注射用水微生物含量与贮存温度、方式及时间的关系

Relationship of Microbial Content of Injection Water with Storage Temperature,Way and Time

目的验证注射用水微生物含量与贮存温度、方式及时间的相互关系。方法参照2010年版《中国药典(二部)》附录微生物限度检查法,检测不同贮存温度、不同贮存方式、不同贮存时间的注射用水中微生物含量。结果注射用水微生物含量与贮存温度成反比,与时间成正比,高温循环贮存方式可有效抑制注射用水中微生物生长。结论注射用水的贮存温度、方式与美国食品药物管理局和《药品生产质量管理规范》的要求一致时,可有效抑制微生物的生长,确保注射用水及配制成品的质量。

Objective To verify the relationship of microbial content of injection water with the storage temperature,way and time.Methods Refering to the microbial limit test described in the China Pharmacopeia 2010,the microbial content in injection water at different storage temperatures,ways and time were detected.Results The inverse relation was found between microbial content in injection water and the storage temperature while there was the proportional relation between microbial content in injection water and the storage time.High temperature and cycle storage way could effectively inhibit microbial growth in injection water.Conclusion When the storage temperature,way and time are consistent with the requirement of FDA and GMP,which can effectively inhibit microbial growth in injection water and ensure the quality of injection water and prepared products.