EP 增补9.1内容

CONTENTS OF SUPPLEMENT 9.1 欧洲药典增补9.1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.

Individual copies of texts will not be supplied.

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 April 2017at the latest.

以下文本为EP中首次出现，它们最迟将于2017年4月1日生效。

GENERAL CHAPTERS

2.6.34. Host-cell protein assays

MONOGRAPHS

Herbal drugs and herbal drug preparations

Andrographis herb (2712)

Chinese goldthread rhizome (2715)

Dioscorea nipponica rhizome (2890)

Lycopus lucidus herb (2723)

Monographs

Gadodiamide hydrate (2225)

REVISED TEXTS 修订内容

The following texts have been technically revised since their last publication. They will be implemented on 1 April 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4月1日生效。

GENERAL CHAPTERS

2.2.14. Melting point - capillary method 熔点---毛细管法

2.7.5. Assay of heparin  肝素含量

2.9.14. Specific surface area by air permeability 空气渗透法测定比表面积

2.9.40. Uniformity of dosage units 含量均匀度

4. Reagents (new, revised, corrected)

5.8. Pharmacopoeial harmonisation

5.22. Names of herbal drugs used in traditional Chinese medicine 传统中药中所用草药名

MONOGRAPHS

General monographs

Substances for pharmaceutical use (2034) 药用物质

Vaccines for human use

Poliomyelitis vaccine (oral) (0215)

Herbal drugs and herbal drug preparations

Angelica sinensis root (2558)

Salvia miltiorrhiza root and rhizome (2663)

Valerian root (0453)

Valerian root, cut (2526)

Homoeopathic preparations(1)

Homoeopathic preparations (1038)

Homoeopathic pillules, impregnated (2079)

Monographs

Alfuzosin hydrochloride (1287)

Atenolol (0703)

Bacitracin (0465)

Bacitracin zinc (0466)

Bromhexine hydrochloride (0706)

Caprylocaproyl macrogolglycerides (1184)

Chloramphenicol (0071)

Dicycloverine hydrochloride (1197)

Estradiol hemihydrate (0821)

Etoposide (0823)

Lauroyl macrogolglycerides (1231)

Linoleoyl macrogolglycerides (1232)

Montelukast sodium (2583)

Oleoyl macrogolglycerides (1249)

Phenoxymethylpenicillin (0148)

Phenoxymethylpenicillin potassium (0149)

Pholcodine monohydrate (0522)

Sesame oil, refined (0433)

Sitagliptin phosphate monohydrate (2778)

Sodium starch glycolate (type A) (0983)

Sodium starch glycolate (type B) (0984)

Sorbitan laurate (1040)

Sorbitan oleate (1041)

Sorbitan palmitate (1042)

Sorbitan sesquioleate (1916)

Sorbitan stearate (1043)

Sorbitan trioleate (1044)

Stearoyl macrogolglycerides (1268)

Vecuronium bromide (1769)

Water for injections (0169)

(1) ERRATUM: delete the title ‘Ammonium carbonicum for homoeopathic preparations (2916)’ from section IV. Contents of the 9th Edition (9.0 - page xxii), ‘Revised texts’ section,

‘Homoeopathic preparations’ sub-section, which was inadvertently introduced into the list.

CORRECTED TEXTS 更正内容

The following texts have been corrected for Supplement 9.1 and specify ‘corrected 9.1’ above the title. These corrections are to be taken into account as soon as possible and not later than 30 November 2016 (the end of the month following the month of publication of Supplement 9.1).

以下文本经过了更正，在标题上标明“corrected 9.1 ”。这些更正应尽快考虑，不得迟于2016年11月30日（第9.1版发布的当月月底）。

MONOGRAPHS

Herbal drugs and herbal drug preparations

Polygonum orientale fruit (2726)

Schisandra fruit (2428)

Homoeopathic preparations

Histaminum for homoeopathic preparations (2671)

Monographs

Filgrastim concentrated solution (2206)

Glucose (0177)

Glucose monohydrate (0178)

Sodium laurilsulfate (0098)

HARMONISED TEXTS 统一的内容

The following text has undergone pharmacopoeial harmonisation (see chapter 5.8. Pharmacopoeial harmonisation).

以下文本经过了第9版本EP的药典统一。（参见5.8药典统一）

GENERAL CHAPTERS

2.9.40. Uniformity of dosage units

TEXTS WHOSE TITLE HAS CHANGED 标题修改的内容

The title of the following text has been changed in Supplement 9.1.

以下内容在增补9.1中修改了标题。

MONOGRAPHS

Monographs

Pholcodine monohydrate (0522) (previously Pholcodine)

DELETED TEXTS 删除内容

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