HPLC法同时测定速克感冒胶囊中5种成分的含量

目的：建立高效液相色谱法同时测定速克感冒胶囊中绿原酸、马来酸氯苯那敏、乙酰水杨酸、蒙花苷和次野鸢尾黄素。方法：采用Venusil XBP C₁₈色谱柱（4.6 mm×250 mm，5 μm），以乙腈（A）-0.5%磷酸溶液（B）为流动相，梯度洗脱，流速1.0 mL·min^-1，检测波长327 nm（绿原酸）、260 nm（氯苯那敏）、276 nm（乙酰水杨酸）、334 nm（蒙花苷）和266 nm（次野鸢尾黄素）。结果：5种待测成分分离度良好，阴性无干扰；绿原酸、马来酸氯苯那敏、乙酰水杨酸、蒙花苷和次野鸢尾黄素进样量分别在0.078~0.388 μg（r=0.999 9）、0.196~0.978 μg（r=0.999 7）、4.066~20.332 μg（r=0.999 9）、0.165~0.825 μg（r=0.999 9）和0.048~0.238 μg（r=0.999 0）范围内线性关系良好；平均回收率分别为96.8%、101.2%、96.8%、100.0%和101.3%，RSD分别为1.8%、2.4%、1.1%、1.9%和3.9%。3批样品中绿原酸、马来酸氯苯那敏、乙酰水杨酸、蒙花苷和次野鸢尾黄素的平均含量分别为0.88~1.00、2.05~2.20、110.02~116.00、2.18~2.45和0.06~0.10 mg·粒^-1。结论：该方法可作为评价和监控速克感冒胶囊质量的方法。

Objective: To establish an HPLC method for simultaneous determination of chlorogenic acid,chlorphenamine maleate,acetylsalicylic acid,linarin,and irisflorentin in Suke Ganmao capsules. Methods: The chromatographic separations were performed on a Venusil XBP C₁₈ column(4.6 mm×250 mm,5μm),with the mobile phase consisting of acetonitrile(A)-0.5% phosphoric acid(B)in gradient elution mode with the flow rate of 1.0 mL·min^-1.The UV detection wavelength was set at the maximum absorption wavelength of 327 nm for neochlorogenic acid,260 nm for chlorphenamine,276 nm for acetylsalicylic acid,334 nm for linarin,and 266 nm for irisflorentin. Results: The analytes were separated perfectly by chromatography without disturbing peaks from negative samples.The linear ranges of chlorogenic acid,chlorphenamine maleate,acetylsalicylic acid,linarin,and irisflorentin were 0.078-0.388 μg(r=0.999 9),0.196-0.978 μg(r=0.999 7),4.066-20.332 μg(r=0.999 9),0.165-0.825 μg(r=0.999 9),and 0.048-0.238 μg(r=0.999 0),respectively.The average recovery rates of the analytes above were 96.8%,101.2%,96.8%,100.0% and 101.3%,with RSDs of 1.8%,2.4%,1.1%,1.9% and 3.9%,respectively.The determination results of 3-batch samples were as follows:in each capsule of Suke Ganmao capsule,the contents of chlorogenic acid,chlorphenamine maleate,acetylsalicylic acid,linarin,and irisflorentin were 0.88-1.00 mg,2.05-2.20 mg,110.02-116.00 mg,2.18-2.45 mg and 0.06-0.10 mg,respectively. Conclusion: The method can be used for the evaluation and quality control of Suke Ganmao capsules.

