CO6160301A2 - Preparacion solida que contiene alogliptina y clorhidrato de metformina - Google Patents
Preparacion solida que contiene alogliptina y clorhidrato de metforminaInfo
- Publication number
- CO6160301A2 CO6160301A2 CO10019969A CO10019969A CO6160301A2 CO 6160301 A2 CO6160301 A2 CO 6160301A2 CO 10019969 A CO10019969 A CO 10019969A CO 10019969 A CO10019969 A CO 10019969A CO 6160301 A2 CO6160301 A2 CO 6160301A2
- Authority
- CO
- Colombia
- Prior art keywords
- solid preparation
- methyl
- metformin hydrochloride
- salts
- substantially free
- Prior art date
Links
- 238000002360 preparation method Methods 0.000 title abstract 8
- 239000007787 solid Substances 0.000 title abstract 8
- XZWYZXLIPXDOLR-UHFFFAOYSA-N metformin Chemical compound CN(C)C(=N)NC(N)=N XZWYZXLIPXDOLR-UHFFFAOYSA-N 0.000 title abstract 7
- ZSBOMTDTBDDKMP-OAHLLOKOSA-N alogliptin Chemical compound C=1C=CC=C(C#N)C=1CN1C(=O)N(C)C(=O)C=C1N1CCC[C@@H](N)C1 ZSBOMTDTBDDKMP-OAHLLOKOSA-N 0.000 title 1
- 229960003105 metformin Drugs 0.000 title 1
- 229960004329 metformin hydrochloride Drugs 0.000 abstract 6
- OETHQSJEHLVLGH-UHFFFAOYSA-N metformin hydrochloride Chemical compound Cl.CN(C)C(=N)N=C(N)N OETHQSJEHLVLGH-UHFFFAOYSA-N 0.000 abstract 6
- 150000003839 salts Chemical class 0.000 abstract 6
- 150000001875 compounds Chemical class 0.000 abstract 4
- ZSBOMTDTBDDKMP-UHFFFAOYSA-N 2-[[6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxopyrimidin-1-yl]methyl]benzonitrile Chemical compound C=1C=CC=C(C#N)C=1CN1C(=O)N(C)C(=O)C=C1N1CCCC(N)C1 ZSBOMTDTBDDKMP-UHFFFAOYSA-N 0.000 abstract 3
- 239000002245 particle Substances 0.000 abstract 2
- 239000000654 additive Substances 0.000 abstract 1
- 230000000996 additive effect Effects 0.000 abstract 1
- 206010012601 diabetes mellitus Diseases 0.000 abstract 1
- 238000004321 preservation Methods 0.000 abstract 1
- 229940126585 therapeutic drug Drugs 0.000 abstract 1
Classifications
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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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K31/13—Amines
- A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/513—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
-
- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
-
- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
-
- 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
- A61K9/2833—Organic macromolecular compounds
- A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
-
- 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
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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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
-
- 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
- A61P3/06—Antihyperlipidemics
-
- 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
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- 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
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Diabetes (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Child & Adolescent Psychology (AREA)
- Endocrinology (AREA)
- Emergency Medicine (AREA)
- Vascular Medicine (AREA)
- Urology & Nephrology (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
