CN1812769A - 包含恩氟沙星和矫味剂和/或香料的片剂 - Google Patents
包含恩氟沙星和矫味剂和/或香料的片剂 Download PDFInfo
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- CN1812769A CN1812769A CNA2004800180704A CN200480018070A CN1812769A CN 1812769 A CN1812769 A CN 1812769A CN A2004800180704 A CNA2004800180704 A CN A2004800180704A CN 200480018070 A CN200480018070 A CN 200480018070A CN 1812769 A CN1812769 A CN 1812769A
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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- A—HUMAN NECESSITIES
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Nutrition Science (AREA)
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- Physiology (AREA)
- Zoology (AREA)
- Molecular Biology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Communicable Diseases (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Oncology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
- Coloring Foods And Improving Nutritive Qualities (AREA)
Abstract
本发明涉及用于动物的片剂，所说的片剂包含恩氟沙星以及矫味剂和/或香料。
Description
本发明涉及用于动物的片剂，该片剂包含恩氟沙星以及矫味剂(Geschmacksstoff)和/或香料(Aromastoffe)。
因为片剂对动物根本没有吸引力并且通常仅仅被其非自愿地摄取，所以将片剂给药于动物存在困难。为施用片剂，通常必须将片剂包裹于饲料中。当这样做时，不能总是确保该药品被全部给药，从而不能确保其以正确的剂量被给药。当在饲料中被给药时，药物组合物的释放特性也可能会发生改变。
原则上已知可以通过加入适宜的香料和/或矫味剂来增加适口性。但是，加入这些物质常常会损害片剂的机械性质，使其机械性被损害至在实践中不能接受的程度。
因此，需要具有可接受的机械性质的很可口的片剂。
本发明涉及一些片剂，其包含：
20至45重量％的恩氟沙星
18至35重量％的乳糖
5至10重量％的微晶纤维素，和
5至20重量％的肉香料。
该重量百分比值是以该片剂的总重量为基础的。
恩氟沙星的用量为20至45重量％，优选地为23至42重量％。
恩氟沙星的系统命名为1-环丙基-7-(4-乙基-1-哌嗪基)-6-氟-1，4-二氢-4-氧代-3-喹啉羧酸并且具有下面的结构式：
根据本发明，恩氟沙星还可以以其可药用的盐和水合物的形式被使用。
适宜的盐有可药用的酸加成盐和碱盐。
可药用的盐应被理解为例如盐酸、硫酸、醋酸、乙醇酸、乳酸、琥珀酸、柠檬酸、酒石酸、甲磺酸、4-甲苯磺酸、半乳糖醛酸、葡萄糖酸、恩波酸、谷氨酸或天门冬氨酸的盐。此外，恩氟沙星还可以与酸性或碱性离子交换剂结合。可提及的可药用碱盐有碱金属盐，例如钠盐或钾盐，碱土金属盐，例如镁盐或钙盐，锌盐、银盐和胍盐。
水合物应被理解为指的是恩氟沙星本身的水合物以及其盐的水合物。
乳糖是一种可以通过商业途径获得的药用助剂，其可以以各种形式被获得，例如可以以喷雾干燥或无水乳糖的形式被获得。根据本发明，优选地使用乳糖单水合物(例如得自DMV International公司的Milchzucker fein)。以该片剂的总重量为基础，本发明的片剂包含18至35重量％，优选19至30重量％的乳糖。
微晶纤维素是一种可以通过商业途径获得的药用助剂(例如得自FMC公司的AvicelPH 101)。以该片剂的总重量为基础，本发明的片剂包含5至10重量％，优选5.5至8重量％的微晶纤维素。
