色甘酸钠滴眼液的质量评价研究  

Studies on Quality Evaluation of Sodium Cromoglicate Eye Drops

作　　者：金丽[1] 张晓丹[1] 杭娟[1] 张心悦[1] 卜莹[1] 

机构地区：[1]南京军区联勤部药品仪器检验所,南京210002

出　　处：《中国药品标准》2017年第6期411-415,共5页Drug Standards of China

摘　　要：目的:从色甘酸钠滴眼液的溶液颜色、渗透压摩尔浓度、色甘酸钠含量和有关物质等方面开展一系列探索性研究,以期为色甘酸钠滴眼液的安全性和有效性作出更加合理的评价。方法:参照《中国药典》2015年版四部通则,对色甘酸钠滴眼液的溶液颜色进行目视法和色差计法检查,并测定其渗透压摩尔浓度;采用高效液相色谱法测定色甘酸钠滴眼液中色甘酸钠的含量,并与现行药典标准的紫外吸收系数法测定结果比较;在含量测定色谱条件下对13批次样品的有关物质相对含量进行测定。结果:色甘酸钠滴眼液的溶液颜色与性状描述的"无色或几乎无色"不符;渗透压摩尔浓度的测定结果显示,13批次样品中有10批次样品达不到等渗要求;含量测定结果表明:HPLC法测得的色甘酸钠含量略低于UV法所测含量;有关物质测定结果显示:色甘酸钠滴眼液的杂质相对含量总体较低,但随着贮藏时间的延长,杂质相对含量会增大。结论:色甘酸钠滴眼液现行质量标准性状描述不准确,缺乏渗透压摩尔浓度检查项,紫外吸收系数法测定色甘酸钠含量专属性差,易受干扰,不能有效地控制产品内在质量,建议修订质量标准。Objective： In order to make a more reasonable evaluation on the safety and efficacy of Sodium Cromo- glicate Eye Drops, a series of exploratory studies were made on the solution colour, osmolarity, content of cromogli- cate sodium and related substances. Methods： The general notices of ChP 2015 Vol IV were referred to. The solu- tion colour of Sodium Cromoglicate Eye Drops was examined by the visual and colorimeter methods, and its osmolal- ity was tested. The content of Sodium Cromoglicate in Sodium Cromoglicate Eye Drops was determined by HPLC, and the result was compared with that obtained by the ultraviolet absorption coefficient method in ChP 2015. The related substances in 13 batches of samples were determined under the chromatographic condition same as that in Assay. Results： The solution colour of Sodium Cromoglicate Eye Drops was inconsistent with the description of ＂colorless or almost colorless＂. The osmolality of 10 batches of samples can＇t meet the requirements. The contents of sodium citrate obtained by HPLC were slightly lower than that obtained by UV. The relative content of total im- purities in Sodium Cromoglicate Eye Drops was lower generally. But the relative content of impurities increased with the storage time extension. Conclusion： The current specification of Sodium Cromoglicate Eye Drops has the issues of the inaccurate description, lack of osmolality test, the poor specificity and interference of UV absorption coeffi- cient method which can＇t control the quality of the products effectively. It is proposed to revise the current specifi- cation of Sodium Cromoglicate Eye Drops.

关 键 词：色甘酸钠滴眼液 色甘酸钠 溶液颜色 HPLC 渗透压摩尔浓度 

分 类 号：R921.2[医药卫生—药学]