CN1067244C - 三七皂甙粉针剂 - Google Patents
三七皂甙粉针剂 Download PDFInfo
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- CN1067244C CN1067244C CN96101652A CN96101652A CN1067244C CN 1067244 C CN1067244 C CN 1067244C CN 96101652 A CN96101652 A CN 96101652A CN 96101652 A CN96101652 A CN 96101652A CN 1067244 C CN1067244 C CN 1067244C
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- notoginsenoside
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- 229930189092 Notoginsenoside Natural products 0.000 title claims abstract description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 9
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 6
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 4
- 229920002307 Dextran Polymers 0.000 claims description 3
- 235000002639 sodium chloride Nutrition 0.000 claims description 3
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 2
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 2
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 2
- 229930195725 Mannitol Natural products 0.000 claims description 2
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- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 2
- 239000004227 calcium gluconate Substances 0.000 claims description 2
- 229960004494 calcium gluconate Drugs 0.000 claims description 2
- 235000013927 calcium gluconate Nutrition 0.000 claims description 2
- NEEHYRZPVYRGPP-UHFFFAOYSA-L calcium;2,3,4,5,6-pentahydroxyhexanoate Chemical compound [Ca+2].OCC(O)C(O)C(O)C(O)C([O-])=O.OCC(O)C(O)C(O)C(O)C([O-])=O NEEHYRZPVYRGPP-UHFFFAOYSA-L 0.000 claims description 2
- 239000008103 glucose Substances 0.000 claims description 2
- 239000008101 lactose Substances 0.000 claims description 2
- 239000000594 mannitol Substances 0.000 claims description 2
- 235000010355 mannitol Nutrition 0.000 claims description 2
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 2
- 239000011780 sodium chloride Substances 0.000 claims description 2
- 125000003275 alpha amino acid group Chemical group 0.000 claims 1
- 239000001506 calcium phosphate Substances 0.000 claims 1
- 229910000389 calcium phosphate Inorganic materials 0.000 claims 1
- 235000011010 calcium phosphates Nutrition 0.000 claims 1
- FZWBNHMXJMCXLU-BLAUPYHCSA-N isomaltotriose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O)O1 FZWBNHMXJMCXLU-BLAUPYHCSA-N 0.000 claims 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims 1
- 239000008280 blood Substances 0.000 abstract description 4
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- 206010002383 Angina Pectoris Diseases 0.000 abstract description 2
- 206010008132 Cerebral thrombosis Diseases 0.000 abstract description 2
- 201000001429 Intracranial Thrombosis Diseases 0.000 abstract description 2
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 abstract description 2
- 230000017531 blood circulation Effects 0.000 abstract description 2
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- 230000000694 effects Effects 0.000 abstract description 2
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- 229910052760 oxygen Inorganic materials 0.000 abstract description 2
- 239000001301 oxygen Substances 0.000 abstract description 2
- 230000036284 oxygen consumption Effects 0.000 abstract description 2
- 230000001737 promoting effect Effects 0.000 abstract description 2
- 230000002490 cerebral effect Effects 0.000 abstract 1
