[Experimental study on preclinical quality control, urgent poison and irritation of Dendrobium aurantiacum eye drops, a class I new drug against diabetic cataract].

To establish a quality control method of Dendrobium aurantiacum eye drops,in order to evaluate acute toxicity,irritation and irritability and lay a foundation for its development and utilization in the future.The content of gigantol and SA in D.aurantiacum eye drops were determined by high-performance liquid chromatography(HPLC).The linear ranges of gigantol and SA were 0.040 8-1.530 0 g·L-1(r = 0.999 9) and 0.100 8-0.504 0 g·L-1(r = 0.999 9),with the average recoveries being 100.8%,99.84%,and RSD being 1.4%,1.8%(n = 9) respectively.The sample solution was stable at room temperature within 72 h.The acute toxicity test showed no toxic reaction of D.aurantiacum eye drops in mice.The irritating test for single-dose and multiple-dose administrations of D.aurantiacum eye drops and physiological saline in rabbit eyes and skin,as well as the allergic test in guinea pigs showed no eye irritation and skin irritation and irritability.These findings indicated that D.aurantiacum eye drops are safe and stable,with a good druggability.