嗜热脂肪地芽孢杆菌的芽孢在4种溶液中的D值比较研究  

Comparison of D Values of Geobacillus stearothermophilus Spores in Different Solutions

作　　者：王似锦[1] 褚婧 马仕洪[1] WANG Sijin;CHU Jing;MA Shihong(NMPA Key Lab.for Quality Research and Evaluation of Chemical Drugs,National Institutes for Food and Drug Control,Beijing 100050)

机构地区：[1]中国食品药品检定研究院,国家药品监督管理局化学药品质量研究与评价重点实验室,北京100050

出　　处：《中国医药工业杂志》2023年第1期131-134,153,共5页Chinese Journal of Pharmaceuticals

摘　　要：将嗜热脂肪地芽孢杆菌(Geobacillus stearothermophilus,ATCC7953)的芽孢悬浮于不同的溶液中,采用残存曲线法测定121℃下的耐受性(D值)并进行比较。结果表明,嗜热脂肪地芽孢杆菌的芽孢在纯化水、胰酪大豆胨(TSB)液体培养基、5%葡萄糖注射液和碳酸氢钠注射液中的D值分别为3.26、3.61、0.97和2.94 min。芽孢在不同介质中所表现出的耐受性不同,因此在灭菌工艺验证过程中进行生物学确认时,选择芽孢和生物指示剂应考虑芽孢在不同溶液中耐受性的差异,应根据所测定的不同D值计算初始的芽孢接种量,以得到准确的生物杀灭力,使灭菌工艺的热力学杀灭效果保持足够的冗余,从而提供足够的无菌保证水平。In this paper, spores of Geobacillus stearothermophilus were inoculated to different solutions, and their heat resistances(D values) were determined by the survivor curve method. The results indicated that D values of spores of Geobacillus stearothermophilus in purified water, trypticase soy broth(TSB) medium, 5% glucose injection,and sodium bicarbonate injection were 3.26, 3.61, 0.97, and 2.94 min, respectively. So, differences in heat resistance of spores in different solutions should be generally considered when selecting spores and biological indicators, and the inoculum size should be calculated by D values to get more accurate biological lethality in the biological qualification of sterilization validation, and keep enough safety margin for the thermal lethality in order to provide sufficient sterility assurance level in the sterilization process performance qualification of the parenteral drugs.

关 键 词：生物指示剂 嗜热脂肪地芽孢杆菌 芽孢 残存曲线法 耐热性 D值 

分 类 号：R187[医药卫生—流行病学]