奥硝唑片与参比制剂在不同介质中溶出曲线的对比研究

A Comparative Study on Dissolution Curves of Ornidazole Tablets and Reference Preparations in Different Dissolution Mediums

目的通过测定奥硝唑片在4种溶出介质中的溶出曲线,并与参比制剂的溶出曲线进行对比,为全面评价该药品体外溶出提供参考数据。方法采用高效液相色谱法,YMC-C_(18)色谱柱(4.6 mm×150 mm,5μm),以甲醇-水(30∶70)为流动相,流速为1.0 mL·min^(-1),检测波长为318 nm,柱温为30℃;溶出度试验采用浆法,转速为50 r·min^(-1),以pH 1.0盐酸溶液、pH 4.5缓冲液、pH 6.8缓冲液和水为溶出介质,采用高效液相色谱法测定平均累积溶出量绘制多条溶出曲线,并采用f_(2)因子法计算相似度。结果被测奥硝唑片与参比制剂具备相似的体外溶出行为。结论建立了该品种在不同介质中溶出曲线的测定方法。

OBJECTIVE To determine the dissolution curves of ornidazole tablets in four dissolution mediums,and compared with the reference preparations,which could provide reference data for a comprehensive evaluation of in vitro dissolution of ornidazole tablets.METHODS YMC-C_(18) column(4.6 mm×150 mm,5μm)was adopted and the mobile phase was methanol/water with volume ratio of 30∶70,which the flow rate was 1.0 mL·min^(-1).The detection wavelength was 318 nm,and the column temperature was 30℃.The paddle method was adopted at 50 r·min^(-1),and pH 1.0 hydrochloric acid solution,pH 4.5 buffer solution,pH 6.8 buffer solution and water were used as dissolution mediums.Multiple dissolution curves were drawn by average cumulative dissolution with HPLC,and the similarity degree was calculated by f_(2) factor.RESULTS The dissolution behaviors of ornidazole tablets were similar to those of the reference preparations in vitro.CONCLUSION A method for determining the dissolution curves of the variety in different mediums was established.