烟酸注射剂质量评价研究

Quality Analysis of Nicotinic Acid for Injection

目的:评价国产烟酸注射剂的质量。方法:采用法定标准检验方法与探索性研究相结合,对抽验样品进行研究,分析检验结果,综合评价产品质量及其质量标准。结果:按现行质量标准对25批样品进行检验,合格率为100%。探索性研究建立了HPLC法测定烟酸注射剂含量,并同标准方法(UV法)进行比较,两种方法测定结果间的差异无统计学意义(P>0.05)。建立了HPLC法测定烟酸原料和注射剂的有关物质,结果显示注射用烟酸中杂质检出个数与杂质总量多于其标准方法,各企业原料及制剂中杂质个数和杂质含量相当,按拟定限度均符合规定。对烟酸注射剂进行血管刺激、热原、异常毒性、溶血与凝聚等方面考察,结果显示该产品有一定血管刺激性,其余各项指标均符合规定。结论:目前烟酸注射剂的产品质量状况较好,现行质量标准存在不足,建议完善或补充有关物质检查方法。

Objective:To evaluate the quality of nicotinic acid for injection.Methods:Statutory testing methods and exploratory research methods were used to examine the samples,and the quality status of nicotinic acid for injection was evaluated according to the results.Results:All of 25 batches of samples met the requirements of current specification.An HPLC method was established for the content determination of nicotinic acid injection in the exploratory research.And the results obtained showed no significant differences when compared with those in the standard method(UV spectrophotometric method).An HPLC method for the determination of related substances was established,and the new method detected out more impurities than the standard method for nicotinic acid for injection.The impurity species and contents in the raw materials and the corresponding preparation from various enterprises were equivalent.Safety of nicotinic acid for injection was evaluated by vascular irritation,pyrogens,undue toxicity and in vitro hemolysis tests,and the results showed that the injection preparations induced a certain degree of vascular irritation,while other indexes conformed to the regulations.Conclusion:The quality of nicotinic acid for injection is generally good.However,the determination method for related substances needs to be further improved or supplemented.