Evaluation and Consideration of Clinical Safety of Traditional Chinese Medicine Based on Toxic Components

doi:10.19803/j.1672-8629.2021.06.06

Abstract

Abstract: Objective Based on many factors in clinical application, this article aimed to analysis the clinical safety of traditional Chinese medicine (TCM), which contained toxic ingredients. And discussed the safety risk assessment model to provide technical support for clinical rational use of TCM. Methods This study described the toxicity characteristics of exogenous harmful substances and endogenous toxic ingredients in TCM, it is based on dietary risk assessment methods after combined multiple factors such as drugs, organism, and clinical medication, and assigned appropriate weights to risk factors. We established a risk evaluation model that reflected the characteristics of clinical medication. Results We tried to apply the model to analysis the safety of TCM which contained toxic and harmful ingredients. The preliminary verification had been obtained, and the foundation had been laid for the safe clinical use of drugs in the future. Conclusion This study believed that only under the control of medication frequency, course of treatment, dosage and other medication factors, can TCM contained toxic ingredients be used safely and reasonably in clinical practice.

Key words: traditional Chinese medicine, toxic components, clinical safety, risk assessment, rational use of drug

CLC Number:

R994.11

LI Yaolei, ZHANG Bing, ZHANG Xiaomeng, LIN Zhijian. Evaluation and Consideration of Clinical Safety of Traditional Chinese Medicine Based on Toxic Components[J]. Chinese Journal of Pharmacovigilance, 2021, 18(6): 520-524.

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https://zgywjj.magtechjournal.com/EN/Y2021/V18/I6/520

