美国药典25版等规定细菌内毒素检查项的药品品种

美国药典美国药典 25 版等规定细菌内毒素检查项的药品品种版等规定细菌内毒素检查项的药品品种 自从美国药典 20 版 1980 年 正式收载 细菌内毒素检查法 以来 原规定的热原检 查项逐步被细菌内毒素检查项所取代 美国药典 23 版 1995 年 收载的药品中 已经有 471 种药品规定了细菌内毒素检查项的品种很少 中国药典只有 13 种 中国药典 2000 年 版规定细菌内毒素检查项的品种也只有 69 种 而美国药典 2000 年版 规定细菌内毒素检 查项的品种正版已达 586 种 不包括 2000 年版以后的增补本 相比之下我国就落后了许 多 为促进我国尽快用细菌内毒素检查项取代热原检查项 现列出美国药典 25 版规定有细 菌内毒素检查项的药品品种供大家参考 英英 文文 名名译译 名名内毒素限值内毒素限值 Acetazolamide for Injection乙酰唑胺注射液0 5EU mg Acetic Acid Irrigation醋酸灌注液0 5EU ml Adenosine Injection注射用阿昔洛韦0 174EU mg Alfentanil Injection乙醇葡萄糖注射注0 5EU ml Alcohol in Dextrose Injection磷酸腺昔注射液 快速静脉注射 11 62 EU mg 连续静脉注射 5 95 EU mg Alprostadil Injection阿芬尼注射液10 EU ml Alteplase前列地尔注射液5 EU 100ug Aletplase for Inj 阿替普酶1 EU mg Amifostine ror Injection注射用阿替普酶10 的注射认要稀释至 10 检验 Dextrose and Sodium Chloride Inj 葡萄糖氯化钠注射液10 0EU g Diatrizoate Meglumine Inj 泛影葡胺注射液1 1EU ml 50 5 0EU ml 50 Diatrizoate Meglumine and Diatrizoate Sodium Inj 泛影葡胺和泛影酸钠注射 液 1 8EU mg 10 Mannitol in sodium Chloride Inj 甘露醇氯化钠注射液0 04EU mg Mechlorethamine Hydrochloride for Inj 注射用盐酸氮芥12 5EU mg Menadill Sodium Diphosphate Inj 甲萘氢醌磷酸钠注射液25 5EU mg Menadione Inj 甲萘醌注射液58 3EU mg Menotropins 尿促性素2 5EU 促配子成熟激素单位 Menotropins for Inj 注射击用尿促性素2 5EU 促配子成熟激素单位 Meperidine Hydrochloride Inj 盐酸哌替啶注射液2 4EU mg Mepivacaine Hydrochloride Inj 盐酸甲哌卡因注射液0 8EU mg Mepivacaine Hydrochloride and Levonordefrin Hydrochloride Inj 盐酸甲哌卡因和可巴群注 射液 0 8EU mg Meropenem for Injection美洛培南0 125EU mg Mesoridazine Besylate Inj 美索达嗪苯磺酸酯注射液7 0EU mg Metaraminol Bitartrate Inj 二酒石酸间羟胺注射液3 5EU mg Methadone Hydrochloride Inj 盐酸美沙酮注射液8 8EU mg Methicillin sodirm甲氧西林钠0 10EU mg Methicillin sodium for Inj 注射用甲氧西林钠0 10EU mg Methocarbamol Inj 美索巴注射液0 2EU mg Methohexital Sodium for Inj 注射用美索比妥钠0 5EU mg Methotrexate Inj 甲氨蝶呤注射液0 4EU mg Methotrexate for Inj 注射用甲氨蝶呤0 4EU mg Methotrimetrazine Inj 左美丙嗪注射液17 9EU mg Methyldopate Hydrochloride Inj 盐酸甲基多巴注射液0 5EU mg Methylene Blre Inj 亚甲基蓝注射击液2 5EU ml Methylergonovine Maleate Inj 马来酸甲麦角新碱注射液1 7EU ug Methylprednisolone Sodium Succinate for Inj 注射用甲泼尼龙琥珀酸钠0 17EU mg Metoclopramide Inj 甲氧氯普胺注射液2 5EU mg Metprolol Tartrate Inj 酒石酸美托洛尔注射液25 0EU mg Metronidazole Inj 甲硝唑注射液0 35EU mg Mezlocillin Sodium美洛西林钠0 06EU mg Mezlocillin for Inj 注射用美洛西林钠0 06EU mg Miconazode Inj 米康唑注射液0 10EU mg Minocycline Hydrochloride盐酸米诺环素1 25EU mg Minocycline for Inj 注射用米诺环素1 25EU mg Mitomycin for Inj 注射用丝裂霉素10 0EU mg Mitoxantrone Inj 米托蒽醌注射液5EU mg Morphine Sulfate Inj 硫酸码啡注射液 17 0EU