基于毒/效记载演变探讨补骨脂的安全应用研究进展

doi:10.19803/j.1672-8629.20220409

摘要/Abstract

摘要： 补骨脂具有温肾助阳/补肾健骨的功效,临床多用于骨质疏松、骨折、骨性关节炎等疾病的治疗。随着补骨脂的广泛使用,其不良反应报道不断增多,存在潜在安全风险,影响了补骨脂的临床用药安全。本文从古籍功效/毒性考证、临床不良反应研究、活性成分的药理作用及毒性研究、毒性机制研究、减毒控毒方法等角度对补骨脂毒/效研究进展进行分析,以期为补骨脂及其制剂的临床安全应用提供证据支持。

关键词: 补骨脂, 药理作用, 功效, 毒性, 安全性, 临床应用

Abstract: Psoralea corylifolia L. is a traditional non-toxic Chinese herbal medicine, which is used for the treatment of osteoporosis, fractures, osteoarthritis and other diseases. However, liver injury caused by Chinese herb preparations, including Psoralea corylifolia, is frequently reported over the years, which affects the clinical and safe use of psoralen. This study is expected to provide data for evaluation and prevention of safety risks of Psoralea corylifolia.

Key words: Psoralea corylifolia L., pharmacology, effect, toxicity, security, clinical application

中图分类号:

R977
R994.11

地力乎马·地力木拉提, 石伟, 王伽伯, 高源. 基于毒/效记载演变探讨补骨脂的安全应用研究进展[J]. 中国药物警戒, 2023, 20(8): 939-945.

DILHUMAR Dilmurat, SHI Wei, WANG Jiabo, GAO Yuan. Research progress in safe use of Psoralea corylifolia based on evolution of toxicity/efficacy[J]. Chinese Journal of Pharmacovigilance, 2023, 20(8): 939-945.

