CN1122109A - 含有质子泵抑制剂的兽医用组合物 - Google Patents
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Abstract
一种稳定的口服药物组合物,其中含有质子泵抑制剂和用于治疗与胃酸有关动物疾病的胶凝剂。该组合物的制备方法及其应用。
Description
技术领域
本发明涉及一种含质子泵抑制剂(PP1)和用于治疗与胃酸有关的动物疾病的口服药物组合物。
发明背景
质子泵抑制剂是有效的胃酸分泌抑制剂并用于治疗与胃酸有关的人类疾病,例如胃溃疡和十二指肠溃疡。这些物质对酸反应和中性介质中的降解/转变是灵敏的。人类口服给药的药物配方最好是包有肠溶衣的。在长期贮存时,这些配方对湿气是敏感的和必须密封保存。
消化器官溃疡病在某些动物,特别是马和骆驼也是常见病。与治疗消化器官溃疡病有关的其它动物是,例如海豚,海狮,驼羊,狗,猫和猪。通过马的内窥镜评价,在鳞状粘膜,非腺底,腺胃和十二指肠中发现了溃疡。马的胃-十二指肠溃疡的病因学大抵还不清楚,不过,在某些情形中应激反应起着重要的作用。
抗溃疡化合物例如组胺-2-受体拮抗药已报导经口服或鼻-胃管每天给马投药几次。对于马可能外用并需镇静。对于人来说口服为好。
Omeprazole和其它质子泵抑制剂是有效的动物胃酸分泌的抑制剂。通过抑制H+K+-ATPase,导致壁细胞中产生氢离子的酶,进而阻止胃酸的产生。质子泵抑制剂引起酸抑制但不象多数其它抗溃疡化合物如H2一阻滞剂那样,Omeprazole可以一天给药一次。按照本发明包有肠溶衣的在凝胶配方中含有Omeprazole的药珠可在野外条件下容易地施于马的舌背上并容易被马接受。
含有质子泵抑制剂的包有肠溶衣的药珠的这种湿凝胶,在室温下长期贮存时是不稳定的和必须临时制备。目前,在市场上还没有这种稳定的配方。
Omeprazole,即5-甲氧基-2(((4-甲氧基-3,5-二甲基-2-吡啶基)甲基)亚磺酰基)-1H-苯并咪唑作为胃酸分泌的有效抑制剂公开于欧洲专利No.5129中。
Lansoparzole,即2-[[[3-甲基-4-(2,2,2-三氟乙氧基)-2-吡啶基]甲基]亚磺酰基]-1H-苯并咪唑作为胃酸分泌的有效抑制剂公开于欧洲专利No.174726中。
Pantoprazole作为胃酸分泌的有效抑制剂公开于欧洲专利No.166287中。
Leminoprazole公开于英国专利No.2163747中。
发明的详细说明
本发明的目的是提供容易给马或其它动物投药的口服药物组合物。质子泵抑制剂是涂有一层或多层包衣且其中一层是肠溶衣的干颗粒形式,如珠或片。药珠或药片可以通过压制,结晶,将质子泵抑制剂的溶液或悬浮液施于惰性核心上,挤压和成珠或类似方法制备。肠溶衣珠或片与干燥的胶凝剂如黄原胶、瓜耳胶、剌槐豆胶、黄蓍胶、改性的纤维素衍生物或类似的形成凝胶的化合物混合。当加水到此混合物中时,形成浆状凝胶。该凝胶例如以合适的施药器施于动物如马的舌部。
在本发明的组合物中使用的质子泵抑制剂是通式I的化合物,其中Ra是或
R1和R3独立地选自氢,低级烷基,低级烷氧基和卤素,R2选自氢,低级烷基,低级烷氧基,低级烷氧基-低级烷氧基,低级氟代烷氧基和R4和R5独立地选自低级烷基,A为或
R6和R7独立地选自氢,低级烷基,低级烷氧基,低级氟代烷氧基,低级氟代烷基,卤素,其中R8是低级烷基或低级烷氧基。
本发明组合物中所用的质子泵抑制剂可以是中性形式或碱式盐形式,例如Mg2+,Ca2+,Na+,或K+盐,最好是Mg2+或Na+盐。实际应用中,上列化合物可以用外消旋形式或实际上纯对映体的形式。
在本发明的一个实施方案中,包有肠溶衣的颗粒与适宜的物质如钾、钙、镁或铝的适宜的无机或有机水溶性盐混合。当把适当的聚合物或化合物如Kappa-角叉菜胶、果胶、已知与带正电荷的金属离子生成凝胶的阴离子聚合物,或类似化合物的水溶液加到此混合物中时,由于离子与聚合物间的相互作用形成浆状凝胶。
在本发明的另一实施方案中,包有肠溶衣的颗粒与适宜的组分混合。当加入温度敏感聚合物的低粘性溶液例如乙基羟基乙基纤维素(EHEC)或聚亚乙基聚丙二醇或类似物质时,将体系温热至33-35℃或更高,形成一种粘性浆状凝胶。
在本发明的又一实施方案中,包有肠溶衣的颗粒与胶凝剂形式的适宜物质如干胶凝剂混合。可以使用的胶凝剂例如是阿拉伯树胶,琼脂,藻酸,羧甲基纤维素钠,羟丙基纤维素,羟丙基甲基纤维素或其它纤维素衍生物,岩藻依聚糖,黄原胶,帚叉藻聚糖,昆布多糖或类似的胶凝剂。
在本发明的最佳实施方案中,质子泵抑制剂是Omeprazole。
本发明组合物中不同组分的量可以改变且主要取决于各种因素例如被治疗动物的特殊要求。
胶凝剂的量可以改变,但以湿凝胶的量计算应在0.02-20%(重量)范围内,较好是0.2-20%和特别好是0.5-5%(重量)。
活性物质即该包有肠溶衣的颗粒的量取决于动物的特殊剂量。例如,包有肠溶衣的颗粒的量,马的每次剂量通常为0.1-20g,较好为0.2-10g。给予马的最终凝胶的总体积为5-50ml。
可以掺入本发明组合物的其它适宜物质是制药领域已知的调味物质。
