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CN104352477A - Traditional Chinese medicine pain-relieving capsule and preparation method thereof - Google Patents

Traditional Chinese medicine pain-relieving capsule and preparation method thereof Download PDF

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Publication number
CN104352477A
CN104352477A CN201410609436.0A CN201410609436A CN104352477A CN 104352477 A CN104352477 A CN 104352477A CN 201410609436 A CN201410609436 A CN 201410609436A CN 104352477 A CN104352477 A CN 104352477A
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China
Prior art keywords
mentioned steps
radix sophorae
sophorae flavescentis
magnesium stearate
opaca
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CN201410609436.0A
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Chinese (zh)
Inventor
李庆忠
彭亚聪
彭长褔
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HUNAN LINUO BIOLOGICAL PHARMACEUTICAL Co Ltd
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HUNAN LINUO BIOLOGICAL PHARMACEUTICAL Co Ltd
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Priority to CN201410609436.0A priority Critical patent/CN104352477A/en
Publication of CN104352477A publication Critical patent/CN104352477A/en
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Abstract

The invention discloses a traditional Chinese medicine pain-relieving capsule which is prepared from the following raw materials in parts by weight: 70-170 parts of radix sophorae flavescentis, 25-35 parts of rhizoma hterosmilacis and 1-6 parts of an auxiliary material magnesium stearate. A preparation method comprises the following steps: a, crushing radix sophorae flavescentis and rhizoma hterosmilacis into crude powder; b, putting the crude powder into an extraction tank, adding a hydrochloric acid solution for soaking, filtering, and collecting the soak solution; c, adding water into the medicine residues, boiling, filtering, and collecting and combining the decoction; d, combining the soak solution and the decoction, putting into an extraction tank, performing enzymolysis, leaving to stand, and sucking the supernate; e, adding a natural clarifying agent, leaving to stand, and sucking the supernate again; f, concentrating the supernate to be 600-1400ml, further adding ethanol, performing centrifugal separation, and further concentrating the filtrate, g, adding ethanol, performing centrifugal separation, and concentrating the filtrate; and h, drying at low temperature, adding magnesium stearate, crushing into fine powder, and subsequently preparing the capsule.

