参柏洗剂质量标准提高研究

Research on the Improvement in Quality Control of Shenbo Lotion(参柏洗剂)

目的对参柏洗剂原有定性和定量方法进行标准提高研究。方法在原标准定性方法基础上,增加苦参碱和氧化苦参碱、盐酸小檗碱对照品鉴别及地骨皮薄层色谱鉴别;增加高效液相色谱法测定方中君药苦参所含有效成分苦参碱和氧化苦参碱含量。结果薄层色谱法定性鉴别中,苦参、苦参碱、槐定碱、黄柏、盐酸小檗碱、地骨皮斑点清晰且对应良好,阴性无干扰;苦参碱和氧化苦参碱分别在0.545~5.45μg(苦参碱r=0.99988)、0.2226~2.226μg(氧化苦参碱r=0.99993)浓度范围内,与色谱峰面积线性关系均良好;苦参碱平均回收率99.27%(n=9),RSD为2.11%;氧化苦参碱平均回收率103.07%(n=9),RSD为1.68%。结论该研究所完善、建立的定性和定量分析方法简便,重复性好,准确可靠,可用于参柏洗剂的质量控制。

Objective To improve the original qualitative and quantitative standard of Shenbo Lotion(参柏洗剂).Methods On the basis of the original qualitative method,TLC identification of matrine,oxymatrine,berberine hydrochloride and Digupi(Lycii Cortex)were added;The content of matrine and oxymatrine,active ingredients in Kushen(Sophorae Flavescentis Radix),were determined by HPLC.Results In the qualitative identification of TLC,the spots of Kushen(Sophorae Flavescentis Radix),matrine,oxymatrine,Huangbo(Phellodendri Chinensis Cortex),berberine hydrochloride and Digupi(Lycii Cortex)were clear in good correspondence,without interference;The linear ranges were 0.545-5.45μg(Matrine,r=0.99988),0.2226-2.226μg(oxymatrine,r=0.99993);the average recoveries(n=9)were 99.27%for matrine(RSD=2.11%),103.07%for oxymatrine(RSD=1.68%).Conclusion The qualitative and quantitative analysis methods improved and established in the study are simple,reproducible,accurate and reliable,they can be applied to control the quality of Shenbo Lotion.