The Construction And Quality Evaluation Of Timolol Microemulsion Gel

Objective: To prepare timolol microemulsion gel,study its optimal formulation and preparation process,and evaluate its quality,to fill the gap in local treatment of infantile hemangiomas.Methods: The first part,a UV analysis method for determining timolol content was established.The content of timolol was determined by UV spectrophotometry.Through the calculation of its linearity,specificity,recovery rate and precision,the UV spectrophotometric method for the determination of timolol content was verified.The second part,Prescription study of timolol microemulsion.Preparation process of Timolol microemulsion The blank microemulsion was prepared by using oleic acid as the oil phase,Span80 and Tween80 as surfactants,and anhydrous ethanol as the co-surfactant.Pseudo-ternary phases were drawn at different ratios.Figure,select the optimal ratio of oil phase,surfactant and co-surfactant,select the best prescription design.Then,the timolol microemulsion delivery system was optimized using a star design-response surface method to examine the ratio of oil phase(X1),surfactant(X2),surfactant and co-surfactant(X3)to microemulsion Changes in the formulation of microemulsions were influenced by factors that had significant effects.Three-dimensional effect surface maps were plotted using a three-factor and five-level star design to analyze the effect of each factor on each effect value.Finally,timolol microemulsion drug delivery system was prepared by superposing and superimposing the effect planes and selecting the optimum conditions.The third part,evaluated the quality of timolol microemulsion.A method for the determination of timolol microemulsion was established.Three batches of microemulsion samples were assayed.The results showed that the microemulsion quality met the quality requirements;afterwards,the appearance was examined with a transmission electron microscope;and the grain size was measured with a Zeta potential meter.Trail inspection.Place 1,2,4,6 months at room temperature and observe its long-term stability.The fourth part,the preparation technology of timolol microemulsion gel was studied.The appearance and consistency of the gel were used as indicators to screen the common matrix of the gel.The timolol microemulsion gel was prepared by selecting the optimal matrix.Evaluate its quality.Results: First,in the concentration range of 2.0-40 ?g/m L,the detection wavelength was 295 nm,timolol concentration and absorbance linear relationship is good,the correlation coefficient is 0.9998,the methodological relationship is good,high precision and recovery rate are consistent Analytical method requirements;Second,timolol microemulsion best prescription for oleic acid 30%,mixed surfactant 24%,anhydrous ethanol 30%,water 15.5%,timolol 0.5%;Three,placed 6 Monthly,microemulsion appearance,particle size,content have no significant changes,long-term stability;Four,Carbomer 940 is the best substrate,with its preparation of timolol microemulsion gel transparent appearance,bright color,The viscosity is moderate,the texture is even and delicate,and the stability is high.Conclusion: The timolol microemulsion gel prepared by the pseudo-ternary phase diagram and the star point design-response surface method has reliable quality,good stability,and is easy to use.It is used to treat infantile hemangiomas.A new formulation.