CN1813953A - Chinese medicine formulation for promoting blood circulation to arrest pain, and its preparing method and quality control method - Google Patents
Chinese medicine formulation for promoting blood circulation to arrest pain, and its preparing method and quality control method Download PDFInfo
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- CN1813953A CN1813953A CN 200510032492 CN200510032492A CN1813953A CN 1813953 A CN1813953 A CN 1813953A CN 200510032492 CN200510032492 CN 200510032492 CN 200510032492 A CN200510032492 A CN 200510032492A CN 1813953 A CN1813953 A CN 1813953A
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Abstract
The present invention discloses a Chinese medicine preparation with the functions of promoting blood circulation and stopping pain, its preparation method and quality control method. Said Chinese medicine preparation can be Lingxian Dieda dripping pills or micropill capsule or granules or soft capsule prepared by using the Chinese medicinal materials of clematis root, flying squirrel's droppings and prepared aconite main tuber. Said invention also provides the concrete steps of its preparation method.
Description
Technical field:
The present invention relates to a kind of Chinese medicine preparation and preparation method thereof and method of quality control, relate in particular to a kind of Chinese medicine preparation and preparation method thereof and method of quality control of promoting blood circulation and stopping pain.
Background technology:
Drop pill in the Chinese medicine preparation or micropill or pellet capsule or granule or soft capsule, change dosage form or technology and manage as new drug research according to the relevant laws and regulations of China's drug control as a kind of pharmaceutical dosage form.
Existing Radix Clematidis traumatic injury sheet has been listed Chinese traditional patent formulation preparation promulgated by the ministries or commissions of the Central Government (the 7th) in, and its technology features is to get Oletum Trogopterori to be ground into fine powder; Radix Clematidis decocts with water filtration, and filtrate is left standstill, and gets supernatant and shortens thick paste into; The Radix Aconiti Preparata alcohol extraction is left standstill, and gets supernatant and reclaims ethanol, is condensed into thick paste, with above-mentioned powder and thick paste mixing; Add right amount of auxiliary materials, granulate, drying, tabletting, sugar coating, promptly.
There is long, shortcoming such as produce effects is slow, bioavailability is low disintegration in existing Radix Clematidis traumatic injury sheet.
Summary of the invention:
The Chinese medicine preparation and preparation method thereof and the method for quality control that the purpose of this invention is to provide a kind of promoting blood circulation and stopping pain overcome the above-mentioned drawback of prior art, improve quality, curative effect, the bioavailability of product, satisfy the needs of medical treatment better.
The objective of the invention is to be achieved through the following technical solutions.
A kind of Chinese medicine preparation of promoting blood circulation and stopping pain, it is that Main Ingredients and Appearance is Radix Clematidis traumatic injury drop pill or micropill or pellet capsule or the granule or the soft capsule of Radix Clematidis, Oletum Trogopterori, Radix Aconiti Preparata.
