目的:建立一种快速的高效液相色谱法(HPLC)同时测定复尔康注射液中维A酸和甘草酸铵的血药浓度,利用3P97药动学软件计算药动学参数,并与维A酸注射液比较其药动学特征。方法:色谱柱:Dikma Kromasil C18(250mm×4.6mm,5μm);流动相:乙腈-0.1%磷酸溶液;流速:1.0mL·min^-1;检测波长:分段变波长测定,0-23min为252栅,23-40min为355nm;柱温:30℃;进样量:20μl。结果:复尔康注射液中维A酸和甘草酸铵及雏A酸注射液在家兔体内均符合开放二室动力学模型特征。复尔康注射液中维A酸的t1/2α=10.61min,t1/2β=99.44min,K10=0.02min^-1,AUC=257.14μg·min·ml^-1,CL=0.02mg·kg^-1·min^-1;维A酸注射液的t1/2α=8.61min,t1/2β=54.05min,K10=0.03min^-1,AUC=174.86μg·min·ml^-1,CL=0.03mg·kg^-1·min^-1;复尔康注射液中甘草酸铵的t1/2α=5.50min,t1/2α=129.06min,K10=0.02min^-1,AUC=28611.23μg·min·ml^-1,CL=0.01mg·kg^-1·min^-1。结论:HPLC简便、快速、精确,可同时检测复尔康注射液中维A酸和甘草酸铵的血药浓度和药动学参数。
Objective: To develop a rapid HPLC method for the determination of tretinoin and ammonium glyeyrrhizinate of Fuerkang injection in rabbit plasma, calculate pharmacokinetics parameters by special software Pharmacokinetics Analysis of 3P97, and compare with Tretinoin injection. Method: Dikma Kromasil C18 250 mm 4. 6 mm,5 m). Mobile phase was acetonitrile- 0. 1% phosphorie acid. Flow rate was 1.0 ml·min^-1. Detection wave length was paragraph and alteration, 0-23min was 252 urn, 23-40min was 355 nm. Clunm temperature was 30℃ and sample size was 20μl. Results. Tretinoin and ammonium glycyrrhizinate of Fuerkang injection and tretinoin injection showed typical characteristics of open two--compartment dynamic model. Tretinoin of Fuerkang injection: t1/2α=10. 61min, t1/2β= 99. 44 min,K10=0. 02 min^-1, AUC=257. 14 μg·min·ml^-1, CL=0.02 mg·kg^-1 ·min^-1. Tretinoin injection: t1/2α=8. 61 min, t1/2β=54.05 min, K10=0. 03 min^-1, AUC=174. 86μg·min·ml^-1 , CL=0. 03 mg · kg^-1 ·min^-1 ; Ammonium glycyrrhizinate of Fuerkang injection: t1/2α=5. 50 min, t1/2β=129. 06 min, K10=0. 02 min^-1 , ALIC=28611. 23μg·min·ml^-1, CL=0. 01 mg kg^-1 min^-1. Conclusion: HPLC method was simple,rapid,accurate,and it can be used to determine simultaneously the plasma concentration and pharmacokinetics parameters of tretinoin and ammonium glycyrrhizinate of Fuerkang injection.