首页|僵蚕药材及饮片质量标准研究

僵蚕药材及饮片质量标准研究

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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.
Study on Quality Standard for Bombyx Batryticatus
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 Bom-byx 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.

Bombyx BatryticatusBeauvericinAmmonium oxalateQuality evaluation

高鹏、文永盛、罗霄、代琪、李及、许莉

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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

僵蚕 白僵菌素 草酸铵 质量评价

中国药品监管科学行动计划重点项目(第二批)四川省药品监督管理局科技项目

NMPAJGKX-2023-0732022011

2024

中国药物评价
国家食品药品监督管理局信息中心

中国药物评价

影响因子:1.09
ISSN:2095-3593
年,卷(期):2024.41(1)
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