Quality analysis of Guci tablets based on national drug evaluation sampling

doi:10.19803/j.1672-8629.20210776

Abstract

Abstract: Objective To evaluate the quality of Guci tablets based on national drug evaluation sampling. Methods This quality analysis was based on inspections of standards and research. Since the prescription involved four toxic crude drugs, in-depth research on safety and effectiveness was carried out by targeting the problems found during inspections of standards. Results The qualified rate of inspections of standards was 98.1%. There were 2 batches of unqualified samples and their contents of strychnine fell short of the standard. Research indicated that arsenic and mercury exceeded standard limits in some samples. High concentrations of arsenic and mercury posed a risk to safety. In addition, some crude drugs might have been of poor quality or crude drugs were not used according to the prescriptions. Conclusion Importance should be attached to the safety and effectiveness of drugs. It is recommended that manufacturers strengthen the control over the source of drugs and production processes in order to ensure the safety and effectiveness of medicines.

Key words: Guci tablets, national drug evaluation sampling, aconitine, strychnine, brucine, heavy metal, aflatoxin, quality analysis

CLC Number:

R917

LIU Jing, LIU Yan, ZHENG Xiaowei, WANG Qi, HE Fengyan, WANG Feifei, WANG Yadan, HE Yi, NIE Lixing, HU Xiaoru, DAI Zhong, MA Shuangcheng. Quality analysis of Guci tablets based on national drug evaluation sampling[J]. Chinese Journal of Pharmacovigilance, 2023, 20(3): 292-295.

References

[1] Drug Standard of Ministry of Public Health. Traditional Chinese Medicine Preparations Volume 17 WS₃-B-3290-98《中药成方制剂》[S]. 1998: 202.
[2] ZHANG S, YUAN XF, ZHANG Y.Determination of naringin and paeoniflorin in Gu Ci Tablet by HPLC[J].Guangzhou Chemical Industry(广州化工), 2015, 43(16): 140-142.
[3] CAO L, FENG YL, WANG YC, et al.Study on quality control of Guci Tablets[J].Drug Standards of China(中国药品标准), 2011, 12(3): 191-195.
[4] YUAN XF, ZHANG S.Research on HPLC fingerprint of Guci Tablets[J]. Chinese Journal of Hospital Pharmacy(中国医院药学杂志), 2015, 35(4): 314-317.
[5] ZHANG YM, XIE QF, LU J, et al.Revision study on quality standard of Radix Aconiti Kusnezoffii[J]. Chinese Journal of Pharmaceutical Analysis(药物分析杂志), 2010, 30(5): 940-944.
[6] LIU S, LIU XY, LI Y, et al.Experimental study on acute toxicity of the Aconiti kusnezoffii Radix and its processed products[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2015, 12(9): 513-521.
[7] LI ZY, ZHANG SF, CHANG HS, et al.Changes of DDAs content affected by different processing time and its relationship with safety of processed Fuzi[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2009, 34(9): 1086-1089.
[8] ZHENG Q, LU HW, HAO WW, et al.Study on hydrolysis of Aconitum alkaloids and quantitative analysis method of their hydrolysates[J]. Chinese Pharmaceutical Journal(中国药学杂志), 2011, 46(9): 652-656.
[9] HE FY, HE Y, DAI Z, et al.Simultaneous determination of 7 alkaloids in Guci tablets by HPLC-MS/MS[J]. Chinese Journal of Pharmaceutical Analysis(药物分析杂志), 2018, 38(10): 1810-1816.
[10] Chinese Pharmacopoeia Commission.Pharmacopoeia of the People's Republic of China,Volume I I(中华人民共和国药典二部)[M]. Beijing: China Medical Science Press. 2020: 201.
[11] Chinese Pharmacopoeia Commission.Pharmacopoeia of the People's Republic of China,Volume I I(中华人民共和国药典二部)[M]. Beijing: China Medical Science Press.2020: 41-42.
[12] Chinese Pharmacopoeia Commission.Pharmacopoeia of the People's Republic of China,Volume I I(中华人民共和国药典二部)[M]. Beijing: China Medical Science Press. 2020:248.
[13] SONG HB, DU XX.Literature study on adverse reactions of Strychni semen and analysis of risk factors[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2015, 12(7): 411-416.
[14] PAN JH, YAN GJ, ZHOU JJ.Determination of strychnine and brucine in Semen Strychni Pulveratum by HPLC assay[J]. Chinese Pharmaceutical Journal(中国药学杂志), 2010, 45(13): 1024-1029.
[15] WANG FF, ZHANG YM, ZHENG XW, et al.Study on assay method of brucine and strychnine in Guci Tablets[J]. Chinese Journal of Pharmaceutical Analysis(药物分析杂志), 2018, 38(10): 1824-1829.
[16] Chinese Pharmacopoeia Commission.Pharmacopoeia of the People's Republic of China,Volume I I(中华人民共和国药典二部)[M]. Beijing: China Medical Science Press.2020: 53.
[17] LIU J, ZHANG JP, MENG J, et al.Acute toxic effect of Guci Tablets on zebrafish embryo development[J]. Drug Evaluation Research(药物评价研究), 2018, 41(10): 1804-1809.
[18] ZHA YF, NIE LX, YU JD, et al.Study on identification methods of Guci Tablets by high pergormance thin layer chromatography[J]. China Pharmaceuticals(中国药业), 2018, 27(8): 18-21.
[19] WANG YD,DAI Z,SUN CL,et al.Quality control of Guci tablets using UPLC-ELSDfingerprint analysis coupled with chemometrics[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2018, 43(6):1156-1161.
[20] WANG YD, DAI Z, HE FY, et al.Simultaneous determination of 14 ompounds in Guci tablets using RPLC-MS/MS method[J]. Chinese Journal of Pharmaceutical Analysis(药物分析杂志), 2019, 39(4): 595-607.