生化丸质量标准提高研究

Research on the improvement of quality standard of Shenghua pills

目的:补充和完善生化丸质量标准。方法:用TLC法定性鉴别甘草、当归、桃仁、川芎;利用HPLC法检测阿魏酸含量;用丹皮酚作藁本内酯替代品,在不同条件下测定丹皮酚相对于藁本内酯的校正因子,从而间接测定藁本内酯含量。结果:TLC斑点明显,阴性样品无干扰。阿魏酸在0.0249~0.3980μg(r=0.9999)之间线性关系较好;回收率为99.52%(RSD=2.28%)。替代法测得回收率为97.66%(RSD=2.00%);藁本内酯和丹皮酚分别在0.2268~0.9071μg(r=0.9998)和0.1747~0.8735μg(r=0.9999)内存在良好的线性关系;综合校正因子f=2.0137。结论:该研究建立的方法可用于生化丸的质量控制。

Objective:To supplement and improve the quality standards of Shenghua pills.Methods:HPLC was used to measure ferulic acid content.Glycyrrhizae Radix and Rhizoma,Angelicae sinensis Radix,Persicae Semen and Chuanxiong Rhizoma were identified by TLC.Using paeonol as a substitute for ligustilide,the correction factor of paeonol relative to ligustilide was determined under various conditions,and the content of ligustilide was calculated indirectly by using the correction factor.Results:Spots was visible and clear,and negative samples did not interfere.Ferulic acid had a very good relevance with 0.0249~0.3980μg(r=0.9999),the average recovery was 99.52%(RSD=2.28%).The average recovery rate measured by the alternative method was 97.66%(RSD=2.00%).There was a good correlation between ligustilide and paeonol in 0.2268~0.9071μg(r=0.9998)and 0.1747~0.8735μg(r=0.9999).Comprehensive correction factor f was 2.0137.Conclusion:The quality control was feasible with this research method.