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《China Pharmaceuticals》 2018-18
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Study on Prescription Optimization and Quality Standard of Compound Chloramphenicol Cream

Yu Ji;Lin Cai;Sun Hongwu;Yang Qinjun;Department of Pharmacy,The First Affiliated Hospital of Army Medical University;National Engineering Research Center for Immunological Products and Department of Microbiology and Biochemistry,Department of Pharmacy,Army Medical University;  
Objective To optimize the prescription of the Compound Chloramphenicol Cream and establish its quality standard method. Methods The appearance,particle size and stability of the cream were investigated to optimize the prescription. The content of metronidazole and chloramphenicol in the cream was determined by HPLC,the chromatographic column was C18 column( 150 mm × 4. 6 mm,5 μm),the mobile phase was ethanol-water( 35 ∶ 65),the detection wavelength was 280 nm,the flow rate was 1. 0 m L/min,the column temperature was 30 ℃,and the sample size was 10 μL. Results The stability and particle size of Compound Chloramphenicol Cream prepared according to No. 5 prescription was the best. The concentration of metronidazole in the cream showed a good linear relationship with the peak area in the range of 40. 40-64. 64 μg/m L,the recovery rate was 99. 68%,RSD was 1. 83%( n = 9). The concentration of chloramphenicol in the cream showed a good linear relationship with the peak area in the range of 40. 40-64. 64 μg/m L,the recovery rate was 99. 50%,RSD was 1. 87%( n = 9). Conclusion The optimization prescription of the Compound Chloramphenicol Cream is No. 5 prescription. The established content determination method is simple,rapid,accurate and reliable with good separation,which can be used for simultaneous determination of metronidazole and chloramphenicol.
【Fund】: 国家自然科学基金面上项目[31670938];; 重庆市自然科学基金项目[cstc2014jcyj A10107]
【CateGory Index】: R943
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