Determination of lead in Smilax luzonensis herbal preparations in Malaysia.
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.
Ang
Hooi-Hoon
HH
School of Pharmaceutical Sciences, University Science Malaysia, Minden, Penang, Malaysia. hhang@usm.my
Lee
Kheng-Leng
KL
Kiyoshi
Matsumoto
M
D004340:Drug Contamination; D007854:Lead / Q000032:analysis*; D008296:Malaysia; D028321:Plant Preparations / Q000737:chemistry* / Q000592:standards; D011786:Quality Control; D015203:Reproducibility of Results; D032281:Smilax / Q000737:chemistry*; D013054:Spectrophotometry, Atomic
D028321:Plant Preparations; D007854:Lead