清开灵注射液生产过程中金银花提取液的在线质量控制方法研究

为建立清开灵注射液生产过程中的中间体金银花提取液快速准确的在线质量控制方法,通过对金银花提取液的UV原始光谱、一阶导数光谱进行波长点的数据筛选,选择与HPLC法测得的绿原酸含量相关性最好的光谱类型和波长点进行建模,建立绿原酸含量的UV预测方程.另取10批金银花提取液检验预测结果的可靠性.UV原始光谱中最佳波长为294 nm(r=0.991 9,n=28);一阶导数光谱中最佳波长为316nm(r=0.995 9,n=28).绿原酸含量的预测方程为:c(mg·mL-1)=506.254 3×A316nm 0.177 1.经检验,预测方程准确、可靠(r=0.997 1,n=10),可直接应用于在线检测.绿原酸含量的预测结果为:约90%的金银花提取液中绿原酸含量分布为0.4～4.0 mg·mL-1.此法简单、快速、准确,可作为清开灵注射液生产过程中金银花提取液的在线质量控制方法.

Study on the Method of Rapid Quality Control of Aqueous Solution of Flos Lonicerae Japonicae Extraction in the Preparation of Qingkailing Injection

To establish a rapid and accurate on-line quality control method for aqueous solution of Flos Lonicerae Japonicae extraction (ASFLJE) in the preparation of Qingkailing injection, the wavelength of UV original spectrum and its first derivative spectrum of ASFLJE were scanned. The most suitable spectrum type and wavelength correlated with the chlorogenic acid content in ASFLJE determined by RP-HPLC were chosen to build a regress model. The UV equation for predicting chlorogenic acid content in ASFLJE was established. Other 10 batches of ASFLJE were used for testing the on-line prediction results by comparison of the values of chlorogenic acid content determined by HPLC and predicting equation respectively. The most suitable wavelengths correlated with chlorogenic acid content were 294 nm (r = 0.991 9, n = 28) in the original UV spectrum and 316 nm (r = 0.995 9, n = 28) in the first derivative spectrum respectively. The predicting equation of chlorogenic acid content was: c(mg x mL(-1)) = 506. 254 3 x A316 nm + 0.177 1 (r = 0.995 9, n = 28). This predicting equation is credible and accurate, as tested by HPLC method (r = 0.991 5, n = 10). The prediction results of chlorogenic acid content were: the chlorogenic acid content in probable 90 percent ASFLJE was: 0.4-4.0(mg x mL(-1)). This method is rapid, simple and accurate, and can be used for the on-line quality control of ASFLJE in Qingkailing injection preparation.