ファーマシューティカ アナリティカ アクタ

概要

Efficacy and Stability of Scorpion Antivenom: At Different Storage Conditions

Elhag DE and Mahmoud RAK

The aim of this study was to investigate the efficacy and stability of scorpion antivenom brand. Several tests were applied on scorpion antivenom samples obtained from the same batch. The samples were subdivided into two groups. The first group was stored at real storage conditions i.e. at (3 ± 2°C) dry storage areas while the second group was subjected to accelerated storage conditions i.e. (25 ± 3°C, RH75%). Many samples taken from both conditions were tested chemically through determining the pH values, m-cresol preservative levels, albumin content by polyacryl amide gel electrophoresis (PAGE) and measuring the protein content. These samples were also tested pharmacologically for determining the potency, measuring the LD50 (lethal dose which kills 50% of the test animals), pyrogen testing, sterility testing and abnormal toxicity. The results obtained from both chemical and pharmacological tests using antivenom samples stored at real time storage condition (3 ± 2°C) and accelerated storage condition (25 ± 3°C, RH75%) showed no significant changes in terms of potency, pH values, sterility, preservative content, the pharmacological effect and efficacy.