摘要
分别采用阴性分数法和残存曲线法,测定湿热灭菌用自含式生物指示剂的D值,并对测定结果进行比较分析。阴性分数法和残存曲线法的测定结果分别为(2.22±0.10)min和(1.91±0.10)min,二者均高于标示值1.7 min。相比较而言,阴性分数法试验操作较为简便,但样品用量较大;而残存曲线法试验操作较为复杂,样品用量较小。通过分析比较可知,2种方法均适用于湿热灭菌用自含式生物指示剂的D值测定,可以根据实际情况和需求选择使用。
Fraction negative method and survivor curve method were used to determine the D value of self- contained biological indicator for steam sterilization. The results were compared and analyzed. The determined D values of fraction negative method and survivor curve method were (2.22±0.10) min and (1.91±0.10) min, both of which were higher than the labeled D value (1.7 min). As a result, the operation for fraction negative method is simpler but it needs a larger amount of sample, meanwhile, the survivor curve method is more complicated to operate but its sample volume is smaller. Both of them can be used to determine D value of self-contained biological indicator for steam sterilization. Fraction negative method is recommended to be preferred, however, if the sample is insufficient, survivor curve method is an alternative method. Experimenters could choose the most suitable method according to the actual situation.
作者
马仕洪
王似锦
熊骏
肖璜
胡昌勤
MA Shihong;WANG Sijin;XIONG Jun;XIAO Huang;HU Changqin(National Institutes for Food and Drug Control, Beijing 100050;JiangXi Institute for Drug Control, Nanchang 330029;Beijing SanYao Science & Technology Development Co., Beijing 100176)
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2018年第5期667-671,共5页
Chinese Journal of Pharmaceuticals
基金
国家十二五"重大新药创制"专项(2015ZX09303001002001)
关键词
湿热灭菌
生物指示剂
D值
阴性分数法
残存曲线法
steam sterilization
biological indicator
D value
fraction negative method
survivor curve method