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目的:对氨利口腔膜剂进行处方优化。方法:以聚乙烯醇(PVA17-88)、羧甲基纤维素纳(CMC-Na)、甘油为成膜材料,以膜的柔软性、成膜性、光滑性、均匀性、溶出度作为考察指标,采用正交设计优化处方。结果:最佳成膜材料处方为PVA17-88 3.0 g,CMC-Na 2.0 g,甘油2.5 ml。按照最优处方制备的膜剂符合《中国药典》的有关规定,膜剂体外释药曲线符合Higuchi方程。结论:该膜剂处方和制备工艺可行。
OBJECTIVE: To optimize the prescription of Amway oral film. Methods: Polyvinyl alcohol (PVA17-88), CMC-Na and glycerol were used as film-forming materials to investigate the film’s softness, film-forming property, smoothness, uniformity and dissolution Indicators, using orthogonal design optimization prescription. Results: The optimum film forming materials prescription PVA17-88 3.0 g, CMC-Na 2.0 g, glycerol 2.5 ml. The film prepared according to the optimal prescription complies with the relevant regulations of “Chinese Pharmacopoeia”, and the in vitro release curve of the film meets the Higuchi equation. Conclusion: The film prescription and preparation process is feasible.