皮内药物试验用药物制剂

S. Ménétré, S. Robert, B. Demoré
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引用次数: 1

摘要

过敏科的医学皮肤试验全部由我科药物科负责。生产在特定的场所进行,使用合格和校准的设备,由合格和定期评估的工作人员按照法国制备指南进行。整个活动由药剂师负责,由医院的药学技术人员进行处理。每一项新的皮内皮肤试验需求都会导致可行性分析——刺激性、稀释溶剂、浓度——这些信息都会被收集到辞典中。生产步骤如下:处方验证,生产单和标签印刷,所需设备的准备,批号和有效期检查,在垂直层流罩下处理和生产后的控制。制剂活性不断增加,目前词典内容为302行,包括药物、稀释和重构溶剂、纯溶液浓度和皮内试验的最大浓度。在降低成本和优化资源方面有一定的前景。由于过敏症专家的信任,两个部门之间的合作可以继续下去。这保证了在患者身上测试的制剂的质量,也保证了皮肤测试的可重复性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Pharmaceutical Preparations for Intradermal Drug Tests
Abstract Our department of pharmacy takes over all the medical skin tests prescribed by the allergy department. The production takes place in specific premises, with qualified and calibrated equipment, by a qualified and regularly assessed staff—in compliance with the French preparation guidelines. The whole activity is under the responsibility of a pharmacist—handlings are performed by hospital pharmacy technicians. Each new intradermal skin test demand leads to a feasibility analysis—irritating nature, dilution solvent, concentration—this information is gathered in a thesaurus. The manufacturing steps are the following: prescription validation, production sheet and label printing, preparation of the needed equipment, batch numbers and expiration date checking, handling under a vertical laminar flow hood and control after production. The preparation activity increases continuously and the thesaurus currently contents 302 rows with following information: drug, dilution and reconstitution solvent, pure solution concentration and maximum concentration to test with intradermal tests. Work would prospect in costs reduction and resources optimization. Thanks to the allergists’ confidence, the partnership between the two departments can go on. This guarantees the quality of the preparations tested on patients but also the skin tests reproducibility.
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