汉防己甲素干粉吸入剂制剂学研究.pdfVIP

汉防己甲素干粉吸入剂的制剂学研究 樊婷，朱云峰，曹青日，崔京浩* （苏州大学药学院，苏州215123 ） Tel ：051265882077 ，E-mail: jhcui@suda.edu.cn 摘要：目的：以汉防己甲素（Tetrandrine ，TET ）为模型药物，制备干粉吸入剂并对其进行 制剂学研究。方法：采用喷雾干燥法制备TET 微粉，将微粉与乳糖载体混合制备干粉吸入 剂，并以排空率、有效部位沉积率等为指标筛选、优化处方。结果：喷雾干燥法制备药物微 粉的过程简单可控；所制备的药物微粉的体积平均粒径为 2.8±0.3 μm ，体外沉积率 （59.4±2.9 ）% ，排空率（95.7±0.2 ）% ；与适当的乳糖载体混合后，有效部位沉积率达 （78.9±0.8 ）% ，排空率（98.1±0.1 ）% 。结论：所制备的TET 干粉吸入剂能够有效的将药 物输送至模拟肺部，具有良好的雾化能力。 关键词：汉防己甲素；干粉吸入剂；有效沉积率；排空率 Pharmaceutics research of Tetrandrine dry power inhaler Abstract FAN Ting ，ZHU Yunfeng, CAO Qingri ，CUI Jinghao * （Department of pharmaceutics, College of Pharmaceutical Science, Soochow University, Suzhou, 215123, China. ）Tel ：051265882077 ，E-mail: jhcui@suda.edu.cn Objective: To prepare tetrandrine extract dry powder inhaler (TET-DPI) as the model drug and to evaluate its pharmaceutics properties in vitro. Methods: According to a certain mass ratio, TET-DPI was prepared by mixing spray dried TET with lactose specially used for pulmonary delivery. The formulation and processing parameters TET-DPI were optimized by investigation of the fine particles fraction and emitted dose. The lactose carrier was optimized through univariate design and different types of solvents are investigated for the effects of dry powder inhalation aerosol performance through the process of spray drying .Results:Spray drying was a feasible way to prepare micronized TET with controllable parameters. controlled with 1 to 10 μm, the fine particles fraction and emitted dose of the mixture of TET and lactose were improved from (59.4±2.9) % to (95.7±0.2) % and (56.4±2.2) % to (95.9 ± 3.0) %, respectively. Conclusion: The preparation and evaluation methods of TET dry powder inhalation for pulmonary delivery are successfully est