CN101732409B - Salvia miltiorrhiza soft capsule and preparation method thereof - Google Patents
Salvia miltiorrhiza soft capsule and preparation method thereof Download PDFInfo
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- CN101732409B CN101732409B CN2010101110496A CN201010111049A CN101732409B CN 101732409 B CN101732409 B CN 101732409B CN 2010101110496 A CN2010101110496 A CN 2010101110496A CN 201010111049 A CN201010111049 A CN 201010111049A CN 101732409 B CN101732409 B CN 101732409B
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- 238000002360 preparation method Methods 0.000 title claims abstract description 31
- 241000304195 Salvia miltiorrhiza Species 0.000 title claims abstract 10
- 239000007788 liquid Substances 0.000 claims abstract description 37
- 239000000284 extract Substances 0.000 claims abstract description 25
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims abstract description 24
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract description 23
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Abstract
The invention provides a salvia miltiorrhiza soft capsule and a preparation method thereof. The salvia miltiorrhiza soft capsule is prepared from salvia miltiorrhiza extract, polyethylene glycol 400, glycerin, propylene glycol, sodium pyrosulfite, sorbitol and polyethylene glycol 600. The invention aims at the disadvantageous procedures in the conventional salvia miltioorrhiza extraction process, a large number of tests are carried out aiming at overcoming the influence of light and heat on the unstable effective ingredients, thereby avoiding the great loss of the effective ingredients and finally realizing the novel process for preparing medicine liquid by using the salvia miltiorrhiza extract to directly mix with appropriate auxiliary material to obtain the novel salvia miltiorrhiza soft capsule with high effective ingredient content, fast effectiveness and good stability; and meanwhile, the energy consumption during production is reduced, and enormous social benefit is brought.
Description
Technical field
The present invention relates to medical technical field, exactly relate to a kind of salvia miltiorrhiza soft capsule and preparation method thereof.
Background technology
Radix Salviae Miltiorrhizae is the dry root and rhizome of dicotyledon Labiatae.Hardship is slightly cold, GUIXIN, Liver Channel.The root master contains diterpene quinones pigment, TANSHINONES (tanshinone) II A, cryptotanshinone (cryptotanshinone), iso tanshinone (isotanshinones), different cryptotanshinone (lsocryptotanshinone), miltirone (miltirone), Methyl tanshinoate (methyl tanshinonate), hydroxyl Tanshinone I I A (hydroxytanshinone) etc.Except that diterpene quinone, still contain protocatechualdehyde (protocatechuic aldehyde), cupreol and D (+) β-(3,4 one dihydroxy phenyl) lactic acid (being danshensu, saivianic acid A), and the carboxylic acid compound that contracts (salvianolic acids) A, E etc.Salvianolic acid B is that three molecule danshensus and the condensation of a part caffeic acid form, and is one of more salvianolic acid of research at present, and organs such as the heart, brain, liver, kidney are all had the valuable pharmacological effect.
The pharmacological action of Radix Salviae Miltiorrhizae mainly contains following several respects:
(1) effect of cardiovascular system
1. heart tonifying is strengthened myocardial contraction, is improved cardiac function, does not increase myocardial oxygen consumption
2. to the blood vessel function coronary artery dilating, increase myocardial flow; The expansion peripheral blood vessel, blood flow increases; Cerebral blood flow descends
3. antithrombotic forms and improves plasmin activity; Prolong, clotting time; Anticoagulant (it is synthetic to improve the interior cAMP level inhibition of platelet TXA2); Improve hemorheological properties (blood viscosity reduction, erythrocyte electrophoretic time shorten)
4. microcirculation improvement
(2) reparation and the regeneration of promotion tissue
1. promote the reparation and the treatment of regeneration red sage formulation of tissue: necrotic myocardium is removed fast; Fibroblast differentiation, collagen fiber form more obvious; Granulation forms comparative maturity.Local congestion alleviates, blood circulation improves, and healing time shortens.
2. suppress hyperplasia the fibroblast of hyperplasia is had inhibitory action.
(3) protect the liver and improve the liver microcirculation.
(4) contain cryptotanshinone, dihydrotanshinone in the antibiotic red sage formulation, external staphylococcus, escherichia coli, degeneration bacillus are had inhibitory action.
