两种氯沙坦/氢氯噻嗪复方片剂的人体生物等效性评价

两种氯沙坦/氢氯噻嗪复方片剂的人体生物等效性评价

杨平, 李琳, 孙进, 何仲贵^*

沈阳药科大学药学院生物药剂学研究室, 辽宁沈阳 110016

收稿日期:2006-03-15 修回日期:2006-08-10 出版日期:2006-09-15 发布日期:2006-09-15
通讯作者: 何仲贵*

Bioequivalent Evaluation of Two Brands of Losartan/Hydrochlorothiazide Compound Tablets in Healthy Chinese Male Volunteers

YANG Ping, LI Lin, SUN Jin, HE Zhong-gui^*

Department of Biopharmaceutics, School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China

Received:2006-03-15 Revised:2006-08-10 Online:2006-09-15 Published:2006-09-15
Contact: HE Zhong-gui*

摘要/Abstract

摘要： 目的评价两种氯沙坦/氢氯噻嗪(50 mg/12.5 mg)复方片剂在中国男性健康志愿者体内的生物等效性。方法本研究采用随机、开放、双周期交叉设计, 洗净期为7天。20名男性健康志愿者先后单剂量口服氯沙坦/氢氯噻嗪(50 mg/12.5 mg)受试及参比制剂。血药浓度由已确证的HPLC-ESI-MS法测定。结果双单侧检验结果显示, 氯沙坦的AUC_0-120及C_max的90%置信区间分别为86% – 112%及89% – 134%, 氢氯噻嗪分别为85% – 100%及75% – 102%, 均在中国药典所规定的可接受范围内。结论两种速释氯沙坦/氢氯噻嗪复方片剂生物等效。

关键词: 氯沙坦, 氯沙坦, 氯沙坦, 氢氯噻嗪, 氢氯噻嗪, 氢氯噻嗪, 生物等效性, 生物等效性, 生物等效性, HPLC-ESI-MS, HPLC-ESI-MS, HPLC-ESI-MS

Abstract: Aim To evaluate the bioequivalence of two brands of losartan/hydrochlorothiazide (50 mg/12.5 mg) compound tablets in healthy Chinese male volunteers. Methods An open, randomized, single-dose, two-period cross-over studywith a wash-out period of 7 d was conducted. Twenty healthy male volunteers were givena single dose 50 mg losartan/12.5 mg hydrochlorothiazide of either test (T) or reference (R) compound tablets,respectively. Blood samples were collected up to 48 h after oral administration. The concentrations of losartan and hydrochlorothiazide in plasma were determined by a validated HPLC-ESI-MS method. Results In the case of losartan, the 90% confidence intervals of two one-side test for percent ratios with a significant level (α) of 0.05 were 86% – 112% for AUC_0-120 and 89% – 134% for C_max, respectively, which were within the interval proposed in the Chinese Pharmacopoeia, 80% – 125% of AUC and 70% – 143% of C_max, respectively. Similarly, the 90% confidence intervals for percent ratios were 85% – 100% and 75% – 102% for hydrochlorothiazide, both of which fell into the accepted interval. Conclusion Two immediate-release compound tablets of losartan/hydrochlorothiazideare bioequivalent from a statistical standpoint in the extent and rate of absorption from the single-dose study in healthy Chinese male volunteers.

Key words: losartan, losartan, hydrochlorothiazide, hydrochlorothiazide, bioequivalence, bioequivalence, HPLC-ESI-MS, HPLC-ESI-MS

中图分类号:

R917.4

R945.2

Supporting: ^*Corresponding author. Tel./fax: 86-24-23986321

杨平, 李琳, 孙进, 何仲贵^*. 两种氯沙坦/氢氯噻嗪复方片剂的人体生物等效性评价[J]. .

YANG Ping, LI Lin, SUN Jin, HE Zhong-gui^*. Bioequivalent Evaluation of Two Brands of Losartan/Hydrochlorothiazide Compound Tablets in Healthy Chinese Male Volunteers[J]. .

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