| 注射用丹参多酚酸化学成分及质量控制研究进展 |
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| 引用本文： | 李德坤,苏志刚,苏小琴,王蕴华,岳洪水,鞠爱春.注射用丹参多酚酸化学成分及质量控制研究进展[J].现代药物与临床,2019,42(2):362-368. |
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| 作者姓名： | 李德坤 苏志刚 苏小琴 王蕴华 岳洪水 鞠爱春 |
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| 作者单位： | 天津天士力之骄药业有限公司, 天津 300410;天津市中药注射剂安全性评价企业重点实验室, 天津 300410,天津天士力医药商业有限公司, 天津 300410,天津天士力之骄药业有限公司, 天津 300410;天津市中药注射剂安全性评价企业重点实验室, 天津 300410,天津天士力之骄药业有限公司, 天津 300410;天津市中药注射剂安全性评价企业重点实验室, 天津 300410,天津天士力之骄药业有限公司, 天津 300410;天津市中药注射剂安全性评价企业重点实验室, 天津 300410,天津天士力之骄药业有限公司, 天津 300410;天津市中药注射剂安全性评价企业重点实验室, 天津 300410 |
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| 基金项目： | 天津市中药注射剂关键技术校企协同创新实验室建设（项目编号：17PTSYJC00090） |
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| 摘 要： | 注射用丹参多酚酸是以丹参的水溶性有效部位丹参多酚酸为活性成分制成的冻干粉针剂，主要化学成分为丹酚酸B、迷迭香酸、紫草酸、丹酚酸D及丹酚酸Y等水溶性酚酸类成分。临床上用于中风病中经络（轻中度脑梗死）恢复期瘀血阻络证，治疗轻中度脑梗死引起的半身不遂、口舌歪斜、舌强言蹇、偏身麻木的症状。就近10年注射用丹参多酚酸的化学成分、药材质量评价、产品质量控制方法、配伍合理性及药动学研究进展进行综述，为临床上更加安全合理使用该药提供依据和参考。
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| 关 键 词： | 注射用丹参多酚酸 化学成分 质量控制 配伍 药动学 丹酚酸B 迷迭香酸 紫草酸 丹酚酸D 丹酚酸Y |
| 收稿时间： | 2019/1/10 0:00:00 |
Research progress on chemical composition and quality control of Salvianolic Acids for Injection |
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| LI Dekun,SU Zhigang,SU Xiaoqin,WANG Yunhu,YUE Hongshui and JU Aichun.Research progress on chemical composition and quality control of Salvianolic Acids for Injection[J].Drugs & Clinic,2019,42(2):362-368. |
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| Authors: | LI Dekun SU Zhigang SU Xiaoqin WANG Yunhu YUE Hongshui and JU Aichun |
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| Institution: | Tianjin Tasly Pride Pharmaceutical Co., Ltd., Tianjin 300410, China;Tianjin Key Laboratory of Safety Evaluation Enterprise of Traditional Chinese Medicine Injections, Tianjin 300410, China,Tianjin Tasly Pharmaceutical Commercial Co., Ltd., Tianjin 300410, China,Tianjin Tasly Pride Pharmaceutical Co., Ltd., Tianjin 300410, China;Tianjin Key Laboratory of Safety Evaluation Enterprise of Traditional Chinese Medicine Injections, Tianjin 300410, China,Tianjin Tasly Pride Pharmaceutical Co., Ltd., Tianjin 300410, China;Tianjin Key Laboratory of Safety Evaluation Enterprise of Traditional Chinese Medicine Injections, Tianjin 300410, China,Tianjin Tasly Pride Pharmaceutical Co., Ltd., Tianjin 300410, China;Tianjin Key Laboratory of Safety Evaluation Enterprise of Traditional Chinese Medicine Injections, Tianjin 300410, China and Tianjin Tasly Pride Pharmaceutical Co., Ltd., Tianjin 300410, China;Tianjin Key Laboratory of Safety Evaluation Enterprise of Traditional Chinese Medicine Injections, Tianjin 300410, China |
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| Abstract: | Salvianolic Acids for Injection (SAFI) is a traditional Chinese medicinal preparation composed of multiple salvianolic acids from the aqueous extracts of Salvia miltiorrhiza. The main chemical components include salvianolic acid B, rosmarinic acid, lithospermic acid, salvianolic acid D, salvianolic acid Y and other aqueous phenolic acids. SAFI is mainly used for the treatment of stroke. In this article, the contents of chemical components, quality control of raw materials and preparation, compatibility, and pharmacokinetics in the past 10 years are reviewed, providing a basis and reference for safer and rational drug use in clinic. |
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| Keywords: | Salvianolic Acids for Injection chemical composition quality control compatibility pharmacokinetics salvianolic acid B rosmarinic acid lithospermic acid salvianolic acid D salvianolic acid Y |
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