Radiation screening of Chaihu Shugan pills via photostimulated luminescence

doi:10.19803/j.1672-8629.20211101

Abstract

Abstract: Objective To establish a photostimulated luminescence (PSL) method for radiation screening of Chaihu Shugan pills so as to provide reference for quality control and safe use of these pills. Methods Combined with the national drug evaluation sampling test and in line with the European Standard (EN) 13751:2009, a radiation screening method of Chaihu Shugan pills was established by using the SURRC PPSL irradiation food screening system after the samples were crushed or laminated. Results This method proved to be feasible after methodological investigation. The measured values could reflect whether the sample had been irradiated. The negative control was free of interference. A total of 102 batches of samples from 10 enterprises were tested for radiation. The results showed that 26 of these batches of samples by 6 enterprises were positive for radiation screening and had been treated by radiation sterilization, accounting for 25.5% of the total. Conclusion The established method can quickly screen the irradiation residues without complex pretreatment, which is simple, rapid and economical, and can provide reference for quality control and safe use of Chaihu Shugan pills.

Key words: Chaihu Shugan pills, photostimulated luminescence (PSL), radiation screening, quality control

CLC Number:

R926

WANG Zhao, ZHAO Jianfeng, YU Xinlan, JIN Hongyu, MA Shuangcheng. Radiation screening of Chaihu Shugan pills via photostimulated luminescence[J]. Chinese Journal of Pharmacovigilance, 2023, 20(5): 514-518.

References

[1] Chinese Pharmacopoeia Commission.ChP 2020.Vol Ⅳ[S]. Beijing: China Medical Science Press, 2020:204-205.
[2] National Medical Products Administration. An announcement about technical guidelines for irradiation sterilization of Traditional Chinese medicine issued by China Food and Drug Administration(CFDA) ( 2015 year No. 86)[EB/OL].(2015-11-09)[2022-03-07]. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/qtggtg/20151109120001767.html.
[3] ZHANG LW,JING YQ,LIN T,et al.Status quo of detection of irradiation traditional Chinese medicine[J]. J Chin Med Mater(中药材), 2011, 34(3): 483-485.
[4] ZHAO YJ, PENG W, LIU L, et al.Dose control and preliminary applications of radiation sterilization of medical and health care products using 10 Me V electron beams[J]. J Radiat Res Radiat Process(辐射研究与辐射工艺学报), 2022, 40(1): 0104021-0104028.
[5] WANG Z.The preliminary study on the effect of sulfur fumigation and irradiation sterilization on the quality of Traditional Chinese medicine[D]. Beijing: National Institutes for Food and Drug Control, 2015.
[6] Chinese Pharmacopoeia Commission.Pharmacopoeia of the People’s Republic of China 2020(VolⅠ)[S]. Beijing: China Medical Science Press, 2020: 1456.
[7] LIU HX,LI YN,CAO XY,et al.Analysis and reflection on gas sterilization quality standards of Chinese pharmacopoeia[J]. Chinese Journal of Antibiotics, 2020, 45(8): 733-737.
[8] SUN Y.Study on sterilization methods of traditional Chinese medicine[J]. Chin J Clin Pharmacol, 2018, 34(19): 2380-2382.
[9] KANG CC,WANG XC,WU ZF,et al.Research progress on sterilization technology of Chinese materia medica powder based on physicochemical and biological evaluation[J]. Chinese Traditional and Herbal Drugs(中草药), 2020, 51(2): 507-515.
[10] ZHANG LW, LIN T, BI FJ, et al.Establishment and evaluation of photostimulated luminescence methods for detection of irradiated Chinese medicine[J]. Tradit Chin Drug Res Clin Pharm(中药新药与临床药理), 2013, 24(1): 92-96.
[11] LYU YJ, CUI C, HUO NN, et al.Effect of Co-gamma 60 Ray irradiation on chemical composition clusters of Qingreling granules[J]. Journal of Henan University(河南大学学报), 2019, 38(4): 238-241.
[12] WANG YQ, ZHONG SS, ZHANG HF.Effect of irradiation⁶⁰Co-γray sterilization on the antithrombin activity of hirudo[J]. Chinese Journal of Rational Drug Use(中国合理用药探索), 2021, 18(3): 92-94.
[13] LI ZS, QI JZ, CHEN ZY, et al.Comparative study on the safety of Gan maolingcompound granules irradiated with different doses of ⁶⁰Co[J]. Chin J Pharm Anal(药物分析杂志), 2021, 41(11): 1960-1967.
[14] WANG Z, CHEN J, LIN T, et al.Utilization status of radiation sterilization in Chinese materia medica and their preparations and regulatory suggestions[J]. Chin Pharm J(中国药学杂志), 2015, 50(4): 314-316.
[15] LIN T, BI FJ, LYU WS, et al.Status and control of radicidation of traditional Chinese medicine[J]. Chin Pharm J(中国药学杂志), 2019, 54(17): 1442-1447.
[16] Center For Drug Evaluation, NMPA. Notice on the Release of Technical Guidelines for Research on Pharmaceutical Changes of Listed Chinese Medicines (Trial)[EB/OL]. (2021-04-01)[2023-03-01]. http://www.gov.cn/zhengce/zhengceku/2021-04/08/content_5598335.htm.