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目的:比较茶苯海明口腔崩解片及其普通片在恒河猴体内的药代动力学特征。方法:采用随机、自身对照方法考察两制剂在恒河猴体内的药代动力学特点;采用HPLC-UV法测定分别口服给予相应剂量的药物(均为茶苯海明50 mg)后恒河猴体内血药浓度;并采用DAS2.0对药代动力学参数进行统计分析。结果:茶苯海明口腔崩解片相对生物利用度(F_(0-12h),F_(0-∞))分别为(154±42)%和(150±53)%。两制剂间的血药浓度时间-曲线下面积(AUC_(0-∞))差异无统计学意义(P>0.05),而C_(max)和AUC_(0-12)差异有统计学意义(P<0.05)。此外,茶苯海明口腔崩解片t_(max)与普通片比较明显缩短,但差异无统计学意义(P>0.05)。茶苯海明在恒河猴空白血浆中10～2000 ng/mL浓度范围内线性良好(r=0.99995),最低检测限(LLOQ)10 ng/mL。其他确证数据如准确度、精密度等均在要求范围内。结论:茶苯海明口腔崩解片在体内吸收比普通片快。
OBJECTIVE: To compare the pharmacokinetic characteristics of ambbenzene orally disintegrating tablets and their common tablets in rhesus monkeys. Methods: Randomized, self-control method was used to investigate the pharmacokinetics of the two preparations in rhesus monkeys. HPLC-UV method was used to determine the pharmacokinetics of rhesus monkey In vivo blood concentration; and using DAS2.0 statistical analysis of pharmacokinetic parameters. Results: The relative bioavailability (0 ~ 12h, F_ (0 ~ ∞)) of etophamine orally disintegrating tablets were (154 ± 42)% and (150 ± 53)%, respectively. There was no significant difference in the area under the curve of plasma concentration between the two preparations (AUC_ (0-∞)) (P> 0.05), while the difference between Cmax and AUC_ (0-12) was statistically significant (P <0.05). In addition, the value of t_ (max) in omeprazole orally disintegrating tablets was significantly shorter than that of normal tablets, but the difference was not statistically significant (P> 0.05). Phenylephrin had a good linearity (r = 0.99995) and a lowest limit of detection (LLOQ) of 10 ng / mL in 10 ~ 2000 ng / mL rhesus monkey blank plasma. Other confirmatory data such as accuracy, precision, etc. are in the required range. CONCLUSION: Calcitianamine orally disintegrating tablets in the body faster than ordinary tablets.