基于单纯形质心设计的大株红景天片制剂成型工艺优化研究

Study on the Optimization of the Molding Process of Rhodiola sachalinensis Tablets Based on Simple Shape Centroid Design

目的通过优化大株红景天片制剂处方的辅料配比,提高素片崩解时间与硬度的风险控制水平。方法以大株红景天素片为研究对象,以崩解时间与硬度为考察指标,采用单纯形质心设计研究糊精、玉米淀粉和微晶纤维素对素片质量的影响,并在此基础上加入超级崩解剂进一步降低大株红景天片的崩解时间,以颗粒成型率、素片硬度、素片脆碎度、素片崩解时间、素片溶出度与红景天苷含量为指标进行验证,确定最佳辅料配比。结果最佳辅料配比为24%糊精、74%玉米淀粉和2%微晶纤维素,并外加总量3%的CMS-Na,制得的大株红景天素片崩解时间小于40 min,满足60 min控制限需求,硬度大于45 N,满足34.3 N控制限需求,红景天苷含量合格,终点溶出度达到95%。结论该辅料配比可以有效降低大株红景天素片崩解时间,并确保素片硬度、脆碎度与溶出度良好,红景天苷含量符合标准要求,提高了生产过程的风险控制水平,为片剂处方工艺优化提供一定的技术支撑。

Objective To improve the risk control level of disintegration time and hardness of plain tablets by optimizing the proportion of excipients in the formulation of Dazhu Rhodiola tablets.Methods With the disintegration time and hardness as indicators,the effects of dextrin,corn starch and microcrystalline cellulose on the quality of Dazhu Rhodiola tablets were studied by simple shape centroid design.On this basis,super disintegrating agent was added to further reduce the disintegration time of Dazhu Rhodiola tablets.The dissolution of plain tablets and salidroside content were verified as indicators to determine the optimal ratio of excipients.Results The optimum ratio of excipients was 24%dextrin,74%corn starch and 2%microcrystalline cellulose,and 3%CMS Na was added.The disintegration time of the large plant salidrocin tablets was less than 40 min,meeting the control limit of 60 min,the hardness was more than 45 N,meeting the control limit of 34.3 N.The content of salidroside was qualified,and the terminal dissolution was 95%.Conclusion The excipient ratio can effectively reduce the disintegration time of salidroside tablets,ensure good hardness,fragility and dissolution of the tablets,and ensure that the content of salidroside meets the standard requirements,improve the risk control level in the production process,and provide some technical support for the optimization of tablet formulation process.