近日，欧洲药典10.0发布，其中新增章节和修订的章节将于2020年1月1日生效，此外还有部分作了修正的章节，要求制药公司最迟不得迟于2019年8月31日作出变更！具体如下：

The 10th edition of the Ph. Eur.will be released in July 2019 and will be updated with eight supplements over the next 3 years to 10.8). The new and revised Texts of the 10th Edition will become official on 1 January 2020.

欧洲药典第十版，将于2019年7月发布，并将在未来3年至10.8)更新8个增补本。第十版的新文本和修订文本将于2020年1月1日正式生效。

As of the 10th Edition of the Ph. Eur.,

欧洲药典10.0版内容：

• revised and / or corrected parts of texts are indicated by vertical lines (print version),
• 文本的修改和/或更正已用竖线标出(印刷版)
• horizontal lines indicate where parts of texts have been deleted (print version),
• 划线表示文本已被删除(印刷版)
• a QR Code is included at the start of each text, providing a link to further information . the Knowledge database),
• 每篇文章的开头都有二维码，提供进一步信息的链接(如知识库)
• the wording used in the calculation of percentage contents in tests for related substances has been modified to specify the full name of the substance . including counter-ions, hydrates etc.),
• 对有关物质检测中计算百分含量的措辞进行了修改，明确了该物质的全称(包括反离子、水合物等)，
• tests using diphosphorus pentoxide, mainly tests for loss on drying, have been modified to avoid the use of this substance due to its toxicity,
• 需要使用五氧化二磷的测试，主要是干燥失重测试，已经进行了修改，以避免使用这种有毒物质，
• the names and descriptions of the reagents used to describe stationary GC phases have been revised,
• 修改气相色谱固定相的试剂的名称和描述，
• ‘Tamper-proof ’ has been replaced by ‘tamper-evident’,
• 术语‘Tamper-proof ’改为‘tamper-evident’,
• reference to general chapter 2.8.23. Microscopic examination of herbal drugs has been added when microscopic examination is carried out using a powder with a non-standard sieve size,
• 通则第2.8.23《草药显微镜检查》：当使用非标准筛尺寸的粉末进行显微镜检查时，增加了参考文献
• the terms ‘coarse’ and ‘coarsely’ have been deleted from ‘coarse powder’ and ‘coarsely powdered herbal drug’ . Sieve test),
• “粗”和“粗的”两词已从“粗粉”和“植物药粗粉”中删除筛分试验),
• results are expressed in per cent instead of per cent m/m in the tests 2.8.16 Dry residue of extracts and 2.8.17 Loss on drying of extracts.
• 在2.8.16萃取物干燥残渣和2.8.17萃取物干燥损失的测试中，结果用百分数表示，而不是用百分数m/m表示。

新增内容：

The following texts appear for the first time in the European Pharmacopoeia. They will be implemented on 1 January 2020at the latest.

新增以下章节，它们最迟将于2020年1月1日生效！

• 2.6.35. Quantification and characterisation of residual host-cell DNA
• 残留宿主细胞DNA的定量和定性
• 2.9.49. Powder flow properties by shear cell methods
• 剪切细胞方法检查粉末流动特性
• 2.9.52. Scanning electron microscopy
• 扫描电子显微镜
• 3.3. Containers for human blood and blood components, and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes
• 用于人体血液和血液成分的容器及其制造中使用的材料；输血套及其生产物料；注射器
• 5.25. Process analytical technology
• 过程分析技术

修订部分：

The following texts have been technically revised since their last publication. They will be implemented on 1 January 2020 at the latest.

