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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2017, Vol. 22 ›› Issue (5): 545-550.

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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

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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