Chondroitin product selection for the glucosamine/chondroitin arthritis intervention trial
Chondroitin product selection for the glucosamine/chondroitin arthritis intervention trial
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DOI：
10.1331/154434506775268616
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发表时间：
2006-01-01
影响因子：
2.1
通讯作者：
Clegg, Daniel O.
中科院分区：
文献类型：
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作者：
Barnhill, Jamie G.;Fye, Carol L.;Clegg, Daniel O.
目的：为美国国立卫生研究院的葡萄糖胺/软骨素关节炎干预试验（步态）选择高质量的软骨素剂型和/或适当的软骨素钠来源。设计：对照实验试验。设置:实验室。患者或参与者：不适用。干预措施:对市售的软骨素产品进行了回顾，并通过测试(红外和近红外识别、水分含量、pH值、旋光性、粉末制备的水溶液的颜色和清晰度、蛋白质污染、着火后总残留物和氮含量、软骨素钠分子量测定、双糖分析和软骨素、钠、总糖胺聚糖含量)和现场供应商审核。主要观察指标：软骨素钠粉的纯度、效力和质量。结果：没有市售的软骨素产品被认为适合用于步态。来自两家供应商的软骨素钠粉末样品显示出相似的双糖和糖胺聚糖含量。每种含有大约2%的透明质酸和8%-9%的无硫双糖。不同组间效价不一致，可能与分析方法和标准品选择不同有关。五种不同方法获得的平均效价范围为：一种供应商的82.2%至95.5%，另一种供应商的92.5%至110.1%，市售标准品的95.1%至112.5%。结果提出的关键问题包括参考标准的选择，测定方法的选择，以及来自一个供应商的所有三个批次中出现的不可识别污染物的一致外观。结论：这项盲法研究确定了确定可接受药物的方法，并提供了结果，除了符合法规的供应商审计外，还形成了步态中软骨素产品选择的基础。
Objective: To select a high-quality chondroitin dosage form and/ or an appropriate source of sodium chondroitin for the National Institutes of Health's Glucosamine/ Chondroitin Arthritis Intervention Trial ( GAIT).Design: Controlled experimental trials.Setting: Laboratory.Patients or Participants: Not applicable.Interventions: Commercially available chondroitin products were reviewed, and purified sodium chondroitin from two suppliers was evaluated through tests ( infrared and near-infrared identification, moisture content, pH, optical rotation, color and clarity of aqueous solutions prepared from the powders, protein contamination, total residue following ignition and nitrogen content, determination of sodium chondroitin molecular weight, disaccharide analysis, and measurement of chondroitin, sodium, and total glycosaminoglycan content) and an onsite supplier audit.Main Outcome Measures: Purity, potency, and quality of sodium chondroitin powders.Results: No commercially available chondroitin product was deemed appropriate for use in GAIT. Samples of sodium chondroitin powder from two suppliers exhibited similar disaccharide and glycosaminoglycan content. Each contained approximately 2% hyaluronic acid and 8%-9% unsulfated disaccharide. Potency was inconsistent across groups, which might have resulted from different analytical methods and choice of reference standard. Mean potency obtained by five separate methods ranged from 82.2% to 95.5% for one supplier, 92.5% to 110.1% for another, and 95.1% to 112.5% for a commercially obtained reference standard. Critical issues raised by the results include choice of reference standard, selection of assay method, and the consistent appearance of an unidentifiable contaminant present in all three lots from one supplier.Conclusion: This blinded study determined methods to identify acceptable agents and provided results, which, in addition to regulatory compliance supplier audits, formed the basis for chondroitin product selection in GAIT.