以下章节作了技术性的修订，它们最迟将于2020年1月1日生效！

• 2.2.25. Absorption spectrophotometry, ultraviolet and visible
• 紫外可见吸收分光光度法
• 2.6.8. Pyrogens
• 热原
• 2.6.33. Residual pertussis toxin
• 百日咳毒素残留
• 2.7.2. Microbiological assay of antibiotics
• 抗生素微生物测定
• 2.7.23. Numeration of CD34/CD45+ cells in haematopoietic products
• 造血产品中CD34/CD45+细胞的计数
• 2.7.35. Immunonephelometry for vaccine component assay
• 免疫比浊法测定疫苗成分
• 2.8.25. High-performance thin-layer chromatography of herbal drugs and herbal drug preparations
• 中药和中药制剂的高效薄层色谱
• 2.9.1. Disintegration of tablets and capsules
• 片剂和胶囊的崩解
• 2.9.20. Particulate contamination: visible particles
• 颗粒污染：可见颗粒
• 3.1.13. Plastic additives
• 塑料添加剂
• 3.3.1. Materials for containers for human blood and blood components
• 人体血液和血液成分容器的材料
• 3.3.2. Materials based on plasticised poly(vinyl chloride) for containers for human blood and blood components
• 用于人体血液和血液成分容器的塑料聚合物(氯乙烯) 材料
• 3.3.3. Materials based on plasticised poly(vinyl chloride) for tubing used in sets for the transfusion of blood and blood components
• 用于血液和血液成分输液器管材的塑料聚合物(氯乙烯) 材料
• 3.3.4. Sterile plastic containers for human blood and blood components
• 用于人体血液和血液成分的无菌塑料容器
• 3.3.5. Empty sterile containers of plasticised poly(vinyl chloride) for human blood and blood components
• 用于人体血液和血液成分的塑料聚合物(氯乙烯)无菌空容器
• 3.3.6. Sterile containers of plasticised poly(vinyl chloride) for human blood containing anticoagulant solution
• 用于人体血液（含有抗凝液）的塑料聚合物 (氯乙烯)无菌容器
• 3.3.7. Sets for the transfusion of blood and blood components
• 用于输送血液和血液成分的装置
• 3.3.8. Sterile single-use plastic syringes
• 无菌一次性塑料注射器
• 4. Reagents
• 试剂
• 5.3. Statistical analysis of results of biological assays and tests
• 生物含量结果的统计分析和检验
• 5.8. Pharmacopoeial harmonisation
• 药典协调
• 5.21. Chemometric methods applied to analytical data
• 应用于分析数据的化学测量方法
• 5.22. Names of herbal drugs used in traditional Chinese medicine
• 中药用草药名称
• 5.24. Chemical imaging
• 化学成像

修正的部分

The following texts have been corrected for the 10th Edition and specify ‘corrected 10.0’ above the title. These corrections are to be taken into account as soon as possible and not later than 31 August 2019 (the end of the month following the month of publication of the 10th Edition).

以下章节作了修正，并在其标题上标注了“10.0版修正”应尽快考虑这些修正，并最迟不得迟于2019年8月31日。

• 1. General notices
• 凡例
• 2.2.5. Relative density
• 相对密度
• 2.2.29. Liquid chromatography
• 液相色谱
• 2.2.31. Electrophoresis
• 电泳法
• 2.4.23. Sterols in fatty oils
• 脂肪油中的甾醇
• 2.4.25. Ethylene oxide and dioxan
• 环氧乙烷和二恶英
• 2.4.26. N,N-DiMethylaniline
• NN-二甲基苯胺
• 2.4.32. Total cholesterol in oils rich in omega-3 acids
• 富含欧米伽-3酸的油中的总胆固醇
• 2.5.19. O-Acetyl in polysaccharide vaccines
• 多糖疫苗中的O-乙酰
• 2.5.37. Methyl, ethyl and isopropyl methanesulfonate in methanesulfonic acid
• 甲磺酸中的甲基、乙基和亚丙基磺酸
• 2.5.38. Methyl, ethyl and isopropyl methanesulfonate in active substances
• 活性物质中的甲基、乙基和甲磺酸异丙酯
• 2.5.39. Methanesulfonyl chloride in methanesulfonic acid
• 甲磺酸中的甲基酰氯
• 2.5.40. Methyl, ethyl and isopropyl toluenesulfonate in active substances
• 活性物质中的甲基、乙基和甲苯磺酸异丙酯
• 2.5.41. Methyl, ethyl and isopropyl benzenesulfonate in active substances
• 活性物质中的甲基、乙基和异丙基苯磺酸盐
• 2.7.8. Assay of tetanus vaccine (adsorbed)
• 破伤风疫苗的测定(吸附)
• 2.8.9. Residue on evaporation of essential oils
• 精油蒸发残渣
• 2.9.10. Ethanol content
• 乙醇含量
• 2.9.11. Test for methanol and 2-propanol
• 甲醇和2丙醇的检验
• 3.1.14. Materials based on plasticised poly(vinyl chloride) for containers for aqueous solutions for intravenous infusion
• 用于静脉输液容器的塑料聚合物(氯乙烯)材料
• 3.2. Containers
• 容器
• 5.1.2. Biological indicators and related microbial preparations used in the manufacture of sterile products
• 用于无菌产品生产的生物指示剂及相关微生物制品
• 5.1.6. Alternative methods for control of microbiological quality
• 微生物质量控制的替代方法
• 5.2.12. Raw materials of biological origin for the production of cell-based and gene therapy medicinal products
• 生产细胞和基因治疗药品的生物原料
• 5.9. Polymorphism
• 多晶型
• 5.10. Control of impurities in substances for pharmaceutical use
• 药用物质的杂质控制
• 5.12. Reference standards
• 标准品
• 5.15. Functionality-related characteristics of excipients
• 辅料的功能相关特性
• 5.16. Crystallinity
• 结晶性

此外，还有一部分修改了标题和编号。

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