三种益生菌制剂活菌的稳定性

Stability of three probiotics preparations

目的检测3种益生菌制剂的稳定性,了解其所含活菌的稳定性信息。方法按药物稳定性试验指导原则进行加速稳定性试验和长期稳定性试验。加速稳定性试验在第0、1、2、3、6个月各检测1次,共5次;长期稳定性试验在第0、3、6个月各检测1次,共3次。制剂1的加速条件为(30±2)℃、相对湿度(65±5)%,长期条件为(18±2)℃、相对湿度(60±10)%;制剂2、3的加速条件为(25±2)℃、相对湿度(60±10)%,长期条件为(6±2)℃、相对湿度(60±10)%。检测项目包括崩解时限检查、干燥失重检测和活菌计数。结果3种益生菌制剂在实验前后含水量等指标相对稳定,菌种含量有轻微变化,除制剂1中的嗜酸乳杆菌外,其余菌种含量均较稳定,在标示含量范围内(均P>0.05)。结论3种益生菌制剂在加速条件和长期条件下稳定性均较好,生物学特性未发生明显改变。

Objective To detect the stability of three probiotic preparations and understand the stability information of the living bacteria contained in them.Methods The accelerated experiment and long-term experiment were conducted according to the guideline of drug stability experiment.The accelerated experiment was carried out once at month 0,1,2,3and 6for a total of 5times,respectively;The long-term experiment was carried out once at month 0,3and 6for a total of 3times,respectively.The acceleration conditions of preparation 1were(30±2)℃and relative humidity(65±5)%,long-term conditions were(18±2)℃,relative humidity(60±10)%.The acceleration conditions of preparations 2and 3were(25±2)℃and relative humidity(60±10)%,and the long-term conditions were(6±2)℃and relative humidity(60±10)%.The disintegration time limits,losses on drying and viable cell counts of the 3preparations were observed.Results There were no significant differences in the environmental impact and water contents of the three probiotics preparations before and after the experiments.There was slight change in the content of bacteria.Despite of Lactobacillus acidophilus in preparation 1,the contents of other bacteria were relatively stable and were within the marked content ranges.Conclusion The three preparations were stable under the conditions of both experiments,and their biological characteristics did not have significant changes.