Preparation Of Carboxymethyl Chitosan And Iodoform Film

Objective To screen and determine the prescription of carboxymethyl chitosan and iodoform film, establish its quality control standards. Methods The main drug and accessories were screened with L9(34) orthogonal experiment method to determine the best prescription. Appearance of prepared films and the release rate of iodoform were used as the determinant factors for the prescription selection. According to Chinese Pharmacopoeia(2010 edition), Appendix ⅣA,the quantity of iodoform was assessed by UV spectrophotometry;the uniformity of the film was determined following the method "content uniformity test" in the Chinese Pharmacopoeia(2010 edition), Appendix XI E; The in vitro release rate of iodoform was determined with the "basket method" as mentioned in Chinese Pharmacopoeia(2010 edition), Appendix XC; "Microbial limit test" was used to detect the number of bacteria,mold count,yeast and controlling the number of bacteria as described in Chinese Pharmacopoeia(2010 edition), Appendix XI J. Results The best prescription determined with L9(34) orthogonal experiment method includes: iodoform 0.5g,chitosan 1.6g,carboxymethyl chitosan 1.6g,glycerol 2.5% and 20 x volume of water.The maximum absorption of iodoform solution was observed at wavelength 340 nm in UV spectrophotometry, with the linear regression equation of A=0.023C-0.0007,r=0.9999,indicating a good linear relationship of iodoform reference solution within the concentration range of 6~20ug/ml;The average content of iodoform in film was 100.04%(ratio of the actual amount to the labeled amount)?RSD=0.98%. "Content uniformity test" got a result of A+1.80S﹦7.59,indicating that the content uniformity meets the requirement of Chinese Pharmacopoeia;The cumulative release rate of iodoform for 10 minutes,30 minutes,one hour,two hours,four hours,six hours,eight hours and ten hours were 13.9% ? 39.0% ? 59.3% ? 66.5% ? 69.5% ? 73.3% ? 77.1% and 80.2%,respectively, as determined with the "basket method". Conclusions Both appearance and cumulative release rate of the carboxymethyl chitosan and iodoform film prepared with L9(34) orthogonal-optimized prescription meet the requirement of Chinese Pharmacopoeia. The preparation is simple,quality control methods are accurate and reliable.