本文選題：微量量熱法　切入點：無菌檢查　出處：《第三軍醫(yī)大學學報》2015年20期

【摘要】：目的建立快速靈敏準確的無菌檢查新方法,克服現(xiàn)有無菌檢查方法檢查周期長(14~21 d)、靈敏度低、自動化程度不高、容易引起誤判等局限。方法采用微量量熱法,以常規(guī)方法為參照,對方法靈敏度進行考察,建立基于微量量熱法的無菌檢查新方法;考察該方法對復(fù)方茵陳注射液正常樣品、未滅菌樣品、滅菌不徹底樣品的檢查能力。結(jié)果微量量熱無菌檢查法能夠在10 h內(nèi)檢出各陽性菌(金黃色葡萄球菌、大腸埃希菌、銅綠假單胞菌、枯草芽孢桿菌、生孢梭菌、白色念珠菌、黑曲霉),檢出限度100 cfu,并能夠快速檢出模式藥物未滅菌樣品與滅菌不徹底樣品,較常規(guī)檢查方法更為靈敏快速。結(jié)論建立的微量量熱無菌檢查法靈敏、快速、準確,可實現(xiàn)自動在線監(jiān)測,可以作為無菌檢查的新方法。
[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.
【作者單位】： 中南民族大學藥學院藥劑學教研室;解放軍第302醫(yī)院全軍中藥研究所;
【基金】：國家自然科學基金(81202935,81173542)~~
【分類號】：R927

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本文編號：1664725