Abstract:
OBJECTIVE To improve the quality control methods of Shengmai Liyan mixture.
METHODS Establishing the HPLC fingerprint of Shengmai Liyan mixtures. Establishing the HPLC method for determining the content of the main active ingredients baicalin and wogonin. And the content determination of antiseptic was also established by HPLC.
RESULTS Under the same fingerprint chromatogram condition, the methodological results were satisfactory to 10 batches of the samples. The content of baicalin and wogonoside were within the range of 2.12-4.48 mg·mL
-1 and 0.51-0.92 mg·mL
-1 respectively. The contents of benzoic acid in 10 batches of samples were <0.3%. The established fingerprint identification methed is simple and highly reproducible, and can provide scientific basis for the quality control of Shengmailiyan mixture. The established method for determination of content is simple, reproducible, and the resolution meets the requirements, and the active ingredients of Shengmaili mixture can be accurately detected.
CONCLUSION It is recommended that the content of baicalin in the preparation is limited to 2.30 mg·mL
-1. And it is recommended to increase the testing items that affect the safety of the preparation so as to control the quality of the preparation strictly.