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目的研究饮食对谱圣康口服液在健康受试者体内的药代动力学变化及影响。方法试验用随机、自身对照设计。12例受试者随机分为2组,每组6例,分别于空腹和进食后服用谱圣康口服液60 m L,给药前后按不同点采集血浆样品,测定血药和尿液浓度并计算药代动力学参数。结果受试者空腹和进食后服用谱圣康口服液后,活性成分三萜皂苷CKL-A03在血浆中的药代动力学参数分别为:t_(1/2)为(126.13±74.04),(104.81±68.44)min;t_(max)为(53.75±10.03),(58.75±11.89)min;C_(max)分别为(3.06±0.86),(3.81±2.82)μg·L~(-1);AUC_(0-t)分别为(268.81±84.25),(355.03±177.82)μg·L~(-1)·min。尿液中CKL-A03的t_(1/2)分别为(1.14±0.12),(1.24±0.16)h。结论饮食可能对谱圣康的吸收和在体内的消除速度均有影响。
Objective To study the effects of diet on the pharmacokinetics of Sibhengkang oral liquid in healthy volunteers. Methods Tests were randomized, self-controlled design. Twelve subjects were randomly divided into 2 groups with 6 cases in each group. After taking fasting and taking food for 60 m L of Shengkang Oral Liquid respectively, plasma samples were collected before and after different doses, Pharmacokinetic parameters were calculated. Results The pharmacokinetic parameters of the triterpenoid saponin CKL-A03 in plasma were as follows: t 1/2 (126.13 ± 74.04), ( 104.81 ± 68.44) min; t max was (53.75 ± 10.03) and (58.75 ± 11.89) min, respectively, and C max were 3.06 ± 0.86 and 3.81 ± 2.82 μg · L -1, respectively; The AUC_ (0-t) were (268.81 ± 84.25) and (355.03 ± 177.82) μg · L -1 min -1, respectively. The t_ (1/2) of urine CKL-A03 were (1.14 ± 0.12) and (1.24 ± 0.16) h, respectively. Conclusion Diet may affect the absorption of spectral Shengkang and the speed of elimination in the body.