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醋酸地塞米松为甾体激素类药物,《中国药典》1995年版规定,原料为HPLC法测定含量,而片剂仍然沿用传统的紫外法测定。我们通过对本市两家制药厂生产的醋酸地塞米松片含量及含量均匀度有关数据进行了统计对比,发现其含量测定所得平均含量与含量均匀度测定所得平均含量有显著的差异(n=28,n=13,P<0.05),平均相差2.69％和6.97％,且据厂方反映,其测得的颗粒含量和片剂含量常高于投料理论值的5％～10％。这说明醋酸地塞米松片在生产过程中引入了某种干扰因素,从而使含量测定结果升高。
Dexamethasone acetate is a steroid hormone drugs, “Chinese Pharmacopoeia” 1995 edition provides that the raw material for the determination of HPLC content, while the tablet still follow the traditional UV method. We conducted a statistical comparison between the contents of dexamethasone acetate tablets and the evenness of contents produced by the two pharmaceutical factories in this Municipality and found that there was a significant difference between the average content of the dexamethasone acetate and the content average content (n = 28 , n = 13, P <0.05), the average difference of 2.69% and 6.97%, and according to the factory, the measured particle content and tablet content is often higher than the expected theoretical value of 5% to 10%. This shows that dexamethasone acetate tablets in the production process introduced some kind of interference factors, so that the content determination results.