摘要
目的建立油浴法测定芽胞悬液形式的湿热灭菌用生物指示剂的D值以及Z值。方法将芽胞悬液密封于玻璃毛细管内,置恒温的油浴仪内达到灭菌条件,采用残存曲线法测定不同温度下的D值,并计算Z值。结果嗜热脂肪地芽胞杆菌(Geobacillus stearothermophilus ATCC7953)芽胞悬液在117、121和125℃下的D值为7.04、2.18和0.65 min,Z值为7.75℃。生孢梭菌[Clostridium sporogenes CMCC(B)64941]芽胞悬液在95、100和105℃下的D值为11.36、2.85和0.45 min,Z值为7.14℃。结论油浴法直接模拟液体制剂的灭菌,能够方便、准确的测定芽胞悬液形式的生物指示剂D值和Z值,线性水平良好(r^2均达到0.980 0以上),可用于制药行业芽胞悬液形式的湿热灭菌用生物指示剂的耐热性研究。
OBJECTIVE To establish an oil bath method to determine the D values and Z value of biological indicators in spore suspension forms for moist heat sterilization. METHODS Spore suspension was sealed up in glass capillary, which was heated by thermostat oil bath. D value and Z value were determined by survivor curve method. RESULTS The D values of Geobacillus stearothermophilus ATCC7953 spores suspension at 117, 121 and 125 ℃ were 7.04, 2. 18 and 0. 65 min, respectively, and the Z value was 7.75 ℃. The D values of Clostridium sporogenes CMCC ( B ) 64941 spores suspension at 95, 100 and 105 ℃ were 11.36, 2.85 and 0. 45 rain, respectively, and the Z value was 7. 14℃. CONCLUSION By simulating the sterilization of aqueous liquid with oil bath method, the D values and Z values of biological indicators in spore suspension forms for moist heat sterilization can be determined conveniently and accurately(r^2P is above 0. 980 0). The oil bath method can be used for heat resistance research of biological indicators in spore suspension form for moist heat sterilization.
作者
王似锦
武永秀
肖璜
马仕洪
胡昌勤
WANG Si-jin;WU Yong-xiu;XIAO Huang;MA Shi-hong;HU Chang-qin(National Institutes for Food and Drug Control, Beijing 100050, China;Beijing SanYao Science & Technology Development Co. , Beijing 100176, China)
出处
《中国药学杂志》
CAS
CSCD
北大核心
2018年第11期912-917,共6页
Chinese Pharmaceutical Journal
基金
国家十二五"重大新药创制"专项-"化药制剂质量评价关键技术研究"资助(2015ZX09303001002001)
关键词
生物指示剂
耐热性
D值
Z值
油浴
biological indicator
heat resistance
D value
Z value
oil bath