论文部分内容阅读
目的:优选左金浓缩丸的成型工艺.方法:采用单因素试验法,以成型效果优选最佳的辅料类型和润湿剂类型;采用正交试验法,以溶散时限、成型率、外观质量为评价指标,以辅料比例、药辅比、润湿剂加入量为考察因素优选最佳成型工艺.结果:左金浓缩丸的最佳成型工艺为:辅料微晶纤维素(MCC):聚乙烯呲咯烷酮-K30(PVP-K30)(3:1),药辅比为1:1,润湿剂为5%水,混合均匀制成软材,投入制丸机中,制得左金浓缩丸.结论:优选出的成型工艺稳定、重复性好,所制丸粒圆整、色泽均一,符合中国药典2015年版四部0108丸剂项下对浓缩丸的要求,为进一步的研究开发提供了参考依据.“,”Objective:To optimize the forming technology of Zuojin concentrated pills. Methods: Single factor test was used to optimize the types of excipients and wetting agents with the shaping result as the index. Orthogonal test was used to optimize the forming technology taking the dissolution time,shaping rate and appearance quality as the evaluation indices,and the proportion of excipients, the rate of drugs to excipients and wetting agent amount as the investigation factors. Results: The best forming technology of Zuojin concentrated pills was as follows:MCC and PVP-K30 were used as the excipients with the ratio of 3:1,the ratio of drugs to excipients was 1:1,5% water was used as the wetting agent to obtain the damp mass,and then Zuojin concentrated pills were prepared in a pill machine. Conclusion:The optimized forming technology is stable with good reproducibility,and the pills are round and smooth with u-niform color,whose quality meets the requirements described in Chinese Pharmacopoeia(2015 edition,partⅣ,page 0108 for concen-trated pills). The study provides reference for the further study.