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琥珀酸索利那新片自研制剂与原研制剂溶出曲线的相似性评价
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| 篇名： | 琥珀酸索利那新片自研制剂与原研制剂溶出曲线的相似性评价 |
| TITLE： | |
| 摘要： | 目的：考察琥珀酸索利那新片自研制剂与原研制剂溶出曲线的相似性，为前者的处方和工艺筛选以及与后者的质量一致性评价提供参考。方法：采用桨法，转速为50 r/min，分别以水、pH1.2盐酸溶液、pH4.5乙酸盐缓冲液和pH6.8磷酸盐缓冲液为溶出介质进行溶出度试验，采用高效液相色谱法（HPLC）测定琥珀酸索利那新片自研制剂与原研制剂中主成分在不同时间点的累积溶出度，并绘制溶出度曲线，进而采用相似因子（f2）法评价二者溶出曲线的相似性。结果：在4种溶出介质中，琥珀酸索利那新片自研制剂与原研制剂的f2均＞50，说明二者溶出曲线具有相似性。结论：所建立的HPLC法适用于琥珀酸索利那新片的溶出度测定；自研制剂与原研制剂的溶出行为基本一致，一定程度说明自研制剂的处方和工艺具有可行性。 |
| ABSTRACT： | OBJECTIVE： To explore the similarity of dissolution profiles of self-development and original preparation of Solifenacin succinate tablet， and provide reference for the prescription and process screening of the former one and the quality similarity evaluation of the latter one. METHODS： The paddle method was adopted with rotational speed of 50 r/min， using water， pH1.2 hydrochloric acid solution， pH4.0 acetate buffer solution and pH6.8 phosphate buffer solution as dissolution media， HPLC was used to determine the cumulative dissolution of main components of self-development and original preparation of Solifenacin succinate tablet at different time points， dissolution profile was drew， then f2 was used to evaluate its similarity. RESULTS： In the 4 dissolution media， the f2 of both self-development and original preparation of Solifenacin succinate tablet was higher than 50， which indicated that the dissolution profiles showed similarity. CONCLUSIONS： The established HPLC is suitable for the dissolution determination of Solifenacin succinate tablet； the dissolution profiles of the self-development and original preparations are basically similar， which indicates the prescription and technology of self-development preparation are feasible. |
| 期刊： | 2016年第27卷第30期 |
| 作者： | 龚俊强，陈仙，徐彩虹，张霞，吴春梅，王萍，傅旭春 |
| AUTHORS： | GONG Junqiang，CHEN Xian，XU Caihong，ZHANG Xia，WU Chunmei，WANG Ping，FU Xuchun |
| 关键字： | 琥珀酸索利那新片；自研制剂；原研制剂；高效液相色谱法；溶出曲线；相似因子法；评价 |
| KEYWORDS： | Solifenacin succinate tablet； Self-development； Original preparation； HPLC； Dissolution profiles； f2 similarity factor； Evaluation |
| 阅读数： | 1036 次 |
| 本月下载数： | 7 次 |
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