六种大容量灭菌制剂中的细菌内毒素及5-HMF的限量测定

目的:建议合理地制定5%葡萄糖注射液(5%G.S)、10%葡萄糖注射液(10%G.S)、葡萄糖氯化钠注射液(G.S.NaCl)、0.9%氯化钠注射液(0.9%NaCl)、甲硝唑葡萄糖注射液(甲-G)、甲硝唑注射液(甲硝唑)等六种大容量灭菌制剂中内毒素和5-HMF的质控新标准.方法:依<药典>规定的测定方法对全国11家G.M.P认证企业和已通过G.M.P验收的三家医疗单位,共计14个单位六种46批大容量灭菌制剂进行了细菌内毒素的限量测定及5-HMF的测定.结果:六种大容量灭菌制剂中的细菌内毒素含量均＜0.125EU·ml-1,又随意抽测了九批大容量灭菌制剂做更高灵敏度内毒素测定,结果均＜0.0625EU·mL-1;5%G.S、10%G.S中的5-HMF吸收度平均为0.086;G.S.NaCl中的5-HMF吸收度平均为0.033;甲-G中的5-HMF吸收度平均为0.003.结论:考虑到内毒素测定时的各种影响因素,为此,建议六种大容量灭菌制剂的内毒素限量值(Et)应规定为0.25EU·ml-1、5%G.S、10%G.S中的5-HMF吸收度限量值应规定为0.20、G.S.NaCl中的5-HMF吸收度限量值应规定为0.15、甲-G中的5-HMF吸收度限量值应规定为0.06则较为合理.

Limit Test of Bacterial Endotoxins and 5-HMF in Six Large Volume Sterilized Preparations

Objective: To establish the reasonable new standards of quality control for bacterial endotoxins test and 5-HMF in 5% G.S,10% G.S,G.S-NaCl,0.9% NaCl,Metronidazole-G.S Injection and Metronidazole Injection.Methods: According to assay method of Pharmacopoeia of China,limit test of bacterial endotoxins and 5-HMF in six large volume sterilized preparations were determined in 46 batches,which came from eleven G.M.P conformity certification enterprises and their medicine units.Results: Content of bacterial endotoxins in those preparations were lower than 0.125EU·ml^-1,while they were lower than 0.0625 EU·ml^-1 in nine batches by random sampling.Average absorbance of 5-HMF was 0.086 in 5% G.S and 10% G.S,while it was 0.033 in G.S-NaCl and 0.003 in Metronidazole-G.S Injection.Conclusion: Because of various kinds of influence factors,we suggest that confinement quantity (Et) of bacterial endotoxins test in those preparations is specified at 0.25 EU·ml^-1.Absorbance of 5-HMF is specified at 0.20 in 5% G.S,0.15 in G.S-NaCl and 0.06 in Metronidazole-G.S injection,respectively.