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目的:优化复方奥硝唑大黄口腔膜的制备工艺。方法:以奥硝唑和大黄提取物为主药,聚乙烯醇(PVA)、羧甲基纤维素纳(CMC-Na)、甘油和甜味素为辅料。以黏附力、黏膜累积透过率为筛选指标,采用正交试验优化复方奥硝唑大黄口腔膜的制备工艺,并用高效液相色谱测定膜剂中奥硝唑体外释放度。结果:最优处方为PVA_(17-88):CMC-Na=2:1,甘油为4%,水为18倍。该膜剂在体外试验中24h后仍有药物释放。结论:该口腔膜制备工艺简便,兼有良好的缓释作用。
Objective: To optimize the preparation process of compound ornidazole rhubarb oral membrane. Methods: Ornidazole and rhubarb extract as the main drug, polyvinyl alcohol (PVA), carboxymethyl cellulose (CMC-Na), glycerol and sweeteners as accessories. The adhesive force and cumulative mucosal transmission rate were used as screening indexes. The orthogonal experiment was used to optimize the preparation process of compound ornidazole rhubarb oral cavity membrane. The in vitro release of ornidazole was determined by high performance liquid chromatography. Results: The optimal prescription was PVA_ (17-88): CMC-Na = 2: 1, glycerol 4% and water 18 times. The film still has drug release after 24h in vitro test. Conclusion: The oral membrane preparation process is simple, both good slow release effect.