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用于评估四硝酸赤藓醇生物利用度的数字体积描记法。

Digital plethysmography for assessing erythrityl tetranitrate bioavailability.

作者信息

Hannemann R E, Erb R J, Stoltman W P, Bronson E C, Williams E J, Long R A, Hull J H, Starbuck R R

出版信息

Clin Pharmacol Ther. 1981 Jan;29(1):35-9. doi: 10.1038/clpt.1981.6.

Abstract

The bioavailability or oral, sublingual, and chewable tablets or erythrityl tetranitrate (ETN) was evaluated in 15 normal men. In a randomized, complete crossover investigation with nitroglycerin and placebo controls, drug-induced changes in the diastolic amplitude response intensity were measured with a digital plethysmogram. Values for area under the response intensity curve (AUC), maximum response intensity (Imax), and time lapse from dosing to peak response (tmax) were obtained by computer processing and converted to intensity values and AUC segments for specific time intervals. Sublingual nitroglycerin induced a response (p less than 0.05) from placebo within the first hour. Although somewhat slower in reaching peak intensity, all forms of ETN induced significant responses over placebo (p less than 0.05) for 2 hr, with oral (swallowed) ETN different 6 hr. Our results indicate that all the ETN dosage forms were bioavailable, with the longest duration of effect by the oral form.

摘要

对15名正常男性评估了硝酸异山梨酯(ETN)的口服片、舌下片和咀嚼片的生物利用度。在一项有硝酸甘油和安慰剂对照的随机、完全交叉研究中,用数字体积描记法测量药物引起的舒张期振幅反应强度变化。通过计算机处理获得反应强度曲线下面积(AUC)、最大反应强度(Imax)以及给药至峰值反应的时间间隔(tmax)的值,并转换为特定时间间隔的强度值和AUC段。舌下硝酸甘油在第一小时内引起了与安慰剂相比有差异的反应(p<0.05)。虽然达到峰值强度的速度稍慢,但所有形式的ETN在2小时内引起了与安慰剂相比有显著差异的反应(p<0.05),口服(吞咽)ETN在6小时内有差异。我们的结果表明,所有ETN剂型都具有生物利用度,口服剂型的作用持续时间最长。

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