近红外技术在珍菊降压片质量研究中的应用
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摘要
目的:建立珍菊降压片的合格性测试模型,考察近红外光谱分析技术在珍菊降压片质量分析中的应用。方法:以208批珍菊降压片为分析对象,用光纤法测定近红外光谱,建立定性、定量模型。结果:定性分析模型能体现不同生产企业、不同批次产品间的差异;定量分析模型能预测芦丁、氢氯噻嗪含量,芦丁定量模型均方根误差(RMSEP)为93.87、R~2为2.65,氢氯噻嗪定量模型RMSEP为87.59、R~2为1.52,初步判定制剂质量的优劣。结论:近红外分析技术可用于珍菊降压片定性、定量分析。
Objective:To establish a test model for the eligibility of Zhenju Jiangya Tablets and to investigate the application of near-infrared spectroscopy in the quality analysis of Zhenju Jiangya Tablets. Methods:Total 208 batches of Zhenju Jiangya Tablets were used as the analysis object,and the near-infrared spectroscopy was determined by optical fiber method to establish a qualitative and quantitative model. Results:The qualitative analysis model can reflect the differences between different enterprises and different batches of products. The quantitative analysis model can predict the content of rutin and hydrochlorothiazide. The quantita-tive model RMSEP of rutin was 93.87,R~2 was 2.65,and the quantitative model RMSEP of hydrochlorothiazide was 87.59,R~2 was 1.52,the quality of the preparation was preliminarily determined. Conclusion:Near-infrared analysis technology can be used for qualitative and quantitative analysis of Zhenju Jiangya Tablets.
Objective:To establish a test model for the eligibility of Zhenju Jiangya Tablets and to investigate the application of near-infrared spectroscopy in the quality analysis of Zhenju Jiangya Tablets. Methods:Total 208 batches of Zhenju Jiangya Tablets were used as the analysis object,and the near-infrared spectroscopy was determined by optical fiber method to establish a qualitative and quantitative model. Results:The qualitative analysis model can reflect the differences between different enterprises and different batches of products. The quantitative analysis model can predict the content of rutin and hydrochlorothiazide. The quantita-tive model RMSEP of rutin was 93.87,R~2 was 2.65,and the quantitative model RMSEP of hydrochlorothiazide was 87.59,R~2 was 1.52,the quality of the preparation was preliminarily determined. Conclusion:Near-infrared analysis technology can be used for qualitative and quantitative analysis of Zhenju Jiangya Tablets.
引文
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[10]王宁,魏红,蔡绍松,等.声光可调-近红外光谱技术快速分析复方丹参片中丹参酮ⅡA和丹酚酸B的新方法[J].中国中药杂志,2008,33(3):261.
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[2]方焕荣,张向红,庄晓丹.珍菊降压片对老年原发性高血压患者的疗效及对内皮功能的影响[J].中国老年学杂志,2012,32(15):3278-3279.
[3]曲政军,李运伦.珍菊降压片治疗原发性高血压疗效及安全性Meta-分析[J].山东中医药大学学报,2014,38(3):220-223.
[4]朱晓峰,李剑. HPLC法同时测定珍菊降压片中绿原酸、氢氯噻嗪和蒙花苷的含量[J].中国药师,2013,16(12):1814-1816.
[5]钱国华,张梦玲,徐玲玲,等. SPE-HPLC法测定珍菊降压片中盐酸可乐定的含量均匀度[J].中成药,2014,36(2):321-324.
[6]谢家骏,周广兴,乔正东,等.珍菊降压片中西药配伍减毒机制[J].中成药,2015,37(8):1633-1641.
[7]朱国琴,顾笑梅.谢家骏,等.珍菊降压片中药物配伍对大鼠肾脏表达谱的影响[J].华西药学杂志,2012,27(1):35-37.
[8]孟琼,黄昊,林锦培,等.珍菊降压片联合缬沙坦治疗原发性高血压(肝阳上亢证)患者的疗效观察[J].中国临床医学,2014,6,21(3):346-348.
[9]朱国琴,王文键,何燕,等.珍菊降压片联合长效降压药物治疗高血压的临床研究[J].中国药师,2015,18(8):1349-1352.
[10]王宁,魏红,蔡绍松,等.声光可调-近红外光谱技术快速分析复方丹参片中丹参酮ⅡA和丹酚酸B的新方法[J].中国中药杂志,2008,33(3):261.
[11]金鸣,胡敏,池文杰,等.近红外漫反射光谱法快速检测维C银翘片中的对乙酰氨基酚[J].中国药房,2011,14(8):1145-1147.
[12]唐海霞,刘全,陈桂良.酚咖片中对乙酰氨基酚和咖啡因的近红外漫反射光谱法测定[J].中国医药工业杂志,2004,35(11):669-671.
[13]耿颖,程奇蕾,何兰.运用近红外光谱法对缬沙坦胶囊进行一致性评价的研究[J].药物分析杂志2015,35(1):161-167.