苦黄口服液质量标准研究

Quality Control of Kuhuang Oral Liquid

目的:建立苦黄口服液的质量标准。方法:用薄层色谱法对制剂中的苦参、大黄、大青叶进行定性鉴别;采用HPLC测定苦参中的苦参碱含量。结果:薄层色谱斑点清晰,阴性样品无干扰;苦参碱在0.1936～7.7440μg具有良好的线性关系,r=1.0000,加样回收率为101.1%(n=6),RSD=2.87%。结论:该方法简便、精确、重现性好,可以很好地确保产品质量。

Objective： To establish the quality standard of Kuhuang oral liquid. Methods： TLC was used for the identification of sophorae flavescentis radix, rhei radix et rhizome and isatidis folium; and HPLC was used to determine the content of matrine which is the efective substance in the preparation. Results： The TLC spots developed were fairly clear, and the blank test showed no interference. The linear range of Matrine was 0. 193 6 -7.744 0μg, the average recovery was 101.1%, and RSD was 2. 87% in HPLC methods. Conclusion： The methods is simple and reliable. It can be used in quality control of Kuhuang oral liquid.