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现在生物利用度试验已在许多制剂研究和生产中应用。本文介绍两种常用的生物利用度试验法供参考。根据有关资料记载,以下几类药物制剂需进行生物利用度试验:(1)制剂的有效药物的治疗剂量与中毒剂量较接近的;(2)药物的溶解度小的;(3)多晶型药物制成的制剂;(4)制剂工艺对药物溶出速率有影响的制剂;(5)制剂工艺处方有改变的(如使用新辅料、新材料改变制剂剂型);(6)脂溶性差的药物制利;(7)新药上临
Bioavailability tests are now used in many formulation studies and manufacturing. This article describes two commonly used bioavailability test methods for reference. According to the data records, the following types of pharmaceutical preparations need to be bioavailability test: (1) the effective dose of the preparation of the drug dose and poisoning dose closer; (2) the drug solubility is small; (3) polymorphic drugs (4) the formulation process on the dissolution rate of the drug formulations; (5) preparation of prescriptions have changed (such as the use of new materials, new materials to change the formulation); (6) poor fat-soluble drugs Lee; (7) new drugs on the scene