首页|不同温度环境下双歧杆菌三联活菌胶囊的活菌数研究

不同温度环境下双歧杆菌三联活菌胶囊的活菌数研究

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目的 探索双歧杆菌三联活菌胶囊在不同温度环境下长时间保存后,活菌数是否符合药品质量要求.方法 将4瓶双歧杆菌三联活菌胶囊作为研究对象,分为高温组和常温组,每组各2瓶,高温组双歧杆菌三联活菌胶囊于室外35℃及以上的环境下放置4 h及6 h,常温组双歧杆菌三联活菌胶囊在25℃室温环境下放置15 d及30 d.对2组制备好的样品中的长型双歧杆菌、嗜酸乳杆菌及粪肠球菌分别进行培养,计算3种细菌每克样本中的活菌数.结果 2组的样本中3种细菌的活菌数均高于药品质量要求中的最低活菌标准.结论 双歧杆菌三联活菌在35℃及以上高温下放置4、6h和25℃室温环境下放置15、30 d,活菌数均符合药品质量要求.
Potency of Bifidobacterium triple viable capsule under different temperature environments
AIM To investigate whether the viable counts of Bifidobacterium triple viable capsules meet the quality requirements of pharmaceuticals after long-term storage under different temperature environments.METHODS A total of 4 bottles of Bifidobacterium triple viable capsules were divided into a high-temperature group and a room-temperature group,with 2 bottles in each group.The high-temperature group was placed outdoors at temperatures exceeding 35℃ for 4 h and 6 h,and those in the room-temperature group were stored at 25℃ for 15 d and 30 d.Samples from the 2 groups were cultured separately for Bifidobacterium longum,Lactobacillus acidophilus,and Enterococcus faecalis,and the viable counts of these 3 bacteria per gram of sample were calculated.RESULTS The viable counts of the 3 types of bacteria in both groups were higher than the minimum viable count standard.CONCLUSION The viable counts of Bifidobacterium triple viable capsules meet the quality requirements after being stored at temperatures exceeding 35℃ for 4 and 6 h,and at room-temperature 25℃ for 15 and 30 d.

Bifidobacterium triple viable bacteriatemperatureviable count

吴轶、戚月明、姜莹、戴佩芳、吕迁洲、叶岩荣

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复旦大学附属中山医院药剂科,上海 200032

双歧杆菌三联活菌 温度 活菌数

2024

中国临床药学杂志
中国药学会

中国临床药学杂志

CSTPCD
影响因子:0.502
ISSN:1007-4406
年,卷(期):2024.33(1)
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