Study On The Compound Diphenhydramine Gel

Diphenhydramine hydrochloride is the anti-histamine drug, which has the use of anti-allergic, anti-itching, anti-swelling. It can be used for urticaria, allergic dermatitis, neurodermatitis, drug eruptions, insect bites and itching of the skin such as the treatment of allergic disease. Dexamethasone sodium phosphate adrenocorticotropic hormone medicines, has anti-inflammatory, anti-allergic, anti-rheumatism, immunosuppressive effects. The combination of the two agents (cream) used in the treatment of contact dermatitis, allergic eczema and dermatitis. This paper has been developed compound diphenhydramine gel, According to the rule of drug register, we took a serial studies on the approach screening, the quality standards, preparation stability and preliminary efficacy.Matrix of the gel of prescriptions screening part of this paper used Carbomer as major accessories, we choose the gel viscosity and the appearance as the indicators, and optimized the ratio of the amount of principal component through numerous tests. We optimized penetration enhancers by using Franz diffusion cell, the release of diphenhydramine hydrochloride and dexamethasone sodium phosphate comply with the Higuchi equation, 1% of the Azone promote two main drugs seepage role better, and no significant difference, with 2% and 3% of the Azone, So we choose 1% Azone as promoting penetration enhancers.On the basis of optimizing prescription, we research appearance, pH, viscosity, concentration, and the stability of the compound diphenhydramine gel. The results showed that the content of gel is uniform. Applying influent factors test and accelerated test to see about the stability of the compound diphenhydramine gel, The results showed that the preparation was stable to light , low temperature and high humidity. But high temperatures can reduce the viscosity and gel content. Compound diphenhydramine gel is stabile in the accelerated tests and long-term tests.The results of rabbit-skin test indicated that the gels had no irrtaton. The preliminary efficacy tests showed that the drug have some inhibition effects on the rat claws swelling caused by egg white and have better inhibition effects on mouse ear edema caused by xylene. High, medium, and low concentrations of compound diphenhydramine hydrochloride gel can be significantly increased histamine itch threshold of guinea pigs caused by phosphorylation. In conclusion, this product is inirritative, safe and effective.