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目的：考察健康人体对国产Ｉ类新药爱康胶囊（人参皂甙Ｒｇ３）的耐受性、限制性毒性、毒性的可逆程度、毒性与剂量及治疗时间的关系。方法：将２１例健康受试者分为６，１２，２４，３６，６０，８４和１０８ｍｇ七个剂量组，ｐｏ，ｂｉｄ，共观察３０ｄ，停药后继续观察１５ｄ。结果：小剂量（６，１２，２４ｍｇ）组有增加食欲、体力和体重的作用；３６ｍｇ以上组（包括３６ｍｇ）口干现象十分普遍，部分志愿者出现咽干、咽痛、眼干等症状，但均能耐受，且随服药天数的延长而自行缓解。６０ｍｇ以上组个别志愿者出现头晕、耳鸣、胸闷、多梦、口腔溃疡等症状，受试者中有１例ＡＬＴ升高，１例ＡＬＰ升高，个别受试者鼻中有血丝或血痂。结论：爱康胶囊安全范围广，耐受程度高，推荐ＩＩ期临床使用剂量为２４ｍｇ，ｂｉｄ。
OBJECTIVE: To investigate the relationship between the tolerability, restrictive toxicity, reversibility of toxicity, toxicity and dose, and duration of treatment for healthy Chinese medicine I capsule (ginsenoside Rg3). METHODS: Twenty-one healthy subjects were divided into 6, 12, 24, 36, 60, 84 and 108 mg seven dose groups, po, bid, for a total of 30 days, and continued for 15 days after discontinuation. RESULTS: The low-dose (6,12,24 mg) group had the effect of increasing appetite, physical strength and body weight; the dry mouth phenomenon was more common in the group of 36 mg (including 36 mg). Some of the volunteers had symptoms of pharynx, sore throat, and dry eyes. However, it can tolerate and relieve itself as the number of medications is extended. Individual volunteers above 60 mg had symptoms such as dizziness, tinnitus, chest tightness, multiple dreams, and oral ulcers. Among the subjects, 1 had elevated ALT and 1 had elevated ALP. Individual subjects had bloodshot or bloody sputum in their nose. Conclusion: Aikang capsule has a wide safety range and high tolerance. It is recommended that the phase II clinical use dose be 24mg, bid.