Stoianov K
Vet Med Nauki. 1979;16(2):74-80.
Laboratory and clinical studies were carried out to elucidate the anaphylactogenic qualities of the Bulgarian goinadotropic preparations PMS (an untreated and a freeze-dried formula), gravohormone, and luteoziman. Comparatively was assessed the sensitivity of three methods employed in the routine determination of drug anaphylactogenicity. One of them is the author's personal modification of a pharmacopeia method (U. S. P. XVII)--sensibilizing doses were introduced in guinea pigs subcutaneously, once daily, in the course of three days at 3-day intervals. The resolution dose was applied intraperitoneally on the 10th day following the last sensibilizing dose. The manifestation of anaphylaxia were recorded immediately after the introduction of the resolution dose or two hours later (at the very latest). Studies revealed that the preparations tested had no equal anaphylactic properties. In guinea pigs, sheep, and cattle PMS induced allergic reactions in 50 per cent of the examined series. In these animals both gravohormone and luteoziman did not generate such response. Suggested is the use of a U. S. P. XVII modified method (as cited above) to determine the anaphylactogenicity of gonadotropic preparations; it makes it possible to qualify such preparations for a shorter time. The new modification is readily applicable at a production control basis.
开展了实验室和临床研究，以阐明保加利亚促性腺激素制剂PMS（一种未处理的和一种冻干配方）、gravohormone和luteoziman的致过敏特性。对常规测定药物致过敏特性所采用的三种方法的敏感性进行了比较评估。其中一种是作者对药典方法（美国药典第十七版）的个人改进——致敏剂量以皮下注射方式给予豚鼠，每天一次，连续三天，间隔三天。在最后一次致敏剂量后的第10天腹腔注射消退剂量。在注射消退剂量后或两小时后（最迟）立即记录过敏反应的表现。研究表明，所测试的制剂没有同等的过敏特性。在豚鼠、绵羊和牛中，PMS在50%的受试组中引发了过敏反应。在这些动物中，gravohormone和luteoziman均未产生此类反应。建议采用美国药典第十七版改进方法（如上所述）来测定促性腺激素制剂的致过敏特性；这使得能够在更短时间内对这类制剂进行鉴定。这种新的改进方法易于应用于生产控制。
