CN1076196C - 药用组合物 - Google Patents
药用组合物 Download PDFInfo
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- CN1076196C CN1076196C CN94109091A CN94109091A CN1076196C CN 1076196 C CN1076196 C CN 1076196C CN 94109091 A CN94109091 A CN 94109091A CN 94109091 A CN94109091 A CN 94109091A CN 1076196 C CN1076196 C CN 1076196C
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- inhibitor
- acarbose
- gluconase
- lipase
- liesitate
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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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
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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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
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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
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/04—Anorexiants; Antiobesity agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
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- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
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Abstract
一种含有葡萄糖甙酶和/或淀粉酶抑制剂和脂肪酶抑制剂作为活性物质和常规药用载体的药物制剂。
Description
本发明涉及含有葡萄糖甙酶和/或淀粉酶抑制剂和脂肪酶抑制剂作为活性物质和常规药用载体的药物制剂。
据发现这种制剂可以用于治疗肥胖症。
因此,本发明还涉及葡萄糖甙酶和/或淀粉酶抑制剂与脂肪酶抑制剂同时合用、单独使用或按时间顺序隔开使用在治疗肥胖方面的用途;涉及一种商业包装,它含有作为药用活性物质的葡萄糖甙酶和/或淀粉酶抑制剂例如阿卡波糖连同说明该药物与脂肪酶抑制剂例如四氢制胰脂菌素在治疗肥胖症中如何同时、单独或按时间顺序隔开使用的联合使用说明书;以及本发明还涉及葡萄糖甙酶和/或淀粉酶抑制剂例如阿卡波糖与脂肪酶抑制剂例如四氢制胰脂菌素组合在制造用于治疗肥胖的药物制剂中的用途。
根据本发明所能应用的葡萄糖甙酶和/或淀粉酶抑制剂有例如阿卡波糖(acarbose),脂解素(adiposine),伏格列糖(voglibose(AO-128)),米格列醇(miglitol(Bay-m-1099)),乙格列酯(emiglitate(Bay-o-1248)),MDL-25637,卡米格列糖(camiglibose(MDL-73945)),淀粉酶抑肽(tendamistate),Al-3688,曲司他丁(trestatin),泊拉弟霉素Q(pradimicin-Q)和沙波司他丁(salbostatin)。
脂肪酶中制剂有:例如四氢制胰脂菌素(Tetrahydrolipstatin),制胰脂菌素(lipstatin),FL-386,WAY-121898,Bay-N-3176,缬基内酯(valilactone),抑脂酶素(esterastin),抑脂酶免疫同A(ebelactone A),抑酯酶免疫酮B(ebelactone B)和RHC80267。
能够进行发酵制备脂肪酶抑制剂例如制胰脂菌素或抑脂酶素的生物量或发酵块,也可以用作为脂肪酶抑制剂。后者在例如欧洲专利EP-A129748和美国专利USP4189438中都有叙述。
已经知道,葡萄糖甙酶和/或淀粉酶抑制剂,例如阿卡波糖,可以阻滞碳水化合物的消化。
也已经知道,脂肪酶抑制剂,例如四氢制胰脂菌素(orlistat(奥列司他特)),可以在肠道内对脂肪酶产生部份抑制作用。
但是,在单种药物治疗中,脂肪酶抑制剂本身结合以节食一般只能起到适度的体重减轻,而葡萄糖甙酶和/或淀粉酶抑制剂基本上起不到使体重减轻的作用。现在惊奇地发现葡萄糖甙酶和/或淀粉酶抑制剂与脂肪酶抑制剂合用却能比单种药物治疗的情况造成大得多的体重减轻。这在下述的试验中得到证明。
该试验是在两个自愿者(A和B)中分两个试验期进行的。在七天的预试期内规定A的平均日热量为2560千卡而B为1850千卡,在这期间不服任何药物。在随后的十四天主试验期中,两个自愿者每餐各给以120mg的奥列司他特和100mg的阿卡波糖。并没有规定特殊的膳食,而将体力活动减至最少。这里,如在预试期中那样也规定,A的平均日热量为2185千卡,而B为2050千卡。从下表中可以看出,两个自愿者的体重减轻是很明显的。
试验日期 | 体重A B | |
123456789101112131415 | 74.374.174.673.973.573.373.073.673.373.172.872.472.472.271.9 | 88.788.589.188.088.488.287.787.887.787.487.287.587.286.486.1 |
体重减轻 | 2.4 | 2.6 |
与此作比较,在一个安慰剂对照的十二个星期的试验期中,用奥列司他特(3×120mg/天)单独治疗的情况下,患者的体重减轻平均为1.8kg(即0.3kg/14天)(Int.J.Obesity 1992;16(增刊1):16,摘要063)。
根据本发明,葡萄糖甙酶和/或淀粉酶抑制剂可以以药物制剂的形式来使用,其中也含有脂肪酶抑制剂,或者与含有脂肪酶抑制剂的制剂混合作为一种特定组合来使用。
