| 对羧甲基纤维素钠标准中项目设置的思考及建议 |
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| 引用本文： | 田甜,颜萍,胡敏.对羧甲基纤维素钠标准中项目设置的思考及建议[J].中国药品标准,2019,20(1):9-12. |
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| 作者姓名： | 田甜 颜萍 胡敏 |
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| 作者单位： | 湖北省药品监督检验研究院,湖北省药品监督检验研究院,湖北省药品监督检验研究院 |
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| 基金项目： | 国家科技重大专项“重大新药创制”资助项目(2015ZX093001002007)；国家药典委员会药品标准制修订研究课题(2018Y045) |
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| 摘 要： | 目的：对羧甲基纤维素钠标准的项目设置和限度进行分析探讨。方法：参考ChP2015、EP9.0、USP41、JP17和国标中羧甲基纤维素钠品种项下的标准,重点对取代度和钠含量等项目进行解析,对样品进行测定。结果与结论：取代度是羧甲基纤维素钠的关键功能性指标之一,与钠含量等指标有一定关系,对其性能、分型及应用有较大影响。建议药典标准增订取代度检查项,完善羧甲基纤维素钠的标准。
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| 关 键 词： | 羧甲基纤维素钠 取代度 钠含量 标准 |
| 收稿时间： | 2018/5/28 0:00:00 |
| 修稿时间： | 2019/1/15 0:00:00 |
The Considerations and Proposals for Item Setting of Carboxymethylcellulose Sodium Specification |
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| Institution: | Hubei Institute for Drug Control,Hubei Institute for Drug Control,Hubei Institute for Drug Control |
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| Abstract: | Objective: To analyze and discuss the test item settings and limits in carboxymethylcellulose sodium specification. Methods: The test items such as substitution degree and sodium content were analyzed according to the monographs in ChP2015, EP9.0, USP41, JP17 and national standard, and the samples were determined. Results and conclusion: The substitution degree was one of the key functional indices of carboxymethylcellulose sodium, which had a certain relationship with the sodium content and other indices, and had a great influence on its performance, classification and application. It is recommended that the substitution degree is listed into Chinese Pharmacopoeia to improve the specification of carboxymethylcellulose sodium. |
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| Keywords: | carboxymethylcellulose sodium the degree of substitution sodium content specification |
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