CN114917226A - 一种缬沙坦左氨氯地平组合物 - Google Patents
一种缬沙坦左氨氯地平组合物 Download PDFInfo
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- HTIQEAQVCYTUBX-KRWDZBQOSA-N (S)-amlodipine Chemical compound CCOC(=O)C1=C(COCCN)NC(C)=C(C(=O)OC)[C@@H]1C1=CC=CC=C1Cl HTIQEAQVCYTUBX-KRWDZBQOSA-N 0.000 title claims abstract description 24
- 229950008554 levamlodipine Drugs 0.000 title claims abstract description 24
- 239000004072 C09CA03 - Valsartan Substances 0.000 title claims abstract description 23
- 229960004699 valsartan Drugs 0.000 title claims abstract description 23
- SJSNUMAYCRRIOM-QFIPXVFZSA-N valsartan Chemical compound C1=CC(CN(C(=O)CCCC)[C@@H](C(C)C)C(O)=O)=CC=C1C1=CC=CC=C1C1=NN=N[N]1 SJSNUMAYCRRIOM-QFIPXVFZSA-N 0.000 title claims abstract description 23
- 239000000203 mixture Substances 0.000 title claims abstract description 18
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 7
- 239000000945 filler Substances 0.000 claims abstract description 4
- 239000000314 lubricant Substances 0.000 claims abstract description 4
- 230000014759 maintenance of location Effects 0.000 claims abstract description 3
- 238000002156 mixing Methods 0.000 claims description 24
- 229920002472 Starch Polymers 0.000 claims description 14
- 239000008107 starch Substances 0.000 claims description 14
- 235000019698 starch Nutrition 0.000 claims description 14
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 10
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 10
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 9
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims description 9
- 229960000913 crospovidone Drugs 0.000 claims description 9
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 9
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 9
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 9
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 9
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims description 9
- 239000002002 slurry Substances 0.000 claims description 8
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 6
- 239000008187 granular material Substances 0.000 claims description 6
- 239000000853 adhesive Substances 0.000 claims description 5
- 230000001070 adhesive effect Effects 0.000 claims description 5
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 claims description 5
- 235000019359 magnesium stearate Nutrition 0.000 claims description 5
- 239000000377 silicon dioxide Substances 0.000 claims description 5
- 235000012239 silicon dioxide Nutrition 0.000 claims description 5
- 239000000463 material Substances 0.000 claims description 4
- 239000011248 coating agent Substances 0.000 claims description 3
- 238000000576 coating method Methods 0.000 claims description 3
- 238000001035 drying Methods 0.000 claims description 3
- 238000001914 filtration Methods 0.000 claims description 3
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 2
- 239000007888 film coating Substances 0.000 claims description 2
- 238000009501 film coating Methods 0.000 claims description 2
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 2
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 2
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 3
- 229960001681 croscarmellose sodium Drugs 0.000 claims 3
