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甲硝唑口服液剂型的研发

The development of oral liquid dosage forms of metronidazole.

作者信息

Mathew M, Das Gupta V, Bethea C

机构信息

Department of Pharmaceutics, University of Houston, TX 77030.

出版信息

J Clin Pharm Ther. 1993 Aug;18(4):291-4. doi: 10.1111/j.1365-2710.1993.tb00590.x.

Abstract

The stability of eight samples of metronidazole in aqueous vehicles was studied using a modified HPLC assay method. The samples were prepared using either metronidazole powder (5 mg/ml), metronidazole hydrochloride injection powder (10 mg/ml), or metronidazole powdered tablets (10 mg/ml). The samples prepared using metronidazole hydrochloride powder were stable and clear for at least 133 days at 25 degrees C. Their pH values were between 1.8 and 2.0. The samples prepared from metronidazole powder had pH values close to neutral and were stable for at least 45 days at room temperature (25 degrees C). However, to keep the drug in solution, the concentration of metronidazole powder was reduced to 5 mg/ml. The powdered tablets did not yield good uniform suspensions.

摘要

采用改良的高效液相色谱分析方法研究了甲硝唑在水性载体中的八个样品的稳定性。样品制备分别使用甲硝唑粉末(5毫克/毫升)、盐酸甲硝唑注射液粉末(10毫克/毫升)或甲硝唑片剂粉末(10毫克/毫升)。用盐酸甲硝唑粉末制备的样品在25℃下至少133天稳定且澄清。其pH值在1.8至2.0之间。由甲硝唑粉末制备的样品pH值接近中性,在室温(25℃)下至少45天稳定。然而,为使药物保持在溶液中,甲硝唑粉末的浓度降至5毫克/毫升。片剂粉末未产生良好的均匀悬浮液。

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