中国医药科学Issue(17)：18-22,5.
四味清口含片的质量标准研究
Study on quality standard of Siweiqing buccal tablets
摘要
Abstract
Objective To establish the quality control standard of Siweiqing buccal tablets. Methods Thin layer chromatography (TLC) was used to identify Cortex Cinnamomi, radix glycyrrhizae, Citrus Chachiensis Hortorum and Asarum heterotropoides Fr. Schmidt var. mandshuricum (Maxim.) Kitag. in these tablets preparation. The high performance liquid chromatography (HPLC) was adopted to determine the content of cinnamaldehyde. The chromatographic conditions were as follows: the chromatographic column Hypersil ODS(C18)column (4.6mm×250mm, 5μm), the detection wavelength of 290nm, the mobile phase of methanol-φ=0.1% phosphoric acid (35∶ 65, v/v), the flow velocity of 1.0mL/min, the column temperature at 30℃, the theoretical plate number no less than 3000. Results Citrus Chachiensis Hortorum, radix glycyrrhizae, Cortex Cinnamomi and Asarum heterotropoides Fr. Schmidt var. mandshuricum (Maxim.) Kitag. can be identified by TLC without interference of negative samples. The linear relationship between content of cinnamaldehyde and peak area was obtained during the range of 0.010-0.500μg, r=0.999 9. RSD's found of the peak area for the precision test, the stability test and the repeatability test were 1.03%, 1.27% and 1.23%, respectively. The recoveries of cinnamaldehyde obtained were in the range of 97.23%-101.54% and the average of 99.43% withRSDof 0.99% (n=9).Conclusion The method can be applied to qualitative identification and quantitative assay of Siweiqing buccal tablets with good reproducibility. The sampling recovery test is in compliance with the requirement. The quality standard can effectively control the quality of Siweiqing buccal Tablets with good specificity, reproducibility and stability. It can be applied to the quality control of Siweiqing buccal tablets.关键词
四味清口含片/质量标准/薄层色谱法/高效液相色谱法/桂皮醛/含量测定Key words
Siweiqing buccal tablets/Quality standards/TLC/HPLC/Cinnamaldehyde/Content determination分类
医药卫生引用本文复制引用
张丽珍,周之荣..四味清口含片的质量标准研究[J].中国医药科学,2014,(17):18-22,5.基金项目
广东省中医药局科研课题资助项目（粤中医[2012]23号，20122109）。 （）
