梨杷止咳合剂的质量标准研究

Studies on Quality Standard of Lipazhike Mixture

目的建立梨杷止咳合剂的质量标准。方法采用薄层色谱法鉴别制剂中的枇杷叶、菊花、甘草、桔梗,采用《中国药典》2010年版一部中的相关方法进行微生物限度检查方法验证。结果制剂中的枇杷叶、菊花、甘草、桔梗的薄层色谱方法专属性强、重现性好;细菌、霉菌及酵母菌计数可用平皿法,控制菌检查可用常规法。结论建立的方法能有效地控制梨杷止咳合剂的质量。

OBJECTIVE To establish the quality standard of Lipazhike mixture. METHODS Eriobotryae Folium,Chrysanthemi Flos,Glycyrrhizae Radix Et Rhizoma and Platycodonis Radix in Lipazhike mixture were identified by TLC. The validation test for microbial limit was carried out according to the methods and instructions described in the Chinese Pharmacopoeia（ 2010 Edition,Volume 1）. RESULTS The TLC methods were specific,reproducible. The plating method can be used for bacteria,mold and yeast count. The routine method can be used for the detection of control bacteria. CONCLUSION The methods can be used for quality control of Lipazhike mixture.