【摘要】 目的确认人血白蛋白和静注人免疫球蛋白(p H4)中间样品的微生物限度检查存放条件和待检有效期。方法取两种血液制品的中间样品,除菌过滤后接种一定浓度的荧光假单胞菌菌悬液,将其放置于不同温度,定时抽取供试品进行微生物限度检查,并对结果进行分析。结果放置在2~8℃,人血白蛋白和静注人免疫球蛋白(p H4)中间样品的待检有效期均为24h;放置在20~25℃,人血白蛋白和静注人免疫球蛋白(p H4)中间样品的待检有效期分别为10h和8h。结论存放温度和储存时间均对中国药典中两种非规定灭菌的血液制品中间样品微生物真实含量有重要影响。严格按照待检有效期要求存放样品,能够使微生物限度检查结果更真实。更多还原

【Abstract】 Objective Confirmed the storage temperature and validity period of the microbial limit test for Human Albumin and Human Immunoglobulin(p H4) for Intravenous Injection during the productive process. Method The sterile filtrations were performed for the two samples of blood products during the productive process. Then inoculate a certain concentration of Pseudomonas fluorescens’ bacteria suspension to the samples and store them in different temperature, extract for microbial limit examination of the test regularly, analyze the results. Results Placed in 2 ~ 8℃, the validity period of both Human Albumin and Human Immunoglobulin(p H4) was 24 h. Placed in 20~25℃, the validity period of Human Albumin was 10 h, and the validity period of Human Immunoglobulin(p H4) for Intravenous Injection was 8h. Conclusion Storage temperature and time have a major impact on the microbial real contents of the two blood products, which are non-regulation sterilization in Chinese Pharmacopoeia. To store the samples in strict accordance with the conditions can make the test results more real.更多还原