乳核内消液的质量标准

Study on Quality Standard for Ruhe Neixiao Liquids

目的:提高乳核内消液的质量标准。方法:采用TLC法定性鉴别;采用HPLC法测定赤芍中芍药苷含量。结果:TLC色谱能明显检出浙贝母、赤芍、柴胡,阴性对照无干扰;芍药苷在0.21～1.74μg范围内线性关系良好,平均回收率为99.86%,RSD为1.69%。结论:定性、定量方法可靠、准确,专属性强,重复性好,可作为本品质量标准,用于该制剂质量控制。

Objective： To improve a quality standard for ruhe neixiao liquids. Method： Ruhe neixiao liquids was identified by TLC ;the effective components in ruhe neixiao liquids were determined by HPLC. Result： The relevent spots in Bulbus Fritillariae Thun- bergii, Radix Paeoniae Rubra and Radix Bupleuri can be identified by TLC. The content of Paeoniflorin in Radix Paeoniae Rubra can be determined by HPLC. The linearity of Paeoniflorin was good in the range of 0. 21-1.74 μg, the average recovery of Paeoniflorin was 99. 86% and RSD was 1.69%. Conclusion： The establisted method is simple,feasible and repeatable,and can be used for quality control of ruhe neixiao liquids.