阿奇霉素纳米晶体片剂的制备及其质量评价
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河北省人力资源和社会保障厅留学人员科技活动择优项目


Preparation and evaluation of tablets of azithromycin nanocrystals
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    摘要:

    以纳米晶体技术为基础制备阿奇霉素纳米晶体片剂,以期提高阿奇霉素的溶出度。采用介质研磨法制备阿奇霉素纳米晶体,在此基础上制备阿奇霉素纳米晶体片剂。参考《中华人民共和国药典》对其质量进行评价,采用浆法测定溶出度,HPLC法测定含量和有关物质。通过影响因素试验、加速试验及留样试验,考察片剂的稳定性。自制阿奇霉素纳米晶体片剂符合《中华人民共和国药典》2010版二部附录片剂项下要求,溶出度较上市片剂显著提高。影响因素试验结果表明,自制片剂对高温和强光较稳定,但对环境湿度较为敏感。加速试验及留样试验结果表明,自制片剂6个月内较为稳定,贮存时应置于密闭、干燥阴凉处。

    Abstract:

    In order to improve the dissolution of azithromycin, azithromycin nanocrystals tablets are studied based on the nanocrystal technology. The media milling method is employed to prepare azithromycin nanocrystals, from which azithromycin nanocrystals tablets are made. The quality of the tablets is evaluated referring to Chinese Pharmacopoeia, the dissolution rates are measured by paddle method, and the content and related substances are determined by HPLC. The stabilities are investigated by impact factors test, short-time test and retention samples test. The results show that the quality of the homemade tablets meets the requirements of tablets in Appendix of volume Ⅱ of Chinese Pharmacopoeia (2010), and their dissolution rates increases significantly compared with the reference preparations. Impact factors test indicates that the homemade tablets are stable in the condition of high temperature or strong light but sensitive to environmental humidity. Short-time test and retention samples test results show that the homemade tablets are stable within 6 months, so they should be sealed and stored in a cool dry place.

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戎欣玉,高 倩,陈 涛,王耀飞,安 培.阿奇霉素纳米晶体片剂的制备及其质量评价[J].河北科技大学学报,2015,36(6):606-612

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  • 收稿日期:2015-02-24
  • 最后修改日期:2015-06-01
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  • 在线发布日期: 2015-12-16
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