- 210000004720 cerebrum Anatomy 0.000 abstract 1
- 239000002552 dosage form Substances 0.000 abstract 1
- 239000002994 raw material Substances 0.000 description 5
- 238000000034 method Methods 0.000 description 4
- 239000008215 water for injection Substances 0.000 description 4
- 241000218628 Ginkgo Species 0.000 description 3
- 235000011201 Ginkgo Nutrition 0.000 description 3
- 235000008100 Ginkgo biloba Nutrition 0.000 description 3
- 238000001914 filtration Methods 0.000 description 3
- 238000002360 preparation method Methods 0.000 description 3
- JGSARLDLIJGVTE-UHFFFAOYSA-N 3,3-dimethyl-7-oxo-6-[(2-phenylacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid Chemical compound O=C1N2C(C(O)=O)C(C)(C)SC2C1NC(=O)CC1=CC=CC=C1 JGSARLDLIJGVTE-UHFFFAOYSA-N 0.000 description 2
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 2
- 239000002671 adjuvant Substances 0.000 description 2
- 210000004556 brain Anatomy 0.000 description 2
- 230000002526 effect on cardiovascular system Effects 0.000 description 2
- 238000000605 extraction Methods 0.000 description 2
- 239000004615 ingredient Substances 0.000 description 2
- 238000012856 packing Methods 0.000 description 2
- 239000001397 quillaja saponaria molina bark Substances 0.000 description 2
- 229930182490 saponin Natural products 0.000 description 2
- 150000007949 saponins Chemical class 0.000 description 2
- 238000001694 spray drying Methods 0.000 description 2
- 239000009692 xuesetong Substances 0.000 description 2
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 description 1
- 208000024172 Cardiovascular disease Diseases 0.000 description 1
- 241000196324 Embryophyta Species 0.000 description 1
- 229910019142 PO4 Inorganic materials 0.000 description 1
- 208000002193 Pain Diseases 0.000 description 1
- 235000003143 Panax notoginseng Nutrition 0.000 description 1
- 241000180649 Panax notoginseng Species 0.000 description 1
- 150000001413 amino acids Chemical class 0.000 description 1
- 239000003708 ampul Substances 0.000 description 1
- 235000019658 bitter taste Nutrition 0.000 description 1
- 239000001110 calcium chloride Substances 0.000 description 1
- 229910001628 calcium chloride Inorganic materials 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 229910002092 carbon dioxide Inorganic materials 0.000 description 1
- 239000001569 carbon dioxide Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000004108 freeze drying Methods 0.000 description 1
- 238000010255 intramuscular injection Methods 0.000 description 1
- 239000007927 intramuscular injection Substances 0.000 description 1
- 238000005192 partition Methods 0.000 description 1
- 239000010452 phosphate Substances 0.000 description 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 1
- 239000002798 polar solvent Substances 0.000 description 1
- 238000007670 refining Methods 0.000 description 1
- 238000012827 research and development Methods 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000001179 sorption measurement Methods 0.000 description 1
- INLFWQCRAJUDCR-LYLBMTSKSA-N spirostane group Chemical group [C@@H]12C[C@@H]3O[C@]4(CC[C@@H](C)CO4)[C@@H](C)[C@@H]3[C@@]1(C)CC[C@H]1[C@H]2CCC2CCCC[C@]12C INLFWQCRAJUDCR-LYLBMTSKSA-N 0.000 description 1
- 230000003637 steroidlike Effects 0.000 description 1
- 238000000194 supercritical-fluid extraction Methods 0.000 description 1
