不同贮存条件下蝎子抗蛇毒血清的疗效和稳定性

Dhia El-Hag, M. Rak
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引用次数: 3

摘要

本研究的目的是考察蝎子抗蛇毒血清品牌的有效性和稳定性。对同一批次的蝎子抗蛇毒血清样品进行了多次试验。这些样本又被分成两组。第一组在实际储存条件下(3±2°C)干燥储存区域储存,而第二组在加速储存条件下(25±3°C, RH75%)储存。在这两种条件下采集的许多样品都进行了化学测试,通过测定pH值、间甲酚防腐剂水平、聚丙烯酰胺凝胶电泳(PAGE)测定白蛋白含量和测量蛋白质含量。这些样品还进行药理学测试,以确定效力,测量LD50(致死剂量,杀死50%的试验动物),热原测试,无菌测试和异常毒性。实时保存条件(3±2°C)和加速保存条件(25±3°C, RH75%)下的抗蛇毒血清样品在效价、pH值、无菌性、防腐剂含量、药理作用和疗效方面均无显著变化。
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Efficacy and Stability of Scorpion Antivenom: At Different Storage Conditions
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.
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