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反式白藜芦醇和反式白藜芦醇苷(藜芦醇苷)的制剂前稳定性。

Preformulation stability of trans-resveratrol and trans-resveratrol glucoside (Piceid).

机构信息

Upsher-Smith Laboratories, Inc, 6701 Evenstad Drive, Maple Grove, Minnesota 55369, USA.

出版信息

J Agric Food Chem. 2010 Feb 10;58(3):1685-90. doi: 10.1021/jf903009f.

DOI:10.1021/jf903009f
PMID:20055412
Abstract

Resveratrol and resveratrol glucoside (piceid) were evaluated in a preformulation stability study. An HPLC assay was used for the analysis of stressed/reference samples. Samples of solid, crystalline material were held under the following conditions: 40 degrees C/75% RH (both open and protected), ambient fluorescent light (open), 70 degrees C (open), and exposed using a light cabinet to achieve ICH conditions for UV/fluorescent light. Both compounds were found to be stable out to 3 months for both accelerated and ambient conditions with negligible degradation. Exposure to UV and fluorescent light under ICH conditions did not significantly degrade the solid materials for UV exposure at 3 times the ICH limit and for fluorescent light exposure at 1 times the ICH limit. The results presented demonstrate crystalline resveratrol and piceid are stable solids. No evidence of oxidation of either material by atmospheric oxidants was seen. The data reported may help to clarify widely held beliefs that resveratrol is unstable and extremely sensitive to oxidation/degradation.

摘要

白藜芦醇和白藜芦醇苷(藜芦醇苷)在预配方稳定性研究中进行了评估。采用 HPLC 分析方法对受应力/对照样品进行分析。将固态、结晶物质的样品置于以下条件下:40°C/75% RH(开放和保护)、环境荧光光(开放)、70°C(开放),并使用光照箱暴露于达到 ICH 规定的 UV/荧光光条件下。结果发现,两种化合物在加速和环境条件下均稳定 3 个月,降解可忽略不计。在 ICH 条件下暴露于 UV 和荧光光下,不会显著降解固体材料,对于 UV 暴露,其暴露量是 ICH 限制的 3 倍,对于荧光光暴露,其暴露量是 ICH 限制的 1 倍。所呈现的结果表明,结晶白藜芦醇和藜芦醇苷是稳定的固体。没有看到两种物质被大气氧化剂氧化的证据。所报告的数据可能有助于澄清人们普遍认为的白藜芦醇不稳定且极易氧化/降解的观点。

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