| 汤慧,吴玉祥,张萍,等.盐酸表柔比星质量标准的比较与探讨[J].安徽医药,2018,22(2):235-237. |
| 盐酸表柔比星质量标准的比较与探讨 |
| Comparisons of standards for the quality of epirubicin hydrochloride |
| 投稿时间：2017-03-02 |
| DOI： |
| 中文关键词: 盐酸表柔比星 质量标准 比对 |
| 英文关键词: epirubicin hydrochloride standards comparisons |
| 基金项目: |
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| 摘要点击次数: 2315 |
| 全文下载次数: 1148 |
| 中文摘要: |
| 目的 对盐酸表柔比星质量标准的可行性进行评价,为进一步完善该品种的检验标准提供参考。 方法 比对最新版《欧洲药典》(EP)、《英国药典》(BP)、《美国药典》(USP)、《日本药局方》(JP)和《中国药典》2015版5部药典中盐酸表柔比星质量标准及注射用盐酸表柔比星国内现行的4部质量标准,并进行评价。 结果 5部现行版药典收载的盐酸表柔比星质量标准在检验项目上大体相同,但在检验方法和判断标准上有部分差异。 结论 注射用盐酸表柔比星国内现行的4个质量标准的项目基本相似,为了更好地进行药品质量控制,建议统一标准。 |
| 英文摘要: |
| Objective To evaluate the feasibility of standards for the quality of epirubicin hydrochloride and to provide a reference for further perfection. Methods To compare and evaluate standards for the quality of Epirubicin Hydrochloride in European Pharmacopoeia 9.0,British Pharmacopoeia 2017,U.S.Pharmacopoeia National Formulary USP40-NF35,the Japanese Pharmacopoeia Seventeenth Edition and the Chinese Pharmacopoeia 2015 Edition.To make comparisons of standards for the quality of Epirubicin Hydrochloride for injection in China. Results Standards for the quality of Epirubicin Hydrochloride are approximately the same on test items,and partially different on test methods and acceptance criteria. Conclusion Standards for the quality of Epirubicin Hydrochloride for injection in China are nearly the same,so that they could be further unified for better controlling of the quality of Epirubicin Hydrochloride for injection. |
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