英国地高辛片剂的治疗不等效性：与片剂溶出率的相关性。
Therapeutic non-equivalence of digoxin tablets in the United Kingdom: correlation with tablet dissolution rate.
作者信息
Shaw T R, Raymond K, Howard M R, Hamer J
出版信息
Br Med J. 1973 Dec 29;4(5895):763-6. doi: 10.1136/bmj.4.5895.763.
Abstract
Seven types of digoxin 0.25 mg tablet in common use in the United Kingdom were administered to a total of 38 patients. Significant differences were found in the mean plasma digoxin levels and in the control of atrial fibrillation achieved with these brands. There was a close correlation between the dissolution rate of the tablets and the plasma digoxin levels. Measurement of in-vitro dissolution rate appears to be a valid method of ensuring that different tablets of digoxin are of equal efficacy. However, in some patients absorption of the drug is markedly sensitive to changes in dissolution rate and new pharmacopoeal standards should not be defined until very rapidly-dissolving formulations have been studied.
摘要
英国常用的7种0.25毫克地高辛片剂被给予了总共38名患者。这些品牌的地高辛在平均血浆地高辛水平以及房颤控制方面存在显著差异。片剂的溶出率与血浆地高辛水平之间存在密切相关性。体外溶出率的测定似乎是确保不同地高辛片剂具有同等疗效的有效方法。然而，在一些患者中，药物的吸收对溶出率的变化明显敏感，在对速溶制剂进行研究之前，不应确定新的药典标准。
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本文引用的文献
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Plasma digoxin concentrations in patients with atrial fibrillation.心房颤动患者的血浆地高辛浓度。
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