复方甲硝唑泡腾栓的制备及质量控制

目的 制备复方甲硝唑泡腾栓并建立质量标准.方法 以甲硝唑、诺氟沙星、醋酸泼尼松为王药制备复万甲硝唑泡腾栓,对其进行性状、重量差异、融变时限、发泡量、卫生学检查,并采用高效液相色谱法测定甲硝唑和诺氟沙星的含量,色谱条件为:色谱柱:Kromasil C18色谱柱(250 mm×4.6 mm,5 μm)；流动相:乙腈-0.03 mol·L-1磷酸溶液(用三乙胺调节pH 3.0)(15∶85),流速:1.0 mL·min-1；柱温:30℃；检测波长:278 nm.结果 所制栓剂的鉴别、检查等结果均符合中国药典2010年版二部相应规定；甲硝唑和诺氟沙星检测浓度线性范围分别为32～160μg·mL1(r=0.999 9)、16～80 μg·mL-1(r=0.999 8)；平均回收率分别为97.4％ (RSD=1.4％),97.3％ (RSD=0.87％).结论 该制备工艺简单,含量测定方法操作简便,结果准确可靠,可用于复方甲硝唑泡腾栓的质量控制.

Preparation and quality control of compound metronidazole effervescent suppository

Objective To prepare compound metronidazole effervescent suppository,and to establish its quality control standard. Methods Compound metronidazole effervescent suppository was prepared with metronidazole,norfloxacin,and prednisone acetate as the main components.Their character,weight variation,melting time,foaming output and hygiene inspection were examined.The content of metronidazole and norfloxacin was determined by HPLC.Kromasil C18 column was used(250 mm×4.6 mm,5 μm) with acetonitrile-0.03 mol·L-1 orthophosphoric acid solution(pH adjusted 3.0 by triethylamine)(15∶85) as the mobile phase.The flow rate was 1.0 mL·min-1.The detection wavelength was 278 nm,and the column temperature was 30 ℃. Results The identification and examination of preparation were in line with the standards in Chinese Pharmacopeia(2010 Editon).The linear range of the metronidazole and norfloxacin was 32-160(r=0.999 9) and 16-80 μg·mL-1(r=0.999 8),respectively.The average recovery of metronidazole and norfloxacin was 97.4%(RSD=1.4%) and 97.3%(RSD=0.87%),respectively. Conclusion The preparation technique is simple,and the determination method is simple and accurate,which can be used for the quality control of compound metronidazole effervescent suppository.