中兽药乌梅颗粒质量标准的研究

张远达 陈志强* 尚静雪 蔡小利 张鹏举 付丽云 李海华

( 内蒙古华天制药有限公司，内蒙古赤峰市，024070)

摘要：目的：建立乌梅颗粒的质量标准。方法：采用薄层色谱法（TLC）对乌梅、黄连进行鉴别；用高效液相色谱法测定乌梅颗粒中枸橼酸的含量。色谱条件为Silgreen C18（4.6mm×250mm，5um）色谱柱；流动相为乙腈-0.5%磷酸二氢铵溶液(3：97)（用磷酸调节pH值至3.0）；检测波长为210nm；流速为0.6ml/min；柱温为室温。结果：建立了乌梅、黄连的薄层色谱定性鉴别的方法；建立了HPLC测定乌梅颗粒中枸橼酸含量的方法。结论：建立的乌梅颗粒鉴别及枸橼酸含量测定方法简单、易于操作、准确度高、重现性好，可用于乌梅颗粒的质量控制。

Study on quality standard of Chinese veterinary medicine wumei granule

ZHANG Yuanda,CHEN Zhiqiang *,SHANG Jing xue,CAI Xiaoli,

ZHANG Pengju,FU Liyun,LI Haihua

(Inner Mongolia huatian pharmaceutical co., LTD., chifeng city, Inner Mongolia, 024070)

Abstract: objective: to establish the quality standard of wumei granules. Methods: thin layer chromatography (TLC) was used to identify the black plum and coptis chinensis. The content of citric acid in wumei granules was determined by HPLC. The chromatographic condition was Silgreen C18 (4.6mm 250mm, 5um) column. The mobile phase was acetonitrile-0.5% ammonium dihydrogen phosphate solution (3:97) (pH value adjusted by phosphoric acid to 3.0). The detection wavelength was 210nm. The flow rate was 0.6ml/min. The column temperature is room temperature. Results: a TLC method for the qualitative identification of fructus mume and rhizoma coptidis was established. HPLC method for determination of citric acid in wumei granules was established. Conclusion: the method is simple, easy to operate, accurate and reproducible. It can be used for quality control of wumei granules.

Keywords: wumei granules; Citrate; Thin layer chromatography; High performance liquid chromatography

乌梅颗粒由乌梅、柿饼、黄连、姜黄、诃子组成。原方乌梅散收载于《中国兽药典》二部^[1]，临床应用于治疗幼畜奶泻。但由于散剂服用剂量大，服用不便，且药材中的有效成分不易溶出，吸收差^[2]。故对乌梅散进行工艺研究将其制成颗粒剂。为控制乌梅颗粒的质量，本文对其进行质量研究，复方中乌梅为制剂的君药，含有大量的有机酸，现代药理研究表明，乌梅的抗菌和固涩作用与有机酸密切相关