mg 14 29EU mg 标明鞘内注射 用时 Morrhuate Sodium Inj 鱼肝油酸钠注射液1 4EU mg Nafcillin Sodium 奈夫西林钠0 13EU mg Nafoillin Inj 奈夫西林钠注射液0 13EU mg Nafoillin for Inj 注射液奈夫西林钠0 13EU mg Nalorphine Hydrochloride Inj 盐酸烯丙吗啡注射液11 6EU mg Naloxone Hydrochloride Inj 盐酸纳洛酮注射液500EU mg Netilmicin sulfate硫酸注射液1 30EU mg Neomycin for Inj 注射用新霉素1 30EU mg Netilmicin sulfate Inj 硫酸奈替米星注射液1 25EU mg Niacin Inj 烟酸注射液3 5EU mg Niacinamide Inj 烟酰胺注射液3 5EU mg Ammonia N 13 Inj 13N 氨注射液 175 V EU ml Nitroglycerin Inj 硝酸甘油注射液0 1EU ug Norepinephrine Bitartrate Inj 二酒石酸去甲肾上腺素注 射液 83 4EU mg Ondansetron Inj 昂丹司琼注射液9 9EU mg Orphenadrine Citrate Inj 枸椽酸奥芬那君5 8EU mg Oxacillin Sodium 苯唑西林钠0 2EU mg Oxacillin Inj 苯唑西林钠注射液0 2EU mg Oxacillin for Inj 注射用苯唑西林钠0 2EU mg Water O15 Inj 15N 水注射液 175 V EU ml Oxymorphone Hydrochloride Inj 盐酸羟吗啡酮注射液238 1EU mg Oxytetracycline土霉素0 4EU mg Oxytetracycline Inj 土霉素注射液0 4EU mg Oxytetracycline Hydrochloride盐酸土霉素0 4EU mg Oxytetracycline for Inj 注射用土霉素0 4EU mg Oxytocin Inj 缩宫素注射液35 7EU 单位 Papaverine Hydrochloride Inj 盐酸罂粟碱注射液2 9EU mg Penicillin G Benzathine苄星青霉素0 01EU 100 单位 Penicillin G Benzathine Injectable Suspension 苄星青霉素注射悬液0 01EU 100 单位 Penicillin G Benzathine and Penicillin G Procaine Injecillin Suspension 苄星青霉素和普鲁卡因青 霉素注射悬液 0 01EU 100 单位 Penicillin G Potassium青霉素钾0 01EU 100 单位 Penicillin G Potassium Injection青霉素钾注射液0 01EU 100 单位 Penicillin G Potassium for Inj 注射用青霉素钾0 01EU 100 单位 Penicillin G Procaine普鲁卡因青霉素0 01EU 100 单位 Penicillin G Procaine Injectable Suspension 普鲁卡因青霉素注射悬浮 液 0 01EU 100 单位 Penicillin G Procaine for Injectable Suspension 注射用鲁卡因青霉素悬浮 液 0 01EU 100 单位 Penicillin G Procaine and Dihydrostreptomycin Sulfate Injectable Suspension 普鲁卡因青霉素 硫酸双 氢链霉素注射悬浮液 0 01EU 100 单位 Penicillin G Procaine Dihydrostreptomycin Sulfate Chlorpheniramine Maleate and Injectable Suspension 普鲁卡因青霉素 硫酸双 氢链霉素 扑尔敏马来酸 盐和地塞米松注射悬浮液 0 01EU 100 单位 Penicillin G Procaine Dihydrostreptomycin Sulfate and Prednisolone Injectable Suspension 普鲁卡因青霉素 硫酸双 氢链霉和氢化泼尼松注射 悬浮液 0 01EU 100 单位 Penicillin G Sodium青霉素钠0 01EU 100 单位 Penicillin G Sodium for Inj 注射用青霉素钠0 01EU 100 单位 Pentazocine Lactate Inj 乳酸喷他佐辛注射液5 8EU mg Pentobarbital Sodium Inj 戊巴比妥钠注射液0 8EU mg Perflutren Protein Type A Microspheres for Injection 注射用 A 型蛋白微球0 5EU ml Perphenazine Inj 奋乃静注射液37 7EU mg Phenobarbital Sodium苯巴比妥钠0 3EU mg Phenobarbital Sodium Inj 苯巴比妥钠注射液0 3EU mg Phenobarbital Sodium for Inj 注射用苯巴比妥钠0 8EU mg Phentolamine Mesylate for Inj 注射用甲碘酸酚妥拉明5 8EU mg