CN1095363C - Process for refining injection 'xuesaitong' - Google Patents

Process for refining injection 'xuesaitong' Download PDF

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Publication number
CN1095363C
CN1095363C CN 99106223 CN99106223A CN1095363C CN 1095363 C CN1095363 C CN 1095363C CN 99106223 CN99106223 CN 99106223 CN 99106223 A CN99106223 A CN 99106223A CN 1095363 C CN1095363 C CN 1095363C
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solution
technology
refining
xuesaitong
ethanol
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CN 99106223
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CN1273114A (en
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盖兆光
梁起臣
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Heilongjiang ZBD Pharmaceutical Co., Ltd.
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方同华
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Abstract

The present invention discloses technology for producing refined Xuesaitong injection, which comprises the steps that crude drugs of panax notoginseng are decocted for two times; filter liquor is merged and concentrated, and ethanol is added; after passing resin columns, solution is refrigerated; the ethanol is recovered, a microporous filtering film is used for filtration, and the pH is adjusted; total panax notoginseng saponin powder is obtained through concentration and drying; the total panax notoginseng saponins powder is mixed with water for injection, and the pH is adjusted; the solution is boiled, and activated carbon is added; the solution is filtered and then filtered finely; Xuesaitong injection is obtained. The Xuesaitong prepared by the technology has the advantages of high clarity and long date of minimum durability and can used for treating cardiovascular diseases.

