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| 基于“五原则”的血必净注射液质量标志物的预测分析 |
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蔡楠1,2, 曹宁宁1, 赵利斌1,3, 裴帅1, 李晓璇1, 张琬靖1, 肖学凤1, 刘昌孝4
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1.天津中医药大学中药学院, 天津 301617;2.天士力控股集团有限公司研究院现代中药开发中心, 天津 300410;3.北京振东光明药物研究院, 北京 100085;4.天津药物研究院释药技术与药物代谢动力学国家重点实验室, 天津 300301
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| 摘要: |
| [目的] 基于中药质量标志物（Q-marker）"五原则"——传递与溯源、特有性、有效性、复方配伍环境及可测性，对血必净注射液的Q-marker进行研究。[方法] 通过中国知网（CNKI）、万方、Pumbed、Medline等数据库，检索血必净注射液的化学成分、药代动力学、药理作用、临床应用以及质量控制等相关文献，并在此基础上，基于Q-marker的"五原则"，预测分析血必净注射液的Q-marker。[结果] 羟基红花黄色素A、丹酚酸B、芍药苷、洋川芎内酯I、洋川芎内酯H可作为血必净注射液的Q-marker。[结论] 研究预测了血必净注射液的Q-marker，为后续临床及质量控制研究提供参考依据。 |
| 关键词: 血必净注射液 质量标志物 五原则 |
| DOI：10.11656/j.issn.1672-1519.2021.08.24 |
| 分类号:R28 |
| 基金项目:国家自然科学基金项目（81973557）；天津市自然科学基金重点项目（20JCZDJC00010）；国家科技重大专项项目（2018ZX09737-019，2018ZX09303-024）；天津中医药大学研究生科研创新项目（YJSKC-20201013）。 |
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| Predictive analysis of quality marker in Xuebijing Injection based on “five principles” |
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CAI Nan1,2, CAO Ningning1, ZHAO Libin1,3, PEI Shuai1, LI Xiaoxuan1, ZHANG Wanjing1, XIAO Xuefeng1, LIU Changxiao4
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1.School of Chinese Materia Medica, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China;2.Traditional Chinese Medicine Research Center, Tasly Holding Group Co. Ltd., Tianjin 300410, China;3.Zhendong Guangming Pharmaceutical Research Institute, Beijing 100085, China;4.State Key Laboratory of Drug Delivery Technology and Pharmacokinetics, Tianjin Institute of Pharmaceutical Research, Tianjin 300301, China
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| Abstract: |
| [Objective] To explore the quality marker (Q-marker) of Xuebijing Injection based on the "five principles" of Q-marker of traditional Chinese medicine:transmission and traceability, specificity, effectiveness, measurability and compatibility environment of compound prescriptions.[Methods] The relevant literature on the chemical constituents, pharmacokinetics, pharmacological activities, clinical application and quality control of Xuebijing Injection were retrieved in the databases such as CNKI, Wanfang, Pumbed and Medline. On the basis of this, the Q-marker of Xuebijing Injection are predicted and analyzed based on the "five principles" of Q-marker of traditional Chinese medicine.[Results] The hydroxysafflor yellow A, salvianolic acid B, paeoniflorin, senkyunolide I and senkyunolide H could be used as Q-marker of Xuebijing Injection.[Conclution] This study predicted the Q-marker of Xuebijing Injection, which could provide reference for its follow-up clinical and quality control research. |
| Key words: Xuebijing Injection quality marker five principles |
