基于微量量热法的无菌制剂快速无菌检查方法研究

发布时间：2018-03-25 20:19

本文选题：微量量热法　切入点：无菌检查　出处：《第三军医大学学报》2015年20期

【摘要】：目的建立快速灵敏准确的无菌检查新方法,克服现有无菌检查方法检查周期长(14~21 d)、灵敏度低、自动化程度不高、容易引起误判等局限。方法采用微量量热法,以常规方法为参照,对方法灵敏度进行考察,建立基于微量量热法的无菌检查新方法;考察该方法对复方茵陈注射液正常样品、未灭菌样品、灭菌不彻底样品的检查能力。结果微量量热无菌检查法能够在10 h内检出各阳性菌(金黄色葡萄球菌、大肠埃希菌、铜绿假单胞菌、枯草芽孢杆菌、生孢梭菌、白色念珠菌、黑曲霉),检出限度100 cfu,并能够快速检出模式药物未灭菌样品与灭菌不彻底样品,较常规检查方法更为灵敏快速。结论建立的微量量热无菌检查法灵敏、快速、准确,可实现自动在线监测,可以作为无菌检查的新方法。
[Abstract]:Objective to establish a rapid, sensitive and accurate new method for aseptic examination, and to overcome the limitations of the existing methods of aseptic examination, such as long inspection period of 1421 days, low sensitivity, low degree of automation, easy to cause misjudgment, etc. The microcalorimetry was used. A new method for aseptic examination based on microcalorimetry was established by using the conventional method as a reference, and the method was used to examine the normal and unsterilized samples of compound Artemisia capillariae injection. Results the positive bacteria (Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Bacillus subtilis, Clostridium sporogenes, Candida albicans) could be detected in 10 hours by microcalorimetry. The detection limit of Aspergillus Niger is 100 cfu.And it can quickly detect the unsterilized sample and incomplete sample of the model drug, which is more sensitive, rapid and accurate than the conventional method. Conclusion the microcaloric aseptic method established is sensitive, rapid and accurate. Automatic online monitoring can be realized, and it can be used as a new method for aseptic inspection.
【作者单位】：中南民族大学药学院药剂学教研室;解放军第302医院全军中药研究所;
【基金】：国家自然科学基金(81202935,81173542)~~
【分类号】：R927

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