通过混合不同物质与包有肠溶衣的颗粒,把适宜的物质加到包有肠溶衣的质子泵抑制剂颗粒中以形成混合物或有序混合物。有序混合物可以通过例如颗粒粘附或包衣方法生产。
包有肠溶衣的质子泵抑制剂颗粒和适宜组分的混合物在混合前或混合后被干燥至质子泵抑制剂具有良好长期稳定性的湿度水平。该混合物最好是配置于注射器形式的一种结实的施药器中。
包有肠溶衣的质子泵抑制剂珠或片与其它组分的混合物也可含有适宜的pH缓冲物质,以便改进该配方通过食管和胃运送期间和到达溶解和吸收质子泵抑制剂的小肠之前的功能稳定性。适宜的缓冲物质是柠檬酸,酒石酸,琥珀酸,马来酸,乳酸,苯甲酸,山梨酸和抗坏血酸以及其它物质。这样的物质可降低产生的凝胶的pH值至5.5以下,以便保护包有肠溶衣的珠和片。
包有肠溶衣的质子泵抑制剂颗粒和适宜组分的混合物还可进一步含有惰性颗粒,例如促进不同组分与包肠溶衣颗粒混合的惰性珠。这样的惰性珠例如是包糖衣珠或任何不伤害动物的其它种类的珠。
包有肠溶衣的珠或片可通过常规方法制备。Omeprazole的包肠溶衣药丸例如可按照U.S.No.4786505(=EP247983)中所述方法制备,因此,将其合并于本文作参考。这样的omeprazole包肠溶衣丸或珠最好包至少两层包衣,其中一层是隔离包衣/包底衣和另一层是肠溶包衣。
本发明的稳定药物组合物的制备是通过掺合珠或片状质子泵抑制剂于浆状凝胶中进行。所说的珠或片包有一或多层包衣,其中之一层是肠溶包衣。
更具体说,浆状凝胶形式的配方的制备是通过以下方法进行的,或者I)混合质子泵抑制剂的包衣颗粒与干的胶凝剂和任意的pH缓冲体系,以便在临时加水以后和在投药给动物之前保护该包衣颗粒,或者II)混合该包衣颗粒与含钾或钙离子的盐和任意的pH缓冲体系,和然后,在投药给动物之前,临时与胶凝剂如聚合物或化合物的低粘性水溶液混合,或者III)在投药给动物之前,临时混合包衣颗粒与温度敏感聚合物形式的胶凝剂的低粘性溶液和任意的pH缓冲体系,然后,轻微加热该混合物。
在下面实例中的Omeprazole包肠溶衣丸按照US-A 4786505(=EP 247983)的实例2制备,因此,该篇专利合并于本文作参考。
实例1
Omeprazole包肠溶衣丸 7g
(相当于约600mg Omeprazole)
黄原胶 0.3g
在注射器中混合。当加10ml水时,形成粘性凝胶。
实例2
Omeprazole包肠溶衣丸 7g
黄原胶 0.3g
柠檬酸 60mg
在注射器中混合。当加10ml水时,形成粘性凝胶。
实例3
Omeprazole包肠溶衣丸 7g
氯化钾 30mg
在注射器中混合。当加10ml 1%的Kappa-角叉菜胶时,形成粘性凝胶。
实例4
Omeprazole包肠溶衣丸 7g
配药于注射器中。加10ml 1.25%EHEC(乙基羟基乙基纤维素)溶液和0.1%十二烷基硫酸钠后,温热至35℃,形成粘性凝胶。
实例5
Lansoprazole包肠溶衣丸 7g
(按EP 2777741的实例1和2制备,因此合并于此作参考)
(相当于约900mg Lansoprazole)
黄原胶 0.45g
柠檬酸 80mg
当加15ml水时,形成粘性凝胶。
实例6
Pantoprazole包肠溶衣丸 7g
(按EP519,365的实例2制备,因此合并于此作参考)
(相当于约1200mg Pantoprazole)
黄原胶 0.3g
柠檬酸 50mg
当加10ml水时,形成粘性凝胶。
目前已知的实施本发明的最佳模式是使用实例2中所述组合物。
Claims (20)
1.一种动物口服给药的药物组合物,含有掺入浆状凝胶中的珠状或片状的质子泵抑制剂,该质子泵抑制剂包有1或多层包衣且其中之一层是肠溶包衣。
2.权利要求1的药物组合物,其中所说的珠或片包有至少两层包衣,其中之一层是包底衣和另一层是肠溶包衣。
3.权利要求1或2的药物组合物,其中该药物组合物供马口服给药。
4.权利要求1或2的药物组合物,其中含有质子泵抑制剂的干肠溶衣珠或片的组分,任意混合物的干组分,这些组分一加水或水溶液就得到浆状凝胶。
5.权利要求1或2的药物组合物,其中含有质子泵抑制剂的干肠溶衣包衣珠或片的组分,干胶凝剂和任意的pH缓冲和/或调味物质,这些组分一加水就成浆状凝胶。
6.权利要求1或2的药物组合物,其中质子泵抑制剂的干肠溶衣包衣珠或片,干胶凝剂和任意的pH缓冲和/或调味物质在加水或水溶液之前混合成干的混合物。
7.权利要求6的药物组合物,其中的混合物是有序混合物。
8.权利要求1或2的药物组合物,其中含有质子泵抑制剂的干肠溶衣包衣珠或片,钾、钙、镁或铝的水溶性有机或无机盐和任意的pH缓冲和/或调味物质组成的第一组组分,和胶凝剂水溶液组成的第二组组分,当混合两组组分时得到浆状凝胶。
9.权利要求1或2的药物组合物,其中含有质子泵抑制剂的干肠溶衣包衣珠或片,任意混合的pH缓冲和/或调味物质组成的第一组组分,和温度敏感的胶凝剂的水溶液组成的第二组组分,当两组组分混合时轻微地加热,得到浆状凝胶。
10.权利要求1的药物组合物,其中的质子泵抑制剂是Omeprazole。
11.权利要求1的药物组合物,其中的质子泵抑制剂是Lansoprazole。
12.权利要求1的药物组合物,其中的质子泵抑制剂是Pantoprazole。
13.权利要求1的药物组合物,其中的质子泵抑制剂是Leminoprazole。
