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[目的]选择健康人为受试者,从安全的初始剂量开始,观察人体对脑络清注射液的耐受性,为制定本品的II期临床试验给药方案,提供安全的剂量范围。[方法]筛选健康受试者60例,分别采用单次给药及连续给药观察该药的安全性和耐受性。[结果]脑络清注射液单剂量组出现化验室检查异常和7例口干症状,随访后均恢复正常,经研究者判断为与药物关系均为可能无关。连续剂量高剂量组出现口干症状,经研究者判断为与药物关系均为可能无关。以上安全级别均为二级。[结论]正常人体对脑络清注射液服用30g/d/人的剂量耐受较好,建议本品可以进行II期临床试验,剂量可在30g/d/人以内。
[Objective] To select the healthy human subjects as subjects, starting from the safe initial dose, observing the tolerance of the human body to Naoluoqing injection and providing a safe dosage range for formulating the Phase II clinical trial dosing regimen. [Method] Sixty healthy subjects were screened, and the safety and tolerability of the drug were observed by single administration and continuous administration respectively. [Results] The single dose of Naoluotu injection group had abnormal laboratory tests and 7 cases of dry mouth symptoms. All patients returned to normal after the follow-up, and the relationship between them could be irrelevant to the drug. Continuous doses of high-dose group of symptoms of dry mouth, the researchers concluded that the relationship with the drug may be irrelevant. The above security level is two. [Conclusion] The normal human body can tolerate the dose of 30g / d / person to Naoluoqing injection well. It is suggested that this product can be used in the phase II clinical trial and the dosage can be within 30g / d / person.