通便灵胶囊质量标准改进

目的提高通便灵胶囊的质量控制标准。方法参照2005年版《中国药典（一部）》番泻叶的质量要求，对该产品的质量进行全面检测，并用薄层色谱法对其番泻苷进行定性鉴别，用紫外分光光度法对总番泻苷含量进行测定。结果采用薄层定性方法，斑点清晰，分离完全，易于区别。含量测定方法的精密度为1．8％，平均回收率为99．43％，RSD=1．05％（n=6）。结论建立的定性及定量方法准确、可靠、重现性好。可作为通便灵胶囊的质量控制方法。

Improvement of Quality Standard for Tongbianling Capsule

Objective To establish the quality control standard of Tongbianling Capsule.Methods The preparation was monitored according to the quality requirements of sennoside in the Chinese Pharmacopoeia.Its ingredient,sennoside was identified by TLC.The total sennoside in the preparation was quantitatively detected by UV.Results The spots were clear and separated completely in the TLC methods.The average recovery rate of the determining method was 99.43% with a RSD of 1.05% and its repeatability was good(standard derivations=1.8%). Conclusion The quality standard of the preparation is provided.The methods of identification and determination are accurate and repro-ducible.It can be used for quality control of Tongbianling Capsule.