孟鲁司特钠口腔崩解片的百分含量测定
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摘要
对孟鲁司特钠口腔崩解片中孟鲁司特钠的百分含量进行测定,建立该制剂的质量控制方法.采用HPLC法,色谱柱为C18柱;以三氟乙酸-乙腈-水(1∶200∶300)为流动相;以220 nm为检测波长;柱温为室温;流速为1 m L/min;进样量为20μL.孟鲁司特钠在0. 05～0. 4 mg/m L范围内质量浓度与峰面积呈现良好的线性关系,回归方程为y=880. 7x+11. 55,r=0. 999 9(n=5),平均回收率为99. 6%,RSD为2. 5%.该法操作简单,重复性良好,结果准确,为孟鲁司特钠口腔崩解片的质量控制提供了基础.
To determine the content of montelukast sodium in the oral tablets of montelukast orally disintegrating tablets and establish the quality control method of the preparation. The HPLC method was used. The column was a phenyl column( C18 column). The detection wavelength was at 220 nm with trifluoroacetic acid-acetonitrile-water( 1∶ 200∶ 300). The flow rate was 1 m L/min. Montelukast in the range of 0. 05 ～ 0. 4 mg/m L showed a good linear relationship( r = 0. 999 9). The average was 99. 6% and RSD was 2. 5%. The HPLC method was accurate and reliable,and can be used for the quality control method of the preparation.
To determine the content of montelukast sodium in the oral tablets of montelukast orally disintegrating tablets and establish the quality control method of the preparation. The HPLC method was used. The column was a phenyl column( C18 column). The detection wavelength was at 220 nm with trifluoroacetic acid-acetonitrile-water( 1∶ 200∶ 300). The flow rate was 1 m L/min. Montelukast in the range of 0. 05 ～ 0. 4 mg/m L showed a good linear relationship( r = 0. 999 9). The average was 99. 6% and RSD was 2. 5%. The HPLC method was accurate and reliable,and can be used for the quality control method of the preparation.
引文
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[14] SALVI S S,KRISHNA M T,SAMPSON A P,et al. The antiinflammatory effects of leukotriene-modifying drugs and their use in asthma[J]. Chest,2001,119(5):1533.
[15] CHENG H,LEFF J A,AMIN R,et al. Pharmacokinetics,bioavailability,and safety of montelukast sodium(MK-0476)in healthy males and females[J]. Pharm Res,1996,13(3):445.
[2]李红燕,隆红艳.儿童咳嗽变异性哮喘气道炎症研究[J].长春中医药大学学报,2015,31(2):414-417.
[3]桂莹,李晓岚.儿童咳嗽变异性哮喘与反复肺炎支原体感染的相关性研究[J].临床肺科杂志,2017,22(2):276-279.
[4]冯莹.孟鲁司特钠制剂及及质量控制研究[D].郑州:河南大学,2012.
[5]石云峰,林丽琴. HPLC法测定孟鲁司特钠含量与有关物质[J].药物分析杂志,2013,33(2):308-311.
[6]李华伟,寇会波,郭栓青.孟鲁司特钠治疗小儿哮喘临床效果、复发及不良反应研究[J].河北医药,2016,38(6):881-883.
[7]魏延,李东升,刘建军,等.孟鲁司特钠联合布地奈德治疗儿童咳嗽变异性哮喘疗效和安全性的Meta分析[J].中国当代儿科杂志,2016,18(11):1100-1105.
[8]王培养.孟鲁司特钠联合沙美特罗替卡松治疗小儿支气管哮喘急性发作临床效果及对免疫因子的影响[J].中国妇幼保健,2016,31(22):4758-4760.
[9]江平,李万锋.孟鲁司特钠在儿科哮喘治疗中的临床应用研究[J].中国继续医学教育,2018(29):148-150.
[10]宋素珍.孟鲁司特钠在小儿喘息性肺炎中的临床应用探讨[J].基层医学论坛,2018,34(22):4922-4923.
[11]叶蓉,尹同进,叶巍岭.国产孟鲁司特钠早期应用对患儿急性呼吸道感染后咳嗽的影响[J].中华医院感染学杂志,2018,28(22):3494-3496,3520.
[12]卢俊英.孟鲁司特钠治疗小儿哮喘的有效性及不良反应观察[J].现代医学与健康研究,2018,19(2):47-48.
[13]刘莹.顺尔宁[J].中国新药杂志,2001,10(2):136-137.
[14] SALVI S S,KRISHNA M T,SAMPSON A P,et al. The antiinflammatory effects of leukotriene-modifying drugs and their use in asthma[J]. Chest,2001,119(5):1533.
[15] CHENG H,LEFF J A,AMIN R,et al. Pharmacokinetics,bioavailability,and safety of montelukast sodium(MK-0476)in healthy males and females[J]. Pharm Res,1996,13(3):445.