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本文对胰岛素注射液的稳定性按药典规定的项目进行了考察。结果:考察了5批武汉生化厂生产的在室温贮存最少4年的产品,发现只有1批比出厂时低6%;检验了15批在室温贮存2年至3年2个月的该厂过期产品,平均效价为98.2%,平均贮存期为2.47年,实验的平均斜率为4.92,可信限率为22.4%; 8批南京、上海等地过期检验的结果,平均效价为90.7%,平均出厂时间2.66年。考察了7批武汉生化厂出厂2年8个月～4年8个月的样品,pH 值、无菌检查均符合规定,澄明度检查在43瓶中只有1瓶有白块,有5瓶长霉,其余均符合规定。由此可见,胰岛素注射液按药典要求的结果来看,还是比较稳定的。
In this paper, the stability of insulin injection according to Pharmacopoeia projects were investigated. RESULTS: Five batches of products stored at least for 4 years at room temperature in Wuhan were examined and found that only 1 batch was 6% less than the factory. 15 batches of the factory that had been stored at room temperature for 2 years to 3 years and 2 months were expired The average titer was 98.2% with an average storage period of 2.47 years. The average slope was 4.92 and the confidence limit was 22.4%. The average titer of 8 batches of products in Nanjing and Shanghai was 90.7% The average factory time is 2.66 years. Seven batches of samples of Wuhan Biochemical Factory, two years and eight months to eight years and four years and eight months from the factory were investigated. The pH value and the sterility tests were in compliance with the regulations. Only one bottle of 43 bottles had whiteness and 5 bottles Mold, the rest are in line with the provisions. Thus, insulin injection according to the requirements of the Pharmacopoeia view, is still relatively stable.