多潘立酮胃内滞留型缓释片的制备

Preparation of Domperidone Sustained-Release Floating Tablets

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HypersilODS2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 2 85nm。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 2 3 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。

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.