白果仁配方颗粒质量标准研究与产品评价  

Study on Quality Standard and Product Evaluation of Baiguoren Dispensing Granules(白果仁配方颗粒)

作　　者：朱亚文 易跃能 易剑平 付猛 魏丹丹 ZHU Yawen;YI Yueneng;YI Jianping;FU Meng;WEI Dandan(Hunan Yineng Biomedical Co.,Ltd,Changsha Hunan 410007,China;Beijing Tongrentang Research Institute,Beijing 100079,China)

机构地区：[1]湖南易能生物医药有限公司,湖南长沙410007 [2]北京同仁堂研究院,北京100079

出　　处：《中医药导报》2022年第9期48-52,共5页Guiding Journal of Traditional Chinese Medicine and Pharmacy

摘　　要：目的:对白果仁配方颗粒质量标准进行研究,对不同产地15批白果仁标准汤剂(冻干粉)及3批白果仁配方颗粒进行评价。方法:采用薄层色谱法,以银杏内酯A、银杏内酯C为指标成分进行定性鉴别;采用高效液相色谱法,以松柏苷为指标成分进行定量测定,并对15批白果仁标准汤剂(冻干粉)和3批白果仁配方颗粒进行质量分析评估。结果:薄层色谱斑点清晰,分离度好;松柏苷在1.065~106.5μg/mL(r=1.000)的范围内与峰面积呈良好的线性关系,平均回收率(n=6)为101.6%,RSD为1.6%。供试品色谱中出现5个特征峰,以松柏苷色谱峰为S峰,各特征峰的相对保留时间在±10%范围之内。结论:建立的质量标准能够控制白果仁配方颗粒的质量。Objective:To study the quality standard of Baiguoren Dispensing Granules and evaluate 15 batches of Baiguoren(Gingko seed)standard decoction(freeze-dried powder)and 3 batches of Baiguoren Dispensing Granules from different origins.Methods:The ginkgolide A and ginkgolide C were used as the index component for qualitative identification by TLC.The Coniferin was used as the index component for quantitative determination by HPLC,and the quality of 15 batches of standard decoction(freeze-dried powder)and 3 batches of Baiguoren Dispensing Granules were analyzed and evaluated.Results:TLC showes clear spots and good resolution.Coniferin showed good linearity with the peak area in the range of 1.065~106.5μg/mL(r=1.000).The average recovery(n=6)was 101.6%and RSD was 1.6%.There were 5 characteristic peaks in the chromatogram of the test article,and the chromatographic peak of Coniferin was the S peak.The relative retention time of each characteristic peak was within±10%.Conclusion:The established quality standard can be used for the quality control of Baiguoren Dispensing Granules.

关 键 词：白果仁配方颗粒 薄层色谱法 高效液相色谱法 质量标准 

分 类 号：R284.1[医药卫生—中药学]