CN1349818A - Effective part group in red sage mixture and its delayed release prepn. medicinal use and prepn process - Google Patents
Effective part group in red sage mixture and its delayed release prepn. medicinal use and prepn process Download PDFInfo
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- CN1349818A CN1349818A CN 01133333 CN01133333A CN1349818A CN 1349818 A CN1349818 A CN 1349818A CN 01133333 CN01133333 CN 01133333 CN 01133333 A CN01133333 A CN 01133333A CN 1349818 A CN1349818 A CN 1349818A
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Abstract
The present invention relates to a compound salvia active component group and its slow-release preparation, medicinal application and preparation method. It features convenient administration and good stability. Said invention contains salvia active component (salvia total phenolic acid content is above 50%), notoginseng active component (notoginseng total saponin content is above 50%) and natural (or artifiical) borneol and its cyclodextrin inclusion. It can be made into various slow-release preparations, and is obtained by using water or pure water to make extraction, dissolving in water, removing impurity by using water to wash and recovering and drying. It can be used for making medicine for curing angiocardiopathy and cerebrovascular diseases.
Description
Technical field:
The present invention relates to medical technical field, exactly it is a kind of effective part group in red sage mixture and slow releasing preparation and medical usage and preparation method of expecting to have as the medical usage of medicament against cardiovascular disease.
Background technology:
" compound Salviae Miltiorrhizae " preparation is made up of Radix Salviae Miltiorrhizae, Radix Notoginseng, Borneolum Syntheticum three herbal medicines, medicine as the treatment cardiovascular disease, have clinically widely and use, has clinical application basis widely, and it is evident in efficacy, but there is shortcomings such as taking inconvenience (take often, easily produce and miss, forget to obey phenomenon), poor stability in such medicine.
Summary of the invention:
The invention provides a kind of effective part group in red sage mixture and slow releasing preparation thereof and medical usage and preparation method.Wherein slow releasing preparation comprises oral sustained release, controlled release forms such as sustained release coating pellet, sustained-release matrix tablet, slow release pulse release tablet, slow release osmotic tablet, sustained release coating tablet.Wherein the sustained release coating technology of Ying Yonging comprise pH dependent sustained release packaging technique, corrosion postpone packaging technique, based on colonic enzyme degraded sustained release coating technology etc.The invention is characterized in " compound Salviae Miltiorrhizae " made oral slow releasing preparation, thereby improve the phenomenon that it takes inconvenience that avoids medicine misses, forgets clothes, better guarantees the clinical practice curative effect of medicine.
The medical usage that above-mentioned compound red sage root extended release formulation is provided is to be used for the treatment of and to prevent cardiovascular and cerebrovascular disease.
The preparation method of above-mentioned compound red sage root extended release formulation is provided, comprising:
A: active component of red sage root (Radix Salviae Miltiorrhizae total phenolic acids content is more than 50%) preparation method is characterized in that: water (or pure water extraction of arbitrary proportion), extracting solution concentrate (or not concentrating), alcohol precipitation (or omitting), supernatant eliminates alcohol, behind the water dissolution, and row polyamide (or anion exchange resin, or macroporous resin) column chromatography, after water elution is removed impurity, reuse alcohol eluting, to the effective ingredient eluting fully till, reclaim alcohol eluen, be drying to obtain.Wherein used pure probability be methanol, ethanol, propanol, butanols, ethylene glycol, carbochain less than 32 alkanols, carbochain less than 32 rare alcohol and phenol etc.Wherein the big pore resin comprises various nonpolar, low poles, Semi-polarity, polar homemade or import macroporous adsorbent resin.
B: Sanchi effective-component (content of the total saponins in radix notoginseng is more than 50%) preparation method, it is characterized in that: water (or pure water extraction of arbitrary proportion), extracting solution concentrate (or not concentrating), alcohol precipitation (or omitting), supernatant eliminates alcohol, behind the water dissolution, row polyamide (or macroporous resin) column chromatography is after water elution is removed impurity, reuse alcohol eluting, to the effective ingredient eluting fully till, reclaim alcohol eluen, be drying to obtain.Wherein institute's alcohol can be methanol, ethanol, propanol, butanols, ethylene glycol, carbochain less than 32 alkanols, carbochain less than 32 rare alcohol and phenol etc.Wherein the big pore resin comprises various nonpolar, low poles, Semi-polarity, polar homemade or import macroporous adsorbent resin.
