盐酸美克洛嗪口腔速溶膜剂的处方工艺研究

目的：对盐酸美克洛嗪口腔速溶膜进行了处方研究和优化。方法：采用正交试验方法，以HPMC E3用量、PEO用量、黄原胶用量和固含量比例为影响因素，以厚度均匀性、溶解时间、最大载荷和断裂伸长率为评价指标，对盐酸美克洛嗪口腔速溶膜进行了处方优化；采用流延法的制备工艺并对主要工艺参数进行了研究。结果：HPMC E3用量、PEO用量、固含量比例分别是影响膜剂强度、溶解时间、厚度均匀性的关键因素。通过工艺研究确定了乳化分散、涂膜厚度、涂膜速度、干燥温度等关键工艺的参数。结论：经过处方工艺研究制得了符合质量要求的膜剂产品。

Formulation and technology of oral soluble films of meclozine hydrochloride

OBJECTIVE To research and optimize the formulation of oral soluble films of meclozine hydrochloride.METHODS With dosages of HPMC E3, PEO, Xanthan gum and the solid content ratios as the influencing factors, the thickness uniformity, the dissolution time, maximum strength and the elongation at break as the evaluation indices, the formulation of oral soluble films of meclozine hydrochloride was optimized by orthogonal test. The oral soluble films of meclozine hydrochloride were prepared by solvent casting technique and the main process parameters were determined.RESULTS The dosages of HPMC E3, the PEO and the solid content ratios were the key factors affecting the maximum strength, the dissolution time and the thickness uniformity of the films. The critical process parameters were determined, including the emulsifying and filming thickness and filming speed and drying speed.CONCLUSION The mechanical properties meet the requirements.