Its preparation method is:
(1) medicine Main Ingredients and Appearance and weight proportion thereof are as follows:
100～500 parts of Radix Clematidis, each 80～500 parts of Oletum Trogopterori, Radix Aconiti Preparatas;
Medicine Main Ingredients and Appearance preferred weight proportioning is:
200～400 parts of Radix Clematidis, each 150～300 parts of Oletum Trogopterori, Radix Aconiti Preparatas;
Medicine Main Ingredients and Appearance optimum weight proportioning is:
300 parts of Radix Clematidis, each 240 parts of Oletum Trogopterori, Radix Aconiti Preparatas;
(2) get Oletum Trogopterori and decoct with water 1～3 time, each 1～4 hour, filter, merging filtrate is concentrated into thick paste; Radix Clematidis decocts with water 1～3 time, and each 1～4 hour, collecting decoction filtered, and filtrate is left standstill, and gets supernatant and shortens thick paste into; Radix Aconiti Preparata is with 60～80% alcohol reflux 1～3 time, and each 1～4 hour, merge extractive liquid, left standstill, and got supernatant and reclaimed ethanol, was condensed into thick paste; Get above-mentioned three kinds of thick pastes, mixing, drying is pulverized, and gets mixing fine powders, and is standby;
(3) with one or more of stearic acid or glyceryl monostearate or insect wax or Cera Flava or Polyethylene Glycol (PEG4000 or PEG6000) or sodium stearate or glycerin gelatine or polyoxyethylene monostearate (S-40) or Poloxamer188 or other suitable adjuvant, use with by arbitrary proportion, add (2) gained mixing fine powders after being heated to whole fusions, be transferred in the liquid containing bottle rapidly after stirring, airtight and the insulation at 70～100 ℃, under heat-retaining condition, go in the liquid coolant (liquid paraffin or methyl-silicone oil or vegetable oil or water or ethanol) by dropping-pill machine, condensation cured becomes ball, coolant is use up and removed to the drop pill drop of molding, dry, coating or coating not promptly get drop pill;
(4) get (2) gained mixing fine powders, add an amount of adjuvant, mix homogeneously is granulated, and coating or coating are not made the micropill of diameter less than 2.5mm; Maybe, incapsulate, promptly get pellet capsule the micropill that makes;
Adjuvant is one or more combination or other suitable adjuvant in the following material, uses with by arbitrary proportion: ethyl cellulose (EC), the polypropylene polysiloxanes, the wax class, Polyethylene Glycol (PEG), stearic acid, Lac, acrylic resin, polyvinyl alcohol, polyvinylpyrrolidone (PVP), methylcellulose, hydroxypropyl cellulose, cellulose propionate, the acrylic resin aqueous dispersion, the pseudo-latex of ethyl cellulose, cellulose acetate-phthalate (CAP) latex, polyphenyl dioctyl phthalate vinyl acetate (PVAP) aqueous dispersion, propylene glycol, glycerol, triacetin, acetyl list monoglyceride, phthalic acid ester, polyoxyethylene sorbitan monoleate, sodium lauryl sulphate, lactose, fructose, sucrose;
(5) get (2) gained mixing fine powders, add an amount of adjuvant, mixing is granulated, drying, and granulate, coating or coating not promptly get granule;
Adjuvant is one or more mixture or other suitable adjuvant in the following material, uses with by arbitrary proportion: stevioside, protein sugar, xylitol, high fructose, cyclamate, beta-schardinger dextrin-, dextrin, lactose, saccharin sodium;
(6) get (2) gained mixing fine powders, add an amount of adjuvant, mix homogeneously is suppressed or is dripped and makes soft capsule;
Adjuvant is one or more mixture or other suitable adjuvant in the following material, uses with by arbitrary proportion: PEG400, vegetable oil, aromatic hydrocarbon esters, glycerol, isopropyl alcohol, tween.
Radix Clematidis traumatic injury micropill or pellet capsule or particulate preparation method can also be:
(1) medicine Main Ingredients and Appearance and weight proportion thereof are as follows:
100～500 parts of Radix Clematidis, each 80～500 parts of Oletum Trogopterori, Radix Aconiti Preparatas;
Medicine Main Ingredients and Appearance preferred weight proportioning is:
200～400 parts of Radix Clematidis, each 150～300 parts of Oletum Trogopterori, Radix Aconiti Preparatas;
Medicine Main Ingredients and Appearance optimum weight proportioning is:
300 parts of Radix Clematidis, each 240 parts of Oletum Trogopterori, Radix Aconiti Preparatas;
