美国药典药用辅料分类大全.docx

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1、Spectrum 药 用 辅 料Spectrum Pharmaceutical ExcipientsTrust Your Ingredients电话 /Tel：+86-21-67601398传真 /Fax：+86-21-57711696地址：中国 上海松江区申港路 3802 号 A20 201611Add：3802 Lane Shen Gang Road,Building A20,Songjiang,Shanghai,China,201611药用辅料 - Spectrum 优势产品线最广泛的 USP/NF,FCC 产品线Pharmaceutical Excipients-Spectrum sp

2、ecial product lineThe broadest USP/NF,FCC product line目 录防腐剂和稳定剂Preservatives and StabilizersL- 氨基酸01最新中文版 USP/NF, FCC 产品目录，除了向客户提供产品信息，更全面介绍各种药用原辅料的功效和应用领域。The newest Chinese USP/NF, FCC catalog. It not only provides basic information, but also introduces the efficiency and application of the APIs

3、and excipients.L-Amino Acid Dietary Supplements03填充剂，稀释剂Fillers, Diluents07崩解剂产品特色Product advantages 可靠的产品质量，有竞争力的价格 1200 多种 USP/NF,BP,EP,JP,FCC 级别的产品，是同类型公司里最丰富的 丰富的产品线，灵活补充新产品 同一产品多种规格，满足不同领域的应用要求 从几毫克到几十公斤的不同包装可供选择 Reliable quality and competitive price 1200USP/NF, BP, EP, JP, FCC grade products,

4、 more than any other source you can find Broad kinds of products, flexible to add new product Several different specifications for one kind of chemical, meet the different requirement of application Different pack size from milligram to kilogram for your choice质量保证Quality Assurance在斯百全，质量是我们第一关注的要点，

5、这个传统从公司成立开始延续至今。我们对于质量的严格可以从我们的合作伙伴和客户那里得到证明。Spectrum had made quality our No.1 priority since we opened in 1971.Our commitment to quality is evi dent in our core business partners.1. 斯百全经过了美国 FDA 的认证，并在运营过程中严格遵循 cGMP 的要求2. 通过了 ISO9001:2008 认证3. 内部严格的质量控制体系，包括质量检测和文件1. Spectrum is FDA registered and

6、 operates under cGMP2. Spectrum is certified under the ISO9001:20083. Our in-house Integrated Quality(IQSM) system requires horough testing and documentation for all chemical productionDisintegrants08粘合剂Binders09抗粘着剂，助流剂，润滑剂Anti-Adherents, Glidants and Lubricants10包衣Coatings11芳香剂，着色剂和甜味剂Flavors, Col

7、ors and Sweeteners13栓剂和软膏基质Suppository and Ointment Bases16悬浮剂和增粘剂Suspending and Viscosity-Increasing Agents17硬化剂Stiffening Agents20pH 调节剂pH Modifiers21乳化剂 / 滋润剂 / 增溶剂Emulsifying/Wetting/Solubilizing Agents23吸附剂，干燥剂和保湿剂Sorbents, Desiccants and Humectants25渗透剂Tonicity Agents26M12775026-62-0Methylpara

8、ben Sodium, NF尼泊金甲酯钠ME16399-76-3Methylparaben, NF尼泊金甲酯P105860-12-8Phenylethyl Alcohol, USP苯乙醇P1077122-99-6Phenoxyethanol苯氧乙醇P1181582-25-2Potassium Benzoate, NF苯甲酸钾P134616731-55-8Potassium Metabisulfite, Crystal, NF焦亚硫酸钾P1453121-79-9Propyl Gallate, NF没食子酸丙酯P145735285-69-9Propylparaben Sodium, NF尼泊金丙酯

9、钠PH120108-95-2Phenol, Fused Crystal, USP苯酚PH125108-95-2Liquefied Phenol, USP液化苯酚PH15555-68-5Phenylmercuric Nitrate, NF硝酸苯汞PO300590-00-1Potassium Sorbate, Powder, NF山梨酸钾PR13394-13-3Propylparaben, NF, EP, BP, JP尼泊金丙酯S14186700-17-0Sodium Propionate, NF丙酸钠SO120532-32-1Sodium Benzoate, Powder, NF苯甲酸钠防腐剂和

