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目的:评价健康受试者对知参解郁胶囊的耐受性和安全性。方法:共选取38名健康受试者,单次给药组28名受试者随机分为5组,分别单次口服729 mg(3粒),972 mg(4粒),1458 mg(6粒),1944mg(8粒),2187 mg(9粒)知参解郁胶囊;10名受试者连续服药7 d,每日2次服用,每次4粒(972 mg)。观察药物的不良反应、实验室检查、心电图以及生命体征。结果:单次服药组,对健康受试者的生命体征和肝肾功能没有明显影响;部分高剂量组(服用1944 mg和2187 mg组)健康受试者出现不良反应,主要有口干、手心发热;多次给药组,服药期间出现的不良反应包括脸红、血压降低或升高、心电图异常、鼻衄、皮疹、头晕和心动过速,所有的不良反应均为轻度,无需特殊处理,不影响日常活动,停药后消失。结论:在观察剂量范围内,单次给药和连续给药耐受性试验表明该药具有良好的耐受性和安全性。
Objective: To evaluate the tolerability and safety of Zhishen Jieyu capsules in healthy subjects. METHODS: A total of 38 healthy subjects were selected. 28 subjects in the single-dose group were randomly divided into 5 groups. They were given a single oral dose of 729 mg (3 capsules), 972 mg (4 capsules), and 1458 mg (6 capsules). ), 1944 mg (8 capsules), 2187 mg (9 capsules) Zhishen Jieyu capsule; 10 subjects took the drug for 7 consecutive days and twice a day, 4 capsules each (972 mg). Observe adverse drug reactions, laboratory tests, electrocardiogram, and vital signs. Results: The single dose group had no significant effect on vital signs and liver and kidney function in healthy subjects; some high dose groups (1944 mg and 2187 mg group) experienced adverse reactions, mainly dry mouth and palms. Fever; multiple dose groups, adverse reactions during medication include blush, blood pressure or elevated, abnormal electrocardiogram, epistaxis, rash, dizziness and tachycardia, all adverse reactions were mild, no special treatment, Does not affect daily activities and disappears after drug withdrawal. Conclusion: The single dose and continuous dose tolerance tests within the observed dose range indicate that the drug is well tolerated and safe.