中国药物警戒 ›› 2016, Vol. 13 ›› Issue (3): 146-147.

• 质量与工艺研究 • 上一篇    下一篇

他扎罗汀乳膏的制备及稳定性考察

邓建华1,2,杨红1,王福东2   

  1. 1 苏州大学医学部药学院,江苏 苏州 215123;
    2 江苏中丹制药有限公司,江苏 泰兴 224248
  • 收稿日期:2016-02-01 修回日期:2016-04-12 出版日期:2016-03-20 发布日期:2016-04-12
  • 通讯作者: 杨红,女,副教授,硕士生导师,药物新剂型与新技术研究。E-mail:yanghong@suda.edu.cn
  • 作者简介:邓建华,男,在读硕士,药品开发。

Study on the Preparation Process of Tazarotene Cream and Its Stability

DENG Jian-hua 1,2， YANG Hong 1，* WANG Fu-dong 2，   

  1. 1 .Pharmaceutical College of Soochow University, Jiangsu Suzhou 215123, China;
    2. Jiangsu Zhongdan Pharmaceutical Manufacture Co.Ltd, Jiangsu Taixing 224248, China
  • Received:2016-02-01 Revised:2016-04-12 Online:2016-03-20 Published:2016-04-12

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摘要： 目的 研究他扎罗汀乳膏的处方工艺及稳定性。方法 采用乳化法制备他扎罗汀乳膏,利用正交设计法优化他扎罗汀乳膏的处方,通过液相色谱法测定乳膏中他扎罗汀的含量。结果 确定了以卡波姆934、卡波姆1342、液状石蜡为稠度调节剂,司盘80为乳化剂,苯甲醇为防腐剂,依地酸二钠为螯合剂的乳膏处方。结论 他扎罗汀乳膏制备工艺简单、可行,制备的他扎罗汀乳膏色泽均匀、质地细腻、便于涂布、稳定性良好。

关键词: 他扎罗汀, 乳膏, 含量, 稳定性, 正交试验。

Abstract: Objective To study the preparation process of tazarotene cream and its stability. Methods Orthogonal design was used to optimize the formula of tazrotene cream. The determination of tazarotene was carried out by HPLC method. Results The optimal formulation contained carbomer 934P, carbomer 1342, liquid paraffin as consistency regulator, span-80 as asemulsifier, benzyl alcohol as preservatives, disodium edetate as sequestering agent. Conclusion The preparation process of tazarotene is simple and available, the quality and stability of the tazarotene cream is good.

Key words: tazarotene, cream, assay, stability, orthogonal experiment

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