14.套药形式的稳定的药物组合物,包括质子泵抑制剂的干肠溶衣包衣珠或片和其它干组分,这些组分一加水或水溶液就成浆状凝胶。
15.套药形式的稳定的药物组合物,包括质子泵抑制剂的干肠溶衣包衣珠或片,钾、钙、镁或铝的水溶性有机或无机盐和任意的pH缓冲和/或调味物质组成的第一组组分,和干胶凝剂组成的第二组组分,这两组组分在水存在下一混合就成浆状凝胶。
16.套药形式的稳定的药物组合物,包括质子泵抑制剂的干肠溶衣包衣珠或片,任意的干pH缓冲和/或调味物质组成的第一组组分,和温度敏感的胶凝剂组成的第二组组分,这两组组分在水存在下混合并轻微加热时得到浆状凝胶。
17.按照权利要求1,15或16的药物组合物,其特征在于该组合物全部或部分配置于注射器形式的施药器中。
18.按照权利要求1的药物组合物的制备方法,其特征在于将包有1或多层包衣且其中一层为肠溶包衣的珠状质子泵抑制剂掺入浆状凝胶中。
19.按照权利要求1,15或16的药物组合物在制备治疗与胃酸有关的动物疾病的活性剂量形式中的应用。
20.治疗与胃酸有关的疾病的方法,其中生理活性量的权利要求1,15或16的药物组合物给予需要这种治疗的动物。
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SE19939301489A SE9301489D0 (sv) | 1993-04-30 | 1993-04-30 | Veterinary composition |
SE93014892 | 1993-04-30 | ||
SE9301489-2 | 1993-04-30 |
Publications (2)
Publication Number | Publication Date |
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CN1122109A true CN1122109A (zh) | 1996-05-08 |
CN1100570C CN1100570C (zh) | 2003-02-05 |
Family
ID=20389791
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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CN94191967A Expired - Fee Related CN1100570C (zh) | 1993-04-30 | 1994-04-26 | 含有质子泵抑制剂的兽医用组合物 |
Country Status (33)
Country | Link |
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US (1) | US5731002A (zh) |
EP (1) | EP0696921B1 (zh) |
JP (1) | JP3872509B2 (zh) |
KR (1) | KR100324451B1 (zh) |
CN (1) | CN1100570C (zh) |
AT (1) | ATE199060T1 (zh) |
AU (1) | AU678830B2 (zh) |
BR (1) | BR9406363A (zh) |
CZ (1) | CZ285191B6 (zh) |
DE (1) | DE69426669T2 (zh) |
DK (1) | DK0696921T3 (zh) |
EE (1) | EE03137B1 (zh) |
EG (1) | EG20401A (zh) |
ES (1) | ES2155473T3 (zh) |
FI (1) | FI955124A0 (zh) |
GR (1) | GR3035831T3 (zh) |
HR (1) | HRP940267A2 (zh) |
HU (1) | HUT74868A (zh) |
IL (1) | IL109245A (zh) |
IS (1) | IS1694B (zh) |
LT (1) | LT3263B (zh) |
MA (1) | MA23170A1 (zh) |
NO (1) | NO312435B1 (zh) |
NZ (1) | NZ265728A (zh) |
PL (1) | PL176755B1 (zh) |
PT (1) | PT696921E (zh) |
RU (1) | RU2131267C1 (zh) |
SE (1) | SE9301489D0 (zh) |
SG (1) | SG52540A1 (zh) |
SK (1) | SK280465B6 (zh) |
TN (1) | TNSN94035A1 (zh) |
WO (1) | WO1994025070A1 (zh) |
YU (1) | YU22794A (zh) |
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CN101087590B (zh) * | 2004-12-22 | 2012-06-13 | 阿斯利康(瑞典)有限公司 | 包含质子泵抑制剂的固体剂型和由其制成的混悬液 |
