| 赵欣,倪薇,宋帆帆,等.国产与原研复方缬沙坦氨氯地平片质量对比研究[J].安徽医药,2023,27(7):1307-1311. |
| 国产与原研复方缬沙坦氨氯地平片质量对比研究 |
| Comparative study on the quality of generic and original compound valsartan and amlodipine besylate tablets |
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| DOI：10.3969/j.issn.1009-6469.2023.07.008 |
| 中文关键词: 抗高血压药 生物仿制药 复方缬沙坦氨氯地平片 硬度 崩解时限 溶出度 溶出曲线 相似性 |
| 英文关键词: Antihypertensive agents Biosimilar pharmaceuticals Valsartan and amlodipine besylate tablets Hardness Disintegration time limited Dissolution rate Dissolution profile Similarity |
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| 摘要点击次数: 839 |
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| 中文摘要: |
| 目的通过测定国产与原研复方缬沙坦氨氯地平片的硬度、崩解时限、溶出度以及体外溶出曲线，评估国产与原研制剂的质量。方法 2020年 10月至 2022年 2月，分别测定国产与原研复方缬沙坦氨氯地平片的硬度、崩解时限、溶出度，并采用 f2相似因子法比较了两种制剂分别在 pH 1.2盐酸溶液、 pH 4.5醋酸盐缓冲液和 pH 6.8磷酸盐缓冲液中的溶出相似性。结果国产与原研复方缬沙坦氨氯地平片的硬度略有差异，崩解时限基本一致，在 pH 6.8磷酸盐缓冲液 30 min内缬沙坦和氨氯地平的溶出度均达到 80%以上；两种制剂在三种溶出介质中的溶出曲线的 f2相似因子值均大于 80，体外溶出相似性较高。结论国产与原研复方缬沙坦氨氯地平片在三种溶出介质中的溶出相似性较好，可为复方缬沙坦氨氯地平片的质量一致性评价提供参考。 |
| 英文摘要: |
| Objective To evaluate the quality of generic and original valsartan and amlodipine besylate tablets by measuring thehardness, disintegration time limited, dissolution and in vitro dissolution profiles.Methods The hardness, disintegration time limited,and dissolution of generic and original valsartan and amlodipine besylate tablets were determined respectively from October 2020 toFebruary 2022. And the f2 similarity factor method was used to compare the dissolution similarity of the two formulations in pH 1.2 hydrochloric acid solution, pH 4.5 acetate buffer and pH 6.8 phosphate buffer, respectively.Results The hardness of generic and original valsartan and amlodipine besylate tablets was slightly different, and the disintegration time limited was basically similar. The dissolution of both valsartan and amlodipine besylate reached more than 80 % within 30 minutes in pH 6.8 phosphate buffer. The f2 similarity factor of the dissolution profiles of the two formulations in the three dissolution media were all greater than 80, indicating high in vi? tro dissolution similarity.Conclusion The generic and original valsartan and amlodipine besylate tablets have good similarity in thethree dissolution media, and it can provide reference for the quality consistency evaluation of valsartan and amlodipine besylate tablets. |
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