兩種Norfloxacin製劑在體內動態學與生物相等性之比較

Comparative Study on the Pharmacokinetics and Bioequivalence of Two Brands of Norfloxacin Preparation

陳英俊(Ing-Jun Chen) ； 楊竹茂(Jwu-Maw Yang) ； 葉竹來(Jwu-Lai Yeh) ； 吳炳男(Being-Nan Wu) ； 黃高彬(Kao-Pin Hwang) ； 江季勛(Chi-Hsiun Chiang)

《The Kaohsiung Journal of Medical Sciences》 6卷9期 (1990/09) Pp. 501-510

https://doi.org/10.6452/KJMS.199009.0501

摘要

The pharmacokinetics and bioequivalence of two norfioxacin, Gentle® capsule and Baccidal® tablet, were compared in eitht healthy male volunteers. A 400 mg dose of norfloxacin was given orally after an overnight fasting to volunteers in a balanced two-way cross-over study. Blood samples were obtained at 0, 0.5, 1.0, 2.0, 4.0, 8.0, 12.0 and 24.0 hours after the dosing. Norfloxacin concentration in serum was assayed by a high pressure liquid chromatographic method using an UV detector. All the data was processed by KMCP computer software and the pharmacokinetic parameters were calculated, based on one-compartment model. The results revealed that the maximal concentration (Cmax) of Gentle® and Baccidal® was 0.96 ± 0.089 and 0.99 ± 0.110; the time to reach maximal concentration (Tmax) was 2.0 ± 0.0 for both; the elimination constant (Kel) was 0.101 ± 0.006 and 0.098 ± 0.005 hr1 the elimination half life (TY2, j3) was 6.909 ± 0.483 and 7.094 ±0.350 hr; the absorption constant (Ka) was 2.444 ± 0.188 and 2.490 ± 0.096 hrt the absorption half life (T½, ce) was 0.278 ± 0.019 and 0.277 ± 0.010 hr; the area under curve (from 0 to 12 hours) (AUCQ 12 was 7.106 ± 1.065 and 7.380 ± 1.044 g.hr/ml; and the area under curve (from 0 hour to infinity) (AUC0) was 9.183 ± 1.257 and 9.550 ± 1.300 ig . hr/ml respectively. There were no significant difference found between the two groups after statistical analysis with two-way ANOVA (p＞ 0.05). A series of statistical parameters including d%, delta, and 95% CI. were calculated by a bioequivalence test computer software of Yamaoka Simi. In order to strengthen the statistical evidence, the power of the test (1 -β) was also calculated. After evaluating all the parameters, there was no significant difference found between the two groups. Therefore, the high similarity of these two formulations is suggested by the authors.

並列摘要

The pharmacokinetics and bioequivalence of two norfioxacin, Gentle® capsule and Baccidal® tablet, were compared in eitht healthy male volunteers. A 400 mg dose of norfloxacin was given orally after an overnight fasting to volunteers in a balanced two-way cross-over study. Blood samples were obtained at 0, 0.5, 1.0, 2.0, 4.0, 8.0, 12.0 and 24.0 hours after the dosing. Norfloxacin concentration in serum was assayed by a high pressure liquid chromatographic method using an UV detector. All the data was processed by KMCP computer software and the pharmacokinetic parameters were calculated, based on one-compartment model. The results revealed that the maximal concentration (Cmax) of Gentle® and Baccidal® was 0.96 ± 0.089 and 0.99 ± 0.110; the time to reach maximal concentration (Tmax) was 2.0 ± 0.0 for both; the elimination constant (Kel) was 0.101 ± 0.006 and 0.098 ± 0.005 hr1 the elimination half life (TY2, j3) was 6.909 ± 0.483 and 7.094 ±0.350 hr; the absorption constant (Ka) was 2.444 ± 0.188 and 2.490 ± 0.096 hrt the absorption half life (T½, ce) was 0.278 ± 0.019 and 0.277 ± 0.010 hr; the area under curve (from 0 to 12 hours) (AUCQ 12 was 7.106 ± 1.065 and 7.380 ± 1.044 g.hr/ml; and the area under curve (from 0 hour to infinity) (AUC0) was 9.183 ± 1.257 and 9.550 ± 1.300 ig . hr/ml respectively. There were no significant difference found between the two groups after statistical analysis with two-way ANOVA (p＞ 0.05). A series of statistical parameters including d%, delta, and 95% CI. were calculated by a bioequivalence test computer software of Yamaoka Simi. In order to strengthen the statistical evidence, the power of the test (1 -β) was also calculated. After evaluating all the parameters, there was no significant difference found between the two groups. Therefore, the high similarity of these two formulations is suggested by the authors.

並列關鍵字

norfloxacin ； pharmacokinetics ； bioequivalence