地西泮-布洛芬栓制备及质量标准研究

目的: 制备地西泮-布洛芬栓,并进行质量控制;建立地西泮及布洛芬含量测定的HPLC方法。 方法: 以混合脂肪酸甘油酯为基质制备地西泮-布洛芬栓,按照2010年版中国药典标准进行质量控制。地西泮及布洛芬含量测定色谱条件为:采用Shim-pack VP-ODS(150 mm×4.6 mm,5 μm)色谱柱;流动相为乙腈-pH 2.5醋酸缓冲液(65:35);流速1 mL·min^-1;检测波长263 nm;柱温25℃。 结果: 栓剂的重量差异、融变时限均符合中国药典标准。 结论: 栓剂的制备方法简单易行,质量控制方法可靠。

Objective: To prepare and control the quality of diazepam-ibuprofen suppository,and establish the HPLC method for the determination of diazepam and ibuprofen. Methods: The mixed fatty acid glyceride was used as the matrix of diazepam-buprofen suppository,according to the Chinese Pharmacopoeia 2010 standards for quality control.The chromatographic conditions of diazepam and ibuprofen for quantitative determination were as follows:the Shim-pack VP-ODS(150 mm×4.6 mm,5 μm)column was used in the chromatographic process;the mobile phase was acetonitrile-pH2.5 acetate buffer(65: 35),the flow rate was 1 mL·min^-1;the detective wavelength was 263 nm;the column temperature was 25℃. Results: Suppository weight differences,melting time were in line with the Chinese Pharmacopoeia standard. Conclusion: The preparation method is easy to operate,and the quality control method is reliable.

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