CN1652754B (zh) * | 2002-03-11 | 2013-05-22 | 诺瓦提斯公司 | 掩味兽用固体组合物 |
US9132082B2 (en) | 2005-05-11 | 2015-09-15 | Vecta, Ltd. | Compositions and methods for inhibiting gastric acid secretion |
US9233092B2 (en) | 2006-07-25 | 2016-01-12 | Vecta, Ltd. | Compositions and methods for inhibiting gastric acid secretion using derivatives of small dicarboxylic acids in combination with PPI |
US9278080B2 (en) | 2005-05-11 | 2016-03-08 | Vecta, Ltd. | Compositions and methods for inhibiting gastric acid secretion |
CN107468652A (zh) * | 2016-06-07 | 2017-12-15 | 北京新领先医药科技发展有限公司 | 一种固体干混悬温敏凝胶剂及其制备方法 |
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US6262085B1 (en) | 1999-08-26 | 2001-07-17 | Robert R. Whittle | Alkoxy substituted Benzimidazole compounds, pharmaceutical preparations containing the same, and methods of using the same |
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DK130287D0 (da) * | 1987-03-13 | 1987-03-13 | Benzon As Alfred | Oralt praeparat |
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-
1993
- 1993-04-30 SE SE19939301489A patent/SE9301489D0/xx unknown
-
1994
- 1994-04-06 IS IS4146A patent/IS1694B/is unknown
- 1994-04-07 IL IL10924594A patent/IL109245A/xx not_active IP Right Cessation
- 1994-04-22 MA MA23476A patent/MA23170A1/fr unknown
- 1994-04-22 HR HR9301489-2A patent/HRP940267A2/hr not_active Application Discontinuation
- 1994-04-22 LT LTIP1920A patent/LT3263B/lt not_active IP Right Cessation
- 1994-04-26 DE DE69426669T patent/DE69426669T2/de not_active Expired - Fee Related
- 1994-04-26 KR KR1019950704741A patent/KR100324451B1/ko not_active IP Right Cessation
- 1994-04-26 SK SK1354-95A patent/SK280465B6/sk unknown
- 1994-04-26 ES ES94914665T patent/ES2155473T3/es not_active Expired - Lifetime
- 1994-04-26 BR BR9406363A patent/BR9406363A/pt not_active Application Discontinuation
- 1994-04-26 CN CN94191967A patent/CN1100570C/zh not_active Expired - Fee Related
- 1994-04-26 AU AU66938/94A patent/AU678830B2/en not_active Ceased
- 1994-04-26 SG SG1996005767A patent/SG52540A1/en unknown
- 1994-04-26 PT PT94914665T patent/PT696921E/pt unknown
- 1994-04-26 JP JP52415994A patent/JP3872509B2/ja not_active Expired - Fee Related
