肠安口服液质量标准的制订

Study on the Quality Standard of Changan Oral Solution

目的:制订中药制剂肠安口服液的质量标准。方法:采用薄层层析法及硫酸-糠醛法对猪胆汁进行鉴别,薄层扫描法测定猪去氧胆酸的含量。结果:鉴别方法专属性强;含量测定猪去氧胆酸在3.50～12.25μg内积分值与点样量呈线性,回收率为100.5%,RSD为3.2%。结论:本质量标准可用于肠安口服液的质量控制。

Objective:To study the quality standard of Changan oral solution.Method:Thin layer chromatography was used for identification pig's bile plaster.TLC scanning was used for the determination of hyodeoxycholic acid.Results:The TLC identifica- tion was highly specific and the spots was clear and concentrated.Linear regression for hyodeoxycholic acid was over the range of 3.50～12.25μg.The average recovery of hyodeoxycholic acid was 100.5 %,RSD was 3.2 %.Conclusion:This standard was capa- ble to effectively control the quality of Changan oral solution.