CN101632678A - 一种氯沙坦钾氢氯噻嗪组合物及其制备方法 - Google Patents
一种氯沙坦钾氢氯噻嗪组合物及其制备方法 Download PDFInfo
- Publication number
- CN101632678A CN101632678A CN200910070305A CN200910070305A CN101632678A CN 101632678 A CN101632678 A CN 101632678A CN 200910070305 A CN200910070305 A CN 200910070305A CN 200910070305 A CN200910070305 A CN 200910070305A CN 101632678 A CN101632678 A CN 101632678A
- Authority
- CN
- China
- Prior art keywords
- hydrochlorothiazide
- losartan potassium
- preparation
- microcrystalline cellulose
- potassium
- 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.)
- Granted
Links
- JZUFKLXOESDKRF-UHFFFAOYSA-N Chlorothiazide Chemical compound C1=C(Cl)C(S(=O)(=O)N)=CC2=C1NCNS2(=O)=O JZUFKLXOESDKRF-UHFFFAOYSA-N 0.000 title claims abstract description 33
- 229960002003 hydrochlorothiazide Drugs 0.000 title claims abstract description 33
- 239000002083 C09CA01 - Losartan Substances 0.000 title claims abstract description 24
- 229960000519 losartan potassium Drugs 0.000 title claims abstract description 24
- OXCMYAYHXIHQOA-UHFFFAOYSA-N potassium;[2-butyl-5-chloro-3-[[4-[2-(1,2,4-triaza-3-azanidacyclopenta-1,4-dien-5-yl)phenyl]phenyl]methyl]imidazol-4-yl]methanol Chemical compound [K+].CCCCC1=NC(Cl)=C(CO)N1CC1=CC=C(C=2C(=CC=CC=2)C2=N[N-]N=N2)C=C1 OXCMYAYHXIHQOA-UHFFFAOYSA-N 0.000 title claims abstract description 24
- 238000002360 preparation method Methods 0.000 title claims abstract description 16
- 239000000203 mixture Substances 0.000 title claims description 14
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 18
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract description 13
- 239000008108 microcrystalline cellulose Substances 0.000 claims abstract description 13
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract description 13
- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract description 13
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims abstract description 9
- 229920000881 Modified starch Polymers 0.000 claims abstract description 9
- 238000004090 dissolution Methods 0.000 claims abstract description 9
- 239000008101 lactose Substances 0.000 claims abstract description 9
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 9
- 238000000034 method Methods 0.000 claims abstract description 7
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract 3
- 239000011248 coating agent Substances 0.000 claims description 16
- 238000000576 coating method Methods 0.000 claims description 16
- 239000008187 granular material Substances 0.000 claims description 10
- 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 8
- 230000001476 alcoholic effect Effects 0.000 claims description 8
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 8
- 238000004132 cross linking Methods 0.000 claims description 8
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 8
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 8
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 claims description 7
- 239000011591 potassium Substances 0.000 claims description 7
- 229910052700 potassium Inorganic materials 0.000 claims description 7
- 238000001035 drying Methods 0.000 claims description 4
- 239000000843 powder Substances 0.000 claims description 4
- 210000002784 stomach Anatomy 0.000 claims description 4
- 238000005303 weighing Methods 0.000 claims description 4
- 230000008569 process Effects 0.000 abstract description 4
- 238000002156 mixing Methods 0.000 abstract description 3
- 238000000338 in vitro Methods 0.000 abstract description 2
- 238000005453 pelletization Methods 0.000 abstract 2
- 229920002785 Croscarmellose sodium Polymers 0.000 abstract 1
