| 宫珊珊,李艳华,王冬.不同生产企业五氟利多片含量均匀度考察[J].中国药品标准,2016,17(5):329-331 |
| 不同生产企业五氟利多片含量均匀度考察 |
| Study on Content Uniformity for Penfluridol Tablets from Different Manufacturers |
| 投稿时间：2016-07-21 修订日期：2016-09-12 |
| DOI： |
| 中文关键词: 五氟利多片 含量均匀度 A+2.2S |
| 英文关键词: Penfluridol Tablets content uniformity A 2.2S |
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| 中文摘要: |
| 目的：考察不同企业生产的五氟利多片的含量均匀度。方法：采用HPLC法，DiamonsilTM C18（4.6 mm×250 mm, 5μm）色谱柱，流动相为甲醇-0.2%三乙胺溶液（用磷酸调节pH值至2.5）(70∶30）， 检测波长219nm。结果：不同企业生产的五氟利多片的含量均匀度检查结果差异较大。结论：标准中增加含量均匀度检查项，可以加强对生产企业的监督管理，保证药品质量。 |
| 英文摘要: |
| Objective: To investigate the content uniformity of Penfluridol Tablets from different manufacturers . Methods: HPLC method was performed on a DiamonsilTM C18 column（4.6 mm×250 mm, 5μm）, the mobile phase was consisted of methanol -0.2% triethylamine solution（ adjusted pH to 2.5 with phosphoric acid）（70∶30）and the detection wavelength was set at 219 nm. Results: There were significant differences in content uniformity of Penfluridol Tablets from different enterprises. Conclusion: Adding content uniformity item to the official standard of Penfluridol Tablets could reinforce the management of pharmaceutical enterprises and guarantee the quality of the drugs. |
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