Evaluation of Rabbit Skin Irritation and in vitro Transdermal Absorption of Diclofenac Sodium Microemul-sion / 中国药房

ABSTRACT

OBJECTIVE:To investigate the property,skin irritation and in vitro transdermal absorption of Diclofenac sodium microemulsion(DS-ME),and to explore the feasibility of local external use of it. METHODS:The content of DS in DS-ME was determined by ultraviolet spectrophotometry. The distribution of particle size was determined by laser particle size analyzer. The ef-fects of DS-ME and blank micro-emulsion on normal skin of single administration,normal skin of multiple administration and dam-aged skin of single administration were investigated by rabbit skin irritation test. The transdermal parameters of DS-ME and commer-cially available DS gel through isolated skin of mice were compared by Franz diffusion cell. RESULTS:The prepared DS-ME was O/W microemulsion with particle size of(30.140±9.020)nm. Compared with blank ME,DS-ME had no significant difference in rabbit skin irritation score. Steady permeation rates of DS-ME and commercially available DS gel were 34.16 and 18.62 μg/(cm2·h), respectively;the permeation coefficient of them were 1.029 and 0.561 cm/h;the delay time were 0.124 2 and 0.367 2 h. CONCLU-SIONSThe particle size of DS-ME is small and not irritant to skin,and can improve transdermal absorption rate of DS.