新健胃片的制剂工艺优化及质量评价

Technological optimization and quality evaluation of Xinjianwei Tablet

目的 对新健胃片制剂工艺进行优化研究，并建立制剂中橙皮苷的定量测定方法。方法 将处方中陈皮由传统的加水提取变为直接原粉入药，对工艺和制剂过程进行研究实验；以陈皮中的主要成分橙皮苷的量为评价指标，验证新工艺的效果。结果 新工艺制法产品橙皮苷的量优于原有工艺，整个处方的物质基础基本无改变，产品制成总量不变；采用RP-HPLC法测定新健胃片中橙皮苷的量，线性范围10.1～202.5 μg/mL，r＝0.999 9；平均回收率为98.37%，RSD为1.0%。结论 改进后的新健胃片工艺简便、可行；所建立的HPLC法定量测定新健胃片中橙皮苷的量，方法简便、可靠、重复性好，可用于新健胃片的质量控制。

Objective To optimize the preparation for Xinjianwei Tablet, and to establish a method for the quantitative determination of hesperidin. Methods The new process used dried tangerine peel raw powder as medicine to replace the traditional water decocting process. The effect of the new process was verified with the content of hesperidin as evaluation index. Results The new process is superior to the traditional one on the premise of the basic substances and the total yield did not change basically. RP-HPLC was used to determine hesperidin and the linearity was good in the range of 10.1-202.5 μg/mL, r = 0.999 9. The average recovery was 98.37% with RSD = 1.0%. Conclusion The improved process is more rational and simple, and the method based on HPLC is simple, reliable, and reproducible. It could be used effectively for the quality control of Xinjianwei Tablet.