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目的对复方阿司匹林-双嘧达莫双层缓释片在家犬体内进行了药物动力学及生物等效性的研究。方法采用HPLC法,对受试样品(复方阿司匹林-双嘧达莫双层缓释片)及参比制剂Aggrenox(复方阿司匹林-双嘧达莫缓释胶囊)进行了家犬生物利用度对照。采用交叉实验设计、三因素方差分析及双单侧检验对试验结果进行分析。结果自制制剂与国外参比制剂相比生物利用度无显著差异。其单剂量给药实验结果表明:受试片剂对国外参比制剂的阿司匹林相对生物利用度(AUC0-t)为(104.9±10.4)%,(AUC0-∞)为(105.6±12.6)%,双嘧达莫相对生物利用度(AUC0-t)为(97.3±14.1)%,(AUC0-∞)为(95.6±16.0)%。结论制备的样品与参比制剂吸收程度相同。
Objective To study the pharmacokinetics and bioequivalence of compound aspirin-dipyridamole sustained-release tablets in dogs. Methods The HPLC method was used to compare the bioavailability of the tested samples (compound aspirin - dipyridamole double - coated sustained release tablets) and the reference formulation Aggrenox (compound aspirin - dipyridamole sustained - release capsules). Cross-experimental design, three-factor analysis of variance and two single-sided test results of the analysis. Results There was no significant difference in bioavailability of homemade preparations compared with foreign reference preparations. The results of single-dose administration showed that the relative bioavailability (AUC0-t) of the tested tablets to foreign reference preparations was (104.9 ± 10.4)%, (AUC0-∞) was (105.6 ± 12.6)%, The relative bioavailability of dipyridamole (AUC0-t) was (97.3 ± 14.1)%, (AUC0-∞) was (95.6 ± 16.0)%. Conclusion The samples prepared have the same degree of absorption as the reference preparation.