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Acta Pharmaceutica Sinica ; (12): 2695-2701, 2020.
Article in Chinese | WPRIM | ID: wpr-837522


Heavy metals and other harmful elements in traditional Chinese medicines inflict serious damage on public health. Therefore, risk assessment of Chinese raw materials has gained increasing attention. To date, few reports have been published on the health risk assessment of heavy metals and harmful elements in Chinese patent medicines. To gain a comprehensive understanding of heavy metals and other harmful elements in Chinese patent medicines and to establish proper limits, residual Pb, Cd, As, Hg, Cu and Cr in 15 054 samples of 295 drugs was analyzed with regard to distribution and variation between elements and dosage forms. In addition, in accord with procedures including hazard identification, hazard characterization, exposure assessment and risk characterization, basic procedures and specific parameters for risk assessment of heavy metals and harmful elements in Chinese patent medicines were clarified based on the health risk assessment of 14 787 samples and 276 drugs. A method and equation for establishing residual limits is proposed. The results show that content and target hazard quotients (THQs) of the investigated elements in all samples showed a skewed distribution approaching 0. Content of Pb, As, Cu, Hg, Cd or Cr in the samples exceeded 100 mg·kg-1 and the content of Pb, As, or Cu in individual samples exceeded 1 000 mg·kg-1. THQs of 586 samples and four drugs were above 1. We believe that the health risk of Hg, Pb and As in Chinese patent medicines with dosage forms of pill, capsule, tablet and powder, especially those in raw powder preparations, warrant concern.

Chinese Pharmaceutical Journal ; (24): 1617-1621, 2019.
Article in Chinese | WPRIM | ID: wpr-857898


OBJECTIVE: To discuss the quality status of TCM raw powder preparations based on TCM raw powder preparation special project of national post-market drug surveillance in 2018. METHODS: The statutory standards of seven TCM raw powder preparations, including Qingwei Huanglian pills, Jianpi pills, Qipi pills, Shangqing pills, Renshen Guipi pills, Yimu pills and Niuhuang Qingwei pills, were analyzed. The test methods for adulteration, dyeing, sulfur dioxide, pesticide residues, aflatoxins, heavy metals and harmful elements and irradiation were established to reveal the safety risk. Whole-ingredient identification methods were developed to evaluate the authenticity of the drug. RESULTS: The statutory standards of the TCM raw powder preparations tested in national post market surveillance in 2018 are simple and inadequate to comprehensively control the quality of the drugs. Unqualified feeding, adulteration, and contamination with Pb, As and Hg were the main problems currently. Dyeing, aflatoxins and pesticide residues were found in very few samples. Contamination risk of sulfur dioxide was low in TCM raw powder preparations. Most manufacturers adopted irradiation for sterilization. CONCLUSION: The standards of TCM raw powder preparations should be improved to realize whole-ingredient identification. And heavy metals and harmful elements should be investigated. The manufacturers should enhance quality control of the raw material and pay attention to the risk of adulteration and harmful residues. Special project of national post-market surveillance can reveal common problems of similar drugs, which is a powerful measure for drug regulation.

Chinese Pharmaceutical Journal ; (24): 506-512, 2016.
Article in Chinese | WPRIM | ID: wpr-859181


OBJECTIVE: To discuss quality control of Chinese patent medicine with animal ingredients, providing reference for standards improvement, quality supervision and regulated production. METHODS: Statutory standards and exploratory studies of Chinese patent medicines with animal ingredients tested in national post market surveillance between 2010 and 2014 were summarized. And technologies and methods developed for specific drugs were analyzed from the perspectives of safety, authenticity, effectiveness and controllability. RESULTS: Use of HPLC and GC is becoming more mature. Traditional microscopic and TLC methods can play a positive role in identification of animal drugs without index component. Mass spectrometry has been successfully applied in quality control of Chinese patent medicine with animal ingredients. CONCLUSION: National post market surveillance can provide comprehensive and elaborate evaluation on drug quality and can reveal potential risks. It's a powerful measure to promote quality of animal medicine.