摘要
目的:建立重组人白介素-2(rhIL-2)吸入粉雾剂的含量测定方法,测定该制剂中 rhIL-2的含量。方法:建立高效液相色谱法测定 rhIL-2吸入粉雾剂中 rhIL-2的含量,并且将由含量换算出的效价值,和 CTLL-2依赖细胞株的 MTT 比色法的测定结果进行比较。结果:该法专属性强,可用于 rhIL-2原料和吸人粉雾制剂的测定。测定的含量值换算成效价值后,与MTT 比色法相比,测定结果有较好的相关性。结论:基于方法的简便性,精密性,确定在制剂研究中,选择以 HPLC 法进行初筛,对较优处方结合 MTT 比色法进行复筛。
Objective ：To set up an appropriate method to determine recombinant human interleukin -2 （rhIL- 2） in rhIL - 2 powder for inhalation. Methods： Set up RP - HPLC to determine rhIL - 2 and compare the methods with MTr colorimetry. Results：The method of RP - HPLC was specific and suitable for determining rhIL -2 and rhIL - 2 powder for inhalation. And the titers conversed from the contents by HPLC are equal to those by MTY colorimetry. Conclusion： RP - HPLC method is applied to study the formulations extensively and MTT colorimetry method is applied for verification of the selected formulations by RP - HPLC.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2005年第11期1360-1363,共4页
Chinese Journal of Pharmaceutical Analysis
基金
中国药科大学抗非典科技攻关基金项目(Y0308)