10、稳定剂Preservatives and Stabilizers理想防腐剂的特性1. 低浓度 , 有效地针对广泛的微生物2. 可溶，可以按照配方要求的浓度溶解3. 药物中的浓度对消费者无毒，无过敏性4. 兼容其他配方成分5. 对配方性质没有物理影响6. 在较宽 pH 值和温度范围内稳定7. 成本低Characteristics for an ideal preservative1. Effective at low concentrations against a wide spectrum of microbes2. Soluble in the formulation at the req

11、uired concentration3. Non-toxic and non-sensitizing to the consumer at in-use concentrations4. Compatible with other formulation components5. No physical effect on formulation characteristics6. Stable over a wide range of pH and temperatureSO1827681-57-4Sodium Metabisulfite, Granular, NF, EP, BP, 焦亚

12、硫酸钠JPCAT#CASEnglish name 英文名称Chinese name 中文名称A1372137-66-6Ascorbyl Palmitate, NFL- 抗坏血酸棕榈酸酯B10688001-54-5Benzalkonium Chloride 50 % Solution, NF苯扎氯铵溶液，50%B119425013-16-5Butylated Hydroxyanisole, Flakes, NF叔丁基 -4- 羟基苯甲醚B1196128-37-0Butylated Hydroxytoluene, Granular, NF丁基羟基苯甲醚B16208001-54-5Benzalkon

13、ium Chloride, NF苯扎氯铵BE129121-54-0Benzethonium Chloride, USP苄索氯铵BE14065-85-0Benzoic Acid, Crystal, USP, EP, BP, JP苯甲酸BE158100-51-6Benzyl Alcohol, NF苯甲醇BU11594-26-8Butylparaben, NF尼泊金丁酯C2773108-39-4Metacresol, USP间甲酚CE1216004-24-6Cetylpyridinium Chloride, Monohydrate, USP氯化十六烷吡啶CH1226001-64-5Chlorobut

14、anol, Hydrous, NF三氯叔丁醇CH12357-15-8Chlorobutanol, Anhydrous, NF三氯叔丁醇ET117120-47-8Ethylparaben, NF尼泊金乙酯SO21010102-17-7Sodium Thiosulfate, Pentahydrate, Crystal, USP, EP, BP, JP硫代硫酸钠SO215110-44-1Sorbic Acid, Powder, NF山梨酸T105089-83-8Thymol, Crystal, NF百里酚TH12554-64-8Thimerosal, USP硫柳汞VI13510191-41-0Vit

15、amin E, USP (1 mg = 1.1 IU)维生素 E7. InexpensiveSpectrum Pharmaceutical Excipients01 Spectrum 药用辅料Spectrum Pharmaceutical Excipients 02CAT#CASEnglish name 英文名称Chinese name 中文名称A1372137-66-6Ascorbyl Palmitate, NFL- 抗坏血酸棕榈酸酯AM12556-40-6Glycine, USP甘氨酸G104156-40-6Glycine, FCC甘氨酸A125356-41-7Alanine, USP丙氨

16、酸A125256-41-7L-Alanine, FCCL- 丙氨酸AL11556-41-7L-AlanineL- 丙氨酸A133474-79-3Arginine, USP精氨酸A133674-79-3L-Arginine, FCCL- 精氨酸AR12074-79-3L-ArginineL- 精氨酸A13371119-34-2Arginine Hydrochloride, USPL- 精氨酸盐酸盐A13381119-34-2L-Arginine Monohydrochloride, FCCL- 精氨酸盐酸盐AR1251119-34-2L-Arginine HydrochlorideL- 精氨酸盐

17、酸盐AS1155794-13-8L-Asparagine, MonohydrateL- 天门冬酰胺一水合物A137656-84-8L-Aspartic Acid, FCCL- 天门冬氨酸AS12556-84-8L-Aspartic AcidL- 天门冬氨酸L- 氨基酸L-Amino Acid Dietary Supplements市场上有二十余种商业化、高纯度的生物活性氨基酸。这些氨基酸在各种各样的领域有重要用途，包括药用原料，膳食补充剂原料 , 化妆 品和个人护理用品原料和以及一些工业应用。 Spectrum 提供全部 22 种 L- 氨基酸及其盐 类满足实验室和生产所需。The L-Ami

18、no Acid Dietary Supplements market is made up of twenty commercial, high purity, biologically active amino acids. This group plays many roles in a variety of fieldsincluding dietary supplement ingredients, cosmetic & personal care ingredientsand pharmaceutical ingredients as well as some industrial

