驱铅颗粒质量标准研究

Quality Standard of Quqian Granules

目的:建立驱铅颗粒的质量标准。方法:采用薄层色谱(TLC)法对制剂中丹参、木香、黄连进行鉴别;采用高效液相色谱(HPLC)法测定制剂中盐酸小檗碱的含量,色谱柱:Hvpersil BDS C_(18)柱(200mm×4.6 mm,5μm)柱;流动相:乙腈-0.033mol·L^(-1)KH_2PO_4溶液(35:65);流速:1.0 ml,min^(-1);检测波长:345 nm;柱温:30℃。结果:TLC鉴别丹参酮Ⅱ_A、去氢木香烃内酯、盐酸小檗碱在薄层板上有清晰的斑点,分离效果良好。盐酸小檗碱含量在4.08～130.82μg·ml^(-1)浓度范围内线性关系良好(r=0.999 9),平均回收率为98.1%(RSD=1.46%,n=9)。3批样品中盐酸小檗碱含量分别为0.67,0.71,0.58 mg·g^(-1)。结论:所建立的薄层鉴别方法专属性强,定量方法简便,准确,可用于驱铅颗粒的质量控制。

Objective：To establish the quality standard of Quqian granules.Method：Snlvlae miltiorrhizae Radix el rhizoma, Aucklandlae Radix and Coptidis Rhizome were identified by TLC.The content of berberine hydrochloride in the preparation was determined by HPLC with a Hypersil BDS C_（18）column（200 mm×.6 mm,5μm）,the mobile phase of acelonitrile -0.033 mol·L^（-1） KH_2PO_4 solution（35：65 ） at the flow rate of 1.0ml·min^（-1）,the detection wavelength of 345nm and the column temperature of 30℃. Result：The TLC spots o（tanshinoneⅡ_A,dehydrogenase costunolide and berberine were clear with good separation.The content of berberine hydrochloride was linear within the concentration range of 4.08-130.82μg·ml^（-1） and the average recovery was 98.1%（r= 0.999 9,RSD = 1.46%）.The content of berberine hydrochloride in three batches of samples was 0.67,0.71,0.58 mg·g ^（-1）,respectively. Conclusion：The TLC identification method has high specificity,the quantitative determination method is simple and accurate, and can be used in the quality control of Quqian granules.