RESUMO
Objective To establish a gas chromatography ( GC) method for determination of aniline,2-aminophenol and 4-aminophenol in mesalamine sustained release granules. Methods An HP-5 (10 m×0.53 mm,2.65 μm) capillary GC column was adopted. The carrier gas was high purity nitrogen at a flow rate of 15 mL.min-1 . The inlet temperature was controlled at 280 ℃ and the FID detector temperature was 300℃. The oven temperature was initially held at 70℃ for 2 min and was then programmed to 150 ℃ at 10℃.min-1 and held for 6 min. Results A good resolution was obtained between the peaks of the 3 impurities at chromatographic conditions above. The recoveries of aniline, 2-aminophenol and 4-aminophenol were among 98.04% to 103.00%. The precision and linearity equations were good. Conclusion The method can be adopted for the quality control of mesalazine sustained release granules.
RESUMO
Objective To investigate the efficacy ,safety and compliance of mesalazine sustained‐release (SR) granules taking once daily or multi‐times daily in the treatment of patients with mild to moderate active ulcerative colitis .Methods Sixty patients with mild to moderate active ulcerative colitis were divided into group A ,B and C with 20 patients in each group .Group A received mesalazine SR granules 4 g once daily ,Group B with 2 g each time and twice daily ,Group C with 1 g each time and four times daily . The total course was eight weeks . The vital signs ,Mayo score ,compliance and adverse effects of patients were monitored at 0 ,4th ,8th weeks .At 0 and 8th weeks ,colonoscopy were performed . The parameters of efficacy assessment were clinical complete remission rate , clinical remission rate , efficacy rate ,mucosal healing rate ,remission time and safety .The F test ,t test or Chi‐square test was performed for comparison among groups .Results The clinical complete remission rate of group A ,B and C was 20% (4/20) ,10% (2/20) and 10% (2/20) ,respectively .The clinical complete remission rate was 70% (14/20) ,65% (13/20) and 70% (14/20) ,respectively .The efficacy rate was 95% (19/20) ,85%(17/20) and 90% (18/20) ,respectively .The mucosal healing rate was 70% (14/20) ,60% (12/20) and 50% (10/20) ,respectively .The side effects rate was 20% (4/20) ,15% (3/20) and 20% (4/20) .There was no significant difference between groups (all P > 0 .05) .The remission time of group A and B was (15 .4 ± 3 .7) days and (15 .6 ± 2 .9) days ,which were both shorter than that of group C (18 .4 ± 3 .6) days ,and the differences were statistically significant (t= 2 .661 and 2 .710 ,both P< 0 .05) .There was no significant difference among three groups in gender ,disease course , severity , location and clinical remission rate of sub‐groups .Conclusions The efficacy and safety of mesalazine SR granules taking once daily or multi‐times daily are similar in the treatment of patients with mild to moderate active ulcerative colitis .Once daily have better compliance than other regimens .