复方奥硝唑大黄口腔膜的制备工艺优化

Optimization of Preparation of Compound Ornidazole-Rhubarb Buccal Film

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 of compound ornidazole-rhubarb buccal film. Method： Compound ornidazole - rhubarb buccal film was prepared with ornidazole, rhubarb extract, polyvinyl alcohol （ PVA） , carboxymethylcellulose sodium （ CMC-Na） , glycerol, sodium cyclamate. The preparation process was optimized using an orthogonal design according to the adhesive force and cumulative transmittance of mucosa. The in vitro release of ornidazole in the film was determined by the HPLC. Result： The optimal formula of the ornidazole-rhubarb buccal film was consisted of PVA17-88 ： CMC-Na = 2- 1, 4% glycerol, 18 times water. The ornidazole in vitro was still released after 24 hours. Conclusion ： The preparation of ornidazole - rhubarb buccal film is convenient. The buccal film is a good slow-release typed formulation.