中成药及保健食品中非法添加调血脂类药物的HPLC快速检测方法研究  

Rapid HPLC testing method for lipid-regulating drugs illegally added in traditional Chinese medicines and health food

作　　者：邓鸣 朱斌 尹利辉[2] 

机构地区：[1]广西食品药品检验所,南宁530021 [2]中国食品药品检定研究院,北京100050

出　　处：《药物分析杂志》2016年第9期1639-1647,共9页Chinese Journal of Pharmaceutical Analysis

基　　金：十二五国家科技重大专项"重大新药创制"课题"化学新药质量标准研究与评价技术平台"(2011ZX09303-001)

摘　　要：目的:建立中成药及保健食品中非法添加9种调血脂类药物成分(普伐他汀钠、苯扎贝特、阿托伐他汀钙、氟伐他汀钠、氯贝丁酯、美伐他汀、吉非罗齐、洛伐他汀、辛伐他汀)的高效液相色谱快速检验方法。方法:采用Alltima C18(53 mm×7 mm,3μm)色谱柱,以0.05 mol·L^(-1)磷酸二氢钾溶液(磷酸调p H至3.5)-甲醇(25∶75)为流动相,流速1.0 m L·min^(-1),检测波长为237 nm(普伐他汀钠、洛伐他汀、辛伐他汀)、229 nm(苯扎贝特)、245 nm(阿托伐他汀钙)、233 nm(氟伐他汀钠)、225 nm(氯贝丁酯)、236 nm(美伐他汀)和218 nm(吉非罗齐),柱温35℃。采用相对容量因子和紫外光谱相似度双指标进行定性,相对校正因子法进行定量分析。结果:建立了在同一色谱系统检测9种调血脂类药物的分析方法,减少流动相的切换,提高分析速度;采用紫外光谱相似度和相对容量因子进行定性,结果准确可靠;相对校正因子含量测定法,能有效减少对照品的使用;采用外标法及相对校正因子法计算回收率,结果分别为93.1%~109.4%及91.3%~117.3%,差异较小,回收率良好。结论:本方法可作为同时检测中成药及保健食品中是否非法添加有上述9种药物的快速检测方法。Objective：To establish a rapid HPLC method for simultaneous determination of 9 kinds of lipid-regulating drugs（pravastatin sodium,benzafibrate,atoravstatin calcium,fluvastain sodium,clofibrate,mevastatin,gemfibrozil,lovastatin,simvastatin）illegally added in traditional Chinese medicines and health food.Methods：Chromatographic separation was carried out on an Alltima C18（53 mm×7 mm,3 μm）column,the mobile phase was 0.05 mol·L^（-1） potassium dihydrogen phosphate（phosphoric acid to adjust p H to 3.5）-methanol（25∶75）at the flow rate of 1.0 m L·min^（-1）,the detection wavelength was 237 nm（pravastatin sodium、lovastatin、simvastatin）,229 nm（bezafibrate）,245 nm（atorvastatin calcium）,233 nm（fluvastatin sodium）,225 nm（clofibrate）,236 nm（mevastatin）,and 218 nm（gemfibrozil）,and the column temperature was 35 ℃.The qualitative analysis was performed using relative capacity factor and ultraviolet（UV）spectral similarity as the double indicator.The relative correction factor for quantification analysis was used for content determination.Results：The nine compounds were completely separated under the above described condition which reduced the switch of mobile phase and accelerated the analyzing speed.The qualitative analysis was more accurate by applying UV spectral similarity and relative capacity factor.The relative correction factor method for quantification which required less reference substances.Recoveries ranged from 93.1%^（-1）09.4% as calculated use external standard method and 91.3%^（-1）17.3% as calculated use relative correction factor method.Conclusion：The established method is suitable for simultaneous determine of 9 kinds of lipid-regulating drugs illegally added in traditional Chinese medicines and health food.

关 键 词：中成药 保健食品 调血脂类药物 苯扎贝特 普伐他汀钠 阿托伐他汀钙 氟伐他汀钠 氯贝丁酯 美伐他汀 吉非罗齐 洛伐他汀 辛伐他汀 快速检测 高效液相色谱法 相对容量因子 紫外光谱相似度 相对校正因子法 

分 类 号：R917[医药卫生—药物分析学]