Chao Ming-Yu, Liu Kung-Tien, Hsia Yi-Chih, Liao Mei-Hsiu, Shen Lie-Hang
Chemical Analysis Division, Institute of Nuclear Energy Research, Taoyuan, Taiwan.
J Biomed Biotechnol. 2011;2011:196238. doi: 10.1155/2011/196238. Epub 2011 Jun 9.
Technetium-99m ethyl cysteinate dimer (Tc-99m-ECD) is an essential imaging agent used in evaluating the regional cerebral blood flow in patients with cerebrovascular diseases. Determination of active pharmaceutical ingredient, that is, L-Cysteine, N, N'-1,2-ethanediylbis-, diethyl ester, dihydrochloride (ECD) in ECD Kit is a relevant requirement for the pharmaceutical quality control in processes of mass fabrication. We here presented a direct solid sample determination method of ECD in ECD Kit without sample dissolution to avoid the rapid degradation of ECD. An elemental analyzer equipped with a nondispersive infrared detector and a calibration curve of coal standard was used for the quantitation of sulfur in ECD Kit. No significant matrix effect was found. The peak area of coal standard against the amount of sulfur was linear over the range of 0.03-0.10 mg, with a correlation coefficient (r) of 0.9993. Method validation parameters were achieved to demonstrate the potential of this method.
锝-99m 半胱氨酸乙酯二聚体（Tc-99m-ECD）是一种用于评估脑血管疾病患者局部脑血流量的重要显像剂。测定 ECD 试剂盒中的活性药物成分，即 L-半胱氨酸，N，N'-1,2-乙二基双-，二乙酯，二盐酸盐（ECD），是大规模生产过程中药物质量控制的一项相关要求。我们在此提出了一种无需样品溶解的直接固体样品测定 ECD 试剂盒中 ECD 的方法，以避免 ECD 的快速降解。配备非色散红外探测器的元素分析仪和煤标准品校准曲线用于定量 ECD 试剂盒中的硫。未发现明显的基质效应。煤标准品的峰面积与硫含量在 0.03 - 0.10 mg 范围内呈线性关系，相关系数（r）为 0.9993。获得了方法验证参数以证明该方法的潜力。
