论文部分内容阅读
目的分析《中国药典》三部(2010版)细菌内毒素检查法凝胶半定量试验判断模式的合理性,为其修订提供科学依据。方法通过分析407批冻干人用狂犬病疫苗(Vero细胞)凝胶半定量试验结果,评价《中国药典》三部(2010版)细菌内毒素检查法凝胶半定量试验判断模式。结果 407批样品的内毒素检验结果中,符合规定404批(99.26%),不符合规定1批(0.25%),共有2批次出现无法判断情况,占0.49%。结论建议将《中国药典》三部(2015版)细菌内毒素检查法凝胶半定量试验判断模式修订为:系列溶液A中每一系列平行管的终点稀释倍数乘以λ,为每个系列的反应终点浓度;若每一系列内毒素浓度均小于规定的限值,判定供试品符合规定,否则判定供试品不符合规定。修订后的判断模式不存在无法判断的情况,更科学严谨。
Objective To analyze the rationality of the semi-quantitative test of gel endotoxin in the three Chinese Pharmacopoeia (2010 edition) bacterial bacterial toxins test to provide a scientific basis for its revision. Methods The gel semiquantitative test results of 407 batches of lyophilized human rabies vaccine (Vero cells) were analyzed to evaluate the semi-quantitative assay of gel endotoxin in the Chinese Pharmacopoeia (2010). Results Of the 407 batches of samples, 404 batches (99.26%) of the endotoxin test results did not meet the requirements and 1 batch (0.25%) did not meet the requirements. A total of 2 batches of them could not be judged, accounting for 0.49%. Conclusions It is suggested that the semi-quantitative test of bacterial endotoxin test in the three parts of Chinese Pharmacopoeia (2015 edition) should be revised as follows: the end point dilution times of each series of parallel tubes in series A times λ, Reaction end point concentration; if each series of endotoxin concentrations are less than the prescribed limit, determine the test product meets the requirements, otherwise determine the test product does not meet the requirements. The revised judgment mode does not exist to judge the situation, more scientific and rigorous.