ABSTRACT
The goal of the current study is to develop and validate a new chromatographic method for Fosfomycin Trometamol's determination in both pure form and pharmaceutical formulation. In the present study, a pre chromatographic derivatization of Fosfomycin Trometamol was done by forming an ion-pair complex of Heterocyclic nitrogen using the acidic dye methyl orange and phthalate buffer of pH-6. The yellow ion-pair complex was extracted with chloroform and it was further extracted with aqueous solution of 0.01M HCL. The ion-pair complex of Fosfomycin Trometamol and methyl orange obeyed Beer's law in the range of 30 -70 ?g/ml with a correlation coefficient (r2) of 0.9946. A Liquid chromatography system equipped with an Agilent ACE C18 column (250 X 4.6mm, 5?m) was used as a stationary phase in this work. The developed method was validated according to ICH guidelines. For determining the medication in bulk and formulation, the devised approach was proven to be accurate, sensitive, and repeatable
ABSTRACT
Objective To analyze the clinical value of Guizhi Fuling capsules combined with fosfomycin trometamol power in the treatment of pelvic inflammatory disease and pelvic effusion.Methods A total of 60 patients with pelvic inflammatory disease and pelvic effusion from February 2013 to March 2016 in our hospital were selected and divided into the control group and the observation group , 30 cases in each group.The control group were treated with fosfomycin trometamol power, and the observation group were additionally treated with Guizhi Fuling capsules.The therapeutic effects and changes of TCM syndrome scores were compared between the two groups.The levels of serum C reactive protein ( CRP ) in the two groups were determined before and after treatment and the ultrasound examination was performed and changes of pelvic effusion diameter was determined before and after treatment.Results The total effective rate of the observation group was higher than that of the control group, the difference was statistically significant (P<0.05).There was no significant difference in TCM syndrome scores between the two groups before treatment .After treatment, the TCM symptom scores of both groups were decreased, the difference was statistically significant ( P<0.05 ) .The scores of lumbosacral swelling pain, abdominal pain, morbid leucorrhoea increase, fatigue, low-grade fever and soreness of waist in the observation group were lower than those in the control group, the difference was statistically significant (P<0.05).Before treatment, there was no statistically significant difference in pelvic effusion and CRP levels between the two groups.After treatment, the pelvic effusion diameter and CRP levels were decreased, the difference was statistically significant (P<0.05), and those in the observation group were lower than the control group, the difference was statistically significant (P<0.05). Conclusion Guizhi Fuling capsules combined with the fosfomycin trometamol power is significantly effective in the treatment of pelvic inflammatory disease and pelvic effusion.It can significantly reduce the inflammatory reactions of patients, and improve the TCM syndrome scores.
ABSTRACT
Objective to investigate a new synthesis for the preparation of fosfomycin tromethamine and to seek for the opti‐mized process and crystallization conditions .Methods An inorganic method ,utilizing in situ generated tromethamine bisulfate to re‐act with fosfomycin sodium was used to gain fosfomycin tromethamine .Results After the optimization of reaction and crystalliza‐tion condition ,it can produce fosfomycin tromethamine .Conclusion Inorganic acid salt synthesis technology is feasible with high yield .
ABSTRACT
Objective To evaluate the efficacy and safety of Fosfomycin trometamol(FMT)versus Norfloxacin(FPA)in elderly diabetic patients with acute urological tract infections.Methods From Jan.2012 to Mar.2013,eighty-six patients with uncomplicated and complicated urinary tract infection were randomized into FMT group(n =43)and FPA group(n =43).Patients in both groups were balanced with regard to baseline urinary tract symptoms,fever,leukocytosis,positive urinary culture and disease type(P＞0.05).Patients received FMT 3 g daily and Norfloxacin 0.4 g twice daily for a week.Extended treatment was given to 35 patients not cured within a week.Total treatment course should not exceed two weeks.Patient's symptoms,signs,complete blood count,urinalysis,urine culture,pharmacological sensitivity tests,renal and liver function tests were performed.Results After one week of FMT treatment,28(65.1％)cases were cured and 10 cases were improved(1 was with abnormal urinalysis,9 had positive urine culture).In total,in 38(88.4％)patients treatment was as effective;In FPA group,23(53.5％)were cured and 7 cases were improved(7 had positive urine culture).In total,there were 30(69.8％)patients classified as effective.Difference was statistically significant(P＜0.05 =.After 2 weeks of FMT treatment,38(88.4％)cases were cured and 2 patients were improved(1 was with abnormal urinalysis,1 had positive urine culture).In total,40(93.0％)patients were classified as effective.In FPA group,25(58.1％)cases were cured and in 8 patients were improved(8 had positive urine culture).In total,there were 33(76.7％)patients classified as effective;Difference was statistically significant(P＜0.05 =.Bacterial clearance rate in FMT and FPA group was 88.9％ and 72.7％,respectively.Difference was statistically significant(P＜0.05 =.The adverse reaction rates were 9.3％ and 14.0％,respectively.Difference was not statistically significant(P＞0.05).Conclusions FMT is an effective and safe antibiotic in the treatment of urinary tract infections in elderly diabetic patients.