Description

Zhitong Jiaonang and preparation method thereof
Technical field
The present invention relates to a kind of Zhitong Jiaonang, also relate to a kind of preparation method of this capsule.
Background technology
At present, analgesic is based on Western medicine, and Chinese medicine analgesic is few.And Chinese medicine analgesic has the effect of its uniqueness, side effect is little, and prospect of the application is wide.Have a kind of Chinese medicine analgesic in prior art, name is called FUFANG KUSHEN ZHUSHEYE, sees Chinese patent, the patent No. 97112532.The FUFANG KUSHEN ZHUSHEYE dosage form of this patent carries out extraction with traditional handicraft to Radix Sophorae Flavescentis and Smilax lanceaefolia Roxb. Var.opaca A.DC. to be prepared from.Radix Sophorae Flavescentis and Smilax lanceaefolia Roxb. Var.opaca A.DC. compositions are the good Chinese medicine analgesic of a kind of effect, and component is simple, are mainly used in cancer pain.Clinical observation result shows, liver cancer patient uses after FUFANG KUSHEN ZHUSHEYE, quality of life improvement rate be 41.6%, pain improvement rate is 71%.But, the FUFANG KUSHEN ZHUSHEYE of this patent, its preparation process length consuming time, energy consumption are large, and active ingredient loss is comparatively large, and product purity is not high; And, compatibility not also effect is best; Based on intravenous injection in use, the help that patient must obtain medical worker could use, and uses inconvenience, and there is potential untoward reaction, is especially unsuitable for patient with advanced cancer and uses.
If be prepared into a kind of capsule, can overcome and use inconvenient defect.But, also cannot be prepared into capsule by the method for prior art.
For a long time, those skilled in the art catch at the Radix Sophorae Flavescentis and Smilax lanceaefolia Roxb. Var.opaca A.DC. Zhitong Jiaonang that a kind of purity is higher, analgesic effect is better, easy to use.But, also do not obtain so far.
Summary of the invention
The technical problem to be solved in the present invention is just to provide the Zhitong Jiaonang that a kind of purity is higher, analgesic effect is better, easy to use.A kind of method of this Zhitong Jiaonang is also provided.
In order to solve the problems of the technologies described above, Zhitong Jiaonang of the present invention is prepared into capsule by the raw material of following weight portion: Radix Sophorae Flavescentis 70-170, Smilax lanceaefolia Roxb. Var.opaca A.DC. 25-35, and adjuvant magnesium stearate weight portion is 1-6.
The parts by weight of raw materials of Zhitong Jiaonang is preferably Radix Sophorae Flavescentis 70-150, Smilax lanceaefolia Roxb. Var.opaca A.DC. 30-35, adjuvant magnesium stearate 1-5; Be preferably Radix Sophorae Flavescentis 70, Smilax lanceaefolia Roxb. Var.opaca A.DC. 30 again, adjuvant magnesium stearate 2; Be more preferably Radix Sophorae Flavescentis 75, Smilax lanceaefolia Roxb. Var.opaca A.DC. 30, adjuvant magnesium stearate 1.
The preparation method of Zhitong Jiaonang provided by the invention comprises the steps:
A. the Radix Sophorae Flavescentis of described weight portion and Smilax lanceaefolia Roxb. Var.opaca A.DC. are ground into coarse powder;
B. will put in extraction pot through above-mentioned steps gained coarse powder, adding raw material weight 4-8 concentration is doubly the hydrochloric acid solution of 0.3-1.5%, and soak at room temperature 40-60 hour, then filters, and collects soak;
C. the medicinal residues after above-mentioned steps process are added the water of 4-8 times of weight, 85 DEG C decoct 2-3 time, and each 0.5-2.5 hour filters, collects and merge decoction liquor;
D. above-mentioned steps gained soak and decoction liquor are merged, put in extraction pot, tune pH value is 5.0-8.0, is heated to 60-80 DEG C, then adds the a-amylase of raw material weight 0.1-0.5%, enzymolysis 1-3 hour, and cooling leaves standstill, and extracts supernatant;
E. above-mentioned steps gained supernatant is heated to 60-80 DEG C, adds the natural clarifying agent of raw material weight 0.2-0.6%, reaction 0.5-2 hour, cooling, leaves standstill, then extracts supernatant;
F. above-mentioned steps gained supernatant 70 DEG C is evaporated to 600-1400ml, then adds ethanol and make alcohol content reach 50-70%, hold over night, centrifugalize, then by decompression filtrate recycling ethanol, be concentrated into 400-800ml;
G. above-mentioned steps gained concentrated solution being added ethanol again makes alcohol content reach 60-90%, hold over night, centrifugalize, then by decompression filtrate recycling ethanol, be concentrated into 200-400ml;
