EP 增补9.2内容

CONTENTS OF SUPPLEMENT 9.2 欧洲药典增补9.2内容

A vertical line in the margin indicates where part of a text has been revised or corrected. A horizontal line in the margin indicates where part of a text has been deleted. However, these indications, which are not necessarily exhaustive, are given for information and do not form an official part of the texts. Editorial changes are not indicated.

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Subscribers to the current version (printed or electronic) of the European Pharmacopoeia have access to an online archive version of all previous editions of the European Pharmacopoeia.

A list of new reagents published during the course of this edition is available under ‘Useful information’ in Pharmeuropa Online.

在页边有一条垂直的线标识的文字部分是经过修订或更正的。在页中的横线则表示这部分文字已被删除。但是这些标记并不一定能标识全部的更新内容，只是供参考，而并不成为文本内容的正式部分。编辑性变更不显示。

在本版本EP中公布的单个文件拷贝将不再单独提供。

订购当前EP版本（印刷本或电子）者可以进入所有之前的EP版的在线存档版本。

在此版本中公布的新试剂清单在药典在线帮助信息下可以找到。

NEW TEXTS新内容

The following texts appear for the first time in the European Pharmacopoeia. They will be implemented on 1 July 2017 at the latest.

以下内容为EP中首次出现，它们最迟将于2017年7月1日生效。

GENERAL CHAPTERS

5.1.11. Determination of bactericidal, fungicidal or yeasticidal activity of antiseptic medicinal products

MONOGRAPHS

Radiopharmaceutical preparations and starting materials for radiopharmaceutical preparations

Lutetium (177Lu) solution for radiolabelling (2798)

Sodium pyrophosphate decahydrate for radiopharmaceutical preparations (2552)

Herbal drugs and herbal drug preparations

Evodia fruit (2718)

Homoeopathic preparations

Selenium for homoeopathic preparations (2844)

Monographs

Egg phospholipids for injection (2315)

Isopropyl isostearate (2867)

Milbemycin oxime for veterinary use (2536)

Remifentanil hydrochloride (2644)

Terlipressin (2646)

REVISED TEXTS 修订内容

The following texts have been technically revised since their last publication. They will be implemented on 1 July 2017.

以下内容在上次发布内容的基础做了技术修订，它们最迟将于2017年7月1日生效。

GENERAL CHAPTERS

2.2.1. Clarity and degree of opalescence of liquids

2.6.27. Microbiological examination of cell-based preparations

2.6.30. Monocyte-activation test

3.1.3. Polyolefins

3.1.4. Polyethylene without additives for containers for parenteral preparations and for ophthalmic preparations

3.1.5. Polyethylene with additives for containers for parenteral preparations and for ophthalmic preparations

3.1.6. Polypropylene for containers and closures for parenteral preparations and ophthalmic preparations

3.1.7. Poly(ethylene - vinyl acetate) for containers and tubing for total parenteral nutrition preparations

4. Reagents (new, revised, corrected)

5.1.1. Methods of preparation of sterile products

5.1.2. Biological indicators and related microbial preparations used in the manufacture of sterile products

5.1.6. Alternative methods for control of microbiological quality

5.8. Pharmacopoeial harmonisation

5.15. Functionality-related characteristics of excipients

5.22. Names of herbal drugs used in traditional Chinese medicine

MONOGRAPHS

General monographs

Herbal drugs (1433)

Dosage forms

Glossary (1502)

Vaccines for veterinary use

Furunculosis vaccine (inactivated, oil-adjuvanted, injectable) for salmonids (1521)

Vibriosis (cold-water) vaccine (inactivated) for salmonids (1580)

Vibriosis vaccine (inactivated) for salmonids (1581)

Yersiniosis vaccine (inactivated) for salmonids (1950)

Radiopharmaceutical preparations and starting materials for radiopharmaceutical preparations

Copper tetramibi tetrafluoroborate for radiopharmaceutical preparations (2547)

Iobenguane sulfate for radiopharmaceutical preparations (2351)

Medronic acid for radiopharmaceutical preparations (2350)

Sodium iodohippurate dihydrate for radiopharmaceutical preparations (2352)

Technetium (99mTc) bicisate injection (2123)

Technetium (99mTc) mebrofenin injection (2393)

Tetra-O-acetyl-mannose triflate for radiopharmaceutical preparations (2294)

Herbal drugs and herbal drug preparations

Acanthopanax bark (2432)

