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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13~130μg.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 Jie Kang lotion for gynecology and establish its quality standard. METHODS: TLC method was used to identify the oxymatrine from chlorogenic acid, berberine from Sophora flavescens and Sophora flavescens in the honeysuckle. The content of osthole was determined by HPLC: the chromatographic column was C18 (250mm×4.6). Mm, 5 μm), the mobile phase was acetonitrile-water (54:46), the flow rate was 1.1 mL.min-1, and the detection wavelength was 321 nm. RESULTS: The main active ingredients in Jiekang lotion had the same identification response as the corresponding reference substance; the osthol was in a good linear relationship with the integral value of peak area in the concentration range of 13~130μg.mL-1. Conclusion: The preparation is sensitive to the qualitative reaction, TLC identification specificity, HPLC quantitative results accurate, reproducible, the standard can be used for the quality control of Jiekang lotion.