得自牛、家禽、羊或猪，优选得自家禽和猪的干燥的肝脏粉末以及其它的香料制剂适宜用作肉香料。可以通过商业途径以ArtificialBeef Flavor和BAYOPAL的命名获得的由Pharma Chemie公司(Artificial Beef Flavor)以及Haarmann和Reimer(BAYOPAL)公司提供的香料十分合适。
所用肉香料的量优选为5％至20％，更优选7％至15％，特别优选9％至11％。在这里，百分比数字是成品片剂的重量百分比。
除上述成分外，本发明的片剂还可以包含常规的药用赋形剂和助剂。
可以用所有生理学上可耐受的惰性固体物质作为赋形剂。无机和有机物质可用于此目的。无机物质的实例有氯化钠、碳酸盐如碳酸钙，碳酸氢盐、氧化铝、硅酸、粘土、沉淀的或胶体二氧化硅和磷酸盐。
以该片剂的总重量为基础，本发明的片剂优选地包含0.05至0.3重量％，特别是0.1至0.2重量％的二氧化硅，特别是无水胶体二氧化硅。
有机物质的实例有糖、纤维素、食品和饲料如奶粉、屠体粗粉(Tiermehl)、面粉和粗面粉以及淀粉。
本发明的片剂优选地包含淀粉如玉米淀粉作为另外的赋形剂，其含量通常为该片剂总重量的10至40重量％，优选15至30重量％，特别优选地为18至26重量％。
该片剂可包含另外的常规药用助剂。可提及的助剂有：润滑剂和助流剂，如硬脂酸镁、硬脂酸、滑石粉和皂土；促崩解的物质如淀粉、交联羧甲基纤维素钠或交联聚乙烯吡咯烷酮；粘合剂，如淀粉、明胶、纤维素醚或线型聚乙烯吡咯烷酮以及干粘合剂如微晶纤维素。
以该片剂的总重量为基础，本发明的片剂优选地包含0.4至1.0重量％，优选0.5至0.8重量％的润滑剂，特别是硬脂酸镁。
本发明的片剂优选地包含为该片剂总重量1.5至4重量％，优选2至3重量％的粘合剂，特别是聚乙烯吡咯烷酮(例如聚维酮)。
本发明的片剂可以用一种包括下面步骤的方法来进行制备：
(a)将恩氟沙星、乳糖，任选地将肉香料以及任选地将另外的助剂进行混合，
(b)在加入水或另外的助剂的水溶液的情况下将该混合物制粒，
(c)将这种混合物干燥，
(d)在干燥后，向其中混入微晶纤维素和任选地混入另外的助剂以及肉香料(前提是在步骤(a)中没有加入这种物质)，
(e)随后，将该混合物压成片剂。
在步骤(a)中，优选地加入淀粉，特别是玉米淀粉作为另外的助剂。特别有利的是这时仅加入所用淀粉总量的一部分。
在步骤(b)中，优选地加入聚乙烯吡咯烷酮的水溶液作为另外的助剂。
对步骤(c)中的干燥而言，发现将残余水分保持在低于5％，优选保持在1至4％(以干燥失重的形式测得)的水平上是有利的。
在步骤(d)中，优选地加入淀粉、胶体二氧化硅和硬脂酸镁作为另外的助剂。只要在步骤(a)中已经加入了一部分淀粉，在步骤(d)中就要混入该淀粉总量的第二部分。
恩氟沙星的抗菌作用范围是已知的。因此，本发明的药物组合物适于预防和治疗相应的细菌性疾病和由细菌样微生物造成的疾病。本发明的组合物通常适用于从事生产的动物、育种的动物、动物园的动物、实验室的动物、实验动物和宠物的动物饲养和动物繁殖。自然优选是将其用于期望通过加入肉香料来改善适口性的动物中。
从事生产的动物和育种动物包括哺乳动物，如牛、马、绵羊、猪、山羊、骆驼、水牛、驴、兔子、梅花鹿、驯鹿和毛皮动物如貂、灰鼠和浣熊。
实验室动物和实验动物包括小鼠、大鼠、豚鼠、金地鼠、狗和猫。
宠物包括狗和猫。
本发明的组合物特别优选地被用于狗和猫，特别是狗。
动物的细菌性疾病包括例如猪疟疾；牛、猪、马和狗的钩端螺旋体病；牛的弯曲杆菌肠炎；绵羊和猪的弯曲杆菌流产；皮肤感染；狗的脓皮病；外耳炎；牛、绵羊和山羊的乳腺炎；链状球菌所导致的乳腺炎；马、猪和其它动物的链状球菌感染；小牛和其它动物的肺炎球菌感染；鼻疽病；结膜炎；肠炎(Enteritiden)；肺炎；牛、绵羊和猪的布氏菌病；猪的萎缩性鼻炎；牛、马、绵羊和其它动物的沙门菌病；败血病；小猪的大肠杆菌感染；子宫炎-乳腺炎-无乳(MMA)综合症；克雷白杆菌感染；假结核病；感染性胸膜肺炎；原生巴斯德氏菌病(primre Pasteureliosen)；关节病；牛和家畜的坏死杆菌病；钩端螺旋体病；猪和其它动物的丹毒；李斯特菌病；炭疽热；梭状芽胞杆菌病(Clostridiosen)；破伤风感染；肉毒杆菌病；化脓棒状杆菌感染；牛、猪和其它动物的结核病；反刍动物的类结核病；诺卡菌病；Q热；鹦鹉热-鹦鹉病；脑脊髓炎；牛和其它动物的支原体病；猪的地方性兽病性肺炎。
本发明的片剂具有相对较低的硬度(例如在实施例(1)中所述的片剂具有5mm的直径和20-30N的硬度)；这对于加有香料的片剂是已知的问题。令人吃惊的是，本发明的片剂的特征在于与其低硬度相比的高耐磨蚀特性，从而使其易于在实践中被应用。药典(例如欧洲或USP药典)中对片剂耐磨蚀性的试验方法以及其最低要求进行了描述。
实施例
| 成分 | (1)mg | (2)mg | (3)mg |
| 恩氟沙星 | 15.00 | 50.00 | 150.00 |
| 乳糖单水合物 | 17.80 | 23.60 | 100.40 |
