血栓通注射剂质量分析

刘永利，王常顺，王璐，苏建，孙慧珠，孔亚萍

中国药学杂志 ›› 2014, Vol. 49 ›› Issue (16) : 1448-1450.

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中国药学杂志
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中国药学杂志 ›› 2014, Vol. 49 ›› Issue (16) : 1448-1450. DOI: 10.11669/cpj.2014.16.018
论著

血栓通注射剂质量分析

  • 刘永利，王常顺，王璐，苏建，孙慧珠，孔亚萍
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Quality Analysis for Xueshuantong Injections

  • LIU Yong-li, WANG Chang-shun, WANG Lu, SU Jian, SUN Hui-zhu,KONG Ya-ping
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摘要

目的 通过对5个生产企业84批次血栓通注射剂的抽验，评价血栓通注射剂的质量状况和现行质量标准的可行性。方法 通过法定标准检验，结合药品安全性、稳定性及有效性等探索性研究，综合评价其质量状况。结果 84批次血栓通注射剂样品按现行法定标准检验，合格率为100%;探索性研究检验合格率仍为100%。结论 血栓通注射剂的质量状况较好，现行标准可行。

Abstract

OBJECTIVE To evaluate the quality of Xueshuantong injections and the feasibility of the current legal quality standards through testing 84 batches of samples from five factories. METHODS The samples were tested according to the legal quality standards, combined with the exploration of the safety, stability and effectiveness of the drug to comprehensively evaluate its quality. RESULTS The qualified rate of the 84 batches of samples of Xueshuantong injections was 100% according to the current legal quality standards; the qualified rate by exploratory examination was 100%. CONCLUSION The quality status of Xueshuantong injections is good, and the current quality standard is feasible.

关键词

血栓通注射剂 / 国家评价抽验 / 质量分析 / 三七总皂苷

Key words

Xueshuantong injection / national assessment program / quality analysis / Panax notoginseng saponin

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刘永利，王常顺，王璐，苏建，孙慧珠，孔亚萍. 血栓通注射剂质量分析[J]. 中国药学杂志, 2014, 49(16): 1448-1450 https://doi.org/10.11669/cpj.2014.16.018
LIU Yong-li, WANG Chang-shun, WANG Lu, SU Jian, SUN Hui-zhu,KONG Ya-ping. Quality Analysis for Xueshuantong Injections[J]. Chinese Pharmaceutical Journal, 2014, 49(16): 1448-1450 https://doi.org/10.11669/cpj.2014.16.018
中图分类号： R917   

参考文献

Drug Specifications for Traditional Chinese Medicine Promulgated by Ministry of Public Health. PR China. Vol.2(卫生部药品标准中药成方制剂第二十册):113. Drug standard of SFDA(国家药品标准). WS3-B-3829-98-2011. Drug standards compilation for Traditional Chinese Medicine of SFDA. Vol. Meridian branch limb brain(国家中成药标准汇编经络肢体脑系分册): 235. Drug standard of SFDA(国家药品标准). WS-10460(ZD-0460)-2002-2011Z. ZHANG Q.Clinical application of Xueshuantong injection. Hunan Guiding J Tradit Chin Med Pharmacol(湖南中医药导报), 2004,10(4):63 . WANG Z Q,DING Z L. The clinical research of Xueshuantong. Chin Pharm(中国药业),2007,16(11):62. Ch.P(中国药典) . 2010,VolⅠ(一部): Appendix(附录): 70. YANG J, ZHANG C Z. Chinese medicine injection adverse reactions issues . People′s Mil Sur(人民军医), 2011, 54(6):535. ZHOU H J. International Technical Requirements for Registration of Pharmaceuticals(药品注册的国际技术要求). Beijing: People′s Health Publishing House, 2001:343.
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