Formulation and Improvement of Quality Standard for Sulfur-Free Codonopsis Radix Decoction Pieces ········ LIU Guoxiu,

ZHAI Huaqiang, QIAN Zhongzhi, LI Siyu, LI Ningning, DAI Ying, WANG Ningning, LI Hongyan, SHAN Xiaosong

1. College of Pharmacy, Beijing University of Chinese Medicine, Beijing 100029, China; 2. National Pharmacopoeia Commission, Beijing 100061, China; 3. The Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing 100029, China; 4. Baohetang (Jiaozuo) Pharmaceutical Co., Ltd., Jiaozuo 454850, China

Abstract: Objective To study the safety and effectiveness of quality standards of sulfur-free Codonopsis Radix Decoction Pieces; To provide references for the quality monitoring and clinical application of sulfur-free Codonopsis Radix Decoction Pieces. Methods The check items (water, total ash, sulphur dioxide, and ethanol-soluble extractives) of 21 batches of sulfur-free Codonopsis Radix Decoction Pieces from five producing areas were determined by TLC and GC. Heavy metals, harmful elements and pesticide residues were detected by atomic absorption spectrophotometry and GC. The method for content determination of Lobetyolin in Codonopsis Radix was established by HPLC. Results Safety index check items of 21 batches of Codonopsis Radix Decoction Pieces showed: Sulfur dioxide residue ≤ 7 mg/kg, Pb content ≤ 1.124 mg/kg, As content ≤ 0.067 mg/kg, Cd content ≤ 0.058 mg/kg, Hg content ≤ 0.003 mg/kg, Cu content ≤ 14.121 mg/kg. total BHC ≤ 0.03 mg/kg, total DDT ≤ 0.031 mg/kg, and pentachloronitrobenzene (PCNB) ≤ 0.008 mg/kg. The average sample recovery rate of Lobetyolin content was 97.71%, RSD was 1.32%, and the average fraction was 0.138%. Conclusion The safety index of sulfur-free Codonopsis Radix Decoction Pieces is sulfur dioxide residue ≤ 10 mg/kg. The heavy metal and pesticide residue standards meet the limit standard for Codonopsis Radix in pharmacopoeia. The method for determining the effectiveness index is reliable, which can provide a basis for the quality control and clinical use of Codonopsis Radix.

Keywords: Codonopsis Radix; quality standards; safety; effectiveness; content determination