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

作　　者：萨仁其木格 王青虎[1] 毕力格图 包文强 郝俊生 Sa-ren-qi-mu-ge;WANG Qing-hu;BI-Li-ge-tu;BAO Wen-qiang;HAO Jun-sheng(College of Traditional Mongolian Medicine,Inner Mongolia University for Nationalities,Tongliao 028000,China)

机构地区：[1]内蒙古民族大学蒙医药学院,通辽028000

出　　处：《药物分析杂志》2020年第6期1069-1075,共7页Chinese Journal of Pharmaceutical Analysis

基　　金：重点提升为国家级重点实验室平台能力建设项目(NMKJZX1702);内蒙古蒙医药标准化项目(MB017)。

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%(RSD1.7%),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。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.

关 键 词：阿给鼻炎喷雾剂 气相色谱 薄层色谱 桉油精 樟脑 龙脑 

分 类 号：R917[医药卫生—药物分析学]