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目的:研究尼群地平口服定时释药片的成型工艺。方法:以崩解时间为指标筛选片芯处方、工艺。应用薄膜包衣技术,采用羟丙基甲基纤维素(HPMC)为成膜材料,巴西棕榈蜡和蜂蜡混合物为阻滞剂制备尼群地平口服定时释药片,并考察巴西棕榈蜡和蜂蜡混合物用量、比例、片芯增重量、不同pH溶出介质和转篮转速对定时释药的影响。结果:经过筛选确定片芯处方为每片含尼群地平10mg,微晶纤维素(MCC)81mg,低取代羟丙基纤维素(L-HPC)9mg,硬脂酸镁0.5%;包衣混悬液处方为5%HPMC,3.5%巴西棕榈蜡,1.5%蜂蜡,0.5%PEG4000,0.5%吐温-80,89%水。结论:巴西棕榈蜡和蜂蜡混合物用量与比例,包衣层厚度,是影响定时释药的主要因素。巴西棕榈蜡和蜂蜡混合物用量越多,释药时滞越长;混合物总量不变,蜂蜡用量增大,释药时滞变长;包衣层厚度越厚,释药时滞变长。
Objective: To study the forming process of nitrendipine oral sustained-release tablets. Methods: Using disintegration time as the index to screen core tablets and process. The sustained release tablets of nitrendipine were prepared by using the film coating technology with hydroxypropylmethyl cellulose (HPMC) as the film-forming material and the mixture of carnauba wax and beeswax as blockers. The dosage of mixture of carnauba wax and beeswax , The proportion of tablets core weight, different pH dissolution medium and spin-drying speed on the timing of drug release. Results: The core tablets were determined to contain 10 mg of nitrendipine per tablet, 81 mg of microcrystalline cellulose (MCC), 9 mg of low-substituted hydroxypropylcellulose (L-HPC) and 0.5% of magnesium stearate after screening. The suspension formulation was 5% HPMC, 3.5% carnauba wax, 1.5% beeswax, 0.5% PEG 4000, 0.5% Tween-80, 89% water. Conclusion: The amount and proportion of mixture of carnauba wax and beeswax and the thickness of coating layer are the main factors affecting the time release of drug. The more dosage of mixture of carnauba wax and beeswax, the longer the delay of drug release; the total amount of mixture remains unchanged, the amount of beeswax increases, the delay of drug release becomes longer; the thicker the coating layer, the longer the delay of drug release.