- 229920002472 Starch Polymers 0.000 abstract 1
- 239000001767 crosslinked sodium carboxy methyl cellulose Substances 0.000 abstract 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 abstract 1
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 abstract 1
- 239000007888 film coating Substances 0.000 abstract 1
- 238000009501 film coating Methods 0.000 abstract 1
- 230000003993 interaction Effects 0.000 abstract 1
- 239000010410 layer Substances 0.000 abstract 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 abstract 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 abstract 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 abstract 1
- 235000019698 starch Nutrition 0.000 abstract 1
- 239000008107 starch Substances 0.000 abstract 1
- 239000003814 drug Substances 0.000 description 21
- 206010020772 Hypertension Diseases 0.000 description 17
- 230000000694 effects Effects 0.000 description 12
- 229940079593 drug Drugs 0.000 description 9
- 230000036772 blood pressure Effects 0.000 description 7
- 239000002934 diuretic Substances 0.000 description 6
- 230000001882 diuretic effect Effects 0.000 description 6
- LEHOTFFKMJEONL-UHFFFAOYSA-N Uric Acid Chemical compound N1C(=O)NC(=O)C2=C1NC(=O)N2 LEHOTFFKMJEONL-UHFFFAOYSA-N 0.000 description 5
- 239000005555 hypertensive agent Substances 0.000 description 5
- 230000001225 therapeutic effect Effects 0.000 description 5
- 102000008873 Angiotensin II receptor Human genes 0.000 description 4
- 108050000824 Angiotensin II receptor Proteins 0.000 description 4
- 239000002981 blocking agent Substances 0.000 description 4
- 150000001875 compounds Chemical class 0.000 description 4
- 230000000994 depressogenic effect Effects 0.000 description 4
- 230000001631 hypertensive effect Effects 0.000 description 4
- 102000005862 Angiotensin II Human genes 0.000 description 3
- 101800000733 Angiotensin-2 Proteins 0.000 description 3
- CZGUSIXMZVURDU-JZXHSEFVSA-N Ile(5)-angiotensin II Chemical compound C([C@@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](CC=1NC=NC=1)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CC=1C=CC=CC=1)C([O-])=O)NC(=O)[C@@H](NC(=O)[C@H](CCCNC(N)=[NH2+])NC(=O)[C@@H]([NH3+])CC([O-])=O)C(C)C)C1=CC=C(O)C=C1 CZGUSIXMZVURDU-JZXHSEFVSA-N 0.000 description 3
- 206010041277 Sodium retention Diseases 0.000 description 3
- TVWHNULVHGKJHS-UHFFFAOYSA-N Uric acid Natural products N1C(=O)NC(=O)C2NC(=O)NC21 TVWHNULVHGKJHS-UHFFFAOYSA-N 0.000 description 3
- 229950006323 angiotensin ii Drugs 0.000 description 3
- 230000003276 anti-hypertensive effect Effects 0.000 description 3
- ASCWBYZMMHUZMQ-UHFFFAOYSA-N bis(2-propoxyethyl) 4-[2-(difluoromethoxy)phenyl]-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate Chemical compound CCCOCCOC(=O)C1=C(C)NC(C)=C(C(=O)OCCOCCC)C1C1=CC=CC=C1OC(F)F ASCWBYZMMHUZMQ-UHFFFAOYSA-N 0.000 description 3
- 210000002464 muscle smooth vascular Anatomy 0.000 description 3
- 238000013112 stability test Methods 0.000 description 3
- 108010021724 tonin Proteins 0.000 description 3
- 229940116269 uric acid Drugs 0.000 description 3
- 239000005541 ACE inhibitor Substances 0.000 description 2
- 101710129690 Angiotensin-converting enzyme inhibitor Proteins 0.000 description 2
- 101710086378 Bradykinin-potentiating and C-type natriuretic peptides Proteins 0.000 description 2
- 208000024172 Cardiovascular disease Diseases 0.000 description 2
- 206010008190 Cerebrovascular accident Diseases 0.000 description 2
- 206010013786 Dry skin Diseases 0.000 description 2
- 206010019280 Heart failures Diseases 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 208000006011 Stroke Diseases 0.000 description 2