Phenylbutazone Inj 保泰松注射液1 1EU mg Phenylephrine Hydrochloride Inj 盐酸去氧肾上腺素注射液25 0EU mg Phenytoin Sodium Inj 苯妥英钠注射液0 3EU mg Chromic Phosphate P 32 Suspension磷 32P 酸铬悬浮液 175 V EU ml Sodium Phosphate P 32 Solution磷 32P 酸钠溶液 175 V EU ml Physostigmine Salicylate Inj 水杨酸毒扁豆碱注射液83 4EU mg Phytoadione Inj 二氢维生素 K1 注射液14 0EU mg Piperacillin哌拉西林0 07EU mg Piperacillin Sodium哌拉西林钠0 07EU mg Piperacillin for Inj 注射用哌拉西林0 07EU mg Plicamycin for Inj 注射用普卡霉素100EU mg Potassium Acetate Inj 醋酸钾注射液8 80EU mEq Potassium Chloride for Inj Concentrate注射用氯化钾浓缩液8 80EU mEq Potassium Chloride in Dextrose Inj 氯化钾葡萄糖注射液0 5EU ml Potassium Chloride in Dextrose and Sodium Chloride Inj 氯化钾葡萄糖和氯化钠注 射液 0 5EU ml Potassium Chloride in Lactated Ringer s and Dextrose Inj 氯化钾乳酸化林格氏和葡 萄糖注射液 0 5EU ml Potassium Chloride in Sodium Chloride Inj 氯化钾氯化钠注射液0 5EU ml Potassium Phosphates Inj 磷酸钾注射液1 10EU mg Pralidoxime Chloride氯解磷定0 10EU mg Pralidoxime Chloride for Inj 注射用氯解磷定0 10EU mg Prednisolone Sodium Phosphate Inj 泼尼松龙磷酸钠注射液5 0EU mg Prednisolone Sodium Succinate for Inj 注射用泼尼松龙琥珀酸钠5 8EU mg Prednisolone Tebutate Injectable Suspension 泼尼松龙醋酸特丁酯注射 悬浮液 8 8EU mg Prednisone Injectable Suspension泼尼松注射悬浮液2 27EU mg Prilocaine Hydrochloride Inj 盐酸丙胺卡因注射液0 9EU mg Prilocaine and Epinephrine Inj 丙胺卡因和肾上腺素注射 液 0 9EU mg Procainamide Hydrochloride Inj 盐酸普鲁卡因胺注射液0 35EU mg Procaine Hydrochloride 盐酸普鲁卡因0 6EU mg Procaine Hydrochloride Inj 盐酸普鲁卡因注射液0 6EU mg Procaine Hydrochloride Epinephrine Inj 盐酸普鲁卡因和肾上腺素 注射液 0 6EU mg Procaine and Tetracaine Hydrochlorides and Levonordefrin Inj 普鲁卡因和盐酸丁卡因和 可巴君注射液 0 6EU mg Prochlorperazine Edisylate Inj 乙二磺酸丙氯拉嗪注射液17 9EU mg Promazine Hydrochloride Inj 盐酸丙嗪注射液1 8EU mg Promethazine Hydrochloride Inj 盐酸异丙嗪注射液5 0EU mg Promethazine and Procaine Hydrochloride and Levonordefrin Inj 丙氧卡因和盐酸普鲁卡因 和巴君注射液 0 8EU mg Procaine and Tetracaine Hydrochlorides and Norepinephrine Bitrtrate Inj 丙氧卡因和盐酸普鲁卡因 和去甲皮肤上腺素注射液 0 8EU mg Propanolol Hydrochloride Inj 盐酸普奈洛尔注射液55 6EU mg Protamine Sulfate Inj 硫酸鱼精蛋白注射液7 0EU mg Protamine Sulfate for Inj 注射用硫酸鱼精蛋白7 0EU mg Protein Hydrolysate Inj 水解蛋白注射液0 5EU mg Pyridostigmine Bromide Inj 溴吡斯的明注射液17 0EU mg Pyridoxine Hydrochloride Inj 盐酸维生素 B6 注射液0 4EU mg Quinidine Gluconate Inj 葡萄糖酸奎尼丁注射液0 6EU mgEU mg Ranitidine Inj 雷尼替丁注射液7 00EU mg Ranitidine In sodium Chloride Inj 雷尼替丁氯化钠注射液7 0EU mg Reserpine Inj 利舍平注射液71 5EU mg Riboflavin Inj 维生素 B2 注射液7 1EU mg Rifampin for Inj 注射用利福霉素 稀释至 0 12EU mL 后进行检验 内毒素浓 