复神丸的质量标准研究

Study on quality standard of Fushen pills

目的:制备纯中药制剂复神丸,并进行质量标准研究。方法:将处方组成的中药经粉碎、过筛、混匀、加工制成丸剂,按《中华人民共和国药典》丸剂项下有关规定检验,采用薄层色谱(TLC)法对陈皮和石菖蒲进行鉴别,采用高效液相色谱法(HPLC)对橙皮苷进行含量测定。结果:复神丸经过检验,其崩解时限、水分均符合《中华人民共和国药典》丸剂项下有关规定,质量控制方法专属性好,稳定可行。结论:复神丸的制备方法简便,质量控制方法可靠。

Objective:The pure traditional Chinese medicine Fushen pills was developed and the quality standard was studied.Method:The prescription of traditional Chinese medicine was smashed,sifted,mixed and processed into pills.According to the relevant provisions of the"Chinese pharmacopoeia"pill,the TLC method was used to qualitatively identify Citri Reticulatae pericarpium and Acori Tatarinowii Rhizome in the pill,the content of hesperidin was determined by HPLC.Result:The developed Fushen pill has been tested,and its disintegration time limit and water content are in accordance with the relevant regulations of the"Chinese pharmacopoeia"pill.The quality control method has good specificity,stability,and feasibility.Conclusion:The preparation method of Fushen pills was simple and the quality control method was reliable.