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刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nicpbp.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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基于对照制剂的抗宫炎片质量评价新模式的探讨

Discussion on a novel model for quality evaluation of Kanggongyan tablets based on reference drug

分类号:R917
出版年·卷·期(页码):2019,39 (10):1762-1770
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的:探讨抗宫炎片的质量评价新模式。方法:采用薄层色谱法对抗宫炎片进行全方药味鉴别研究,采用高效液相色谱法对方中广东紫珠、乌药进行含量测定以及指纹图谱相似度研究,并将对照制剂作为随行对照,对不同企业的抗宫炎片样品进行质量优劣评价。结果:5个生产企业18批样品中有7批的含量及相似度测定值均高于对照制剂测定值的90%,6批的去甲异波尔定含量低于拟定限度(1.12 mg·g-1),其他5批样品均符合拟定限度要求。结论:所建立的方法能更加全面地控制抗宫炎片的质量,并可对其质量优劣进行初评价,为进一步建立中成药质量评价新模式提供了示范和参考。

-----英文摘要:---------------------------------------------------------------------------------------

Objective: To explore a new quality evaluation model for Kanggongyan tablets. Methods: TLC was used to identify whole ingredients in Kanggongyan tablets,and HPLC was used to analyze the contents of Callicarpae Caulis et Folium and Linderae Radix,and the similarities of the fingerprints. With reference drug as the accompanying control,the quality of Kanggongyan tablets from different enterprises was evaluated. Results: According to the results of 18 samples from 5 manufactures by quality evaluation,the contents and similarities of 7 batches of samples were higher than 90% of those values of the reference drug. The contents of norisoboldine in 6 batches of samples failed the proposed limit (1.12 mg·g-1). The other 5 batches of samples met the proposed limit. Conclusion: The proposed method offers a more comprehensive approach for quality control of Kanggongyan tablets,and the quality of the product can be evaluated preliminarily. And it provides a model and reference for the further establishment of a new quality evaluation model of Chinese patent medicine.

-----参考文献:---------------------------------------------------------------------------------------

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