妇康宝口服液的质量标准研究

Study on the Quality Standard for Fukangbao Oral Liquid

目的 :建立妇康宝口服液的质量标准。方法 :用薄层色谱法对白芍、当归和川芎进行了定性鉴别 ,用反相高效液相色谱 (RP HPLC)法测定了口服液中芍药苷的含量。结果 :定性鉴别分离度好 ,专属性强 ;芍药苷在 0 .1 99～ 1 .988μg范围内呈良好的线性关系 ,r =0 .9999,平均加样回收率为 98.73% ,RSD为 0 .86 %。结论 :所建立的方法简便准确、灵敏度高 ,可用于妇康宝口服液的质量控制。

Objective: To establish the quality standard of Fukangbao Oral Liquid. Method :TLC was used for qualitative identification of the Radix Paeoniase,Radix Angelicase Sinensis,Rhizoma Chuanxiong,and RP HPLC was used for assay of Paeoniflorin in the preparation.Result: The study showed that spots of samples on TLC could be well separated,and the method had strong specificity. Paeoniflorin showed a good linear relationship at a range of 0.199～1.988 μg,r=0.999 9.The average recovery was 98.73%,and RSD was 0.86%.Conclusion : The method is simple,accurate and high sensitive. It can be used for quality control of Fukangbao Oral Liquid.