Description

The production technology of refining XUESAITONG ZHUSHEYE
The present invention relates to field of medicine preparations, particularly the production technology of refining XUESAITONG ZHUSHEYE.
Radix Notoginseng is the herbaceos perennial of Araliaceae, contains multiple Saponin in its root, has blood vessel dilating, and the effect of anticoagulant is traditional Chinese medicine.With the Radix Notoginseng total arasaponins is that the injection XUESAITONG that effective ingredient is made has blood circulation promoting and blood stasis dispelling clinically, and the demountable function of promoting blood circulation can be used for treating diseases of cardiovascular and cerebrovascular systems, apoplexy sequela, central retinal vein occlusion, hyphema etc.
At present, owing to do not use the filter process of greater efficiency in the technology of production Radix Notoginseng total arasaponins powder, do not adopt highly effective method precipitated impurities yet, there is not the conciliation of pH value when reclaiming ethanol, thereby the net content of its Radix Notoginseng total arasaponins is on the low side in the Radix Notoginseng total arasaponins powder of producing, can only reach 85% (mg/ml) of labelled amount with the Radix Notoginseng total arasaponins content in the injection XUESAITONG of this Radix Notoginseng total arasaponins powder production, and injection is all existing certain problem aspect the stability of medicine and the clarity.
It is higher to the purpose of this invention is to provide a kind of production Radix Notoginseng total arasaponins content, clarity height, the technology of the XUESAITONG ZHUSHEYE of good stability.
For achieving the above object, the present invention takes following design: a kind of technology of producing refining XUESAITONG ZHUSHEYE may further comprise the steps:
(1) the Radix Notoginseng crude drug is decocted 2 times each 1-2 hour in proper amount of boiling water;
(2) decoct the merging of gained filtrate with above-mentioned twice, concentrate, and add ethanol, make that ethanol content reaches 75%-85% in the solution;
(3) solution being crossed behind the resin column under 0 ℃ of-5 ℃ of condition cold preservation placed 24-48 hour;
(4) ethanol in the solution after the cold preservation placement is recycled;
(5) above-mentioned gained solution is carried out filtering with microporous membrane after, regulate pH value to 4.8-6.0;
(6) step (5) gained solution concentration, drying are obtained the Radix Notoginseng total arasaponins powder;
(7) with above-mentioned Radix Notoginseng total arasaponins powder with after water for injection mixes by the weight ratio of 0.8-1.2: 800-1200, adjust pH is to 5.0-7.0;
(8) gained solution heated and boiled after 15-20 minute, is added active carbon 0.25-0.5%;
(9) with after the filtration of gained solution, carry out fine straining again;
(10), obtain XUESAITONG ZHUSHEYE after the sterilization with the filled with solution behind the above-mentioned fine straining.
In the production process of the present invention owing to used resin column that solution is filtered, impurity in the solution is reduced the crucial effect of having played significantly, use cold preservation and place (being heat treatment refrigeration precipitated impurities), impurity is further being precipitated to cold change procedure from heat, pH value behind the recovery ethanol is regulated, positive role has also been played in elimination to impurity, the net content of Radix Notoginseng total arasaponins increases substantially in the solution, for the clarity and the stability that improve XUESAITONG ZHUSHEYE are laid a good foundation, the clarity of XUESAITONG ZHUSHEYE of the present invention and stability have had and have increased substantially, the content of Radix Notoginseng total arasaponins can reach the 90.0-110.0% (mg/ml) of labelled amount in the injection, and the effective active composition is improved.
By showing with the acute toxicity test and the pharmacodynamic study of animal to XUESAITONG, injection of the present invention is actual safe drugs, can suppress significantly and to antithrombotic formation, reduce cerebrovascular permeability, reduce cerebral edema, strengthen the ability of mice anoxia enduring, anticoagulant function and blood viscosity lowering, change hemorheological property, reduce blood coagulation and prolong clotting time; By statistical procedures, experimental result and blank group or model group all have significant difference, prove that this medicine is a good drug for invigorating blood circulation and eliminating stasis, are the active drugs of treatment diseases of cardiovascular and cerebrovascular systems.
The invention will be further described below in conjunction with specific embodiment.
Embodiment 1:
1, gets 2 kilograms of Radix Notoginseng crude drugs, add tap water, boil the back and decoct each 2 hours 2 times;
2, decoct the merging of gained filtrate with above-mentioned twice, proportion was 1.12 when heating was concentrated into 75 ℃, added 95% ethanol and carried out precipitation process, made that ethanol content reaches 75% in the solution;
3, solution is crossed the polyamide macroporous resin column after, cold preservation was placed 40 hours under 4 ℃ of conditions, to reach heat treatment, cryoprecipitate;
4, the solution after the cold preservation placement is reclaimed ethanol with alcohol distillation column;
5, will reclaim the filtering with microporous membrane that alcoholic acid solution carries out 0.65 micron after, regulate pH value to 5.5 with the HCL of 2 mol;
Proportion is 1.12 during 6, with gained solution concentration to 75 ℃, carries out vacuum drying with 0.15 Pascal's negative pressure, obtains Radix Notoginseng total arasaponins powder 20g;
7, with above-mentioned 20g Radix Notoginseng total arasaponins powder with after the water for injection of 20kg mixes, with 40%NaOH adjust pH to 6.0;
8, gained solution heated and boiled after 20 minutes, is added 0.4% active carbon;
9, take off charcoal with filter paper filtering after, again solution is carried out fine straining with 0.25 micron microporous filter membrane;
10,, ultraviolet disinfection, promptly obtain XUESAITONG ZHUSHEYE with above-mentioned solution packing.
Embodiment 2:
1, gets 2 kilograms of Radix Notoginseng crude drugs, add tap water, boil the back and decoct each 1 hour 2 times;
2, decoct the merging of gained filtrate with above-mentioned twice, proportion was 1.10 when heating was concentrated into 80 ℃, added 95% ethanol and carried out precipitation process, made that ethanol content reaches 85% in the solution;
3, solution is crossed the resin anion (R.A.) post after, cold preservation was placed 24 hours under 0 ℃ of condition, to reach heat treatment, cryoprecipitate;
4, the solution after the cold preservation placement is reclaimed ethanol with alcohol distillation column;
5, will reclaim alcoholic acid solution with 0.65 micron filtering with microporous membrane after, regulate pH value to 4.8 with the HCL of 2 mol;
Proportion is 1.10 during 6, with gained solution concentration to 80 ℃, carries out drying under reduced pressure under 0.1 Pascal's pressure, obtains Radix Notoginseng total arasaponins powder 19g;
7, with above-mentioned 8g Radix Notoginseng total arasaponins powder with after the water for injection of 12kg mixes, with 40%NaOH adjust pH to 5.0;
8, gained solution heated and boiled after 20 minutes, is added 0.25% active carbon;
9, take off charcoal with filter paper filtering after, again solution is carried out fine straining with 0.8 micron microporous filter membrane;
10,, ultraviolet disinfection, promptly obtain XUESAITONG ZHUSHEYE with above-mentioned solution packing.
Embodiment 3:
1, gets 2 kilograms of Radix Notoginseng crude drugs, add tap water, boil the back and decoct each 1.5 hours 2 times;
2, decoct the merging of gained filtrate with above-mentioned twice, proportion was 1.15 when heating was concentrated into 75 ℃, added 95% ethanol and carried out precipitation process, made that ethanol content reaches 80% in the solution;
3, solution is crossed the polyamide macroporous resin column after, cold preservation was placed 48 hours under 5 ℃ of conditions, to reach heat treatment, cryoprecipitate;
4, the solution after the cold preservation placement is reclaimed ethanol with alcohol distillation column;
5, will reclaim alcoholic acid solution with 0.65 micron filtering with microporous membrane after, regulate pH value to 6.0 with the HCL of 2 mol;
Proportion is 1.11 during 6, with gained solution concentration to 75 ℃, carries out spray drying, obtains Radix Notoginseng total arasaponins powder 19.5g;
7, with above-mentioned 10g Radix Notoginseng total arasaponins powder with after the water for injection of 15kg mixes, with 40%NaOH adjust pH to 7.0;
8, gained solution heated and boiled after 20 minutes, is added 0.5% active carbon;
9, take off charcoal with filter paper filtering after, again solution is carried out fine straining with 0.65 micron microporous filter membrane;
10,, ultraviolet disinfection, promptly obtain XUESAITONG ZHUSHEYE with above-mentioned solution packing.

