CAJ | 학술논문

目的：磺胺嘧啶银乳膏为2013年国家药品计划抽验品种，通过对44批次样品进行法定标准检验及探索性研究，对该品种的质量及标准状况作出总体分析及评价。方法：法定标准检验依据《中国药典》2010年版和国家食品药品监督管理局注册标准，探索性研究建立了HPLC梯度洗脱同时测定磺胺嘧啶银、羟苯酯类防腐剂含量测定方法；采用LC-MS联用技术确证A企业样品中杂质结构并采用外标法计算含量，查明杂质来源和避免杂质产生的解决办法；pH值测定；TLC鉴别；建立无菌检查方法。结果：按法定标准检验，合格率100.0%；按探索性研究检验，合格率68.2%。结论：探索性研究增加了标准的专属性、可控性及安全性，为进一步修订药品标准，控制药品质量提供参考。
목적：광알밀정은유고위2013년국가약품계화추험품충，통과대44비차양품진행법정표준검험급탐색성연구，대해품충적질량급표준상황작출총체분석급평개。방법：법정표준검험의거《중국약전》2010년판화국가식품약품감독관리국주책표준，탐색성연구건립료HPLC제도세탈동시측정광알밀정은、간분지류방부제함량측정방법；채용LC-MS련용기술학증A기업양품중잡질결구병채용외표법계산함량，사명잡질래원화피면잡질산생적해결판법；pH치측정；TLC감별；건립무균검사방법。결과：안법정표준검험，합격솔100.0%；안탐색성연구검험，합격솔68.2%。결론：탐색성연구증가료표준적전속성、가공성급안전성，위진일보수정약품표준，공제약품질량제공삼고。
Objective:To analyze 44 batches of samples of sulfadiazine silver, one of the items of national sampling survey in 2013, according to the quality standard conduct an exploratory research on the samples, and analyze and evaluate the overall quality and standard condition of this variety.Methods:According to the quality standards inChinese Pharmacopoeia (2010 edition) and registration standards of the State Food and Drug Administration, the exploratory research was conducted to develop an HPLC method for the determination of sulfadiazine silver, methylparaben, ethylparaben and propyl-paraben in sulfadiazine silver cream. The structure of impurities in samples from Company A was conifrmed by LC-MS and the contents of impurities were calculated by external standard method. The source of impurities and the methods to avoid production of impurities were searched. The pH value was measured and the TLC identiifcation was conducted. The method for sterility test was established.Results:The qualified rate of the samples was 100.0% according to the mandatory standard. However, the qualified rate was 68.2% according to the exploratory research.Conclusion:The exploratory research is more speciifc, controllable, and safe for tests which provided references for further revision of drug standards and monitoring of drug quality.