| 含挥发油饮片配方颗粒国家标准现状与制定技术对策分析 |
| 投稿时间：2022-04-13 点此下载全文
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| 引用本文：赵剑锋,张雪,祁进,宋宗华.含挥发油饮片配方颗粒国家标准现状与制定技术对策分析[J].中国现代中药,2023,25(4):773-776 |
| DOI：10.13313/j.issn.1673-4890.20220413001 |
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| 中文摘要:中药配方颗粒试点工作结束以来，国家药品监督管理局已分2批颁布了196个中药配方颗粒的国家标准。对已颁布的中药配方颗粒国家标准进行梳理，截至目前，仅有薄荷、荆芥、苍术（北苍术）、连翘（青翘）、肉桂5个配方颗粒制法项目涉及挥发油提取及包合工序。其中连翘（青翘）、苍术（北苍术）配方颗粒制法项明确了挥发油加入量，尚未对挥发油含量进行控制；薄荷、荆芥、肉桂配方颗粒制法项未明确挥发油加入量，但对挥发油含量上、下限进行了规定。通过对比分析上述含挥发油饮片配方颗粒国家标准制法及含量测定项目，对何种饮片配方颗粒需要收集挥发油、挥发油加入量，以及如何控制中药配方颗粒中挥发油含量等问题进行探讨分析，以期为今后含挥发油饮片配方颗粒国家标准的制定提供参考。 |
| 中文关键词:配方颗粒 挥发油 国家标准 质量控制 |
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| Anlysis of National Standard for Formula Granules Containing Volatile Oil and Formulation Technical Countermeasures |
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| Abstract:Following the trials of formula granules, the National Medical Products Administration (NMPA) has issued 196 national standards of formula granules in two batches. The present study summarized the existing national standards of formula granules and found that up to now, only Menthae Haplocalycis Herba, Schizonepetae Herba, Atractylodis Rhizoma, Forsythiae Fructus, and Cinnamomi Cortex granules involved extraction and inclusion of volatile oil in the preparation sections. The preparation sections of Forsythiae Fructus and Atractylodis Rhizoma granules specified the content of volatile oil, but the content of volatile oil was not controlled. The preparation sections of Menthae Haplocalycis Herba, Schizonepetae Herba, and Cinnamomi Cortex granules did not specify the content of volatile oil, but specified the upper and lower limits of the volatile oil content. This study compared and analyzed the above-mentioned national standards and content determination of formula granules containing volatile oil and explored the certain granules needing volatile oil, the added amount of volatile oil, and the control of the volatile oil in the formula granules, which provided references for the formulation of national standards of formula granules containing volatile oil. |
| keywords:formula granules volatile oil national standard quality control |
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