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims 3
- 238000000034 method Methods 0.000 claims 3
- 239000004375 Dextrin Substances 0.000 claims 2
- 229920001353 Dextrin Polymers 0.000 claims 2
- 235000019425 dextrin Nutrition 0.000 claims 2
- 229920003123 carboxymethyl cellulose sodium Polymers 0.000 claims 1
- 229940063834 carboxymethylcellulose sodium Drugs 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 abstract description 5
- -1 carboxypropyl methyl Chemical group 0.000 abstract description 2
- 238000013268 sustained release Methods 0.000 abstract 2
- 239000012730 sustained-release form Substances 0.000 abstract 2
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 abstract 1
- 229920002125 Sokalan® Polymers 0.000 abstract 1
- 229960001631 carbomer Drugs 0.000 abstract 1
- 229920000609 methyl cellulose Polymers 0.000 abstract 1
- 239000001923 methylcellulose Substances 0.000 abstract 1
- 235000010981 methylcellulose Nutrition 0.000 abstract 1
- 230000000694 effects Effects 0.000 description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 3
- 206010020772 Hypertension Diseases 0.000 description 2
- 239000008194 pharmaceutical composition Substances 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 206010002383 Angina Pectoris Diseases 0.000 description 1
- 229940127291 Calcium channel antagonist Drugs 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 239000002333 angiotensin II receptor antagonist Substances 0.000 description 1
- 229940126317 angiotensin II receptor antagonist Drugs 0.000 description 1
- 230000003257 anti-anginal effect Effects 0.000 description 1
- 230000003276 anti-hypertensive effect Effects 0.000 description 1
- 239000002220 antihypertensive agent Substances 0.000 description 1
- 229940127088 antihypertensive drug Drugs 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 230000002459 sustained effect Effects 0.000 description 1
- 230000024883 vasodilation Effects 0.000 description 1
Classifications
-
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
-
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
-
- 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
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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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
-
- 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
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
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Abstract
本发明提供一种缬沙坦左氨氯地平组合物，涉及制药领域，包括缬沙坦815g、苯磺酸左旋氨氯地平70g、填充剂、崩解剂、润滑剂、助留剂、缓释剂，所述缓释剂为羧丙基甲基纤维素、卡波姆共645g。本发明中，且缬沙坦和苯磺酸左旋氨氯地平两种药物联合用药，降低部分老年患者由于少服或漏服药物的风险。
Description
技术领域
本发明涉及制药领域，尤其涉及一种缬沙坦左氨氯地平组合物。
背景技术
缬沙坦是一款血管紧张素II受体拮抗剂抗高血压类药物，苯磺酸左旋氨氯地平片主要具有治疗高血压病、用于轻度和中度的高血压患者、治疗心绞痛，苯磺酸左旋氨氯地平的独特性质是与其它钙拮抗剂有所不同，表现为长效、缓慢吸收，逐渐产生血管扩张效应。降血压和抗心绞痛作用时间长，每日服用一次即可，作用时间可维持近24小时。副作用比较轻微，病人一般都能耐受，因而越来越广泛地应用于临床。
专利号为CN102349903A的申请文件公开了一种含有左旋氨氯地平和缬沙坦的全新药物组合物及其制备方法，其中具体公开了采用较少的崩解剂就能达到90％以上的溶出度，具有稳定性良好，崩解更快的优点。
但是根据患者病情应当选择快速崩解的组合物。
发明内容
本发明的目的是解决现有技术存在的以下问题：针对于慢性患者，如何缓释持久作用。
为解决现有技术存在的问题，本发明提供了一种缬沙坦左氨氯地平组合物，包括包括缬沙坦815g、苯磺酸左旋氨氯地平70g、填充剂、崩解剂、润滑剂、助留剂、粘合剂，所述粘合剂为淀粉、羧甲基纤维素钠共201g，通过在制备中添加粘合剂，降低药物崩解速度，延长药物释放时间。
与现有技术相比，缬沙坦和苯磺酸左旋氨氯地平两种药物联合用药，降低部分老年患者由于少服或漏服药物的风险。
具体实施方式
下面描述本发明的具体实施例。
