The Preparation And The Quality Control Of Liposome Podophyllotoxin Chitosan Film And Determination Of Its Bio-adhesion In Vitro

The incidence rates of condyloma acuminatum(CA) is increasing annually, it is the second of sexually transmitted diseases(STDS) in our country now. lots of evidence have improved that female CA, CIN and cervix cancer related with HPV infection, WHO had appointed 0.5% Podophyllotoxin tincture as the preferred drug, Use of liposome encapsulated drug can accumulate and slowly release in skin and epidermis cells and low the drug concentration in the blood. The medicaments of podophyllotoxin have tincture, ointment, etc. According to the female cervix physiologist peculiarity, the film should be the best choice. The chitosan film which was prepared from carapace has good bio- consistent, good bio- degraded, easy preparing and good flexility, Besides, it has the function of diminish inflammation and antibacterial. Chitosan can be degraded and absorbed in acetous solution, bacteriolysin can improve it. Good bio-adhesion as the chitosan gel is, so the chitosan film fits the apply to female cervix The purpose of this study:1. Prepare the podophyllotoxin liposome liquid and. observe the podophyllotoxin liposome embedding ratio.2. Use orthogonal design method to optimize the formula of liposome podophyllotoxin chitosan film and prepare the film.3. To observe the podophyllotoxin liposome embedding ratio of liposome podophyllotoxin chitosan film.4. To accurately determine the podophyllotoxin content in the film.5. To determinate its bio-adhesion in vitro and compare it with other two medicaments.Methods:1. The podophyllotoxin liposome liquid was prepared by rotary film evaporation and ultrasonic wave and use low temperature centrifugal methods and ultraviolet spectrophotometry to determine the content ofpodophyllotoxin in the liquid.2. Liposome podophyllotoxin chitosan films were prepared according to different formulas deliver from the results of orthogonal design by selecting chitosan, acetic acid and gelatin as 3 factors for preparation, each factor including 3 levels with liposome podophyllotoxin as blank factor. Comprehensive evaluation of the formula was performed on the basis of the conglutination and solubility of the prepared film to select the optimal formula.3. Use distilled water to dissolve liposome podophyllotoxin chitosan film and use low temperature centrifugal methods and ultraviolet spectrophotometry to determine the content of podophyllotoxin in the film.4. The content of phdophyllotoxin of the film was determined by ultraviolet spectrophotometry.5. Use bio-adhension mensurate equipment to mensurate the bio-adhension of the film and compare the result with that of dophyllotoxin chitosan film and podophyllotoxin carbomer gel.Results:1. The lowest podophyllotoxin liposome embedding ratio is 68. 8%, thehighest embedding ratio is 76. 5%, and the average ratio is 71.1%.2. The conglutination and solubility were optimal of the film prepared from2% chitosan, 1% acetic acid , 2% gelatin and 2.8% liposome podophyllotoxin chitosan.3. The lowest podophyllotoxin liposome embedding ratio of the film is 48.4%, the highest embedding ratio is 55.3%, and the average ratio is 52%.4. The average content of podophyllotoxin of the film is 1.018mg/cm2 andthe RSD is 4.42%.5 . The bio-adhesion of liposome podophyllotoxin chitosan film was obviously higher than that of podophyllotoxin chitosan film andpodophyllotoxin carbomer gel, the results of them were 19.1g/0.5cm2, 16.6g/0.5cm2 and 14.0g/0.5cm2. Conclusion:1. The optimal prescription of the film was 2% chitosan, 1% acetic acid, 2% gelatin and 2.8% liposome podophyllotoxin chitosan.2. The podophyllotoxin liposome embedding ratio of the film was ideal.3. The podophyllotoxin content of film was accorded with the request and have good equality.4. The bio-adhesion of film was obviously higher than that of podophyllotoxincarbomer gel. It fits the use of female cervix.