医院制剂肺炎合剂质量控制的方法研究
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摘要
目的优化院内制剂肺炎合剂质量控制方法。方法采用薄层色谱(TLC)法对肺炎合剂处方中君药麻黄的主要活性成分盐酸麻黄碱进行定性鉴别;采用高效液相色谱(HPLC)法对肺炎合剂中的盐酸麻黄碱和盐酸伪麻黄碱进行含量测定。结果 TLC图谱中盐酸麻黄碱特征斑点清晰,阴性对照无干扰,专属性强;3批样品中盐酸麻黄碱含量分别为17.25、17.38、17.13μg/mL,盐酸伪麻黄碱含量分别为27.50、27.42、27.26μg/mL。结论该方法简便可行、重复性好,结果稳定、准确,适用于肺炎合剂质量控制。
Objective To optimize quality control methods of pneumonia mixture. Methods Ephedrine hydrochloride was identified by Thin Layer Chromatography(TLC). The contents of ephedrine hydrochloride and pseudoephedrine hydrochloride were determined by HPLC. Results The spots of ephedrine hydrochloride in TLC were clear without interference. The contents of the ephedrine hydrochloride in three batches of samples were 17.25, 17.38 and 17.13 μg/mL, and those of pseudoephedrine hydrochloride were 27.50, 27.42 and 27.26 μg/mL, respectively. Conclusion This method we described here was simple, reproducible, stable and accurate, and it can be used for quality control of pneumonia mixture.
Objective To optimize quality control methods of pneumonia mixture. Methods Ephedrine hydrochloride was identified by Thin Layer Chromatography(TLC). The contents of ephedrine hydrochloride and pseudoephedrine hydrochloride were determined by HPLC. Results The spots of ephedrine hydrochloride in TLC were clear without interference. The contents of the ephedrine hydrochloride in three batches of samples were 17.25, 17.38 and 17.13 μg/mL, and those of pseudoephedrine hydrochloride were 27.50, 27.42 and 27.26 μg/mL, respectively. Conclusion This method we described here was simple, reproducible, stable and accurate, and it can be used for quality control of pneumonia mixture.
引文
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[6] 木合塔尔·吐尔洪,楚刚辉,木尼热·阿不都克里木.新疆戈壁野生木贼麻黄中麻黄碱和盐酸伪麻黄碱含量的测定[J].南开大学学报(自然科学版),2016,49(5):74-78.
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[12] 张金花,刘陶世,程建明,等.多指标综合评分优选大孔树脂分离纯化三拗缓释片提取液工艺研究[J].中草药,2016,47(2):255-261.
[13] 徐飞鹤.高效液相色谱法测定消炎止咳片中盐酸麻黄碱的含量[J].中国医院药学杂志,2012,32(23):1931-1932.
[14] 刘永利,袁浩,李冬梅,等.双波长-高效液相色谱法同时测定镇咳宁糖浆中盐酸麻黄碱、甘草苷、甘草酸的含量[J].沈阳药科大学学报,2012,29(1):26-30.
[2] 杨昕宇,肖长芳,张凯熠,等.麻黄临床应用与药理作用研究进展[J].中华中医药学刊,2015,33(12):2874-2877.
[3] 涂发平,曹小平.麻黄碱预防异丙酚诱导时的血流动力学反应[J].川北医学院学报,2001,16(12):33-34.
[4] 国家药典委员会.中华人民共和国药典(四部)[S].北京:中国医药科技出版社,2015,73-74,77-78.
[5] 王玲,高晓黎.麻黄及其复方制剂中麻黄碱含量测定的研究进展[J].新疆医科大学学报,2016,29(10):1005-1007.
[6] 木合塔尔·吐尔洪,楚刚辉,木尼热·阿不都克里木.新疆戈壁野生木贼麻黄中麻黄碱和盐酸伪麻黄碱含量的测定[J].南开大学学报(自然科学版),2016,49(5):74-78.
[7] 国家药典委员会.中华人民共和国药典(一部)[S].北京:中国医药科技出版社,2015,320-321.
[8] 陈磊,李玉琴,逯海龙.高效液相色谱法同时测定感冒疏风颗粒盐酸麻黄碱、盐酸伪麻黄碱的含量[J].中国医院药学杂志,2012,32(10):807-808.
[9] MAKINO Y.Simple HPLC method for detection of trace ephed-rine and pseudoephedrine in high-purity methamphetamine[J].Biomed Chromatogr,2012,26(3):327-330.
[10] SHU X Y,TANG Y P,JING C X,et al.Comparative analysis of the main bioactive components of San-ao decoction and its series of formulations[J].Molecules,2012,17(11):12925-12937.
[11] 鲍慧玮,徐阳,刘芳馨.超滤法测定盐酸麻黄碱的血浆蛋白结合率[J].长春师范大学学报,2018,37(10):78-81.
[12] 张金花,刘陶世,程建明,等.多指标综合评分优选大孔树脂分离纯化三拗缓释片提取液工艺研究[J].中草药,2016,47(2):255-261.
[13] 徐飞鹤.高效液相色谱法测定消炎止咳片中盐酸麻黄碱的含量[J].中国医院药学杂志,2012,32(23):1931-1932.
[14] 刘永利,袁浩,李冬梅,等.双波长-高效液相色谱法同时测定镇咳宁糖浆中盐酸麻黄碱、甘草苷、甘草酸的含量[J].沈阳药科大学学报,2012,29(1):26-30.