硼酸甘油滴耳液质量标准提高研究

Quality Standard of Boric Acid Glycerine Ear Drops

目的改进硼酸甘油滴耳液的鉴别以及含量测定的方法,以提高该制剂的质量标准。方法硼酸盐、甘油的鉴别反应均采用《中国药典》的鉴别方法;含量测定方法依据国家药品标准技术规范规定,增加取样量。结果分别对上述鉴别以及含量测定的方法进行试验验证,鉴别方法重复性良好,含量测定方法经过准确性、耐用性验证以及与原方法进行比较可行。结论所建立和改进的方法简便、灵敏、准确、专属性强,可作为硼酸甘油滴耳液的质量控制方法。

Objective To improve determination methods of boric acid glycerine ear drops in order to improve the quality standard of this preparation. Methods Methods for identification specified in ＂Chinese Pharmacopoeia＂ （2010 edition） were adopted. Identification methods of glycerol are based on the current version of ＂Chinese Pharmacopoeia ＂. Methods for determination of the content were based on the national technical specifications. Results Methods for determination and identification were verified respectively. The identification method showed good reproducibility and the one for determination of the content proved feasible. Conclusion The established method is simple, sensitive, accurate, reproducible, and can be used for quality control of boric acid ear drops.