冰片细菌内毒素检查方法研究

doi:10.19803/j.1672-8629.20260121

中国药物警戒 ›› 2026, Vol. 23 ›› Issue (9): 1011-1016.
DOI: 10.19803/j.1672-8629.20260121

冰片细菌内毒素检查方法研究

陈忠¹, 杨斌², 张煌³, 邓新贵², 林燕琴^1,*, 方志锴¹

¹福建省微生物研究所新药筛选研究室,福建省新药（微生物）筛选重点实验室,福建福州 350007;
²福建南平青松化工有限公司,福建省松节油加工重点实验室,福建南平 354200;
³南平青华科技有限公司,福建南平 354200

收稿日期:2026-02-10 出版日期:2026-09-15 发布日期:2026-09-15
通讯作者: ^*林燕琴,女,硕士,工程师,药物分析学。E-mail: 542040031@qq.com
作者简介:陈忠,男,本科,高级工程师,药品研发。
基金资助:
福建省自然科学基金项目（2022J01387）; 国家科技计划项目备案项目—福建省科技计划中央引导地方科技发展专项（2023L3066）; 福建省科技计划区域发展项目（2022H4024）

Testing methods for bacterial endotoxins in borneol

Chen Zhong¹, Yang Bin², Zhang Huang³, Deng Xingui², Lin Yanqin^1,*, Fang Zhikai¹

¹New Drug Screening Laboratory, Fujian Key Laboratory of Screening for Novel Microbial Products, Fujian Institute of Microbiology, Fuzhou Fujian 350007, China;
²Fujian Nanping Green Pine Chemical Co., Ltd., Fujian Key Laboratory of Turpentine Oil Derivatives, Nanping Fujian 354200, China;
³Nanpin Qinghua Technology Co., Ltd., Nanping Fujian 354200, China

Received:2026-02-10 Online:2026-09-15 Published:2026-09-15

摘要/Abstract

摘要： 目的建立难溶性药物冰片的细菌内毒素限值及检查方法,并进行方法学考察。方法根据《中华人民共和国药典》（2025年版）相关要求,确定冰片的细菌内毒素限值;用无水乙醇溶解冰片,再以细菌内毒素检查用水（BET水）稀释,分别采用凝胶法和动态浊度法开展干扰试验和细菌内毒素回收试验。结果供试品经无水乙醇溶解后,用BET水稀释40倍以上时,对凝胶法和动态浊度法检查无干扰,检查结果符合规定。结论建立的方法适用于冰片细菌内毒素检查,有助于中药冰片的质量标准提升,也为其他难溶性药物的细菌内毒素检测提供参考。

关键词: 冰片, 细菌内毒素, 凝胶法, 动态浊度法, 无水乙醇, 难溶性, 干扰试验

Abstract: Objective To establish the bacterial endotoxin limit and test method for the insoluble drug—borneol—and to validate the method. Methods The bacterial endotoxin limit for borneol was determined according to the Chinese Pharmacopoeia (2025 Edition). Borneol was dissolved in anhydrous ethanol and diluted with water for the bacterial endotoxin test (BET water). Interference and bacterial endotoxin recovery tests were performed using the gel method and kinetic turbidimetric assay. Results No interference was observed with either method when the sample dissolved in anhydrous ethanol was diluted at a dilution factor of 40 or more with BET water, and the results of each test met the related requirements. Conclusion The established method is applicable to testing of bacterial endotoxins in borneol, which can contribute to the improvement of quality standards for borneol as a traditional Chinese medicine. This study is expected to provide a reference for related tests.

Key words: Borneol, Bacterial Endotoxin, Gel Method, Kinetic Turbidimetric Assay, Anhydrous Ethanol, Insolubility, Interference Test

中图分类号:

R927.1

陈忠, 杨斌, 张煌, 邓新贵, 林燕琴, 方志锴. 冰片细菌内毒素检查方法研究[J]. 中国药物警戒, 2026, 23(9): 1011-1016.

