The Studies On Xinzhi Thermo-Ion-Sensitive In Situ Gel

OBJECTIVE:To preparate and evaluate Xinzhi thermo-ion-sensitive in situ gel.METHOD:(1)The extraction conditions of volatile oil were optimized with the volatile oil content as the index.(2)The extraction conditions of medicinal materials were optimized with the Magnolin and Imperatorin content as the index using orthogonal test, which were determined by RH-HPLC.(3)Applicable rotate viscometer, respectively in speed different shear force were different concentrations of in situ gel the viscosity of the change, and to select the best deacetylated gellan gum concentration.(4)The in situ gel was respectively prepared with0.3%(w) deacetylated gellan gum and17.0%(w)、18.0%(w)、19.0%(w) poloxamer407, determination of critical phase transition temperature gel, is used to make the optimum poloxamer407concentration.With Single factor, investigate prescription components to the influence of the temperature.(5)No film in vitro release degrees and gel determination of the characteristics of the solution. (6)Regularity of the drug release was studied by using the Franz diffusion cell model and mechanism of the drug release was study by using the membrane-less dissolution model.(7)Uses TLC to carry on the qualitative distinction of Magnolia sprengeri Pamp、Ligusticum chuanxiong Hort、Radix Angelicae dahurica and Xanthium sibiricum Patr. The Magnolin and Imperatorin content in Xinzhi thermo-ion-sensitive was determined by HPLC to establish the tentative quality standard of the preparation.(8)The elementary pharmaco-dynamics tests of Xinzhi thermo-ion-se nsitive in situ gel.RESULTS:(1)The optimized extraction condition of volatile oil was as follows:Soaking12h with10times water and extracting with4h.(2)The optimized extraction conditions of medicinal materials were as follows:adding8times of ethyl acetate, refluxing and extracting for1h, totally extracting3times.(3)The viscosity tests of the gellan gum show that the viscosity of Xinzhi thermo-ion-sensitive in situ gel employing0.3%gellan gum as material was moderate. The optimal concentration of poloxamer407is18.0%(w).(4)The optimum formulation of Xinzhi thermo-ion-sensitive in situ gel consists of1%vitamin E,1%twain80,1%alcohol,15%1.2-propylene glycol,0.3%menthol crystal and0.05%benzalkonium bromide.(5)The process of no film of Xinzhi thermo-ion-sensitive in situ gel in vitro followed Higuchi-equation. The action of drug release of Xinzhi thermo-ion-sensitive in situ gel was erosion and it was not diffusion.(6)The Process of endosmotic permeation of Xinzhi thermo-ion-sensitive in situ gel in vitro across the scalper nose mucosa followed zero-order.(7)The quality standard was simple, convenient and practical, which can be used for controlling the quality of Xinzhi thermo-ion-sensitive in situ gel.(8)The results of elementary pharmacodynamics tests showed that it is effective in prevention and treatment for the rhiniti of SD rats.CONCLUSIONS:The well-chosen preparation technology of Xinzhi thermo-ion-sensitive in situ gel is reasonable, and the qualitiy control methods are practicable. It is effective to preventing and treating coryza of SD rats. The study results mentioned above show that it is a novel dosage form of drug for nose it is valuable for further research and development.