Moest T, Dechow H J, Pich C H
Arzneimittelforschung. 1981;31(9a):1623-38.
Besides the characterization of the active ingredient 4-amino-6-methoxy-1-phenmyl-pyridazinium methyl sulfate (ameziuniummetilsulfate, LU 1631, Regulton) the formulation and process development for tablets containing 10 mg active substance are described. The mixing behaviour of the ingredients and the compressing properties of the resulting directly compressible mixture are elucidated so that a reliable and reproducible manufacturing process is ensured. The quality of the active substance and tablet is described in detail and the stability for up to five years is demonstrated. The analytical specifications used are given.
除了对活性成分4-氨基-6-甲氧基-1-苯基哒嗪硫酸甲酯（阿美齐铵硫酸甲酯，LU 1631，Regulton）进行表征外，还描述了含10mg活性物质片剂的配方和工艺开发。阐明了各成分的混合行为以及所得直接压片混合物的压缩性能，从而确保了可靠且可重复的制造工艺。详细描述了活性物质和片剂的质量，并证明了长达五年的稳定性。给出了所使用的分析规范。
