[Anaphylactogenic properties of Bulgarian gonadotropic preparations]

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.