中国药事
中國藥事
중국약사
Chinese Pharmaceutical Affairs
2015年
9期
932-939
,共8页
药品监测%克拉霉素制剂%国家评价性抽验%质量分析%有关物质检查%杂质谱%溶出曲线
藥品鑑測%剋拉黴素製劑%國傢評價性抽驗%質量分析%有關物質檢查%雜質譜%溶齣麯線
약품감측%극랍매소제제%국가평개성추험%질량분석%유관물질검사%잡질보%용출곡선
drug monitoring%clarithromycin preparations%national assessment programs%quality analysis%determination of related substances%impurity proifle%the dissolution curve
目的：对克拉霉素制剂的内在质量进行评价分析，为其生产、质控、监管提供参考。方法：对277批样品按照现行法定标准进行检验，并对检验结果进行统计分析；采用自行建立的方法对117批样品进行有关物质研究；考察了克拉霉素片在4种溶出介质中的溶出行为。结果：按法定标准检验，277批样品结果全部符合规定；自行建立的有关物质检查方法优于药典标准方法，共检出13种有关物质，杂质E、F是主要杂质，均来自原料；国产克拉霉素片的溶出行为各异，多数厂家产品与参比制剂的溶出曲线存在一定的差异。结论：虽然克拉霉素制剂按法定标准检验结果全部符合规定，但探索性研究结果表明，克拉霉素制剂质量还有进一步提高的空间，质量还有待于进一步优化提高。
目的：對剋拉黴素製劑的內在質量進行評價分析，為其生產、質控、鑑管提供參攷。方法：對277批樣品按照現行法定標準進行檢驗，併對檢驗結果進行統計分析；採用自行建立的方法對117批樣品進行有關物質研究；攷察瞭剋拉黴素片在4種溶齣介質中的溶齣行為。結果：按法定標準檢驗，277批樣品結果全部符閤規定；自行建立的有關物質檢查方法優于藥典標準方法，共檢齣13種有關物質，雜質E、F是主要雜質，均來自原料；國產剋拉黴素片的溶齣行為各異，多數廠傢產品與參比製劑的溶齣麯線存在一定的差異。結論：雖然剋拉黴素製劑按法定標準檢驗結果全部符閤規定，但探索性研究結果錶明，剋拉黴素製劑質量還有進一步提高的空間，質量還有待于進一步優化提高。
목적：대극랍매소제제적내재질량진행평개분석，위기생산、질공、감관제공삼고。방법：대277비양품안조현행법정표준진행검험，병대검험결과진행통계분석；채용자행건립적방법대117비양품진행유관물질연구；고찰료극랍매소편재4충용출개질중적용출행위。결과：안법정표준검험，277비양품결과전부부합규정；자행건립적유관물질검사방법우우약전표준방법，공검출13충유관물질，잡질E、F시주요잡질，균래자원료；국산극랍매소편적용출행위각이，다수엄가산품여삼비제제적용출곡선존재일정적차이。결론：수연극랍매소제제안법정표준검험결과전부부합규정，단탐색성연구결과표명，극랍매소제제질량환유진일보제고적공간，질량환유대우진일보우화제고。
Objective:To evaluate and analyze the quality of Clarithromycin preparations, so as to provide references for manufacturing, quality control and inspection.Methods: A total of 277 samples were tested according to the current ofifcial standards and data were collected for statistical analysis. Totally 117 samples were evaluated with self-developed methodology. The dissolution of Clarithromycin tablets in four kinds of solutions was inspected.Results:All the 277 samples tested by ofifcial standards were in accordance with the provisions. Self-developed method was superior to the ofifcial standards, which was able to detect 13 substances including the major impurities E and F from raw material. Clarithromycin tablets from domestic manufacturers had various dissolutional behaviors that mostly deviated from the reference sample to various extents.Conclusion:Although all samples fulifll the demands by ofifcial standards, our pioneer study suggests that there is much more we can do to improve the quality of clarithromycin.
