Dermody W C, Pastushok C A, Sakowski R, Vaitkus J W, Reel J R
J Pharm Sci. 1977 Mar;66(3):386-8. doi: 10.1002/jps.2600660319.
Selected synthetic luteinizing hormone releasing hormone preparations were assayed, and their potencies were determined relative to one sample utilizing primary cultures of enzymatically dispersed rat anterior pituitary cells. Preliminary cell culture experiments indicated that luteinizing hormone releasing hormone had to be in constant contact with cells for continued luteinizing hormone secretion. Luteinizing hormone levels in media reached a maximum concentration after 4 hr of continuous luteinizing hormone releasing hormone exposure. Cell culture bioassay was selected over the bioassay employing chronically ovariectomized steroid-blocked rats due to greater sensitivity and economy. The assay of each luteinizing hormone releasing hormone preparation was replicated four to seven times. Preparations from several companies were less potent (p less than 0.05) than the reference product. Contaminants were disclosed by TLC in preparations with potencies lower than the reference product.
对选定的合成促黄体生成素释放激素制剂进行了测定,并相对于使用酶分散的大鼠垂体前叶细胞原代培养物的一个样品确定了它们的效价。初步细胞培养实验表明,促黄体生成素释放激素必须与细胞持续接触才能持续分泌促黄体生成素。在持续暴露于促黄体生成素释放激素4小时后,培养基中的促黄体生成素水平达到最大浓度。由于更高的灵敏度和经济性,选择细胞培养生物测定法而非采用长期卵巢切除的类固醇阻断大鼠的生物测定法。每种促黄体生成素释放激素制剂的测定重复进行4至7次。几家公司的制剂效价比参考产品低(p小于0.05)。在效价低于参考产品的制剂中,通过薄层色谱法发现了污染物。