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目的:制备尼莫地平柱塞型脉冲释药胶囊。方法:采用灌注法制备非渗透性囊体,以HPMC K15M为缓释骨架材料制备柱塞片,以PEG6000和PEG4000为基质制备尼莫地平滴丸,用柱塞片将滴丸密封于非渗透性囊体内制备尼莫地平柱塞型脉冲释药胶囊。结果:溶剂为丙酮/二氯甲烷/乙酸乙酯(2∶0.7∶0.3),醋酸纤维素溶液浓度为10.5%,柱塞片缓释骨架材料HPMC K15M和乳糖比例为1∶10,制得的尼莫地平柱塞型脉冲释药胶囊体外呈明显的脉冲释放,释药时滞为4~5 h。结论:通过调节柱塞片中HPMC K15M和乳糖比例可调节脉冲胶囊的释药时滞,将尼莫地平制成滴丸可满足脉冲胶囊时滞后快速释药的要求。
Objective: To prepare nimodipine plunger-type pulse-release capsules. Methods: Non-permeable capsules were prepared by perfusion method. HPMC K15M was used as the sustained-release matrix material to prepare the plunger pieces. The nimodipine pills were prepared with PEG6000 and PEG4000 as matrix. Preparation of nimodipine plunger-type pulse-release capsules in the capsule. Results: The solvent was acetone / methylene chloride / ethyl acetate (2: 0.7: 0.3), the concentration of cellulose acetate solution was 10.5%, the ratio of HPMC K15M to lactose was 1:10, Nimodipine plunger-type pulse release capsules in vitro showed significant pulse release, drug release delay of 4 ~ 5 h. Conclusion: By adjusting the proportion of HPMC K15M and lactose in the plunger slice, the time delay of release of pulse capsule can be adjusted, and the drip pill of nimodipine can meet the requirement of rapid release after pulse capsule delay.