(2) get Oletum Trogopterori and be ground into fine powder, sieve; Radix Clematidis decocts with water 1～3 time, and each 1～4 hour, collecting decoction filtered, and filtrate is left standstill, and gets supernatant and shortens thick paste into; Radix Aconiti Preparata is with 60～80% alcohol reflux 1～3 time, and each 1～4 hour, merge extractive liquid, left standstill, and got supernatant and reclaimed ethanol, was condensed into thick paste, with above-mentioned fine powder and thick paste mixing, drying, pulverize, mixing fine powders, standby;
(3) get (2) gained mixing fine powders, add an amount of adjuvant, mix homogeneously is granulated, and coating or coating are not made the micropill of diameter less than 2.5mm; Maybe, incapsulate, promptly get pellet capsule the micropill that makes;
Adjuvant is one or more combination or other suitable adjuvant in the following material, uses with by arbitrary proportion: ethyl cellulose (EC), the polypropylene polysiloxanes, the wax class, Polyethylene Glycol (PEG), stearic acid, Lac, acrylic resin, polyvinyl alcohol, polyvinylpyrrolidone (PVP), methylcellulose, hydroxypropyl cellulose, cellulose propionate, the acrylic resin aqueous dispersion, the pseudo-latex of ethyl cellulose, cellulose acetate-phthalate (CAP) latex, polyphenyl dioctyl phthalate vinyl acetate (PVAP) aqueous dispersion, propylene glycol, glycerol, triacetin, acetyl list monoglyceride, phthalic acid ester, polyoxyethylene sorbitan monoleate, sodium lauryl sulphate, lactose, fructose, sucrose;
(4) get (2) gained mixing fine powders, add an amount of adjuvant, mixing is granulated, drying, and granulate, coating or coating are not promptly made granule;
Adjuvant is one or more mixture or other suitable adjuvant in the following material, uses with by arbitrary proportion: stevioside, protein sugar, xylitol, high fructose, cyclamate, beta-schardinger dextrin-, dextrin, lactose, saccharin sodium.
A kind of method of quality control of Chinese medicine preparation of promoting blood circulation and stopping pain, it is the method for quality control of Radix Clematidis traumatic injury drop pill or micropill or pellet capsule or granule or soft capsule:
Differentiate that the Radix Clematidis thin layer chromatography is differentiated: get this product 2～10g, porphyrize adds water 10～30ml, grind, filter, filtrate is put in the separatory funnel, adds chloroform 10～20ml and extracts, divide and get the chloroform layer, evaporate to dryness in the water-bath, residue add methanol 1ml makes dissolving, as need testing solution; Other gets Radix Clematidis control medicinal material 0.2～2g, with the method operation, makes control medicinal material solution; Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2005), draw each 5～20 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with benzene-ether (2～10: 0.5～5) be developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect, in the test sample chromatograph, on the corresponding position of control medicinal material, show the speckle of same color;
Check that aconitine limit is got the content 5～20g of this product, adds ammonia solution 5～20ml, flooded 0.5～2 hour, the 40～60ml that adds diethyl ether, dipping spends the night, and filters, and filtrate evaporate to dryness, residue add dehydrated alcohol 2ml makes dissolving, as need testing solution; Other gets the aconitine reference substance, adds dehydrated alcohol and makes the solution that contains 0.5～2mg among every 1ml, in contrast product solution; Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw above-mentioned need testing solution 5～20 μ l, reference substance solution 2～10 μ l, put respectively on same silica gel g thin-layer plate, with normal hexane-ethyl acetate-methanol-strong ammonia solution (5～20: 5～15: 1～5: 0.05～2) be developing solvent, launch, take out, dry, spray is with rare bismuth potassium iodide test solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on the speckle that occurs should or speckle appear less than the speckle of reference substance.
Specific embodiments:
The present invention further specifies in conjunction with specific embodiments, and is only for reference, do not limit the scope of the invention:
A kind of Chinese medicine preparation of promoting blood circulation and stopping pain, it is that Main Ingredients and Appearance is Radix Clematidis traumatic injury drop pill or micropill or pellet capsule or the granule or the soft capsule of Radix Clematidis, Oletum Trogopterori, Radix Aconiti Preparata.
A kind of Chinese medicine preparation of promoting blood circulation and stopping pain has the effect of diffusing wind damp eliminating, promoting blood circulation and stopping pain.Be used for paralysis of the limbs, the time diseases such as pain, traumatic injury, unbearably painful or paralysis of aching.
