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目的制备枫蓼肠胃康分散片并建立其质量控制方法。方法以崩解时间为指标,采用单因素考察和正交试验设计优选枫蓼肠胃康分散片的处方;采用HPLC法测定枫蓼肠胃康分散片中芦丁的量及其溶出度。结果选择10%交联羧甲基纤维素钠(cCMC-Na)、10%羧甲基淀粉钠(CMS-Na)、10%低取代羟丙基纤维素(LS-HPC)为崩解剂,24%微晶纤维素为填充剂,50%乙醇为黏合剂,2%微粉硅胶为润滑剂制备分散片工艺较佳;芦丁进样量在26.48～370.72 ng线性关系良好(r=0.999 8),平均加样回收率为98.1%,RSD为0.72%;不同批次枫蓼肠胃康分散片中芦丁的量及溶出度无明显差异。结论本优选处方辅料种类及比例适宜,崩解时间符合要求;所建立方法操作简便,稳定可靠,可用于枫蓼肠胃康分散片的质量控制。
Objective To prepare Fengliao Changweikang dispersible tablet and establish its quality control method. Methods Taking the disintegration time as the index, the prescription of Fengliao Changweikang dispersible tablets was designed by single factor test and orthogonal design. The content of rutin in Fengliao Changweikang dispersible tablets and its dissolution were determined by HPLC. Results 10% croscarmellose sodium (cCMC-Na), 10% sodium carboxymethyl starch (CMS-Na) and 10% low-substituted hydroxypropylcellulose (LS- 24% microcrystalline cellulose as filler, 50% ethanol as binder, and 2% silica as lubricant. The rutin injection volume was good at 26.48-370.72 ng (r = 0.999 8) , The average recovery rate was 98.1%, RSD 0.72%; different batches of Fengliao Weiweikang dispersible tablets rutin amount and dissolution no significant difference. Conclusion The prescription of the preferred prescription types and the proportion of appropriate, disintegration time to meet the requirements; The established method is simple, stable and reliable, can be used for the quality control of Fengliao Changweikang dispersible tablets.