益智合剂的制备及质量控制

目的:制备益智合剂并建立其质量控制方法。方法:水煮法制备益智合剂,用薄层色谱法对益智合剂中的远志、黄柏、甘草进行定性鉴别;用液-质联用法对益智合剂中痕量的芍药苷进行含量测定。结果:薄层色谱鉴别色谱特征明显,易于区别;本品中芍药苷检测浓度在0.25~10mg.L-1范围内与峰面积积分值呈良好线性关系,平均加样回收率为99.06%,RSD=4.91%(n=5)。结论:本合剂处方合理,制备工艺简便,建立了该合剂的质量标准,其鉴别与含量测定方法简单、可靠、实用。

Preparation and Quality Control of Yizhi Mixture

OBJECTIVE： To prepare Yizhi Mixture and establish a method for its quality control. METHODS： The mixture was prepared by water decoction method, Radix Polygalae, Cortex Phellodendri, and Radix et Rhizoma Glycyrrhizae uralensis Fisch.in the mixture were identified qualitatively by TLC. The contents of trace amount of paeoniflorin in Yizhi mixture was determined by HPLC. RESULTS： The studies on the quality control showed that the characteristics for identification by TLC were distinct. The linear range of peoniflorin was 0.25-10 mg · L ^-1.The average recovery was 99.06% and its RSD was 4.91% （n = 5） .CONCLUSION： The mixture is reasonable in formula and simple in preparation technology. A quality standard has been established for the mixture. The methods for identification and quantification were simple, reliable and practical.