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丹红注射液对阿托伐他汀钙在大鼠体内药动学的影响
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| 篇名： | 丹红注射液对阿托伐他汀钙在大鼠体内药动学的影响 |
| TITLE： | |
| 摘要： | 目的：研究丹红注射液对阿托伐他汀钙（ATV）在大鼠体内药动学的影响。方法：以盐酸噻氯匹定为内标，采用超高效液相色谱-串联质谱法测定大鼠血浆中ATV的药物浓度。色谱柱为AcquityTM BEH C18，流动相为5 mmol/L甲酸铵溶液（含0.1％甲酸）-甲醇（梯度洗脱）；离子源为电喷雾离子源，采用多反应离子监测（MRM）模式，质荷比（m/z）分别为559.20→440.20（ATV）、264.20→154.05（内标）。将24只SD大鼠随机分为ATV单用组（单独给予ATV，10 mg/kg）和丹红注射液低、中、高剂量联用组（给予丹红注射液1、2、4 mL/kg+ATV 10 mg/kg），分别于不同时间点取血，测定ATV血药浓度并计算其药动学参数。结果：ATV的血药浓度线性范围为0.25～62.50 ng/mL，定量下限为0.25 ng/mL；精密度、稳定性试验的RSD均小于15％；提取回收率、基质效应均大于85％。丹红注射液中、高剂量联用组ATV的cmax分别为（23.78±6.40）、（33.66±8.15）ng/mL，显著高于ATV单用组的（13.99±2.54）ng/mL（P＜0.05）；丹红注射液低、中、高剂量联用组ATV的AUC0-24 h分别为（67.20±15.22）、（88.16±14.84）、（126.84±31.55）ng·h/mL，显著高于ATV单用组的（46.08±7.47）ng·h/mL（P＜0.05或P＜0.01）。结论：丹红注射液联合给药可显著增加ATV在大鼠体内的暴露量。 |
| ABSTRACT： | OBJECTIVE： To study the effects of Danhong injection on the pharmacokinetics of atorvastatin calcium （ATV） in rats. METHODS： The plasma concentration of ATV in rats was determined by UPLC-MS/MS using hydrochloric piperidine as internal standard. The determination was performed on AcquityTM BEH C18 column with mobile phase consisted of 5 mmol/L ammonium formate solution （containing 0.1％ formic acid）-methanol （gradient elution）. The ion source was ESI， and the mass transfer ratio （m/z） was 559.20→440.20 （ATV） and 264.20→154.05 （internal standard） by multiple reaction monitoring （MRM） mode. A total of 24 SD rats were randomly divided into ATV alone group （ATV， 10 mg/kg）， Danhong injection low-dose， medium-dose and high-dose groups （Danhong injection 1， 2， 4 mL/kg+ATV 10 mg/kg）. Blood samples were collected at different time points， and plasma concentration was determined and pharmacokinetic parameters of ATV were calculated. RESULTS： The linear range of ATV was 0.25-62.50 ng/mL， and the limit of quantitation was 0.25 ng/mL. RSDs of precision and stability tests were all lower than 15％. Extraction recovery and matrix effect were all higher than 85％. The pharmacokinetic parameter cmax of ATV in Danhong injection medium-dose and high-dose groups were （23.78±6.4）， （33.66±8.15） ng/mL， which were significantly higher than （13.99±2.54） ng/mL in ATV alone group （P＜0.05）. AUC0-24 h of Danhong injection low-dose， medium-dose and high-dose groups were （67.20±15.22）， （88.16±14.84）， （126.84±31.55） ng·h/mL， which were significantly higher than （46.08±7.47） ng·h/mL in ATV alone group （P＜0.05 or P＜0.01）. CONCLUSIONS： Combined administration of Danhong injection can significantly increase the plasma exposure of ATV in rats. |
| 期刊： | 2018年第29卷第24期 |
| 作者： | 朱金燕，彭灿，胡容峰，汤继辉，金涌 |
| AUTHORS： | ZHU Jinyan，PENG Can，HU Rongfeng，TANG Jihui，JIN Yong |
| 关键字： | 阿托伐他汀钙；丹红注射液；药动学；联合用药；大鼠 |
| KEYWORDS： | Atorvastatin calcium； Danhong injection； Pharmacokinetics； Combined administration； Rat |
| 阅读数： | 332 次 |
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