C: the preparation method of cyclodextrin inclusion compound Borneolum Syntheticum is characterized in that: Borneolum Syntheticum is dissolved in alcohol, the acetone organic solvent, adds 0.01-100: 1 cyclodextrin behind the recovery solvent, is drying to obtain.
D: the preparation method of compound red sage root extended release coated micropill is characterized in that: on the basis of conventional medicine micropill, adopt the sustained release film coat technology, prepare the micropill of different release times, reach once and take, keep the purpose of blood drug level for a long time.Wherein use the sustained release coating technology comprise pH dependent sustained release packaging technique, " time dependence " packaging technique, corrosion postpone packaging technique, based on colonic enzyme degraded sustained release coating technology etc.
E: the preparation method of other Salvia Miltiorrhiza delayed-release preparations is characterized in that: based on the slow releasing tablet of bulk erosion principle, contain the film coating slow releasing tablet of the pulse release sheet heart, based on the slow releasing tablet of the coated tablet of osmotic pump principle.Wherein the sustained release coating of Ying Yonging comprise pH dependent sustained release packaging technique, corrosion postpone packaging technique, based on colonic enzyme degraded sustained release coating technology etc.
Both at home and abroad " " effective part group of preparation and slow releasing preparation thereof, medical usage and preparation method are not seen bibliographical information to compound Salviae Miltiorrhizae to compound Salviae Miltiorrhizae " preparation is widely used in having and prevents and treat cardiovascular disease, but to " to report as yet.We investigate its protection cardiovascular disease effect.The result shows that effective part group in red sage mixture has significant blood vessel dilating effect, anti-thrombosis function, blood coagulation resisting function, antiplatelet aggregation, microcirculation improvement effect, effects such as anti-oxidative damage.Its pharmacodynamics characteristics are: 1) effective site is clear and definite, acts on extremely strongly, and total effective parts people's every day consumption only is 30～60mg; 2) pharmacodynamic action is remarkable, and each result of the test all can repeat; 3) consistently with document pharmacodynamic study result illustrate that we have accurately found the effective part group of this Chinese medicine compound.
Characteristics of the present invention have provided can expect to be used for the treatment of and to prevent the effective part group of the medical usage of cardiovascular and cerebrovascular disease, and is made into slow release formulation, has the effect of very strong treatment and prevention cardiovascular and cerebrovascular disease and takes characteristics easily.Use extracting method of the present invention, the impurity such as a large amount of albumen, saccharide, starch that can be removed get high-purity active component of red sage root (Radix Salviae Miltiorrhizae total phenolic acids content is more than 50%) and Sanchi effective-component (content of the total saponins in radix notoginseng is more than 50%).Use preparation method of the present invention, can get the compound red sage root preparation of slow release, controlled release.
Description of drawings:
Fig. 1 is preparation technology's flow chart of compound red sage root extended release coated micropill of the present invention
The specific embodiment:
Following examples are represented practicality of the present invention, and the present invention is not limited.
Embodiment 1:
The preparation of active component of red sage root: get red rooted salvia and be ground into coarse powder, add the water of 10 times of medical material weight, in 80 ℃ of heating extraction 2 times, each 1.5 hours, filter, merge secondary raffinate, be quickly cooled to room temperature after.According to upper prop sample (amounting to medical material) amount and wet resin amount (1: 15/W: ratio V), the row polyamide absorption column chromatography, water is with 1-2ml/cm
210 bed volumes of the flow velocity eluting of/min continue with 60% ethanol 1-2ml/cm
210 bed volumes of the flow velocity eluting of/min, 60% ethanol elution partly is Radix Salviae Miltiorrhizae total phenolic acids effective site, and 70 ℃ of left and right sides decompression and solvent recoveries are the fluid extract of 1.09-1.11 to proportion.With above-mentioned Radix Salviae Miltiorrhizae total phenolic acids fluid extract, in 80 ℃ of reduced vacuum dryings, pulverize, promptly get pale brown color Radix Salviae Miltiorrhizae total phenolic acids finished product, yield is no less than 0.4%.
