清热解毒口服液中所含药味龙胆的质量评价

Quality Evaluation of Gentiana scabra in Qingre Jiedu Oral Solution

目的:评价清热解毒口服液处方中药味龙胆的质量。方法:建立龙胆主要有效成分龙胆苦苷的高效液相色谱(HPLC)含量测定方法,并对流通领域的清热解毒口服液(299批)进行测定和评价。结果:建立的HPLC法简便可靠,流通领域中清热解毒口服液样品所含药味龙胆的质量情况不容乐观。结论:应加强清热解毒口服液生产过程监管,并对龙胆作进一步的质量控制。

OBJECTIVE： To evaluate the quality of Gentiana scabra in Qingre jiedu oral solution. METHODS： HPLC method was established to determine the content of gentiamarin in the oral solution. 299 batches of Qingre jiedu oral solution in circulation were measured and evaluated. RESULTS： Developed HPLC method is simple and reliable. The quality of Qingre jiedu oral solution in circulation is not satisfied. CONCLUSION： Great importance should be attached to the manufacture procedures monitoring of Qingre jiedu oral solution and quality control of G. scabra.