美他多辛栓剂的制备及含量测定

Preparation and content determination of metadoxine suppository

目的：探讨美他多辛栓剂的制备过程及其含量测定方法。方法：以美他多辛为主药制备栓剂,采用HPLC法测定栓剂中美他多辛的含量。色谱条件如下：Gemini 5U-C18色谱柱（250mm×4.6mm,5μm）;柱温：35℃;流动相：乙腈-0.1%磷酸溶液（1∶99）;流速：1ml/min;检测波长：205nm。结果：制备的美他多辛栓剂为米黄色圆锥形固体。美他多辛在20.2~101μg/ml浓度范围内呈良好线性关系,标准曲线方程为A=56.83 c＋47.88（r=0.999 9）。低、中、高3种浓度（40.4、60.6、80.8μg/ml）美他多辛的加样回收率分别为（99.97±0.032）%、（99.91±0.076）%和（99.86±0.046）%（n=3）。结论：本研究建立的栓剂制备方法可行,含量测定方法可用于美他多辛栓剂的研究。

Objective： To investigate the preparation process and to determine the content of metadoxine suppository. Methods：Suppositories were prepared with metadoxine as the main component. The content of metadoxine in the suppository was determined by HPLC method. The HPLC method was applied on a Gemini 5U-C18 column（250 mm × 4. 6 mm, 5 μm）, at 35 ℃ column temperature,with the mobile phase consisting of acetonitrile-0.1% phosphoric acid solution（1 ： 99）, flow rate of 1 ml/min and the detection wavelength of 205 nm. Results： The prepared metadoxine suppository was an ecru conical solid. Metadoxine presented good linearity in the range of 20.2-101 μg/ml. The standard curve equation was A=56.83 c＋47.88（r= 0. 999 9）. The recovery rates of low, medium and high concentrations（40. 4,60. 6,80. 8 μg/ml） of metadoxine were （99. 97 ± 0. 032） %, （99.91 ± 0. 076）% and （99.86 ± 0. 046）% （n = 3）, respectively. Conclusion： The method established by this research for suppository preparation is feasible, and the content determination method could be used for the study of metadoxine suppository.