Embodiment 2:
The preparation of Sanchi effective-component
Get pseudo-ginseng and be ground into coarse powder, add 70% ethanol of 10 times of medical material weight, reflux, extract, 2 times, each 2.5 hours, filter, merge secondary raffinate, 70 ℃ of left and right sides decompression and solvent recoveries are the fluid extract of 1.10-1.12 to proportion.Be diluted with water to 1: 1 concentration (amounting to medical material g/ml), according to upper prop sample (amounting to medical material) amount and wet resin amount (1: 15/W: ratio V), row macroporous resin HPD100 adsorpting column chromatogram, water is with 1-2ml/cm
210 bed volumes of the flow velocity eluting of/min continue with 90% ethanol-2ml/cm
210 bed volumes of the flow velocity eluting of/min, continuing partly is the Radix Notoginseng total arasaponins crude product with 90% ethanol elution, subtract about 70 ℃ and reclaim very much solvent, to 1: 1 concentration (amounting to medical material g/ml) solution.In above-mentioned Radix Notoginseng total arasaponins solution, add the MgO of 8% (g/ amounts to medical material g)
2: Al
2O
3(1: 1) decolouring is filtered, and filtrate is pulverized in 80 ℃ of reduced vacuum dryings, promptly gets faint yellow Radix Notoginseng total arasaponins finished product, and yield is no less than 4.0%.
Embodiment 3:
The preparation of Borneolum Syntheticum cyclodextrin clathrate
Borneolum Syntheticum is dissolved in the ethanol, adds 1: 15 cyclodextrin, behind the recovery solvent, be drying to obtain.
Embodiment 4:
The preparation of compound red sage root extended release coated micropill
Wherein: ball heart prescription:
Active component of red sage root 5mg
Sanchi effective-component 5mg
Borneolum Syntheticum cyclodextrin clathrate 150mg
Sodium chloride 8mg
Carboxymethyl starch sodium 25mg
Lactose 42mg
Coating fluid prescription 1 (every 100ml consumption):
Ethyl cellulose 3g
PEG400 2g
Diethyl phthalate 0.6g
Ethanol is to 100ml coating fluid prescription 2 (every 100ml consumption):
Ethyl cellulose 3g
PEG400 1.3g
Diethyl phthalate 0.6g
Ethanol is to 100ml coating fluid prescription 3 (every 100ml consumption):
Ethyl cellulose 3g
PEG400 0.3g
Diethyl phthalate 0.6g
Ethanol is to 100ml
Claims (5)
1, effective part group in red sage mixture and slow releasing preparation thereof and medical usage and preparation method, it is characterized in that: the active component of red sage root of arbitrary proportion, Radix Salviae Miltiorrhizae total phenolic acids content more than 50%, Sanchi effective-component, content of the total saponins in radix notoginseng are more than 50% and natural or artificial Borneolum Syntheticum and cyclodextrin clathrate thereof.
2, effective part group in red sage mixture according to claim 1 and slow releasing preparation thereof and medical usage and preparation method is characterized in that: the slow releasing preparation of effective part group in red sage mixture comprises oral sustained release, controlled release forms such as sustained release coating pellet, sustained-release matrix tablet, slow release pulse release tablet, slow release osmotic tablet, sustained release coating tablet.
3, effective part group in red sage mixture according to claim 2 and slow releasing preparation thereof and medical usage and preparation method is characterized in that: the sustained release coating technology that slow releasing preparation is used comprise pH dependent sustained release packaging technique, corrosion postpone packaging technique, based on colonic enzyme degraded sustained release coating technology.
