一测多评法测定心可宁胶囊中6种蟾蜍二烯内酯类化合物

目的 建立一测多评法同时测定心可宁胶囊中6种蟾蜍二烯内酯类化合物的含量，并验证此方法在心可宁胶囊中应用的可行性和准确性。方法 以华蟾酥毒基为内参物，建立日蟾毒它灵、沙蟾毒精、蟾毒它灵、蟾毒灵和脂蟾毒配基与华蟾酥毒基的相对校正因子。分别采用外标法和一测多评法测定心可宁胶囊中6种蟾蜍二烯内酯类化合物的含量，比较2种方法的结果差异，验证一测多评法的可行性和准确性。结果 日蟾毒它灵、沙蟾毒精、蟾毒它灵、蟾毒灵和脂蟾毒配基与华蟾酥毒基的相对校正因子分别为1.06，0.862，0.897，1.09，0.915；2种方法结果无显著差异。结论 以华蟾酥毒基为内参物建立的相对校正因子重现性好，一测多评法可用于心可宁胶囊中多个蟾蜍二烯内酯类成分的质量评价。

Simultaneous Determination of Six Bufadienolides in Xinkening Capsules with Quantitative Analysis of Multi-components by Single-marker

OBJECTIVE To establish quantitative analysis of multi-components by single-marker(QAMS) method for simultaneously determining contents of six bufadienolides in Xinkening Capsules, and to verify the feasibility and accuracy of the method in quality control of Xinkening Capsules. METHODS Cinobufagin was used as the internal reference substance and the relative correlation factors of gamabufotalin, arenobufagin, bufotalin, bufalin and resibufogenin to cinobufagin were calculated. The contents of these six bufadienolides were determined by external standard method and QAMS method respectively, and the difference between the results from the two methods was compared to verify the easibility and accuracy of QAMS method. RESULTS The relative correlation factors were 1.06, 0.862, 0.897, 1.09, 0.915 for gamabufotalin, arenobufagin, bufotalin, bufalin and resibufogenin. There was no significant difference between the quantitative rusults of the QAMS method and the external standard method. CONCLUSION The relative correlation factors established with cinobufagin as the internal reference substance have good reproduciblity. The QAMS method can be used for the quality evaluation of multiple bufadienolides in Xinkening Capsules.