References

[1] Ji HY, Tong XL, Han JR, et al.Three-type-drugs in Shennong Materia Medica and clinical rational dosage[J]. Global Traditional Chinese Medicine(环球中医药), 2012, 5(6): 413-416.
[2] Shi L, Liu X, Zhang B.Study on prevention of drug toxicity in pharmacovi-gilance thought of the compendium of Materia Medica[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2019, 16(7): 404-410.
[3] Bi MJ.Exploring mechanisms of damage by lead induced disturbance of selenium homeostasis[D]. Shandong university, 2019.
[4] Chen H, Lu Y, Cao Z, et al.Cadmium induces NLRP3 inflam-masome-dependent pyroptosis in vascular endothelial cells[J]. Toxicology Letters, 2016, 246: 7-16.
[5] Li YL, Liu Y, Han X, et al.Arsenic species in Cordyceps sinensis and its potential health risks[J]. Frontiers in Pharmacology, 2019, 10: 1-10.
[6] Gardner RM, Nyland JF, Silbergeld EK, et al.Differential immunotoxic effects of inorganic and organic mercury species in vitro[J]. Toxicology Letters, 2010, 198: 182-190.
[7] Luo L, Dong LL, Huang Q, et al.Detection and risk assessments of multi-pesticides in 1771 cultivated herbal medicines by LC/MS-MS and GC/MS-MS[J]. Chemosphere, 2021, 262: 127477.
[8] Tang YM, Zeng YT.Pyrethroids: toxicity and health risks[J]. China Science and Technology Information(中国科技信息), 2019(1): 111-112.
[9] Zhou JH.The reproductive endocrine toxicity of typical or 2ano-chlorine pesticide, benzimidazole fungicide and triazole fungicide[D]. Zhejiang University , 2016.
[10] Xie GY, Wen YN, Wang QK, et al.Toxicological characteristics of atrazine[J]. Chinese Journal of Industrial Medicine(中国工业医学杂志), 2018, 31(5): 371-374.
[11] Li YL, Liu LN, Yao Y, et al.Quantitative detection of aflatoxin B1 in traditional Chinese medicine by colloidal gold immunoch-romatography[J]. Chinese Pharmaceutical Journal(中国药学杂志), 2019, 54(17): 1432-1437.
[12] Wang YJ, Zhang LS.Research progress on toxicity of zearalenone[J]. Chin-ese Journal of Food Hygiene(中国食品卫生杂志), 2002, 14(5): 40-43.
[13] Zhao CY, Yuan FS, Bai JY, et al.Toxicity of sodium sulfite to HepG2 hepatocytes[J]. Journal of Environment and Health(环境与健康杂志), 2012, 29(3): 203-206.
[14] Yang ZH, Song L, Qiao RX, et al.Study of extrinsic harmful residue-sulfur dioxide in traditional Chinese medicine[J]. Chinese Journal of Pharmaceutical Analysis(药物分析杂志), 2010, 30(11): 2246-2250.
[15] Kang CZ, Lai CJS, Zhao D, et al.A practical protocol for comprehensive evaluation of sulfur-fumigation of Gastrodia Rhizoma using metabolome and health risk assessment analysis[J]. Journal of Hazardous Materials, 2017, 340: 221-230.
[16] Stiborova M, Martinek V, Frei E, et al.Enzymes metabolizing aristolochic acid and their contribution to the development of aristolochic acid nephropathy and urothelial cancer[J]. Curr Drug Metab, 2013, 14(6): 695-705.
[17] Stiborova M, Frei E, Arlt VM, et al.Knockout and humanized mice as suitable tools to identify enzymes metabolizing the human carcinogen aristolochic acid[J]. Xenobiotica, 2014, 44(2): 135-145.
[18] Wu Y, Liu BL.Safety considerations of traditional Chinese medicine containing pyrrolizidine alkaloids[J]. The Chinese Journal of Clinical Pharmacology(中国临床药理学杂志), 2020, 36(23): 3954-3956.
[19] Gastroenterology Society of Chinese Medical Association Hepatobiliary Disease Cooperative Group. Expert consensus on diagnosis and treatment of pyrrolidine alkaloids-related sinusoidal obstruction syndrome (2017, Nanjing)[J]. Journal of Clinical Hepatology(临床肝胆病杂志), 2017, 33(9): 1627-1637.
[20] Tao MB, Zhang L, Liu F, et al.Contains anthraquinones constituents of traditional Chinese medicine security research progress[J]. Pharmacology and Clinics of Chinese Materia Medica(中药药理与临床), 2016, 32(6): 238-243.
[21] Yu HB, Dai L, Li JT, et al.Analysis of endoscopic and clinical features of melanosis of the colon[J]. Clinical Journal of Medical Officers(临床军医杂志), 2015, 43(10): 1093-1094.
[22] Duan YH.Literature analysis of traditional Chinese medicine varieties causing renal damage[J]. Strait Pharmaceutical Journal(海峡药学), 2014, 26(4): 138-139.
[23] Huang ZJ, Que HQ, Zhu H, et al.Research progress in toxicity of triptolide on reproductive system[J]. Drug Evaluation Research(药物评价研究), 2013, 36(3): 224-227.
[24] Zhang W, Zhu JH, Guan W.Experimental pathological study of triptolide intoxication in rat myocardial[J]. Journal of Medical Reaserch(医学研究杂志), 2010, 39(6): 67-68.
[25] Wang HY.The role and mechanism study of arsenic trioxide inhibiting metastasis and cancer stem cells in liver cancer[D]. Academy of Military Sciences, 2020.
[26] Chai BJ, Li Y, Chen JW.Effect of Rhubarb and compatibilities on liver and kidney of rats[J]. Pharmacology and Clinics of Chinese Materia Medica(中药药理与临床), 2012, 28(3): 66-69.
[27] Wang H, Zhang JX, Li MW, et al.Study on arecoline metabolism in liver microsomes under different compatibility[J]. Acta Chinese Medicine and Pharmacology(中医药学报), 2018, 46(5): 58-61.
[28] Zhang DK, Han X, Zhou YF, et al.Development of Fuzi precision decoction pieces (PDP) (Ⅰ): Specification and quality uniformity[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2015, 40(17): 3488-3495.
[29] Luo C.Analysis on the relationship between adverse reactions of aconite and decocting time and dose[J]. World Latest Medicne Information(世界最新医学信息文摘), 2016, 16(30): 118-128.
[30] Liu LN, Li XF, Liao YM, et al.Modern research and thinking on the special decoction method for toxic Chinese materia medica in Shanghan Zabing[J]. Pharmacy and Clinics of Chinese Materia Medica(中药与临床), 2019, 10(Z2): 65-69.
[31] Liu H.Study on mercury/arsenic speciation analysis and safety research of mineral medicines and animal drugs[D]. Jilin Agricu-ltural University, 2019.
[32] Zong SY, Liu Y, Sun TT, et al.Research progress in the toxicity and control methods of Asari Radix et Rhizoma[J]. China Pharmacist(中国药师), 2020, 23(5): 942-945.
[33] Xiong F, Jiang KY, Xiong AZ, et al.Quantification of hepatotoxic pyrrolizidine alkaloid adonifoline in traditional Chinese medicine preparations containing Senecionis Scandentis Herba[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2020, 45(1): 92-97.
[34] Zuo TT, Wang Y, Zhang L, et al.Guideline of risk assessment of exogenous harmful residues in traditional Chinese medicines[J]. Chinese Journal of Pharmaceutical Analysis(药物分析杂志), 2019, 39(10): 1902-1907.
[35] Public statement on contamination of herbal medicinal products/traditional herbal medicinal products 1 with pyrrolizidine alkaloids [R]. products 1 with pyrrolizidine alkaloids [R]. EMA/HMPC/328782-2016.