Analysis of lead content in herbal preparations in Malaysia
Analysis of lead content in herbal preparations in Malaysia
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DOI：
10.1191/0960327103ht382oa
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发表时间：
2003-08-01
影响因子：
2.8
通讯作者：
Matsumoto, K
中科院分区：
文献类型：
--
作者：
Ang, HH;Lee, EL;Matsumoto, K
在马来西亚，1992年1月1日根据1984年《药物和化妆品管制条例》实施了传统药物第三阶段登记，强调传统药物制剂的所有药物剂型的质量、功效和安全性（包括检测是否存在重金属）。因此，使用原子吸收分光光度计分析了草药制剂的各种药物剂型中的总共100种产品的铅含量。结果显示，8%（8种产品）含有10.64-20.72 ppm的铅，因此不符合马来西亚传统药物的质量要求。其中一种产品，M-Tongkat Ali（铅含量为10.64 +/- 0.37 ppm），实际上已经在马来西亚DCA注册。其余的，Sukarno Tongkat Ali，Eurycoma Madu，Super Pill Tongkat Ali，Force Pill Tongkat Ali，Tender Pill Tongkat Ali，Super Pill Tongkat Ali Plus和Great Pill Tongkat Ali Plus没有在DCA马来西亚注册，并显示出12.24-20.72 ppm的铅。虽然这项研究表明，只有92%的产品符合马来西亚传统药物的质量要求，但是，由于批次之间的不一致性，它们不能被认为是安全的。
In Malaysia, the phase 3 registration for traditional medicines was implemented on 1 January 1992 under the Control of Drugs and Cosmetics Regulation 1984, emphasizing quality, efficacy and safety (including the detection of the presence of heavy metals) in all pharmaceutical dosage forms of traditional medicine preparations. Therefore, a total of 100 products in various pharmaceutical dosage forms of a herbal preparation, were analysed for lead content using atomic absorption spectrophotometer. Results showed that 8% (eight products) possessed 10.64-20.72 ppm of lead, and therefore, do not comply with the quality requirement for traditional medicines in Malaysia. One of these products, M-Tongkat Ali (exhibited 10.64 +/- 0.37 ppm of lead), was in fact already registered with the DCA Malaysia. The rest, Sukarno Tongkat Ali, Eurycoma Madu, Super Pill Tongkat Ali, Force Pill Tongkat Ali, Tender Pill Tongkat Ali, Super Pill Tongkat Ali Plus and Great Pill Tongkat Ali Plus have not registered with the DCA Malaysia and exhibited 12.24-20.72 ppm of lead. Although this study showed that only 92% of the products complied with the quality requirement for traditional medicines in Malaysia, however, they cannot be assumed safe from lead contamination because of batch-to-batch inconsistency.