4, the medical usage of effective part group in red sage mixture and slow releasing preparation thereof is characterized in that: the application in preparation, treatment and prevention cardiovascular and cerebrovascular disease of effective part group in red sage mixture and slow releasing preparation thereof.
5, the preparation method of effective part group in red sage mixture and slow releasing preparation thereof is characterized in that:
A: active component of red sage root Radix Salviae Miltiorrhizae total phenolic acids content 50% above preparation method, it is characterized in that: the pure water extraction of water or arbitrary proportion, extracting solution concentrates or does not concentrate, alcohol precipitates or omits, supernatant eliminates alcohol, behind the water dissolution, row polyamide or anion exchange resin, or macroporous resin column chromatography, after water elution is removed impurity, reuse alcohol eluting, to the effective ingredient eluting fully till, reclaim alcohol eluen, be drying to obtain, wherein used pure probability is a methanol, ethanol, propanol, butanols, ethylene glycol, carbochain is less than 32 alkanols, carbochain is less than 32 rare alcohol and phenol, and wherein the big pore resin comprises various nonpolar, low pole, Semi-polarity, polar homemade or import macroporous adsorbent resin;
B: Sanchi effective-component content of the total saponins in radix notoginseng 50% above preparation method, it is characterized in that: the pure water extraction of water or arbitrary proportion, extracting solution concentrates or does not concentrate, alcohol precipitates or omits, supernatant eliminates alcohol, behind the water dissolution, row polyamide or macroporous resin column chromatography, after water elution is removed impurity, reuse alcohol eluting, to the effective ingredient eluting fully till, reclaim alcohol eluen, be drying to obtain, wherein institute's alcohol can be methanol, ethanol, propanol, butanols, ethylene glycol, carbochain is less than 32 alkanols, carbochain is less than 32 rare alcohol and phenol, and wherein the big pore resin comprises various nonpolar, low pole, Semi-polarity, polar homemade or import macroporous adsorbent resin;
C: the preparation method of cyclodextrin inclusion compound Borneolum Syntheticum is characterized in that: Borneolum Syntheticum is dissolved in alcohol, the acetone organic solvent, adds 0.01-100: 1 cyclodextrin behind the recovery solvent, is drying to obtain.
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| CN 01133333 CN1349818A (en) | 2001-10-24 | 2001-10-24 | Effective part group in red sage mixture and its delayed release prepn. medicinal use and prepn process |
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| CN1294927C (en) * | 2004-08-19 | 2007-01-17 | 文山壮族苗族自治州三七科学技术研究所 | Liver disease treating medicine |
| CN1296063C (en) * | 2002-12-23 | 2007-01-24 | 北京采瑞医药有限公司 | Compound red sage prepn for treating cardiac and cerebral vascular diseases and its prepn process |
| CN1297279C (en) * | 2004-07-28 | 2007-01-31 | 广东天之骄生命科技有限公司 | Medicinal composition containing danshensu, total ara-saponin and camphol and its preparation and use |
| CN1297278C (en) * | 2004-07-28 | 2007-01-31 | 广东天之骄生命科技有限公司 | Medicinal composition containing salvianolic acid B, total ara-saponin and camphol and its preparation and use |
| CN1303980C (en) * | 2004-08-13 | 2007-03-14 | 王明学 | Orally quick releasing tablet of compound red sage root, its medical uses and preparation process |
| CN1309397C (en) * | 2002-12-23 | 2007-04-11 | 北京采瑞医药有限公司 | Compound red sage capsule for treating cardiac and cerebral vascular diseases and its prepn process |
| CN100339085C (en) * | 2003-09-23 | 2007-09-26 | 天津天士力制药股份有限公司 | Combination of Chinese traditional medicine for curing cardiovascular and cerebrovascular diseases |
