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目的:建立新生化片质量标准。方法:采用TLC法对川芎、当归、甘草、干姜以及益母草进行鉴别;用HPLC法测定盐酸水苏碱的含量,色谱柱Agela Technologies Venusil HILIC柱(250 mm×4.6 mm,5μm),流动相:乙腈-0.2%冰醋酸(87:13),柱温为35℃,流速为0.8 ml·min~(-1),检测器:ELSD。结果:TLC色谱斑点清晰;盐酸水苏碱对照品在1.616～21.553μg范围内线性关系良好(r=0.999 2),平均回收率为100.14%,RSD为0.87%(n=6)。结论:本法简便、可靠、准确,以用于该制剂的质量控制。
Objective: To establish a new biochemical tablet quality standards. Methods: Chuanxiong, Angelica sinensis, Glycyrrhiza uralensis, Ginger and Motherwort were identified by TLC. The content of stachydrine hydrochloride was determined by HPLC. The column was Agela Technologies Venusil HILIC column (250 mm × 4.6 mm, 5 μm) Acetonitrile-0.2% glacial acetic acid (87:13). The column temperature was 35 ℃ and the flow rate was 0.8 ml · min -1. The detector was ELSD. Results: TLC chromatographic spots were clear. The reference standard for stachydrine hydrochloride had good linearity (r = 0.999 2) in the range of 1.616-21.553 μg with an average recovery of 100.14% and a RSD of 0.87% (n = 6). Conclusion: This method is simple, reliable and accurate for the quality control of this preparation.