The Development And Quality Research On Adapalene And Benzoyl Peroxide Gel

Acne is the most common skin disease among teenagers.The skin disease tend to attack in the face,chest,back and neck,and its specific pathogenesis is unclear.Now,there is a new view changing our cognition for acne vulgaris Pathogenesis:except the propionibacterium acnes,natural immune mediated produces a series of acne inflammation are especially important.Through the gene technology foreign scholar Del and Kircik detect IL-1 ? and integrin expression in subclinical skin lesion,so we believe that the non-inflammatory acne(open or closed comedo)also have the participation of inflammation.Related studies have shown that acne is a primary accompanying symptoms of inflammation of the skin disease,the inflammatory response throughout the progress of acne,including the process of the so-called non-inflammatory acne to inflammatory acne,and even to erythema,pigmentation and scar formation.Because of the inflammatory response throughout the whole course of the acne,the treatment effect depends on both anti-infection treatment and the anti-inflammatory treatment,and it will be a new direction of acne treatment.Although acne has less interference of the normal physiological function of the human body,but the defects of the appearance often accompanied by mental stress and psychologicalburden.Therefore,for the treatment of acne drug research and development has been highly valued.In this study,we combine adapalene which has potent anti-inflammatory effect and benzoyl peroxide which has strong bactericidal action these two main drugs,and glycerol,disodium edetate,propylene glycol,sodium docetate,SIMUGEL 600 PHA,poloxamer 124,sodium hydroxide these pharmaceutical excipients developed a new compound preparation-Adapalene and Benzoyl peroxide gel.And carried out the following research:First of all,we research its formulation and technology : screening the most appropriate preservatives,wetting agents and Simugel600 PHA,propylene glycol dosage.By examining the properties,pH,viscosity and particle size of gels to determine the optimal prescription process.Secondly followed by quality research,we reference to the State Food and Drug Administration issued Adapalene gel standards,The American Pharmacopoeia record of the standard of benzoyl peroxide gel to conducted a systematic study of self-made gels.Gel traits,identification,viscosity,pH,related substances,content and other indicators are all our focus of the study.During the course of the experiment,we used two different chromatographic conditions to determine the related substances and contents of adapalene and the related substances of benzoyl peroxide,determine the contents of benzoyl peroxide by iodometric method,we made a series of methodological research of the relevant substances and content determination and establish the quality testing standards.the relevant substances and content determination of the methodological research and the establishment of a series of qualitytesting standards.Which not only protects the safety and effectiveness of clinical medicine,but also provides the experimental basis for quality control.These process not only protects the safety and effectiveness of clinical medicine,but also provides the experimental basis for quality control.secondly,we investigated the stability of the gel.Stability studies are an integral part of quality research,we designed the experiment by studying the tendency of the gel to change with temperature,humidity,and light over time,preliminary study of adapalene and benzoyl peroxide gel in three aspects: influencing factors,accelerated test and long-term stability,The experimental results show that adapalene and benzoyl peroxide gel has good stability and is stored in dark and cool place.Finally,we conducted an in vitro transdermal absorption experiment on the gel.The results showed that the cumulative permeation of the main drug had a good linear relationship with the permeation time,and the correlation coefficient between self-made and commercially control,transdermal rate,12 h cumulative infiltration are all very parallel and comparable.Through variance analysis,we determine the treatment of the two equivalent.