目的 优选补肾益脑分散片的处方，建立补肾益脑分散片质量控制方法。方法 以崩解时间为指标，采用单因素试验优选补肾益脑分散片的处方；采用HPLC法测定补肾益脑分散片中补骨脂素、异补骨脂素的总量；测定其溶出度并与其他2种制剂进行比较。结果 选择交联聚乙烯吡咯烷酮（PVPP）为崩解剂，微晶纤维素（MCC）为填充剂，辅料（PVPP-MCC）比例为1∶2.7，80%乙醇为黏合剂制备分散片工艺较好；补骨脂素在4.2～52.5 μg/mL（r＝0.999 8），异补骨脂素在4.6～57.5 μg/mL（r＝0.999 8）与峰面积呈良好的线性关系。补骨脂素平均加样回收率为98.89%，RSD为0.53%；异补骨脂素平均加样回收率为100.65%，RSD为0.93%。不同批次补肾益脑分散片中补骨脂素、异补骨脂素的总量及溶出度无明显差异；与其他制剂比较，补肾益脑分散片体外溶出速率较快，且能达到最大溶出率。结论 本法研制的补肾益脑分散片处方合理、工艺可行；所建立方法操作简便、稳定可靠，可用于补肾益脑分散片的质量控制。

Objective To optimize the preparation technology of Bushen Yinao Dispersible Tablets (BYDT) and establish a method for the quality control of BYDT. Methods The prescription of BYDT was optimized by single factor test with the disintegrating time as index. The contents of psoralen and isopsoralen were determined by HPLC. The dissolution of BYDT was determined and compared with other two preparations. Results PVPP was optimized as the disintegrants, MCC was optimized as the stuffing bulking agents, the proportion of PVPP and MCC was 1∶2.7, and 80% ethanol was optimized as adhesives. The concentration of psoralen and isopsoralen showed a good linear relationship at the range of 4.2－52.5 and 4.6－57.5 μg/mL (r = 0.999 8), respectively. The average recoveries of psoralen and isopsoralen were 98.89% with RSD of 0.53%; and 100.65% with RSD of 0.93%, respectively. The total content and dissolution of psoralen and isopsoralen had no significant differences among different batches. BYDT had the higher dissolution speed and could reach the highest dissolution rate in vitro compared with the other preparations. Conclusion This prescription of BYDT is reasonable and effective. The method is simple and accurate and could be used for the quality control of BYDT.