H. by the cold drying of above-mentioned steps gained concentrated solution, add the magnesium stearate of described weight portion, be ground into fine powder, then make capsule.
The diastatic enzyme activity of described a-is 50000u/g.
Natural clarifying agent used is the clarifier that prior art is commonly used.
Cold drying is that the low temperature belt vacuum that prior art is commonly used is dry, and baking temperature is 60-80 DEG C.
Capule size of the present invention: every 400mg.Using method: oral, each 2-3 grain, every day 3 times.By clinical trial, capsule of the present invention has extraordinary analgesic effect to central pain, inflammatory pain.Through pharmacological effect test prove, this capsule analgesic effect median dose reaches dolantin level, and without self additive and drug dependence.
By showing with the pharmacological effect controlled trial of FUFANG KUSHEN ZHUSHEYE, for bone cancer pain rat, capsule of the present invention presents obvious analgesic activity, significantly improve the burning pain threshold value of bone cancer pain rat and mechanical pain threshold, and FUFANG KUSHEN ZHUSHEYE treatment group does not see obvious analgesic effect.Illustrate that capsule of the present invention is for alleviating cancerous pain, analgesic effect is significantly better than existing injection, particularly outstanding to the analgesic effect of bone cancer pain.Contrast test data see the following form.
Table one, on the impact of bone cancer pain SD rat experiment burning pain threshold value
##P < 0.01, #P < 0.05vs sham operated rats, * P < 0.05vs model group
Table two, on the impact of bone cancer pain SD rat machinery pain threshold
##P < 0.01, #P < 0.05vs sham operated rats, * * P < 0.01, * P < 0.05vs model group
By repetition test, find: when Radix Sophorae Flavescentis be 70-170 part, Smilax lanceaefolia Roxb. Var.opaca A.DC. be 25-35 part time, Radix Sophorae Flavescentis, effect when Smilax lanceaefolia Roxb. Var.opaca A.DC. compositions analgesic effect is obviously better than other weight; When Radix Sophorae Flavescentis 70-150, Smilax lanceaefolia Roxb. Var.opaca A.DC. 30-35, analgesic effect is more obvious; When Radix Sophorae Flavescentis be 70 parts, Smilax lanceaefolia Roxb. Var.opaca A.DC. be 30 parts time, Radix Sophorae Flavescentis, Smilax lanceaefolia Roxb. Var.opaca A.DC. compositions analgesic effect are better; When Radix Sophorae Flavescentis be 75 parts, Smilax lanceaefolia Roxb. Var.opaca A.DC. be 30 parts time, Radix Sophorae Flavescentis, Smilax lanceaefolia Roxb. Var.opaca A.DC. compositions analgesic effect are best.Dosage form adopts capsule, easy to use, is particularly suited for patient with advanced cancer and uses.
Method of the present invention adopts acid solution merceration desmoenzyme cracking mode process raw material, at merceration, on the basis decocted, adopt a-amylase enzymolysis and natural clarifying agent clarification, active ingredient in parcel is fully decomposed, while raising medicinal liquid clarity, remain again active ingredient do not lose and do not change its structure, make to improve the retention rate mainly containing effective constituent in follow-up precipitate with ethanol process, improve total amount and the yield of matrine, thus improve content and the purity of wherein effective ingredient, improve the quality standard of this product, thus analgesic effect is better.
Method effective component extraction rate and the content comparison or purity of method of the present invention and prior art see the following form:
Extracting method Extraction ratio Content (purity) Character Yield
Tradition extraction method 70% 0.128mg/mg Dark-brown 6%
The inventive method 91% 0.182mg/mg Brown color 10%
Adopt method of the present invention can realize object of the present invention, the better potent Zhitong Jiaonang of analgesic effect can be prepared.
Detailed description of the invention
The following detailed description of the embodiment of the inventive method, but be not limited only to following examples.
Embodiment one
A. the Radix Sophorae Flavescentis of weight portion 75 and the Smilax lanceaefolia Roxb. Var.opaca A.DC. of 30 are ground into coarse powder;
B. will put in extraction pot through above-mentioned steps gained coarse powder, the concentration adding raw material weight 4 times is the hydrochloric acid solution of 0.3%, and soak at room temperature 48 hours, then filters, and collects soak;
C. the medicinal residues after above-mentioned steps process are added the water of 4 times of weight, 85 DEG C decoct 2 times, each 1 hour, filter, collect and merge decoction liquor;
