| Recurrent herpes simplex labialis, also known as cold sores or orofacial herpes, is a common diseases caused by herpes simplex virus infection. Although oral or topical treatment with antiviral agents can reduce the replication of herpes simplex virus,the primary benefits of antiviral therapies for recurrent herpes simplex labialis have been limited to modest reductions in healing time, they can not reduce the accompanying immune-mediated response of the host to the virus. The addition of a topical corticosteroid hydrocortisone to an antiviral acyclovir has been hypothesized to improve the clinical effect of herpes simplex labialis by decreasing the HSV-related immune-mediated inflammatory skin reaction. The developed topical compound cream containing5%acyclovir and1%hydrocortisone in a novel cream vehicle has been shown to be safe and effective for early treatment of signs and symptoms of recurrent herpes labialis to reduce the likelihood of ulcerative cold sores in adults and adolescents12years of age and older. The treatment was well and tolerated, and there was no evidence of emergence of viral resistance to acyclovir with the addition of hydrocortisone.In this article, acyclovir and hydrocortisone as model drugs make up a compound preparation to which the pharmaceutical research is conducting.First, the prescription and the procedure of preparing the acyclovir and hydrocortisone cream was studied. Suitable emulsifiers, moisturizers, percutaneous penetration enhancers, thickeners, antioxidants, pH regulating agents were selected. We screened for the composition and ratio of oil phase, water phase, sodium hydroxide used to dissolve the active ingredient, and pH regulating agents hydrochloric acid by judging the creams appearance, pH, centrifuge test, cold and heat tests and other evaluation index. The creams’conventional preparation method was used in the experiment to determine the optimal prescription.Part of the quality studies, the research on quality standards was conducted according to the relative requirement. The main indexes were the appearance, identification, filling weight, particle size, pH, the related substances, assay and so on. The high performance liquid chromatography method to determine the related substance and content was established and the methodology was validated. Detecting standard of the final quality control was established by the examination of those indexes above.Finally, the stability study was carried out by the influence factor tests of investigating temperature, humidity and illumination, the stability tests of6months’accelerating experiment and6months’long-term studies. The experiment results showed that the compound was table. Storage conditions are dark, sealed and stored in a cool dark dry place. |