论文部分内容阅读
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: Twenty male healthy volunteers were randomized to take oral fasting oral clindamycin hydrochloride capsules (test product) and the clindamycin hydrochloride capsules (reference substance) manufactured by Suzhou No.4 Pharmaceutical Factory ) Of each 600 mg, the plasma drug concentration measured by high performance liquid chromatography. Results: The average peak plasma concentrations of testosterone and test compound after single oral fasting oral test substance and reference substance were (4.07 ± 0.86) mg / L and (4.57 ± 0. 98) mg / L, the measured mean peak time was (0.53 ± 0.11) h and (0.55 ± 0.15) h, respectively. The mean elimination half-lives were (3.12 ± 1.01) h and (3.2 0 ± 1.2 6) h, respectively, and the area under the curve of mean measured drug concentration was (14.92 ± 3.2 9) h · mg / L and (14.41 ± 3.94) h · mg / L, respectively. Pharmacokinetic parameters of the two preparations were not significantly different by ANOVA (P> 0.05). Compared with the control, the relative bioavailability of the test product was (110.52 ± 37.2 1)%. The parameters of cmax and AUC of the two drugs were analyzed by two-way one-sided t-test and (1 ~ 2α) confidence interval method. The results showed that the two drugs were bioequivalent. Conclusion: Clindamycin Hydrochloride Capsules in vivo process in line with the two-compartment extravascular model, after oral absorption quickly. The test and reference products are bioequivalent.