地衣芽孢杆菌活菌颗粒杂菌检查方法验证

Validation for Contaminating Microorganisms Test in Bacillus Licheniformis Particles

目的建立地衣芽孢杆菌活菌颗粒杂菌检查方法。方法控制菌检查采用平皿涂布法;非致病性杂菌检查以杂菌率不得过0.1%为限度指标,采用营养琼脂平皿涂布法37℃培养;真菌计数采用玫瑰红钠琼脂平皿涂布法25℃培养。结果控制菌检查、非致病性杂菌检查和真菌计数方法均满足中国药典2010年版验证试验的基本要求。结论该方法可作为地衣芽孢杆菌活菌颗粒杂菌检查方法。

OBJECTIVE To establish a method for contaminating microorganisms test in Bacillus licheniformis particles.METHODS Spread plate method was used in the control bacteria examination; the non-pathogenic microbes was counted in nutrient agar and growth at 37 ℃,the maximum acceptable count was suggested in 0.1% of total microbes; the sodium rose Bengal agar and growth at 25 ℃ was used to do the fungi count.RESULTS The method was accepted in validation test of Chinese pharmacopoeia 2010.CONCLUSION The method can be used in contaminants test for Bacillus licheniformis particles control.