Chen Zhong, Yang Bin, Zhang Huang, Deng Xingui, Lin Yanqin, Fang Zhikai. Testing methods for bacterial endotoxins in borneol[J]. Chinese Journal of Pharmacovigilance, 2026, 23(9): 1011-1016.

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参考文献

[1] Pan Li, Wei Ruonan, Yu Tongyue, et al.An exploration on the clinical application and dosage of borneol[J]. Journal of Changchun University of Chinese Medicine(长春中医药大学学报), 2021, 37(5): 980-982.
[2] Cheng Hongyan, Tao Wenwen, Tao Wenkang, et al.Research progress on the“guiding drug up”effect and dosage forms of borneol[J]. Journal of Pharmaceutical Research(药学研究), 2024, 43(6): 586-593.
[3] Zhou Wen, Zhao Xiuli.Research progress of edaravone and dextranol in ischemic stroke[J]. Advances in Clinical Medicine(临床医学进展), 2023, 13(6): 9947-9951.
[4] Zhang Namin, Chen Fang, Yang Jiayong. Research progress on the efficacy and safety of edaravone dexborneol for the treatment of ischemic stroke(海峡药学), 2023, 35(7): 87-90.
[5] Sun Qian, Yang Xue, Zhang Fan.Real-world study on safety of edaravone dexcamphenol[J]. Practical Pharmacy and Clinical Remedies(实用药物与临床), 2024, 27(7): 510-513.
[6] Zhang Yuan, Sun Shuxue.Research progress of bacterial endotoxin detection methods[J]. Chinese Journal of Biologicals(中国生物制品学杂志), 2023, 36(3): 368-372.
[7] Chinese Pharmacopoeia Commission.Pharmacopoeia of the People's Republic of China, Volume I(中华人民共和国药典一部)[M]. Beijing: China Medical Science Press, 2025.
[8] Yang Yating, Lyu Xiaojun, Zhang Ju, et al.Method of bacterial endotoxins test in flumazenil bulk drug[J]. Herald of Medicine(医药导报), 2024, 43(9): 1470-1476.
[9] Chinese Pharmacopoeia Commission.Pharmacopoeia of the People's Republic of China, Volume IV(中华人民共和国药典四部)[M]. Beijing: China Medical Science Press, 2025.
[10] Chen Xing, He Limin, Liu Rong.Progress on the detection of bacterial endotoxin[J]. Chinese Journal of Analysis Laboratory(分析试验室), 2023, 42(9): 1242-1250.
[11] Zhao Yuxin, Cai Tong, Sun Huimin, et al.Testing methods for bacterial endotoxin in a pharmaceutical excipient of trimethyl-phloroglucinol[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2025, 22(4): 368-371.
[12] Wen Yaoming, Fan Jianhui, Wu Wenqing, et al.Determination of bacterial endotoxin content in sirolimus API by adding surfactant[J]. Chinese Pharmaceutical Affairs(中国药事), 2022, 36(3): 301-305.
[13] Zhang Hongmei, Fang Fang, Li Xiangsheng, et al.Bacterial endotoxin test methodology of insulin glargine active pharmaceutical ingred-ients[J]. China Pharmaceuticals(中国药业), 2022, 31(20): 72-74.
[14] Xu Meibao, Pei Yusheng, Chen Chen, et al.Bacterial endotoxin test of (R)-lansoprazole raw material[J]. Chinese Journal of Pharmacovi-gilance(中国药物警戒), 2024, 21(8): 852-856.
[15] Zhang Ju, Lyu Xiaojun, Yang Yating, et al.Bacterial endotoxins test method study of active pharmaceutical ingredient of insoluble adrenaline[J]. Chinese Pharmaceutical Journal(中国药学杂志), 2024, 59(12): 1156-1160.

冰片细菌内毒素检查方法研究

Testing methods for bacterial endotoxins in borneol

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