19、applications. Spectrum Chemical offers all 22 L-amino acids plus a variety of their salts in laboratory and production quantities.A1375323194-76-9 L-Aspartic Acid Sodium Salt, MonohydrateL- 天门冬氨酸钠一水合物CY11052-90-4L-CysteineL- 半胱氨酸C14737048-04-6Cysteine Hydrochloride, Monohydrate, USP L- 盐酸半胱氨酸一水合物C14

20、727048-04-6L-Cysteine Monohydrochloride,Monohydrate, FCCL- 盐酸半胱氨酸一水合物CY1157048-04-6L-Cysteine Hydrochloride, MonohydrateL- 盐酸半胱氨酸一水合物C147656-89-3L-Cystine, FCCL- 胱氨酸CY12056-89-3L-CystineL- 胱氨酸C303830925-07-6L-Cystine DihydrochlorideL- 胱氨酸二盐酸盐C303564704-23-0L-Cystine Disodium Salt, MonohydrateL- 胱氨酸二

21、钠盐，一水合物G103656-86-0L-Glutamic Acid, FCCL- 谷氨酸GL12556-86-0L-Glutamic AcidL- 谷氨酸ectrum 药用辅料03 SSppectrum 药用辅料Spectrum Pharmaceutical Excipients 04G1037138-15-8L-Glutamic Acid Hydrochloride, FCCL- 谷氨酸盐酸盐P1434147-85-3Proline, USPL- 脯氨酸GL130138-15-8L-Glutamic Acid HydrochlorideL- 谷氨酸盐酸盐P1436147-85-3L-Pro

22、line, FCCL- 脯氨酸G109019473-49-5L-Glutamic Acid Monopotassium SaltL- 谷氨酸钾盐PR120147-85-3L-ProlineL- 脯氨酸G10516106-04-3Monosodium Glutamate, NFL- 谷氨酸钠S102356-45-1Serine, USPL- 丝氨酸G10386106-04-3Monosodium L-Glutamate, FCCL- 谷氨酸钠S102156-45-1L-Serine, FCCL- 丝氨酸GL1356106-04-3L-Glutamic Acid Monosodium SaltL-

23、 谷氨酸钠SE12556-45-1L-SerineL- 丝氨酸G103956-85-9L-Glutamine, FCCL- 谷氨酰胺T105672-19-5Threonine, Crystal, USPL- 苏氨酸GL13656-85-9L-GlutamineL- 谷氨酰胺T105772-19-5L-Threonine, Crystal, FCCL- 苏氨酸H102171-00-1L-Histidine, USPL- 组氨酸TH15072-19-5L-Threonine, CrystalL- 苏氨酸H101571-00-1L-Histidine, FCCL- 组氨酸T161073-22-3Tr

24、yptophan, USPL- 色氨酸HI12071-00-1L-HistidineL- 组氨酸T115360-18-4Tyrosine, USPL- 酪氨酸H10225934-29-2L-Histidine Monohydrochloride,Monohydrate, FCCL- 盐酸组氨酸一水合物TY10560-18-4L-TyrosineL- 酪氨酸T115060-18-4L-Tyrosine, FCCL- 酪氨酸I105873-32-5L-Isoleucine, FCCL- 异亮氨酸I105473-32-5L-Isoleucine, USPL- 异亮氨酸T305416870-43-2L

25、-Tyrosine HydrochlorideL- 酪氨酸盐酸盐T307869847-45-6L-Tyrosine Disodium SaltL- 酪氨酸二钠盐L120261-90-5Leucine, USPL- 亮氨酸IS11073-32-5L-Isoleucine, CrystalL- 异亮氨酸V100872-18-4L-Valine, Crystal, FCCL- 缬氨酸V100572-18-4Valine, USPL- 缬氨酸LE11561-90-5L-LeucineL- 亮氨酸L120361-90-5L-Leucine, FCCL- 亮氨酸VA12072-18-4L-Valine,

26、CrystalL- 缬氨酸LY106657-26-1L-Lysine DihydrochlorideL- 赖氨酸二盐酸盐L114639665-12-8L-(+)-Lysine, HydrateL- 赖氨酸一水合物L1142657-27-2Lysine Hydrochloride, Granular, USPL- 赖氨酸盐酸盐L1143657-27-2L-Lysine Monohydrochloride, FCCL- 赖氨酸盐酸盐LY105657-27-2L-Lysine MonohydrochlorideL- 赖氨酸盐酸盐M144163-68-3Methionine, USPL- 蛋氨酸M11

27、4163-68-3L-Methionine, FCCL- 蛋氨酸ME130 63-68-3L-MethionineL- 蛋氨酸P158263-91-2Phenylalanine, USPL- 苯丙氨酸P158363-91-2L-Phenylalanine, FCCL- 苯丙氨酸PH14563-91-2L-PhenylalanineL- 苯丙氨酸05 Spectrum 药用辅料Spectrum Pharmaceutical Excipients 06LA10564044-51-5Lactose, Monohydrate, Spray-Dried Powder, D(+)- 乳糖一水合物NF填充剂

28、，稀释剂Fillers, Diluents稀释剂，又称作填充剂，用来增加药物产品剂型的体积和重量。Diluents, sometimes called fillers, increase the weight or volume of a pharmaceutical dosage form.CAT#CASEnglish name 英文名称Chinese name 中文名称C18907757-93-9Calcium Phosphate Dibasic, Anhydrous,Powder, USP无水磷酸氢钙CA130471-34-1Calcium Carbonate, Light Powder

29、, USP碳酸钙CA131471-34-1Calcium Carbonate, Heavy Powder, USP碳酸钙CA16512167-74-7Tribasic Calcium Phosphate, Powder, NF磷酸钙CA17010101-41-4Calcium Sulfate, Dihydrate, NF二水硫酸钙CE1129004-34-6Microcrystalline Cellulose, NF微晶纤维素FR10657-48-7Fructose, Granular, USP果糖KA1051332-58-7Kaolin, Powder, USP高岭土LA10363-42-3

30、Lactose, Anhydrous, NF乳糖LA10664044-51-5Lactose, Monohydrate, Powder, NFD(+)- 乳糖一水合物M1051585-88-6Maltitol Solution, NF麦芽糖醇溶液MA165 69-65-8Mannitol, Powder, USPD- 甘露糖醇崩解剂Disintegrants将崩解剂加入片剂（和一些胶囊剂），以促进片剂（或胶囊剂）在水相中裂解成更小的碎片，从而增加有效表面积，促进药物快速释放。Disintegrants are agents added to tablet (and some encapsula

31、ted) formulations to promote the breakup of the tablet (or capsule “slugs”) into smaller fragments in an aqueous environment, thereby increasing the available surface area and promoting a more rapid release of the drug substance.CAT#CASEnglish name 英文名称Chinese name 中文名称SO21950-70-4Sorbitol, Powder,

32、NF山梨醇SU10357-50-1Sucrose, Crystal, NF蔗糖07 Spectrum 药用辅料SO22050-70-4Sorbitol, 70% Solution, USP山梨醇溶液，70%S15529005-25-8Corn Starch, Powder, NF谷物淀粉AL1729005-32-7Alginic Acid, NF海藻酸C136674811-65-7Croscarmellose Sodium, NF交联羟甲基纤维素C16799004-34-6Cellulose, Microcrystalline, NF微晶纤维素S15529005-25-8Corn Starch

33、, Powder, NF谷物淀粉S19629063-38-1Sodium Starch Glycolate, pH 5.5-7.5, TypeA, NF乙醇酸淀粉钠Spectrum 药用辅料Spectrum Pharmaceutical Excipients 08粘合剂Binders当药物成分不能直接压缩形成片剂时，必须使用湿法制粒。在此过程中粘合剂有助于粉末聚集成颗粒。粘合剂有助于维持干燥颗粒适当的大小，还可能影响颗粒属性，如流动性，触感，强度，溶解度，抗压性能和药物释放度。When pharmaceutical ingredients cannot be directly compress

34、ed to form a tablet, wet granulation must be employed. In this process binders facilitate agglomeration of powder into granules. Binders serve to maintain the resulting dry granules in the appropriate size and may also affect granule properties such as flow, handling, strength, solubility, compactio

35、n or drug release.CAT#CASEnglish name 英文名称Chinese name 中文名称AL1729005-32-7Alginic Acid, NF海藻酸ET1109004-57-3Ethylcellulose, NF乙基纤维素G10449000-30-0Guar Gum, NF瓜尔豆胶GE1059000-70-8Gelatin, Powder, NF明胶 GU1159000-01-5Acacia, Spray-Dried Powder, NF阿拉伯树胶 GU1179000-01-5Acacia, Milled Powder, NF阿拉伯树胶H11289004-6

