Abstract

Background

Clinical studies have reported inconsistent outcomes of glucosamine therapy in osteoarthritis patients. One possible reason could be the use of glucosamine products of varying quality.

Objective

Hence, this study aimed to assess the quality of glucosamine products marketed in Australia and India. This is the first study to investigate both the content and dissolution profiles of glucosamine products.

Method

The content and dissolution analysis of Australian (n = 25 brands) and Indian (n = 21 brands) glucosamine products was performed according to the criteria specified in the United States Pharmacopoeia (USP).

Results

The quality analysis revealed that 16% and 18% of Australian brands, as well as 24% and 19% of Indian brands, did not fulfil the USP content and dissolution criteria, respectively. In approximately half of these cases, the glucosamine content was only slightly below (<3%) that specified by the USP and dissolution was achieved within 15 min after the duration specified by the USP.

Conclusions

The majority of the brands did meet both the content and dissolution analysis criteria of the USP. The extent of deviation from the specified criteria for the other brands was probably insufficient to account for the significant variability in clinical effects. Hence, the study proposed that inter-patient pharmacokinetic variations in glucosamine could be another potential reason for inconsistent therapeutic effects.

Highlights

• Glucosamine is widely used in osteoarthritis, despite variable outcomes in trials.
• Quality analysis was performed to test Australian and Indian brands of glucosamine.
• The majority fulfilled content and dissolution criteria.
• The quality of products is unlikely to explain variable outcomes with glucosamine

中文翻译：

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氨基葡萄糖产品的质量：是骨关节炎临床结果不一致的潜在原因吗？

抽象的

背景

临床研究报告了骨关节炎患者中葡萄糖胺疗法的预后不一致。一种可能的原因可能是使用了质量不一的葡糖胺产品。

客观的

因此，本研究旨在评估在澳大利亚和印度销售的氨基葡萄糖产品的质量。这是首次研究葡萄糖胺产品的含量和溶出曲线的研究。

方法

根据美国药典（USP）中指定的标准，对澳大利亚（n  =  25个品牌）和印度（n  =  21个品牌）葡糖胺产品进行了含量和溶出度分析。

结果

质量分析显示，分别有16％和18％的澳大利亚品牌以及24％和19％的印度品牌不符合USP含量和溶出度标准。在这些情况的大约一半中，氨基葡萄糖含量仅略低于USP规定的含量（<3％），并且在USP指定的持续时间后15分钟内即可达到溶解状态。

结论

大多数品牌确实符合USP的含量和溶出度分析标准。与其他品牌的指定标准偏离的程度可能不足以说明临床效果的显着差异。因此，该研究提出，患者体内葡萄糖胺的药代动力学变化可能是治疗效果不一致的另一个潜在原因。

强调

• 尽管试验结果不尽相同，但氨基葡萄糖仍广泛用于骨关节炎。
• 进行质量分析以测试澳大利亚和印度品牌的葡萄糖胺。
• 大多数满足含量和溶出度标准。
• 产品的质量不太可能解释葡萄糖胺的可变结果