摘要
目的:建立重组人血小板衍生生长因子(rhPDGF-BB)的质控方法和质量标准。方法:以BALB/C 3T3细胞增殖实验及MTT染色法测定dIPDGF-BB的生物学活性,还原型SDS-PAGE确定B链分子量,SDS-PAGE和反相高效液相色谱测定纯度,毛细管电泳法测定等电点,用胰蛋白酶酶切后分析肽图,其余检测项目按《中国生物制品规程》2000版规定进行。结果:用建立的方法对连续3批rhPDGF-BB原液和成品进行了检定,各项指标均符合《重组DNA制品质量控制要点》和《中国生物制品规程》的要求。结论:建立的质控方法和质量标准具有保证产品安全、有效、质量可控的特点,可用于重组人血小板衍生生长因子产品的常规检定。
Objective: To establish methods and requirements for quality control of recombinant human platelet -derived growth factor - BB ( rhPDGF - BB). Method: Biological potency of rhPDGF - BB was determined by BALB/C 3T3 cell proliferation assay. Molecular weight of rhPDGF B chain was detected by reduced SDS - PAGE. Purity of rhPDGF - BB was analysed by SDS - PAGE and RP - HPLC. Isoelectric point and peptide mapping were detected separately by CE and tryptic digestion. Routine test were all fulfilled accordingly to the National Requirements for Biological Products. Results: The requirements and methods for quality control of rhPDGF - BB had been established and used for quality control of three simultaneous batches of bulk and final product. The results of all test complied with the requirements of quality control of rhPDGF - BB. Conclusion: The methods and requirements for quality control of rhPDGF - BB showed advantages of assuring the products safety and efficiency, which can be used for routine quality control of rhPDGF - BB.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2004年第1期4-7,共4页
Chinese Journal of Pharmaceutical Analysis
基金
国家863"十五"计划项目
课题编号:2001AA215071
