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近红外光谱用于注射用复方甘草酸苷质量控制研究
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作者单位
汪义程,郭志永,闫宇,薛洪宝,陈鹏,宫文武 1. 蚌埠医学院 公共基础学院安徽 蚌埠 233030 2. 安徽宏业药业有限公司 生产技术部 安徽 蚌埠 233045 3. 安徽省药品监督管理局第五分局安徽 蚌埠 233000 
基金项目:安徽省级大学生创新创业训练计划项目(S202010367004S);安徽省高校学科(专业)拔尖人才学术资助项目(gxbjZD2022041);蚌埠市科技创新指导项目(20200352)
中文摘要:该文通过采集70批注射用复方甘草酸苷样品的近红外光谱(NIRS)图,基于其中甘氨酸、甘草酸苷、盐酸半胱氨酸3种组分的含量,采用偏最小二乘法(PLS)建立定量分析模型,并进行了验证。所建模型中,甘氨酸、甘草酸苷、盐酸半胱氨酸的相关系数(R)分别为0.999 54、0.947 01和0.999 95,校正均方根误差(RMSEC)依次为0.289、0.098 0、0.001 07。13批验证集样品中上述3种组分测定值与预测值之间的平均相对误差分别为0.41%、0.72%、0.86%,测定值与预测值之间无显著性差异(P > 0.05)。
中文关键词:近红外光谱(NIRS)  定量模型  注射用复方甘草酸苷
 
Quality Control of Compound Glycyrrhizin for Injection by Near Infrared Spectroscopy
Abstract:In this paper,a quantitative analysis model was established by partial least squares method(PLS),based on the contents of glycine,glycyrrhizin and cysteine hydrochloride in compound glycyrrhizin by collecting near infrared spectrum(NIRS) of 70 batches of samples,and verified.Results showed that linear correlation coefficients(R) of the established model for glycine,glycyrrhizin and cysteine hydrochloride were 0.999 54,0.947 01 and 0.999 95,while the root mean squared error of correction set(RMSECs) were 0.289,0.098 0 and 0.001 07,respectively.Furthermore,the mean relative deviations between the reference values and the predicted values of the three components in 13 batches of samples were 0.41%,0.72% and 0.86%,respectively,and there was no significant difference in the T test(P > 0.05).
Key Words:near infrared spectrum(NIRS)  quantitative model  compound glycyrrhizin for injection
引用本文:汪义程,郭志永,闫宇,薛洪宝,陈鹏,宫文武.近红外光谱用于注射用复方甘草酸苷质量控制研究[J].分析测试学报,2023,(1):101-106.
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