A kind of Chinese medicine preparation Radix Clematidis traumatic injury drop pill of promoting blood circulation and stopping pain or or micropill or pellet capsule or granule or preparation of soft capsule method be:
(1) medicine Main Ingredients and Appearance and weight consumption are as follows:
Radix Clematidis 300g, Oletum Trogopterori, each 240g of Radix Aconiti Preparata;
(2) get Oletum Trogopterori and decoct with water secondary, each 2 hours, filter, merging filtrate is concentrated into thick paste; Radix Clematidis decocts with water secondary, and each 3 hours, collecting decoction filtered, and filtrate is left standstill, and gets supernatant and shortens thick paste into; Radix Aconiti Preparata is with 70% alcohol reflux secondary, and each 3 hours, merge extractive liquid, left standstill, and gets supernatant and reclaims ethanol, is condensed into thick paste; Get above-mentioned three kinds of thick paste mixings, drying is pulverized, and gets mixing fine powders, and is standby;
(3) a kind of Chinese medicine preparation drop pill of promoting blood circulation and stopping pain is a Radix Clematidis traumatic injury drop pill, its preparation method is taking polyethylene glycol PEG6000 50g, stearic acid 40g, Poloxamer188 35g, treat to add above-mentioned (2) gained mixing fine powders after Polyethylene Glycol PEG6000, stearic acid, Poloxamer188 are heated to whole fusions, be transferred in the liquid containing bottle rapidly after stirring, airtight and the insulation at 80 ℃, at heat-retaining condition by splashing in the liquid paraffin, be condensed into ball, with the drop pill drop of molding to the greatest extent and the erasing liquor paraffin body, cold drying, promptly.
(4) a kind of Chinese medicine preparation drop pill of promoting blood circulation and stopping pain is a Radix Clematidis traumatic injury enteric coated drop pill, its preparation method is taking polyethylene glycol PEG6000 50g, stearic acid 40g, Poloxamer188 35g, treat Polyethylene Glycol PEG6000, stearic acid, Poloxamer188 adds above-mentioned (2) gained mixing fine powders after being heated to whole fusions, be transferred in the liquid containing bottle rapidly after stirring, airtight and the insulation at 80 ℃, at heat-retaining condition by splashing in the liquid paraffin, be condensed into ball, with the drop pill drop of molding to the greatest extent and the erasing liquor paraffin body, cold drying, use acrylic resin, phthalic acid diethyl ester, the mixed liquor coating that the Semen Ricini wet goods is made, promptly.
(5) a kind of Chinese medicine preparation micropill of promoting blood circulation and stopping pain is a Radix Clematidis traumatic injury micropill, its preparation method is to get (2) gained mixing fine powders, with 100g microcrystalline Cellulose mix homogeneously, 5%PVP alcohol liquid is binding agent, at first prepare 60 purpose granules and make parent nucleus, be binding agent with 5%PVP alcohol liquid again, add the mixed powder amplification and make 40 purpose micropills, promptly.
(6) a kind of Chinese medicine preparation pellet capsule of promoting blood circulation and stopping pain is a Radix Clematidis traumatic injury pellet capsule, its preparation method is to get (2) gained mixing fine powders, with 100g microcrystalline Cellulose mix homogeneously, 5%PVP alcohol liquid is binding agent, at first preparing 60 purpose granules and make parent nucleus, is binding agent with 5%PVP alcohol liquid again, adds the mixed powder amplification and makes 40 purpose micropills, incapsulate, promptly.
(7) a kind of Chinese medicine preparation granule of promoting blood circulation and stopping pain is a Radix Clematidis traumatic injury granule, and its preparation method is: get (2) gained mixing fine powders, add B-cyclodextrin 280g, and mixing, drying adds the 0.5g stevioside, granulates, drying, promptly.