参考文献

[1] Chinese Society of Traditional Chinese Medicine. Chinese Medical Code(中华医典) [M] Version 5. Changsha: Hunan Electronic Audio and Video Publishing House, Changsha Jiahong Technology Development Co, 2014.
[2] ZHEN Q.Theory of medicinal properties (药性论) [M]. Beijing: People's Medical Publishing House, 1992.
[3] CHANG MY. Niwako Herbal (日华子本草)[M]. Ningbo: Ningbo Municipal Health Bureau, 1984.
[4] LU DX. Kaibao Herbal(开宝本草) [M]. Hefei: Anhui Science and Technology Publishing House, 1998.
[5] LI SZ.Compendium of Materia Medica(本草纲目)[M]. Shijiazhuang: Hebei Science and Technology Press, 2013.
[6] HUANG YY.Sorbus officinalis solution (玉楸药解) [M]. Beijing: China Pharmaceutical Science and Technology Press, 2017.
[7] LEI X.Lei's Treatise on Preparing Drugs (雷公炮炙论) [M]. Nanjing: Jiangsu Science and Technology Press, 1985 .
[8] ZHOU ZY, YU WM. Bencao Feng Yuan(本草逢原) [M]. Changsha: Hunan Science and Technology Publishing House, 2014.
[9] YAN J, SHI W, HONG W. De Pei Bencao (得配本草) [M]. Beijing: People's Medical Publishing House, 2007.
[10] MIU XY. Bencao Jing Shu (本草经疏)[M]. Beijing: Ancient books of traditional Chinese medicine, 2017
[11] NAM SW, BAEK JT, LEE DS, et al.A case of acute cholestatic hepatitis associated with the seeds of Psoralea corylifolia[J]. Clin Toxicol, 2005, 43(6):589.
[12] DEBORAH AS, STEWART M.A rare case of acute hepatitis induced by use of Babchi seeds as an ayurvedic remedy for vitiligo[J]. BMJ Case Rep,2014, 2014(8): 061.
[13] LI YF, CHENG GY.Clinical pharmacists participate in the pharmaceutical monitoring of liver damage caused by psoralen[J]. Evaluation and Analysis of Drug-Use in Hospitals of China(中国医院用药评价与分析) , 2016, 16(4): 571.
[14] WANG XT.Allergic reactions caused by oral and external psoralen preparations[J]. Shaanxi Correspondence of Traditional Chinese Medicine(陕西中医函授) , 1997 (3): 30.
[15] HU MC.A case of pigmentation caused by contact with psoralen[J]. Journal of Sichuan Traditional Chinese Medicine(四川中医) , 1987 (4): 41.
[16] ZHANG SG, WU LS.15 cases of phototoxic contact dermatitis caused by psoralen[J]. Tianjin Pharmacy(天津药学) , 1998, 10(4): 77.
[17] YAO FL, CHEN H, MA TN, et al.Report of 12 cases of acute phototoxic contact dermatitis caused by psoralen (with light patch test)[J]. Chinese Journal of Dermatology(中国皮肤性病学杂志) , 2000, 14(6): 410
[18] JIA M.4 cases of photosensitive contact dermatitis caused by washing psoralen[J]. Adverse Drug Reactions Journal(药物不良反应杂志) , 2009, 11(5): 376.
[19] ZHANG WB, BAO ZY.A case of photosensitive drug eruption caused by psoralen[J]. Modern Journal of Integrated Traditional Chinese and Western Medicine(现代中西医结合杂志) , 2001, 10(9): 858.
[20] CHEUNG WI, TSE ML,NGAN T, et al.Liver injury associated with the use of Fructus Psoraleae (Bol-gol-zhee or Bu-gu-zhi) and its related proprietary medicine[J]. Clin Toxicol (Phila), 2009, 47(7): 683-685.
[21] RYAN B, KONG LY.Study on the chemical constituents of Psoralea corylifolia[J]. Modern Chinese Medicine(中国现代中药), 2005, 7(4): 7-9.
[22] ZHU Y, LI Y G, WANG Y, et al.Analysis of clinical characteristics of liver injury caused by traditional Chinese medicine[J]. Chinese Journal of Integrative Medicine,(中国中西医结合杂志), 2016, 36(1): 5.
[23] YI M.Safety evaluation and risk control measures of psoralea corylifolia[J]. China Journal of Chinese Materia Medica(中国中药杂志) , 2017, 42(21): 8.
[24] National Medical Products Administration. Adverse Drug Reaction Information Notification (Issue 16) Be alert to the liver damage caused by Zhuanggu Joint Pill[EB/OL]. (2008-08-09) [2022-04-17]. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/yjjsh/ypblfytb/20080809162301345.html.
[25] National Medical Products Administration. Adverse Drug Reaction Information Notification (Issue 72) Alert to the risk of liver injury caused by Xianlinggubao oral preparation. [EB/OL]. (2016-12-08) [2022-04-17]. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/yjjsh/ypblfytb/20161208170501622.html.
[26] State Food and Drug Administration. The ninth issue of Adverse drug reaction information bulletin[J]. Chinese Community Doctors(中国社区医师) , 2005, 21(23): 1.
