CN1273114A - Process for refining injection 'Xuesaitong' - Google Patents
Process for refining injection 'Xuesaitong' Download PDFInfo
- Publication number
- CN1273114A CN1273114A CN 99106223 CN99106223A CN1273114A CN 1273114 A CN1273114 A CN 1273114A CN 99106223 CN99106223 CN 99106223 CN 99106223 A CN99106223 A CN 99106223A CN 1273114 A CN1273114 A CN 1273114A
- Authority
- CN
- China
- Prior art keywords
- solution
- refining
- technology
- production according
- xuesaitong zhusheye
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 239000009692 xuesetong Substances 0.000 title claims abstract description 24
- 238000007670 refining Methods 0.000 title claims description 12
- 238000002347 injection Methods 0.000 title abstract description 8
- 239000007924 injection Substances 0.000 title abstract description 8
- 238000000034 method Methods 0.000 title description 7
- 239000000243 solution Substances 0.000 claims abstract description 47
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 44
- 241000180649 Panax notoginseng Species 0.000 claims abstract description 28
- 235000003143 Panax notoginseng Nutrition 0.000 claims abstract description 28
- 238000001914 filtration Methods 0.000 claims abstract description 15
- 239000000843 powder Substances 0.000 claims abstract description 15
- 239000011347 resin Substances 0.000 claims abstract description 9
- 229920005989 resin Polymers 0.000 claims abstract description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 9
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims abstract description 7
- 239000000706 filtrate Substances 0.000 claims abstract description 6
- 239000012528 membrane Substances 0.000 claims abstract description 5
- 238000001035 drying Methods 0.000 claims abstract description 4
- 238000009835 boiling Methods 0.000 claims abstract description 3
- 238000005516 engineering process Methods 0.000 claims description 13
- 238000004519 manufacturing process Methods 0.000 claims description 13
- 239000003814 drug Substances 0.000 claims description 12
- 238000004321 preservation Methods 0.000 claims description 11
- 229940079593 drug Drugs 0.000 claims description 8
- 239000008215 water for injection Substances 0.000 claims description 6
- 229910052799 carbon Inorganic materials 0.000 claims description 5
- 239000012982 microporous membrane Substances 0.000 claims description 5
- 238000004659 sterilization and disinfection Methods 0.000 claims description 5
- 239000002253 acid Substances 0.000 claims description 4
- 230000001476 alcoholic effect Effects 0.000 claims description 4
- 238000004821 distillation Methods 0.000 claims description 4
- 239000004952 Polyamide Substances 0.000 claims description 3
- 229920002647 polyamide Polymers 0.000 claims description 3
- 239000012141 concentrate Substances 0.000 claims description 2
- 230000001954 sterilising effect Effects 0.000 claims description 2
- 230000001105 regulatory effect Effects 0.000 abstract description 3
- 239000001397 quillaja saponaria molina bark Substances 0.000 abstract description 2
- 229930182490 saponin Natural products 0.000 abstract description 2
- 150000007949 saponins Chemical class 0.000 abstract description 2
- 208000024172 Cardiovascular disease Diseases 0.000 abstract 1
- 239000000047 product Substances 0.000 abstract 1
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 9
- 238000010438 heat treatment Methods 0.000 description 7
- 239000012535 impurity Substances 0.000 description 5
- 239000003146 anticoagulant agent Substances 0.000 description 3
- 230000017531 blood circulation Effects 0.000 description 3
- 239000003610 charcoal Substances 0.000 description 3
- 238000012856 packing Methods 0.000 description 3
- 238000001556 precipitation Methods 0.000 description 3
- 239000008399 tap water Substances 0.000 description 3
- 235000020679 tap water Nutrition 0.000 description 3
- 229940127219 anticoagulant drug Drugs 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 230000002526 effect on cardiovascular system Effects 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 230000001737 promoting effect Effects 0.000 description 2
- 206010002660 Anoxia Diseases 0.000 description 1
- 241000976983 Anoxia Species 0.000 description 1
- 241000208340 Araliaceae Species 0.000 description 1
- 206010048962 Brain oedema Diseases 0.000 description 1
- 206010008190 Cerebrovascular accident Diseases 0.000 description 1
- 206010053567 Coagulopathies Diseases 0.000 description 1
- 208000031354 Hyphema Diseases 0.000 description 1
- 206010021143 Hypoxia Diseases 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 241000699670 Mus sp. Species 0.000 description 1
- 208000006011 Stroke Diseases 0.000 description 1
- 231100000215 acute (single dose) toxicity testing Toxicity 0.000 description 1
- 238000011047 acute toxicity test Methods 0.000 description 1
- 150000001450 anions Chemical class 0.000 description 1
- 230000007953 anoxia Effects 0.000 description 1
- 230000002785 anti-thrombosis Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000023555 blood coagulation Effects 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 208000006752 brain edema Diseases 0.000 description 1
- 201000005667 central retinal vein occlusion Diseases 0.000 description 1
- 230000035602 clotting Effects 0.000 description 1
- 230000000916 dilatatory effect Effects 0.000 description 1
- 230000008030 elimination Effects 0.000 description 1
- 238000003379 elimination reaction Methods 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 230000035699 permeability Effects 0.000 description 1
- 230000003285 pharmacodynamic effect Effects 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 238000005057 refrigeration Methods 0.000 description 1
- 208000004644 retinal vein occlusion Diseases 0.000 description 1
- 238000001694 spray drying Methods 0.000 description 1
- 238000012109 statistical procedure Methods 0.000 description 1
- 238000001291 vacuum drying Methods 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
A refined injection "Xuesaitong" is prepared through decocting notoginseng twice; merging filtrates, concentrating, adding alcohol; filtering by resin column then cold storage; recovering alcohol; filtering with millipore filter membrane, regulating pH; concentrating, and drying to obtain total saponin powder of notoginseng; mixing it with the injection water, regulating pH value; boiling the solution, adding activated carbon; filtering and fine-filtering to obtain the product. Its advantages are high transparency, and long storage period. It can be used for treating cardiovascular disease.