(8) a kind of Chinese medicine preparation granule of promoting blood circulation and stopping pain is a Radix Clematidis traumatic injury enteric coated particles, its preparation method is to get (2) gained mixing fine powders, add dextrin 260g, granulate, dry, granulate, the mixed liquor coating made from acrylic resin, polyvinylpyrrolidone (PVP), medicinal alcohol, distilled water etc., promptly.
(9) a kind of Chinese medicine preparation soft capsule of promoting blood circulation and stopping pain is a Radix Clematidis traumatic injury soft capsule, its preparation method is: get (2) gained mixing fine powders, behind water dissolution, the adding adjuvant is the combination of one or more different proportions in PEG400, vegetable oil, aromatic hydrocarbon esters, glycerol, isopropyl alcohol, the tween, a compacting or a system, promptly.
(10) a kind of Chinese medicine preparation of promoting blood circulation and stopping pain is Radix Clematidis traumatic injury micropill or pellet capsule or granule, and its preparation method is:
1. medicine Main Ingredients and Appearance and weight consumption are as follows:
Radix Clematidis 300g, Oletum Trogopterori, each 240g of Radix Aconiti Preparata;
2. get Oletum Trogopterori and be ground into fine powder, sieve; Radix Clematidis decocts with water secondary, and each 3 hours, collecting decoction, filter, filtrate is left standstill, and gets supernatant and shortens thick paste into, Radix Aconiti Preparata is with 70% alcohol reflux secondary, each 3 hours, merge extractive liquid,, leave standstill, get supernatant and reclaim ethanol, be condensed into thick paste, with above-mentioned powder and thick paste mixing, drying, pulverize, get mixing fine powders, standby;
3. a kind of Chinese medicine preparation micropill of promoting blood circulation and stopping pain is a Radix Clematidis traumatic injury micropill, its preparation method is to get 2. gained mixing fine powders, with 60g microcrystalline Cellulose mix homogeneously, 5%PVP alcohol liquid is binding agent, at first preparing 60 purpose granules and make parent nucleus, is binding agent with 5%PVP alcohol liquid again, adds the mixed powder amplification and makes 40 purpose micropills, mixing, promptly.
4. a kind of Chinese medicine preparation pellet capsule of promoting blood circulation and stopping pain is a Radix Clematidis traumatic injury pellet capsule, its preparation method is to get 2. gained mixing fine powders, with 60g microcrystalline Cellulose mix homogeneously, 5%PVP alcohol liquid is binding agent, at first prepares 60 purpose granules and makes parent nucleus, and be binding agent with 5%PVP alcohol liquid again, add the mixed powder amplification and make 40 purpose micropills, mixing incapsulates, promptly.
5. a kind of Chinese medicine preparation granule of promoting blood circulation and stopping pain is a Radix Clematidis traumatic injury granule, and its preparation method is: get 2. gained mixing fine powders, add B-cyclodextrin 60g, add oligomeric lactose 40g and fully stir, and mixing, spray drying adds the 1g stevioside, granulates, drying, promptly.
A kind of method of quality control of Chinese medicine preparation of promoting blood circulation and stopping pain, it is the method for quality control of Radix Clematidis traumatic injury drop pill or micropill or pellet capsule or granule or soft capsule:
Differentiate that the Radix Clematidis thin layer chromatography is differentiated: get this product or this product content 3g, porphyrize adds water 20ml, grind, filter, filtrate is put in the separatory funnel, adds chloroform 15ml and extracts, divide and get the chloroform layer, evaporate to dryness in the water-bath, residue add methanol 1ml makes dissolving, as need testing solution; Other gets Radix Clematidis control medicinal material 1g, with the method operation, makes control medicinal material solution; Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2005), draw each 10 μ l of above-mentioned two kinds of solution, putting respectively on same silica gel g thin-layer plate, is developing solvent with benzene-ether (7: 3), launches, take out, dry, put under the ultra-violet lamp (365nm) and inspect, in the test sample chromatograph, on the corresponding position of control medicinal material, show the speckle of same color.
