4种枸橼酸莫沙比利片的体外溶出度比较

Comparison of external dissolution among four mosapride citrate tablets

目的考察4个厂家枸橼酸莫沙比利片的体外溶出度,评价其片剂质量。方法采用《中华人民共和国药典》(2005年版)溶出度测定法第三法,以盐酸溶液(9→1000)为溶出介质,转速为75 r.min-1,采用HPLC法测定溶出量,测定波长为274nm,计算累积溶出量。结果在30min内不同厂家的待测药物累积溶出量均>70%。结论不同厂家的枸橼酸莫沙比利片均符合质量标准,但不同厂家的产品之间还是存在很大的差异。

OBJECTIVE To compare the qualities of mosapride citrate tablets from four enterprises in items of dissolution. METHODS The content of mosapride citrate was detem ined by HPLC at 263 nm, Hydrochloric acid （9 →1000） was used as the solvent, and the paddle rotated at 75 revolutions per minute. RESULTS The accumulated releases of different mosapride citrate tablets were over 70% in 30 minutes. CONCLUSION The mosapride citrate badets from different enterprises are in the quality standands, but there is quality difference among them.