| 郭文旭,王丹丹.四种药典空心胶囊及其原料标准现状及研究[J].中国药品标准,2023,24(2): |
| 四种药典空心胶囊及其原料标准现状及研究 |
| Status and research of four kinds of pharmacopoeia hollow capsules and their raw material standards |
| 投稿时间：2022-07-18 修订日期：2023-03-29 |
| DOI： |
| 中文关键词: 空心胶囊 药典 胶囊原料 限度标准 比较研究 |
| 英文关键词: Hollow Capsules Pharmacopoeia Capsule Raw Materials Limit Standards Comparative Study |
| 基金项目:浙江省药品监管系统科技计划项目 |
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| 摘要点击次数: 349 |
| 全文下载次数: 1179 |
| 中文摘要: |
| 空心胶囊作为药物的常用载体，具有掩盖药物不良气味、提高生物利用度，便于吞服等优点。《中国药典》2020 年版、EP10.8、USP44-NF39、JP18均收载了对不同空心胶囊及其原料进行质量控制的相关标准。本文通过比较不同国家之间收载标准的差异，将空心胶囊及其原料检查项目进行了梳理，研究表明，国外药典对胶囊和胶囊原材料的质量控制更为精细，可为我国对空心胶囊及其原料标准的完善和提高提供参考。 |
| 英文摘要: |
| As a common carrier for drugs,hollow capsules have the advantages of masking undesirable drug odors, improving bioavailability, and facilitating swallowing. Standards for quality control of different hollow capsules and their raw materials are included in the Chinese Pharmacopoeia 2020, EP10.8, USP44-NF39, JP18. In this paper, by comparing the differences between the standards contained in different countries, the hollow capsules and their raw materials are checked and sorted out. The study shows that the quality control of capsules and capsule raw materials in foreign pharmacopoeias is more refined, which can provide reference for the improvement and enhancement of the standards of hollow capsules and their raw materials in China. |
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