| CN100404035C (en) * | 2003-09-23 | 2008-07-23 | 天津天士力制药股份有限公司 | Combination of Chinese traditional medicine for curing cardiovascular diseases and cerebrovascular disease |
| CN100417387C (en) * | 2004-06-17 | 2008-09-10 | 秦引林 | Compound injection formulation compose dof borneol and pseudo-ginseng total saponin and its preparing method |
| CN100418534C (en) * | 2002-12-19 | 2008-09-17 | 上海博泰医药科技有限公司 | Traditional Chinese medicine active part compound preparation for curing cardiac and cerebral vascular diseases and its preparing method |
| CN100421683C (en) * | 2002-12-31 | 2008-10-01 | 北京采瑞医药有限公司 | Composite red sage root micro-capsules for cardio-cerebral diseases and its preparing method |
| CN1785253B (en) * | 2004-12-10 | 2010-04-28 | 天津天士力制药股份有限公司 | Micro-balls of compound red-rooted salvia injection, and its preparation method |
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| CN101214275B (en) * | 2005-10-27 | 2011-07-27 | 广东药学院 | Compound red sage root extended release formulation and preparation thereof |
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| CN100418534C (en) * | 2002-12-19 | 2008-09-17 | 上海博泰医药科技有限公司 | Traditional Chinese medicine active part compound preparation for curing cardiac and cerebral vascular diseases and its preparing method |
| CN1309397C (en) * | 2002-12-23 | 2007-04-11 | 北京采瑞医药有限公司 | Compound red sage capsule for treating cardiac and cerebral vascular diseases and its prepn process |
| CN1296063C (en) * | 2002-12-23 | 2007-01-24 | 北京采瑞医药有限公司 | Compound red sage prepn for treating cardiac and cerebral vascular diseases and its prepn process |
| CN100421683C (en) * | 2002-12-31 | 2008-10-01 | 北京采瑞医药有限公司 | Composite red sage root micro-capsules for cardio-cerebral diseases and its preparing method |
| CN100339085C (en) * | 2003-09-23 | 2007-09-26 | 天津天士力制药股份有限公司 | Combination of Chinese traditional medicine for curing cardiovascular and cerebrovascular diseases |
| CN100404035C (en) * | 2003-09-23 | 2008-07-23 | 天津天士力制药股份有限公司 | Combination of Chinese traditional medicine for curing cardiovascular diseases and cerebrovascular disease |
| CN100417387C (en) * | 2004-06-17 | 2008-09-10 | 秦引林 | Compound injection formulation compose dof borneol and pseudo-ginseng total saponin and its preparing method |
| CN1297278C (en) * | 2004-07-28 | 2007-01-31 | 广东天之骄生命科技有限公司 | Medicinal composition containing salvianolic acid B, total ara-saponin and camphol and its preparation and use |
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| CN1303980C (en) * | 2004-08-13 | 2007-03-14 | 王明学 | Orally quick releasing tablet of compound red sage root, its medical uses and preparation process |
| CN1294927C (en) * | 2004-08-19 | 2007-01-17 | 文山壮族苗族自治州三七科学技术研究所 | Liver disease treating medicine |
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| CN1919241B (en) * | 2005-08-24 | 2011-06-08 | 天津天士力制药股份有限公司 | Chinese medicinal preparation for treating cardiovascular and cerebrovascular disease |
| CN1919244B (en) * | 2005-08-24 | 2011-04-27 | 天津天士力制药股份有限公司 | Chinese traditional medicine for treating cardiovascular disease |
| CN101214275B (en) * | 2005-10-27 | 2011-07-27 | 广东药学院 | Compound red sage root extended release formulation and preparation thereof |
| CN101073598B (en) * | 2006-05-17 | 2012-05-30 | 天津药物研究院 | Medicinal composition for treating cardiovascular and cerebrovascular disease and its preparation |
| CN101744879A (en) * | 2008-12-05 | 2010-06-23 | 天津天士力之骄药业有限公司 | Method for decoloring salvia-soluble extract |
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| CN103127221A (en) * | 2013-02-01 | 2013-06-05 | 中国中医科学院广安门医院 | Multicomponent simultaneous equilibrium drug release long-term preparation |
| CN103127221B (en) * | 2013-02-01 | 2014-09-03 | 中国中医科学院广安门医院 | Multicomponent simultaneous equilibrium drug release long-term preparation |
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