药学研究
藥學研究
약학연구
Journal of Pharmaceutical Research
2015年
10期
588-590
,共3页
任传杰%李坤娓%黄国英%张健
任傳傑%李坤娓%黃國英%張健
임전걸%리곤미%황국영%장건
羟乙基淀粉130/0.4%超滤%中空纤维%重均分子量
羥乙基澱粉130/0.4%超濾%中空纖維%重均分子量
간을기정분130/0.4%초려%중공섬유%중균분자량
Hydroxyethyl starch 130/0.4%Ultrafiltration%Hollow fiber%Weight average molecular weight
目的:比较6 kD 和10 kD 截留分子量中空纤维超滤膜对羟乙基淀粉130/0.4的洗滤能力和去除小分子羟乙基淀粉的能力。方法通过恒压试验,考察过膜压力、通量及水通量恢复率。以重均分子量与分子量分布为检测指标,通过凝胶渗透色谱-多角度激光光散射法检测不同洗滤倍数下的变化。结果恒压试验下6 kD 和10 kD 超滤膜平均通量分别为13.8 LMH 和13.3 LMH,基本一致。经6 kD 超滤膜8倍洗滤,重均分子量与分子量分布可符合《欧洲药典》要求。经10 kD 超滤膜洗滤,重均分子量与分子量分布无法同时满足《欧洲药典》要求。结论截留分子量为6 kD 的中空纤维超滤膜更适合羟乙基淀粉130/0.4的超滤精制。
目的:比較6 kD 和10 kD 截留分子量中空纖維超濾膜對羥乙基澱粉130/0.4的洗濾能力和去除小分子羥乙基澱粉的能力。方法通過恆壓試驗,攷察過膜壓力、通量及水通量恢複率。以重均分子量與分子量分佈為檢測指標,通過凝膠滲透色譜-多角度激光光散射法檢測不同洗濾倍數下的變化。結果恆壓試驗下6 kD 和10 kD 超濾膜平均通量分彆為13.8 LMH 和13.3 LMH,基本一緻。經6 kD 超濾膜8倍洗濾,重均分子量與分子量分佈可符閤《歐洲藥典》要求。經10 kD 超濾膜洗濾,重均分子量與分子量分佈無法同時滿足《歐洲藥典》要求。結論截留分子量為6 kD 的中空纖維超濾膜更適閤羥乙基澱粉130/0.4的超濾精製。
목적:비교6 kD 화10 kD 절류분자량중공섬유초려막대간을기정분130/0.4적세려능력화거제소분자간을기정분적능력。방법통과항압시험,고찰과막압력、통량급수통량회복솔。이중균분자량여분자량분포위검측지표,통과응효삼투색보-다각도격광광산사법검측불동세려배수하적변화。결과항압시험하6 kD 화10 kD 초려막평균통량분별위13.8 LMH 화13.3 LMH,기본일치。경6 kD 초려막8배세려,중균분자량여분자량분포가부합《구주약전》요구。경10 kD 초려막세려,중균분자량여분자량분포무법동시만족《구주약전》요구。결론절류분자량위6 kD 적중공섬유초려막경괄합간을기정분130/0.4적초려정제。
Objective To compare 6 kD and 10 kD MWCO hollow fiber ultrafiltration membrane's effect of hydroxy-ethyl starch 130 / 0. 4 ultrafiltration and the ability to remove small molecules hydroxyethyl starch. Methods The recovery rates of membrane pressure,flux and water flux were investigated by the constant pressure test. Through SEC - MALLS method to detect changes in weight average molecular weight and molecular weight distributions at different diafiltration time. Results Under constant pressure test,6 kD and 10 kD ultrafiltration membrane average flux was 13. 8 LMH and 13. 3 LMH,basically the same. After filtrating 8 times by 6 kD ultrafiltration membrane,the weight average molecular weight and molecular weight distribution could meet the requirements of European Pharmacopoeia. After filtrating by 10 kD ultrafiltra-tion membrane,the solution weight average molecular weight molecular weight distribution could not meet the requirements of European Pharmacopoeia. Conclusion 6 kD MWCO hollow fiber membrane was more suitable for hydroxyethyl starch 130 / 0. 4 ultrafiltration.