硫酸卡那霉素注射液及滴眼液的质量评价

目的 评价国内不同厂家生产的硫酸卡那霉素注射液及滴眼液的质量现状及存在问题。方法 按照国家评价性抽验计划总体要求，采用法定检验方法结合探索性研究进行样品研究，统计分析检验结果。结果 按照法定标准检验抽取的112批次样品，不合格率1.8%，不合格项目为装量、渗透压摩尔浓度和可见异物。标准检验发现现行标准不统一，存在限度不合理、安全性项目(有关物质、防腐剂)缺失问题。探索性研究新建了完善的杂质谱分析方法，对主要杂质的来源与结构进行了确证；新建了滴眼液中防腐剂检查方法和氯离子、硫酸根离子及硫代硫酸根离子的含量测定方法。结论 目前国产硫酸卡那霉素注射液及滴眼液的产品质量基本能符合现行标准要求，而探索性研究提示现行标准存在缺陷，不能全面反映产品的质量，需进一步完善，以保证药物的安全和有效；建议企业对原料工艺进行优选，以提高产品质量。

Quality assessment of kanamycin sulfate injection and eye drops

Objective To evaluate the suitability of the statutory standard and the quality status of kanamycin sulfate injection and eye drops of different domestic manufacturers. Methods According to the general requirements of national assessment programs, the statutory standard methods combined with exploratory researches were used to evaluate the quality of kanamycin sulfate injection and eye drops. Results According to the statutory standards for the examination of the 112 batches, the unqualified rate was 1.8% and the unqualified items were minimum fill, osmotic pressure molar concentration, and visible particles. The standard test results showed that current standardswere not uniform. The limits were not reasonable and safety items (such as related substances and preservatives) were missing. The impurity profile was established. The sources and structures of major impurities were confirmed. New methods for the determination for preservatives and ions (chlorine ion, sulfate ion, and thiosulfate ion) were established. Conclusion On the one hand, the quality of domestic kanamycin sulfate injection and eye drops generally met the requirement of the current statutory standards. On the other hand, exploratory research results suggested that the current standards had defects. The quality control specifications need to be further improved. An improvement was put forward to promote the quality by material