复方青黛散的质量标准研究  

Study on quality standard of compound qingdai powder

作　　者：马宏达[1] 崔英宇[1] 高军[1] 王琳琳[1] 史国兵[1] 

机构地区：[1]沈阳军区总医院药剂科,沈阳110016

出　　处：《实用药物与临床》2016年第2期211-215,共5页Practical Pharmacy and Clinical Remedies

基　　金：军队医疗机构制剂标准提高科研专项重点课题(13ZJZ02)

摘　　要：目的建立复方青黛散的质量标准。方法采用TLC法对本制剂中青黛、牛黄、黄柏、甘草、冰片进行薄层鉴别。采用HPLC法对盐酸小檗碱进行含量测定：以Agilent C18（250 mm×4.6 mm,5μm）为色谱柱,流动相为乙腈-0.1%磷酸水溶液（40∶60）（每100mL水中加入0.05 g十二烷基磺酸钠）,流速为1.0mL/min,检测波长为265 nm。结果薄层鉴别斑点清晰、分离较好,阴性对照无干扰;盐酸小檗碱在0.0020.10 mg/mL范围内与峰面积呈良好的线性关系（r=0.999 6）,平均加样回收率为100.31%,RSD=1.57%（n=6）。结论方法准确可靠、重现性好,能有效控制复方青黛散的质量,为提高复方青黛散的质量标准提供了依据。Objective To establish the quality standard of compound qingdai powder.Methods TLC method was used for the qualitative identification of indigo naturalis,bovis calculus,phellodendri chinensis cort,glycyrrhizae radix et rhizoma,borneolum syntheticum.HPLC was used to determine the content of berberine hydrochloride.The determination was performed on Agilent C18（250 mm ×4.6 mm,5μm） column with mobile phase of acetonitrile-0.1%phosphoric acid water（40：60）（SDS 0.05 g was added in 100 mL water） at the flow rate of 1.0 mL/min.The detection wavelength was set at 265 nm.Results TLC spots were clear and well-separated without negative interference.The linear range of berberine hydrochloride was 0.0020.10 mg/mL（r=0.999 6） with an average recovery of100.31%,RSD = 1.57%（n =6）.Conclusion The method is simple,accurate and reproducible.It is effective in controlling the quality of compound qingdai powder and providing the basis to improve the quality standards.

关 键 词：复方青黛散 质量标准 盐酸小檗碱 薄层色谱法 高效液相色谱法 

分 类 号：R286.0[医药卫生—中药学]