Check that aconitine limit is got this product or this product content 10g, adds ammonia solution 10ml, flooded 1 hour, the 50ml that adds diethyl ether, dipping spends the night, and filters, and filtrate evaporate to dryness, residue add dehydrated alcohol 2ml makes dissolving, as need testing solution.Other gets the aconitine reference substance, adds dehydrated alcohol and makes the solution that contains 1mg among every 1ml, in contrast product solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw above-mentioned need testing solution 10 μ l, reference substance solution 5 μ l, put respectively on same silica gel g thin-layer plate, (10: 10: 3: 0.1) be developing solvent, expansion was taken out with normal hexane-ethyl acetate-methanol-strong ammonia solution, dry, spray is with rare bismuth potassium iodide test solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on the speckle that occurs should or speckle appear less than the speckle of reference substance.
Advantage of the present invention is:
Take, easy to carry, the bioavilability height is applicable to the difference crowd that takes medicine, and is conducive to improve drug effect.
Claims (7)
1, a kind of Chinese medicine preparation of promoting blood circulation and stopping pain is characterized in that it is that Main Ingredients and Appearance is Radix Clematidis traumatic injury drop pill or micropill or pellet capsule or the granule or the soft capsule of Radix Clematidis, Oletum Trogopterori, Radix Aconiti Preparata.
2, a kind of preparation method of Chinese medicine preparation of promoting blood circulation and stopping pain, it is Radix Clematidis traumatic injury drop pill or micropill or pellet capsule or granule or preparation of soft capsule method, it is characterized in that:
(1) medicine main component and weight proportion thereof are as follows:
100～500 parts of Radix Clematidis, each 80～500 parts of Oletum Trogopterori, Radix Aconiti Preparatas;
(2) get Oletum Trogopterori and decoct with water 1～3 time, each 1～4 hour, filter, merging filtrate is concentrated into thick paste; Radix Clematidis decocts with water 1～3 time, and each 1～4 hour, collecting decoction filtered, and filtrate is left standstill, and gets supernatant and shortens thick paste into; Radix Aconiti Preparata is with 60～80% alcohol reflux 1～3 time, and each 1～4 hour, merge extractive liquid, left standstill, and got supernatant and reclaimed ethanol, was condensed into thick paste; Get above-mentioned three kinds of thick pastes, mixing, drying is pulverized, and gets mixing fine powders, and is standby;
(3) get (2) gained mixing fine powders, add suitable adjuvant, make drop pill or micropill or pellet capsule or granule or soft capsule;
The preparation method of its drop pill is: with one or more of stearic acid or glyceryl monostearate or insect wax or Cera Flava or Polyethylene Glycol (PEG4000 or PEG6000) or sodium stearate or glycerin gelatine or polyoxyethylene monostearate (S-40) or Poloxamer188 or other suitable adjuvant, use with by arbitrary proportion, add (2) gained mixing fine powders after being heated to whole fusions, be transferred in the liquid containing bottle rapidly after stirring, airtight and the insulation at 70～100 ℃, under heat-retaining condition, go in the liquid coolant (liquid paraffin or methyl-silicone oil or vegetable oil or water or ethanol) by dropping-pill machine, condensation cured becomes ball, coolant is use up and removed to the drop pill drop of molding, dry, coating or coating not promptly get drop pill;
The preparation method of its micropill or pellet capsule is: get (2) gained mixing fine powders, add an amount of adjuvant, mix homogeneously is granulated, and coating or coating are not made the micropill of diameter less than 2.5mm; Maybe, incapsulate, promptly get pellet capsule the micropill that makes;
Adjuvant is one or more combination or other suitable adjuvant in the following material, uses with by arbitrary proportion: ethyl cellulose (EC), the polypropylene polysiloxanes, the wax class, Polyethylene Glycol (PEG), stearic acid, Lac, acrylic resin, polyvinyl alcohol, polyvinylpyrrolidone (PVP), methylcellulose, hydroxypropyl cellulose, cellulose propionate, the acrylic resin aqueous dispersion, the pseudo-latex of ethyl cellulose, cellulose acetate-phthalate (CAP) latex, polyphenyl dioctyl phthalate vinyl acetate (PVAP) aqueous dispersion, propylene glycol, glycerol, triacetin, acetyl list monoglyceride, phthalic acid ester, polyoxyethylene sorbitan monoleate, sodium lauryl sulphate, lactose, fructose, sucrose;
Its particulate preparation method is: get (2) gained mixing fine powders, add an amount of adjuvant, mixing is granulated, drying, and granulate, coating or coating not promptly get granule;
Adjuvant is one or more mixture or other suitable adjuvant in the following material, uses with by arbitrary proportion: stevioside, protein sugar, xylitol, high fructose, cyclamate, beta-schardinger dextrin-, dextrin, lactose, saccharin sodium;
Its preparation of soft capsule method is: get (2) gained mixing fine powders, add an amount of adjuvant, mix homogeneously is suppressed or is dripped and makes soft capsule;
Adjuvant is one or more mixture or other suitable adjuvant in the following material, uses with by arbitrary proportion:
PEG400, vegetable oil, aromatic hydrocarbon esters, glycerol, isopropyl alcohol, tween.
