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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。
OBJECTIVE: To study and optimize the oral solution of meclizine hydrochloride instant film. Methods: The orthogonal experiment was used to evaluate the effects of HPMC E3 dosage, PEO dosage, xanthan gum dosage and solid content ratio on the thickness uniformity, dissolution time, maximum load and elongation at break. The oral solution of clenbuterol was optimized by prescription. The preparation process of casting method and the main process parameters were studied. Results: The amount of HPMC E3, the amount of PEO and the ratio of solid content were the key factors affecting the strength of film, dissolution time and thickness uniformity respectively. Through the process of research to determine the emulsion dispersion, coating thickness, coating speed, drying temperature and other key parameters of the process. CONCLUSIONS: Film-forming products that meet quality requirements have been obtained after the study of the prescription process.