| 耿东升,王晓娟,赵婷.一种崩解加溶出考察固体制剂质量的序贯检测方法[J].中国药品标准,2016,17(3):184-189 |
| 一种崩解加溶出考察固体制剂质量的序贯检测方法 |
| A Sequential Analysis Method of Drug Disintegration and Dissolution Test for Quality Investigation of Solid Preparations |
| 投稿时间：2016-01-04 修订日期：2016-03-23 |
| DOI： |
| 中文关键词: 固体制剂 序贯试验 药品崩解时限 药物溶出度 |
| 英文关键词: solid preparation sequential analysis drug disintegration time drug dissolution |
| 基金项目:新疆维吾尔自治区自然科学基金课题“药物溶出/释放度及崩解时限测定的规范性研究”(2013211A119)。 |
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| 中文摘要: |
| 目的：建立固体制剂的崩解和药物溶出度质量考察的序贯试验方法。 方法：选取9种具有代表性的固体制剂，按照序贯试验方法，分别在三种 不同酸度的崩解液中测定药品的崩解时限。统一在pH 7.6的磷酸盐缓冲液中，固定实验装置和转速，采用光纤实时药物溶出度仪监测药物溶出度，并用《中国药典》各品种项下溶出度检查规定的溶出介质作对照；药物溶出曲线采用weibull模型拟合，通过其拟合参数的变异度，评估制剂间药物溶出行为的差异程度。 结果：比较各制剂在三种崩解液中的崩解时限，有的一致性好，有的差异较大；与参比制剂比较，药品崩解时限差异明显的受试制剂，其用新方法监测的药物溶出度差异也较大。 结论：药品崩解加药物溶出的序贯检测方法，可以提高固体制剂质量的检验效能。 |
| 英文摘要: |
| Objective: To establish a sequential analysis method for quality investigation of solid preparation. Methods: 9 representative solid preparations were selected, according to the sequential analysis method：firstly， disintegration times were respectively tested in 3 disintegration liquids of different acidity，and successively，dissolution of the durgs were monitored in pH 7.6 phosphate buffer ，with an optical fiber in site dissolution testing instrument at a fixed speed.Simultaneously，the drug dissolution results of new method were compared with that of ChP demanded media.Drug dissolution curves were fitted by model weibull, the differences of the preparations were evaluated by the variation of the fitting parameters. Results: Some preparations had good consistency and some had significant difference by comparing the disintegration time of the preparations in 3 disintegration liquids，. And compared with the reference preparation, the difference of drug disintegration time was obviously great , the difference of the dissolution was also great by new method. Conclusion：The sequential analysis method of drug disintegration and dissolution test can promote efficacy of quality test of solid preparation. |
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