论文部分内容阅读
目的:建立芪蟾口服结肠靶向片的质量控制标准。方法:采用TLC法对制剂中黄芪、干蟾皮、苦参进行定性鉴别;采用UPLC和HPLC法对制剂中黄芪甲苷、酯蟾毒配基和华蟾酥毒基、苦参碱进行定量分析。结果:薄层色谱主斑点清晰、特征明显、专属性强;黄芪甲苷线性范围为0.233 6～0.817 6μg(r=0.999 6,n=6),平均回收率为99.66%(RSD 1.14%);酯蟾毒配基线性范围为0.001 75～0.010 5μg,(r=1.000 0,n=6),平均回收率为100.44%(RSD 1.94%);华蟾酥毒基线性范围为0.003 51～0.021 06μg,(r=1.000 0,n=6),平均回收率为99.57%(RSD 2.73%);苦参碱线性范围为0.336 8～1.178 8μg,(r=0.999 8,n=6),平均回收率为100.30%(RSD 1.11%)。结论:检测方法简便、可靠、重复性好,可作为芪蟾口服结肠靶向片的质量标准控制方法。
OBJECTIVE: To establish a quality control standard for oral administration of Radix Astragali atresia tablets. METHODS: Astragalus membranaceus, dry goose skin and Sophora flavescens were identified qualitatively by TLC. The contents of astragaloside, resibufogenin, cinobufagin and matrine were quantitatively analyzed by UPLC and HPLC. Results: The main spots of TLC were clear and distinct with strong specificity. Astragaloside had a linear range of 0.233 6-0.817 6 μg (r = 0.999 6, n = 6) with an average recovery of 99.66% (RSD 1.14%). The linear range of resveratrol toxin was 0.001 75 ~ 0.010 5 μg (r = 1.000 0, n = 6) with an average recovery of 100.44% (RSD 1.94%). The linear range of cinobufagin was 0.003 51 ~ 0.021 06 μg, The average recovery was 99.57% (RSD 2.73%). The linear range of matrine was 0.336 8 ~ 1.178 8μg (r = 0.999 8, n = 6) 100.30% (RSD 1.11%). Conclusion: The detection method is simple, reliable and reproducible. It can be used as a quality control standard for oral administration of Radix Astragali toads.