双黄连粉针剂高效液相指纹图谱的建立及应用

Establishment and application of fingerprints of Shuanghuanglian Powder-Injection by HPLC

目的:建立双黄连粉针剂(金银花、黄芩、连翘)的高效液相(HPLC)指纹图谱的检测方法,并用于制剂质量的分析。方法:采用YMC-Pack ODS-A C18色谱柱(4.6 mm×250 mm,5μ),流动相为甲醇-0.012 5 mol/L醋酸铵-醋酸水溶液线性梯度洗脱,流速为1.0 mL/m in,检测器为二极管阵列检测器(PDA)与蒸发光散射检测器(ELSD)串联使用。结果:得到分离度较好的HPLC-PDA(254 nm)和HPLC-ELSD两种指纹图谱,两者具有良好的相关性和互补性。以黄芩苷为参照物,分别识别了13个特征共有峰,10批次制剂的结果显示了质量的一致性。结论:该方法稳定、准确、可靠,同时提供的信息较多,可用于双黄连粉针剂的全面质量控制。

AIM： To establish the fingerprints of Shuanghuanglian Pwder-lnjection（ Flos Lonieerae Japonicae, Radix Scutellariae, Fructus Forsythiae） by high performance liquid chromatography（HPLC） so as to control quality of the injection. METHODS ： The experimental conditions of the HPLC method were as follows： YMC-Pack ODSA C18 column（4.6 mm ×250 mm, 5 μm, mobile phase consisting of methanol and 0. 012 5 N ammonium acetate/ acetic acid buffer eluted with a linear gradient, flow rate at 1.0 mL/min, the detectors of phtodiode array detector （PDA） and evaporative light scattering detector（ELSD） connected in series, RESULTS： The method provided two kinds of fingerprints with excellent spearation, which were HPLC-PDA（254 nm） fingerprint and HPLC-ELSD fingerprint. They had a good correlation and complementation each other. Baicalin was used as a standard substance. Thirteen common peaks were the picture of fingerprints features. The resuhs showed the coincidence of the quality in the total ten batches of the injections. CONCLUSION： The method is stable, accurate and creditable, meanwhile it provides much useful information for the quality control of Shuanghuanglian Powder-lnjeetion.