湖北省眼用制剂中抑菌剂的使用及控制

Use and Administration Condition of Bacteriostatic Agents for Ophthalmic Preparations in Hubei Province

目的分析湖北省眼用制剂中抑菌剂的使用情况及控制状况,为眼用制剂质量控制及监管提出建议,促进湖北省眼用制剂质量的提升。方法调查湖北省眼用制剂生产企业50个眼用制剂品种的80个处方,检测22批有代表性品种中抑菌剂的种类和含量。结果处方中添加抑菌剂有羟苯酯类、季铵盐类、有机汞类、三氯叔丁醇和其他醇类。50个品种中仅20%质量标准中控制了抑菌剂,且存在控制种类和处方种类不一致现象。抑菌剂的含量低于处方量80%的占40.9%。结论湖北省部分眼用制剂中抑菌剂缺乏控制,部分产品抑菌剂低于处方量。建议从标准制定、处方合理性、工艺等方面联合提升眼用制剂的质量。

Objective To analyze and investigate the use and administration condition of bacteriostatic agents in ophthalmic preparations in Hubei province, provide suggestions for the quality control and supervision, and promote the quality of the ophthalmic preparations. Methods Eighty prescriptions of 50 ophthalmic preparations from all ophthalmic preparation manufacturing enterprise in Hubei province were included in the investigation. Twenty-two representative batches were tested and evaluated according to the types and contents of bacteriostatic agents. Results The bacteriostatic agents added to the prescription included hydroxyphenyl esters, quaternary ammonium salts, organic mercury, chlorobutanol and other alcohols. Only 20% quality standards of the 50 preparations evaluated bacteriostatic agents, and there are inconsistencies between control types and prescription types. About 40.9% of ophthalmic preparations have a bacteriostatic agent content lower than 80% of the prescription amount. Conclusion In a part of ophthalmic preparations in Hubei province, there is a lack of quality control in bacteriostatic agents, and some products have lower bacteriostatic agent content than prescriptions. In order to improve the quality of ophthalmic preparations, hard work is needed from the aspects of standard setting, prescription rationality and manufacturing technique.