刺梨片的制备工艺量化控制

Quantification Control of Preparation Technology of Rosa roxburghii Tratt.Tablets

以刺梨为原料,研究工艺因素和原料性质对片剂质量的影响,建立刺梨片的制备工艺量化控制方法。采用粉末直接压片法,通过单因素试验考察填充深度、转台转速、原料粒度对刺梨片质量的影响,结合响应面试验,以片重差异、硬度、脆碎度、崩解时间、维生素C含量的综合评分作为评价指标,优化刺梨片的制备工艺。结果表明:优化所得刺梨片的最佳制备工艺为填充深度5.5 mm、转台转速16.5 r/min、原料粒度425μm,在此条件下刺梨片的综合评分为0.7228;进行验证试验,综合评分平均值为0.7114,与预测值相接近,且各项质量评价指标检测均符合要求。该试验所建立的工艺量化控制方法稳定可靠,可为刺梨片的制备工艺制定提供理论指导。

Use Rosa roxburghii Tratt.as the main raw material,study the effects of technological factors and raw material property on the quality of the tablet,and establish quantification control of preparation technology of Rosa roxburghii Tratt.tablets.The powder direct compression method was adopted.The preparation technology was optimized by single factor experiments,which were conducted to investigate the effects of filling depth,rotating speed of the turntable and raw material granularity on the quality of Rosa roxburghii Tratt.tablets,combining with response surface experiment,which was carried out with the comprehensive score of weight difference,hardness,brittleness,disintegration time and the content of vitamin C as evaluation index.The results showed that the optimized preparation technology of Rosa roxburghii Tratt.tablets was as follows:the filling depth 5.5 mm,the rotating speed of the turntable 16.5 r/min,and the raw material granularity 425μm.Under this condition,the comprehensive score of Rosa roxburghii Tratt.tablets was 0.7228.Verification experiments were carried out,the average comprehensive score was 0.7114,which was close to the predicted value,and all quality evaluation indexes were in line with the requirements.The methods established for quantification control of preparation technology were stable and reliable,and could provide theoretical guidance for the formulation of preparation technology of Rosa roxburghii Tratt.tablets.