly gets water extract;
(3) get residue after residue medical material and the extraction, with 50~95% ethanol immersion earlier 30~60 minutes, reheat reflux, extract, 2~5 times, each 0.5~3 hour, merge extractive liquid,, concentrating under reduced pressure becomes thick paste, and is standby.
Above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing various preparations such as drop pill of the present invention and soft capsule.
Method b:(technology 2.)
(1) get Myrrha, the Radix Aconiti Kusnezoffii Preparata medical material is beaten powder and is used as medicine;
(2) prescription residue medical material is handled the same;
(3) above active component lumps together the active constituents of medicine into preparation of the present invention, and this active component is suitable for preparing the various preparations except that drop pill and soft capsule 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: active constituents of medicine is mixed with proper auxiliary materials, obtain uniform suspension and/or solution, regulate content weight, compacting, dry getting final product.
CN 200510134434 2005-12-15 2005-12-15 Blood quickening pain relieving medicinal preparation and its new preparation method Pending CN1824114A (en)

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CN1824114A true CN1824114A (en) 2006-08-30

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