优选使用阿卡波糖和奥列司他特。
为治疗肥胖症,这些活性成份口服使用。
它们可以以每公斤体重每日约0.003mg至约20mg优选0.015mg至10mg葡萄糖甙酶和/或淀粉酶抑制剂和大约0.15mg至20mg优选0.5mg至10mg脂肪酶抑制剂的剂量服用。
用于口服的本发明制剂可以采用片剂、胶囊、溶液或乳剂的形式。
固体剂型例如片剂和胶囊剂,每一剂量单位宜包含大约0.2mg至约100mg的葡萄糖甙酶和/或淀粉酶抑制剂和10mg至200mg的脂肪酶抑制剂。
除了治疗肥胖症之外,本发明的制剂或活性物质的组合可以用于对常与肥胖相联系发生的疾病如糖尿病、高血压、高脂血症以及耐胰岛素综合症等的治疗与预防。
对于所有这些适应症,所述活性物质都可以按上述的剂量范围来使用,个别的剂量可根据所治疗的疾病的性质以及患者的年龄和情况而定,可以在医学专家所认可的范围内来确定。
本发明通过下列的实施例详述。
具下列组成的药物制剂以本身已知的方法制备:
实施例A软明胶胶囊:
每一胶囊的用量奥列司他特 60mg中链甘油三酯 450μl阿卡波糖 50mg
实施例B硬明胶胶囊:阿卡波糖 25.0mg奥列司他特 30.0mg晶状乳糖 37.0mg微晶纤维素 20.0mg聚乙烯聚吡咯烷酮 8.5mg羧甲基淀粉钠 8.5mg滑石粉 4.5mg硬脂酸镁 1.5mg
胶囊内充物重量 135.0mg
实施例C片剂:阿卡波糖 25.0mg奥列司他特 30.0mg无水乳糖 118.0mg微晶纤维素 30.0mg聚乙烯聚吡咯烷酮 10.0mg羧甲基纤维素 10.0mg硬脂酸镁 1.2mg
片剂重量 225.0mg
实施例D具有控制的活性物质释放和在胃中存留时间增长的片剂:阿卡波糖 50.0mg奥列司他特 60.0mg粉末状乳糖 70.0mg羟丙基甲基纤维素 52.5mg聚乙烯聚吡咯烷酮 7.5mg滑石粉 8.0mg硬脂酸镁 1.0mg胶体硅酸 1.0mg
芯重 250.0mg羟丙基甲基纤维素 2.5mg滑石粉 1.25mg二氧化钛 1.25mg
薄膜包衣重量 5.0mg
实施例E用于再制的粉末:阿卡波糖 100.0mg奥列司他特 120.0mg乙基香兰素 10.0mg天冬酰苯丙氨酸甲酯 30.0mg喷雾法制的脱脂奶粉 4740.0mg
总计 5000.0mg
Claims (1)
1.一种含有阿卡波糖和四氢制胰脂菌素和常规药用载体的药物制剂。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CH2339/93 | 1993-08-05 | ||
CH233993 | 1993-08-05 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1106701A CN1106701A (zh) | 1995-08-16 |
CN1076196C true CN1076196C (zh) | 2001-12-19 |
Family
ID=4231504
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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CN94109091A Expired - Lifetime CN1076196C (zh) | 1993-08-05 | 1994-08-04 | 药用组合物 |
Country Status (24)
Country | Link |
---|---|
US (1) | US5643874A (zh) |
EP (1) | EP0638317B1 (zh) |
JP (1) | JP2780932B2 (zh) |
KR (1) | KR100342285B1 (zh) |
CN (1) | CN1076196C (zh) |
AT (1) | ATE190503T1 (zh) |
AU (1) | AU684793B2 (zh) |
BR (1) | BR9403170A (zh) |
CA (1) | CA2128044C (zh) |
CZ (1) | CZ286202B6 (zh) |
DE (1) | DE59409200D1 (zh) |
DK (1) | DK0638317T3 (zh) |
ES (1) | ES2144019T3 (zh) |
GR (1) | GR3033643T3 (zh) |
HU (1) | HU222346B1 (zh) |
IL (1) | IL110510A (zh) |
NO (1) | NO313490B1 (zh) |
NZ (1) | NZ264142A (zh) |
PL (1) | PL175997B1 (zh) |
PT (1) | PT638317E (zh) |
RU (1) | RU2141844C1 (zh) |
SA (1) | SA94150156B1 (zh) |
TW (1) | TW381025B (zh) |
ZA (1) | ZA945673B (zh) |
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US20150050371A1 (en) | 2012-03-09 | 2015-02-19 | Biotropics Malaysia Berhad | Extract Formulations of Rhodamnia Cinerea And Uses Thereof |
CN104812737A (zh) * | 2012-05-08 | 2015-07-29 | 塞利克斯比奥私人有限公司 | 用于治疗高血糖症的组合物和方法 |
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FR3017536B1 (fr) | 2014-02-18 | 2017-05-26 | Univ La Rochelle | Compositions pour la prevention et/ou le traitement de pathologies liees a l'alpha-glucosidase |
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CN107308154A (zh) * | 2017-07-19 | 2017-11-03 | 重庆植恩药业有限公司 | 治疗或预防肥胖症以及代谢综合征的药物组合物及其应用 |
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