Analysis of lead content in herbal preparations in Malaysia.
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.
Ang
H H
HH
School of Pharmaceutical Sciences, Universiti Sains Malaysia, Minden, 11800, Penang, Malaysia. hhang@usm.my
Lee
E L
EL
Matsumoto
K
K
D002214:Capsules; D004338:Drug Combinations; D007854:Lead / Q000032:analysis*; D007855:Lead Poisoning / Q000453:epidemiology / Q000209:etiology; D008296:Malaysia / Q000453:epidemiology; D028321:Plant Preparations / Q000032:analysis* / Q000506:poisoning; D010946:Plants, Medicinal / Q000737:chemistry*; D013054:Spectrophotometry, Atomic; D013607:Tablets
D002214:Capsules; D004338:Drug Combinations; D028321:Plant Preparations; D013607:Tablets; D007854:Lead