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美他多辛片的稳定性研究

Studies on sability of Metadoxine Tablets.

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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.
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.

Metadoxine TabletsStabilityPeriod of ValidityLight TestAccelerate TestLong-term Tests

王丽、杜笑、刘杰、翟海民

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山东齐都药业有限公司,山东淄博,255400

美他多辛片 稳定性 有效期 光照试验 加速试验 长期试验

2009

中国医药技术经济与管理
中国科学技术信息研究所(ISTIC) 科学技术文献出版社

中国医药技术经济与管理

ISSN:1673-9809
年,卷(期):2009.3(7)
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