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枇杷止咳颗粒薄荷脑β-环糊精包合工艺及质量评价研究

沈硕 赵文玉 余俊 左言东 吕迎四 王莉莉 汪道顺

中国当代医药2025,Vol.32Issue(16):14-19,6.
中国当代医药2025,Vol.32Issue(16):14-19,6.DOI:10.3969/j.issn.1674-4721.2025.16.03

枇杷止咳颗粒薄荷脑β-环糊精包合工艺及质量评价研究

Research on the inclusion process and quality evaluation of menthol β-cy-clodextrin in Pipa Zhike Granules

沈硕 1赵文玉 2余俊 3左言东 1吕迎四 1王莉莉 1汪道顺1

作者信息

  • 1. 国药集团精方(安徽)药业股份有限公司,安徽宣城 242000
  • 2. 北京农业职业学院食品与生物工程学院,北京 102442
  • 3. 宣城市食品药品检验中心,安徽宣城 242000
  • 折叠

摘要

Abstract

Objective The aim is to improve the stability of menthol in the prescription of loquat cough relieving granules,clarify the process parameters of menthol β-cyclodextrin inclusion,and establish the characteristic map of loquat cough re-lieving granules and the quality evaluation method of menthol content determination.Methods The stability of menthol in the prescription was enhanced by using the β-cyclodextrin inclusion technique.The characteristic map examination method of Pipa Zhike Granules was established by high performance liquid chromatography,and the content determination method of β-cyclodextrin inclusion menthol was constructed by gas chromatography.Results The average metastasis rate of menthol in the prescription of Loquat Cough Granules increased from 15%to 73%,and the stability of menthol encapsulated byβ-cyclodextrin was good.In the check of the characteristic spectra,A total of 13 characteristic peaks were determined us-ing chlorogenic acid and picoside A as reference peaks,and 4 chemical components among them were identified.In terms of the determination of menthol content,the linear relationship of menthol was good within the range of 41.13-205.63 μg/ml.The RSD of the test results of precision,repeatability and stability were all less than 2.0%,and the recovery rate of sample addition was 97.6%.Conclusion In this study,the inclusion process parameters of menthol β-cyclodextrin were deter-mined,and the methods for the determination of menthol content and the inspection of characteristic spectra were established,providing strong support for ensuring the stable quality of Pipa Zhike Granules.

关键词

枇杷止咳颗粒/β-环糊精包合/薄荷脑/特征图谱/质量评价

Key words

Pipa Zhike Granules/β-Cyclodextrin inclusion/Characteristic atlas/Menthol/Quality evaluation

分类

医药卫生

引用本文复制引用

沈硕,赵文玉,余俊,左言东,吕迎四,王莉莉,汪道顺..枇杷止咳颗粒薄荷脑β-环糊精包合工艺及质量评价研究[J].中国当代医药,2025,32(16):14-19,6.

基金项目

安徽省药品监督管理局科技创新项目(AHYJ-KJ202221). (AHYJ-KJ202221)

中国当代医药

1674-4721

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