基于国家药品抽验任务探讨含动物类成分中成药的质量控制

聂黎行,胡晓茹,张聿梅,郑笑为,何轶,王菲菲,戴忠,马双成,朱炯,成双红

中国药学杂志 ›› 2016, Vol. 51 ›› Issue (6) : 506-512.

PDF(1021 KB)
PDF(1021 KB)
中国药学杂志 ›› 2016, Vol. 51 ›› Issue (6) : 506-512. DOI: 10.11669/cpj.2016.06.019
论 著

基于国家药品抽验任务探讨含动物类成分中成药的质量控制

  • 聂黎行,胡晓茹,张聿梅,郑笑为,何轶,王菲菲,戴忠,马双成*,朱炯,成双红
作者信息 +

Discussion of Quality Control of Chinese Patent Medicine with Animal Ingredients Based on National Post-Market Drug Surveillance

  • NIE Li-xing,HU Xiao-ru,ZHANG Yu-mei,ZHENG Xiao-wei,HE Yi,WANG Fei-fei,DAI Zhong,MA Shuang-cheng*,ZHU Jiong,CHENG Shuang-hong
Author information +
文章历史 +

摘要

目的 探讨含动物类成分中成药的质量控制,以期为其标准提高、质量监督和规范生产提供参考。方法 对2010~2014年国家药品抽验抽取的含动物类成分中成药的执行标准和探索性研究内容加以梳理,从安全性、真实性、有效性、可控性等角度出发,分析具体品种质量控制的技术与方法 结果 高效液相、气相等色谱技术的运用日趋成熟,传统的显微鉴别和薄层鉴别方法 可以在指标成分缺乏的动物药的鉴别方面发挥很好的作用,质谱联用技术已成功应用于中成药中动物药的质量控制。结论 国家评价抽验能够对药品质量进行综合、细致地评价,发现潜在风险,是促进动物药质量提高的有利手段。

Abstract

OBJECTIVE To discuss quality control of Chinese patent medicine with animal ingredients,providing reference for standards improvement,quality supervision and regulated production. METHODS Statutory standards and exploratory studies of Chinese patent medicines with animal ingredients tested in national post market surveillance between 2010 and 2014 were summarized. And technologies and METHODS developed for specific drugs were analyzed from the perspectives of safety,authenticity,effectiveness and controllability. RESULTS Use of HPLC and GC is becoming more mature. Traditional microscopic and TLC METHODS can play a positive role in identification of animal drugs without index component. Mass spectrometry has been successfully applied in quality control of Chinese patent medicine with animal ingredients. CONCLUSION National post market surveillance can provide comprehensive and elaborate evaluation on drug quality and can reveal potential risks. It′s a powerful measure to promote quality of animal medicine.

关键词

动物药 / 中成药 / 国家药品抽验 / 质量控制

Key words

animal medicine / Chinese patent medicine / national post-market drug surveillance / quality control

引用本文

导出引用
聂黎行,胡晓茹,张聿梅,郑笑为,何轶,王菲菲,戴忠,马双成,朱炯,成双红. 基于国家药品抽验任务探讨含动物类成分中成药的质量控制[J]. 中国药学杂志, 2016, 51(6): 506-512 https://doi.org/10.11669/cpj.2016.06.019
NIE Li-xing,HU Xiao-ru,ZHANG Yu-mei,ZHENG Xiao-wei,HE Yi,WANG Fei-fei,DAI Zhong,MA Shuang-cheng,ZHU Jiong,CHENG Shuang-hong. Discussion of Quality Control of Chinese Patent Medicine with Animal Ingredients Based on National Post-Market Drug Surveillance[J]. Chinese Pharmaceutical Journal, 2016, 51(6): 506-512 https://doi.org/10.11669/cpj.2016.06.019
中图分类号: R284   

