| 浅谈2010年版《中华人民共和国药典》纯化水检查方法的完善 |
| 投稿时间：2015-01-15 修订日期：2015-05-15 点此下载全文 |
| 引用本文：柳强,孙治国,陈熠,陈琦,黄华林,高静.浅谈2010年版《中华人民共和国药典》纯化水检查方法的完善[J].药学实践杂志,2016,34(3):252~254 |
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| 基金项目:重大新药创制专项(2013ZX09J13109-04B);第二军医大学大学生创新能力培养基金(ZD2013027) |
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| 中文摘要:目的 对《中华人民共和国药典》2010年版二部附录XVI制药用水项下纯化水中酸碱度、硝酸盐、亚硝酸盐、氨以及微生物的检查方法提出修改建议。方法 对纯化水中硝酸盐、亚硝酸盐及氨的检查中所用试剂和比色器皿的使用、操作方法进行分析探讨,提出平皿法能否用于纯化水微生物的检查,探讨了仪器分析在纯化水各指标检查中使用的可行性。结果 明确了纯化水杂质检查比色器皿的选择及试剂量的精密度范围等;平皿法适用于对纯化水中微生物的检查,可以替代薄膜过滤法;仪器分析是纯化水检查的发展趋势,值得提倡。结论 应完善并及时修订纯化水中硝酸盐、亚硝酸盐及氨的检查标准;微生物检查方法使用薄膜过滤法或平皿法均可;《中国药典》应提倡利用仪器分析等现代技术手段对纯化水进行检查检测。 |
| 中文关键词:纯化水 硝酸盐 亚硝酸盐 氨 仪器分析 |
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| Discussion on the purified water inspection methods in the Chinese Pharmacopoeia of edition 2010 |
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| Abstract:Objective To modify the purified water analysis methods in the Chinese Pharmacopoeia (Vol.Ⅱ, Edition 2010), and mainly focus on the pH value determination, analysis of nitrate and nitrite, and the inspection of microorganism. Methods The usage of regents and colorimetric tubes in the analysis of nitrate and nitrite were inquired, the feasibility of plating culture used in the inspection of microorganism were proposed, and the suggestion of using more instrumental analysis instead of titrimetric analysis in the purified water inspection wasraised. Results The choice of colormetric apparatus and the precision of the regents were explicit. The plating method was better in convenience and reliability than membrane-filter procedure during the microorganism inspection. Instrumental analysis is the trend of purified water inspection and deserved to be recommended. Conclusion Based on our own and others' studies, the methods of impurity analysis are improved, which might be accepted in the revision of Chinese Pharmacopoeia in future. |
| keywords:purified water nitrate nitrite ammonia instrumental analysis |
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