摘要
目的研究脾肾两助丸的质量控制方法。方法采用薄层色谱(TLC)法对脾肾两助丸中黄芪、白芍中指标性成分进行定性鉴别。采用高效液相色谱(HPLC)法测定制剂中有效成分莫诺苷、马钱苷的含量,色谱柱为Aglient-5-TC-C18柱(250 mm×4.6 mm,5μm),流动相为A为乙腈,B为3 m L/L磷酸,梯度洗脱(0~5 min时5%A,5~20 min时8%A,20~35 min时20%A,35~45 min时60%A,45~55 min时60%A),流速为1.0 m L/min,检测波长为240 nm,进样量为10μL,柱温为40℃。结果TLC法能检出黄芪、白芍中指标性成分的特征斑点。山茱萸有效成分莫诺苷、马钱苷质量浓度线性范围分别为1.269~40.596μg/m L(r=0.9999,n=6),1.170~37.440μg/m L(r=0.9999,n=6),平均回收率分别为97.82%和98.19%,RSD分别为2.30%和1.90%(n=6)。结论该方法可行、准确、重复性好,可用于脾肾两助丸的质量控制。
Objective To establish the quanlity standard of Pishen Liangzhu Pills.Methods Indicator components in Astragalus membranaceus and Paeoniae alba were identified by thin layer chromatography(TLC)for qualitative identification.The contents of morroniside and loganin were quantatively analyzed by high performance liquid chromatography(HPLC).Chromatographic column:Agliant-5-TC-C18 column(250 mm×4.6 mm,5μm);mobile phase:A was acetonitrile,B was 3 m L/L phosphoric acid;gradient elution(5%A at0 to 5 min,8%A at 5 to 20 min,20%A at 20 to 35 min,60%A at 35 to 45 min,60%A at 45 to 55 min);flow rate:1.0 m L/min;detection wavelength:240 nm;injection volume:10μL;column temperature:40℃.Results The TLC method could detect the characteristics and fixed point of the index components of Astragalus membranaceus and Paeoniae alba.The linear ranges of mononoside and loganin were 1.269-40.596μg/m L(r=0.9999,n=6)and 1.170-37.440μg/m L(r=0.9999,n=6);the average recoveries were97.82%and 98.19%,RSDs were 2.30%and 1.90%respectively(n=6).Conclusion This method was feasible,accurate and repeatable.
作者
张卫莲
曹蓉蓉
刘继青
陈浩
ZHANG Weilian;CAO Rongrong;LIU Jiqing;CHEN Hao(Institute for Food and Drug Control,Yulin,Shaanxi,China 719000)
出处
《中国药业》
CAS
2020年第5期117-120,共4页
China Pharmaceuticals
