温脾补肾片的成型工艺研究

目的 研究温脾补肾片的最佳成型工艺.方法 通过单因素重复试验,考察填充剂、润湿剂和润滑剂的种类及用量对本制剂成型性能的影响,以颗粒的吸湿性、片剂的外观、颗粒的流动性、片剂的硬度、片剂的崩解度等为指标,优选出最佳成型工艺.结果 最佳成型工艺为选用淀粉为填充剂(浸膏粉与淀粉的配比为5:1),以90%乙醇(20%)为润湿剂制软材,并用硬脂酸镁(0.5%)为润滑剂.结论 制得的片剂符合<中国药典>2010版有关项下的规定.

Study on formation process of Wenpi Bushen tablets

Objective To research the optimal formation process of Wenpi Bushen tablets,Methods Through the repeated experiment with signal factor,the varieties and amounts of diluents,adhesives and lubricants were investigated,and regarding the moisture absorption of granular,the appearance of tablets,the particle mobility,the hardness and the disintegration of tablets as the indicator,the best optimal formation process was found,Results The best optimal process condition of Wenpi Bushen tablets were 20% starch as the diluents,90%EtOH as the adhesive and 0.5% magnesium lubricant as the lubricant,Conclusion The quality of compound tablet is fit for the criterion of China pharmacopoeia(2010).