Determination of lead in Smilax myosotiflora herbal preparations obtained in Malaysia.
The DCA (Drug Control Authority), Malaysia implemented the phase 3 registration of traditional medicines on 1 January 1992 with special emphasis on the quality, efficacy and safety (including the presence of heavy metals) in all pharmaceutical dosage forms of traditional medicinal preparations. As such, a total of 100 traditional medicinal preparations, containing Smilax myosotiflora, in various pharmaceutical dosage forms, which were bought in the Malaysian market, were analysed for lead content using atomic absorption spectrophotometry. Results showed that 15% of the products analysed possessed 10.23-23.05 ppm of lead, and therefore, do not comply with the quality requirement for traditional medicines in Malaysia. The quality requirement for traditional medicines in Malaysia is that they should not exceed 10 ppm of lead. Out of these 15 products, five products exhibited 10.23-23.05 ppm of lead, in fact they have already been registered with the DCA Malaysia. However, the rest of the products, which possessed 12.24-20.72 ppm of lead, have still not been registered with the DCA Malaysia. Although this study successfully showed that only 85% of the products complied with the quality requirement for traditional medicines in Malaysia pertaining to lead, they cannot, however, be assumed to be safe from lead contamination because of batch-to-batch inconsistency.
Ang
H H
HH
School of Pharmaceutical Sciences, Universiti Sains Malaysia, Minden, Penang. hhang@usm.my
Lee
K L
KL
Kiyoshi
M
M
D004340:Drug Contamination; D019983:Guideline Adherence; D029001:Herbal Medicine / Q000592:standards; D007854:Lead / Q000032:analysis*; D008296:Malaysia; D028321:Plant Preparations / Q000737:chemistry* / Q000592:standards*; D011786:Quality Control; D015203:Reproducibility of Results; D012449:Safety; D032281:Smilax / Q000737:chemistry*
D028321:Plant Preparations; D007854:Lead