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作 者:张广仁[1,2] 吴云[2,3] 靳瑞婷 吴莎[2] 毕宇安[2,3] 王振中[2,3] 萧伟[1,3]
机构地区:[1]南京中医药大学药学院,南京210000 [2]中药制药过程新技术国家重点实验室,连云港222001 [3]江苏康缘药业股份有限公司,连云港222001
出 处:《世界科学技术-中医药现代化》2015年第1期146-151,共6页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology
基 金:科学技术部国家"重大新药创制"科技重大专项(2011ZX09201-201-20):子宫内膜异位症首选用药-散结镇痛胶囊大品种技术改造;负责人:荣根新
摘 要:目的:利用近红外光谱分析技术(NIRS)快速测定散结镇痛胶囊中龙血素A、B的含量。方法:利用HPLC法测定散结镇痛胶囊龙血素A、B的含量,运用偏最小二乘法(PLS)建立NIRS与HPLC测定值之间的多元校正模型,对未知样品进行预测。结果:龙血素A、B的定量校正模型相关系数r分别为0.987 9、0.981 5,校正集验证均方差(RMSEC)分别为0.021 3、0.020 7,内部交叉验证均方差(RMSEV)分别为0.025 5、0.023 6,对预测集进行预测,预测值与真实值的相关性良好。结论:近红外光谱法对散结镇痛胶囊中龙血素A和龙血素B含量预测结果较好,能满足制药中检测的精度要求,为中药生产过程的在线、无损定量分析提供了依据。This study was aimed to determine the content of loureirin A and loureirin B in San-Jie Zhen-Tong (SJZT) capsules by near-infrared spectroscopy (NIRS). High-performance liquid chromatography (HPLC) was used to determine the content of loureirin A and loureirin B in SJZT capsules. Multivariate calibration model based on PLS was developed to correlate the spectra and the corresponding values determined by NIRS and HPLC. The results showed that the correlation coefficient r of the calibration model for loureirin A and loureirin B was 0.987 9 and 0.981 5, respectively. The RMSEC of the model for loureirin A and loureirin B was 0.021 3 and 0.020 7, respectively. The RMSEV of the model was 0.025 5 and 0.023 6, respectively. It was concluded that NIRS can be used in the content determination of loureirin A and loureirin B in SJZT capsules. It was able to satisfy the precision requirement in pharmaceutical testing. It provided evidences for the online medicine production process and non-destructive quantitative analysis for Chinese medicine.
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