Radix Salviae Miltiorrhizae Tabellae comes out for many years, is used for clinical treatment, determined curative effect, and blood circulation promoting and blood stasis dispelling is used for the thoracic obstruction due to the blood stasis impatency, and disease sees that chest pain, sore spot are fixed, purplish tongue; Angina pectoris is seen above-mentioned patient, and still, tablet exists effective ingredient solution to go out slowly the problem of defectives such as onset in time.
Chinese patent application number: 200410155513.6 disclose a kind of salvia miltiorrhiza soft capsule and preparation technology thereof, and it is to be wrapped in Radix Salviae Miltiorrhizae extract and proper quantity of medicinal auxiliary material constitution content thing to make soft capsule in the soft capsule shell.Though its dosage is reasonable, and is rapid-action, preparation method technology is simple, and is easy to use, in its drying in leaching process, the pulverizing process, and the temperature height, the time is long, and energy resource consumption is big, and effective ingredient is destroyed.
China Patent No.: 02111976.7 discloses the patent of invention that a kind of name is called " a kind of FUFANG DANSHEN JIAONANG and preparation method ".It is Radix Salviae Miltiorrhizae, Radix Notoginseng and Borneolum Syntheticum to be combined and hard capsule or the soft capsule made.But wherein the active component extract mixes acquisition by Radix Salviae Miltiorrhizae, Radix Notoginseng with Borneolum Syntheticum after co_2 supercritical fluid extraction separates, though there is not exsiccant operating procedure, but its production process is to the equipment requirements height, and the working condition limitation is big, unfavorable factors such as energy cost height.
In sum, but exist some problems in the preparation of red sage formulation, as follows:
1, in the leaching process of red sage formulation, puies forward two steps, extract the back and reclaim ethanol, concentrated, dry, make extractum through alcohol extraction, water.The temperature required height of receipts cream drying process in said process, the time is long, and in the medical material some are destroyed light, heat-labile composition, causes the loss of active ingredients in the medical material.In receiving cream and dry run, there is part coking phenomenon simultaneously.
2, in the said extracted process, especially operation such as drying is many, long flow path, and production efficiency is low, and energy resource consumption is big.
3, be that the Radix Salviae Miltiorrhizae Injection, Radix Salviae Miltiorrhizae Tabellae, capsule of red sage root of main component produced by administrative department of public health's approval with the Radix Salviae Miltiorrhizae, but injection carries, administration is all inconvenient; Tablet, capsule exist effective ingredient solution to go out slowly defectives such as onset in time.
4, now Chinese medicinal soft capsule is used more and morely, and the composition of the volatility of Chinese medicine, photo-labile, bad smell was all got good improvement.But also having an important problem now, is exactly its poor stability, and the disintegrate of placing soft capsule of a specified duration is defective, therefore, and problem such as salvia miltiorrhiza soft capsule also exists stability bad, and effect duration is short.
In research process of the present invention, the main difficult problem of solution: be prepared into soft capsule in order to realize Radix Salviae Miltiorrhizae extract, carried out a large amount of tests at the unfavorable operation that exists in the existing Radix Salviae Miltiorrhizae extraction process.On the one hand, the softgel shell of soft capsule has determined that the used diluent of medicinal liquid can not be water, ethanol and the bigger organic solvent of some toxicity, and ideal is that oil substances becomes liquid or suspension with drug regimen; On the other hand, active ingredient in long dry run, is added crushing process to light, thermally labile in the Radix Salviae Miltiorrhizae, causes the loss of active ingredients in the medical material.Finally realized with Radix Salviae Miltiorrhizae extract directly and appropriate amount of auxiliary materials be mixed with the new technology of content medicinal liquid.
Technical problem to be solved by this invention is to overcome the weak point that exists in the existing manufacturing technique, obtain a kind of new salvia miltiorrhiza soft capsule of effective component content height, rapid-action, good stability, and the energy resource consumption in the reduction production process, bring the huge social benefit.
Summary of the invention
The invention provides a kind of salvia miltiorrhiza soft capsule, it is characterized in that this salvia miltiorrhiza soft capsule made by Radix Salviae Miltiorrhizae extract, PEG400, glycerol, propylene glycol, sodium pyrosulfite, sorbitol, polyethylene glycol 6000, the weight ratio of Radix Salviae Miltiorrhizae extract and PEG400, glycerol, propylene glycol, sodium pyrosulfite, sorbitol, polyethylene glycol 6000 is 19: 76: 5: 0.00001: 0.000006: 0.000004: 0.00012.
