国产甲泼尼龙片剂的生物等效性研究

 目的用进口片剂(A)为对照品，评价国产片剂(B)的相对生物利用度和生物等效性。方法采用随机交叉分组试验设计，18名健康成年男性受试者分别以150 mL牛奶空腹送服单剂量40mg测试品和对照品，按设计采集14h内动态血标本；用一改进的HPLC测定血浆药物浓度，以非房室模型计算AUC和t_1/2，t_max和c_max为实测值。按新药审评标准对AUC和c_max进行方差分析和双单侧t检验，以判定两制剂是否生物等效。结果对照品和测试品的t_max分别为(2.1±0.5) h和(1.9±0.5)h，c_max分别为(572.6±121.7)ng·mL^-1和(597.6±119.8)ng·mL^-1，AUC_0-∞分别为(2571.2±647.4)h·ng·mL^-1和(2528.4±558.8)h·ng·mL^-1，t_1/2分别为(2.3±0.4) h和(2.2±0.4)h；片剂B相对A的平均生物利用度为99.62%。结论统计分析显示，测试片剂B与进口对照片剂A具生物等效性。

Study on bioequivalence ofdomestic methylprednisolone tablets

OBJECTIVE　To study the bioequivalence of methylprednisolone (MP) tablets in healthy volunteers.METHOD　A rapid and sensitive RP-HPLC assay was modified for the determination of the drug levels in plasma. In a randomized two-way crossover design, 40 mg single dose po domestic (B) and imported (A, MedrolTM) MP tablets, respectively, were given to 18 male healthy volunteers. The parameters were estimated by non-compartment model with a statistic analysis of ANOVA and two one-side t-test.RESULTS　The tmax,cmax,t1/2 and AUC0～∞ of tablet-B and-A were (1.9±0.5) h and (2.1±0.5) h, (597.6±119.8 ) ng*mL-1 and (572.6±121.7) ng*mL-1,(2.2±0.4) h and (2.3±0.4) h,(2528.4±558.8) h*ng*mL-1 and (2571.2±647.4) h*ng*mL-1,respectively.The mean relative bioavailability of the tablet-B vs A was 99.62%. There was no significant difference between the two products.CONCLUSION　The results suggested that these two products were bioequivalent.