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Pharmacokinetics of Controlled Release and Immediate Release Morphine Sulphate Tablets after a Single Dose and Multiple Doses in Chinese Volunteers

Pharmacokinetics of Controlled Release and Immediate Release Morphine Sulphate Tablets after a Single Dose and Multiple Doses in Chinese Volunteers
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摘要 The pharmacokinetics of morphine sulphate was studied in 10 Chinese healthy volunteers after a single oral dose. Blood samples were collected before and after administration of controlled release tablets (CRMS, 30 mg) and immediate release tablets (IRMS, 20 mg). The plasma concentration of morphine was determined by GC MS. The pharmacokinetic parameters of controlled release tablets and immediate release tablets were calculated∶ C max was 19.38±3.80 and 21.27±6.21 ng/ml, t max was 2.36 ±0.37 h and 0.56±0.16 h, t 1/2β was 3.53±0.87 and 3.03±0.74 h, AUC was 145.15±17.65 and 93.08±16.65 ng/ml, respectively. The steady state plasma concentration of morphine sulphate in cancer patients after multiple doses was achieved, C max of CRMS and IRMS was 27.43±0.33 ng/ml and 22.68±0.16 ng/ml, C min of CRMS and IRMS was 19.45±1.44 ng/ml and 18.14±0.49 ng/ml, respectively. 健康志愿者10名,随机交叉口服硫酸吗啡控释片(CRMS)30mg(30mg×1)和硫酸吗啡普通片(IRMS)20mg(10mg×2),分别于服药前后各时点取静脉血,用GCMS测定血浆中吗啡含量。以药代软件程序处理,分别求得CRMS和IRMS的Cmax为19.38±3.80和21.27±6.21ng/ml;tmax为2.36±0.37h和0.55±0.16h;t1/2β为3.53±0.87h和3.03±0.74h,曲线下面积AUC为145.15±17.65和93.08±16.65ng·h/ml。癌症病人多次口服硫酸吗啡至稳态,CRMS和IRMS的峰浓度分别为27.43±0.33ng/ml,22.68±0.16ng/ml;谷浓度分别为19.45±1.44ng/ml;18.14±0.49ng/ml。
出处 《Journal of Chinese Pharmaceutical Sciences》 CAS 1997年第4期39-42,共4页 中国药学(英文版)
关键词 Controlled release morphine sulphate tablet Immediate release morphine sulphate tablet PHARMACOKINETICS Single dose Multiple doses GC MS 硫酸吗啡控释片 硫酸吗啡普通片 药代动力学 单次给药 多次给药 GC-MS
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