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采用三交叉、自身对照的方法,研究了3种药用空心胶囊的体内相对利用度,并评估了其生物等效性,以检验海藻多糖植物空心胶囊替代动物明胶空心胶囊的可行性。实验选择了12名志愿者,以布洛芬为模型药物,采用高效液相色谱法(HPLC)检测志愿者体内的血药浓度变化,用DAS 2.0计算主要药动学参数,并评价其生物利用度及生物等效性。结果显示,海藻多糖植物空心胶囊替代动物明胶空心胶囊并不影响人体内药物吸收;海藻多糖植物空心胶囊布洛芬胶囊剂与日本Qualicaps布洛芬胶囊剂(相对生物利用度94.9%)、明胶布洛芬胶囊剂(相对生物利用度97.5%)均具有生物等效性。
Using the method of three-crossover and self-control, the relative availability of three kinds of medical hollow capsules was studied in vivo and the bioequivalence was evaluated to test the feasibility of hollow alginate capsules instead of animal hollow capsules. Twelve volunteers were chosen for the experiment, ibuprofen was used as a model drug, the plasma concentration of the volunteers was detected by HPLC, the main pharmacokinetic parameters were calculated by DAS 2.0, and their bioavailability was evaluated Degree and bioequivalence. The results showed that algae polysaccharide plant hollow capsules instead of animal gelatin hollow capsules did not affect the absorption of drugs in the human body; algae polysaccharide plant hollow capsules ibuprofen capsules and Japanese Qualicaps ibuprofen capsules (relative bioavailability 94.9%), gelatin Lupine capsules (relative bioavailability 97.5%) are bioequivalent.