关键词: 尼可地尔片, 质量分析, 药品监管, 仿制药一致性评价

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