Dechow H J, Lämmerhirt K, Pich C H, Schikarski M
Arzneimittelforschung. 1980;30(10):1738-46.
An account if given of the aim of the galenical development of the new remedy, indanazolin nose-spray. The description of the quality of the active ingredient N-(2-imidazolin-2-yl)-N-(4-indanyl)amine monohydrochloride (indanazoline, Farial) and the dosage form allows a pharmaceutical evaluation. The descriptions of the organoleptic, physical and chemical properties of the active substance are given in detail. The formulation, the procedures for manufacturing, and the specifications for the packaging materials give some idea of the galenical aspects. The quality of the finished dosage form is defined by means of product specifications relating to the identity, purity, and potency, and is proved by suitably designed stability studies. Finally a detailed summary is made of the analytical methods which were used.
介绍了新型药物茚达唑啉鼻喷雾剂的盖伦制剂研发目的。对活性成分N-(2-咪唑啉-2-基)-N-(4-茚满基)胺盐酸盐（茚达唑啉，法里亚尔）的质量描述以及剂型进行了药物评价。详细给出了活性物质的感官、物理和化学性质描述。制剂配方、生产工艺以及包装材料规格体现了盖伦制剂方面的一些情况。成品剂型的质量通过与鉴别、纯度和效价相关的产品规格来界定，并通过精心设计的稳定性研究加以证明。最后对所使用的分析方法进行了详细总结。
