首页|基于含量测定和指纹图谱评价电子束辐照灭菌对藏药小檗膏耳用散剂质量的影响

基于含量测定和指纹图谱评价电子束辐照灭菌对藏药小檗膏耳用散剂质量的影响

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目的 评价电子束辐照灭菌对藏药小檗膏耳用散剂质量的影响.方法 分别采用0、2、4、6、8、10kGy剂量的电子束辐照处理小檗膏耳用散剂,研究不同剂量电子束辐照对其性状、指纹图谱、生物负载及指标成分盐酸小檗碱、没食子酸和西红花苷-Ⅰ含量的影响.结果 电子束辐照剂量增加时,粉末颜色略有加深,各组之间无明显变化,均为棕黄色粉末;电子束辐照能够有效降低小檗膏耳用散剂中细菌和霉菌、酵母菌菌落总数,随着辐照剂量增大,其存活数显著降低(P<0.05);电子束辐照对小檗膏耳用散剂中主要成分盐酸小檗碱、没食子酸和西红花苷-Ⅰ的含量无显著影响(P>0.05).不同剂量电子束辐照处理的小檗膏耳用散剂指纹图谱的相似度均大于0.958,表明经电子束辐照处理的样品与未辐照样品相比无显著变化.结论 10 kGy以下电子束辐照灭菌对藏药小檗膏耳用散剂的多个指标成分的含量无明显影响,而6kGy以下电子束辐照灭菌即可符合《中国药典》2020年版微生物限度标准的规定.电子束辐照适用于小檗膏耳用散剂的灭菌,为电子束辐照技术在小檗膏耳用散剂灭菌中的应用提供了科学依据.
Effect of electron beam irradiation sterilization on the quality of Tibetan medicine berberis extract ear powder based on content determination and fingerprints
Objective To evaluate the effect of electron beam irradiation sterilization on the quality of berberis extract ear powder.Methods Berberis extract ear powder was treated with 0,2,4,6,8,and 10 kGy electron beam irradiation to determine the effect of different doses of irradiation on its properties,fingerprint,biological load and the content of index components berberine hydrochloride,gallic acid and crocin-Ⅰ.Results The color of powder slightly deepened with the electron beam irradiation dose,but with no obvious change among all groups.Electron beam irradiation effectively reduced the total number of bacterial and fungal yeast colonies in the powder,and the survival number was significantly decreased with the increase of irradiation dose(P<0.05).The content of berberine hydrochloride,gallic acid and crocin-Ⅰ was not significantly affected by electron beam irradiation sterilization(P>0.05).The similarity of fingerprint of berberis extract ear powder treated with different doses of electron beam irradiation was larger than 0.958,indicating no significant change between the samples with irradiation and those without.Conclusion Electron beam irradiation sterilization less than 10 kGy has no obvious effect on the quality of multiple index components of berberis extract ear powder.Irradiation at 6 kGy meets the standard 2020 edition of Chinese Pharmacopoeia.Electron beam irradiation is suitable for the sterilization of berberis extract ear powder,providing a scientific basis for the application of electron beam irradiation in the sterilization process.

berberis extract ear powdersterilization by irradiationberberine hydrochloridegallic acidcrocin-Ⅰ

高平、曲悦、王彩芬、伍丽、王弼聪、张继稳、谢和兵

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安徽中医药大学药学院,合肥 230012

长三角药物高等研究院,江苏 南通 226000

江苏云构药物科技有限公司,江苏 南通 226000

西藏神猴药业有限责任公司,西藏 日喀则 857000

中国科学院上海药物研究所,上海 201210

北京神州数码有限公司,北京 100080

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小檗膏耳用散剂 辐照灭菌 盐酸小檗碱 没食子酸 西红花苷-Ⅰ

西藏自治区科技厅区域科技协同创新专项

QYXTZX-RKZ2022-07

2024

中南药学
湖南省药学会

中南药学

CSTPCD
影响因子:0.736
ISSN:1672-2981
年,卷(期):2024.22(5)
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