摘要
目的建立复方甘草酸单铵注射液血药浓度的测定方法,并探讨其在家兔体内的药代动力学过程。方法复方甘草酸单铵注射液于家兔耳缘处静脉滴注,分别于0.5,1,2,3,4,8,10,12,18,24 h取血,30 min内分离血浆,以甲醇沉淀蛋白,取上清液20μL进样测定。色谱柱为Eclipse XDB-C18柱(150 mm×4.6 mm,5μm),流动相为0.01 mol/L磷酸-乙腈(68∶32),柱温为30℃,流速为1 mL/min,检测波长为257 nm。结果甘草酸单铵高、中、低质量浓度的日内精密度分别为0.93%,2.15%和3.66%,日间精密度分别为1.33%,3.90%和5.11%。甘草酸单铵质量浓度在5～1 000 mg/L时,与峰面积有良好的线性关系(r2=0.999 6)。血药峰浓度为(470.3±85.9)mg/L,达峰时间为(30.1±16.2)min,0～∞药时曲线下面积(AUC0～∞)为(95 752.4±5 781.5)mg/(L.min),清除率(CLz)为(0.000 8±0.000 2)L/(min.kg),表观分布容积(Vz)为(0.19±0.03)L/kg,半衰期为(145.3±35.3)min。结论该测定方法简便、准确、重现性好,可用于家兔体内甘草酸单铵血药浓度的测定,并得到主要药物动力学参数。
Objective To establish a method for monammonium glycyrrhizinate in hare plasma by RP- HPLC. Methods The plasma samples were collected after monoammonium glycyrrhizininate injection were injected, at 0.5,1,2,3,4,8,10,12, 18,24 h, blood samples were centrifuged within 30 minutes. Methanol was added to precipitate the proteins. 20 IxL of the supernatant liquid was injected into the HPLC system. The samples were separated on a Eclipse XDB- C18（150 mm×4.6 mm,5 μm）,Using a mobile phase of 0.01 mol/L phosphoric acid and methanol（68：32）. At 30 ℃,the /low rate was I mL/min,the detection wavelength was 257 nm. Results The recoveries of the control samples of low,medium and high concentrations of precisions,the intraday RSD were 0.93% ,2. 15% and 3.66%; and the interday RSD were 1.33% ,3.90% and 5. 11%.The standard curve was linear over the range of 5-1 000 mg/L concentrations of the monammonium glycyrrhizinate （ r2 = 0. 999 6）and the Cmax = （470. 3 ± 85. 9）rag/L, Tmax = （30. 1 ± 16.2）min, A UG0-∞ = （95 752.4±5 781.5）mg/（L . min） CLz=（0.000 8±0.000 2）L/（min . kg）, Vz=（0.19±0.03）L/kg, T1/2=（145.3±35.3）min. Conclusion This method is simple, accurate, reproducible, and suitable for the determination of monammonium glycyrrhizinate in hare plasma.
出处
《中国药业》
CAS
2012年第6期26-27,共2页
China Pharmaceuticals
