Feasibility study of QAMS for quality control on three kinds of related preparations of Salvia miltiorrhiza / 中草药

ABSTRACT

Objective: To establish a quantitative analysis method of multi-components by single marker (QAMS) for the simultaneous determination of four tanshinones [tanshinone IIA (TIIA), dihydrotanshinone I (DTI), cryptotanshinone (CT), and tanshinone I (TI)], and to explore its accuracy and feasibility on quality evaluation of traditional chinese medicine preparations about three kinds of related preparations of Salvia miltiorrhiza. Methods: An HPLC method was used to calculate relative correction factors (fi/s) between other three components with TIIA. The component positioning methods were compared including retention time difference value, relative retention value, and linear regression methods. Meanwhile, the contents of tanshinones in different preparations of S. miltiorrhiza were determinated by the external standard method (ESM), including Danshen Tablet, Compound Danshen Tablet, and Guanxin Danshen Capsule. Measured content value was compared with calculated content value to evaluate the accuracy of QAMS method. Results: Within a certain range, the fi/s of DTI, TI, and CT to TIIA were 0.734, 0.916, and 0.774, respectively, with the good repeatability in different experimental conditions. The fi/s between other three components with TIIA was accurate and reliable, and there was no significant difference between QAMS and ESM method. Besides, the relative retention value method could be used to accurately locate the measuring component. The relative retention values of DTI, TI, and CT to TIIA were 0.314, 0.518, and 0.561, respectively. The contents of three kinds of S. miltiorrhiza preparations showed there were some differences in the intrinsic quality of the products from different factories, even from different batches of the same manufacturer. Conclusion: The QAMS method could be used for quality control about related preparations of S. miltiorrhiza and provide references for quality evaluation of other preparations. At the same time, the above three kinds of traditional Chinese medicine preparations should be further strengthened the control and supervision.