Description
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.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 99106223 CN1095363C (en) | 1999-05-05 | 1999-05-05 | Process for refining injection 'xuesaitong' |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 99106223 CN1095363C (en) | 1999-05-05 | 1999-05-05 | Process for refining injection 'xuesaitong' |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1273114A true CN1273114A (en) | 2000-11-15 |
| CN1095363C CN1095363C (en) | 2002-12-04 |
Family
ID=5272334
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 99106223 Expired - Lifetime CN1095363C (en) | 1999-05-05 | 1999-05-05 | Process for refining injection 'xuesaitong' |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1095363C (en) |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2004098623A1 (en) * | 2003-05-07 | 2004-11-18 | Li Min Pharmaceutical Factory Of Livzon Pharmaceutical Group | A notoginseng saponin intravenous injection and the method for preparing this injection |
| CN1293887C (en) * | 2004-12-10 | 2007-01-10 | 张平 | Medicine composition for treating cardiovascular and cerebrovascular diseases, and preparation method thereof |
| JP2007505936A (en) * | 2003-09-23 | 2007-03-15 | ティアンジン タスリー ファーマシューティカル カンパニー リミテッド | Pharmaceutical compositions for the treatment of cardiovascular and cerebrovascular diseases |
| 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 |
| 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 |
-
1999
- 1999-05-05 CN CN 99106223 patent/CN1095363C/en not_active Expired - Lifetime
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2004098623A1 (en) * | 2003-05-07 | 2004-11-18 | Li Min Pharmaceutical Factory Of Livzon Pharmaceutical Group | A notoginseng saponin intravenous injection and the method for preparing this injection |
| JP2006525240A (en) * | 2003-05-07 | 2006-11-09 | リジュジトゥアンリミンジヤオチャン | Radixnotoginshen saponin family intravenous injection and method for its preparation |
| JP4718443B2 (en) * | 2003-05-07 | 2011-07-06 | リジュイヤオジトゥアンリミンジヤオチャン | Radixnotoginshen saponin family intravenous injection and method for its preparation |
| JP2007505936A (en) * | 2003-09-23 | 2007-03-15 | ティアンジン タスリー ファーマシューティカル カンパニー リミテッド | Pharmaceutical compositions for the treatment of cardiovascular and cerebrovascular diseases |
| JP4943846B2 (en) * | 2003-09-23 | 2012-05-30 | ティアンジン タスリー ファーマシューティカル カンパニー リミテッド | Pharmaceutical compositions for the treatment of 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 |
| 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 |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1095363C (en) | 2002-12-04 |
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Effective date of registration: 20100601 Address after: 158400 Hulin Red Star Street, Heilongjiang, No. 72 Patentee after: Helongjiang Zhenbaodao Pharmaceutical Co., Ltd. Address before: 158400 Chen-pao Island Pharmaceutical Co., Ltd. Heilongjiang 72, Hongxing street, Hulin Town, Heilongjiang, Hulin Patentee before: Fang Tonghua |
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Address after: 158400 Hulin Red Star Street, Heilongjiang, No. 72 Patentee after: Heilongjiang ZBD Pharmaceutical Co., Ltd. Address before: 158400 Hulin Red Star Street, Heilongjiang, No. 72 Patentee before: Helongjiang Zhenbaodao Pharmaceutical Co., Ltd. |
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Granted publication date: 20021204 |
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