Pharmacokinetic properties of hydroxysafflor yellow A in healthy Chinese female volunteers

Abstract

Ethnopharmacological relevance: Hydroxysafflor yellow A (HSYA) was isolated from the dried flower of Carthamus tinctorius L. which was extensively used in traditional Chinese medicine to treat diseases due to blood stasis. However, there have been few detailed pharmacokinetic studies about HSYA on human beings.

Aim of the study: The aim was to investigate the pharmacokinetic characteristics of HSYA in healthy Chinese female volunteers.

Materials and methods: The volunteers were given intravenous infusion of single doses of safflor yellow injection (containing HSYA 35, 70 and 140 mg) in separate trial periods with 1 week washout period. The concentration levels of HSYA in plasma were determined with HPLC. Various pharmacokinetic parameters were estimated from the plasma concentration versus time data using non-compartmental methods.

Results: The C(max) values were 2.02+/-0.18, 7.47+/-0.67 and 14.48+/-4.71 microg/mL after the administration of single doses of 35, 70, and 140 mg of HSYA, respectively. The corresponding values of AUC(0-15 h) were 6.57+/-1.20, 25.90+/-4.62 and 48.47+/-12.11 microg/(mL h(-1)), and the values of t(1/2) were 3.21+/-1.26, 3.33+/-0.68 and 2.98+/-0.09 h. The Student-Newman-Keuls test results showed that C(max) and AUC(0-15 h) were both linearly related to dose.

Conclusions: In this study, the pharmacokinetic properties of HSYA are based on first-order kinetics over the dose range tested.