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目的:以山茱萸药材为研究对象,探索以对照药材标定法对中药材进行含量测定的质量控制新方法。方法:通过高效液相色谱法对山茱萸药材中的马钱苷和莫诺苷的含量进行标定。再以标定好的山茱萸对照药材为标准对山茱萸样品的含量进行测定。结果:10份对照药材样本的马钱苷和莫诺苷含量的RSD均小于1.0%。以对照药材标定法和对照品外标法对21批药材样品进行含量测定,结果显示RSD小于1.5%。结论:采用对照药材标定法对药材进行质量控制方法可行。该方法可大大降低质量控制成本,更全面控制药材质量,为研究建立新的中药质量控制方法提供科学依据。
OBJECTIVE: To take Cornus officinalis as the research object and explore a new quality control method for the determination of Chinese herbal medicines by the method of calibration of reference materials. Methods: The contents of loganin and morroniside in Cornus officinalis were determined by HPLC. The content of dogwood samples was determined by the calibrated dogwood reference materials. Results: The RSDs of both loganin and morroniside in 10 samples were less than 1.0%. The contents of 21 medicinal samples were determined by the reference standard method and the reference standard method. The results showed that the RSD was less than 1.5%. Conclusion: The method of quality control of medicinal materials is feasible by using the standard of reference materials. The method can greatly reduce the cost of quality control, and more fully control the quality of medicinal materials, providing a scientific basis for establishing a new quality control method for traditional Chinese medicines.