Aniseed (0262)

Astragalus mongholicus root (2435)

Aucklandia root (1797)

Coix seed (2454)

Drynaria rhizome (2563)

Eclipta herb (2564)

Eucommia bark (2412)

Myrrh (1349)

Myrrh tincture (1877)

Peppermint leaf (0406)

Peppermint leaf dry extract (2382)

Monographs

Amiloride hydrochloride dihydrate (0651)

Benzylpenicillin potassium (0113)

Benzylpenicillin sodium (0114)

Cellulose acetate (0887)

Cholesterol for parenteral use (2397)

Colistimethate sodium (0319)

Ethylcellulose (0822)

Glycerol monostearate 40-55 (0495)

Human plasma (pooled and treated for virus inactivation) (1646)

Imatinib mesilate (2736)

Manganese sulfate monohydrate (1543)

Minocycline hydrochloride dihydrate (1030)

Netilmicin sulfate (1351)

Omega-3-acid ethyl esters 90 (1250)

Povidone (0685)

Pregabalin (2777)

Proguanil hydrochloride (2002)

Propylene glycol dilaurate (2087)

Ranitidine hydrochloride (0946)

Sildenafil citrate (2270)

Sucralose (2368)

Xanthan gum (1277)

CORRECTED TEXTS 更正内容

The following texts have been corrected for Supplement 9.2 and specify ‘corrected 9.2’ above the title. These corrections are to be taken into account as soon as possible and not later than 28 February 2017 (the end of the month following the month of publication of Supplement 9.2).

以下文本经过了更正，在标题上标明“corrected 9.2 ”。这些更正应尽快考虑，不得迟于2017年2月28日（第9.2版发布的当月月底）。

GENERAL CHAPTERS

1. General notices

2.2.46. Chromatographic separation techniques 色谱分离技术

5.3. Statistical analysis of results of biological assays and tests 生物效价结果统计分析和检测

5.7. Table of physical characteristics of radionuclides mentioned in the European Pharmacopoeia

MONOGRAPHS

Radiopharmaceutical preparations and starting materials for radiopharmaceutical preparations

Technetium (99mTc) sestamibi injection (1926)

Herbal drugs and herbal drug preparations

Belladonna leaf (0221)

Belladonna leaf dry extract, standardised (1294)

Belladonna leaf tincture, standardised (1812)

Belladonna, prepared (0222)

Dioscorea nipponica rhizome (2890)

Fumitory (1869)

Magnolia officinalis bark (2567)

Polygonum orientale fruit (2726)

Stramonium leaf (0246)

Stramonium, prepared (0247)

Homoeopathic preparations

Methods of preparation of homoeopathic stocks and potentisation (2371)

Belladonna for homoeopathic preparations (2489)

Monographs

Ambroxol hydrochloride (1489)

Benzylpenicillin, procaine (0115)

Cefepime dihydrochloride monohydrate (2126)

Cefuroxime axetil (1300)

Deferoxamine mesilate (0896)

Dembrexine hydrochloride monohydrate for veterinary use (2169)

Dextrin (1507)

Dihydralazine sulfate, hydrated (1310)

Dinoprostone (1311)

Enrofloxacin for veterinary use (2229)

Erythromycin lactobionate (1098)

Fluorouracil (0611)

Foscarnet sodium hexahydrate (1520)

Hydralazine hydrochloride (0829)

Mannitol (0559)

Mesna (1674)

Oseltamivir phosphate (2422)

Polysorbate 80 (0428)

Spiramycin (0293)

Sulfasalazine (0863)

TEXTS WHOSE TITLE HAS CHANGED 标题修改的内容

The titles of the following texts have been changed in Supplement 9.2.

以下内容在增补9.2中修改了标题。

GENERAL CHAPTERS

2.6.27. Microbiological examination of cell-based preparations (previouslyMicrobiological control of cellular products)

5.1.2. Biological indicators and related microbial preparations used in the manufacture of sterile products (previously Biological indicators of sterilisation)

DELETED TEXTS 删除内容

The following text is deleted as of 1 July 2017.

以下内容自2017年7月1日起删除。

GENERAL CHAPTERS

2.6.19. Test for neurovirulence of poliomyelitis vaccine (oral)

The following text is deleted as of 1 April 2017.

以下内容自2017年4月1日起删除。

GENERAL CHAPTERS

2.2.60. Melting point - instrumental method