度不大于 0 5EU mg Ringer s Inj 林格氏注射液0 5EU mg Ringer s and Dextrose Inj 林格氏葡萄糖注射液0 5EU mg Lactated Ringer s Inj 乳酸林格氏注射液0 5EU mg Lactated Ringer s and Dextrose Inj 乳酸林格氏和葡萄糖注射 液 0 5EU mg Half Strength Lactated Ringer s and Dextrose Inj 半浓乳酸化林氏和葡萄糖 注射液 0 5EU ml Modified Lactated Ringer s and Dextrose Inj 缓和乳酸化林格氏和葡萄 糖注射液 0 5EU ml Ringer s Irrigation林格氏灌注液0 5EU ml Ritodrine Hydrochloride Inj 盐酸利托君注射液0 5EU mg Rubidium Chloride Rb 82 Inj 氯化铷 82Rb 注射液 175 V EU ml Samarium Sm 153 Lexidronam Injection 来昔决南钐 153Sm 注射液 175 V EU ml Sargramostim 沙格司亭5 0EU mg Sargramostim for Inj 注射用沙格司亭50EU mg Scopolamine Hydrochloride Inj 氢溴东莨菪碱注射液555 0EU mg Secobarbital sodium司可巴比妥钠0 9EU mg Secobarbital sodium Inj 司可巴比妥钠注射液0 9EU mg Secobarbital sodium for Inj 注射用司可巴比妥钠0 9EU mg Selenious Acid Inj 亚硒酸注射液3 5EU ug Sincalide for Inj 注射用辛卡利特83 3EU ug Sisomicin Sulfate Inj 硫酸西索米星注射液0 5EU mg Sodium Acetate Inj 醋酸钠注射液3 90EU mEq Sodium Bicarbonate Inj 碳酸氢钠注射液5 0EU mEq Sodium Chloride Inj 氯化钠注射液0 5EU ml 0 5 0 9 3 6EU ml 3 0 24 3 Bacteriostateic Sodium Chloride Inj 抑菌氯化钠注射液1 0EU ml Sodium Chloride Irrigation乳酸钠氯化钠注射液0 5EU ml Sodium Lactate Inj 乳酸钠灌注射液2 0EU mEq Sodium Nitite Inj 亚硝酸钠注射液0 33EU mg Sodium Nitoprusside硝普钠注射液0 05EU ug Sodium Nitoprusside for Inj 注射用硝普钠0 05EU ug Sodium Phosphate Inj 磷酸钠注射液1 10EU mg Sodium Thiosulfate Inj 硫代硫酸钠注射液0 03EU mg Spectinomycin Hydrochloride盐酸大观霉素0 09EU mg Spectinomycin for Injectable Suspension 大观霉素注射悬浮液0 09EU mg Streptomycin Sulfate硫酸链霉素0 25EU mg Streptomycin Inj 链霉素注射液0 25EU mg Streptomycin for Inj 注射用链霉素0 25EU mg Strontium Chloride Sr 89 Inj 氯化锶 89Sr 注射液 175 V EU ml Succinylcholine Chloride 氯琥珀胆碱2 0EU ml Succinylcholine Chloride Inj 氯琥珀胆碱注射液2 0EU mg Succinylcholine Chloride for Inj 注射用氯琥珀胆碱2 0EU mg Sufentanil Citrate Inj 枸橼酸舒芬太尼注射液6 25EU ml Invert srgar Inj 转化糖注射液0 5EU ml Sulbactam Sodium 舒巴坦钠0 17EU mg Sulfadiazine Sodium Inj 磺胺嘧啶钠注射液0 1EU mg Technetium Tc99M Albumin Inj 锝 99mTc 白蛋白注射液 175 V EU ml Technetium Tc99M Albumin Aggregated Inj 锝 99mTc 总白蛋白注射 液 175 V EU ml Technetium Tc99M Albumin Colloid Inj 锝 99mTc 聚白蛋白注射 液 175 V EU ml Technetium Tc99M Apcitide锝 99mTc 阿西肽注射液 175 V EU ml Technetium Tc99M Arcitumomab Injection 锝 99mTc 阿西莫单抗注 射液 175 V EU ml Technetium Tc99M Bicisate Inj 锝 99mTc 比西酸注射液 175 V EU ml Technetium Tc99M Disofenin Inj 锝 99mTc 地索苯宁注射 液 175 V EU ml Technetium Tc99M Etidronate Inj 锝 99mTc 羟乙二膦酸注 射液 175 V EU ml Technetium Tc99M Exametazime Inj 锝 99mTc 依沙美胯注射 液 