| Rheumatoid arthritis(RA)is a kind of autoimmune disease,which is one of the most common diseases in clin ic.According to relevant statistics,the world' s RA patients accounted for 1.4% of the total popul ation,the incidence of foreign RA in about 2%,some areas up to 5%.The averag e incidence of RA in China is 0.4%,the total number of patients up to 5 m illion 520 thousand.At present,there are 4 m ain types of RA drug t herapy,including fi rst-line,second-line,line three an d immunotherapy drugs.One of the first-line drugs is a class of salicylic acid and non-body-like anti-inflammatory drugs(NSAIDs).Second line drugs represent changes in condition(DMARDs)and cytotoxi c drugs.The three line represents a glucocorticoid drug.Immunotherapy drugs,not yet mature.The pathogenesis of RA is still not com pletely clear,so its treatment is m ainly symptomatic treatment,to control the symptoms of inflammatory changes,reduce the pain of patients,but can not be completely cured.In December 17,2004,the long-term cancer preven tion Celebrex colonic adenoma(APC test)showed an increas e in cardio vascular risk,since then,the U.S.Food and Drug Administration(FDA)risk prompts 21 painkillers for ibuprofen.Our country has carried on 51 kinds of fa ce regulatory painkillers containing ibuprofen and ketoprofen.In this situation,the advant age of paeonol is very obvious,paeonol can inhibit a vari ety of acute and chronic inflammatory reaction,and is no m ore than the anti-inflammatory drug adverse effects,the clinical effect is good.Howeve r paeonol unique phys icochemical properties of insoluble in water,volatile and dif ficult to prepar ation,because of its unique biological characteristics of short half-life,oral number,low bioavailability,require frequent dosing,give patients drugs inconvenience,easy to leak medication,resulting in blood concentration.Too big,did not reach the ef fective concentration,it is dif ficult to effectively treat.The present invention is used in the treatment of rheumatoid arthritis of wind like rheum atoid arthritis,such as common tablet,com pound emulsion,gel and dropping pills.Paeonol preparations are available because of some shortcomings,such as drug use is not c onvenient,affected by the dispersion medium,easy to cause the chemical degradation of drugs,reduce the ef fect or even failure,m ildew,the key problems of preparation and clinical treatm ent of paeonol system,such as volatile,difficult storage;insoluble in water is not conducive to the disso lution of Paeonol in the human body and absorption,and there is no effective solution.T herefore,this topic through the use of m odern science and technology,with Paeonol T ablets as a model drug,the preparation of its formulation into a dispersed tablet.Pack the preparation of paeonol by HP-beta-CD drug carrier,and study the package and,determine the optimum inclusion process,the inclusion complex was evaluated on identification and perform ance,improve th e effect of paeonol inclusion yield,effectively increase the solubility of Paeonol and im prove the stability in the preparation period and give full play to the ef ficacy of the drug ef fect.The prescription and technology of the prep aration and the prep aration of paeonol dispersible tablets were investigated.The formulation factors including disintegrating agent screening,screening of lubricant and filler,glidants screening;process factors including disintegrating agent adding m ethods of investigation,investigation of particle size,particle ef fects of drying te mperature,drying tim e of pa rticles etc..Through the research of this subject,the di spersible tablet of paeonol has becom e a new kind of m edicine with high bioavailability,reasonable production process and high quality control. |
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