Another object of the present invention provides the preparation method of above-mentioned a kind of salvia miltiorrhiza soft capsule, and this method comprises the following steps:
(1) preparation of Radix Salviae Miltiorrhizae extract
Get Radix Salviae Miltiorrhizae 1000g, add 90% ethanol 4000ml and refluxed 1.5 hours, filter, filtrate recycling ethanol is to an amount of; Medicinal residues add water an amount of (for example 4000ml) and decocted 1 hour, filter, filtrate and the merging of above-mentioned thick paste, concentrating under reduced pressure, to relative density be 1.2-1.30 (40 ℃), promptly get Radix Salviae Miltiorrhizae extract 95g, standby.
(2) preparation of auxiliary material liquid
Taking polyethylene glycol 400 380g, glycerol 25g, propylene glycol 0.00005g, sodium pyrosulfite 0.00003g, sorbitol 0.00002g, polyethylene glycol 6000 0.00006g mixing promptly get auxiliary material liquid in addition, and be standby.
(3) preparation of contents mixed liquid
With Radix Salviae Miltiorrhizae extract and auxiliary material liquid mix homogeneously, promptly get contents mixed liquid.
(4) preparation of soft capsule
With the contents mixed liquid for preparing, pour in the medicinal liquid bucket,, adopt soft capsule maker compacting soft capsule with the gelatin solution (for example can be added with opacifier and pigment) that has prepared, the soft capsule that fill becomes is inserted in the dry rotating cage of rustless steel, dry setting, lamp inspection selects ball, polishing, remove underproof soft capsule, packing is made 1000 (every loading amount 0.5g, every contains Tanshinone I I A is that 0.8-0.2mg, salvianolic acid B are 18-11mg) after quality inspection is qualified.
The specific embodiment:
Embodiment 1:
The preparation technology of above embodiment salvia miltiorrhiza soft capsule is:
(1) preparation of Radix Salviae Miltiorrhizae extract
Get Radix Salviae Miltiorrhizae 10000g, add 90% ethanol 35000ml and refluxed 1.5 hours, filter, filtrate recycling ethanol is to an amount of; Medicinal residues add water 45000ml and decocted 1 hour, filter, filtrate and the merging of above-mentioned thick paste, concentrating under reduced pressure, to relative density be 1.2-1.30 (40 ℃), promptly get Radix Salviae Miltiorrhizae extract 950g, standby.
(2) preparation of auxiliary material liquid
Taking polyethylene glycol 400 3800g, glycerol 250g, propylene glycol 0.0005g, sodium pyrosulfite 0.0003g, sorbitol 0.0002g, polyethylene glycol 6000 0.0006g mixing promptly get auxiliary material liquid in addition, and be standby.
(3) preparation of contents mixed liquid
With Radix Salviae Miltiorrhizae extract and auxiliary material liquid mix homogeneously, promptly get contents mixed liquid.
(4) preparation of soft capsule
With the contents mixed liquid for preparing, pour in the medicinal liquid bucket, with the gelatin solution that has prepared (for example can be added with opacifier and pigment), adopt soft capsule maker compacting soft capsule, the soft capsule that fill becomes is inserted in the dry rotating cage of rustless steel, dry setting, lamp inspection selects ball, and underproof soft capsule is removed in polishing, packing is made 10000 (every loading amount 0.5g) after quality inspection is qualified.
Containing Tanshinone I I A through every of salvia miltiorrhiza soft capsule of check is that 0.42mg, salvianolic acid B are 13.5mg.
Embodiment 2:
The preparation technology of above embodiment salvia miltiorrhiza soft capsule is:
(1) preparation of Radix Salviae Miltiorrhizae extract
Get Radix Salviae Miltiorrhizae 10000g, add 90% ethanol 40000ml and refluxed 1.5 hours, filter, filtrate recycling ethanol is to an amount of; Medicinal residues add water 40000ml and decocted 1 hour, filter, filtrate and the merging of above-mentioned thick paste, concentrating under reduced pressure, to relative density be 1.2-1.30 (40 ℃), promptly get Radix Salviae Miltiorrhizae extract 950g, standby.