- 229940044094 angiotensin-converting-enzyme inhibitor Drugs 0.000 description 2
- 210000001367 artery Anatomy 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 208000029078 coronary artery disease Diseases 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 230000029142 excretion Effects 0.000 description 2
- 230000036541 health Effects 0.000 description 2
- 230000001077 hypotensive effect Effects 0.000 description 2
- 208000017169 kidney disease Diseases 0.000 description 2
- 230000036454 renin-angiotensin system Effects 0.000 description 2
- 210000002966 serum Anatomy 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 206010002383 Angina Pectoris Diseases 0.000 description 1
- 206010011224 Cough Diseases 0.000 description 1
- 206010055171 Hypertensive nephropathy Diseases 0.000 description 1
- 208000031662 Noncommunicable disease Diseases 0.000 description 1
- ZPBWCRDSRKPIDG-UHFFFAOYSA-N amlodipine benzenesulfonate Chemical compound OS(=O)(=O)C1=CC=CC=C1.CCOC(=O)C1=C(COCCN)NC(C)=C(C(=O)OC)C1C1=CC=CC=C1Cl ZPBWCRDSRKPIDG-UHFFFAOYSA-N 0.000 description 1
- 229960004005 amlodipine besylate Drugs 0.000 description 1
- 230000008485 antagonism Effects 0.000 description 1
- 239000002876 beta blocker Substances 0.000 description 1
- 229940097320 beta blocking agent Drugs 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- FAKRSMQSSFJEIM-RQJHMYQMSA-N captopril Chemical compound SC[C@@H](C)C(=O)N1CCC[C@H]1C(O)=O FAKRSMQSSFJEIM-RQJHMYQMSA-N 0.000 description 1
- 229960000830 captopril Drugs 0.000 description 1
- 231100000749 chronicity Toxicity 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 230000008602 contraction Effects 0.000 description 1
- 230000001276 controlling effect Effects 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 229940124567 diuretic antihypertensive agent Drugs 0.000 description 1
- 239000000890 drug combination Substances 0.000 description 1
- 230000008406 drug-drug interaction Effects 0.000 description 1
- 230000002526 effect on cardiovascular system Effects 0.000 description 1
- 230000008753 endothelial function Effects 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 238000011031 large-scale manufacturing process Methods 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000010534 mechanism of action Effects 0.000 description 1
- 238000002483 medication Methods 0.000 description 1
- 210000005036 nerve Anatomy 0.000 description 1
- 230000008520 organization Effects 0.000 description 1
- 230000008506 pathogenesis Effects 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 230000029547 smooth muscle hypertrophy Effects 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 230000002889 sympathetic effect Effects 0.000 description 1
- 230000002782 sympathoadrenal effect Effects 0.000 description 1
- 210000005239 tubule Anatomy 0.000 description 1
- 230000009441 vascular protection Effects 0.000 description 1
- 238000012795 verification Methods 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
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Priority Applications (1)
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CN2009100703059A CN101632678B (zh) | 2009-09-01 | 2009-09-01 | 一种氯沙坦钾氢氯噻嗪组合物及其制备方法 |
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CN2009100703059A CN101632678B (zh) | 2009-09-01 | 2009-09-01 | 一种氯沙坦钾氢氯噻嗪组合物及其制备方法 |
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CN101632678A true CN101632678A (zh) | 2010-01-27 |
CN101632678B CN101632678B (zh) | 2011-09-14 |
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CN2009100703059A Active CN101632678B (zh) | 2009-09-01 | 2009-09-01 | 一种氯沙坦钾氢氯噻嗪组合物及其制备方法 |
