洁康洗剂的制备及质量标准研究

Study on Preparation and Quality Standard of Jiekang Lotion

目的：制备妇科用洁康洗剂并建立其质量标准.方法：采用TLC法对金银花中的绿原酸、黄柏中的小檗碱、苦参中的氧化苦参碱进行鉴别;采用HPLC法对蛇床子素进行含量测定：色谱柱为C18（250mm×4.6mm,5μm）,流动相为乙腈-水（54∶46）,流速为1.1mL·min^-1,检测波长为321nm.结果：洁康洗剂中的主要有效成分与相应对照品均有相同的鉴别反应;蛇床子素在13～130 μg·mL^-1浓度范围内与峰面积积分值呈良好线性关系.结论：该制剂定性反应灵敏,TLC鉴别专属性强,HPLC定量结果准确、重现性好,所建标准可用于洁康洗剂的质量控制.

OBJECTIVE： To prepare gynecological Jiekang lotion and to establish its quality standard. METHODS： The Caffeotannic acid in Flos Lonicerae, the Berberine in Cortex Phellodendri and the Ammothamnine in Radix Sophorae Flavescentis were identified by TLC; HPLC was adopted to determine the content of Osthole with Hypersil DOS C18 as chromatograpic column. The mobile phase consisted of acetonitrile-water （54 ： 46） with a flow rate of 1.1mL·min^-1. The detection wavelength was set at 321nm. RESULTS： Both the chief components in Jiekang lotion and the corresponding reference substances showed the identical discrimination reactions. The linear range of Osthole was 13-130μg·mL^-1. CONCLUSION ： The method is sensitive in qualitative reaction, specific in TLC identification, accurate in HPLC quantitation and recurrent. The established standard is applicable for the quality control of Jeikang lotion.