摘要
该研究旨在建立石斛滴眼液的质量控制方法,并对其进行急性毒性、刺激性及过敏性评价,为其开发利用奠定基础。采用高效液相色谱法测定石斛滴眼液的主要成分石斛酚和丁香酸的含量,石斛酚和丁香酸质量浓度线性范围分别是0.0408～1.5300g·L-1(r=0.9999),0.1008～0.5040g·L-1(r=0.9999),平均回收率分别为100.8%,99.84%,RSD分别为1.4%,1.8%(n=9),样品溶液在室温72h内稳定。小鼠急性毒性实验结果显示石斛滴眼液对小鼠无毒性反应;单次给药和连续给药1周对家兔眼和皮肤的刺激性实验及豚鼠过敏性实验结果显示石斛滴眼液无眼刺激性和无皮肤刺激性及过敏性,表明石斛滴眼液安全、稳定,具有较好的成药性。
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-I （ r = 0. 999 9 ） and 0. 100 8-0. 504 0 g · L -1 （ r = O. 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.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2013年第7期1061-1066,共6页
China Journal of Chinese Materia Medica
基金
国家自然科学基金项目(81102674,81274157)
广东省自然科学基金项目(S2011010005661)
广东省科技计划项目(2011B031700076,2009B090300335)
关键词
石斛滴眼液
质量控制
急性毒性
刺激性
Dendrobium aurantiacum eye drops
quality control
acute toxicity
irritation
