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目的通过熔融剪切制粒法制备阿司匹林片。方法采用不同比例的聚乙二醇6000(polyethylene glycol,PEG)与山嵛酸甘油酯(glyceryl behenate,GB)混合物与主药进行熔融剪切制粒,以溶出度及稳定性为主要考察指标对颗粒进行处方筛选。将颗粒与不同比例微晶纤维素(microcrystalline cellulose,MCC)混合压片,考察片剂片重差异、脆碎度、硬度、溶出度及稳定性以确定最优片剂处方。结果以质量比为3∶7的PEG6000与山嵛酸甘油酯混合物作为蜡质黏合剂所得颗粒性质最优。其收率为86%,流动学指数为75,45 min溶出大于80%,加速条件稳定性良好。制得片重为200 mg的阿司匹林片溶出快速,稳定性好于粉末直压工艺所得片。结论熔融剪切制粒法制备阿司匹林片的工艺省时适于工业化生产。
Objective To prepare aspirin tablets by melt shear granulation. Methods Different proportions of polyethylene glycol (PEG) and glyceryl behenate (GB) mixture were melted and granulated with the main drug. The dissolution rate and stability were the main indexes Granules for prescription screening. The granules were mixed with different proportions of microcrystalline cellulose (MCC) to determine the optimal formulation of the tablets. The tablet weight difference, friability, hardness, dissolution and stability were investigated. As a result, the granule obtained by using a mixture of PEG 6000 and behenic acid in a mass ratio of 3: 7 as a waxy binder had the best properties. The yield was 86%, the mobility index was 75, the dissolution rate was 45% at 80 min, and the stability of accelerated conditions was good. Aspirin tablets with a weight of 200 mg were rapidly eluted and the stability was better than those obtained by the powder direct pressure process. Conclusion Melting shear granulation process preparation aspirin tablets time-saving for industrial production.