金振口服液质量标准研究

Studies on Quality Standard of Jinzhen Oral Liquid

目的:提高和完善金振口服液的薄层鉴别和含量测定方法。方法:改进《中国药典》(2010版)中金振口服液项下大黄、黄芩、人工牛黄和甘草薄层鉴别方法。采用HPLC同时测定处方中黄芩苷和甘草酸含量,用Waters C_(18)(150 mm×4.6 mm,5μm)色谱柱,以乙腈-0.1%甲酸为流动相,梯度洗脱,流速为0.8 mL·min^(-1),检测波长为250 nm,柱温为室温。结果:简化了供试液的制备方法,4种中药的薄层鉴别共用1个供试品溶液,取样量由120 mL降为10 mL。黄芩苷和甘草酸的质量浓度分别在8.29~99.5 mg·L^(-1)(r=0.999 7,n=5)和3.90~46.8mg·L^(-1)(r=0.999 2,n=5)与峰面积呈良好的线性关系;平均加样回收率分别为97.6%和97.8%,RSD分别为2.4%和2.6%。结论:改进后的薄层鉴别法简便、易于操作、节约实验样品和实验时间,含量测定方法科学准确、重复性高,均可作为金振口服液的质量控制方法。

Objective： To Improve TLC identification and determination for Jinzhen oral liquid. Methods： Improve the TLC identification of Rhei Radix Et Rhizoma, Scutellariae Radix, Boris Calculus Artifactus and Glycyr-rhizae Radix Et Rhizoma for Jinzhen oral liquid in Edition 2010 of Chinese Pharmacopoeia. The contents of baicalin and glycyrrhizic acid were determined simultaneously by HPLC. The HPLC was conducted on Waters C18 column at room temperature. The mobile phase consisted of acetonitrile and 0. 1% formic acid solution with gradient elution, the flow is 0. 8 mL·min^-1, wavelength is 250 nm. Results： The four test solution of the of Rhei Radix Et Rhizoma, Scutellar-iae Radix, Bovis Calculus Artifaetus and Glycyrrhizae Radix Et Rhizoma were simplified into one. The sampling vol-ume was reduced from 120 mL to 10 mL. The linear ranges were 8. 29-99. 5 mg·L^-1 for baicalin（r =0. 999 7, n = 5 ） and 3.90 - 46. 8 mg· L^-1 for glyeyrrhizic acid （ r = 0. 999 2, n = 5 ）, respectively. The average recoveries rates were 97.6 % with RSD 2. 4% for baicalin and 97.8% with RSD 2. 6% for glycyrrhizic acid. Conclusion： The im-proved TLC identification method is simple, could save samples and time. The content determination is scientific, accurate, with high repeatability and could be used for the quality control of Jinzhen oral liquid.