中国医药技术经济与管理
中國醫藥技術經濟與管理
중국의약기술경제여관리
CHINESE JOURNAL OF PHARMACEUTICAL TECHNOLOGY ECONOMICS & MANAGEMENT
2009年
7期
63-68
,共6页
王丽%杜笑%刘杰%翟海民
王麗%杜笑%劉傑%翟海民
왕려%두소%류걸%적해민
美他多辛片%稳定性%有效期%光照试验%加速试验%长期试验
美他多辛片%穩定性%有效期%光照試驗%加速試驗%長期試驗
미타다신편%은정성%유효기%광조시험%가속시험%장기시험
Metadoxine Tablets%Stability%Period of Validity%Light Test%Accelerate Test%Long-term Tests
目的 研究美他多辛片的稳定性,为药品储存、有效期的确定提供实验依据.方法 采用HPLc法测定美他多辛片中美他多辛的含量.通过光照试验、加速试验和长期试验,应用动力学公式Arrhenius方程及统计学原理计算出K25℃和预测药品有效期.结果 美他多辛片对光不稳定.预测有效期与长期试验结果相吻合.结论 美他多辛片在避光、室温条件下储存的有效期为24个月.
目的 研究美他多辛片的穩定性,為藥品儲存、有效期的確定提供實驗依據.方法 採用HPLc法測定美他多辛片中美他多辛的含量.通過光照試驗、加速試驗和長期試驗,應用動力學公式Arrhenius方程及統計學原理計算齣K25℃和預測藥品有效期.結果 美他多辛片對光不穩定.預測有效期與長期試驗結果相吻閤.結論 美他多辛片在避光、室溫條件下儲存的有效期為24箇月.
목적 연구미타다신편적은정성,위약품저존、유효기적학정제공실험의거.방법 채용HPLc법측정미타다신편중미타다신적함량.통과광조시험、가속시험화장기시험,응용동역학공식Arrhenius방정급통계학원리계산출K25℃화예측약품유효기.결과 미타다신편대광불은정.예측유효기여장기시험결과상문합.결론 미타다신편재피광、실온조건하저존적유효기위24개월.
To provide a experimental basis for the determination of the period of validity and identify drugs storage conditions, the stability of metadoxine tablets were determined. Methods: Its contents were determined with HPLC Determination. The stability of metadoxine tablets were determined by the light test, the accelerate test and long-term tests, application of the formula of Arrhenius and the statistical principle for equation to calculate K25℃ and predict drug valid. Results: Metadoxine tablets were not stable in the case of light. The results of long-term tests is consistented with the predicated drug valid. Conclusions: The predicated effective deadline is twenty-four monthes at room temperature, protected from light.
