康绍建 赵琪钟 侯安国

【摘 要】 目的：提高克淋通胶囊的质量标准，便于控制其质量。方法：采用薄层色谱法（TLC）法鉴别黄柏，并检查关黄柏;采用高相液相色谱法（HPLC）法测定克淋通胶囊中没食子酸的含量。结果：TLC方法斑点清晰，专属性强;HPLC法测定没食子酸在0.04242～0.6363μg范围内线性关系良好，平均加样回收率为99.76%，RSD值0.25%。结论：该方法操作简便、结果准确可靠、专属性及重现性好，可用于有效地控制克淋通胶囊的质量。

【关键词】 TLC;HPLC;克淋通胶囊;没食子酸;含量测定

【中图分类号】P284.1   【文献标志码】 A    【文章编号】1007-8517（2021）24-0031-04

Promotion on Quality Standard of Kelintong Capsules

KANG Shaojian1 ZHAO Qizhong2 HOU Anguo3*

1.      Center for Food And Drug Inspection of Yunnan Province，Kunming 650011，China;2.Puer Center for Drug

Control，Puer 665000，China;3.Yunnan University of Traditional Chinese Medicine，Kunming 650500，China

Abstract：Objective  To improve the quality standards of Kelintong Capsules in order to conveniently and effectively control its internal quality. Methods The TLC method was used to identify Phellodendron amurense and check Guan Phellodendron，and the content of gallic acid in Kelintong capsules was determined by HPLC. Results The TLC method has clear spots and strong specificity. The linear relationship of gallic acid measured by HPLC in the range of 0.04242～0.6363 μg is good. The average recovery rate is 99.76% and RSD=0.25%.Conclusion This method is easy to operate，accurate and reliable，specific and reproducible，and can be used to effectively control the quality of Kelintong capsules.

Key words：TLC; HPLC; Kelintong Capsules; Gallic Acid; Content Determination

泌尿系統感染通常指肾脏、输尿管、膀胱、尿道各个部位感染的总称，严重威胁人类健康[1-2]，尿路感染是继呼吸系统及消化道之后的第三位感染性疾病。克淋通胶囊由头花蓼（四季红）、黄柏等二味药制成，具有清热解毒、利湿通淋作用，临床上常用于治疗泌尿系统感染。对头花蓼的药理研究[3-4]表明，其对泌尿系统感染有抗菌作用，盐酸小檗碱和盐酸巴马汀是黄柏的主要化学成分，其盐酸小檗碱具有抑制炎症反应[5-8]、抗病原微生物的作用[9-11]，巴马汀也具有抗炎作用[12-13]，这些作用皆与克淋通胶囊用药功效一致。克淋通胶囊原标准[标准号：WS-11282-（ZD-1282）-2002]中仅有头花蓼的薄层鉴别和盐酸小檗碱的HPLC法含量测定，故为了更好地控制此胶囊剂的质量，对其质量标准进行提升研究，本试验在克淋通胶囊原标准中增加了黄柏和关黄柏的薄层鉴别，同时采用HPLC法建立了头花蓼（四季红）中没食子酸的含量测定方法[14-20]，为克淋通胶囊的质量控制提供科学依据。……