提高儿童开胃乐口服液质量标准的方法  

Quality standard improvement for Ertong KaiWeile Oral Liquid

作　　者：王欢欢[1] 黄晓舞[1] WANG Huan-huan, HUANG Xiao-wu(Preparation Center, Chinese PLA General Hospital, Beijing 100853, CHINA)

机构地区：[1]中国人民解放军总医院制剂中心,北京100853

出　　处：《海南医学》2018年第6期812-814,共3页Hainan Medical Journal

摘　　要：目的建立完善的儿童开胃乐口服液质量标准。方法采用薄层色谱法对儿童开胃乐处方中山楂、莱菔子进行定性鉴别;参照《中国药典》2015年版四部通则1101建立儿童开胃乐口服液微生物限度检查方法;进行相对密度、pH值及装量检查。结果薄层色谱点清晰,分离良好,专属性强,阴性无干扰;微生物限度检查方法可行,相对密度及pH值符合规定。结论本研究建立的质量标准方法准确、可靠、稳定、专属性强,可作为该制剂质量控制方法。Objective To establish and improve the quality standard for Ertong KaiWeilc Oral Liquid. Methods Thin layer chromatography （TLC） was used to qualitatively identify Crataegi Fructus and Raphani Semen in Ertong KaiWeile Oral Liquid. The relative density, pH value and microbial limit were measured and revised according to Chinese Pharmacopoeia （2015 Edition） 1101. Results The TLC spots were clear and well-separated without any inter- fercnce from the negative sample. The relative density, pH value and microbial limit were qualified. Conclusion The established quality standard is accurate, reliable, stable and specific, which can be well used for the quality control of Er- tong KaiWeile Oral Liquid.

关 键 词：儿童开胃乐口服液 质量标准 薄层色谱 微生物限度检查 

分 类 号：R985[医药卫生—药品]