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目的:研究近红外定量分析误差和中药产品质量控制限度之间的关系,建立可靠的中药质量实时放行测试(RTRT)方法。方法:以三七总皂苷(PNS)速释片为载体,采用偏最小二乘法(PLS)建立近红外(NIR)漫反射光谱预测三七总皂苷含量的定量模型;通过实验设计计算不同浓度NIR定量分析误差,基于β-期望容忍区间估计质量控制上下限处的定量分析风险,在一定置信水平下建立有效组分含量实时放行控制限。结果:所建NIR定量模型性能偏差比(RPD)为4.34,说明预测性能良好;在90%置信水平下,NIR分析的样品RTRT下限为0.2665g/g,上限为0.2918g/g,较标准质控限度有所缩减。结论:本研究所建中药片剂含量实时放行测试方法,可提高放行可靠性和效率,并可推广用于其他产品放行检验。
Objective: To study the relationship between quantitative error of near-infrared spectroscopy and quality control limit of traditional Chinese medicine (TCM), and to establish a reliable real-time release test of traditional Chinese medicine (RTRT) method. Methods: A quantitative model of total saponins in Panax notoginseng was established by partial least squares (PLS) using near-infrared (NIR) diffuse reflectance spectroscopy. The effects of different concentrations of NIR Quantitative analysis of errors, quantitative risk analysis based on the upper and lower limits of quality control of β-expected tolerance interval, and establish the real-time control limit of effective components content under a certain confidence level. Results: The RPD of the built NIR quantitative model was 4.34, indicating a good predictive performance. At the 90% confidence level, the lower limit of RTRT for the NIR analysis was 0.2665 g / g and the upper limit was 0.2918 g / g, Control limits have been reduced. Conclusion: The real-time release test method for Chinese medicine tablet content in this study can improve the reliability and efficiency of release and can be widely used for the release test of other products.