Study on quality control methods of Shaofu Zhuyu pills

Abstract

In order to solve the problems in the identification of Shaofu Zhuyu pills in the current pharmacopoeia of the People's Republic of China, such as single items and inconsistent quality control standards among different dasage forms, a more comprehensive quality control method for Shaofu Zhuyu pills was established by qualitative and quantitative research on the main pharmacodynamic components in the prescription. Three medicinal herbs including Pollen typhae, Corydalis Rhizoma and Cinnamon in the prescription are identified by TLC, and the content of Paeoniflorin in Shaofu Zhuyu pills is determined by HPLC. Characteristic spots of Pollen typhae, Corydalis Rhizoma and Cinnamon are observed in the thin-layer chromatogram. The linearity of Paeoniflorin is investigated and the results show a good linear relationship in the range of 0.128~1.28 μg. The RSDs of precision, the stability test and the reproducibility are all no more than 2.0%, the average recovery if of 92.10%, and the RSD is of 1.40%(n=9). It is suggested that the content limit of Paeoniflorin should not be less than 1.20 mg/g. The established method is accurate and reliable with high feasibility and good repeatability, and can provide the basis for the total quality control of Shaofu Zhuyu pills.

Keywords

• chromatographic analysis
• thin layer chromatography (TLC)
• high performance liquid chromatography (HPLC)
• Shaofu Zhuyu pills
• quality control