CHINESE JOURNAL OF MEDICINAL GUIDE >

2025 , Vol. 27 >Issue 5: 522 - 527

DOI: https://doi.org/magtech.2025.03.18-00002

Quality Analysis of Nicorandil Tablets

  • Lin / Wang ,
  • Xiao-Yue ZHU ,
  • Bin / Wu
Expand
  • Beijing Institute for Drug Control， NMPA Key Laboratory for Research and Evaluation of Generic Drugs，
    Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine， Beijing 102206， China

Received date: 2025-03-18

  Revised date: 2025-04-20

  Accepted date: 2025-04-25

  Online published: 2025-07-23

Fold

Abstract

 Objective： To analysis and evaluate the suitability of quality standard and the quality status of nicorandil tablets.Methods： A total of 88 batches of nicorandil tablets were tested using statutory testing methods and statistically analyzed. Exploratory studies were conducted to investigate and evaluate critical quality attributes， including related substances， dissolution profiles， content uniformity， and assay determination for domestically manufactured nicorandil tablets.Results： All 88 batches met the requirements of the statutory testing standards， yielding a 100% qualification rate. However， exploratory studies revealed deficiencies in the current statutory testing methods， including incomplete testing items and poor specificity of certain analytical methods， which hindered the accurate determination of the actual drug content. Furthermore， specific excipients， manufacturing processes， and packaging materials were identified as factors prone to increasing moisture absorption in samples， thereby compromising product stability.Conclusion： The collected nicorandil tablets exhibited quality gaps compared to the original product. It is recommended that manufacturers optimize excipient selection， enhance moisture control of raw materials and intermediates， refine critical process parameters （e.g.， temperature and humidity）， and improve packaging designs to minimize impurity formation. Additionally， the adoption of discriminative dissolution testing methods and comprehensive generic drug quality and therapeutic efficacy consistency evaluations are crucial for product quality enhancement. The existing quality standards are deficient and require enhancement in identification， related substances， dissolution， content uniformity， and contene assay.


Key words： Nicorandil tablets； Quality evaluation； ; Drug supervision； Consistency evaluation for generic drugs

Cite this article

Lin / Wang , Xiao-Yue ZHU , Bin / Wu .

Quality Analysis of Nicorandil Tablets

[J]. CHINESE JOURNAL OF MEDICINAL GUIDE, 2025 , 27(5) : 522 -527 . DOI: magtech.2025.03.18-00002

References

  ［1］ Uchida Y，Yoshinoto N，Murao S.Effect of 2-nicotinamidethyl nitrate （SG 75） on coronary circulation［J］.Japanese Heart Journal，1978，19：112-124.

         ［2］  Matsumoto T，Takahashi M，Omura T，et al.Heterogeneity in the vasorelaxing effect of nicorandil on dog epicardial coronary arteries：comparison with other NO donors［J］.J Cardiovasc Pharmacol， 1997，29（6）：772.

         ［3］  石玉龙，谷成玉，杨宇轩，等.尼可地尔的一种合成工艺改进及表征［J］.山东化工，2022，51（19）：45-46，50.

         ［4］  徐敏，姜丽丽.尼可地尔在心脏病治疗中的作用［J］.中国新药杂志，1999，8（9）：590-592.

         ［5］  吕漫.注射用尼可地尔药物利用评价标准的建立与成效［J］.中国药业， 2022，31（12）：119-122

         ［6］  邓远泽.尼可地尔片制剂工艺及质量控制研究［D］.河南大学，2024.

         ［7］  尼可地尔［J］.药学通报，1988，23（3）：182.

         ［8］  国家药品监督管理局.WS-10001-（HD-0151）-2002 尼可地尔片［S］.国家药品标准化学药品地方标准上升国家标准：第二册，2002：61.

         ［9］  BP2025 Vol III：Nicorandil Tablets ［S］.2025：1153-1155.

         ［10］ BP2016 Vol III：Nicorandil Tablets ［S］.2016：905-907.

         ［11］ BP2017 Vol III：Nicorandil Tablets ［S］.2017：937-939.

         ［12］ BP2021 Vol III：Nicorandil Tablets［S］.2021：1070-1072.

         ［13］ 朱丽娜.HPLC校正因子法测定尼可地尔片的有关物质［J］.中国药事，2023，（37）：808-816.

         ［14］ Korolev AM，Eremenko LT，Dubikhin VV，et al.N-（2-Nitroxyethyl） nicotinamide （Nicorandil） as amonomer in quaternazation polymerization［J］.Russian Chemical Bulletin （International Edition）， 2000，49（8）：1487-1488.

         ［15］ 谢沐风.简介日本“药品品质再评价”工程（溶出度研究系列一）［J］.中国药品标准，2005，6（6）：42-46.

         ［16］ 谢沐风.改进溶出度评价方法，提高固体药物制剂水平-论如何提高我国口服固体制剂的内在品质（溶出度研究系列二）［J］.中国药品标准，2006，7（1）：48-51.

         ［17］ JP-orange Book Association.Nicorandil tablets［EB/OL］.（2001-12-25）［2020-06-15］.http：//www.jp-orangebook.gr.jp/cgi-bin/search_h/search_e.cgi？action=diss_frame&effect=217&find=Nicorandil.

         ［18］ 国家药典委员会.中华人民共和国药典（四部）［S］.北京：中国医药科技出版社，2020：132-137.

Options
Outlines

/

〈 〉