摘要
目的 :研究盐酸克林霉素胶囊剂的生物等效性。方法 :2 0名男性健康志愿者随机交叉空腹口服普强苏州制药有限公司研制的盐酸克林霉素胶囊剂 (试验品 )和苏州第四制药厂生产的盐酸克林霉素胶囊剂 (对照品 )各 6 0 0mg ,其血浆药物浓度以高效液相色谱法测定。结果 :受试者单剂空腹口服试验品和对照品 6 0 0mg后 ,其平均实测血药高峰浓度分别为 (4 .6 7± 0 .86 )mg/L和 (4 .5 7± 0 .98)mg/L ,实测平均达峰时间分别为 (0 .5 3± 0 .11)h和 (0 .5 5± 0 .15 )h ,平均消除半衰期分别为 (3.12± 1.0 1)h和 (3.2 0± 1.2 6 )h ,实测平均药时曲线下面积分别为 (14.92± 3.2 9)h·mg/L和 (14.41± 3.94)h·mg/L。两制剂的药代动力学参数经方差分析差异均无显著性 (P >0 .0 5 )。试验品与对照品相比 ,其相对生物利用度为 (110 .5 2± 37.2 1) %。对两药品的cmax和AUC等参数以双向单侧t检验法和 (1～ 2α)置信区间法分析 ,结果均表明两药具生物等效性。结论 :盐酸克林霉素胶囊剂体内过程符合血管外二室模型 ,口服后吸收迅速。试验品与对照品具有生物等效性。
Objective: To study the bioequivalence of clindamycin hydrochloride capsules. Methods: 20 healthy male volunteers were given a single dose of 600 mg clindamycin hydrochloride capsules manufactured by Upjohn Suzhou Pharmacentical (test) or Suzhou fourth pharmaceutical factory (control) in a randomized crossover study. Serum concentrations were determined by high performance liquid chromatographic assay (HPLC). Results: The mean c max was (4.67±0.86)?mg/L and (4.57±0.98)?mg/L, t max was (0.53±0.11)?h and (0.55±0.15)?h, t 1/2β was (3.12±1.01)?h and(3.20±1.26)?h, AUC was (14.92±3.29)?h·mg/L and (14.41±3.94)?h·mg/L. The pharmacokinetic parameters of the two formulations were compared by analysis of variance test; the difference was not statistically significant (P>0.05). The relative bioavailability of the test capsules was (110.52± 37.21 )%. Parameters c max and AUC were further analyzed by two one-side test and (1-2α) confidential interval. There was no significant difference. Conclusions: The pharmacokinetic profile of clindamycin hydrochloride capsules fits two-model compartment. The two formulations were bioequivalence.
出处
《中国抗感染化疗杂志》
2002年第2期92-94,共3页
Chinese Journal of Infection and Chemotherapy
关键词
盐酸克林霉素
高效液相色谱法
生物等效性
药代动力学
Clindamycin hydrochloride
High performance liquid chromatographic assay
Bioequivalence
