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目的 评价黄精多糖滴眼液的安全性。方法 依据改良Blach Well法确定初始剂量及最大剂量,评价其安全性。采用单次给药、一天多次给药、连续多次给药的方法,观察用药后生命体征,眼局部安全性指标,全身安全性指标及胸部X线体征的改变。结果 0.8％黄精多糖滴眼液的耐受量试验未引发受试者全身、局部症状的异常,未引发不良反应症状。结论 0.8％黄精多糖滴眼液滴眼是安全的,推荐进行Ⅱ期临床试验的用药量及疗程为每天6次,每次0.05 mL,共用药18 d。
Objective To evaluate the safety of Huang Jing polysaccharide eye drops. Methods According to the modified Blach Well method, the initial dose and the maximum dose were determined to evaluate the safety. The methods of single dose, multiple doses, and multiple doses were used to observe the vital signs after the administration, the local eye safety indicators, the general safety indicators and chest X-ray signs. RESULTS: Tolerance test of 0.8% Huangqin polysaccharide eye drops did not induce abnormal body and local symptoms and did not cause adverse reactions. Conclusions 0.8% polysaccharides of Polygonatum polysaccharides are safe for eye drops. The recommended dose and duration of phase II clinical trials are 6 times per day, 0.05 mL each, for 18 days.