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Content Analysis of 5 Kinds of Heavy Metal in Yougui Pills / 中国药房
China Pharmacy ; (12): 2377-2382, 2021.
Article in Chinese | WPRIM | ID: wpr-886920
ABSTRACT
OBJECTIVE:To investigate the contents of 5 kinds of heavy metal as copper (Cu),arsenic(As),cadmium (Cd),mercury(Hg)and lead (Pb)in Yougui pills ,and to evaluate its safety risk. METHODS :Using yttrium (89Y),indium (115In)and bismuth (209bi)as internal standard ,the contents of each element were determined by ICP-MS. ICP-MS condition included that atomization gas flow rate was 0.95 L/min,auxiliary gas flow rate was 1.2 L/min,plasma gas (argon)flow rate was 18 L/min,pump speed was 30 r/min. RF power of inductively coupled plasma was 1 200 W,the voltage in simulation stage was 1 750 V,the voltage in pulse stage was 1 300 V,the voltage of deflection device was -12 V,and the detector was in analog and pulse dual-mode. The determination methods of various elements were investigated ,and 45 batches of marketed Yougui pills were determined. Hazard index (HI)was used to analyze the non-carcinogenic risk of each element and calculate the maximum residual limit(MRL)of each element. RESULTS :The linear range of Cu ,As,Cd,Hg and Pb ranged from 10-200,1-50,0.4-30,0.2-6 and 2-100 μg/L(all r>0.999 0),respectively. The limits of quantitation were 0.67,0.23,0.20,0.07,0.27 μg/L. The limits of detection were 0.20,0.07,0.06,0.02,0.08 μg/L. RSDs of precision,stability and reproducibility tests were all lower than 3.5% (n=6 or n=5). Average recoveries were 92.96%-100.89%(RSD=2.23%-3.62%,n=3). Average contents of Cu ,As,Cd,Hg and Pb in 45 batches of Yougui pills were 2.72,0.28,0.07,0.05,0.62 mg/kg,and superimposed HI of each element was less than 1. The contents of 5 kinds of heavy metals in Yougui pills were lower than the proposed MRL (MRL of Cu ,As,Cd,Hg and Pb were 20,2,1,0.2,5 mg/kg or 111.11,4.44,2.22,1.48,8.89 mg/kg respectively ). CONCLUSIONS :Established method can be used for the determination of content of 5 kinds of heavy metal in Yougui pills ;the heavy metal pollution rate of marketed Yougui pills is low and the safety risk is small.

Full text: Available Index: WPRIM (Western Pacific) Language: Chinese Journal: China Pharmacy Year: 2021 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Language: Chinese Journal: China Pharmacy Year: 2021 Type: Article