胰岛素微粒剂的制备、含量、包裹率与生物活性稳定性

Studies on the Preparation,the Contents,the Encapsulation Efficiencies and the Bioactive Stabilities of Insulin Microparticles(INS MP)

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．

The contents of INS MP were measured by the method of the insulin biopotency and radioimmunoassay(RIA).The encapsulation efficiency was determined to be over 90% according to the RIA.By taking the biopotency as an index and using accelerated tests,the bioactive stabilities were determined.The contents were 0.51 u/mg and 0.55 IU/mg and the bioactivity at 25℃ was valid for 12.5 months.