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在第一报筛选出两个多相脂质体(139,76)处方的基础上,进一步对其混悬型静脉注射液的稳定性与临床前药理进行了试验研究。多相脂质体属于热力学不稳定系统,分散相易于合并而破坏。因此,对制剂稳定性的评价是十分必要的。我们采用了激光散射法测定了139、76二处方配制的成品中的粒度分布情况,结果指出,139和76在1.0μ以下的粒子分别占98.88%和83.76%,而大于5.0μ的粒子只在76中占1.32%;经80℃处理72小时后再进行粒度
On the basis of the first screening of two multiphasic liposomes (139, 76) prescription, the stability and preclinical pharmacology of the suspension intravenous injection were further studied. Heterogeneous liposomes are thermodynamically unstable systems, and disperse phases tend to combine and destroy. Therefore, the stability of the formulation evaluation is very necessary. The laser scattering method was used to determine the particle size distribution in the finished products of 139 and 76. The results showed that particles 139 and 76 less than 1.0μ accounted for 98.88% and 83.76%, respectively, whereas particles larger than 5.0μ 76 accounted for 1.32%; after 80 ℃ for 72 hours before the particle size