3, the preparation method of the Chinese medicine preparation of a kind of promoting blood circulation and stopping pain according to claim 2, it is characterized in that by adding suitable adjuvant, can make other any pharmaceutically useful dosage forms, comprise sheet (plain sheet, coated tablet, Film coated tablets, enteric coatel tablets, effervescent tablet, slow-release tablet, dispersible tablet, fast-release tablet, oral cavity disintegration tablet, buccal tablet), ball, cream, loose, slow, controlled release capsule, effervescent granule, oral liquid, injection etc.
4, the preparation method of the Chinese medicine preparation of a kind of promoting blood circulation and stopping pain according to claim 2 is characterized in that Radix Clematidis traumatic injury micropill or pellet capsule or particulate preparation method also can be:
(1) medicine Main Ingredients and Appearance and weight proportion thereof are as follows:
100～500 parts of Radix Clematidis, each 80～500 parts of Oletum Trogopterori, Radix Aconiti Preparatas;
(2) get Oletum Trogopterori and be ground into fine powder, sieve; Radix Clematidis decocts with water 1～3 time, and each 1～4 hour, collecting decoction filtered, and filtrate is left standstill, and gets supernatant and shortens thick paste into; Radix Aconiti Preparata is with 60～80% alcohol reflux 1～3 time, and each 1～4 hour, merge extractive liquid, left standstill, and got supernatant and reclaimed ethanol, was condensed into thick paste, with above-mentioned fine powder and thick paste mixing, drying, pulverize, mixing fine powders, standby;
(3) get (2) gained mixing fine powders, add an amount of adjuvant, make micropill or pellet capsule or granule;
The preparation method of its micropill or pellet capsule is: get (2) gained mixing fine powders, add an amount of adjuvant, mix homogeneously is granulated, and coating or coating are not made the micropill of diameter less than 2.5mm; Maybe, incapsulate, promptly get pellet capsule the micropill that makes;
Adjuvant is one or more combination or other suitable adjuvant in the following material, uses with by arbitrary proportion: ethyl cellulose (EC), the polypropylene polysiloxanes, the wax class, Polyethylene Glycol (PEG), stearic acid, Lac, acrylic resin, polyvinyl alcohol, polyvinylpyrrolidone (PVP), methylcellulose, hydroxypropyl cellulose, cellulose propionate, the acrylic resin aqueous dispersion, the pseudo-latex of ethyl cellulose, cellulose acetate-phthalate (CAP) latex, polyphenyl dioctyl phthalate vinyl acetate (PVAP) aqueous dispersion, propylene glycol, glycerol, triacetin, acetyl list monoglyceride, phthalic acid ester, polyoxyethylene sorbitan monoleate, sodium lauryl sulphate, lactose, fructose, sucrose;
Its particulate preparation method is: get (2) gained mixing fine powders, add an amount of adjuvant, mixing is granulated, drying, and granulate, coating or coating not promptly get granule;
Adjuvant is one or more mixture or other suitable adjuvant in the following material, uses with by arbitrary proportion: stevioside, protein sugar, xylitol, high fructose, cyclamate, beta-schardinger dextrin-, dextrin, lactose, saccharin sodium.
