Studies On Quality Standards Of Belladonna Sulfamethoxazle And Trimethoprim Tablets

Belladonna Sulfamethoxazle and Trimethoprim Tablets,the main ingredient in this product is sulfamethoxazole,trimethoprim,and Belladonna liquid extract,The prod uct has a good antibacterial effect of Enterobacteriaceae,Neisseria gonorrhoeae,Neisseria meningitidis and Staphy,lococcus aureus.In the clinical treatment,it mainly used of chronic diarrhea and enteritis,which caused by bacteria,and viruses.This product is also due to fewer side effects and low cost advantage so it is widely used in clinical.This article in the preparation process maturity after the product character,identification,inspection,Traits,identification,inspection,Determination of dissolution,the content determination of the system test,to determine the appropriate quality standards and control index.The experimental results are as follows:(1)We use chemical method to identify sulfamethoxazole and trimethoprim,nd the results showed a positive reaction,then we using the HPLC method for the identification of these two main components,the results showed SMZ,TMP and reference have the same retention time.Chemical method Belladonna liquid extract were identified,the results showed a positive reaction.the weight difference of Belladonna sulfur Trimethoprim Tablets are within 3%,in line with Pharmacopoeia.the results of the friability of the product:The product is less than 1%loss of volume,and no ground breaking products;Disintegration time measurement results is:disintegration timeaveragein3min,in line with Pharmacopoeia;Microbiall imit check,bacteria,fungi,yeast count of less than10cfu/g,Escherichiacoli was not detected.(2)Determination results:HPLC method for simultaneous determination of trimethoprim and sulfamethoxazole,Linear least-square regression analysis of the calibration graph demonstrated linearity between the response(peak area)and the nominal concentrations of TMP(6.01?g/ml~90.15?g/ml)r-0.9998 and SMX(30.04?g/ml~450.6?g/ml)r=0.9992(3)The measurement results of the dissolution:After testing the best solution dissolution is:Hydrochloric acid solution(9 1000)as the dissolution medium,volume of 1000ml,basket method at 150 revolutions per minute test speed,sampling time30 minutes and treated with 0.8?m membrane filter sample solution.In three batches of 30 minutes for the dissolution of the sample of greater than 80%.Conclusion:This product is a slight change in bright light,humidity and other conditions,but did not change significantly,Therefore,in the production process should be to minimize the humidity,to ensure product quality.Its storage conditions is shading,sealed,dry place,therefore,when saving drugs we should pay attention to storage conditions Determination by HPLC test,measurement results were greater than90.0%.We go through a systematic test,believe that the quality of the product research method is reliable,reproducible,and simple,can control the quality of the product.Dissolution of the trial,only with rotating basket method were determined by HPLC dissolution,the measured results were greater than80%.According to the basic requirements for stability,the stability of the belladonna sulfonamide trimethoprim tablets were investigated,including six months accelerated testing study,the results showed that the content decreased slightly,other indicators did not change significantly,microbiological limits results of compliance.This product is by a long-term study stay like 12 months,the index did not change significantly.This product was accelerated testsixmonthsandl2months of long-term stay kind study results show that the indicators were not changed significantly,indicating good stability belladonna sulfonamide trimethoprim tablets.