D. above-mentioned steps gained soak and decoction liquor are merged, put in extraction pot, adjust pH value to be 7, be heated to 75 DEG C, then add the a-amylase of raw material weight 0.15%, enzyme activity is 50000u/g, enzymolysis 2 hours, and cooling leaves standstill, and extracts supernatant;
E. above-mentioned steps gained supernatant is heated to 75 DEG C, adds the natural clarifying agent of raw material weight 0.2%, react 0.5 hour, cooling, leave standstill, then extract supernatant;
F. above-mentioned steps gained supernatant 70 DEG C is evaporated to 800ml, then adds ethanol and make alcohol content reach 65%, hold over night, centrifugalize, then by decompression filtrate recycling ethanol, be concentrated into 800ml;
G. above-mentioned steps gained concentrated solution being added ethanol again makes alcohol content reach 75%, hold over night, centrifugalize, then by decompression filtrate recycling ethanol, be concentrated into 400ml;
H. by the cold drying of above-mentioned steps gained concentrated solution, add weight portion 1 part of magnesium stearate, be ground into fine powder, then make capsule.
Embodiment two
A. the Radix Sophorae Flavescentis of weight portion 150 and the Smilax lanceaefolia Roxb. Var.opaca A.DC. of 35 are ground into coarse powder;
B. will put in extraction pot through above-mentioned steps gained coarse powder, the concentration adding raw material weight 6 times is the hydrochloric acid solution of 0.8%, and soak at room temperature 50 hours, then filters, and collects soak;
C. the medicinal residues after above-mentioned steps process are added the water of 6 times of weight, 85 DEG C decoct 2 times, each 2.5 hours, filter, collect and merge decoction liquor;
D. above-mentioned steps gained soak and decoction liquor are merged, put in extraction pot, adjust pH value to be 5, be heated to 60 DEG C, then add the a-amylase of raw material weight 0.1%, enzyme activity is 50000u/g, enzymolysis 3 hours, and cooling leaves standstill, and extracts supernatant;
E. above-mentioned steps gained supernatant is heated to 80 DEG C, adds the natural clarifying agent of raw material weight 0.4%, react 1 hour, cooling, leave standstill, then extract supernatant;
F. above-mentioned steps gained supernatant 70 DEG C is evaporated to 600ml, then adds ethanol and make alcohol content reach 50%, hold over night, centrifugalize, then by decompression filtrate recycling ethanol, be concentrated into 600ml;
G. above-mentioned steps gained concentrated solution being added ethanol again makes alcohol content reach 90%, hold over night, centrifugalize, then by decompression filtrate recycling ethanol, be concentrated into 400ml;
H. by the cold drying of above-mentioned steps gained concentrated solution, add weight portion 2 parts of magnesium stearate, be ground into fine powder, then make capsule.
Embodiment three
A. the Radix Sophorae Flavescentis of weight portion 170 and the Smilax lanceaefolia Roxb. Var.opaca A.DC. of 25 are ground into coarse powder;
B. will put in extraction pot through above-mentioned steps gained coarse powder, the concentration adding raw material weight 8 times is the hydrochloric acid solution of 1.5%, and soak at room temperature 60 hours, then filters, and collects soak;
C. the medicinal residues after above-mentioned steps process are added the water of 8 times of weight, 85 DEG C decoct 3 times, each 0.5 hour, filter, collect and merge decoction liquor;
D. above-mentioned steps gained soak and decoction liquor are merged, put in extraction pot, adjust pH value to be 8, be heated to 80 DEG C, then add the a-amylase of raw material weight 0.5%, enzyme activity is 50000u/g, enzymolysis 1 hour, and cooling leaves standstill, and extracts supernatant;
E. above-mentioned steps gained supernatant is heated to 60 DEG C, adds the natural clarifying agent of raw material weight 0.6%, react 2 hours, cooling, leave standstill, then extract supernatant;
F. above-mentioned steps gained supernatant 70 DEG C is evaporated to 1400ml, then adds ethanol and make alcohol content reach 70%, hold over night, centrifugalize, then by decompression filtrate recycling ethanol, be concentrated into 400ml;
G. above-mentioned steps gained concentrated solution being added ethanol again makes alcohol content reach 60%, hold over night, centrifugalize, then by decompression filtrate recycling ethanol, be concentrated into 200ml;
H. by the cold drying of above-mentioned steps gained concentrated solution, add weight portion 6 parts of magnesium stearate, be ground into fine powder, then make capsule.

