摘要
目的通过相对校正因子同时测定红曲米药材中两种洛伐他汀的含量。方法以洛伐他汀为对照,通过高效液相色谱法建立该成分与开环洛伐他汀的相对校正因子,并通过相对校正因子计算开环洛伐他汀的量;同时为验证方法的准确性及适用性,比较17批红曲米药材外标法实测值与相对校正因子法的测定值。结果相对校正因子法得到的17批红曲米药材中洛伐他汀与开环洛伐他汀的总量与高效液相外标法测得的总含量值无显著性差异。结论相对校正因子法可以作为红曲米药材质量控制方法;该法以洛伐他汀一种对照品同时控制2种成分的量,节约了试验成本,为多指标成分中药材质量评价模式提供参考。
Objective To establish the relative correction factor for the content of two lovastatins in the Hongqu rice.Methods Lovastatin was used as an indicator,and to establish the relative between the lovastatin and the lovastatin acid.The relative correction factor was used to calculate the amount of lovastatin acid.At the same time,the accuracy of the relative correction factor was evaluated by comparing the contents of lovastatin acid with those obtained by the external standard method and to evaluate the accuracy and usability of the relative correction factor in the Hongqu rice.Results There is no significant difference between the relative correction factor and the measured values of external standard in the total amount of lovastatin and lovastatin acid of the 17 batches of red rice.Conclusion The relative correction factor can be used to control the amount of two components and this study provided a reference for the quality evaluation model of multi-index components of traditional Chinese medicine.
作者
解盈盈
汪冰
栾永福
林永强
郭红梅
XIE Yingying;WANG Bing;LUAN Yongfu;LIN Yongqiang;GUO Hongmei(NMPA Key Laboratory for Quality Evaluation of Gelatin Products,Shandong Engineering Laboratory for Standard Innovation and Quality Evaluation of TCM,Shandong Institute for Food and Drug Control,Jinan 250101,China;Dongfang Huiyi<Shandong>Pharmaceutical Co.,Ltd.,Jinan 250101,China)
出处
《药学研究》
CAS
2023年第2期109-112,116,共5页
Journal of Pharmaceutical Research
基金
山东省重点研发计划重大科技创新工程项目(No.2021CXGC010511)
山东省重点研发计划项目(No.2020RKB24001)
山东省人文社会科学课题(No.2021-YYGL-44)。