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目的对不同厂家吲达帕胺缓释制剂的体外释放情况进行考察,评价其内在质量。方法采用溶出度测定仪和HPLC法测定6个厂家吲达帕胺缓释制剂在不同p H溶出介质中的溶出曲线,溶出介质500 ml,流动相为甲醇-水-冰醋酸(45∶55∶0.1),检测波长为240 nm。结果在水、p H 1.2氯化钠盐酸、p H 4.0醋酸盐缓冲液和p H 6.8磷酸盐缓冲液中,各厂家吲达帕胺缓释制剂的释放度有差异。结论不同厂家生产的吲达帕胺缓释制剂的释放度明显不一致,进行释放度检查有助于控制质量。建议有关厂家对影响制剂释放度的辅料及生产工艺进行改进,以提高产品质量。
OBJECTIVE To investigate the in vitro release of indapamide sustained-release preparations from different manufacturers and evaluate its intrinsic quality. Methods The dissolution profiles of 6 manufacturers of indapamide sustained-release preparations in different p H dissolution media were determined by dissolution tester and HPLC method. The dissolution medium was 500 ml and the mobile phase was methanol-water-glacial acetic acid (45:55: 0.1), the detection wavelength is 240 nm. Results There was a difference in the release of indapamide sustained-release preparations from various manufacturers in water, p H 1.2 sodium chloride hydrochloride, p H 4.0 acetate buffer and p H 6.8 phosphate buffer. Conclusion The release of indapamide sustained-release preparations produced by different manufacturers is obviously inconsistent, and the release test can help to control the quality. It is suggested that the manufacturers concerned make improvements on the excipients and the production processes that affect the release of the preparation so as to improve the product quality.