Claims (8)

1, a kind of technology of producing refining XUESAITONG ZHUSHEYE is characterized in that: may further comprise the steps:
(1) the Radix Notoginseng crude drug is decocted 2 times each 1-2 hour in proper amount of boiling water;
(2) decoct the merging of gained filtrate with above-mentioned twice, concentrate, and add ethanol, make that ethanol content reaches 75%-85% in the solution;
(3) solution being crossed behind the resin column under 0 ℃ of-5 ℃ of condition cold preservation placed 24-48 hour;
(4) ethanol in the solution after the cold preservation placement is recycled;
(5) above-mentioned gained solution is carried out filtering with microporous membrane after, regulate pH value to 4.8-6.0;
(6) step (5) gained solution concentration, drying are obtained the Radix Notoginseng total arasaponins powder;
(7) with above-mentioned Radix Notoginseng total arasaponins powder with after water for injection mixes by the weight ratio of 0.8-1.2: 800-1200, adjust pH is to 5.0-7.0;
(8) gained solution heated and boiled after 15-20 minute, is added active carbon 0.25-0.5%;
(9) with after the filtration of gained solution, carry out fine straining again;
(10), obtain XUESAITONG ZHUSHEYE after the sterilization with the filled with solution behind the above-mentioned fine straining.
2, the technology of the refining XUESAITONG ZHUSHEYE of production according to claim 1 is characterized in that: in (2) step during with solution concentration to 70 ℃-80 ℃ proportion be 1.10-1.15.
3, the technology of the refining XUESAITONG ZHUSHEYE of production according to claim 1 is characterized in that: in (2) step, behind the adding ethanol, alcoholic acid content is 75% in the solution.
4, the technology of the refining XUESAITONG ZHUSHEYE of production according to claim 1 is characterized in that: in (3) step, being used for filtering resin column is the polyamide macroporous resin column.
5, the technology of the refining XUESAITONG ZHUSHEYE of production according to claim 1 is characterized in that: in (4) step, reclaim ethanol with alcohol distillation column.
6, the technology of the refining XUESAITONG ZHUSHEYE of production according to claim 1 is characterized in that: in (5) step, used microporous filter membrane is the 0.25-0.8 micron.
7, the technology of the refining XUESAITONG ZHUSHEYE of production according to claim 1 is characterized in that: in (6) step during with solution concentration to 70 ℃-80 ℃ proportion be 1.10-1.12.
8, the technology of the refining XUESAITONG ZHUSHEYE of production according to claim 1 is characterized in that: in (7) step, the weight ratio of Radix Notoginseng total arasaponins powder and water for injection is 1: 1000.
CN 99106223 1999-05-05 1999-05-05 Process for refining injection 'xuesaitong' Expired - Lifetime CN1095363C (en)

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Application Number Priority Date Filing Date Title
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108030795A (en) * 2018-02-07 2018-05-15 宁夏天心医药有限责任公司 A kind of XUESHUANTONG ZHUSHEYE and preparation method thereof

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1329037C (en) * 2003-05-07 2007-08-01 丽珠集团利民制药厂 Intravenous inject contg. pseudo-ginseng total saponin and its prodn. 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
CN1293887C (en) * 2004-12-10 2007-01-10 张平 Medicine composition for treating cardiovascular and cerebrovascular diseases, and preparation method thereof
CN102228495A (en) * 2011-07-01 2011-11-02 天圣制药集团股份有限公司 Preparation method of injection for treating cardio-cerebral vascular diseases
CN104606345A (en) * 2015-01-07 2015-05-13 四川金堂海纳生物医药技术研究所 Traditional Chinese medicine decoction for treating hyphema and preparation method thereof

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108030795A (en) * 2018-02-07 2018-05-15 宁夏天心医药有限责任公司 A kind of XUESHUANTONG ZHUSHEYE and preparation method thereof

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