| 王立峰,王新亮,张春鸿,等.国产盐酸奥洛他定口服制剂质量评价[J].安徽医药,2020,24(11):2146-2150. |
| 国产盐酸奥洛他定口服制剂质量评价 |
| Quality evaluation of domestic olopatadine hydrochloride oral preparations |
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| DOI：10.3969/j.issn.1009?6469.2020.11.007 |
| 中文关键词: 盐酸奥洛他定/分析 药物污染 口服制剂 质量评价 对比研究 |
| 英文关键词: |
| 基金项目: |
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| 中文摘要: |
| 目的评价国产盐酸奥洛他定口服制剂的质量。方法采用高效液相色谱法(HPLC)测定奥洛他定制剂中的有关物质，控制 4个特定杂质，并与原研制剂的杂质谱对比研究。结果国产盐酸奥洛他定片的杂质种类、数量均不大于原研制剂。但胶囊剂杂质种类、数量均大于原研制剂。结论基于杂质谱等方面研究，国产盐酸奥洛他定片质量好。 |
| 英文摘要: |
| Objective To investigate the quality of domestic olopatadine hydrochloride oral preparations. Methods The HPLC method was established to determine the related substances in the olopatadine hydrochloride oral preparations and control fourknown impurities.Comparative study on impurity profile was performed between generic drugs and reference listed drug(RLD).Re? sults The types and quantities of impurities in domestic olopatadine hydrochloride tablets were not greater than those in the RLD.While the types and quantities of impurities in domestic olopatadinehydrochloride capsules were greater than those in the RLD.Conclusion Based on the investigation of impurity profile，the quailty of domestic olopatadine hydrochloride tablets is good. Key words:Olopatadine hydrochloride/analysis； Drug contamination； Oral preparations； Quality evaluation； Comparativestudy |
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