La presente invención proporciona una preparación sólida que contiene el compuesto (I) [el compuesto (I) es como se define en la memoria descriptiva] o una de sus sales, y clorhidrato de metformina, que es útil como fármaco terapéutico para diabetes y similares y superior en la estabilidad de preservación. Una preparación sólida que tiene una primera parte y una segunda parte: una primera parte: una parte que contiene un compuesto (I) o una de sus sales y está sustancialmente libre de clorhidrato de metformina; una segunda parte: una parte que contiene clorhidrato de metformina y está sustancialmente libre del compuesto (I) y una de sus sales. 1.- Una preparación sólida caracterizada porque comprende la primera y la segunda parte siguientes; primera parte: una parte que comprende 2-[[6-[(3R)-3-amino-1-piperidinil]-3,4-dihidro-3-metil-2,4-dioxo-1(2H)-pirimidinil]metil]benzonitrilo o una de sus sales y está sustancialmente libre de clorhidrato de metformina segunda parte: una parte que comprende clorhidrato de metformina y está sustancialmente libre de 2-[[6-[(3R)-3- amino-1-piperidinil]-3,4-dihidro-3-metil-2,4-dioxo-1(2H)-pirimidinil]metil]benzonitrilo y una de sus sales. 2.- La preparación sólida tal y como se describe en la reivindicación 1, caracterizada porque además comprende un aditivo. 3.- La preparación sólida tal y como se describe en la reivindicación 2, caracterizada porque comprende aproximadamente 0.5 - 200 mg de 2-[[6-[(3R)-3-amino-1- piperidinil]-3,4-dihidro-3-metil-2,4-dioxo-1(2H)-pirimidinil] metil]benzonitrilo o una de sus sales, y aproximadamente 0.1 hasta aproximadamente 2 g de clorhidrato de metformina. 4.- La preparación sólida tal y como se describe en la reivindicación 2, caracterizada porque comprende la primera parte con un diámetro más corto de no menos de aproximadamente 100 µm en al menos una parte, y la segunda parte con un diámetro más corto de no menos de aproximadamente 100 µm en al menos una parte. 5.- La preparación sólida tal y como se describe en la reivindicación 2, caracterizada porque la primera parte tiene un tamaño de partícula promedio de no menos de aproximadamente 75 µm, y la segunda parte tiene un tamaño de partícula promedio de no menos de aproximadamente 75 µm.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2007188574 | 2007-07-19 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CO6160301A2 true CO6160301A2 (es) | 2010-05-20 |
Family
ID=39930391
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CO10019969A CO6160301A2 (es) | 2007-07-19 | 2010-02-19 | Preparacion solida que contiene alogliptina y clorhidrato de metformina |
Country Status (27)
| Country | Link |
|---|---|
| US (1) | US8900638B2 (es) |
| EP (1) | EP2185138B1 (es) |
| JP (2) | JP5479318B2 (es) |
| KR (1) | KR101536786B1 (es) |
| CN (1) | CN101801351B (es) |
| AR (1) | AR067557A1 (es) |
| AU (1) | AU2008276842C9 (es) |
| BR (1) | BRPI0814299B8 (es) |
| CA (1) | CA2694620C (es) |
| CO (1) | CO6160301A2 (es) |
| CR (1) | CR11267A (es) |
| DO (1) | DOP2010000028A (es) |
| EA (1) | EA020870B1 (es) |
| EC (1) | ECSP109979A (es) |
| ES (1) | ES2603879T3 (es) |
| GE (1) | GEP20125672B (es) |
| IL (1) | IL203171A (es) |
| JO (1) | JO3272B1 (es) |
| MA (1) | MA31592B1 (es) |
| MY (1) | MY159203A (es) |
| NZ (1) | NZ583346A (es) |
| PE (2) | PE20090882A1 (es) |
| TN (1) | TN2010000019A1 (es) |
| TW (1) | TWI421102B (es) |
| UA (1) | UA98799C2 (es) |
| WO (1) | WO2009011451A1 (es) |
| ZA (1) | ZA201000831B (es) |
Families Citing this family (55)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7407955B2 (en) | 2002-08-21 | 2008-08-05 | Boehringer Ingelheim Pharma Gmbh & Co., Kg | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions |
| DE102004054054A1 (de) | 2004-11-05 | 2006-05-11 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Verfahren zur Herstellung chiraler 8-(3-Amino-piperidin-1-yl)-xanthine |
| PE20080251A1 (es) | 2006-05-04 | 2008-04-25 | Boehringer Ingelheim Int | Usos de inhibidores de dpp iv |
| EP1852108A1 (en) | 2006-05-04 | 2007-11-07 | Boehringer Ingelheim Pharma GmbH & Co.KG | DPP IV inhibitor formulations |
| MX2008014024A (es) | 2006-05-04 | 2008-11-14 | Boehringer Ingelheim Int | Formas poliformas. |
| JO3272B1 (ar) * | 2007-07-19 | 2018-09-16 | Takeda Pharmaceuticals Co | مستحضر صلب يشمل ألوجليبتين وميتفورمين هيدروكلوريد |
| JP4989733B2 (ja) | 2008-02-13 | 2012-08-01 | 大日本住友製薬株式会社 | 口腔内崩壊錠 |
| PE20091730A1 (es) | 2008-04-03 | 2009-12-10 | Boehringer Ingelheim Int | Formulaciones que comprenden un inhibidor de dpp4 |
| BRPI0916997A2 (pt) | 2008-08-06 | 2020-12-15 | Boehringer Ingelheim International Gmbh | Inibidor de dpp-4 e seu uso |
| UY32030A (es) | 2008-08-06 | 2010-03-26 | Boehringer Ingelheim Int | "tratamiento para diabetes en pacientes inapropiados para terapia con metformina" |
| MY164581A (en) | 2008-08-15 | 2018-01-15 | Boehringer Ingelheim Int | Purin derivatives for use in the treatment of fab-related diseases |
| UY32126A (es) * | 2008-09-25 | 2010-04-30 | Takeda Pharmaceutical | Composición farmacéutica sólida |
| US20200155558A1 (en) | 2018-11-20 | 2020-05-21 | Boehringer Ingelheim International Gmbh | Treatment for diabetes in patients with insufficient glycemic control despite therapy with an oral antidiabetic drug |
| TW201036975A (en) | 2009-01-07 | 2010-10-16 | Boehringer Ingelheim Int | Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy |
| TWI466672B (zh) | 2009-01-29 | 2015-01-01 | Boehringer Ingelheim Int | 小兒科病人糖尿病之治療 |
| EA029759B1 (ru) | 2009-02-13 | 2018-05-31 | Бёрингер Ингельхайм Интернациональ Гмбх | Антидиабетические лекарственные средства, содержащие ингибитор dpp-4 (линаглиптин) необязательно в комбинации с другими антидиабетическими средствами |
| CN102361557A (zh) | 2009-03-26 | 2012-02-22 | Mapi医药公司 | 制备阿格列汀的方法 |
| CA2758812C (en) * | 2009-05-13 | 2015-03-31 | Wyeth Llc | Method to stabilize a dietary supplement comprising glucosamine |
| ES2693686T3 (es) | 2009-11-13 | 2018-12-13 | Astrazeneca Ab | Formulaciones de comprimidos de liberación inmediata |
| WO2011060256A2 (en) | 2009-11-13 | 2011-05-19 | Bristol-Myers Squibb Company | Bilayer tablet formulations |
| EP3646859A1 (en) | 2009-11-27 | 2020-05-06 | Boehringer Ingelheim International GmbH | Treatment of genotyped diabetic patients with dpp-iv inhibitors such as linagliptin |
| US20130109703A1 (en) | 2010-03-18 | 2013-05-02 | Boehringer Ingelheim International Gmbh | Combination of a GPR119 Agonist and the DPP-IV Inhibitor Linagliptin for Use in the Treatment of Diabetes and Related Conditions |
| AU2011249722B2 (en) | 2010-05-05 | 2015-09-17 | Boehringer Ingelheim International Gmbh | Combination therapy |
| EP2568985A4 (en) * | 2010-05-12 | 2013-10-23 | Mapi Pharma Ltd | ALOGLIPTINBENZOAT-POLYMORPHS |
| CN106975074A (zh) | 2010-06-24 | 2017-07-25 | 勃林格殷格翰国际有限公司 | 糖尿病治疗 |
| JP2012051832A (ja) * | 2010-08-31 | 2012-03-15 | Fancl Corp | 顆粒組成物及びそれを含有する食品又は医薬品 |
| AR083878A1 (es) | 2010-11-15 | 2013-03-27 | Boehringer Ingelheim Int | Terapia antidiabetica vasoprotectora y cardioprotectora, linagliptina, metodo de tratamiento |
| WO2013077825A1 (en) * | 2011-11-23 | 2013-05-30 | Mahmut Bilgic | Preparation process for a formulation comprising metformin |
| WO2013171167A1 (en) | 2012-05-14 | 2013-11-21 | