利福平水溶液的稳定性考察

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     薛梅妍¹，王东凯¹，高 红¹，纪 标¹, 李丹丹¹，徐 飒²

    (1. 沈阳药科大学 药学院 辽宁 沈阳 110016； 2. 沈阳沃森药物研究所 辽宁 沈阳 110016)

    摘要 目的 通过利福平水溶液稳定的pH测定，优化利福平输液处方及制备工艺。方法 针对影响利福平水溶液稳定性的因素，分别对溶液pH值和抗氧剂进行考察，并进行处方优化。采用加速试验考察物理稳定性。结果 取利福平1.2 g、甲醛合次硫酸氢钠0.3 g、抗坏血酸钠0.3 g、枸橼酸钠0.07 g、赖氨酸0.10 g、丙二醇15 mL，注射用水加至1 000 mL，可得到稳定的利福平水溶液。利福平水溶液稳定pH值为6.0～7.0。结论 溶液的pH值和抗氧剂的抗氧化作用是利福平水溶液长期稳定的主要因素。

    关键词： 药剂学；药物稳定性；pH值；利福平水溶液；抗氧剂

    中图分类号：R94 文献标识码：A

    contents

    Study on the stability of rifampicin solution

    XUE Mei-yan¹, WANG Dong-kai¹, GAO Hong¹, JI Biao¹, LI Dan-dan¹, XU Sa²

    (1. School of Pharmacy， Shenyang Pharmaceutical University， Shenyang 110016，china 2. Shenyang Watson Pharmaceutical Institute， Shenyang 110016， China)

    Abstract：Objective To study the appropriate pH for rifampicin solution and choose the optimal formulation of rifampicin solution. Methods According to the factors that affect the stability of rifampicin solution, pH and antioxidant were studied. The physical stability was studied using accelerated experiment. Results The appropriate pH of rifampicin solution was 6.0-7.0. The optimum formulation was consisted of rifampicin 1.2 g, sodium formaldehyde sulfoxylate 0.3 g, sodium ascorbate 0.3 g, sodium citrate 0.079 g, lysine 0.10 g, propylene glycol 15 mL, adding purified water to 1 000 mL. Conclusions pH and the antioxidants are the main factors affected stability of rifampicin solution.

    Key words: pharmaceutics; drug stability; drug pH; rifampicin solution; antioxidant

    http://www.100md.com/html/DirDu/2006/07/19/12/01/91.htm

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