Horváth Péter, Elekné Vörös Zsuzsanna, Sinkó Bálint, Vámos József, Takácsné Novák Krisztina
Semmelweis Egyetem, Gyógyszerészi Kémiai Intézet, Budapest.
Acta Pharm Hung. 2006;76(2):86-94.
Quality controll has fundamental importance in drug safety. During the last 15 years the regulatory changes resulted many problems in the quality controll of pharmaceutical preparations manufactured in pharmacys. The issue of Formulae Normales (FoNo VII.) and the 8th Hungarian Pharmacopoeia raises further questions. Our intentions to show the results have been achived in the area of elaborating new analytical prescriptions (identification and assay) which are crucial due to the obsolescence of previously used prescriptions.
质量控制在药物安全方面具有根本重要性。在过去15年中，监管变化给药房生产的药物制剂质量控制带来了诸多问题。《标准配方（FoNo VII.）》和第8版匈牙利药典的问题引发了更多疑问。我们意在展示在制定新的分析方法（鉴别和含量测定）方面所取得的成果，由于先前使用的方法过时，这些新方法至关重要。
