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硝酸甘油片参比制剂与仿制制剂的体外质量一致性评价
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| 篇名： | 硝酸甘油片参比制剂与仿制制剂的体外质量一致性评价 |
| TITLE： | Consistency Evaluation of in vitro Quality of Nitroglycerin Tablet Reference Preparation and Imitative Preparation |
| 摘要： | 目的：考察国内硝酸甘油片仿制制剂与参比制剂（原研药）的体外质量一致性。方法：参照硝酸甘油片进口药品注册标准JX20010267测定硝酸甘油片1批参比制剂（A厂家）和4批仿制制剂（B、C、D、E厂家）中硝酸甘油和有关物质的含量。采用溶出度测定方法中的桨法，转速为50r/min，以高效液相色谱法测定上述5批制剂在4种不同溶出介质（pH1.2盐酸溶液、pH4.0醋酸盐缓冲液、pH6.8磷酸盐缓冲液、水）中10min内的溶出量，计算累积溶出度，绘制溶出曲线，并以2、5、8min时的累积溶出度计算相似因子（f2），评价溶出曲线的相似性。结果：A、B、C、D、E厂家制剂中硝酸甘油含量分别为99.8％、98.3％、94.0％、93.3％、96.7％（n＝2），有关物质含量分别为0.46％、0.55％、0.63％、0.72％、0.49％（n＝2）。以A厂家参比制剂为对照，在pH1.2盐酸溶液中B、C、D、E厂家仿制制剂的f2分别为74、28、25、67，在pH4.0醋酸盐缓冲液中的f2分别为76、26、28、84，在pH6.8磷酸盐缓冲液中的f2分别为79、39、35、71，在水中的f2分别为69、32、37、62。结论：本方法适用于硝酸甘油片仿制制剂的体外质量一致性评价。与参比制剂比较，C、D厂家的仿制制剂主药含量较低，体外溶出曲线不具有相似性。 |
| ABSTRACT： | OBJECTIVE：To investigate the in vitro quality consistency of domestic Nitroglycerin table t imitative preparation and reference preparation （original drug ）. METHODS ：The contents of nitroglycerin and related substances in 1 batch of Nitroglycerin tablet reference preparation （manufacturer A ）and 4 batches of imitative preparation （manufacturer B ，C，D，E） were determined according to Nitroglycerin Tablet Import Drugs Registration Standard JX 20010267. The paddle method of dissolution determination method was adopted ，with the rotating speed of 50 r/min. HPLC method was adopted to determine the dissolution amount of 5 batches of above preparations in 4 kinds of dissolution mediums （pH 1.2 hydrochloric acid solution ，pH 4.0 acetate buffer solution ，pH 6.8 phosphate buffer solution ，water） within 10 min.The accumulative dissolution rate was calculated，and dissolution curves of samples were drawn.The similarity of the dissolution curves was evaluated by calculating similarity factor （f2）of 2，5，8 min accumulative dissolution rate. RESULTS ：The contents of nitroglycerin in the preparations from manufacturer A ，B，C，D，E were 99.8％，98.3％，94.0％，93.3％，96.7％，respectively（n＝2）；the contents of related substance were 0.46％，0.55％，0.63％，0.72％，0.49％，respectively（n＝2）. Using reference preparation of manufacturer A as control，f2 of imitative preparation from manufacturer B ，C，D，E were 74，28，25，67 in pH 1.2 hydrochloric acid solution ；76， 26，28，84 in pH 4.0 acetate buffer solution ；79，39，35，71 in pH 6.8 phosphate buffer solution ；69，32，37，62 in water ， respectively. CONCLUSIONS ：The method is suitable for in vitro quality consistency evaluation of Nitroglycerin table timitative preparation. Compared with reference preparation ，the contents of main components in the imitative preparations from manufacturer C，D are lower ；in vitro dissolution curves of those imitative preparation are not similar to reference preparation . |
| 期刊： | 2020年第31卷第05期 |
| 作者： | 孙婷，姜建国，张菁，张西如，徐艳梅，王柳，蒋凝 |
| AUTHORS： | SUN Ting，JIANG Jianguo ，ZHANG Jing，ZHANG Xiru，XU Yanmei ，WANG Liu，JIANG Ning |
| 关键字： | 硝酸甘油片；仿制制剂；参比制剂；溶出介质；溶出曲线；相似性；体外质量；一致性评价 |
| KEYWORDS： | Nitroglycerin tablet ； Imitative preparation ； Reference preparation ； Dissolution media ； Dissolution curve ； |
| 阅读数： | 691 次 |
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