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不同厂家比沙可啶肠溶片仿制制剂与参比制剂溶出曲线的相似性评价
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| 篇名： | 不同厂家比沙可啶肠溶片仿制制剂与参比制剂溶出曲线的相似性评价 |
| TITLE： | |
| 摘要： | 目的：考察比沙可啶肠溶片不同仿制制剂与参比制剂在多种溶出介质中溶出曲线的相似性，为其仿制制剂的生产工艺和内在质量提升提供参考。方法：采用桨法，转速75 r/min，分别以1 000 mL的含2％十二烷基硫酸钠的pH 6.0磷酸盐缓冲液、pH 6.8磷酸盐缓冲液、水为溶出介质进行溶出试验，采用高效液相色谱法测定比沙可啶肠溶片3种仿制制剂与参比制剂中主成分在不同时间点的平均累积溶出度，并绘制溶出曲线，进而采用相似因子（f2）法评价其溶出曲线的相似性。结果：参比制剂在3种溶出介质中的溶出曲线基本一致；3个厂家生产的仿制制剂中有1种与参比制剂溶出曲线的f2≥50，即具有相似性。结论：不同厂家生产的比沙可啶肠溶片仿制制剂质量存在明显差异，其在生产工艺和内在质量上有待提高。有必要加强对仿制制剂溶出曲线的实时监控，确保药品质量的可控性。 |
| ABSTRACT： | OBJECTIVE： To investigate the similarity of dissolution curves between generic preparations and reference preparations of Bisacodyl enteric-coated tablets in various dissolution mediums， and to provide reference for improving production technology and internal quality of generic preparations. METHODS： Paddle method was adopted with rotation speed of 75 r/min. The dissolution test was performed using 1 000 mL pH 6.0 phosphate buffer solution， pH 6.8 phosphate buffer solution， water containing 2％ sodium lauryl sulfate. HPLC method was used to determine average accumulative dissolution of main components from 3 kinds of generic preparations and reference preparations at different time points to draw out dissolution curves. Similarity factor （f2） method was used to the similarity of dissolution curves. RESULTS：Dissolution curves of reference preparations were basically the same in 3 kinds of dissolution mediums. But the dissolution curve f2 of one generic preparation among 3 manufactures to dissolution curve of reference preparation were ≥50， namely the similarity. CONCLUSIONS： The quality of generic Bisacodyl enteric-coated tablets produced by different manufacturers is obviously different； the generic preparations needs to be further improved in the production technology and internal quality. For domestic generic preparation， it is necessary to strengthen the real-time monitoring of its dissolution curve， to ensure the drug quality. |
| 期刊： | 2017年第28卷第9期 |
| 作者： | 孙婷，姜建国，郭永辉，韩学静 |
| AUTHORS： | SUN Ting，JIANG Jianguo，GUO Yonghui，HAN Xuejing |
| 关键字： | 比沙可啶肠溶片；仿制制剂；参比制剂；高效液相色谱法；相似因子法；溶出曲线 |
| KEYWORDS： | Bisacodyl enteric-coated?tablets； Generic preparation； Reference preparation； HPLC； Similarity factors method； Dissolution curves |
| 阅读数： | 458 次 |
| 本月下载数： | 5 次 |
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