(2) preparation of auxiliary material liquid
Taking polyethylene glycol 400 3800g, glycerol 250g, propylene glycol 0.0005g, sodium pyrosulfite 0.0003g, sorbitol 0.0002g, polyethylene glycol 6000 0.0006g mixing promptly get auxiliary material liquid in addition, and be standby.
(3) preparation of contents mixed liquid
With Radix Salviae Miltiorrhizae extract and auxiliary material liquid mix homogeneously, promptly get contents mixed liquid.
(4) preparation of soft capsule
With the contents mixed liquid for preparing, pour in the medicinal liquid bucket, with the gelatin solution that has prepared (for example can be added with opacifier and pigment), adopt soft capsule maker compacting soft capsule, the soft capsule that fill becomes is inserted in the dry rotating cage of rustless steel, dry setting, lamp inspection selects ball, and underproof soft capsule is removed in polishing, packing is made 10000 (every loading amount 0.5g) after quality inspection is qualified.
Containing Tanshinone I I A through every of salvia miltiorrhiza soft capsule of check is that 0.45mg, salvianolic acid B are 12.5mg.
The remarkable advantage that salvia miltiorrhiza soft capsule of the present invention has: (the novel salvia miltiorrhiza soft capsule that the present invention provides is compared with the salvia miltiorrhiza soft capsule of prior art)
The salvia miltiorrhiza soft capsule of prior art number is that embodiment 1 in 200410155513.6 is an example with publication, is described below: 5 parts of medicines; 2.79 parts of PEG400s; 0.1 part of polyethylene glycol 6000; 0.05 part of citric acid; 0.06 part of Tween 80; The preparation of substrate: taking polyethylene glycol 400 558g, add polyethylene glycol 6000 20g, citric acid 10g, Tween 80 12g, mix homogeneously gets soft capsule matrix 600g altogether.Preparation of soft capsule: get Radix Salviae Miltiorrhizae 1000g, add 90% alcohol reflux 1.5 hours, filter filtrate recycling ethanol; Medicinal residues decoct with water 1 hour, filter; Merge above-mentioned filtrate, be evaporated to an amount of after drying and pulverize, medicated powder and an amount of pharmaceutic adjuvant mixing are wrapped in and form soft capsule in the soft capsule shell, promptly.
The technical solution that the present invention provides is: get the 1000g red rooted salvia, break into coarse powder, add 90% alcohol reflux 1.5, filter, filtrate recycling ethanol is to an amount of; Medicinal residues decoct with water 1 hour, filter, and filtrate merges with above-mentioned alcohol extract, the continuation concentrating under reduced pressure, to relative density be 1.2-1.30 (40 ℃), promptly get Radix Salviae Miltiorrhizae extract, standby.Taking polyethylene glycol 400 380g, glycerol 25g, propylene glycol 0.00005g, sodium pyrosulfite 0.00003g, sorbitol 0.00002g, polyethylene glycol 6000 0.00006g mixing promptly get auxiliary material liquid in addition, and be standby.With Radix Salviae Miltiorrhizae extract and auxiliary material liquid mix homogeneously, promptly get contents mixed liquid.With the contents mixed liquid for preparing, pour in the medicinal liquid bucket, with the gelatin solution that has prepared (adding opacifier and pigment), adopt soft capsule maker compacting soft capsule, the soft capsule that fill becomes is inserted in the dry rotating cage of rustless steel, dry setting, lamp inspection selects ball, and underproof soft capsule is removed in polishing, packing after quality inspection is qualified, promptly.
Above two kinds of technical processs, improvements:
1, cancelled dry run.
2, the soft capsule of preparation good stability.
The benefit of bringing after the improvement is:
1, the destruction that not only can avoid high temperature to bring, avoided coking phenomenon in receiving cream and dry run simultaneously, effective ingredient in a large amount of as far as possible reservation medical materials, so be fit to extract, adopt such operating process can overcome the destruction of former extraction drying process to wet, heat, photosensitivity composition for wet, heat, photosensitivity medicine (Radix Salviae Miltiorrhizae of this preparation).And reduced operation, flow process is short, efficient is high, can reduce the energy, reduces cost, reduce to pollute.