- 1994-04-26 WO PCT/SE1994/000368 patent/WO1994025070A1/en active IP Right Grant
- 1994-04-26 HU HU9503085A patent/HUT74868A/hu unknown
- 1994-04-26 RU RU95122630/13A patent/RU2131267C1/ru active
- 1994-04-26 PL PL94311276A patent/PL176755B1/pl unknown
- 1994-04-26 CZ CZ952825A patent/CZ285191B6/cs not_active IP Right Cessation
- 1994-04-26 EP EP94914665A patent/EP0696921B1/en not_active Expired - Lifetime
- 1994-04-26 DK DK94914665T patent/DK0696921T3/da active
- 1994-04-26 NZ NZ265728A patent/NZ265728A/en not_active IP Right Cessation
- 1994-04-26 AT AT94914665T patent/ATE199060T1/de not_active IP Right Cessation
- 1994-04-28 TN TNTNSN94035A patent/TNSN94035A1/fr unknown
- 1994-04-28 EG EG24594A patent/EG20401A/xx active
- 1994-04-29 US US08/235,258 patent/US5731002A/en not_active Expired - Lifetime
- 1994-11-17 EE EE9400377A patent/EE03137B1/xx unknown
-
1995
- 1995-04-27 YU YU22794A patent/YU22794A/sh unknown
- 1995-10-23 NO NO19954240A patent/NO312435B1/no unknown
- 1995-10-27 FI FI955124A patent/FI955124A0/fi not_active Application Discontinuation
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2001
- 2001-05-07 GR GR20010400679T patent/GR3035831T3/el not_active IP Right Cessation
Cited By (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN100536844C (zh) * | 2000-12-07 | 2009-09-09 | 尼科梅德有限责任公司 | 包含酸不稳定活性成分的糊剂形式的药物制剂 |
CN1652754B (zh) * | 2002-03-11 | 2013-05-22 | 诺瓦提斯公司 | 掩味兽用固体组合物 |
CN101087590B (zh) * | 2004-12-22 | 2012-06-13 | 阿斯利康(瑞典)有限公司 | 包含质子泵抑制剂的固体剂型和由其制成的混悬液 |
US9132082B2 (en) | 2005-05-11 | 2015-09-15 | Vecta, Ltd. | Compositions and methods for inhibiting gastric acid secretion |
US9278080B2 (en) | 2005-05-11 | 2016-03-08 | Vecta, Ltd. | Compositions and methods for inhibiting gastric acid secretion |
US9370481B2 (en) | 2005-05-11 | 2016-06-21 | Vecta, Ltd. | Compositions and methods for inhibiting gastric acid secretion |
US9233092B2 (en) | 2006-07-25 | 2016-01-12 | Vecta, Ltd. | Compositions and methods for inhibiting gastric acid secretion using derivatives of small dicarboxylic acids in combination with PPI |
CN107468652A (zh) * | 2016-06-07 | 2017-12-15 | 北京新领先医药科技发展有限公司 | 一种固体干混悬温敏凝胶剂及其制备方法 |
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