The Studies On Triptoliide Gels

OBJECTIVE: To prepare and evalutate a new preparation , Triptolide gels, for Rheumatoid Arthritis.METHODS: With carbomer 940 used as gel matrix and azone and propylene glycol as penetration enhancer, the optimum formulation of Triptolide Gels was selected regarding the cumulative amount of Triptolide in Triptolide Gels across the rat skin in vitro as the index with orthogonal test. And the permeation kinetics of Triptolide Gels. The Triptolide content in Triptolide gels was determined by high performance liquid chromatography(HPLC) to establish the tentative quality standad of the preparation. The skin irritation experiments and elementary pharmacodynamics tests of Triptolide gels was conducted.RESULTS: The optimum formulation of Triptolide Gels was 1% carbomer, 10% glycerol, 10% propylene glycol and 1% azone. The process of percutaneous permeation of Triptolide Gels invitro and the process of release of the gels across the dialyzator were both zero-order(r>0.99), and the kinetic equations were Q = 0.419t - 0.682, r=0.9980, Q = 3.436t-2.516, r=.9990, respectly. The results of preliminary stability experiments indicated that Triptolide gels were stable and the drug content of the gels was not obviously changed at ordinary temperature within three months. The quality standard was simple, convenient, which could be used for controlling quality of Triptolide gels. In addition, the results of skin irritation experiments and elementary pharmacodynamics tests showed that the gels had no obvious skin irritation and have certain effect to inflammation induced by Freund's adjuvant. CONCLUSIONS: The well-chosen preparation technology of Triptolide gels is reasonable and reliable, and the qualitiy control methods are practicable. The gels have no skin irritation and have certain effect to inflammation induced by Freund's adjuvant. It is valuable for further research and development...