Takahashi N, Shibahara T, Shiragiku T, Kanbe T, Kanbe K, Sugawara M, Yamashita S
Drug Safety Research Center, Tokushima Research Institute, Japan.
Arzneimittelforschung. 1995 Feb;45(2):195-7.
The fluoroquinolone antibacterial agent, nadifloxacin (NDFX, CAS 124858-35-1), is a racemic compound. The storage effect on the in vitro clastogenicity of a solution of the racemic compound and a mixture solution of the optical isomers of NDFX, prepared by mixing equal amounts of S- and R-enantiomers, was investigated. The potential of NDFX and the enantiomer mixture, prepared from equal amounts of each S- and R-enantiomer, to induce chromosomal aberrations in vitro was investigated in cultured fibroblasts derived from Chinese hamster lung cells immediately, 2 and 4 weeks after preparation of the test solutions (stored at 20 degrees C, protected from light) using 24 h of continuous treatment method. In the results, NDFX did not significantly increase the incidence of chromosomal aberrations at 200 micrograms/ml regardless of the storage period. On the other hand, the mixture significantly increased the incidence of chromosomal aberrations at 200 micrograms/ml immediately after preparation to an extent similar to that of S-enantiomer alone, but the mixture did not do so after 2 and 4 weeks of storage. Neither S- nor R-enantiomer changed the chromosomal aberration inducibility during storage. The content and optical purity of the test substances in each test solution also did not change during storage. These facts suggested that the molecular condition of each optical isomer in the mixture solution became equivalent to that in the racemic solution during storage periods.
氟喹诺酮类抗菌剂那氟沙星(NDFX,CAS 124858 - 35 - 1)是一种外消旋化合物。研究了储存对该外消旋化合物溶液以及通过等量混合S - 和R - 对映体制备的那氟沙星光学异构体混合溶液体外致断裂性的影响。采用24小时连续处理法,在制备测试溶液(于20℃储存,避光)后立即、2周和4周,对由中国仓鼠肺细胞衍生的培养成纤维细胞中,等量的S - 和R - 对映体制备的那氟沙星及其对映体混合物诱导染色体畸变的潜力进行了研究。结果显示,无论储存时间长短,200微克/毫升的那氟沙星均未显著增加染色体畸变的发生率。另一方面,混合物在制备后立即以与单独的S - 对映体相似的程度显著增加了200微克/毫升时的染色体畸变发生率,但在储存2周和4周后未出现这种情况。在储存期间,S - 和R - 对映体均未改变其诱导染色体畸变的能力。各测试溶液中测试物质的含量和光学纯度在储存期间也未发生变化。这些事实表明,在储存期间,混合溶液中各光学异构体的分子状态与外消旋溶液中的分子状态变得等效。