摘要
目的:为开发干扰素α-2b新剂型提供纯化和质控的技术指标。方法:用反相离子对色谱法对干扰素α-2b的粗品进行分离纯化;用分子排阻色谱法测定其蛋白纯度。结果:反相离子对色谱法可使纯度为85％粗品提高到95％以上;分子排阻色谱法可通过峰面积比,快速、客观地确定表达蛋白的百分比,对主峰、次峰的分离度大于1.5。结论:反相离子对HPLC法可作为干扰素α-2b的纯化方法;分子排阻色谱法是鉴定基因工程干扰素的不可缺少的指标之一,它可对提纯工艺起到有效的监控作用。
Objective: To provide technological targets of purification and quality control for developing newer preparation of the interferons α-2b. Methods: The reversed phase ion pair chromalography(RPIPC) was used in sparation and purification of crude and pure interferon α-2b. The molecular exclusion chromatography(MEC') was used in determination of protein purity. Results: The 85 % crude and pure product was purified to 95 % by RPIFC. The percentage of protein could be rapidly and objectirely determined and expressed by molecule exclusion chromatography with the ratio of peak area. The resolution between main peak and hypo-peak was more than 1.5. Conclusion: PRIPC is a purity method of interferons a-2b. The MKC is one of essential target in identifing recombined interferons, it could effectivly control the technique of purification.
出处
《中国药师》
CAS
2000年第5期289-290,共2页
China Pharmacist
基金
深圳市科技局资助项目
关键词
干扰素Α-2B
纯化
蛋白纯度
反相离子对色谱法
Interferons α-2b
Purification
Purity
Ion pair chromatography. reversed phase
Molecule exclusion chromatography