| 玉米淀粉 | 15.20 | 22.40 | 86.10 |
| 微晶纤维素 | 4.00 | 8.00 | 28.00 |
| 聚维酮 | 1.50 | 3.00 | 10.00 |
| 硬脂酸镁 | 0.40 | 0.80 | 2.80 |
| 无水胶体二氧化硅 | 0.10 | 0.20 | 0.70 |
| 经过辐射的人造牛肉香料 | 6.00 | 12.00 | 42.00 |
| 片剂重量 | 60.00 | 120.00 | 420.00 |
Claims (2)
1.片剂，其包含：
20至45重量％的恩氟沙星
18至35重量％的乳糖
5至10重量％的微晶纤维素，和
5至20重量％的肉香料。
2.一种制备如权利要求1所述片剂的方法，其包括：
(a)将恩氟沙星、乳糖、任选地将肉香料以及任选地将另外的助剂进行混合，
(b)在加入水或另外的助剂的水溶液的情况下将该混合物制粒，
(c)将这种混合物干燥，
(d)在干燥后，向其中混入微晶纤维素和任选地混入另外的助剂以及肉香料，前提是在步骤(a)中尚未加入这种物质，
(e)随后，将该混合物压成片剂。
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| CN100341510C (zh) * | 2005-06-10 | 2007-10-10 | 冯莉萍 | 一种恩诺沙星微囊及制备方法 |
| CN100360131C (zh) * | 2006-01-24 | 2008-01-09 | 新昌国邦化学工业有限公司 | 一种掩味恩诺沙星的生产方法 |
| WO2010034853A1 (es) | 2008-09-23 | 2010-04-01 | Laboratorio Jaer, S.A. | Utilización de exilitol o sus derivados para el enmascaramiento gustativo de quimioterapicos del grupo del ácido quinolon-o-naftiridoncarboxilico administrados en alimentos destinados a ganado porcino |
| MX347401B (es) * | 2012-11-14 | 2017-04-18 | Univ Mexico Nac Autonoma | Composicion de vehiculos y formas farmaceuticas de liberacion sostenida y aumento de biodisponibilidad de antibacterianos, anticoccidianos y otros farmacos en aves comericales y cerdos. |
| KR102253847B1 (ko) | 2012-12-19 | 2021-05-21 | 바이엘 애니멀 헬스 게엠베하 | 향상된 수용성 및 우수한 저장 안정성을 가지는 정제 |
| RU2554748C2 (ru) * | 2013-07-09 | 2015-06-27 | Общество с ограниченной ответственностью "БИОН" | Средство для лечения энтеритов у животных |
| MX356443B (es) * | 2013-12-11 | 2018-05-21 | Univ Mexico Nac Autonoma | Complejo recristalizado de clorhidrato de enrofloxacina dihidratado, y metodo para obtener el mismo. |
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| EP0651640A1 (en) * | 1992-07-21 | 1995-05-10 | Knoll AG | Use of 7-fluoro-1-methyl-3-methylsulphinyl-4-quinolone in the treatment of angina pectoris |
| DE19633480A1 (de) * | 1996-08-20 | 1998-02-26 | Bayer Ag | Oral applizierbare Formulierungen von Chinolon- und Naphthyridoncarbonsäuren |
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