维生素C钠片剂的人体相对生物利用度研究

BIOAVAILABILITY OF SODIUM VITAMINE-C TABLET IN HEALTHY SUBJECTS

本文用高效液相色谱法测定人血中维生素Ｃ（ＶｉｔａｍｉｎｕｍＣ，Ｖｃ），对１０名健康志愿者口服Ｖｃ钠片的相对生物利用度及其药代动力学进行研究。结果比较，受试药Ｖｃ钠和对照药Ｖｃ的Ｃｍａｘ分别为４８．６±１２．５和４８．１±１１．０μｍｏｌ·Ｌ－１；Ｔ１／２β为１０．１±６．３和８．６５±２．９ｈ；ＡＵＣ为７５７．２２±３４２．５０和６６２．７８±２１８．６４μｍｏｌ·ｈ·Ｌ－１。各参数经配对Ｔ检验均无显著性差异，显示两种制剂体内吸收、分布和消除基本一致。Ｖｃ钠片人体相对生物利用度为１１３．１±３２％。实验提示，Ｖｃ钠片可作为Ｖｃ片在临床上应用。

The relative bioavailability and pharmacokinetics between vitamine-C tablet (standard drug ) and Sodium vitamine-C tablet (test drug ) was studied in 10 male subjects , Plasma concentration of vitamine-C was determined by high-performane liquid chromatography (HPLC). The peak plasma levels (Cmax) of vitamine-C in standard drug and test drug were 48.6±12.5 and 48.1 ±11.0 mmol·L-1 respectively, elimination half-lives (T1/2β) were 10.1±6.3 and 8.65±2.9 h respectively, and AUC were 757.22±342.50 and 662.78±218.64 μmol·h·L-1,respectively. The pharmacokinetic parameters in sodium vitmine-C tablet were not significantly different from that in Vitamine-C tablet. Therefore , the disposition of two tablets was similar. The relative bioavailability of sodium vitamine-C tablet was 113.1±31%. The results suggested that sodium vitamine-C tablet can be taken to clinical application.