欧洲药典8 EP8(欧洲药典第9版已经出版发行，2017年1月生效) - 药群论坛

自2014年1月起，在欧洲药典成员国，包括欧盟国家，将执行第8版并取代第7版。第7版至12月31日都是有效的。欧洲药典有英文版与法文版，英语与法语是欧洲委员会的官方语言。欧洲药典有印刷版、USB闪存版和在线版。其西班牙文版正在翻译之中，将来包括在在线版中，不再另收取费用。
欧洲药典：一部药品与药用物质的标准

欧洲药典是欧洲药品质量控制的标准。已有多项法律文件使欧洲药典成为法定标准：
2009年经36个欧洲国家和欧盟批准的编撰欧洲药典协议；
关于人用或兽用药品的欧盟指令2001/82/EC、2001/83/EC（修正案）和2003/63/EC，维持了欧洲药典对在欧洲上市药品的强制执行性。这些标准规定了药品、生产用原材料与合成用中间体成份的定性、定量和所用的检验项目。所有药品、药用物质生产企业在欧洲销售或使用其产品时，都必须遵循欧洲药典标准。
欧洲药典的内容具有法律约束力，由行政管理或司法部门强制要求符合欧洲药典。成员国的国家当局必须采用欧洲药典，必要时可替代相同物质国家标准中的个论。
欧洲药典的内容包括活性物质、辅料、化学、动物、人或植物来源的药用物质或制品、顺势疗法制剂和顺势疗法原料、抗生素，以及制剂和容器等。
欧洲药典还适用于生物制品、血液和血浆制品、疫苗和放射药品。

欧洲药典8 EP8相关内容

欧洲药典8.6内容变更

The texts below appear for the first time in the European Pharmacopoeia. They will be implemented on 1 January 2016 at the latest.

Radiopharmaceutical preparations and starting materials for radiopharmaceutical preparations Copper tetramibi tetrafluoroborate for radiopharmaceutical
preparations (2547)
Herbal drugs and herbal drug preparations
Anemarrhena asphodeloides rhizome (2661)
Hamamelis bark (2532)
Indigo plant leaf (2727)
Homoeopathic preparations
Belladonna for homoeopathic preparations (2489)
Petroleum rectificatum for homoeopathic preparations (2683)
Staphysagria for homoeopathic preparations (2289)

Monographs
Exemestane (2766)
Nicorandil (2332)
Pirfenidone (2856)
Sodium selenite (2740)
Solifenacin succinate (2779)
Somatropin solution for injection (2370)

The texts below have been technically revised since their last publication. They will be implemented on 1 January 2016.

GENERAL CHAPTERS
2.2.4. Approximate pH of solutions
2.2.19. Amperometric titration
2.2.20. Potentiometric titration
2.2.34. Thermal analysis
2.2.36. Potentiometric determination of ionic concentration using ion-selective electrodes
2.4.29. Composition of fatty acids in oils rich in omega-3 acids
2.5.5. Peroxide value
2.5.32. Water: micro determination
2.9.3. Dissolution test for solid dosage forms
2.9.40. Uniformity of dosage units
4. Reagents (new, revised, corrected)
5.2.4. Cell cultures for the production of veterinary vaccines
5.8. Pharmacopoeial harmonisation
5.22. Names of herbal drugs used in traditional Chinese medicine

