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 PDF

Info

Publication number
CN114917226A
CN114917226A CN202210257608.7A CN202210257608A CN114917226A CN 114917226 A CN114917226 A CN 114917226A CN 202210257608 A CN202210257608 A CN 202210257608A CN 114917226 A CN114917226 A CN 114917226A
Authority
CN
China
Prior art keywords
valsartan
levamlodipine
mixing
composition
crospovidone
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202210257608.7A
Other languages
English (en)
Inventor
司鹏
付杰
周世文
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Huangshan C King Pharmaceutical Co ltd
Original Assignee
Huangshan C King Pharmaceutical Co ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Huangshan C King Pharmaceutical Co ltd filed Critical Huangshan C King Pharmaceutical Co ltd
Priority to CN202210257608.7A priority Critical patent/CN114917226A/zh
Publication of CN114917226A publication Critical patent/CN114917226A/zh
Priority to NL2033611A priority patent/NL2033611A/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/44221,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/282Organic compounds, e.g. fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

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

一种缬沙坦左氨氯地平组合物
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。
CN202210257608.7A 2022-03-16 2022-03-16 一种缬沙坦左氨氯地平组合物 Pending CN114917226A (zh)

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

Applications Claiming Priority (1)

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

Publications (1)

Publication Number Publication Date
CN114917226A true CN114917226A (zh) 2022-08-19

Family

ID=82804423

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202210257608.7A Pending CN114917226A (zh) 2022-03-16 2022-03-16 一种缬沙坦左氨氯地平组合物

Country Status (2)

Country Link
CN (1) CN114917226A (zh)
NL (1) NL2033611A (zh)

Citations (5)

* Cited by examiner, † Cited by third party
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

Patent Citations (5)

* Cited by examiner, † Cited by third party
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

Also Published As

Publication number Publication date
NL2033611A (en) 2023-09-21

Similar Documents

Publication Publication Date Title
AU2009338267B2 (en) Solid pharmaceutical composition comprising amlodipine and losartan and process for producing same
KR100858848B1 (ko) 메트포르민 서방정
AU756422B2 (en) Formulation of fast-dissolving efavirenz capsules or tablets using super-disintegrants
WO1998022105A1 (fr) Preparation en comprimes
CN103006649B (zh) 一种复方制剂缬沙坦氨氯地平片(ⅰ)及其制备方法
MX2008016099A (es) Composicion farmaceutica que comprende amlodipina y losartan.
EP2494964A1 (en) Combinations of valsartan and amlodipine
AU2008261957A1 (en) Extended release formulation and method of treating adrenergic dysregulation
CN114917226A (zh) 一种缬沙坦左氨氯地平组合物
CN106668016B (zh) 阿齐沙坦和苯磺酸氨氯地平组合物的固体制剂及其制备方法
CN1883478A (zh) 治疗高血压心血管疾病的药物组合物
CN110237073A (zh) 一种奥美沙坦酯氨氯地平片及其制备方法
CN112168796B (zh) 双相缓释系统控制释放的药物缓释制剂及其制备方法
CN109498626A (zh) 一种稳定的复方制剂缬沙坦氨氯地平处方及其制备方法
CN100577152C (zh) 一种氯沙坦钾氢氯噻嗪片及其制备方法
CN112315932A (zh) 一种奥美沙坦酯片及其制备方法
JP2010001242A (ja) レバミピド固形製剤及びその製造方法
CN110693884A (zh) 一种复方制剂缬沙坦氨氯地平片及其制备方法
CN101272791A (zh) 苯磺酸氨氯地平和盐酸贝那普利的稳定的组合
WO2011079156A1 (en) Extended release formulation and methods of treating adrenergic dysregulation
CN112220787A (zh) 一种奥美沙坦酯氨氯地平片及其制备方法
WO2024109927A1 (zh) 包含美阿沙坦钾与钙通道阻滞剂的药物组合物,及其制备方法及应用
KR20060130006A (ko) 경구 서방성 정제
CN111557924B (zh) 一种奥美沙坦酯氢氯噻嗪片的制备方法及奥美沙坦酯氢氯噻嗪片
JPH06345649A (ja) イプサピロン薬剤組成物

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
WD01 Invention patent application deemed withdrawn after publication
WD01 Invention patent application deemed withdrawn after publication

Application publication date: 20220819