2, salvia miltiorrhiza soft capsule of the present invention has avoided tablet, the stripping of capsule effective ingredient slow, defectives such as onset in time.Disclosed relatively Chinese medicinal soft capsule, especially salvia miltiorrhiza soft capsule have improved its stability greatly, have improved the effect duration of salvia miltiorrhiza soft capsule.Salvia miltiorrhiza soft capsule has good economic benefit and social benefit, and appearance and mouthfeel are good, and characteristics evident in efficacy more are applicable to clinical practice.
The result is as shown in the table.
Salvia miltiorrhiza soft capsule of the present invention and prior art salvia miltiorrhiza soft capsule related item comparison sheet
As above show the result as can be known, salvia miltiorrhiza soft capsule of the present invention has saved the operation of high temperature drying and pulverizing in extraction process, and the electric energy of consumption has only 10.2kwh, has saved the electric energy of 65.3kwh.Avoided this two procedures, the extract effective ingredient destroys few, and does not have pyrogenic part, so the effective ingredient ratio that Radix Salviae Miltiorrhizae goes out in the cream is bigger, therefore on 10% paste volume basis, can also obtain high-load tanshinone, with 30% paste volume of prior art quite or strong slightly.In addition; definite prescription of the present invention be through a large amount of experiment screenings come out can better preserved the content prescription of capsule skin; prevent that better the ' Yanming ' capsules for clearing skin is oxidized; improved its stability; placed 28 months through long-term investigation; its disintegration time is 46min, though the time is elongated, still be qualified (requirement is not more than 1 hour) its disintegration.The stability of prior art is just defective at 13 months.
Claims (2)
1. salvia miltiorrhiza soft capsule is characterized in that this salvia miltiorrhiza soft capsule is made by following method:
(1) preparation of Radix Salviae Miltiorrhizae extract
Get Radix Salviae Miltiorrhizae 1000g, add 90% alcohol reflux 1.5 hours, filter, filtrate recycling ethanol is to an amount of; Medicinal residues decoct with water 1 hour, filter, and filtrate and above-mentioned thick paste merge, concentrating under reduced pressure, and relative density is 1.2-1.30 during to 40 ℃, promptly gets Radix Salviae Miltiorrhizae extract, and is standby;
(2) preparation of auxiliary material liquid
Taking polyethylene glycol 400 380g, glycerol 25g, propylene glycol 0.00005g, sodium pyrosulfite 0.00003g, sorbitol 0.00002g, polyethylene glycol 6000 0.00006g mixing promptly get auxiliary material liquid in addition, and be standby;
(3) preparation of contents mixed liquid
With Radix Salviae Miltiorrhizae extract and auxiliary material liquid mix homogeneously, promptly get contents mixed liquid;
(4) preparation of soft capsule
With the contents mixed liquid for preparing, pour in the medicinal liquid bucket, with the gelatin solution that has prepared, adopt soft capsule maker compacting soft capsule, the soft capsule that fill becomes is inserted in the dry rotating cage of rustless steel, dry setting, lamp inspection selects ball, and underproof soft capsule is removed in polishing, packing is made 1000 after quality inspection is qualified.
2. a kind of salvia miltiorrhiza soft capsule according to claim 1 is characterized in that every loading amount 0.5g of every soft capsule of this salvia miltiorrhiza soft capsule, and every capsules to contain tanshinone IIA be that 0.8-0.2mg, salvianolic acid B are 18-11mg.
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| CN102614254A (en) * | 2012-03-27 | 2012-08-01 | 安徽华佗国药股份有限公司 | Method for extracting roots of red-rooted salvia |
| CN106580912A (en) * | 2016-12-27 | 2017-04-26 | 中国药科大学 | Tanshinone IIA soft capsule and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1651024A (en) * | 2004-12-07 | 2005-08-10 | 辽宁大生药业有限公司 | Salvia root capsule and its preparation technology |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1651024A (en) * | 2004-12-07 | 2005-08-10 | 辽宁大生药业有限公司 | Salvia root capsule and its preparation technology |
Non-Patent Citations (1)
| Title |
|---|
| 张亚中等.中药软胶囊的研究进展.《中成药》.2006,第28卷(第6期),871-874. * |
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