[关键词]
[摘要]
目的 建立一种用于测定注射用益气复脉(冻干)滋味的方法,以保证不同生产批次间的质量稳定。方法 采用Alpha MOS公司电子舌(Astree)测定注射用益气复脉(冻干)6批样品,以0.01 mol/L盐酸为校准溶液,以蒸馏水为稀释溶剂,样品采集时间为60 s,每次分析时间120 s,每个样品重复测9次,利用Alpha Soft V14.2软件进行数据分析。结果 注射用益气复脉(冻干)的酸、甜、苦3个滋味表现较明显,且批间差异不大;利用主成分分析能很好地区分不同批次样品在味道上的差异;不同样品间味道的相对强度存在差异;利用独立建模分析对其他批次样品进行鉴定,识别率为100%。结论 所建立的方法具有样品处理方法简单、操作简单、快速、检测成本低、污染小等特点,可用于注射用益气复脉(冻干)滋味的测定。
[Key word]
[Abstract]
Objective A method for determination of the tastes of Yiqi Fumai Lyophilized Injection was established to ensure the quality stability among the different production batches. Methods Alpha MOS electronic tongue (Astree) was used for the determination in 6 batches samples using 0.01 mol/L hydrochloric acid as calibration solution and the distilled water as dilution solvent, the sample collection time was 60 s, the time for each analysis was 120 s, the determination of each sample was repeated 9 times, and the test data was analyzed by Alpha Soft V14.2. Results The performance of sour, sweet, and bitter tastes was significant in Yiqi Fumai Lyophilized Injection, and the difference among the batches was not significant. PCA analysis can be used to distinguish differences of the taste in the different batches samples; The relative intensity of tastes is different among the different batches of samples. The model established by SIMCA was used to identify the other batches of samples with the recognition rate of 100%. Conclusion The established method with the characteristics of simple sample handling, simple operation, short detection period, lower cost and pollution, which is applicable for the determination of the tastes of Yiqi Fumai Lyophilized Injection.
[中图分类号]
[基金项目]
天津市中药注射剂关键技术校企协同创新实验室建设(17PTSYJC00090)