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机构地区:[1]山东医学高等专科学校,济南市250002 [2]济南金宏利实业有限公司,济南市250100 [3]济南宏济堂制药有限责任公司,济南市250100
出 处:《中国药房》2010年第48期4590-4594,共5页China Pharmacy
基 金:山东省自然科学基金资助项目(Y2007C144)
摘 要:目的:建立测定前列欣胶囊中欧前胡素、水分、细菌含量的即时快速检测分析方法。方法:采用声光可调滤光器-近红外(AOTF-NIR)光谱技术。检测器为InGaAs,测样方式为漫反射,光谱范围为1100~2200nm,波长增量为2.0nm,平均次数为300次。采用偏最小二乘法分别建立校正集样本中5个检测指标的NIR定量分析模型,并对验证集样本进行预测。采用TheUnscram-bler软件分析。结果:欧前胡素和水分含量模型的预测结果较好,NIR预测值与化学值之间的相关系数r分别为0.9993和0.9950,平均RSD为2.44%和1.07%;所建细菌梯度模型则可对不同范围内的细菌个数进行较准确预测,预测结果的平均RSD为6.61%和4.59%。结论:AOTF-NIR为前列欣胶囊的全面质量快速分析提供了一种新方法,而且为中成药固体制剂中水分的快速测定提供了借鉴,为中成药生产过程中细菌等微生物的在线检测做了有益的探索。OBJECTIVE:To establish method for real-time rapidly analysis of peulustrin,moisture content,bacterium of Qianliexin capsules.METHODS:acousto-optic tunable filter-near infrared(AOTF-NIR) spectroscopy.The determination condition was as follows:InGaAs detector,diffusion reflection as determination method,spectrum ranged from 1 100 nm to 2 200 nm,wavelength increment of 2.0 nm,average times of 300.The NIR quantitative analysis models of 5 detection indexes in validation set was established using partial least squares(PLS) method.The using Unscrambler software was adopted to analyze data.RESULTS:The quantitative analysis models of peulustrin and moisture content performed well for prediction,with the correlation coefficients r equal to 0.999 3 and 0.995 0.The mean RSD for the test sets were 2.44% and 1.07%;The gradient model of bacterium can accurately predicted the number of bacteria.The mean RSD for the validation set were 6.61% and 4.59%.CONCLUSION:The method not only provides a new approach for rapid analysis of Qianliexin capsule,but also establishes a foundation for the rapid determination of moisture content in Chinese patent solid preparations and on-line detection of bacteria in the production of Chinese patent medicine.
关 键 词:前列欣胶囊 AOTF-近红外光谱技术 欧前胡素 水分 细菌 即时快速分析
分 类 号:R917[医药卫生—药物分析学]
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