论文部分内容阅读
目的建立天泰1号胶囊中5种人参皂苷一测多评(QAMS)的质量控制方法。方法以天泰1号胶囊为研究对象,以人参皂苷Rb_1为内参物,计算天泰1号胶囊中人参皂苷Rg_1、Re、Rf、Rd与人参皂苷Rb_1间的相对校正因子(RCF),通过RCF计算天泰1号胶囊中其他4种成分的含量,并在5批样品中同时应用外标法和一测多评法测定5种人参皂苷的含量,验证一测多评法检测结果的可靠性。结果人参皂苷Rg_1、Re、Rf、Rb_1、Rd分别在1.128~11.28μg、1.224~12.24μg、1.094~10.94μg、1.406~14.06μg、1.496~14.96μg范围内线性关系良好;以Rb_1为内参物,制剂中人参皂苷Rg_1、Re、Rf、Rd的RCF分别为0.906,0.963,1.092,1.041。QAMS法和外标法测定值的相对误差(RE)<3.0%,无显著差异。结论所建立的QAMS法可准确测定天泰1号胶囊中多种人参皂苷成分,为本品提供一种简便、准确、低成本的质量控制方法。
Objective To establish quality control methods for five kinds of ginsenosides-testing multiple assessment (QAMS) in Tiantai No. 1 capsule. Methods Tiantai No. 1 capsule was taken as the study object, and ginsenoside Rb 1 was used as the internal reference to calculate the relative correction factor (RCF) between ginsenosides Rg_1, Re, Rf, Rd and ginsenoside Rb_1 in Tiantai No. 1 capsules. Calculate the contents of the other 4 components in Tiantai No. 1 capsule, and simultaneously determine the five kinds of ginsenosides by using external standard method and one-time multiple-evaluation method in five batches of samples to verify the reliability of one-test multiple-assessment test results. . Results The ginsenosides Rg_1, Re, Rf, Rb_1 and Rd were linear in the range of 1.128-11.28μg, 1.224-12.24μg, 1.094-10.94μg, 1.406-14.06μg, and 1.496-14.96μg, respectively; Rb_1 was used as the internal reference. The RCFs of ginsenosides Rg_1, Re, Rf, and Rd in the preparations were 0.906, 0.963, 1.092, and 1.041, respectively. The relative error between the QAMS method and the external standard method (RE) was less than 3.0%, with no significant difference. Conclusion The established QAMS method can accurately determine the components of multiple ginsenosides in Tiantai No. 1 Capsule, providing a simple, accurate and low-cost quality control method for this product.