Sharma S, Thawani V, Hingorani L, Shrivastava M, Bhate V R, Khiyani R
Pharmacology, Indira Gandhi Medical College, Nagpur, India.
Phytomedicine. 2004 Feb;11(2-3):255-60. doi: 10.1078/0944-7113-00290.
Boswellia serrata has been used in traditional medicine for treatment of inflammatory diseases since antiquity. However human kinetic studies are lacking for this. Hence to better elucidate its effects in humans and determine its optimal dosing, this study was planned.
Twelve healthy adult men volunteers were given capsule Wok Vel containing 333 mg of Boswellia Serrata Extract, orally, after a seven days washout period. Venous blood samples were drawn through indwelling canula from each volunteer prior to drug administration and at 30, 60, 120, 150, 180, 210, 240, 300, 360, 480, 600, 720, 840 minutes after drug administration. Plasma obtained after centrifuge was analyzed to measure concentration of 11-Keto beta-Boswellic Acid (KBA) by HPLC. Various kinetic parameters were then calculated from the plasma concentrations.
The results are expressed as mean +/- Standard Error of Mean. The peak plasma levels (2.72 x 10(-3) +/- 0.18 micromoles/ml) of BSE were reached at 4.5 +/- 0.55 h. The concentration declined with a mean elimination half life of 5.97 +/- 0.95 h. The apparent volume of distribution averaged 142.87 +/- 22.78 L and the plasma clearance was 296.10 +/- 24.09 ml/min. The AUC(0-infinity) was 27.33 x 10(-3) +/- 1.99 micromoles/ml h.
Elimination half life of nearly six hours suggests that the drug needs to be given orally at the interval of six hours. The plasma concentration will attain the steady state after approximately 30 hours. BSE is a safe drug and well tolerated on oral administration. No adverse effects were seen with this drug when administered as single dose in 333 mg.
齿叶乳香自古以来就在传统医学中用于治疗炎症性疾病。然而，目前尚缺乏关于它的人体动力学研究。因此，为了更好地阐明其对人体的作用并确定其最佳剂量，我们开展了这项研究。
12名健康成年男性志愿者在经过7天的洗脱期后，口服含有333毫克齿叶乳香提取物的Wok Vel胶囊。在给药前以及给药后30、60、120、150、180、210、240、300、360、480、600、720、840分钟，通过留置套管从每位志愿者采集静脉血样。离心后获得的血浆通过高效液相色谱法分析，以测量11-酮基-β-乳香酸（KBA）的浓度。然后根据血浆浓度计算各种动力学参数。
结果以平均值±平均标准误差表示。齿叶乳香提取物的血浆峰值水平（2.72×10⁻³±0.18微摩尔/毫升）在4.5±0.55小时达到。浓度下降，平均消除半衰期为5.97±0.95小时。表观分布容积平均为142.87±22.78升，血浆清除率为296.10±24.09毫升/分钟。AUC(0-∞)为27.33×10⁻³±1.99微摩尔/毫升·小时。
近6小时的消除半衰期表明该药物需要每6小时口服一次。血浆浓度将在大约30小时后达到稳态。齿叶乳香提取物是一种安全的药物，口服耐受性良好。以333毫克单剂量给药时，未观察到该药物有不良反应。
