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Objective: To study the curative effect of ofloxacin ear drops combined with Bairui Granules on acute suppurative otitis media in children. Methods: A total of 186 pediatric patients with acute suppurative otitis media treated in Qinhuangdao City Chinese Medicine Hospital were divided into the treatment group and control group according to the random number table method. In the treatment group, 94 patient were treated with 0.3% ofloxacin ear drops combined with Bairui Granules. In the control group, children in the 92 cases only received ofloxacin ear drops (2-3 times a day, 6-10 drops each time; After ear dropping, taking 10 min ear bath). Each group was treated 7-10 d. The curative effect and adverse reactions were observed. Results: The total effective rate of the treatment group was 94.68% and the control group was 82.61%, there was a significant difference between the two groups. (P < 0.05). The improvement in symptom and physical scores of the treatment group was significantly better than that of the control group (P < 0.05). There was no significant difference in the incidence of adverse reactions between two groups. Conclusion: The ofloxacin ear drops can efficiently improve clinical symptoms of the patients with acute suppurative otitis media, and Bairui Granules have antipyretic and antiphlogistic effect. The combination of the two drugs had significant curative effect on acute suppurative otitis media in children with low adverse reactions incidence, so we conclude that it is worthy to be promoted.
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Objective:To developed an HPLC method for the simultaneous content determination of gatifloxacin dexamethasone ac-etate ear drops. Methods:The promising chromatographic separation was achieved on a Phenomenex C18 (250 mm × 4. 6 mm, 5 μm) column. Using gradient elution method, the optimized mobile phase consisted of methanol as the solvent A, and 0. 05% triethylamine solution (adjusting pH to 3. 0 with acetic acid) as the solvent B. The flow rate was 1. 0 ml·min-1, the column temperature was 30℃and the UV detection was carried out at 240 nm. Results: The compounds were separated well, the linearity between the peak areas and the concentrations was observed within the range of 1. 2-60. 0 mg·L-1 for gatifloxacin, and 0. 8-40. 0 mg·L-1 for dexamethasone acetate. The mean recovery of gatifloxacin and dexamethasone acetate was 101. 31% ( RSD =1. 17%) and 99. 71% ( RSD =1. 01%) , respectively. Conclusion: The method is specific and stable in the determination of gatifloxacin dexamethasone acetate ear drops.
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OBJECTIVE: To improve the preparative method of boric acid ear drops.METHODS: Boric acid ear drops were prepared using ultrasonic wave rather than waterbath heating to accelerate the solution of boric acid,and a comparison was conducted between the ultrasonic method and the waterbath heating method.RESULTS: The prepared boric acid ear drops were colorless supernatant liquid,which met the standard stated by the "Stipulations of clinical preparations in Zhejiang Province" in tests,identification and content.By ultrasonic method,the time spent for preparing boric acid ear drops was shorter(29?4.2) min than by waterbath heating method(18?1.4) min.CONCLUSION: The improved preparative method for boric acid ear drops is simple and feasible and the quality of the preparation is stable and controllable.
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OBJECTIVE:To develop a HPLC method for simultaneous determinatio n of ofloxacin and dexamethasone ac?etate in compound ofloxacin ear drops.METHODS:The analysis was carried on a XDB-C 8 ,the mobile phase was composed of methanol-potassium dihydrogen phosphate(0.02mol/L)by gradient elution,the flow rate was1.0ml/min,the column tem?perature was30℃and the detection wavelength was at240nm.RESULTS:The detectable concentrations of ofloxacin and dexamethasone acetate showed good linear correlation in the ranges of100～500?g/ml and10～30?g/ml respectively,the av?erage recoveries of ofloxacin and dexamethasone acetate were100.6%(RSD=0.46%,n=9)and101.3%(RSD=0.72%,n=9)respectively.CONCLUSION:The method is accurate and reproducible and can be used for determination of ofloxacin and dexamethasone acetate in compound ofloxacin ear drops.
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OBJECTIVE:To establish a New Vierordt method for assaying ingredients in compound fleroxacin suppositories and compound fleroxacin ear drops METHODS:New Vierordt method was applied to determination of fleroxacin and tinidazole in compound fleroxacin suppositories and fleroxacin and metronidazole in compound fleroxacin ear drops with no need of separation RESULTS:The fleroxacin and tinidazole in compound fleroxacin suppositories were detected at wavelength 286nm and 317nm respectively The average recoveries were 100 17% and 99 96% with RSDs=0 44% and 0 37% respectively The fleroxacin and metronidazole in the compound fleroxacin ear drops were detected at wavelength 286nm and 318nm respectively The average recoueries were 100 65% and 99 92% with RSDs=0 65% and 0 21% respectively CONCLUSION:The New Vierordt method can be used for quality control of the two compound preparations because of its convenience,accuracy and good repeatability and can eliminate mutual interference of two ingredients in preparations
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OBJECTIVE:To study the quality control,stability and therapeutic effect of compound fleroxacin ear-drops.ME_THODS:The content of fleroxacin in the ear-drops was determined by ultraviolet spectrophotometry.RESULTS:There was a good linearity in a range of concentrations from 2?g/ml to 12?g/ml,r=0.9 998,average rate of recovery was 100.38%,RSD=0.39%(n=6).The preparation showed stable quality and satisfactory effect.CONCLUSION:This ear-drops is simple in preparation,reliable in quality-control and effective in clinical use.
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OBJECTIVE:To prepare the compound chlorhexidine acetate ear drops for treating anaerobic and aerobic infections of antrum auris METHODS:The compound chlorhexidine acetate ear drops was prepared with mixed solvent of glycerin,alcohol and distilled water The contents of two main ingredients were determined by dual-wavelength isobestic point spectrophotometry and the stability of preparation was examined RESULTS:The average recovery of metronidazole was 99 34%(RSD=0 57%,n=6) and that of chlorhexidine acetate was 101 17%(RSD=0 88%,n=6) CONCLUSION:The new preparation is rational in formula,simple in quality control and good in stability and has good prospects in development
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OBJECTIVE:To prepare levofloxacin hydrochloride ear drops METHODS:The content of levofloxacin hydrochloride was determined with UV-spectrophotometry RESULTS:The linearity range was 2～10?g/ml with a regression equation of A=1 83?10-3+0 07 415C and r=0 9 991(n=5) The average recovery was (98 74?0 51)% CONCLUSION:The UV-spectrophotometry method is simple,rapid and accurate and the preparation is powerful in antibacterial action and stable in quality
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OBJECTIVE:To establish the preparation process and method of quality control of econazole nitrate ear-drops.METHODS:With mixture of glycerin and 75% alcohol as solvent,econazole nitrate ear-drops was prepared and the content of econazole was determined by ultraviolet spectrophotometry.The stability,irritation and in vitro antimicrobial tests were carried out.RESULTS:There was a good linearity of calibration curve of econazole in range of 200～600?g/ml,r=0.9 999,the average recovery was 100.76%,RSD=0.82%(n=5).The in vitro antimycotic MICs of econazole nitrate in ear-drops were 2?g/ml and 4?g/ml against standard and clinically isolated strains of Candida albicans respectively.CONCLUSION:The ear-drops is simple in preparation,effective in antimycotic action,good in stability and slight in irritability,and the method of quality control is simple,rapid and accurate.