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采用生物效价与放射免疫分析两种方法对微粒剂胰岛素含量进行测定.通过胰岛素放射免疫活性分析测定了胰岛素包裹率.以胰岛素生物效价为指标,采用恒温加速实验考察了微粒剂的生物活性稳定性,结果表明:微粒剂胰岛素含量分别为0-51u/mg 与0-55IU/mg;包裹率在90 %以上;室温放置1 年,未见生物活性明显改变;25 ℃生物活性有效期为12-5 月.
Two methods of biological potency and radioimmunoassay were used to determine the insulin content of microgranules. Insulin delivery rates were determined by insulin radioimmunoassay. Insulin biological potency as an indicator, the thermostatic accelerated test investigated the stability of the biological activity of the microgranules, the results showed that: microgranules insulin content of 0-51u / mg and 0-55IU / mg; parcel rate of 90% or more; 1 year at room temperature, no significant change in biological activity; 25 ℃ biological activity is valid for 12-5 months.