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Determination of Lead in Smilax luzonensis Herbal Preparations in MalaysiaSchool of Pharmaceutical Sciences, University Science Malaysia, Minden, Penang, Malaysia Correspondence: Address correspondence to Associate Professor Dr. Hooi-Hoon Ang, School of Pharmaceutical Sciences, University Science Malaysia, Minden, 11800, Penang, Malaysia. E-mail:hhang{at}usm.my The DCA (Drug Control Authority) of Malaysia implemented the phase 3 registration of traditional medicines on 1 January 1992. As such, a total of 100 products in various pharmaceutical dosage forms of a herbal preparation containing Smilax luzonensis, either single or combined preparations, were analyzed for the presence of lead, using atomic absorption spectrophotometry. Results showed that 14% of the above products possessed 10.02 to 21.21 ppm of lead, and, therefore, they failed to comply with the quality requirement for traditional medicines in Malaysia (<10 ppm). Although this study showed that 86% of the products complied with the quality requirement for traditional medicines in Malaysia pertaining to lead, they cannot be assumed safe from lead contamination because of batch-to-batch inconsistency.
Key Words: Atomic Absorption Spectrophotometer Drug Control Authority Malaysia Herbal Preparations Lead Determination Quality Requirements for Traditional Medicines Smilax luzonensis
International Journal of Toxicology, Vol. 24, No. 3,
165-171 (2005) |
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