多潘立酮胃内滞留型缓释片的制备

目的：研制多潘立酮胃内滞留型缓释片，建立HPLC法测定多潘立酮胃内滞留型缓释片有关物质的方法。方法：以羟丙甲纤维素和卡波姆为主要凝胶材料制备片剂，考察释放度和漂浮性；采用Hypersil ODS2柱，甲醇-5g/L的乙酸铵溶液-三乙胺为流动相，流速为1ml／min，检测波长为285nm。结果：多潘立酮胃内滞留型缓释片具有较好的漂浮和缓释效果。多潘立酮的最低检测浓度为23．76ng／ml，有关物质可检出杂质4个。结论：本研究制备的多潘立酮胃内滞留型缓释片具有起漂时间快、缓释的特点；有关物质检查方法简单、快速、结果准确。

Preparation of Domperidone Sustained-Release Floating Tablets

AIM:To prepare domperidone sustained-release floating tablets and establish a method for isolation and determination of related substances. METHOD:The tablets were prepared by the use of HPMC and Carbopol as gel matrix. In vitro release rate and floating capability were observed to evaluate the formulation; HPLC is adopted using Hypersil ODS_ 2 column, the mobile phase is methanol-5 g/L ammonium acetate solution-triethylamine, and its mobile rate is 1 ml/min, with detective wavelength of 285 nm. RESULT:The floating capability of domperidone sustained-release floating tablets is good and the formulation could ensure the desired in vitro release rate. The detective limit of domperidone was 23.76 ng/ml, 4 related substances were determined. CONCLUTION:The tablets prepared can achieve sustained release with short floating lagtime; The method of determining related substances was simple, sensitive, and accurate.