文章摘要
顾晓风,沈心,姚玲.复方薄荷脑软膏的质量标准研究[J].中国药品标准,2023,24(1):
复方薄荷脑软膏的质量标准研究
Study on the quality standard of compound menthol ointment
投稿时间:2022-04-01  修订日期:2023-01-30
DOI:
中文关键词: 复方薄荷脑软膏  薄荷脑  樟脑  水杨酸甲酯  质量标准
英文关键词: Compound menthol ointment  Menthol  Camphor  Methyl salicylate  Quality standard
基金项目:
作者单位E-mail
顾晓风* 苏州市药品检验检测研究中心 645889151@qq.com 
沈心 苏州市药品检验检测研究中心  
姚玲 苏州市药品检验检测研究中心  
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中文摘要:
      目的:提高复方薄荷脑软膏的质量标准。方法:以HP-INNOWAX石英毛细管柱为色谱柱,程序升温,进样口温度200 ℃,检测器(FID)温度250 ℃。结果:样品在薄荷脑、樟脑、水杨酸甲酯、桉油精和α-蒎烯对照品相同保留时间处出现色谱峰;薄荷脑、樟脑和水杨酸甲酯的标准曲线呈良好的线性关系(r ≥ 0.9990),平均回收率分别为98.56%、99.27%、98.47%,RSD为1.64%、1.77%、2.34%(n = 9)。结论:该方法准确可靠,可行性强,能有效控制该制剂的质量。
英文摘要:
      Objective: To modify and improve the quality standard of compound menthol ointment. Methods: The capillary column was Agilent HP-INNOWAX, with temperature programmed. The inlet temperature was 200 ℃ and FID detector temperature was 250 ℃. Results: The test solution had peaks at the same retention time with menthol, camphor, methyl salicylate, eucalyptol and α-pinene. Menthol, camphor and methyl salicylate had good linear ranges (r ≥ 0.9990). The average recoveries were 98.56%, 99.27%, 98.47% and RSDs were 1.64%, 1.77%, 2.34% (n = 9) respectively. Conclusion: The method developed is accurate and reliable, which can be more effectively used in the quality control of compound menthol ointment.
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