175 V EU ml Technetium Tc99M Gluceptate Inj 锝 99mTc 葡庚糖酸盐注 射液 175 V EU ml Technetium Tc99M Lidofenin Inj 锝 99mTc 利多苯宁注射 液 175 V EU ml Technetium Tc99M Mebrofenin Inj 锝 99mTc 甲溴菲宁注射 175 V EU ml 液 Technetium Tc99M Meriatide Inj 锝 99mTc 硫乙甘肽注射 液 175 V EU ml Technetium Tc99M Medromate Inj 锝 99mTc 亚甲基二膦酸 盐注射液 175 V EU ml Technetium Tc99M Nofetumomab Merpentan Injection 175 V EU ml Technetium Tc99M Oxidronatd Inj 锝 99mTc 奥昔磷酸盐注 射液 175 V EU ml Technetium Tc99M Pentetate Inj 锝 99mTc 喷替酸盐注射 液 175 V EU ml Sodium Pertechnetate Tc 99m Inj 锝 99mTc 酸钠注射液 175 V EU ml Technetium Tc99M Pyrophosphate Inj 锝 99mTc 焦磷酸盐注射 液 175 V EU ml Technetium Tc99M Pyro and trimeta Phosphate Inj 锝 99mTc 焦和三聚 磷酸盐注射液 175 V EU ml Technetium Tc99M Red Blood Cells Inj 锝 99mTc 血红细胞注射 液 175 V EU ml Technetium Tc99M Sestamibi Inj 锝 99mTc 司他比注射液 175 V EU ml Technetium Tc99M Sulfur Colloid Inj 锝 99mTc 胶体硫注射液 175 V EU ml Technetium Tc99M Succimer Inj 锝 99mTc 琥硫酸盐注射 液 175 V EU ml Technetium Tc99M Tetrofosmin Inj 锝 99mTc 替曲膦注射液 175 V EU ml Terbutaline sulfate Inj 硫酸特布他林注射液1250EU mg Testosterone Injectable Suspension睾酮注射悬浮液3 5EU mg Tetracaine Hydrochloride盐酸丁卡因0 7EU mg Tetracaine Hydrochloride Inj 盐酸丁卡因注射液0 7EU mg Tetracaine Hydrochloride for Inj 注射用盐酸丁卡因0 7EU mg Tetracaine Hydrochloride in Dextrose Inj 盐酸丁卡因葡萄糖注射液1 0EU mg Tetracyaine Hydrochloride 盐酸四环素0 5EU mg Tetracyaine Hydrochloride for Inj 注射用盐酸四环素0 5EU mg Thallous Chloride T1 201 Inj 氯化亚铊 201T1 注射液 175 V EU ml Theophylline In Dextrose Inj 茶碱葡萄糖注射液1 0EU mg Thiamine Hydrochloride Inj 盐酸维生素 B1 注射液3 5EU mg Thiopental Sodium for Inj 注射用硫喷妥钠1 0EU mg Thiotepa for Inj 注射用塞替派6 25EU mg Thiothixene Hydrochloride Inj 盐酸替沃噻吨注射液88 0EU mg Thiothixene Hydrochloride for Inj 注射用盐酸替沃噻吨88 0EU mg Ticarcillin Disodium 替卡西林二钠0 05EU mg Ticarcillin for Inj 注射用替卡西林0 05EU mg Ticarcillin and Clavulanic Acid Inj 替卡西林克拉维酸注射液0 07EU mg Ticarcillin and Clavulanic Acid for Inj 注射用替卡西林克拉维酸0 07EU mg Ticarcillin Monosodium替卡西林一钠0 05EU mg Tiletamine Hydrochloride盐酸替来他明0 07EU mg Tiletamine and Zolazepan for Inj 注射用盐酸替来他明唑拉 西泮 0 07EU mg Tilmicosin Inj 替米考星注射液0 5EU mg Tobramycin 妥布霉素2 0EU mg Tobramycin Inj 妥布霉素注射液2 00EU mg Tobramycin for Inj 注射用妥布霉素2 0EU mg Tobramycin sulfate硫酸妥布霉素2 0EU mg Tolazoline Hydrochloride Inj 盐酸妥拉唑林0 8EU mg Tolbutamide甲苯磺丁脲0 35EU mg Tolbutamide for Inj 注射用甲苯磺丁脲0 35EU mg Triamcinolone Acetonide Injectable suspension 丙酮酸曲胺西龙注射悬浮 液 4 4EU mg Triamcinolone Diacetate Injectable suspen