本文選題：藥品　切入點：殘留溶劑　出處：《中國新藥雜志》2017年17期 　論文類型：期刊論文

【摘要】：目的:介紹各國不同藥典在藥品殘留溶劑測定中的控制理念并探討方法的應用。方法:以頭孢孟多酯鈉的殘留溶劑檢測為例,探討了2015版《中華人民共和國藥典》如何解決殘留溶劑檢測中的不確定性難題,建立適合待測樣品殘留溶劑的檢測方法。結果:應用《中華人民共和國藥典》2015版通則0861殘留溶劑測定法,對不同生產(chǎn)廠家的頭孢孟多酯鈉的殘留溶劑進行了全面準確的測定。結論:不同藥典在殘留溶劑測定中的設計和控制理念并不盡相同,《中華人民共和國藥典》2015版通則中的雙柱定性方法可以快速、準確地鑒別出藥品中未知的殘留溶劑。
[Abstract]:Objective: to introduce the control concept of different pharmacopoeia in the determination of residual solvents in different countries and to explore the application of the method. This paper discusses how to solve the uncertainty problem in the detection of residual solvents in the 2015 edition of the Pharmacopoeia of the people's Republic of China. To establish a suitable method for the determination of residual solvents in the samples to be tested. Results: the method of determination of residual solvents in the Chinese Pharmacopoeia 2015 edition of General Rule 0861 was used. The residual solvents of cefmendium sodium from different manufacturers were determined completely and accurately. Conclusion: different pharmacopoeia have different design and control ideas in the determination of residual solvents. The Pharmacopoeia of the people's Republic of China 2015 Edition. The two-column qualitative method in the general principles can be used quickly. The unknown residual solvent in the drug was identified accurately.
【作者單位】： 中國食品藥品檢定研究院;國家藥典委員會;中國藥學會;
【分類號】：R927.1

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