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OALib Journal期刊
ISSN: 2333-9721
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基于生物热动力学的注射剂无菌检查新方法研究
, PP. 385-391
Keywords: 生物热动力学,微生物污染,无菌检查
Abstract:
为弥补药典常规无菌检查方法周期长、灵敏度低、易误判等局限，尝试建立基于生物热动力学的注射剂无菌检测新方法。依据微生物生长代谢过程中存在热量变化的普遍现象，采用生物热动力学法，以微生物生长速率k≥0及热功率差值pi-p0大于3倍基线噪音为评价指标，检测其热量变化规律以考察新建方法对无菌检查方法学要求菌株及注射剂实际样本中微生物的检测效力。结果显示，新建方法可在10h内检出规定的革兰阳性菌、革兰阴性菌和真菌，且灵敏度均小于100cfu·ml-1；同时在不同灭菌处理的注射剂实际样本中（复方茵陈注射液、注射用双黄连粉针、复方曲安奈德混悬型注射液）成功应用。研究提示，生物热动力学法用于注射剂无菌检查具有快速、灵敏等技术优势，有望为常规无菌检查方法带来有益的补充。
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