本文選題：微量量熱法　切入點(diǎn)：無(wú)菌檢查　出處：《第三軍醫(yī)大學(xué)學(xué)報(bào)》2015年20期

【摘要】：目的建立快速靈敏準(zhǔn)確的無(wú)菌檢查新方法,克服現(xiàn)有無(wú)菌檢查方法檢查周期長(zhǎng)(14~21 d)、靈敏度低、自動(dòng)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(duì)方法靈敏度進(jìn)行考察,建立基于微量量熱法的無(wú)菌檢查新方法;考察該方法對(duì)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(wú)菌檢查法能夠在10 h內(nèi)檢出各陽(yáng)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(wú)菌檢查法靈敏、快速、準(zhǔn)確,可實(shí)現(xiàn)自動(dòng)在線監(jiān)測(cè),可以作為無(wú)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(xué)藥學(xué)院藥劑學(xué)教研室;解放軍第302醫(yī)院全軍中藥研究所;
【基金】：國(guó)家自然科學(xué)基金(81202935,81173542)~~
【分類號(hào)】：R927

【參考文獻(xiàn)】

相關(guān)期刊論文 前10條

1 任永申;鄢丹;張萍;馮雪;譚曼容;肖小河;;基于等溫滴定量熱法表征的紅細(xì)胞凝集反應(yīng)熱動(dòng)力學(xué)特性研究[J];化學(xué)學(xué)報(bào);2011年08期

2 段文海;;最終滅菌無(wú)菌制劑參數(shù)放行[J];食品與藥品;2006年11期

3 張春瑛,吳蔚,盧翔,程櫻,姜紅;無(wú)菌檢查直接接種法不易判斷結(jié)果品種的方法改進(jìn)[J];中國(guó)藥品標(biāo)準(zhǔn);2002年05期

4 宋勤;袁林娜;;中國(guó)藥典與歐州藥典無(wú)菌檢查培養(yǎng)基靈敏度的比較實(shí)驗(yàn)[J];藥物分析雜志;2005年11期

5 馬仕洪;胡昌勤;戴，

本文編號(hào)：1664725