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目的:制备栓塞控制型尼群地平脉冲胶囊,优化制备工艺及处方,考察其体外释药特性。方法:灌注法制备非渗透性胶囊,湿法制粒制备栓塞片及速释片,依次将羧甲基淀粉钠、速释片、栓塞片装于非渗透性胶囊中制得脉冲胶囊,用释放度测定法考察影响释药时滞的各种因素。结果:11%乙基纤维素溶液所制囊身能达到所需非渗透性,含8%低黏度羟丙甲纤维素所制栓塞片能导致适宜的时滞,脉冲胶囊体外释药时滞为(6.5±0.5)h。结论:调节栓塞片处方可获得适当时滞的尼群地平脉冲胶囊,以满足高血压患者的需求。
OBJECTIVE: To prepare embolized controlled-release nitrendipine capsules, optimize preparation process and prescription, and investigate its in vitro release characteristics. Methods: Non-permeable capsules were prepared by perfusion method. The embolization tablets and immediate release tablets were prepared by wet granulation. The sodium carboxymethyl starch, immediate release tablets and embolization tablets were filled into non-permeable capsules to obtain pulse capsule. Determination of various factors that affect the drug release delay. Results: The capsule made of 11% ethylcellulose solution can achieve the required non-permeability. The embolized tablets with 8% low-viscosity hypromellose resulted in suitable time-delay. The time-delay of pulse capsule in vitro release was (6.5 ± 0.5) h. CONCLUSION: Nitrendipine pulse capsules with appropriate time delay can be obtained by adjusting the prescription of embolization tablets to meet the needs of hypertensive patients.