RESUMEN
Objective To compare the dissolution curves of metronidazole tablets from 38 national manufactures and original drugs of Britain in four dissolution mediums,and provide the reference for the quality and clinical effect consistency evaluation of metronidazole tablets.Methods Paddle method was adopted at 50 r · min-1 in four dissolution mediums with the volume of 900 mL.The dissolution profiles were determined by ultraviolet spectrophotometry.The cumulative dissolution percentages were calculated and the dissolution curves were drawn.Similarity factor (f2)was used for comparing of the differences between dissolution curves.Results The dissolution profiles of 4 manufactures in pH 1.2 and 9 manufactures in pH 4.5 were similar (f2 ≥ 50)to that of original drugs,only 1 and 3 were similar to original drugs in water and pH 6.8,respectively.There are no companies whose dissolution curve were similar to that of original drugs in 4 dissolution mediums.Conclusion Great difference exists between domestic manufactures and pharmaceutical enterprises of origin in dissolution behaviors of metronidazole tablets.In order to ensure the consistency between the metronidazole tablets generics and original drugs of Britain in quality and clinical effect.It is advisable for the relevant companies to improve their product quality by improving the formulation and preparation.
RESUMEN
Objective To observe the clinical efficacy of metronidazole tablets combined with sophora gel in treatment of bacterial vaginitis ( BV) . Methods Eighty-seven cases of BV patients were randomly divided into the study group(45cases) and the control group(42cases).The control group was given metronidazole tablets (400 mg, two times a day), oral for seven days, while the study group was given sophora gel (vaginal implantation) on the basis of control group.Seven days as a course of treatment.Pared the leukocyte esterase test positive rate in vaginal fluid and the recurrence rate within a year of the two groups before and after treatment.ResuIts After 7 days’treatment, the positive rate of leukocyte esterase (LE) in two groups were all significantly declined, which was more significant in the study group (P<0.05);the total effective rate of the study group was 95.6%, which was significantly higher than that of the control group 78.6%(P<0.05).The recurrence rate within a year of the study group was 6.7%, which was significantly lower than that of the control group 26.2%( P<0.05 ) .ConcIusion The therapy of metronidazole tablets combined with sophora gel in treating BV can significantly decline the LE positive rate and recurrence rate, and improve the clinical curative efficacy as well.
RESUMEN
OBEJECTIVE:To establish a rapid and exclusive method for the identification of metronidazole tablets.METHODS:The infrared spectrophotometry was adopted,in which the recrystallization was carried out with the dehydrated alcohol as the solvent and with the highly pure potassium bromide tabletting as the infrared absorption spectrum.RESULTS:The infrared absorption spectrum of the metronidazole tablets was completely in conformity with that of the control substance and the standard spectrum of metronidazole issued in Infrared Spectrum Album of Drugs by State Pharmacopoeia Committee.CONCLUSION:This method is specific,fast and accurate,which can be used for the identification of metronidazole prepa-rations.