现代医药卫生
現代醫藥衛生
현대의약위생
Journal of Modern Medicine & Health
2015年
20期
3070-3072
,共3页
抗肿瘤药%氟尿嘧啶%质量控制%参考标准%色谱法,高效液相%药物稳定性
抗腫瘤藥%氟尿嘧啶%質量控製%參攷標準%色譜法,高效液相%藥物穩定性
항종류약%불뇨밀정%질량공제%삼고표준%색보법,고효액상%약물은정성
Antineoplastic agents%Fluorouracil%Quality control%Reference standards%Chromatography,high pressure liquid%Drug stability
目的：建立抗肿瘤药氟尿嘧啶原料药的质量控制方法，并考察其稳定性。方法采用高效液相色谱法测定氟尿嘧啶原料药含量和有关物质，并对其进行稳定性考察。结果建立了氟尿嘧啶原料药的质量控制方法，包括性状、鉴别、干燥失重（≤0.3%）、炽灼残渣（≤0.1%）、重金属（≤0.002%）、有关物质（≤0.5%）和含量测定（98.0%~102.0%），样品检测结果在规定的限度内，对氟尿嘧啶样品进行了影响因素试验考察，在高温、高湿条件下无明显降解，在光照5、10 d条件下含量均无明显变化，并分别在加速试验[（40±2）℃，相对湿度75%±5%]条件下进行了6个月和长期试验[（30±2）℃，相对湿度60%±5%]条件下进行了9个月的稳定性试验，稳定性考察期内各项指标未见明显变化。结论所建立的氟尿嘧啶原料药质量控制方法重复性好、专属性强，结果准确、可靠，耐用性检测结果在规定的限度内，氟尿嘧啶原料药稳定性良好。
目的：建立抗腫瘤藥氟尿嘧啶原料藥的質量控製方法，併攷察其穩定性。方法採用高效液相色譜法測定氟尿嘧啶原料藥含量和有關物質，併對其進行穩定性攷察。結果建立瞭氟尿嘧啶原料藥的質量控製方法，包括性狀、鑒彆、榦燥失重（≤0.3%）、熾灼殘渣（≤0.1%）、重金屬（≤0.002%）、有關物質（≤0.5%）和含量測定（98.0%~102.0%），樣品檢測結果在規定的限度內，對氟尿嘧啶樣品進行瞭影響因素試驗攷察，在高溫、高濕條件下無明顯降解，在光照5、10 d條件下含量均無明顯變化，併分彆在加速試驗[（40±2）℃，相對濕度75%±5%]條件下進行瞭6箇月和長期試驗[（30±2）℃，相對濕度60%±5%]條件下進行瞭9箇月的穩定性試驗，穩定性攷察期內各項指標未見明顯變化。結論所建立的氟尿嘧啶原料藥質量控製方法重複性好、專屬性彊，結果準確、可靠，耐用性檢測結果在規定的限度內，氟尿嘧啶原料藥穩定性良好。
목적：건립항종류약불뇨밀정원료약적질량공제방법，병고찰기은정성。방법채용고효액상색보법측정불뇨밀정원료약함량화유관물질，병대기진행은정성고찰。결과건립료불뇨밀정원료약적질량공제방법，포괄성상、감별、간조실중（≤0.3%）、치작잔사（≤0.1%）、중금속（≤0.002%）、유관물질（≤0.5%）화함량측정（98.0%~102.0%），양품검측결과재규정적한도내，대불뇨밀정양품진행료영향인소시험고찰，재고온、고습조건하무명현강해，재광조5、10 d조건하함량균무명현변화，병분별재가속시험[（40±2）℃，상대습도75%±5%]조건하진행료6개월화장기시험[（30±2）℃，상대습도60%±5%]조건하진행료9개월적은정성시험，은정성고찰기내각항지표미견명현변화。결론소건립적불뇨밀정원료약질량공제방법중복성호、전속성강，결과준학、가고，내용성검측결과재규정적한도내，불뇨밀정원료약은정성량호。
Objective To establish the quality control method of antitumor drug fluorouracil bulk drug and to investigate its stability. Methods The content and related substances in fluorouracil bulk drug were determined by high performance liquid chromatography(HPLC) and its stability was investigated. Results The quality control method of fuorouracil bulk drug was estab-lished,including character,identification,drying loss (≤0.3%),residue on ignition (≤0.1%),heavy metals (≤0.002%),related substances(≤0.5%) and content determination(98.0%-102.0%). The sample test results were all within the limits specified. Mean-while,the fuorouracil sample was performed the influencing factor test,the results showed that there was no obvious fluorouracil degradation under the condition of high temperature and high humidity,there were no obvious changes under the condition of 5,10 d illumination,the 6-month and 9-month stability tests were performed in the condition of the accelerated testing[(40±2)℃,relative humidity(RH)75%±5%] and the long-term testing[(30±2)℃,RH 60%±5%] respectively,the various indicators had no obvious changes during the stability investigation period. Conclusion The established quality control method of fluorouracil bulk drug has good repeatability,strong specificity, and accurate and reliable results,the detection results of the durability test are within the lim-its specified,fluorouracil bulk drug has good stability.
