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地高辛片与地高辛胶丸给药方案的可比性。

The comparability of dosage regimens of Lanoxin tablets and Lanoxicaps.

作者信息

Johnson B F, Smith G, French J

出版信息

Br J Clin Pharmacol. 1977 Apr;4(2):209-11. doi: 10.1111/j.1365-2125.1977.tb00696.x.

Abstract

1 Twice daily administration of 0.25 mg digoxin tablets (Lanoxin) or of 0.2 mg digoxin in solution in soft gelatin capsules (Lanoxicaps) produced similar mean steady state plasma digoxin concentrations in ten healthy volunteers. Respective values were 1.07 +/- 0.075 and 0.95 +/- 0.048 ng ml-1. 2 During continued administration, peak plasma concentrations occurred earlier after capsules with a tendency to higher peak levels. However, area under curve determinations over 7 h were similar. 3 Approximately 10% less digoxin was recovered in urine collected in a 12 h dosage interval during the lower dosage administration of capsules. Mean percentage urinary recovery of administered dose was 57% for tablets and 65% for capsules. 4 The enhanced bioavailability of Lanoxicaps was associated with reduced between-subject variability in plasma concentration. 5 Lanoxicaps (0.2 mg) should be approximately equivalent in effect to digoxin tablets (0.25 mg) currently available in the United Kingdom, though improved consistency would be anticipated.

摘要
  1. 对10名健康志愿者每日两次服用0.25毫克地高辛片(Lanoxin)或服用装在软胶囊中的0.2毫克地高辛溶液(Lanoxicaps),产生的平均稳态血浆地高辛浓度相似。各自的值分别为1.07±0.075和0.95±0.048纳克/毫升。2. 在持续给药期间,服用胶囊后血浆峰值浓度出现得更早,且峰值水平有更高的趋势。然而,7小时内的曲线下面积测定结果相似。3. 在较低剂量服用胶囊期间,在12小时给药间隔收集的尿液中回收的地高辛约少10%。给药剂量的平均尿回收率片剂为57%,胶囊为65%。4. Lanoxicaps生物利用度的提高与血浆浓度受试者间变异性的降低有关。5. Lanoxicaps(0.2毫克)的效果应与英国目前可用的地高辛片(0.25毫克)大致相当,不过预计其一致性会有所改善。

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引用本文的文献

2
The comparative bioavailability of Lanoxin tablets and Lanoxicaps with and without sorbitol.
Eur J Clin Pharmacol. 1978 Dec 18;14(5):357-60. doi: 10.1007/BF00611906.

本文引用的文献

1
Rate of dissolution of digoxin tablets as a predictor of absorption.
Lancet. 1973 Jun 30;1(7818):1473-5. doi: 10.1016/s0140-6736(73)91811-4.
3
A completely absorbed oral preparation of digoxin.
Clin Pharmacol Ther. 1976 Jun;19(6):746-51. doi: 10.1002/cpt1976196746.
4
Superior bioavailability of digoxin solution in capsules.
Clin Pharmacol Ther. 1975 Dec;18(6):761-8. doi: 10.1002/cpt1975186761.

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