清肺口服液质量标准的研究.doc

清肺口服液质量标准的研究
[日期:2009-02-14]
来源:  作者:
[字体:大中小]
                        作者:居玲玲,文红梅,郭立玮
【摘要】  目的建立清肺口服液的质量标准。方法采用薄层色谱法鉴别制剂中葶苈子、黄芩和虎杖;采用高效液相色谱方法测定盐酸麻黄碱的含量。结果薄层鉴别能检出葶苈子、黄芩和虎杖的斑点,且斑点清晰。~ μg/mL之间与峰面积呈良好线性关系,r=,%,%。结论该方法可用于清肺口服液的质量控制。转载于论文联盟
【关键词】  清肺口服液;盐酸麻黄碱;薄层色谱法;高效液相色谱法
Abstract:Objective  To establish the quality standard of Qingfei oral The quality of Descurainia sophia,Scutellaria baicalensis i and Polygonum cuspidatum was identified by TLC. The content of ephedrine hydrochloride was determined by HPLC. Results The spots on TLC plates were clear without interference in the blank control. The liner range of ephedrine hydrochloride was 1641~ μg/mL(r=). The average recovery of ephedrine hydrochloride was % and RSD %.Conclusion  The method can be used for the quality control of Qingfei oral liquor.
Key words:Qingfei oral liquor; ephedrine hydrochloride; thinlayer chromatography; HPLC
清肺口服液由麻黄、葶苈子、黄芩、虎杖等中药精制而成,具有宣肺开闭、清热解毒、化痰止咳之功效,主治小儿病毒性肺炎痰热闭肺证。麻黄为君药,主要含有麻黄碱、伪麻黄碱等生物碱类成分[1],其中麻黄碱含量较高,且为活性成分。为了更好地控制制剂的内在质量,本文建立了制剂中葶苈子、黄芩和虎杖的薄层鉴别方法及麻黄碱的HPLC含量测定方法。
1  仪器与试剂    
美国Waters515泵,Waters 2487紫外可见检测器,Rheodyne 进样器,中科院大连化学物理所WDL95色谱工作站;PBQ I型薄层自动涂布器;薄层层析显色加热器;硅胶G(青岛海洋化工集团);乙醇、甲醇为色谱纯(美国Tedia公司);水为重蒸馏水;其余试剂均为分析纯。    
盐酸麻黄碱对照品(批号171241200303,HPLC法检查纯度大于99%)、黄芩苷对照品(批号110715200212)、大黄素对照品(批号07572002