当归四逆滴丸制备工艺及质量标准研究

Reaserch of Danggui Sini Pill's Quality Standard and Preparation Technology

目的:建立当归四逆滴丸的质量标准。方法:利用正交试验优选出制备滴丸的最佳工艺,并对该处方中当归(君药)中所含阿魏酸进行质量标准研究,用紫外分光光度法对其滴丸剂进行精密度、加样回收率、重现性、专属性及稳定性实验。结果:所制备滴丸剂符合《中华人民共和国药典》2005年版附录对滴丸剂的相关规定,每丸所含阿魏酸在6μg左右,实验精密度、加样回收率、重现性、专属性及稳定性实验结果均良好。结论:建立了一条当归四逆滴丸可行的质量控制方法。

Objective：To establish the quality standard for Danggui Sini pill.Methods：To use orthogonal test to optimizing the best technology,and Angelica sinensis（the most important herb）in the prescription contained ferulic acid,using ferulic acid as the quality standard research,to study precision,recovery,reproducibility,specificity and stability testing by uv spectrophotometry.Results：The made pill accord with the pharmacopoeia of the People’s Republic of China in 2005 edition of dropping the appendix relevant provision,each pill contains 6μg ferulic acid,experimental precision,recovery,reproducibility,specificity and stability results are good.Conclusion：Establishing a feasible elucidated the quality control method for Dangguisini pill.