| 伊潘立酮片溶出度一致性评价研究 |
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| 引用本文： | 米楠,马超,房思萌,臧可昕,苏慕君. 伊潘立酮片溶出度一致性评价研究[J]. 现代药物与临床, 2017, 40(2): 164-168 |
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| 作者姓名： | 米楠 马超 房思萌 臧可昕 苏慕君 |
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| 作者单位： | 天津药物研究院制剂中心, 天津 300193;天津药物研究院释药技术与药代动力学国家重点实验室, 天津 300193;天津药物研究院制剂中心, 天津 300193;天津药物研究院释药技术与药代动力学国家重点实验室, 天津 300193;天津药物研究院制剂中心, 天津 300193;天津药物研究院释药技术与药代动力学国家重点实验室, 天津 300193;天津药物研究院制剂中心, 天津 300193;天津药物研究院释药技术与药代动力学国家重点实验室, 天津 300193;天津药物研究院制剂中心, 天津 300193;天津药物研究院释药技术与药代动力学国家重点实验室, 天津 300193 |
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| 摘 要： | 目的 考察自制伊潘立酮片（1 mg规格）与参比制剂的溶出度一致性。方法 用HPLC法测定伊潘立酮在不同pH溶出介质中的溶解度，绘制伊潘立酮“pH-溶解度”曲线，测定自研制剂与参比制剂在4种不同pH溶出介质（0.1 mol/L HCl溶液、pH 4.5醋酸盐缓冲液、pH 6.8磷酸盐缓冲液、水）中的溶出度，绘制溶出曲线，用相似因子法进行拟合。结果 在所选4种溶出介质下，自研制剂与参比制剂的溶出曲线相似因子f2值均大于50。结论 自研制剂与参比制剂能够达到体外溶出一致。
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| 关 键 词： | 伊潘立酮片 溶出度 一致性评价 相似因子 |
| 收稿时间： | 2016-10-18 |
Evaluation of dissolution consistency of Iloperidone Tablets |
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| MI Nan,MA Chao,FANG Si-meng,ZANG Ke-xin and SU Mu-jun. Evaluation of dissolution consistency of Iloperidone Tablets[J]. Drugs & Clinic, 2017, 40(2): 164-168 |
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| Authors: | MI Nan MA Chao FANG Si-meng ZANG Ke-xin SU Mu-jun |
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| Affiliation: | Centre of Pharmceutics, Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China;State Key Laboratory of Drug Delivery Technology and Pharmacokinetics, Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China;Centre of Pharmceutics, Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China;State Key Laboratory of Drug Delivery Technology and Pharmacokinetics, Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China;Centre of Pharmceutics, Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China;State Key Laboratory of Drug Delivery Technology and Pharmacokinetics, Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China;Centre of Pharmceutics, Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China;State Key Laboratory of Drug Delivery Technology and Pharmacokinetics, Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China;Centre of Pharmceutics, Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China;State Key Laboratory of Drug Delivery Technology and Pharmacokinetics, Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China |
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| Abstract: | Objective To compare the dissolution curves of reference preparation and self-prepared Iloperidone Tablets in four different pH dissolution media (0.1 mol/L HCl solution, pH 4.5 acetate buffer solution, pH 6.8 phosphate buffer solution, and water).Methods The solubility of Iloperidone in different pH solutions was measured, the dissolution curves of two preparations in four different pH dissolution media were determined by HPLC, and the similarity was investigated according to the f2 factor method.Results The f2 factors between reference preparation and self-prepared Iloperidone Tablets in four different media were more than 50.Conclusion The two preparations are equivalent in four different pH dissolution media in vitro. |
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| Keywords: | Iloperidone Tablets dissolution consistency evaluation f2 factor |
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