Soumyanath Amala, Denne Tanya, Hiller Amie, Ramachandran Shaila, Shinto Lynne
1 Department of Neurology, Oregon Health and Science University , Portland, OR.
2 Parkinson's Disease Research, Education and Clinical Center, Veterans Affairs Medical Center , Portland, OR.
J Altern Complement Med. 2018 Feb;24(2):182-186. doi: 10.1089/acm.2017.0054. Epub 2017 Sep 18.
Mucuna pruriens (MP) seeds contain levodopa (up to 2% by weight) and have been used in traditional Indian medicine to treat an illness named "Kampavata," now understood to be Parkinson's disease (PD). Studies have shown MP to be beneficial, and even superior, to levodopa alone in treating PD symptoms. Commercial products containing MP are readily available from online and retail sources to patients and physicians. Products often contain extracts of MP seeds, with significantly higher levodopa content than the seeds. However, MP products have limited regulatory controls with respect to quality and content of active ingredient. The aim of this study was to apply a quantitative method to determine levodopa content in readily available MP products that might be used by patients or in research studies.
Levodopa present in six commercial MP products was quantified by solvent extraction followed by reversed-phase high-performance liquid chromatography (HPLC) coupled to fluorescence detection (FD). Certificates of analysis (COA) were obtained, from manufacturers of MP products, to assess the existence and implementation of specifications for levodopa content.
HPLC-FD analysis revealed that the levodopa content of the six commercial MP products varied from 6% to 141% of individual label claims. No product contained levodopa within normal pharmacopeial limits of 90%-110% label claim. The maximum daily dose of levodopa delivered by the products varied from 14.4 to 720 mg/day. COAs were inconsistent in specifications for and verification of levodopa content.
The commercial products tested varied widely in levodopa content, sometimes deviating widely from the label claim. These deficiencies could impact efficacy and safety of MP products used by PD patients and compromise the results of scientific studies on MP products. The HPLC-FD method described in this study could be utilized by both manufacturers and scientific researchers to verify levodopa content of MP products.
黎豆种子含有左旋多巴(重量比高达2%),在印度传统医学中用于治疗一种名为“Kampavata”的疾病,现在认为该疾病就是帕金森病(PD)。研究表明,在治疗帕金森病症状方面,黎豆比单独使用左旋多巴更有益,甚至更具优势。含有黎豆的商业产品在网上和零售渠道很容易买到,患者和医生都可以获取。这些产品通常含有黎豆种子提取物,其左旋多巴含量明显高于种子。然而,黎豆产品在活性成分的质量和含量方面的监管控制有限。本研究的目的是应用一种定量方法来测定患者可能使用的或用于研究的市售黎豆产品中的左旋多巴含量。
通过溶剂萃取,然后采用反相高效液相色谱(HPLC)结合荧光检测(FD)对六种市售黎豆产品中的左旋多巴进行定量。从黎豆产品制造商处获取分析证书(COA),以评估左旋多巴含量规格的存在和执行情况。
HPLC-FD分析显示,六种市售黎豆产品的左旋多巴含量在各自标签声称量的6%至141%之间。没有一种产品的左旋多巴含量在药典规定的正常标签声称量的90%-110%范围内。这些产品提供的左旋多巴最大日剂量从14.4至720毫克/天不等。分析证书在左旋多巴含量的规格和验证方面不一致。
所测试的商业产品的左旋多巴含量差异很大,有时与标签声称量相差甚远。这些缺陷可能会影响帕金森病患者使用的黎豆产品的疗效和安全性,并损害关于黎豆产品的科学研究结果。本研究中描述的HPLC-FD方法可被制造商和科研人员用于验证黎豆产品的左旋多巴含量。