金莲花软胶囊质量标准提升研究  

Improvement of Quality Standard for Jinlianhua Soft Capsules

作　　者：林凤屏 翁嘉 陈霞飞 李锦妹 欧阳珠 LIN Fengping;WENG Jia;CHEN Xiafei;LI Jinmei;OUYANG Zhu(Huizhou Institute for Food and Drug Control,Huizhou,Guangdong,China 516003)

机构地区：[1]惠州市食品药品检验所,广东惠州516003

出　　处：《中国药业》2023年第22期89-91,共3页China Pharmaceuticals

基　　金：广东省惠州市科技计划项目[2022CZ010449]。

摘　　要：目的 提升金莲花软胶囊的质量标准。方法 采用薄层色谱(TLC)法对制剂中的金莲花进行定性鉴别;采用高效液相色谱(HPLC)法对制剂成分荭草苷进行含量测定,色谱柱为Ultimate XB-C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-乙腈-0.1%磷酸水溶液(10:12:78,V/V/V),流速为1.0 mL/min,检测波长为349 nm,柱温为35℃,进样量为10μL。结果 金莲花的TLC图斑点清晰,分离良好,阴性对照无干扰。荭草苷质量浓度在1.68~168.97μg/mL范围内与峰面积线性关系良好(r=0.999 9);精密度、稳定性、重复性试验结果的RSD均小于1.0%;平均加样回收率为97.87%,RSD为1.70%(n=6)。结论 所建立的方法专属性强、重复性好,结果准确,可用于金莲花软胶囊的质量控制。Objective To improve the quality standard of Jinlianhua Soft Capsules.Methods Flos Trollii in the preparation was identified qualitatively by the thin-layer chromatography(TLC)method.The content of orientin in the preparation was determined by the high-performance liquid chromatography(HPLC)method;the chromatographic column was Ultimate XB-C18 column(250 mm×4.6 mm,5μm),the mobile phase was methanol-acetonitrile-0.1%phosphoric acid aqueous solution(10∶12∶78,V/V/V),the flow rate was 1.0 mL/min,the detection wavelength was 349 nm,the column temperature was 35℃,and the injection volume was 10μL.Results The TLC chromatograms of Flos Trollii showed clear spots,good resoluion and no interference from the negative reference.The linear range of orientin was 1.68-168.97μg/mL(r=0.9999).The RSDs of precision,stability and repeatability tests were all lower than 1.0%.The average recovery rate of orientin was 97.87%,with an RSD of 1.70%(n=6).Conclusion The established method is accurate,specific and repeatable,which can be used for the quality control of Jinlianhua Soft Capsules.

关 键 词：金莲花软胶囊 质量标准 薄层色谱法 高效液相色谱法 荭草苷 

分 类 号：R917[医药卫生—药物分析学] R927[医药卫生—药学]