5, a kind of method of quality control of Chinese medicine preparation of promoting blood circulation and stopping pain, it is the method for quality control of Radix Clematidis traumatic injury drop pill or micropill or pellet capsule or granule or soft capsule, it is characterized in that:
Differentiate, the Radix Clematidis thin layer chromatography is differentiated: get this product or this product content 2～10g, porphyrize adds water 10～30ml, grind, filter, filtrate is put in the separatory funnel, adds chloroform 10～20ml and extracts, divide and get the chloroform layer, evaporate to dryness in the water-bath, residue add methanol 1ml makes dissolving, as need testing solution; Other gets Radix Clematidis control medicinal material 0.2～2g, with the method operation, makes control medicinal material solution; Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), draw each 5～20 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with benzene-ether (2～10: 0.5～5) be developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect, in the test sample chromatograph, on the corresponding position of control medicinal material, show the speckle of same color;
Check that aconitine limit is got this product or this product content 5～20g, adds ammonia solution 5～20ml, flooded 0.5～2 hour, the 40～60ml that adds diethyl ether, dipping spends the night, and filters, and filtrate evaporate to dryness, residue add dehydrated alcohol 2ml makes dissolving, as need testing solution; Other gets the aconitine reference substance, adds dehydrated alcohol and makes the solution that contains 0.5～2mg among every 1ml, in contrast product solution; Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw above-mentioned need testing solution 5～20 μ l, reference substance solution 2～10 μ l, put respectively on same silica gel g thin-layer plate, with normal hexane-ethyl acetate-methanol-strong ammonia solution (5～20: 5～15: 1～5: 0.05～2) be developing solvent, launch, take out, dry, spray is with rare bismuth potassium iodide test solution, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on the speckle that occurs should or speckle appear less than the speckle of reference substance.
6, the preparation method of the Chinese medicine preparation of a kind of promoting blood circulation and stopping pain according to claim 2 is characterized in that the preferred weight proportioning of its main component is:
200～400 parts of Radix Clematidis, each 150～300 parts of Oletum Trogopterori, Radix Aconiti Preparatas.
7, the preparation method of the Chinese medicine preparation of a kind of promoting blood circulation and stopping pain according to claim 2 is characterized in that the optimum weight proportioning of its main component is:
300 parts of Radix Clematidis, each 240 parts of Oletum Trogopterori, Radix Aconiti Preparatas.
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| CN (1) | CN1813953A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102139088A (en) * | 2011-03-21 | 2011-08-03 | 李树彬 | Cervical and lumbar vertebrae rehabilitation pill |
| CN101274053B (en) * | 2008-04-10 | 2012-05-30 | 杨文龙 | Detection method of capsules for curing waist pain |
| CN103149290A (en) * | 2013-02-18 | 2013-06-12 | 青岛市药品检验所 | Rapid detection method of contents of multiple components in Chinese patent medicinal traumatic injury treatment tablet |
-
2005
- 2005-12-02 CN CN 200510032492 patent/CN1813953A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101274053B (en) * | 2008-04-10 | 2012-05-30 | 杨文龙 | Detection method of capsules for curing waist pain |
| CN102139088A (en) * | 2011-03-21 | 2011-08-03 | 李树彬 | Cervical and lumbar vertebrae rehabilitation pill |
| CN102139088B (en) * | 2011-03-21 | 2012-10-24 | 李树彬 | Cervical and lumbar vertebrae rehabilitation pill |
| CN103149290A (en) * | 2013-02-18 | 2013-06-12 | 青岛市药品检验所 | Rapid detection method of contents of multiple components in Chinese patent medicinal traumatic injury treatment tablet |
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