A rapid quantitative analytical method for three components of Lonicerae Japonicae Flos solution (Lonicera Japonica Thumb.) extracted by water was developed using near-infrared (NIR) spectroscopy and the partial least-squares (PLS) method. The NIR spectra of 81 samples collected from a production line were obtained. The concentrations of secologanic acid, chlorogenic acid and galuteolin were determined by using high-performance liquid chromatography-diode array detection as the reference method. Several pretreatment methods for the NIR spectra were used during PLS calibration. The most appropriate latent variable number of the PLS factor was selected based on the standard error of cross-validation (SECV). The performance of the final PLS models was evaluated according to SECV, standard error of prediction (SEP) and determination coefficient (R²). The compounds secologanic acid, chlorogenic acid and galuteolin had SEP values of 0.030, 0.061 and 1.668 μg/mL, respectively and R² values over 0.85. This work shows that NIR spectroscopy is a rapid and convenient method for the analysis of Lonicerae Japonicae Flos solution extracted by water. The proposed method can help in the application of process analytical technology in the pharmaceutical industry, particularly in traditional Chinese medicine injections.

选取a, b, c和d四种类型近红外光谱仪, 分别采用透射模式测定清开灵注射液近红外光谱, 以高效液相色谱法测定值作为参考值, 建立不同仪器类型清开灵注射液中黄芩苷偏最小二乘(PLS)和间隔偏最小二乘(iPLS)定量模型, 并计算模型的多变量检测限(MDL)。 四种仪器的PLS模型决定系数(R2)和预测均方差(SEP)分别为0.976 2和230.4 μg·mL-1(a), 0.956 1和246.4 μg·mL-1(b), 0.966 2和264.4 μg·mL-1(c), 0.998 5和71.5 μg·mL-1(d), 其中d型仪器较其他三种类型能获得更好的模型性能。 经iPLS变量筛选后, a和b两种类型仪器得到的iPLS模型R2pre和SEP分别为0.977 1和218.4 μg·mL-1, 0.975 4和219.4 μg·mL-1, 相较其PLS模型预测性能未见明显提高; c和d未筛选出变量。 不同仪器的MDL(Δ0.05, 0.05)均低于250 μg·mL-1, 其中c和d型MDL分别低至58和2.9 μg·mL-1。 表明不同类型仪器定量预测性能和MDL不同。 创新性采用多变量检测限理论探讨了不同类型近红外仪器的检测性能, 这一方法具有可行性。 在实际应用中应根据研究载体的特征选择合适的仪器类型, 以确保定量准确性。

采用HPLC-DAD-ELSD法, 在最优波长（255 nm）下同时测定了清开灵注射液的10种有效成分, 测定了不同厂家的15个批次清开灵注射液样品, 进行了质量相关性分析。 所建立的分析方法符合规定标准, 所测样品中, 不同厂家及同厂家不同批次样品间各组分的含量差异悬殊（RSD值范围为2.17%～65.54%）。 方法简便可靠, 可用于清开灵注射液的质量控制。 尽量多地控制这些已知的主要有效成分是保证清开灵注射液质量的关键。