岩黄连直肠栓质量标准研究

Study on Quality Standard of Corydalis Saxicola Rectal Suppository

目的建立岩黄连直肠栓的质量标准。方法采用薄层色谱法对岩黄连直肠栓进行定性鉴别,用高效液相色谱法对岩黄连碱(脱氢卡维丁)进行含量测定。结果岩黄连碱质量浓度在12.5～100.0μg/mL范围内与峰面积积分值呈良好线性关系(r=0.999 9),平均加样回收率为100.32%RSD=1.46%(n=6)。结论该质量标准准确、可靠,能有效控制岩黄连直肠栓的质量。

Objective To establish a quality standard for Corydalis Saxicola Rectal Suppository. Methods TCL was adopted for conduct- ing the qualitative identification of Corydalis Saxicola Rectal Suppository;HPLC was used to determine the content of dehydrocavidine in this preparation. Results The sample size of dehydrocavidine in the range of 12.5- 100.0 μg/mL exhibited a good liuearity relation- ship with the peak area（ r =0. 999 9）. The averager recovery rate of dehydrocavidine was 100. 32% （RSD = 1.46%, n =6）. Conclusion This quality standard is accurate and reliable, and can effectively control the quality of Corydalis Saxicola Rectal Suppository.