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北豆根配方颗粒质量评价

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目的 评价北豆根配方颗粒质量.方法 制备 15 批标准汤剂和 3 批配方颗粒,测定出膏率及木兰花碱、蝙蝠葛苏林碱、蝙蝠葛碱含量、转移率,建立HPLC特征图谱,聚类分析进行化学模式识别.结果 3 批配方颗粒出膏率为15.1%~16.6%,木兰花碱、蝙蝠葛苏林碱、蝙蝠葛碱含量分别为18.93~19.39、9.42~9.60、6.79~6.85 mg/g,三者从饮片到配方颗粒的转移率分别为 34.42%~35.25%、43.81%~44.65%、27.27%~27.51%;特征图谱中有 7 个特征峰,相似度均大于 0.95,与标准汤剂一致性良好,并符合相关限度要求.15 批标准汤剂聚为 2 类,吉林、河北、山东产药材可用于配方颗粒制备.结论 该方法合理可靠,可为北豆根配方颗粒质量控制、临床应用提供参考.
Quality evaluation for Beidougen Formula Granules
AIM To evaluate the quality of Beidougen Formula Granules.METHODS Fifteen batches of standard decoctions and three batches of formula granules were prepared,after which paste rate and contents,transfer rates of magnoflorine,daurisoline,dauricine were determined.HPLC specific chromatograms were established,and cluster analysis was adopted in chemical pattern recognition.RESULTS For three batches of formula granules,the paste rates were 15.1%-16.6%,the contents of magnoflorine,daurisoline,dauricine were 18.93-19.39,9.42-9.60,6.79-6.85 mg/g with the transfer rates of 34.42%-35.25%,43.81%-44.65%,27.27%-27.51%from decoction pieces to formula granules,respectively,and there were seven characteristic peaks in the specific chromatograms with the similarities of more than 0.95,which demonstrated good consistence with those of standard decoctions and accorded with related limit requirements.Fifteen batches of standard decoctions were clustered into two types,and the medicinal materials produced from Jilin,Hebei,Shangdong could be used for the preparation of formula granules.CONCLUSION This reasonable and reliable method can provide references for the quality control and clinical application of Beidougen Formula Granules.

Beidougen Formula Granulesstandard decoctioncontent determinationHPLC specific chromatogramscluster analysis

曹桂云、庄雪松、宁波、林永强、王岱杰、崔伟亮、刘洪超、董晓弟、黄蒙蒙、孟兆青

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山东宏济堂制药集团股份有限公司,山东省中医药治疗呼吸系统疾病技术创新中心,山东 济南 250103

山东省食品药品检验研究院,山东 济南 250101

齐鲁工业大学 (山东省科学院),山东省分析测试中心,山东 济南 250014

北豆根配方颗粒 标准汤剂 含量测定 HPLC特征图谱 聚类分析

山东省重点研发计划重大科技创新工程项目泉城产业领军人才计划(2020)泉城"5150"引才倍增计划(2021)

2021CXGC010511

2024

中成药
国家食品药品监督管理局,信息中心中成药信息站,上海中药行业协会

中成药

CSTPCD北大核心
影响因子:1.217
ISSN:1001-1528
年,卷(期):2024.46(3)
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