苦榆顺达灌肠液质量标准研究

Quality Standard of Kuyushunda Enema

目的:建立苦榆顺达灌肠液的质量标准。方法:采用薄层色谱(TLC)法定性鉴别苦参、蛇床子;采用高效液相色谱法测定没食子酸的含量。结果:TLC斑点清晰,分离度良好;没食子酸进样量在0.0722～0.3612μg范围内与峰面积积分值呈良好的线性关系(r=0.9997);平均回收率为97.8%,RSD=1.03%(n=6)。结论:所建标准可用于苦榆顺达灌肠液的质量控制。

OBJECTIVE： To establish the quality standard of Kuyushunda enema. METHODS： Radix Sophorae Flavescentis and Fructus Cnidii were identified by TLC and the content of Gallic acid was determined by HPLC. RESULTS： The TLC spots were clear and well- separated. The calibration curve of Gallic acid was linear within the range of 0.072 2-0.361 2 μg（r = 0.999 7） .The average recovery was 97.8% （RSD 1.03%, n=6） .CONCLUSION： The established standard is applicable for thee quality control of Kuyushunda enema.