硼氯溶液质量标准的改进

Improvement of Quality Standard of Boron Chloride Solution

目的：改进并建立硼氯溶液的质量控制标准。方法：参照《中国药典》2010年版相关鉴别方法,在原质量标准只有硼酸鉴别项目的基础上,增加了硼氯溶液中盐酸萘甲唑啉和氯霉素的鉴别方法,并改进了硼酸的含量测定中滴定反应的介质（由甘露醇改为中性甘油）及确定了取样量为5 ml。结果：硼氯溶液中的主要成分硼酸、盐酸萘甲唑啉及氯霉素鉴别反应均呈阳性。硼酸检测质量浓度线性范围为10～32 mg/ml（r=0.999 5,n=7）,平均加样回收率为101.0%,RSD=1.10%（n=3）。与原标准方法比较,改进后方法终点明确,误差减小。结论：建立的质量控制方法简单、灵敏、准确度高,可提高硼氯溶液的质量标准。

OBJECTIVE：To improve and establish the quality standard of boron chloride solution.METHODS：The determination methods for naphazoline hydrochloride and chloramphenicol were added according to the methods in Chinese Pharmacopoeia（2010 edition）,based on previous standard.The reaction medium in the content determination of boric acid was neutral glycerine instead of mannitol,and sampling amount was 5 ml.RESULTS：The characteristic identification reactions were positive of all main components as boric acid,naphazoline hydrochloride and chloramphenicol.The linear range of boric acid were 10-32 mg/ml（r= 0.999 5,n=7）with an average recovery of 101.0%（RSD=1.10%,n=3）.Improved method had some advantage of clear end point and reduced error,compared with previous method.CONCLUSIONS：The established methods is convenient,sensitive and accurate,and can be used for the quality standard improvement of boron chloride solution.