复方氯唑沙宗片在健康人体的生物等效性  

Bioequivalence of compound chlorzoxazone tablets in healthy volunteers

作　　者：吴黎莉 周可[2] 宗文凯 陈沄[1] 

机构地区：[1]中国医学科学院,中国协和医科大学皮肤病研究所药物研究室,江苏南京210042 [2]天津长征医院皮肤科,天津300120

出　　处：《中国新药与临床杂志》2011年第12期937-941,共5页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的研究2种复方氯唑沙宗片在健康志愿者体内的生物等效性。方法 20例男性健康志愿者随机交叉口服2种复方氯唑沙宗(氯唑沙宗250 mg,对乙酰氨基酚300 mg)片,间隔为1 wk。以格列吡嗪和非那西丁为内标,用高效液相色谱质谱联用法测定氯唑沙宗和对乙酰氨基酚的血药浓度。结果 20名健康志愿者口服复方氯唑沙宗受试片和参比片后,其对乙酰氨基酚p^(max)分别为(5.1±1.5)和(5.2±1.7)mg·L^(-1);t^(max)分别为(0.6±0.4)和(0.6±0.4)h;t_(1/2)分别为(3.0±0.4)和(3.0±0.5)h;AUC_(0-12)分别为(16.4±4.7)和(17.0±5.5)mg·h·L^(-1);AUC0_(0-∞)分别为(17.6±5.1)和(18.2±6.0)mg·h·L^(-1)。氯唑沙宗p^(max)分别为(7.0±1.3)和(7.0±1.3)mg·L^(-1);t^(max)分别为(0.9±0.6)和(1.0±0.5)h;t1/2分别为(0.9±0.1)和(0.9±0.1)h;AUC_(0-10)分别为(16.6±3.5)和(17.0±4.1)mg·h·L^(-1);AUC_(0-∞)分别为(16.7±3.5)和(17.0±4.1)mg·h·L^(-1),2种片剂的药动学参数均无显著差异(P>0.05)。对乙酰氨基酚和氯唑沙宗2种成分的相对生物利用度分别为(99.3±14.3)%和(99.5±14.8)%。结论复方氯唑沙宗受试片与参比片在健康人体内具有生物等效性。AIM To compare the difference in clinical efficacy and adverse reactions between escitalopram and fluoxetine in China.METHODS A total of 5 papers about controlled study comparing escitalopram with fluoxetine in treatment of depression retrieved from 1994 to 2010 in China were subjected to a system evaluation.RESULTS There was no significant difference on clinical efficacy between escitalopram and fluoxetine（P0.05,OR = 1.12,95%CI 0.71 - 1.75）.The incidence rate of blurred vision somnolence lethargy and insomnia in fluoxetine group were significantly higher than that of escitalopram group（x^2 = 6.42, P0.05）,while the incidence rate of sweat in the escitalopram group were significantly higher than that of the fluoxetine group（x^2 = 5.31,P0.05）.There were no significant differences in incidence rates of other reactions between the two groups.CONCLUSION Escitalopram was a safe and effective antidepressant in China.

关 键 词：氯唑沙宗 对乙酰氨基酚 生物等效性 色谱法 高压液相 串联质谱法 药动学 

分 类 号：R969.1[医药卫生—药理学] R971[医药卫生—药学]