Vaccines for veterinary use Brucellosis vaccine (live) (Brucella melitensis Rev. 1 strain) for
veterinary use (0793)
Radiopharmaceutical preparations and starting materials
for radiopharmaceutical preparations
Pentetate sodium calcium for radiopharmaceutical
preparations (2353)
Technetium (99mTc) medronate injection (0641)
Herbal drugs and herbal drug preparations
Benzoin, Siam (2158)
Bilberry fruit, dried (1588)
Bilberry fruit, fresh (1602)
Centella (1498)
Fresh bilberry fruit dry extract, refined and standardised (2394)
Ginseng (1523)
Java tea (1229)
Homoeopathic preparations
Methods of preparation of homoeopathic stocks and potentisation (2371)
Monographs
Aluminium phosphate, hydrated (1598)
Amidotrizoic acid dihydrate (0873)
Amiloride hydrochloride dihydrate (0651)
Amlodipine besilate (1491)
Anticoagulant and preservative solutions for human blood (0209)
Aprotinin (0580)
Aprotinin concentrated solution (0579)
Bromhexine hydrochloride (0706)
Buserelin (1077)
Carbomers (1299)
Carnauba wax (0597)
Chymotrypsin (0476)
Crospovidone (0892)
Demeclocycline hydrochloride (0176)
Dihydralazine sulfate, hydrated (1310)
Diphenhydramine hydrochloride (0023)
Dithranol (1007)
Doxapram hydrochloride (1201)
Filgrastim concentrated solution (2206)
Fluticasone propionate (1750)
Fructose (0188)
Fulvestrant (2443)
Galactose (1215)
Glimepiride (2223)
Glucose, anhydrous (0177)
Glucose monohydrate (0178)
Hexylresorcinol (1437)
Human coagulation factor IX (rDNA) concentrated solution (2522)
Hypromellose (0348)
Iopanoic acid (0700)
Ioxaglic acid (2009)
Isoleucine (0770)
Lactose, anhydrous (1061)
Lactose monohydrate (0187)
Leucine (0771)
Lysine hydrochloride (0930)
Methionine (1027)
Methylcellulose (0345)
Methylprednisolone acetate (0933)
Methylprednisolone hydrogen succinate (1131)
Methylthioninium chloride (1132)
Naftidrofuryl hydrogen oxalate (1594)
Nicotinamide (0047)
Orphenadrine citrate (1759)
Orphenadrine hydrochloride (1760)
Oxeladin hydrogen citrate (1761)
Oxolinic acid (1353)
Pancreas powder (0350)
Phenazone (0421)
Phentolamine mesilate (1138)
Polysorbate 80 (0428)
Potassium hydroxide (0840)
Povidone, iodinated (1142)
Propylene glycol dicaprylocaprate (2122)
Quinidine sulfate (0017)
Quinine hydrochloride (0018)
Quinine sulfate (0019)
Risedronate sodium 2.5-hydrate (2572)
Rivastigmine hydrogen tartrate (2630)
Sodium amidotrizoate (1150)
Sodium hydroxide (0677)
Sodium nitroprusside (0565)
Sodium selenite pentahydrate (1677)
Spirapril hydrochloride monohydrate (1766)
Sucrose (0204)
Sugar spheres (1570)
Sulfacetamide sodium (0107)
Theophylline-ethylenediamine hydrate (0301)
Thiamine hydrochloride (0303)
Thiamine nitrate (0531)
Thiamphenicol (0109)
Tribenoside (1740)
Trypsin (0694)

The texts below have been corrected and are republished in their entirety. These corrections are to be taken into account from the publication date of Supplement 8.6 (1 July 2015), unless otherwise indicated.
GENERAL CHAPTERS
2.4.22. Composition of fatty acids by gas chromatography
2.5.1. Acid value
2.7.14. Assay of hepatitis A vaccine
2.8.13. Pesticide residues
5.7. Table of physical characteristics of radionuclides mentioned in the European Pharmacopoiea
MONOGRAPHS
Radiopharmaceutical preparations and starting materials for radiopharmaceutical preparations
Gallium (68Ga) edotreotide injection (2482)
Monographs
Cimetidine (0756)
Cimetidine hydrochloride (1500)
Flucytosine (0766)
Goserelin (1636)
Human antithrombin III concentrate (0878)(1)
Insulin, bovine (1637)
Insulin, human (0838)
Insulin, porcine (1638)
Insulin preparations, injectable (0854)
Isomalt (1531)
Miconazole nitrate (0513)
Nitric acid (1549)
Oxaliplatin (2017)
Polyoxypropylene stearyl ether (2602)

HARMONISED TEXTS

The texts below have undergone pharmacopoeial harmonisation (see chapter 5.8. Pharmacopoeial harmonisation).
GENERAL CHAPTERS
2.2.34. Thermal analysis
2.9.3. Dissolution test for solid dosage forms
2.9.40. Uniformity of dosage units
MONOGRAPHS
Monographs
Crospovidone (0892)
Glucose, anhydrous (0177)
Glucose monohydrate (0178)
Hypromellose (0348)
Methylcellulose (0345)
Polysorbate 80 (0428)

TEXTS WHOSE TITLE HAS CHANGED

The titles of the following texts have been changed in Supplement 8.6.
GENERAL CHAPTERS
2.2.4. Approximate pH of solutions (previously Relationship between reaction of solution, approximate pH and colour of certain indicators)
MONOGRAPHS
Monographs
Amiloride hydrochloride dihydrate (0651) (previously Amiloride hydrochloride)

The following texts are deleted as of 1 January 2016.
MONOGRAPHS
Immunosera for veterinary use
Clostridium novyi alpha antitoxin for veterinary use (0339)
Clostridium perfringens beta antitoxin for veterinary use (0340)
Clostridium perfringens epsilon antitoxin for veterinary use (0341)
The following text is deleted as of 1 April 2015.
MONOGRAPHS
Monographs
Liquorice ethanolic liquid extract, standardised (1536)