实施例1
将淀粉与水混合均匀制成5的淀粉浆备用；
苯磺酸左旋氨氯地平与交联聚维酮、低取代羟丙基纤维素等量递增混合均匀后，再与等量的微晶纤维素混合均匀，将上述物料加入混合机内，加入缬沙坦和剩余的微晶纤维素开机混合；
其中总混是加入颗粒总量的1％交联聚维酮混合5分钟，再加入0.25的硬脂酸镁及0.2的二氧化硅，加入制备好的5％的淀粉浆制软才，过滤制粒、干燥、整粒、总混、压片包薄膜衣。
实施例2
将淀粉与水混合均匀制成10％的淀粉浆备用；
苯磺酸左旋氨氯地平与交联聚维酮等量递增混合均匀后，再与等量的微晶纤维素混合均匀，将上述物料加入混合机内，加入缬沙坦和剩余的微晶纤维素开机混合；
其中总混是加入颗粒总量的2.5％交联聚维酮混合5分钟，再加入0.5％的硬脂酸镁及1％的二氧化硅，加入制备好的10的淀粉浆制软才，过滤制粒、干燥、整粒、总混、压片包薄膜衣。
实施例3
将淀粉与水混合均匀制成20％的淀粉浆备用；
苯磺酸左旋氨氯地平与交联聚维酮、低取代羟丙基纤维素等量递增混合均匀后，再与等量的微晶纤维素混合均匀，将上述物料加入混合机内，加入缬沙坦和剩余的微晶纤维素开机混合；
其中总混是加入颗粒总量的5％交联聚维酮混合5分钟，再加入1％的硬脂酸镁及2％的二氧化硅，加入制备好的20％的淀粉浆制软才，过滤制粒、干燥、整粒、总混、压片包薄膜衣。
Claims (4)
1.一种缬沙坦左氨氯地平组合物，其特征在于：包括缬沙坦815g、苯磺酸左旋氨氯地平70g、填充剂、崩解剂、润滑剂、助留剂、粘合剂，所述粘合剂为淀粉、羧甲基纤维素钠共201g。
2.根据权利要求1所述的一种缬沙坦左氨氯地平组合物，其特征在于：所述填充剂为微晶纤维素、糊精共384g，崩解剂为交联聚维酮、低取代羟丙基纤维素、交联羧甲基纤维素钠共166g，所述润滑剂为硬脂酸镁8g，所述助流剂为二氧化硅16g。
3.权利要求2所述的一种缬沙坦左氨氯地平组合物的制备方法，其特征在于：包括如下步骤：
S1.将淀粉制成5-20％的淀粉浆备用；
S2.苯磺酸左旋氨氯地平与交联聚维酮、低取代羟丙基纤维素、交联羧甲基纤维素钠其中的一种或多种等量递增混合均匀后，再与等量的微晶纤维素混合均匀，将上述物料加入混合机内，加入缬沙坦和剩余的微晶纤维素、糊精、羧甲基纤维素钠的一种或多种开机混合；
S3.加入制备好的5-20％的淀粉浆制软才，过滤制粒、干燥、整粒、总混、压片包薄膜衣。
4.根据权利要求3所述的一种缬沙坦左氨氯地平组合物的制备方法，其特征在于：所述总混为加入颗粒总量的1-5％交联聚维酮、低取代羟丙基纤维素、交联羧甲基纤维素钠一种或多种混合5分钟，再加入0.25-1％的硬脂酸镁及0.2-2％的二氧化硅。
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210257608.7A CN114917226A (zh) | 2022-03-16 | 2022-03-16 | 一种缬沙坦左氨氯地平组合物 |
| NL2033611A NL2033611A (en) | 2022-03-16 | 2022-11-25 | Valsartan-levamlodipine composition |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210257608.7A CN114917226A (zh) | 2022-03-16 | 2022-03-16 | 一种缬沙坦左氨氯地平组合物 |
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| CN114917226A true CN114917226A (zh) | 2022-08-19 |
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| CN202210257608.7A Pending CN114917226A (zh) | 2022-03-16 | 2022-03-16 | 一种缬沙坦左氨氯地平组合物 |
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| Country | Link |
|---|---|
| CN (1) | CN114917226A (zh) |
| NL (1) | NL2033611A (zh) |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101744813A (zh) * | 2010-01-21 | 2010-06-23 | 扬子江药业集团有限公司 | 复方氨氯地平缬沙坦固体制剂及其制备方法 |
| CN101843615A (zh) * | 2010-06-25 | 2010-09-29 | 包丽昕 | 含有缬沙坦和苯磺酸氨氯地平的分散片及其制备方法 |
| CN103211815A (zh) * | 2012-02-18 | 2013-07-24 | 刘红 | 一种缬沙坦氨氯地平药物组合物及其制备方法 |
| WO2015051771A1 (en) * | 2013-10-08 | 2015-04-16 | Zentiva, K.S. | A stable pharmaceutical composition containing amlodipine and valsartan |
| CN105232551A (zh) * | 2015-11-19 | 2016-01-13 | 哈尔滨圣吉药业股份有限公司 | 一种缬沙坦/苯磺酸氨氯地平复方制剂及其制备方法 |
-
2022
- 2022-03-16 CN CN202210257608.7A patent/CN114917226A/zh active Pending
- 2022-11-25 NL NL2033611A patent/NL2033611A/en unknown
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101744813A (zh) * | 2010-01-21 | 2010-06-23 | 扬子江药业集团有限公司 | 复方氨氯地平缬沙坦固体制剂及其制备方法 |
| CN101843615A (zh) * | 2010-06-25 | 2010-09-29 | 包丽昕 | 含有缬沙坦和苯磺酸氨氯地平的分散片及其制备方法 |
| CN103211815A (zh) * | 2012-02-18 | 2013-07-24 | 刘红 | 一种缬沙坦氨氯地平药物组合物及其制备方法 |
| WO2015051771A1 (en) * | 2013-10-08 | 2015-04-16 | Zentiva, K.S. | A stable pharmaceutical composition containing amlodipine and valsartan |
| CN105232551A (zh) * | 2015-11-19 | 2016-01-13 | 哈尔滨圣吉药业股份有限公司 | 一种缬沙坦/苯磺酸氨氯地平复方制剂及其制备方法 |
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| Publication number | Publication date |
|---|---|
| NL2033611A (en) | 2023-09-21 |
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