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发表于 2023-12-15 10:12:06
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Allergen Extract Stability Following Short Term Temperature Variations
G.A. Plunkett
M. Schell
RATIONALE: To maintain stability allergen extracts should be stored refrigerated. Occasionally extracts can experience appliance failures, power outages or shipping delays. The standardized products have been studied to address such short term non-refrigerator temperatures. Information for a wide range of extracts is limited. This study extends potency determinations to non-standardized extracts exposed to elevated temperatures and freezing.
METHODS: Four non-standardized aqueous and glycerinated allergenic extracts and five standardized extracts were placed at 2-8°C, 25°C(RT) and 40°C for 3 and 6 days. Aqueous birch and grass extracts were frozen. 1:100v/v dilutions in normal saline and human serum albumin (HSA) were also studied. Potency was measured using major allergen ELISAs developed by ALK-Abelló. IgE binding assays and SDS-PAGE were also used to assess stability.
RESULTS: All of the glycerinated 1:20w/v and standardized major allergens maintained their stability at the elevated temperatures with only a decrease in Cyn d 1 at 40°C for Bermuda. The 1:10w/v extracts maintained more than 75% of the allergen content at RT for 3 days. At 40°C, the ragweed, olive and English plantain lost up to 50% of the allergen content at 3 days. The 1:100v/v saline samples showed reduced activity at the elevated temperature but HSA provided more stability with only the grasses and Der p 1 dropping below 60%. The 1:10w/v birch extract lost all Bet v 1 content after being frozen.
CONCLUSIONS: Elevated temperatures for up to 6 days can result in loss of major allergen content in some aqueous extracts but not glycerinated extracts. Freezing aqueous extracts can be very detrimental to potency.
基本原理:为了保持稳定性,过敏原提取物应冷藏保存。 有时,提取可能会遇到设备故障、断电或运输延误的情况。 已对标准化产品进行了研究,以解决此类短期非冰箱温度问题。 各种摘录的信息是有限的。 这项研究将效力测定扩展到暴露于高温和冷冻的非标准化提取物。
方法:将四种非标准化水性甘油化过敏提取物和五种标准化提取物置于 2-8°C、25°C(RT)和 40°C 下 3 和 6 天。 将桦树和草的水提取物冷冻。 还研究了以 1:100v/v 稀释的生理盐水和人血清白蛋白 (HSA)。 使用 ALK-Abelló 开发的主要过敏原 ELISA 测量效力。 IgE 结合测定和 SDS-PAGE 也用于评估稳定性。
结果:所有甘油化 1:20w/v 和标准化主要过敏原在高温下均保持稳定性,仅百慕大的 Cyn d 1 在 40°C 时有所下降。 1:10w/v 提取物在室温下保持 75% 以上的过敏原含量 3 天。 在 40°C 的温度下,豚草、橄榄和英国大蕉在 3 天后损失了高达 50% 的过敏原含量。 1:100v/v 盐水样品在高温下表现出活性降低,但 HSA 提供了更高的稳定性,只有草和 Der p 1 降至 60% 以下。 1:10w/v 桦木提取物在冷冻后失去了所有 Bet v 1 含量。 |
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