盐酸美克洛嗪口腔速溶膜剂的处方工艺研究

发布时间：2018-10-12 13:24

【摘要】：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。
[Abstract]:Objective: to study and optimize the formulation of the oral instant membrane of meclozine hydrochloride. Methods: orthogonal test was carried out with HPMC E3 dosage, PEO dosage, xanthan gum dosage and solid content ratio as the influencing factors. The thickness uniformity, dissolution time, maximum load and elongation at break were taken as the evaluation indexes. The formulation of the oral instant membrane was optimized, and the main technological parameters were studied. Results: the dosage of HPMC E3, the amount of PEO and the ratio of solid content were the key factors affecting the strength, dissolution time and thickness uniformity of the film. The key process parameters such as emulsion dispersion, film thickness, coating speed and drying temperature were determined. Conclusion: the membrane products which meet the quality requirement were prepared by the study of prescription technology.
【作者单位】： 青岛大学附属医院药学部;山东省食品药品监督管理局审评认证中心;山东省药学科学院;
【基金】：国家自然基金项目(编号:81672197)
【分类号】：R943
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本文编号：2266288