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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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蒙药阿给鼻炎喷雾剂的质量标准研究

Study on standard of Mongolia medicine Agei rhinitis spray

分类号:R917
出版年·卷·期(页码):2020,40 (6):1069-1075
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的: 研究阿给鼻炎喷雾剂的质量控制方法。方法: 对不同批号阿给鼻炎喷雾剂进行TLC鉴别,并以茴香醛为内标物,采用GC内标法测定其中桉油精、樟脑和龙脑的含量。结果: 阿给鼻炎喷雾剂薄层鉴别斑点清晰,重复性好,易于鉴别;在选择的GC色谱条件下,桉油精、樟脑和龙脑的校准曲线表现出良好的线性关系(r>0.999 7),其平均回收率分别为97.7%(RSD 1.2%)、97.0%(RSD 1.8%)和96.6%(RSD 1.7%),不同批号阿给鼻炎喷雾剂中桉油精、樟脑和龙脑平均含量范围分别为1.03~1.19,1.86~2.07和0.65~0.87 mg·g-1结论: 建立了阿给鼻炎喷雾剂质量控制方法,为综合评价该药品质量提供依据。

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

Objective: To develop the quality control method for Agei rhinitis spray. Methods: Different batches of Agei spray were identified by TLC. And eucalyptol,camphor and borneol were determined by GC with anisaldehyde as the internal standard. Results: The TLC spots of Agei rhinitis spray were clear and easy to be identified. All calibration curves exhibited good linearity(r>0.999 7)in a relatively wide concentration range. The recoveries of eucalyptol,camphor and borneol were 97.7%(RSD=1.2%),97.0%(RSD=1.8%)and 96.6%(RSD=1.7%),respectively. The content ranges of eucalyptol,camphor and borneol in different batches of Agei spray were 1.03-1.19,1.86-2.07 and 0.65-0.87 mg·g-1,respectively. Conclusion: The quality control methods for Agei rhinitis spray were established for quality control of Agei rhinitis spray.

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