清热解毒口服液质量标准的研究

Quality Standard for Qingrejiedu Oral Liquid

目的:建立清热解毒口服液的质量控制方法,以提高其质量标准。方法:采用薄层色谱法对方中主要药味金银花、栀子、连翘、知母、麦冬、玄参进行定性鉴别研究,采用高效液相色谱法测定口服液中主要有效成分黄芩苷的含量。结果:薄层色谱定性鉴别的特征斑点清晰,专属性强,R f值适中,阴性对照无干扰;HPLC法测定黄芩苷含量在0.0708μg^0.35406μg范围内线性关系良好(r=0.9996,n=6),平均回收率为99.6%(RSD=2.8%,n=6)。结论:该方法简便可靠,专属性强,重现性好,能较全面反映该制剂内在质量,可用于该制剂的质量控制。

Objective： To establish the quality standard for Qingrejiedu Oral Liquid. Method： Medicines in this Description were identified by TLC. The content of baicalin which is the effective substance in the preparation was determined as the index by HPLC. Results： Medicines could be detected by TLC from three batches of samples. The Linear correlation of the baicalin is good in extent of 0. 0708 μg～0. 35406μg and the recovery is 99. 6% （RSD =2. 8%, n =6） . Conclusion： The quality control is feasible and can be applied to control the products from mass production. It can ensure the stability of the pharmaceutical quality .