痛经灵颗粒质量标准研究

Study on the Quality Standard of Tongjingling Granules

目的研究制定痛经灵颗粒的质量标准。方法用薄层色谱法定性鉴别赤芍、香附、元胡、桂枝和红花;用高效液相色谱法测定原儿茶醛的含量。结果原儿茶醛在0.169~1.123μg范围内呈良好的线性关系,r=0.999 7,平均回收率为99.5%,RSD=0.83%。结论鉴别方法专属性强,定量方法简便、准确、可靠,可用于该制剂的质量控制。

Objective To research the quality control standard of Tongjingling Granule.Methods Red Peony Root,Cyperi Rhizoma,Corydalis Rhizoma,Cinnamom Ramulusi and Carthami Flos were identified in Tongjingling granules by TLC.The protocatechuicaldehyde content in Tongjingling granules was determined by RP-HPLC,with methylalcohol-0.5%acetic acid（20：80）as molile phase,the detection wavelength was set at 280 nm and flow rate was 1.0 mL·min-1.Results Protocatechuicaldehyde showed a good linearity in a range of 0.169~1.123 μg（r=0.999 7）.The average recovery of protocatechuicaldehyde was 99.5% and RSD was 0.83%（n=5）.Conclusion The method is simple,specific and accurate.This study provide a method for the quality control of Tongjingling granules.