36、5-3Hypromellose, 2910, 4,000 cps, USP羟丙基甲基纤维素H13939004-65-3Hypromellose 2208, 100,000 cps, USP羟丙基甲基纤维素HY1229004-65-3Hypromellose, 2910, 50 cps, USP羟丙基甲基纤维素HY1239004-65-3Hypromellose 2208, 100 cps, USP羟丙基甲基纤维素HY1249004-65-3Hypromellose 2208, 4,000 cps, USP羟丙基甲基纤维素ME137 9004-67-5Methylcellulose, USP甲基

37、纤维素P14169003-39-8Povidone K-90, USP聚乙烯吡咯烷酮P14549003-39-8Povidone K-30, USP聚乙烯吡咯烷酮S15529005-25-8Corn Starch, Powder, NF谷物淀粉SY105Syrup, NF糖浆抗粘着剂，助流剂，润滑剂Anti-Adherents, Glidants and Lubricants此类辅料有助于改善医药产品的加工过程。 润滑剂可以减少制剂粒子和设备接触面之间的摩擦。防粘剂可以防止制剂粒子粘附在冲头表面或其他部位。助流剂通过减少配方中粒子的内摩擦力以利于均匀、无结块流动。These excipient

38、s all improve the processing of pharmaceutical products.Lubricants decrease friction between the preparations particles and equipment contact surfaces.Anti-adherents prevent sticking to punchfaces and other parts of the equipment.Finally, glidants promote even clump-free flow by reducing inter-parti

39、cle friction within the formulation.CAT# CASEnglish name 英文名称Chinese name 中文名称CA169 1592-23-0 Calcium Stearate, NF硬脂酸钙 MA130 557-04-0 Magnesium Stearate, NF, BP, JP硬脂酸镁 MI500 8042-47-5 Mineral Oil, USP矿物油MI5018042-47-5Light Mineral Oil, NF矿物油P179225322-68-3Polyethylene Glycol 4500, NF聚乙二醇 S14484070-

40、80-8Sodium Stearyl Fumarate, NF硬脂富马酸钠 SO120532-32-1Sodium Benzoate, Powder, NF苯甲酸钠 SO180151-21-3Sodium Lauryl Sulfate, NF, EP, BP, JP十二烷基硫酸钠 ST11057-11-4Stearic Acid, Powder, NF硬脂酸09 Spectrum 药用辅料Spectrum Pharmaceutical Excipients 10包衣Coatings薄膜包衣是片剂，胶囊剂，或丸剂被高分子材料薄膜包被的过程。Film coating is the process

41、whereby a tablet, capsule or pellet is surrounded by a thin layer of polymeric material.羟丙基甲基纤维素（HPMC）Hydroxypropylmethylcellulose (HPMC)即刻释放型包衣Immediate-release coatingsCAT#CASEnglish name 英文名称Chinese name 中文名称H11289004-65-3Hypromellose 2910, 4000 cps, USP羟丙基甲基纤维素H13939004-65-3Hypromellose 2208, 10

42、0,000 cps, USP羟丙基甲基纤维素HY1229004-65-3Hypromellose 2910, 50 cps, USP羟丙基甲基纤维素HY1239004-65-3Hypromellose 2208, 100 cps, USP羟丙基甲基纤维素HY1249004-65-3Hypromellose 2208, 4,000 cps, USP羟丙基甲基纤维素羟丙基纤维素（HPC）Hydroxypropylcellulose (HPC)高度灵活的成膜剂，对难于包衣的片剂是很好的基础包衣。作为聚合物添加剂，提高羟丙基甲基纤维素的功效。消除桥接，提高问题基片的粘合力，减少片剂边缘薄膜破裂的发生率

43、。Highly flexible film former and an excellent subcoat for tablets that are difficult to coat. As a polymer extender, enhances the utility of HPMC. Eliminates bridging, improves adherence to problem tablet substrates and reduces the incidence of film cracking on the tablet edge.CAT#CASEnglish name 英文名称Chinese name 中文名称HY1179004-64-2Hydroxypropyl Cellulose, 75-100 cps, NF羟丙基纤维素乙基纤维素Ethylcellulose用于即刻释放型包衣来掩盖味道，防止潮解或作为密封剂。也用于缓释包衣。For taste masking or as a moisture barrier/sealant in immediate-release coatings. A