[1] 卫生部药品标准.中药成方制剂.第二十册[S]. 1998:307 Drug Specifications Promulgated by Ministry of Public Health, PR China. Chinese Medicines Formula Preparation. Vol 20[S]. 1998:307
[2] 鲁思爱. 忍冬藤的化学成分及其药理应用研究进展[J]. 临沂大学学报, 2012, 34(3):132 LU SA. The chemical composition of the Caulis Lonicerae and pharmacological application research progress[J]. J Linyi Univ, 2012, 34(3):132
[3] 刘丹丹,苗明三.野菊花现代研究及作用特点分析[J]. 中医学报, 2014, 29(4):551 LIU DD, MIAO MS. Modern research and characteristics analysis on Chrysanthemum indicum[J].China J Chin Med, 2014, 29(4):551
[4] 张杰,曾铖,常义生,等. 射干化学成分研究[J].安徽农业科学, 2015,43(24):57 ZHANG J, ZENG C, CHANG YS, et al. Study on chemical constituents of Belamcanda chinensis(L.)DC.[J]. J Anhui Agric Sci,2015, 43(24):57
[5] 赵金娟,戴雪梅,曲永胜,等. 绿原酸药效学研究进展[J]. 中国野生资源, 2013, 32(4):1 ZHAO JJ,DAI XM,QU YS,et al. Progress in the pharmacodynamics of chlorogenic acid[J]. Chin Wild Plant Res, 2013,32(4):1
[6] 左霞,刘春霞,杨金霞,等. HPLC法测定不同来源不同采收期忍冬藤和金银花中绿原酸含量[J]. 中国药师, 2015, 18(4):682 ZUO X, LIU CX, YANG JX, et al. Determination of chlorogenic acid in honeysuckle stem and honeysuckle from different sources in different harvest periods by HPLC[J]. China Pharm,2015,18(4):682
[7] 郭巧生,房海灵,申海进.不同产地野菊花中绿原酸、咖啡酸和蒙花苷含量[J]. 中国中药杂志,2010, 35(9):1160 GUO QS, FANG HL, SHEN HJ. Determination of chlorogenicacid, caffeic acid and linarin in Flos Chrysanthemi Indici from different places by RP-HPLC[J]. China J Chin Meter Med, 2010,35(9):1160
[8] 孟庆玉,符玲,高振,等. 野菊花总黄酮提取方法比较及其抗氧化活性研究[J]. 中草药,2015, 46(21):3194 MENG QY,FU L, GAO Z, et al. Comparison of different extraction processes of total flavonoids in Chrysanthemum indicum and its antioxidant effect[J]. Chin Tradit Herb Drugs, 2015, 46(21):3194
[9] 邹桂欣,尤献民,王光函,等.野鸢尾中异黄酮与其抗炎作用的相关性分析[J]. 中华中医药学刊,2016, 34(10):2406 ZOU GX, YOU XM, WANG GH, et al. Correlation of isoflavones components and anti-inflammatory effects in Iris dichotma[J]. Chin Arch Tradit Chin Med, 2016, 34(10):2406
[10] 康愿涛,邹桂欣,尤献民,等.射干异黄酮成分对5-脂氧合酶的作用研究[J]. 中药与临床,2015, 6(1):43 KANG YT, ZOU GX, YOU XM, et al. The effece of isoflavone in Shegan on 5-lipoxyqenase[J]. Pharm Clin Chin Mater Med,2015, 6(1):43
[11] 王腾,王晓敏,张亚运,等.高效液相色谱法同时测定复方乙酰水杨酸片中各有效成分的含量[J].北京石油化工学院学报, 2012,20(1):41 WANG T, WANG XM, ZHANG YY, et al. Simultaneous determination of three components in compound aspirin tablets by HPLC[J]. J Beijing Inst Petro-Chem Technol,2012,20(1):41
[12] 王丽琼,赵雪,刘明容,等. RP-HPLC法同时测定复方酚咖伪麻胶囊5种组分的含量[J].药物分析杂志, 2016, 36(8):1403 WANG LQ, ZHAO X, LIU MR, et al. Simultaneous determination of five ingredients in compound paracetamol caffeine and pseudoephedrine hydrochloride capsules by RP-HPLC[J]. Chin J Pharm Anal,2016, 36(8):1403
[13] 金鹏飞,夏路风,李铮,等.高效液相色谱同时测定多维元素片中的维生素B1、维生素B6、维生素C、烟酰胺和泛酸[J].药物分析杂志,2012, 32(9):1606 JIN PF, XIA LF, LI Z, et al. Simultaneous determination of vitamin B1, vitamin B6, vitamin C, niacinamide and pantothenic acid in vitamins with minerals tablets by HPLC[J]. Chin J Pharm Anal, 2012,32(9):1606
[14] 王静,袁子民,张振秋,等. HPLC法测定速克感冒胶囊中马来酸氯苯那敏的含量和含量均匀度[J]. 药物分析杂志, 2009, 29(3):467 WANG J, YUAN ZM, ZHANG ZQ, et al. HPLC determination of content and content uniformity of chlorphenam inemaleate in Sukeganmao capsules[J]. Chin J Pharm Anal,2009, 29(3):467
[15] 高颖,郭鹏,李建宇,等. RP-HPLC同时测定速克感冒胶囊中乙酰水杨酸、维生素C含量[J]. 武警后勤学院学报(医学版), 2014,23(5):409 GAO Y, GUO P, LI JY, et al. Determination of acetylsalicylic acid, vitamin C in Sukeganmao capsule by RP-HPLC[J]. J Log Univ PAPF(Med Sci), 2014, 23(5):409
[16] 冯秋红.高效液相色谱法测定速克感冒胶囊中蒙花苷的含量[J].中国药房, 2006, 17(4):297 FENG QH. Determination of linarin in Sukeganmao capsules by HPLC[J]. China Pharm,2006, 17(4):297
[17] 任占军,谷学新,侯士果,等. HPLC法测定速克感冒片中绿原酸的含量[J].药物分析杂志, 2007, 27(5):752 REN ZJ, GU XX, HOU SG, et al. HPLC determination of chlorogenic acid in Suke Ganmao tablets[J]. Chin J Pharm Anal, 2007,27(5):752