畅声口服液质量标准研究

Quality Standard of Changsheng Oral Solution

目的:建立畅声口服液的质量标准。方法:采用薄层色谱(TLC)法对方中黄芪、桔梗、夏枯草及甘草进行定性鉴别;采用高效液相色谱法对甘草苷进行含量测定,色谱柱为Nova-Pak C18(150mm×4.6mm,4μm),流动相为乙腈-2.5%冰醋酸溶液(13∶87),波长为276nm,流速为1.0mL·min-1。结果:TLC斑点清晰;甘草苷的进样量在0.02504～0.62600μg范围内与峰面积积分值呈良好线性关系(r=0.9999),平均回收率为98.66%,RSD=0.52%(n=6)。结论:所建标准可用于畅声口服液的质量控制。

OBJECTIVE： To study the quality standard of Changsheng oral solution. METHODS： Radix Astragali, Radix Platycodi, Spica Prunellae and Radix et Rhizoma Glycyrrhizae in the formula were identified qualitatively by TLC. The content of Liquiritin in Changsheng oral solution was determined by HPLC. The chromatographic separation was performed on Nova-Pak （218 column （150 mm×4.6 mm, 4μm） and the mobile phase consisted of acetonitrile- 2.5% acetic acid （13 ： 87） at a flow rate of 1.0 mL·min^-1. The detective wavelength was set at 276 nm. RESULTS： Clear TLC spots were noted. The linear range of Liquiritin was 0.025 04～0.626 00μg （r = 0.999 9） . The average recovery rate of Liquiritin was 98.66% （RSD = 0.52%, n = 6） .CONCLUSION： The established standard can be used for the quality control of Changsheng oral solution.