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Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101797230A (zh) * | 2010-04-19 | 2010-08-11 | 王明 | 一种氯沙坦钾氢氯噻嗪药物组合物脂质体固体制剂 |
CN102058602A (zh) * | 2010-12-21 | 2011-05-18 | 中国药科大学 | 一种稳定的含氯沙坦钾和氢氯噻嗪的口服固体制剂 |
CN102475707A (zh) * | 2010-11-26 | 2012-05-30 | 天津市汉康医药生物技术有限公司 | 复方氯沙坦钾氢氯噻嗪药物组合物的制备方法 |
CN103006566A (zh) * | 2012-12-27 | 2013-04-03 | 惠州市九惠制药股份有限公司 | 氯沙坦钾与氢氯噻嗪固体分散体或包合物的渗透泵控释片 |
WO2018145268A1 (zh) * | 2017-02-08 | 2018-08-16 | 上海市第六人民医院 | 降压药在预防和治疗骨坏死中的应用 |
CN111297812A (zh) * | 2020-02-25 | 2020-06-19 | 苏州东瑞制药有限公司 | 一种含有氯沙坦钾的复方制剂及其制备方法 |
Family Cites Families (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
PT2260833E (pt) * | 2002-01-16 | 2012-12-26 | Boehringer Ingelheim Pharma | Comprimido farmacêutico de duas camadas compreendendo telmisartan e um diurético |
WO2006067601A1 (en) * | 2004-12-23 | 2006-06-29 | Ranbaxy Laboratories Limited | Oral pharmaceutical compositions of irbesartan and hydrochlorothiazide and processes for their preparation |
DE602007012692D1 (de) * | 2006-06-16 | 2011-04-07 | Lek Pharmaceuticals | Pharmazeutische zusammensetzung mit hydrochlorothiazid und telmisartan |
PL384680A1 (pl) * | 2007-03-28 | 2008-09-29 | Zak & Lstrok Ady Farmaceutyczn | Kompozycja farmaceutyczna zawierająca kandesartan cyleksetylu oraz sposób jej wytwarzania |
EP2203158A4 (en) * | 2007-10-30 | 2012-12-26 | Reddys Lab Ltd Dr | PHARMACEUTICAL FORMULATIONS WITH TELMISARTAN AND HYDROCHLORTHIAZIDE |
EP2067470A1 (en) * | 2007-12-03 | 2009-06-10 | Laboratorios Lesvi, S.L. | Pharmaceutical compositions containing valsartan and process for its preparation |
-
2009
- 2009-09-01 CN CN2009100703059A patent/CN101632678B/zh active Active
Cited By (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101797230A (zh) * | 2010-04-19 | 2010-08-11 | 王明 | 一种氯沙坦钾氢氯噻嗪药物组合物脂质体固体制剂 |
CN102475707A (zh) * | 2010-11-26 | 2012-05-30 | 天津市汉康医药生物技术有限公司 | 复方氯沙坦钾氢氯噻嗪药物组合物的制备方法 |
CN102475707B (zh) * | 2010-11-26 | 2015-03-11 | 天津市汉康医药生物技术有限公司 | 复方氯沙坦钾氢氯噻嗪药物组合物的制备方法 |
CN102058602A (zh) * | 2010-12-21 | 2011-05-18 | 中国药科大学 | 一种稳定的含氯沙坦钾和氢氯噻嗪的口服固体制剂 |
CN102058602B (zh) * | 2010-12-21 | 2013-04-10 | 中国药科大学 | 一种稳定的含氯沙坦钾和氢氯噻嗪的口服固体制剂 |
CN103006566A (zh) * | 2012-12-27 | 2013-04-03 | 惠州市九惠制药股份有限公司 | 氯沙坦钾与氢氯噻嗪固体分散体或包合物的渗透泵控释片 |
WO2018145268A1 (zh) * | 2017-02-08 | 2018-08-16 | 上海市第六人民医院 | 降压药在预防和治疗骨坏死中的应用 |
CN111297812A (zh) * | 2020-02-25 | 2020-06-19 | 苏州东瑞制药有限公司 | 一种含有氯沙坦钾的复方制剂及其制备方法 |
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Publication number | Publication date |
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CN101632678B (zh) | 2011-09-14 |
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Owner name: TIANJIN HANKANG PHARMACEUTICAL BIOTECHNOLOGY CO., Free format text: FORMER OWNER: YAN JIE Effective date: 20120210 |
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Effective date of registration: 20120210 Address after: 300203, Tianjin Dagu South Road, respect 4, 3, Hexi District Patentee after: Tianjin Hankang Pharmaceutical Biotechnology Co., Ltd. Address before: 300203, Tianjin Dagu South Road, respect 4, 3, Hexi District Patentee before: Yan Jie |
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Application publication date: 20100127 Assignee: Xinxin Pharmaceutical Manufactory, Tianjin Zhongxin Pharmaceutical Group Co., Ltd. Assignor: Tianjin Hankang Pharmaceutical Biotechnology Co., Ltd. Contract record no.: 2012120000078 Denomination of invention: Losartan potassium hydrochlorothiazide composition and preparation method thereof Granted publication date: 20110914 License type: Exclusive License Record date: 20121207 |
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