[27] WU MZ, LIAO F, JIA GQ.A case of acute liver failure caused by white corrosion pills[J]. Chinese Journal of Dermatology(中华皮肤科杂志) , 2012, 45(12): 1.
[28] ZHOU KM, SHI LL, YAN YY.A case of acute icteric drug-induced hepatitis caused by Baisheng pill[J]. Journal of Clinical Dermatology(临床皮肤科杂志), 2006, 35(11): 737-738.
[29] KONG XL, LI H, ZHI JQ, et al.One case of suspected drug-induced hepatitis caused by traditional Chinese patent medicines and simple preparations Baishe Pill[J]. Jiangsu Pharmaceutical and Clinical Research(江苏药学与临床研究) , 2004, 12(z1): 79.
[30] ZHAO WY.Two cases of drug-induced hepatitis caused by white corrosion pills[J]. Journal of Qiqihar Medical University(齐齐哈尔医学院学报) , 2004, 25(7): 766.
[31] State Food and Drug Administration. Watch out for liver damage caused by Zhuanggu Joint Pill[J]. Chinese Community Doctors(中国社区医师), 2009, 25(8): 1.
[32] The website of the State Food and Drug Administration. Watch out for the risk of liver injury caused by Xianlinggubao oral preparation[J]. Chinese Journal of Rural Medicine and Pharmacy(中国乡村医药) , 2017, 24(6): 68.
[33] WU ZZ, PQ. Report of 4 cases of acute liver damage caused by “Zhuanggu Joint Pill”[J]. Beijing Medical Journal(北京医学) , 1994, 1: 58-59.
[34] SONG XJ.A case of liver damage caused by Zhuanggu Joint Pill[J]. China Foreign Medical Treatment(中外医疗) , 2009, 28(18): 181.
[35] JING XJ, GE Y, JIN JM.A case of drug-induced liver damage caused by Zhuanggu Joint Pill[J]. Chinese Journal of Hospital Pharmacy(中国医院药学杂志) , 1994, 5: 228-229.
[36] LIU LP, LIU FQ.Three cases of liver damage caused by intrahepatic cholestasis were found by oral Zhuanggu Joint Pill[J]. Chin J New Drugs Clin Remed(新药与临床) , 1995, 14(2): 120.
[37] XU SB.2 cases of liver damage caused by oral Zhuanggu Joint Pill[J]. Chin J Med(中级医刊) , 1996, 11: 46.
[38] LI H, SONG LL.A case of urticaria after taking Zhuanggu Joint Pill[J]. China Journal of Chinese Materia Medica(中国中药杂志) , 1996, 21(2): 59.
[39] LI L, WANG XP.A case of urticaria type drug eruption caused by oral Zhuanggu Joint Pill[J]. Chinese Journal of Dermatology(中国皮肤性病学杂志) , 1996, 10(6): 384.
[40] WANG CS, LI MR, WANG HL.A case of urticaria caused by Zhuanggu Joint Pill[J]. Chinese Journal of Dermatology(中国皮肤性病学杂志) , 1994, 8(2): 131.
[41] YU SL, WANG CL, CONG QZ.A case of anaphylactoid purpura caused by Zhuanggu Joint Pill[J]. Lishizhen Medicine and Materia Medica Research(时珍国药研究), 1996, 7(4): 15.
[42] LUO YQ.One case of hematuria caused by taking Zhuanggu Joint Pill[J]. China Journal of Chinese Materia Medica(中国中药杂志) , 1994, 19(6): 373.
[43] HUANG Y, LIU YL, MA RR, et al.Clinical case analysis and experimental study on liver injury related to Xianlinggubao[J]. Acta Pharmaceutica Sinica B(药学学报), 2021, 56(1): 266-273.
[44] YANG LQ, PENG GL.One case of severe liver damage caused by Xianlinggubao capsule[J]. Chinese Journal of Pharmacovigilance(中国药物警戒) , 2013, 10(1): 62.
[45] PEI DP, CAO YZ.One case of acute drug-induced liver injury caused by Xianling Gubao capsule[J]. Liver(肝脏) , 2009, 14(6): 457.
[46] LIU CH, HE Y.Skin rash caused by Xianling Gubao capsule[J]. Adverse Drug Reactions Journal(药物不良反应杂志), 2013, 15(5): 297.
[47] WANG D, JIA DX, LI ZZ, et al.Discussion on safety evaluation and risk control measures of Herba Epimedii[J]. Chinese Journal of Traditional Medicine(中国中药杂志) , 2019, 44(8): 1715-1723.
[48] BAO J, ZHUO SY, LIANG MT, et al.Research progress on the dual role of psoralen and its active components in liver injury[J]. Journal of Pharmaceutical Research(药学研究) , 2020, 39(6): 4.
[49] LU YQ, ZHANG X, WANG JJ, et al.Research progress in chemical composition and pharmacological action of Psoralea corylifolia[J]. Chinese Journal of Experimental Traditional Medical Formulae(中国实验方剂学杂志) , 2019, 25(3): 10.
[50] ZHANG JQ, QU XL, YAN J, et al.Research progress on liver injury caused by psoralen[J]. Shandong Journal of Traditional Chinese Medicine(山东中医杂志) , 2022, 41(5): 7.
[51] ZHAO QH, SUN R.Research progress on the toxicity of psoralen based on efficacy and substance basis[J]. Chinese Journal of Pharmacovigilance(中国药物警戒) , 2014, 11(8): 3.
[52] LIU XY, SONG M, JIANG LB, et al.Research overview of the effect of active components of psoralen on the signal pathway related to osteoporosis[J]. Chinese Journal of Osteoporosis(中国骨质疏松杂志), 2017, 23(6): 831-836.
[53] WU Y, XU Y, WU L, et al.Clinical adverse reaction report, toxicity study and toxicity reduction thinking of psoralen[J]. Pharmacology and Clinics of Chinese Materia Medica(中药药理与临床) , 2021, 37(6): 207-213.
[54] MU GH, SHI Y, SHEN MM, et al.Research and thinking on main adverse reactions of psoralen[J]. World Journal of Traditional Chinese Medicine(世界中医药) , 2018, 13(4): 1038-1042.
[55] CHEN Y, WU Y, SONG JC.Research progress in chemical composition and biological activity of Psoralea corylifolia[J]. Practical Pharmacy and Clinical Remedies(实用药物与临床) , 2016, 19(9): 1184-1188.
[56] YANG K, GAO R, SHEN BD, et al.Research progress in pharmacological effects of isopsoralen and mechanism of liver and kidney injury[J]. Evaluation and Analysis of Drug-Use in Hospitals of China(中国医院用药评价与分析) , 2021, 21(11): 6.
[57] WANG Y, TANG LM. The discovery of the main toxic components of Psoralea corylifolia and the study on the preparation method of its antidepressant effective component group, Proceedings of the fourth (2019) academic annual meeting of the Chinese Society of Toxicology on toxicology and safety evaluation of traditional Chinese medicine and natural drugs[C]. Hainan: Chinese Society of Toxicology, 2019.
[58] ZHANG HL, WANG YN, WANG JH.Overview of the chemical composition and pharmacological activity of Psoralea corylifolia[J]. Natural Product Research and Development(天然产物研究与开发), 2010, 22(5): 6.
[59] QIN N, XU G, GAO Y, et al.Preliminary study on the regulatory effect and mechanism of psoralen isoflavone on inflammatory corpuscles[J]. Chinese Pharmacological Bulletin(中国药理学通报), 2019, 35(3): 364-370.
[60] ZHANG Y, LYU HZ.Research progress in the chemical composition and pharmacological action of Psoralea corylifolia[J]. Electronic Journal of Clinical Medical Literature(临床医药文献电子杂志) , 2020, 7(30): 195.
[61] WEI MM, WANG SY, YANG W, et al.Progress in the study of chemical composition and main toxicity of Psoralea corylifolia[J]. Chinese Journal of Experimental Traditional Medical Formulae(中国实验方剂学杂志), 2019, 25(7): 207-219.
[62] YANG XW, HE ZC, CHEN LH, et al.Biotransformation of human intestinal flora of psoralen and isopsoralen in psoralen[J]. Chinese Journal of Traditional Chinese Medicine(中国中药杂志), 2022, 47(14): 3822-3827.
[63] YAN DM, GAO XM, KANG LY, et al.Migration characteristics of benzofuran glycosides in psoralen in rat plasma[J]. Chinese Journal of Experimental Traditional Medical Formulae(中国实验方剂学杂志) , 2015, 21(11): 85-88.
[64] YU RL, ZHOU YT, ZHANG Y, et al.Study on gender differences in acute toxicity of psoralen, isopsoralen and psoralen[J]. Journal of Tianjin University of Traditional Chinese Medicine(天津中医药大学学报) , 2022, 41(3): 375-379.
[65] LI XQ, XU KH, JI F.Psoralen isoflavone inhibits osteoclast differentiation and alleviates ovariectomized osteoporosis in mice[J]. Chinese Journal of Tissue Engineering Research(中国组织工程研究), 2021, 25(2): 186-190.
[66] ZHOU K, BI YN, SHI H.Isopsoralen inhibits bile acid accumulation and toxicity in HepG2 cells caused by MRP2 and MRP3[J]. Chinese Pharmacological Bulletin(中国药理学通报), 2015, 31(8): 5.
[67] HUANG JY, WANG Q, BI YN, et al.Effect of isopsoralen on liver function and transporter in rats at different time[J]. Chinese Pharmacological Bulletin(中国药理学通报) , 2019, 35(2): 260-264.
[68] ZHONG YH, SHEN GL, YUAN M, et al.Inhibition and induction of psoralen and isopsoralen on cytochrome P450 enzyme activity in vitro[J]. Chinese Journal of Pharmacology and Toxicology(中国药理学与毒理学杂志) , 2012, 26(4): 522-528.
[69] ZHOU K, WANG AH, CHAI LJ, at al. The cytotoxicity of psoralen on HepG2 and the effects of BSEP, NTCP, FXR, CYP7A1[J]. Toxicology(毒理学杂志) , 2015, 29(3): 4.
[70] CHEN CL, JIANG XY, LIU LL, et al.Study on the hepatotoxicity mechanism of psoralen based on integrated network toxicology and molecular docking[J]. Drug Evaluation Research(药物评价研究), 2022, 45(2): 8.
[71] WANG AH, ZHOU K, CHAI LJ.The effect of psoralen on BSEP and NTCP of HepG2 cells[J]. Lishizhen Medicine and Materia Medica Research(时珍国医国药), 2015, 26(7): 3.
[72] DONG W, WANG YD, ZHOU K, et al.New dihydroisoflavones and their cytotoxic activity in Psoralea corylifolia[J]. Chinese Herbal Medicine(中草药) , 2015, 46(15): 2206-2208.
[73] ZHANG XJ, CAO HQ, XING ZH, et al.Effects of Psoralea corylifolia on mouse hepatocyte morphology, liver function and mitochondrial membrane potential[J]. China Journal of Chinese Materia Medica(中成药) , 2014, 36(1): 3.
[74] XING W, LOU YJ, WANG MX, et al.Furocoumarins affect hepatic cytochrome P450 and renal organic ion transporters in mice[J].Toxicology Letters, 20122, 9(1):67-77.
[75] GUO ZJ, LI P, WANG CG, et al.Five constituents contributed to the psoraleae fructus-induced hepatotoxicity via mitochondrial dysfunction and apoptosis[J]. Frontiers in Pharmacology, 2021, 12(7): 682823.
[76] GAO Y, WANG Z, TANG J, et al.New incompatible pair of TCM: epimedii folium combined with psoraleae fructus induces idiosyncratic hepatotoxicity under immunological stress conditions[J]. Frontiers of medicine, 2020, 14: 68-80.
[77] QIN N, XU G,WANG Y, et al.Bavachin enhances NLRP3 inflammasome activation induced by ATP or nigericin and causes idiosyncratic hepatotoxicity. Frontiers of Medicine, 2021, 15(4):14.
[78] JIANG F, ZHOU XR, WANG Q, et al.The toxicity and mechanism of psoralen and its combination with psoralen on HK-2 cells[J]. Chinese Journal of Pharmacology and Toxicology(中国药理学与毒理学杂志) , 2010 (1): 9.
[79] XIA YN, YU LY, WANG DJ.Study on the effects of different processed products of psoralen on rats with kidney yang deficiency and spleen deficiency[J]. Asia-Pacific Traditional Medicine(亚太传统医药) , 2016, 12(9): 5.
[80] SONG D, CHEN SS, LI PY, et al.Study on the method of modifying and reducing the potential hepatotoxicity of Psoralea corylifolia: alcohol immersion and water bleaching[J]. Acta Pharmaceutica Sinica B(药学学报) , 2020, 55(2): 7.
[81] HU C, TANG XL, LI J, et al.Effect of alcohol extract of psoralea corylifolia on endogenous metabolites in rat urine[J]. Chinese Journal of Pharmacology and Toxicology(中国药理学与毒理学杂志) , 2015, 29(6): 931.
[82] LIN GT, L RW, GENG ZK, et al. Comparison of estrogen like effects of psoralen water and ethanol extracts[J]. China Journal of Chinese Materia Medica(中成药) , 2016, 38(12): 2688.
[83] YI M.Safety evaluation and risk control measures of Psoralea corylifolia[J]. Chinese Journal of Traditional Chinese Medicine(中国中药杂志) , 2017, 42(21): 8.
[84] WU YL, WANG XY, ZHANG H, et al.Study on the pharmacological effect of licorice on liver injury caused by psoralen based on network pharmacology and cell experiment. Chinese Journal of Traditional Chinese Medicine(中国中药杂志) , 2022, 47(1): 176-187.
[85] LIU TT, LIANG LX, XU G, et al.Study on the mechanism of reducing toxicity of Psoralea officinalis-Cilicorice chalcone compatibility[J]. Chinese Journal of Experimental Prescriptions(中国实验方剂学杂志) , 2023, 29(1): 45-51.
[86] LI A, MA N, ZHAO Z, et al.Glycyrrhetinic acid might increase the nephrotoxicity of bakuchiol by inhibiting cytochrome P450 isoenzymes[J]. PeerJ, 2016, 4(9):e2723.
[87] ZHAO ZJ, GONG Z, SHI SZ, et al.Toxicokinetics and hepatorenal toxicity of psoralen and its compatibility with licorice in rats after single administration[J]. Chinese Journal of Traditional Chinese Medicine(中国中药杂志) , 2015, 40(11): 6.
[88] BO ZF, GAO Y, WANG JB, et al.Study on the evaluation and risk prevention and control of liver injury caused by Chinese medicine[J]. Progress in Pharmaceutical Sciences(药学进展), 2020, 44(10): 6.
[89] BO ZF, WANG JB, XIAO XH.Cognitive innovation and safe and precise use of traditional Chinese medicine toxicity[J]. Chinese Journal of Traditional Chinese Medicine(中国中药杂志) , 2022, 47(10): 2557-2564.