改良卵磷脂肉汤法在抗菌洗手液细菌检测中的验证研究

Validation study of Modified Letheen Broth method for bacteria detection in antibacterial hand sanitizer

目的研究改良卵磷脂肉汤(MLB)方法在抗菌洗手液细菌检测中的实用性。方法采用2020年版《中国药典》(三部)药品微生物检验替代方法指导原则中定性方法验证原则,验证MLB方法在抗菌洗手液大肠菌群和溶血性链球菌检验中专属性、检测限和耐用性参数,并与GB 15979—2002《一次性使用卫生用品卫生标准》方法的检测结果进行等效性比较。结果MLB方法的专属性和耐用性良好。该方法检测抗菌洗手液中的大肠菌群和溶血性链球菌代表菌株的50%阳性标本检出限(LOD_(50))分别为1.76和17.44 cfu/g。统计分析结果显示其检测灵敏度显著优于标准方法(P<0.05)。结论MLB方法与标准方法具有等效性,可应用于抗(抑)菌洗手液细菌检测。

Objective To validate the practicability of Modified Letheen Broth(MLB)method for bacteria detection in antibacterial hand sanitizer.Methods According to the verification requirements of qualitative test methods in the guiding principles for validation of alternative methods for microbiological testing in Chinese Pharmacopoeia(2020),equivalence study between MLB method and GB 15979—2002 standard methods for Coliform and Hemolytic streptococcus were conducted in three parameters,including specificity,limit of detection and ruggedness.Results The results demonstrated that the MLB method had good specificity and ruggedness.The 50%detection limit for positive specimens of the representative strains of Coliform and Hemolytic streptococcus detected by this method was 1.76 and 17.44 cfu/g,respectively.According to the statistical analysis,the detection sensitivity of the MLB method was significantly better than that of the standard method(P<0.05).Conclusion The MLB method is equal to the standard method,and can be applied to the detection of bacteria in antibacterial hand sanitizer.