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目的:考察影响水杨酸滴丸制备的因素,确立其最佳成型工艺。方法:考察环境因素、加热温度、基质配比与试验步骤对滴丸制备工艺的影响。以丸重差异、溶出时限及外观质量为综合评价指标,通过正交试验进一步优化滴丸的制备工艺。结果:基质单独加热熔化后再与药液在避光密封的条件下进行混合,可防止药液迅速氧化变红。滴丸的最佳制备工艺为:聚乙二醇400与聚乙二醇6000的比例为1∶5,药液温度为50℃,滴距为8 cm,滴制速度为70滴·min-1。结论:该工艺简单可行,制得滴丸的丸重差异、溶出时限及外观质量均符合质量要求。
Objective: To investigate the factors that affect the preparation of salicylic acid dropping pills and establish the best forming process. Methods: The effects of environmental factors, heating temperature, matrix ratio and test procedure on the preparation of dropping pills were investigated. Pill weight difference, dissolution time limit and appearance quality were comprehensive evaluation indexes, and the preparation technology of dropping pills was further optimized by orthogonal test. Results: After the matrix was melted by heating alone, it was mixed with the liquid in a light-tight seal to prevent the liquid from rapidly oxidizing to red. The optimal preparation process of dropping pills is as follows: the ratio of polyethylene glycol 400 to polyethylene glycol 6000 is 1: 5, the temperature of the liquid is 50 ℃, the dropping distance is 8 cm, the dropping speed is 70 drops · min -1 . Conclusion: The process is simple and feasible. The difference of pill weight and weight, dissolution time and appearance quality are all within the quality requirements.