目的 基于舒筋定痛片的国家药品评价抽检工作,在系统评价其质量现状的基础上,对中成药质量评价方法研究提出建议。方法 结合标准检验和探索性研究,从真实性、安全性和有效性方面对舒筋定痛片的质量状况进行系统评价,并对抽检中发现的问题进行总结、分析。结果 标准检验显示舒筋定痛片合格率较高;探索性研究结果表明,个别样品和批次存在处方药味掺伪或者混用,原料质量差、工艺不合理,重金属及有害元素超过拟定限度等问题。结论 建议在中药质量专属性成分评价、与临床有效性关联的生物效应质量评价及“点-线-面”的全方质量评价模式等方面加强研究,开展中药中矿物药的专项研究,并完善中药中毒性成分检测平台建设和风险评估机制,保障中药的有效性和安全性。
Abstract
OBJECTIVE To evaluate the quality of Shujin Dingtong tablets and give some advice about the quality control of traditional Chinese medicine based on National Drug Evaluation Surveillance. METHODS Statutory inspection and exploratory research can penetrate the quality status of Shujin Dingtong tablets from the authenticity, safety and effectiveness. The quality status revealed the problems were discussed. RESULTS The qualified rate of inspection was 100.0%. There were some defects, such as adulteration or abused use, poor quality of raw materials, insufficient feeding or unreasonable process, heavy metals and harmful elements, and so on. CONCLUSION It is suggested to strengthen the research on the specificity marker of quality control of traditional Chinese medicine, the quality control methods of biological effects related to clinical effectiveness and the “point-line-plane” whole prescription quality control model. Besides these, it is paid attention to improve the quality standard of mineral drugs and perfect the detection platform and safety evaluation of the toxic components of traditional Chinese medicine to ensure the effectiveness and safety of traditional Chinese medicine.
关键词
国家药品抽检 /
中药 /
质量评价 /
舒筋定痛片
{{custom_keyword}} /
Key words
national evaluation sampling /
traditional Chinese medicine /
quality evaluation /
Shujin Dingtong tablets
{{custom_keyword}} /
中图分类号：
R917
{{custom_clc.code}}
({{custom_clc.text}})
{{custom_sec.title}}
{{custom_sec.title}}
{{custom_sec.content}}
参考文献
[1] National Institute for Food and Drug Control. The result of exploratory research in the National Drug Evaluation Surveillance.(VII issue). (国家药品抽检探索性研究情况(第七期)[EB/OL].(2021-01-20) [2021-03-08]. https://www.nifdc.org.cn//nifdc/bshff/gjchj/gjchjtsyj/202101201433142983.html.
[2] XU SH SH, XU J, ZHANG X M, et al. Research progress on Citri Reticulatae Pericarpium, Aurantii Fructus Immaturus, and Aurantii Fructus and Q-marker predictive analysis [J]. Chin Tradit Herb Drugs(中草药), 2018, 49(1):35-44.
[3] Ch.P(2020) Vol Ⅰ(中国药典2020年版.一部)[S]. 2020.
[4] PEI K, XIA F G, CHEN H F, et al. Research review on Citrus reticulatae pericarpium, Citri grandis Exocarpium and Aurantii fructus [J]. Jiangxi J Tradit Chin Med(江西中医药), 2015, 46(4):71-74.
[5] ZHU J N.Study on chemical constituents and quality standard [D]. Beijing:Institute of Chinese Meteria Medica China Academy of Chinese Medical Sciences, 2007.
[6] XIAO C, RAO W W, ZHONG M CH. Study on determination methods for abietic acid in fake myrrha[J]. J Chin Med Mater(中药材), 2012, 35(8):1237-1241.
[7] ZHAI X, PANG K J, TANG H, et al. Quality evaluation of Olibanum marketed in 5 different areas and identification of rosin[J]. Lishizhen Med Mater Med Res(时珍国医国药), 2017, 28(8):1866-1869.
[8] LI A Q, WANG Y H, BI X Y. Comparative analysis of commonly used abietic acid inspection method and the application of three kinds of Traditional Chinese Medicine[J]. J Chin Med Pharmacol(中医药学报),2017,45(1):47-50.
[9] FENG J, LIU Y, WEI J H. Identification of abietic acid from 44 different kinds of chinese agarwood[J]. Mod Chin Med(中国现代中药), 2017, 19(8):1071-1075.
[10] ZHANG L Q, LIU Y J. Mineralogy identification and composition comparison of matural copper[J]. Chin Tradit Pat Med (中成药), 2018, 40(8):1869-1872.
[11] Nat Drug Stand Workbook(Forth Edition) (国家药品标准工作手册. 第4版)[M]. Beijing:China Medical Science and Technology Press, 2013:8-9.
[12] Ch.P(2020) Vol Ⅳ(中国药典2020年版.四部)[S]. 2020.
[13] National Medical Products Administration. The NMPA announcement of 17 supplementary inspection methods including the inspection of Brilliant Crocein in Xinkening capsule (2019 No.58) (国家药监局关于发布心可宁胶囊中酸性红73检查项等17项补充检验方法的公告.2019年第58号)[EB/OL]. (2019-07-18)[2021-02-01]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20190718175301280.html.
[14] LIN Y Q, LIN L, JIAO Y, et al. Research and application of chemical marker based on Q-marker theory[J]. Chin Pharm J(中国药学杂志), 2020, 55(2):161-166.
[15] XIAO X H, ZHANG D K, WANG J B, et al. Controllability pyramid:an integrated control system of quality for traditional Chinese medicines[J]. China J Chin Mater Med (中国中药杂志), 2015, 40(1):7-12.
[16] FENG W W, ZHANG Y, TANG J F, et al. Combination of chemical fingerprinting with bioassay, a preferable approach for quality control of safflower injection [J]. Anal Chim Acta, 2018, 1003:56-63.
[17] LI X J, HUANG Y Y, YANG ZH, et al. Research strategy for quality-biomarkers of traditional Chinese medicine based on effect benchmarks[J]. Acta Pharm Sin(药学学报), 2019, 54(2):204-210.
{{custom_fnGroup.title_cn}}
脚注
{{custom_fn.content}}
PDF(2053 KB)
