人降钙素基因相关肽脂质体质量标准的研究

Study of Requirements for Quality Control of hCGRP Liposome

建立完整的人降钙素基因相关肽脂质体 (LipohCGRP)药物的质量标准。用家兔球睫膜血管扩张法测定hCGRP的生物学活性 ;采用RP HPLC、等电聚焦、薄层层析等方法分别测定样品的纯度、等电点和迁移率及脂质体嵌入率的测定 ,并按照中国生物制品规程的要求完成了甲醇和氯仿等残留物质的分析和动物安全试验。建立了活性测定方法 ,能准确测定样品中不到 1ng的样品活性单位 ,连续三批样品的各项指标均符合质量标准的要求。建立了脂质体多肽药物的质量标准 ,并用于质量检定。

To establish an integral requirements and control methods for quality control of human Calcitonin Gene Related Peptide liposome.Biological activity was determined by enlarging corpuscule vessel of rabbit.The purity,isoelectric point,identification test and insertion rate were done separately,by RP HPLC,isoelectrofocusing and thin layer chromatography.According to the national Requirements for Biological Products,analysis of residual substances,for example,methanol and chroloform,and animal safety tests,were all fulfilled.The method of bioassay was established and used for determining activity of less than 1 ng hCGRP.Every test of three continuous batches of samples complied with the requirements of quality control.Quality criteria of liposome polypeptide drugs had been established,which was used for quality control.\;Key words\ hCGRP;Liposome;Quality control;Biological activity;Insertion ratenvironments,a set of commonly used methods and measures are being explored into.For the offshore engineering expolration,it is necessary to select the exploration methods,floating exploration boat,equipment and technology in line with the concrete condition of environment of the exploration site,in order to fulfil economically,safely and applicably the exploration task.