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复方薄荷脑滴鼻液质量控制方法的改进 被引量:4

Improvement in Quality Control Method of Compound Menthol Nasal Drops
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摘要 目的:采用气相色谱-质谱法(GC-MS)对我院复方薄荷脑滴鼻液中薄荷脑及樟脑的定量测定方法进行补充,完善其质量控制标准。方法:以DB-5(0.25 mm×30 m)弹性石英毛细管柱为色谱柱;萘为内标;初始温度80℃,恒温2 min,再以30℃/min的速率升温至150℃,维持6 min后结束;选择离子的m/z为95、71、128分别对樟脑、薄荷脑、萘进行检测。结果:樟脑的浓度线性范围为10.40~104.0μg/ml(r=0.997 9),平均加样回收率为99.67%;薄荷脑的浓度线性范围为10.32~103.2μg/ml(r=0.997 3),平均加样回收率为99.86%。结论:本测定方法快速、灵敏、准确、重现性好,可用于复方薄荷脑滴鼻液的质量控制。 OBJECTIVE:To improve the quality control standard compound menthol nasal drops by applying gas chromatography-mass spectrometry (GC-MS) as a complement for quantitative determination of menthol and camphor in compound menthol nasal drops. METHODS: The chromatographic column was DB-5 elastic fused silica capillary column (0. 25 mm × 30 m) with naphthalene used as the internal standard. The initial column temperature was maintained at 80℃ for 2 min then it increased to 150℃ (maintained for 6 min) at an increasing speed of 30℃/min. The selected ions in the detection of camphor, menthol and naphthalene were m/z 95, m/z 71 and m/z 128,respectively. RESULTS: The calibration curves of camphor and menthol were linear in the ranges of 10. 40-104. 0 μg/ml( r = 0. 997 9) and 10.32-103.2 μg/ml ( r = 0. 997 3 ) with recovery rates of 99.67% and 99.86%, respectively. CONCLUSION: The method is rapid, sensitive, accurate and reproducible, and it is applicable for the quality control of compound menthol nasal drops.
出处 《中国医院用药评价与分析》 2013年第7期628-630,共3页 Evaluation and Analysis of Drug-use in Hospitals of China
关键词 气相色谱-质谱法 复方薄荷脑滴鼻液 樟脑 薄荷脑 质量控制 GC-MS Compound menthol nasal drops Camphor Menthol Quality control
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