参考文献

[1] YANG M,SUI D J,CHEN W X,et al.Glucolipid metabolism and antioxidant effect of the total flavones of propolis in Gk rats [J]. Chin Pharm J (中国药学杂志),2015,50 (3):217-220.
[2] XIAO L,XU X L,HE K Y,et al.Assay of anticoagulation activity of leeches by using biological standardization method [J]. Chin Pharm J
(中国药学杂志),2015,50 (3):258-262.
[3] JIN J J,W Z B,SU B,et al.Research of anticoagulation effect and establishment of reaction system of bioactivity assay of hirudo in vitro [J]. Chin Pharm J (中国药学杂志),2014,49 (22):1997-2001.
[4] CHENG X L,CHEN J,LI M H,et al.Identification study of glue medicines [J]. Chin Pharm J (中国药学杂志),2015,50 (2):104-108.
[5] XU H,DONG T X,ZHAO K J,et al.Study on identification of cordyceps-a Chinese traditional medicine [J]. Chin Pharm J
(中国药学杂志),2014,49 (4):283-286.
[6] WANG Y T,HE Y,WANG R Z,et al.Simultaneous determination of 5 fatty acids in Nidus Vespae by GC [J]. Chin J Pharm Anal (药物分析杂志),2015,35 (3):420-424.
[7] LIU W Z,FAN J W,LI Y F,et al.Simultaneous determination of seven components in dried Whitmania pigra by HPLC [J]. Chin J Pharm Anal (药物分析杂志),2014,34 (8):1417-1421.
[8] CHEN H Z,XIA Z Y. Determination of total flavonoids in propolis based on NIR spectroscopy technology [J]. Chin J Pharm Anal (药物分析杂志),2014,34 (10):1868-1873.
[9] ZOU Q W,SHI Y,LIU W,et al.The research of quantity test method of various components in succession medicinal substances of cow-bezoar [J]. Chin J Pharm Anal (药物分析杂志),2015,35 (1):8-15.
[10] ZHANG P,ZHENG T J,ZHANG W J,et al.HPLC Characteristic fingerprint and chemical pattern recognition of fermentation mycelium preparations [J]. Chin Pharm J (中国药学杂志),2015,50 (4):293-298.
[11] WANG X M,ZHANF S,WANG M B,et al. In vitro
safety evaluation study of Angong Niuhuang Wan [J]. Spectrosc Spect Anal (光谱学与光谱分析),2015,35 (1):238-241.
[12] ZHENG S G,ZHAO M Q,WU Y J,et al.Effect of Danzhi Jiangtang Capsules on insulin secretion capacity and apoptosis of INS-1 cell exposed to intermittent high glucose [J]. Chin Tradit Pat Med (中成药),2015,37 (4):722-727.
[13] PAN L L,HAO B,YUAN S X,et al.TLC Identification of HPLC fingerprinting of Niuhuang Jiedu Tablets [J]. J Chin Med Mater
(中药材),2014,37 (11):2087-2091.
[14] ZHANG Y H,JIANG J G,SUN T,et al.Identification of artificial and in vitro cultivated Bovis Calculus in chlorphenamine maleate granules [J]. Chin Tradit Pat Med (中成药),2015,37 (2):329-331.
[15] LIU Y,NIE L X,GUO Y. Inorganic elements determination and quality investigation of eupolyphaga [J]. Chin Pharm Aff
(中国药事),2012,26(7):734-736.
[16] WANG Z X,ZHENGY X. Pay attention to Eupolyphaga processed by salt or alum [J]. China J Chin Mater Med(中国中药杂志),1996,21(5):281.
[17] WANG X X. Purity and total ash of 7 batches of Eupolyphaga [J]. China J Chin Mater Med
(中国中药杂志),2003,28(10):2-6.
[18] FENG L J,WANG Y. Pay attention to Eupolyphaga adulterated by alum [J]. Chin J Misdiagn(中国误诊学杂志),2007,7 (1):199.
[19] NIE L X,LIU Y,LU J,et al.Quality evaluation and research of Huoxue Zhitong Preparations [J]. Chin Pharm J
(中国药学杂志),2015,50(2):131-139.
[20] XIE J,YANG H L,LENG J,et al.Determination of aflatoxin (AF) G2,G1,B2 and B1 in 72 batches of Shujin Huoxue pills by HPLC with post-column photochemical derivation [J]. Chin J Pharm Anal (药物分析杂志),2014,34 (3):437-441.
[21] LI H,HAN M,ZHU F Y,et al.Identification of pearl powder from Zhejiang by scanning electron microscope and X-ray diffraction analysis [J]. Chin New Drug J (中国新药杂志),2013,22(23):2817-2821.
[22] ZENG Y W,LV G L,LIAO J,et al.Distinction of pearl and conch powder [J]. J Mater Sci Eng(材料科学与工程学报),2012,30(140):937-938.
[23] XIA J,CAO S,YANG X H,et al.Quality study of calculus bovisin commercial Angong Niuhuang Pills [J]. Chin Pharm J
(中国药学杂志),2013,48(23):2048-2055.
[24] GAO G F,ZHOU H. Study on quality of Huodan Pills [J]. Chin J Pharm (中国医药工业杂志),2013,44(7):705-708.
[25] ZHENG X W,ZHANG Y S,WANG Q,et al.HPLC Determination of cinobufagin and resibufogenin in Niuhuangxiaoyan tablets [J]. Chin J Pharm Anal (药物分析杂志),2013,33 (10):1774-1786.
[26] NIE L X,ZHANG Y,DAI Z,et al.Promoting effect of national post-market drug surveillance to standards of TCM [J]. China Pharm(中国药业),2013,22(22):2-3.
[27] DAI Z,LU J,ZHU J,et al.Thinking on national evaluation inspection of Chinese patent medicines [J]. Chin Pharm J
(中国药学杂志),2015,50(2):93-98.

基金

国家十二五“重大新药创制”专项(2014ZX09304307-002);国家自然科学基金资助项目(81303194、81173506)
PDF(1021 KB)

Accesses

Citation

Detail

段落导航
相关文章

/