优化吡拉西坦片工艺,提高其崩解时限及脆碎度

Optimizing the Technics of Piracetam Tablets, Improving Its Disintegration Time Limited and Friability

目的:提高其崩解时限及脆碎度,确保产品质量。方法:通过正交实验,确定影响吡拉西坦片崩解时限及脆碎度的三个因素,即粘合剂的浓度,温度,湿混时间,从而确定最后工艺。选用两种辅料,进口羧甲基淀粉钠和羟丙纤维素进行对比实验,确定最后辅料的使用。通过辅料的添加形式进行对比实验,确定辅料的最后添加形式。结果:通过以上3种方法及相应的措施,来确定是否能提高吡拉西坦片的崩解时限及脆碎度。吡拉西坦片崩解时限提高到7．1min,脆碎度提高到0．148％。结论:添加4％的羟丙纤维素,吡拉西坦片崩解时限及脆碎度数据最好,因此确定辅料的使用为4％的羟丙纤维素。羟丙纤维素内外各加2％效果最好。

Objective. To improve its disintegration time limited and friability and make sure the quality of the production, Methods： By means of the orthorhombic experiments, make sure the three factors（the binder strength, temperature, wet and humid time）that affect the disintegration time limited and friability, and then make sure the final technics, Choose two kinds of supplementary materials, imported Carboxymethylstach Sodium and Hyprolose, to have the contrastive experiments and make sure the use of final supplementary materials, By the experiments of the addition of supplementary materials, make sure the final form of the supplementary,Materials＇ addition. Results：By way of these three methods and relative measures, make sure whether it can improve the disintegration time limited and friability of Piracetam Tablets. Increase the disintegration time limited to 7.1 min and increase friability to 0. 148%. Conclusion： Add 4% Hyprolose, the disintegration time limited and friability of Piracetam Tablets get best, And then make sure to use 4% Hyprolose as the supplementary materials. Had better add 2 % Hyprolose in and out.