摘要
选择扑热息痛作模型药物，用均匀设计法，采用微机程序处理，筛选出最佳处方和制备工艺，并建立了片剂质量与原料、中间体的关键物理性质、处方组份及工艺条件等相关的非线性多元回归方程，可据其进行量化调节，以保证片剂质量始终被控制在最佳范围之内。用６个厂家的扑热息痛原料经量化调节均可制成满意的片剂，且１５ｍｉｎ即可使溶出度达到１００％。
The relationships between quality of the paracetamol tablets (dissolution, disintegration, hardness and appearance etc) and the characteristics of paracetamol powders were investigated in order to find the main factors and parameters influencing the quality of products. The optimum formula and manufactural process of tableting were selected by means of uniform design method. And equations of non-linear multivariate regression were established according to the parameters with computer programme in order to control the quality of the final products quantitatively during production. The results of examination showed that the 6 kinds of paracetamol powders could be used to prepare satisfactory tablets and their dissolution rate could amount to 100% within 10 min.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
1996年第2期61-65,共5页
Chinese Journal of Pharmaceuticals
关键词
扑热息痛
量化控制
片剂
生产
paracetamol, quantitative control,tablet-making,formulation,technology
