CAJ | 학술논문

目的：改进复方茶碱麻黄碱片现行质量标准中的鉴别方法，建立主成分的HPLC含量测定方法。方法：采用Waters XTerra-C18（4.6×150mm，5μm）色谱柱，以磷酸盐缓冲液（取0.05mol·L-1磷酸二氢钾溶液1000mL，加入三乙胺4mL，用磷酸调节pH值至6.5）-乙腈（90：10）为流动相，鉴别复方茶碱麻黄碱片的5种主成分、测定4种主成分的含量。结果：颠茄浸膏的HPLC鉴别方法，专属性良好，硫酸阿托品的检出限为6.24ng；可可碱、茶碱、盐酸麻黄碱、咖啡因的HPLC鉴别方法，专属性良好，检测限以盐酸麻黄碱计为0.218ng；可可碱、茶碱、盐酸麻黄碱、咖啡因含量的HPLC含量测定方法，专属性、准确度、精密度、重复性、耐用性均良好。结论：改进后的复方茶碱麻黄碱片鉴别方法准确、简便，新建的4种主成分的含量测定方法，简便、快速、准确，可有效的控制产品质量，降低产品质量风险。
목적：개진복방다감마황감편현행질량표준중적감별방법，건립주성분적HPLC함량측정방법。방법：채용Waters XTerra-C18（4.6×150mm，5μm）색보주，이린산염완충액（취0.05mol·L-1린산이경갑용액1000mL，가입삼을알4mL，용린산조절pH치지6.5）-을정（90：10）위류동상，감별복방다감마황감편적5충주성분、측정4충주성분적함량。결과：전가침고적HPLC감별방법，전속성량호，류산아탁품적검출한위6.24ng；가가감、다감、염산마황감、가배인적HPLC감별방법，전속성량호，검측한이염산마황감계위0.218ng；가가감、다감、염산마황감、가배인함량적HPLC함량측정방법，전속성、준학도、정밀도、중복성、내용성균량호。결론：개진후적복방다감마황감편감별방법준학、간편，신건적4충주성분적함량측정방법，간편、쾌속、준학，가유효적공제산품질량，강저산품질량풍험。
Objective:To improve the identification and establish the HPLC determination in the existing standard of Compound Theophylline and Ephedrine Tablets. Method:The HPLC method for the identification of 5 kinds of main components and the deter-mination of 4 kinds of main ingredient content was carried out on a Waters XTerra-C18 (4.6 × 150mm, 5μm) column, with mobile phase of phosphate buffer solution (0.05 mol·L-1 potassium dihydrogen phosphate solution 1000mL, added triethylamine 4mL, adjusted pH to 6.5 with phosphoric acid )-acetonitrile (90:10). Results:The HPLC identification for Belladonna extract had good specificity, the detection limit of atropine sulfate was 6.24ng;The HPLC identification for theobromine, theophylline, ephedrine and caffeine also had good specificity, the limit of detection of was 0.218ng as ephedrine hydrochloride;the specificity, accuracy, precision, repeatability and durability of the HPLC determination for theobromine, theophylline, ephedrine andcaffeine were good. Conclusion:The improved method for identification of Compound theophylline ephedrine tablets was accurate, simple;the new HPLC determination method for 4 kinds of main component iwas simple, rapid, and accurate, and it coule not only control the product quality effectively but also reduce the product quality risk.