摘要
目的建立傅立叶变换近红外光谱(FT-NIR)法测定参芪扶正注射液用黄芪药材品质,以更好控制参芪扶正注射液的药材质量。方法样品粉碎后置于60℃烘箱内烘干,用研钵研碎,过60目筛,采用积分球模块采集漫反射光谱,以空气为背景;采集光谱波长范围为10 000~4 000 cm^(-1);分辨率为8 cm^(-1),采集次数64次;光谱外部环境条件为室温25℃。结果建立了黄芪中4种质量指标的NIR定量分析模型,除总皂苷外,其余模型的各项相关系数均在0.85以上,相对预测偏差均在合理的范围内,表明预测结果较为准确;RMSECV/RMSEP比值均接近1,表明所建模型较为稳健,可用于黄芪药材的快速定量分析。结论建立对黄芪中4种质量指标的NIR定量分析模型方法稳定、可重复,可用于参芪扶正注射液药材的质量控制。
OBJECTIVE To establish a FT-NIR method to determine the quality of Shenqifuzheng injection with Astragalusme mbranaceus,so as to better control the quality of Shenqifuzheng injection. METHODS The sample was crushed 60 ℃ oven drying,with a mortar pestle,60 mesh sieve,the integral ball module collects the diffuse reflectance spectra,with air as the background;acquisition wavelength range was 10 000-4 000 cm^（-1）. The resolution was 8 cm^（-1）,64 times the number of spectral acquisition.External environment condition for the room temperature of 25 ℃. RESULTS The NIR quantitative analysis model of 4 kinds of quality indexes in Astragalus saponins was established. In addition,the correlation coefficients of other models were above 0. 85,relative prediction errors were within a reasonable range,show more accurate forecasting results. RMSECV/RMSEP ratios were close to 1,showed that the model was more robust and could be used for analysis rapid quantification of Radix astragalus. CONCLUSION The NIR quantitative analysis model of Astragalus in 4 quality indicators is stable and reproducible,and it can be used for quality control of Shenqifuzheng injection.
作者
毛小荣
黄文华
宋艳刚
MAO Xiaorong;HUANG Wenhua;SONG Yangang(Livzon Group Limin Pharmaceutical Factory,Shaoguan,Guangdong 512028,China)
出处
《今日药学》
CAS
2018年第8期516-519,共4页
Pharmacy Today
关键词
参芪扶正注射液
黄芪
品质控制
近红外光谱
Shenqifuzheng injection
Astragalus membranaceus
quality control
near infrared spectrum
作者简介
毛小荣，工程师，研究方向：中药制剂生产和质量控制，Tel：0751-8726133，E-mail：maoxiaorong@livzon．cn;通信作者：宋艳刚，高级工程师，研究方向：中药制剂研发和质量控制，Tel：0751-8722690，E-mail：songyangang@livzon．cn
