市售3厂家甲硝唑注射剂的质量评价

目的:对市售3个厂家生产的9批甲硝唑注射剂进行质量比较,为临床选药提供参考。方法:参考《美国药典》、《英国药典》、《中国药典》、卫生部部颁标准和企业内控标准,选择临床有意义的指标进行比较,包括澄明度、pH值、不溶性微粒、渗透压、无菌、细菌内毒素、含量、有关物质等项目。对于药典未收载的注射用无菌粉末建立了以高效液相色谱法测定含量和有关物质的方法,经过验证能满足检测需要。结果:除注射用无菌粉末的渗透压、不溶性微粒较高外,所测各厂产品均符合《中国药典》的要求。结论:不同厂家的产品存在一定的质量差异,建议对甲硝唑注射用无菌粉末的质量项目加以注意并控制。

Quality Control of Commercially Available Metronidazole Injections from 3 Manufacturers

OBJECTIVE： To compare the qualities of 9 batches of Metronidazole injections from 3 manufacturers, and to provide reference for clinical use of drugs. METHODS： The physical and chemical properties, such as clarity, pH, insoluble particle, permeate pressure, asepsis, bacterial endotoxin, content and relevant material, were investigated according to the strict standards, including USP, BP, ChP, National Standard of Ministry of Health （MOH）, and standard of Baxter Healthcare. HPLC method was established to determine the content of sterile powder for injection excluded from pharmacopeia and relevant substances, which could meet the requirement of determination by validating. RESULTS： The quality of sterile powder for injection was in line with the standards stated in Chinese Pharmacopeia except for permeate pressure and insoluble particle of it. CONCLUSION： There are some differences among products from different manufacturers. It is suggested to pay attention to and control the quality of Metronidazole sterile powder for injection.