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中国临床药理学与治疗学 ›› 2017, Vol. 22 ›› Issue (5): 545-550.

• 临床药理学 • 上一篇    下一篇

丹参传统饮片水煎液与破壁饮片混悬液中隐丹参酮及其代谢物的药代动力学研究

郑玲杰1,2，邓 雯3,4，邢 露1,2，张 伟1,2，谭志荣1,2，周宏灏1,2，成金乐3,4   

  1. 1 中南大学湘雅医院临床药理研究所，长沙 410008，湖南； 2 中南大学临床药理研究所遗传药理学湖南省重点实验室，长沙 410078，湖南； 3 国家中医药管理局中药破壁饮片技术与应用重点研究室，中山 528437，广东； 4 中山市中智药业集团有限公司，中山 528437，广东
  • 收稿日期:2016-12-15 修回日期:2017-01-12 出版日期:2017-05-26 发布日期:2017-05-27
  • 通讯作者: 成金乐，男，学士，教授，研究方向：破壁饮片及产业化研究，创新中药研究与开发。 Tel：0760-85312928 E-mail: gdcjl9@126.com
  • 作者简介:郑玲杰，女，硕士研究生，研究方向：遗传药理学和临床药理学。 Tel：18373115527 E-mail:18373115527@163.com
  • 基金资助:

    长沙市科技局一般平台项目（K1403075-61）；中南大学中央高校基本科研业务费专项资金（2016zzts522）；湖南省科技厅省重点研发计划应用基础研究重点项目（2016JC2063）资助；国家中医药科技函【2014】26号基金项目

Pharmacokinetics of cryptotanshinone and its metabolites between traditional decoction piece and ultrafine granular powder of salvia miltiorrhiza

ZHENG Lingjie 1,2, DENG Wen 3,4, XING Lu 1,2, ZHANG Wei 1,2, TAN Zhirong 1,2, ZHOU Honghao 1,2, CHENG Jinle 3,4   

  1. 1 Institute of Clinical Pharmacology, Xiangya Hospital, Central South University, Changsha 410008, Hunan, China; 2 Institute of Clinical Pharmacology, Central South University, Changsha 410078, Hunan, China; 3 Key Research Laboratory of Ultrafine Granular Powder from Traditional Chinese Medicine, State Administration of Traditional Chinese Medicine, Zhongshan 528437, Guangdong, China; 4 Zhongzhi Pharmaceutical Group Co, Zhongshan 528437, Guangdong, China
  • Received:2016-12-15 Revised:2017-01-12 Online:2017-05-26 Published:2017-05-27

PDF (PC)

482

被引次数

1

摘要：

目的: 研究丹参传统饮片水煎液和破壁饮片混悬液中隐丹参酮及其代谢物丹参酮IIA的人体药代动力学及生物等效性。方法: 24名健康受试者，男女各半，分别交叉单剂量口服试验药物或参比药物，用LC-MS法测定隐丹参酮，丹参酮IIA的血药浓度，用DAS Ver3.2.2进行数据处理、SPSS进行统计分析。AUC 0-60、C max经对数转换后，进行双单侧t检验并计算其90%可信区间。结果: 隐丹参酮、丹参酮IIA的药代动力学参数T max、C max、AUC 0-60和t 1/2在不同周期和不同性别间差异无统计学意义(P>0.05)，在两种制剂间的差异有统计学意义(P<0.05)。受试者单次空腹口服试验药物和参比药物后隐丹参酮及其代谢产物丹参酮IIA试验药物和参比药物的相对生物利用度F分别为（4 456.8±3 706.8）%、（4 690.3±3 416.7）%。结论: 破壁饮片混悬液中隐丹参酮，丹参酮IIA的生物利用度显著高于传统饮片水煎液，临床应用中可以减少给药剂量。

关键词: 隐丹参酮, 丹参酮IIA, 丹参传统饮片水煎液, 丹参破壁饮片混悬液, 药代动力学, 生物等效性

Abstract:

AIM: To study the pharmacokinetics and bioequivalence of cryptotanshinone and its metabolites tanshinone IIA between traditional decoction piece and ultrafine granular powder of salvia miltiorrhiza.  METHODS: Twenty-four healthy volunteers, half male and half female were orally administrated with a single dose of subject drug (ultrafine granular powder of salvia miltiorrhiza) and reference drug (traditional decoction piece of salvia miltiorrhiza). Plasma concentrations of cryptotanshinone and tanshinone IIA were determined by a validated LC-MS method. Collected data were calculated and analyzed by DAS Ver3.2.2 and SPSS software. After logarithmic transformation of AUC 0-60 and C max, one-sided t-test was performed and 90% confidence interval was calculated. RESULTS: The main pharmacokinetics parameters of cryptotanshinone and tanshinone IIA in subject drug and reference drug including T max, C max, AUC 0-60 and t 1/2 exhibited no significant difference (P>0.05) between different periods and different genders, while significant difference was observed between different preparations (P<0.05). The relative bioavailability of subject drug and reference drug were as follow:（4 456.8±3 706.8）%，(4 690.3±3 416.7) %. CONCLUSION: The bioavailability of cryptotanshinone and tanshinone IIA in ultrafine granular powder is significantly higher than traditional decoction piece, which is referential for reducing dosage in clinical application.

Key words: cryptotanshinone, tanshinone IIA, traditional decoction piece of salvia miltiorrhiza, ultrafine granular powder of salvia miltiorrhiza, pharmacokinetics, bioequivalence

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