摘要
目的:考察不同厂家生产的双黄连口服液的质量。方法:采用高效液相色谱(HPLC)法对市售的双黄连口服液中的主要成分黄芩苷、绿原酸和连翘苷的含量进行测定。色谱柱为Agilent ZORBAX80A Extend-C18柱(150mm×4.6mm,5μm),柱温为30℃;流动相、流速和检测波长分别为:黄芩苷为甲醇-水-冰醋酸(50∶50∶1,V/V)、1.0mL·min-1、274nm,绿原酸为甲醇-水-冰醋酸(20∶80∶1,V/V)、0.8mL·min-1、324nm,连翘苷为乙腈-水(25∶75,V/V)、1.0mL·min-1、278nm。结果:不同厂家生产的双黄连口服液均符合2005年版《中国药典》(一部)的规定,但双黄连口服液中绿原酸含量相差近3倍,这可能是其临床疗效存在显著性差异的原因。结论:现行双黄连口服液质量标准主要成分含量只规定了下限,建议进一步完善和提高质量标准。
OBJECTIVE： To study the quality of Shuanghuanglian oral solutions from different manufactures. METHODS： The contents of baicalin, chlorogenic acid and forsythin in Shuanghuanglian oral solution on the market were determined by HPLC. The determination was performed on Agilent ZORBAX 80A Extend-C18 （150 mm×4.6 mm,5 μm） column with column temperature set at 30 ℃. The mobile phase for baicalin consisted of methanol-water-acetic acid （50 ∶ 50 ∶ 1, V/V） at flow rate of 1.0 mL·min-1 and detection wavelength of 274 nm. The mobile phase for chlorogenic acid consisted of methanol-water-acetic acid （20 ∶ 80 ∶ 1, V/V） at flow rate of 0.8 mL·min-1 and detection wavelength of 324 nm. The mobile phase for forsythin consisted of acetonifrile-water （25 ∶ 75, V/V） at flow rate of 1.0 mL·min-1 and detection wavelength of 278 nm. RESULTS： Shuanghuanglian oral solutions from different manufactures conformed to the requirements of the first column of Chinese Pharmacopeia （2005 edition）. The content differences of chlorogenic acid in Shuanghuanglian oral solutions were almost 3 times, which may be the cause of the difference of clinical efficacy. CONCLUSION： The minimum detection limit only has been established for the quality standard of Shuanghuanglian oral solution. It is suggested to improve the quality standard of Shuanghuanglian oral solution.
出处
《中国药房》
CAS
CSCD
北大核心
2010年第28期2674-2675,共2页
China Pharmacy