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
本发明涉及到一种用于治疗心脑血管疾病的特殊剂型的药物。本发明所述的三七皂甙粉针剂由三七皂甙和注射用水溶性药用辅料组成，三七皂甙的含量为50-99.5%(重量百分比)，余量为药用辅料或水份。本发明所述粉针剂运输方便，贮存期长，较水针剂产品的稳定性好，质量高，可大规模生产，加入注射用水后所得注射液经检验，各项指标均符合要求。本粉针剂以三七皂甙为活性成分，具有活血化瘀、降低心肌耗氧量、改善心绞痛、溶解脑血栓、增加脑血氧分压和改善大脑的功效。
Description
本发明涉及到一种用于治疗心脑血管疾病的特殊剂型的药物。
中国专利申请CN1085091(申请号93105878)公开了一种“用银杏叶和含皂甙植物制成防治心脑血管症的单复方制剂”，是以银杏叶干燥粉末、银杏叶的提取和分离物和含螺旋甾烷骨架的某些甾体总皂甙为主要原料制成的单方或复方制剂。提取工艺采用极性溶剂并结合吸附分离法以及二氧化碳超临界提取分离法。为解决制剂的苦味，采用分子胶囊技术。
三七为云南特产的名贵中药材，自古就用于心痹气闷等，近代研究确认三七皂甙为其有效成分之一，七十年代开绐研究开发三七皂甙注射液(血塞通)，现在血塞通注射液已受到广大患者的欢迎。但是随着产量不断扩大，质量问题也时有出现，且水针剂在北方冬天冻结起来，不便使用，肌注疼痛，病人不愿使用。这些都为扩大使用设置了障碍。
本发明的目的旨在克服现有技术的不足，提供一种运输方便，贮存期长的三七皂甙粉针剂。
本发明所述的三七皂甙粉针剂由三七皂甙和注射用水溶性药用辅料组成，三七皂甙的含量为50-99.5％(重量百分比)，余量为药用辅料或水份。
本发明所述的注射用水溶性药用辅料为：氨基酸、葡萄糖、乳糖、甘露醇、聚乙烯吡咯烷酮、低分子右旋糖酐等有机或生化辅料，亦可为氯化钠、氯化钙、葡萄酸钙、磷酸盐等无机盐类。
本发明所述粉针剂运输方便，贮存期长，较水针剂产品的稳定性好，质量高，可大规模生产，加入注射用水后所得注射液经检验，各项指标均符合要求。本粉针剂以三七皂甙为活性成分，具有活血化瘀、降低心肌耗氧量、改善心绞痛、溶解脑血栓、增加脑血氧分压和改善大脑的功效。
实施例：
1、在100级以下车间内以三七皂甙为原料，加入5-20倍原料重量的水，在50-80℃的条件下，加入5％低分子右旋糖酐，调节PH为5.5-8.5，溶液经过无菌过滤，无菌喷雾干燥，密闭即得所需粉针剂原料，分装成2ml西林瓶100mg，轧盖，包装即得成品。
2、在生产三七皂甙车间的后工段(精制工段)，将精制工段安置在100级以下车间(空间)内操作，在析出三七皂甙前加入所需比例的辅料，调节好PH值，经无菌过滤，用熔媒法析出三七皂甙，抽滤，100℃以下干燥，即得粉针用原料(亦可用喷雾干燥法)，进一步分装成200mg于5ml西林瓶中，轧盖，包装即得成品。
3、将上述制得的三七皂甙100g溶入700ml注射用水中，加入3gNaH2PO4及2gNa2HPO4，加热至50-60℃溶解，过滤，分装成每支，0.65ml，冷冻干燥，熔封、即得每支安瓿含100mg(有效成分)的冻干粉针剂。
Claims (1)
1、一种三七皂甙粉针剂，其特征在于由三七皂甙和注射液用水溶性药用辅料组成，所述三七皂甙的含量为(重量百分比)50-99.5％，余量为药用辅料，所述药用辅料为氨基酸、葡萄糖、乳糖、甘露醇、聚乙烯吡咯烷酮、低分子右旋糖酐、氯化钠、葡萄糖酸钙或磷酸钙。
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN96101652A CN1067244C (zh) | 1996-02-17 | 1996-02-17 | 三七皂甙粉针剂 |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN96101652A CN1067244C (zh) | 1996-02-17 | 1996-02-17 | 三七皂甙粉针剂 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1157720A CN1157720A (zh) | 1997-08-27 |
| CN1067244C true CN1067244C (zh) | 2001-06-20 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN96101652A Expired - Lifetime CN1067244C (zh) | 1996-02-17 | 1996-02-17 | 三七皂甙粉针剂 |
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| Country | Link |
|---|---|
| CN (1) | CN1067244C (zh) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6500468B1 (en) * | 2002-01-03 | 2002-12-31 | Farlong Pharmaceutical, Inc. | Panax notoginsenoside composition |
| CN1329037C (zh) * | 2003-05-07 | 2007-08-01 | 丽珠集团利民制药厂 | 一种三七总皂苷静脉注射液及其生产方法 |
| CN100339085C (zh) * | 2003-09-23 | 2007-09-26 | 天津天士力制药股份有限公司 | 治疗心脑血管疾病的中药组合物 |
| CN1771978B (zh) * | 2004-11-09 | 2011-06-08 | 成都华神集团股份有限公司制药厂 | 一种三七三醇皂苷组合物及其制备方法和用途 |
| CN100406018C (zh) * | 2005-06-17 | 2008-07-30 | 张晴龙 | 一种纳米血塞通注射制剂及其制备方法 |
| CN100484517C (zh) * | 2006-06-28 | 2009-05-06 | 昆明制药集团股份有限公司 | 一种美观抗碎的三七总皂苷冻干粉针剂及其制备方法 |
| CN101224228B (zh) * | 2007-01-16 | 2013-06-19 | 昆明制药集团股份有限公司 | 一种三七总皂苷冻干粉针剂及其制备方法 |
| CN103536610B (zh) * | 2013-01-09 | 2015-03-11 | 上海中医药大学 | 三七皂苷Fc的医药用途 |
-
1996
- 1996-02-17 CN CN96101652A patent/CN1067244C/zh not_active Expired - Lifetime
Non-Patent Citations (3)
| Title |
|---|
| 中国急救医学，15(4) 1995.1.1 徐琳等人"血塞通注射液颈内动脉注射治疗脑梗塞所致偏瘫35例" * |
| 云南医药，13(5) 1992.1.1 邓士贤"云南几种中草药的药理作用及应用 " * |
| 云南医药，13(5) 1992.1.1 邓士贤"云南几种中草药的药理作用及应用 ";中国急救医学，15(4) 1995.1.1 徐琳等人"血塞通注射液颈内动脉注射治疗脑梗塞所致偏瘫35例" * |
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| Publication number | Publication date |
|---|---|
| CN1157720A (zh) | 1997-08-27 |
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