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目的:建立大鼠血浆中苦参碱浓度的LC-MS/MS测定法,研究苦参碱注射液、注射用苦参碱和苦参碱氯化钠注射液腹腔注射的体内药代动力学一致性。方法:SD大鼠30只,随机分为3组:苦参碱注射液组、注射用苦参碱组,苦参碱氯化钠注射液组,每组10只,分别单剂量(15 mg·mL~(-1))腹腔给药三个厂家苦参碱注射剂后,不同时间点眼内眦取血,LC-MS/MS法测定苦参碱血浆药物浓度,采用DAS 3.0软件计算药动学参数,以药动学参数为评价指标,采用SPSS 17.0软件进行一致性比较分析。结果:腹腔注射15 mg·kg~(-1)的苦参碱注射液、注射用苦参碱和苦参碱氯化钠注射液后AUC_((0-t))分别为(10 166±2 426)、(12 064±3 854)和(9 963±3 159)ng·mL~(-1)·h;AUC_((0-∞))分别为(10 230±2 432)、(12 158±3 910)和(10 037±3 631)ng·mL~(-1)·h;MRT_((0-t))分别为(1.91±0.41)、(2.16±0.56)和(2.15±0.45)h;MRT_((0-∞))分别为(2.01±0.41)、(2.26±0.5870)和(2.37±0.68)h;t_(1/2)分别为(2.26±0.89)、(2.05±0.75)和(2.63±2.44)h;Vd分别为(4.90±2.10)、(4.82±1.32)和(6.52±1.10)L;CL分别为(1.53±0.32)、(1.35±0.42)和(1.63±0.41)L·h~(-1)·kg~(-1);C_(max)分别为(5246±1187)、(5 160±1 517)和(4 680±1 088)ng·mL~(-1)。结论:苦参碱注射液、注射用苦参碱和苦参碱氯化钠注射液3个厂家药品腹腔给药后药动学参数AUC、MRT、t_(1/2)、Vd、CL和C_(max)均无统计学差异。
OBJECTIVE: To establish a LC-MS / MS method for the determination of matrine concentration in rat plasma. The in vivo pharmacokinetics of matrine injection, matrine injection and matrine sodium chloride injection were consistent Sex. Methods: Thirty SD rats were randomly divided into three groups: matrine injection group, matrine injection group and matrine sodium chloride injection group, 10 rats in each group received a single dose of 15 mg · mL -1) intraperitoneal injection of matrine injection of three manufacturers, at different time points intraocular 眦 blood, LC-MS / MS determination of matrine plasma drug concentration, using the DAS 3.0 software to calculate the pharmacokinetic parameters , Using pharmacokinetic parameters as the evaluation index, SPSS 17.0 software was used to compare and analyze the consistency. Results: The intra-peritoneal injection of 15 mg · kg -1 matrine injection, injection of matrine and matrine sodium chloride injection AUC _ ((0-t)) were (10 166 ± 2 426, 1264 ± 3 854 and 9 963 ± 3 159 ng · mL -1 · h, respectively; AUC 0-0∞ were (10 230 ± 2 432), (12 158 (1.91 ± 0.41), (2.16 ± 0.56) and (2.15 ± 0.45), respectively, (1037 ± 3641 ng · mL -1 · h -1) (2.01 ± 0.41), (2.26 ± 0.5870) and (2.37 ± 0.68) h, respectively; (2.26 ± 0.89) and (2.05 ± 0.75) And (2.63 ± 2.44) h respectively; Vd was (4.90 ± 2.10), (4.82 ± 1.32) and (6.52 ± 1.10) L respectively; and CL were (1.53 ± 0.32) and (1.35 ± 0.42) and (1.63 ± 0.41) L · h -1 · kg -1 and C max were (5246 ± 1187), (5 160 ± 1 517) and (4 680 ± 1 088) ng · mL -1 ). Conclusion: The pharmacokinetic parameters AUC, MRT, t_ (1/2), Vd, CL and C_ (3) after intraperitoneal administration of matrine injection, matrine injection and matrine sodium chloride injection (max) no statistical difference.