盐酸阿奇霉素注射液的处方及制备工艺研究

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     黎 玲¹，王东凯¹，高 斐¹，庄 润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 研究盐酸阿奇霉素注射液的处方和制备工艺。方法 通过实验确定处方及工艺，采用HPLC法进行含量测定及有关物质检测。结果 盐酸阿奇霉素注射液的含量按外标法以峰面积计算在99%以上，按自身对照法测定有关物质小于4%。结论 盐酸阿奇霉素注射液的处方和工艺可行，质量稳定。

    关键词：药剂学；制备工艺；高效液相色谱法；盐酸阿奇霉素注射液

    中图分类号：R943 文献标识码：A

    Study on azithromycin hydrochloride injection

    LI Ling¹, WANG Dong-kai¹, GAO Fei¹, ZHUANG Run²

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

    Abstract：Objective To investigate the formulation and procedure for azithromycin hydrochloride injection. Method The formulation and the technology of azithromycin hydrochloride injection were optimized, HPLC method was used for te determination of relative substance. Results The content of azithromycin hydrochloride injection which was calculated by external standard method was more than 99% and the total relative substances which was determined by self-counterpoint was less than 4%. Conclusion Both the formulation and preparation procedure for azithromycin hydrochloride injection are feasible and its quality is stable.

    Key words：pharmaceutics; preparation process; HPLC; azithromycin hydrochloride injection

    http://www.100md.com/html/DirDu/2005/10/19/78/33/43.htm

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