• 中国核心期刊(遴选)数据库收录期刊
  • 中文科技期刊数据库收录期刊
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中国药物评价 ›› 2024, Vol. 41 ›› Issue (1): 47-51.

• 评价技术与方法 • 上一篇    下一篇

僵蚕药材及饮片质量标准研究

高鹏, 文永盛, 罗霄, 代琪, 李及, 许莉*   

  1. 成都市药品检验研究院/国家药品监督管理局中药材质量监测评价重点实验室,四川 成都 610045
  • 收稿日期:2023-12-18 修回日期:2024-01-30 出版日期:2024-02-28 发布日期:2024-02-28
  • 基金资助:
    中国药品监管科学行动计划第二批重点项目(NMPAJGKX-2023-073);四川省药品监督管理局科技计划项目(2022011)

Study on Quality Standard for Bombyx Batryticatus

  1. Chengdu Institute for Drug Control/ NMPA Key Laboratory for Quality Monitoring and Evaluation
         of Traditional Chinese Medicine, Sichuan Chengdu 610045, China
  • Received:2023-12-18 Revised:2024-01-30 Online:2024-02-28 Published:2024-02-28

摘要: 目的:对不同来源僵蚕质量进行评价,完善其质量标准。方法:建立僵蚕中白僵菌素、草酸铵HPLC含量测定方法,对58批次具有代表性的不同来源僵蚕药材及饮片进行测定分析。结果:58批次僵蚕样品中,10批次未检出特征性成分白僵菌素、草酸铵,占比17.2%。白僵菌素含量分布在0.0101%~0.1192%间,草酸铵含量分布在4.71%~10.84%间,两者呈显著正相关(P<0.01)。结论:本研究建立的方法专属性强、灵敏度高、重复性好,可有效评价和控制僵蚕质量。僵蚕存在较高质量风险,有待进一步完善僵蚕质量标准。

关键词: 僵蚕, 白僵菌素, 草酸铵, 质量评价

Abstract: Objective: In response to the quality variations observed in Bombyx Batryticatus, an assessment of Bombyx Batryticatus from different origins was conducted, leading to improve the quality standard. Methods: HPLC methods were established to determine the content of beauvericin and ammonium oxalate in Bombyx Batryticatus. 58 batches of representative medicinal materials and decoction pieces of Bombyx Batryticatus from different sources were analyzed. Results: Among the 58 batches of samples, beauvericin and ammonium oxalate were not detected in 10 batches, accounting for 17.2%. The contents of beauvericin ranged from 0.010 1% to 0.119 2%, and the contents of ammonium oxalate ranged from 4.71% to 10.84%, showing a significant positive correlatation (P<0.01). Conclusion: The established methods have strong specificity, high sensitivity and good repeatability, which can effectively evaluate and control the quality of Bombyx Batryticatus. There is a high quality risk of Bombyx Batryticatus, and the quality standard needs to be further improved.

Key words: Bombyx Batryticatus, Beauvericin, Ammonium oxalate, Quality evaluation

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