Claims (6)

1. a Zhitong Jiaonang, is characterized in that being prepared into capsule by the raw material of following weight portion: Radix Sophorae Flavescentis 70-170, Smilax lanceaefolia Roxb. Var.opaca A.DC. 25-35, adjuvant magnesium stearate 1-6.
2. Zhitong Jiaonang according to claim 1, is characterized in that: Radix Sophorae Flavescentis 70-150, Smilax lanceaefolia Roxb. Var.opaca A.DC. 30-35, adjuvant magnesium stearate 1-5.
3. Zhitong Jiaonang according to claim 1, is characterized in that: Radix Sophorae Flavescentis 75, Smilax lanceaefolia Roxb. Var.opaca A.DC. 30, adjuvant magnesium stearate 1.
4. Zhitong Jiaonang according to claim 1, is characterized in that: Radix Sophorae Flavescentis 70, Smilax lanceaefolia Roxb. Var.opaca A.DC. 30, adjuvant magnesium stearate 2.
5. prepare a method for Zhitong Jiaonang described in claim 1, it is characterized in that comprising the steps:
A. the Radix Sophorae Flavescentis of described weight portion and Smilax lanceaefolia Roxb. Var.opaca A.DC. are ground into coarse powder;
B. will put in extraction pot through above-mentioned steps gained coarse powder, adding raw material weight 4-8 concentration is doubly the hydrochloric acid solution of 0.3-1.5%, and soak at room temperature 40-60 hour, then filters, and collects soak;
C. the medicinal residues after above-mentioned steps process are added the water of 4-8 times of weight, 85 DEG C decoct 2-3 time, and each 0.5-2.5 hour filters, collects and merge decoction liquor;
D. above-mentioned steps gained soak and decoction liquor are merged, put in extraction pot, tune pH value is 5.0-8.0, is heated to 60-80 DEG C, then adds the a-amylase of raw material weight 0.1-0.5%, enzymolysis 1-3 hour, and cooling leaves standstill, and extracts supernatant;
E. above-mentioned steps gained supernatant is heated to 60-80 DEG C, adds the natural clarifying agent of raw material weight 0.2-0.6%, reaction 0.5-2 hour, cooling, leaves standstill, then extracts supernatant;
F. above-mentioned steps gained supernatant 70 DEG C is evaporated to 600-1400ml, then adds ethanol and make alcohol content reach 50-70%, hold over night, centrifugalize, then by decompression filtrate recycling ethanol, be concentrated into 400-800ml;
G. above-mentioned steps gained concentrated solution being added ethanol again makes alcohol content reach 60-90%, hold over night, centrifugalize, then by decompression filtrate recycling ethanol, be concentrated into 200-400ml;
H. by the cold drying of above-mentioned steps gained concentrated solution, add the magnesium stearate of described weight portion, be ground into fine powder, then make capsule.
6. the preparation method of Zhitong Jiaonang according to claim 5, is characterized in that: the diastatic enzyme activity of described a-is 50000u/g.
CN201410609436.0A 2014-11-04 2014-11-04 Traditional Chinese medicine pain-relieving capsule and preparation method thereof Pending CN104352477A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105362335A (en) * 2015-11-16 2016-03-02 湖南利诺生物药业有限公司 Pharmaceutical composition for suppressing pain and preparation method thereof
CN106540045A (en) * 2016-11-30 2017-03-29 四川旭华制药有限公司 A kind of Chinese medicine analgesic composition

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CN1698833A (en) * 2005-06-13 2005-11-23 北京正大绿洲医药科技有限公司 Compound drop pills with flavescent sophora root and its preparation method
CN1803243A (en) * 2005-12-01 2006-07-19 谭登平 Method for quickening filter of starch type traditional Chinese medicine extracting solution
CN101322817A (en) * 2008-05-16 2008-12-17 北京正大绿洲医药科技有限公司 Compound flavescent sophora root sustained-release dropping pill and preparation thereof
CN102038836A (en) * 2009-12-31 2011-05-04 北京振东光明药物研究院有限公司 New application of compound kuh-seng injection in preparation of medicaments for treating prostatitis diseases

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Publication number Priority date Publication date Assignee Title
CN1171960A (en) * 1997-07-16 1998-02-04 山西金晶药业有限公司 Compound sophora flavescens injection
CN1698833A (en) * 2005-06-13 2005-11-23 北京正大绿洲医药科技有限公司 Compound drop pills with flavescent sophora root and its preparation method
CN1803243A (en) * 2005-12-01 2006-07-19 谭登平 Method for quickening filter of starch type traditional Chinese medicine extracting solution
CN101322817A (en) * 2008-05-16 2008-12-17 北京正大绿洲医药科技有限公司 Compound flavescent sophora root sustained-release dropping pill and preparation thereof
CN102038836A (en) * 2009-12-31 2011-05-04 北京振东光明药物研究院有限公司 New application of compound kuh-seng injection in preparation of medicaments for treating prostatitis diseases

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105362335A (en) * 2015-11-16 2016-03-02 湖南利诺生物药业有限公司 Pharmaceutical composition for suppressing pain and preparation method thereof
CN106540045A (en) * 2016-11-30 2017-03-29 四川旭华制药有限公司 A kind of Chinese medicine analgesic composition

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Application publication date: 20150218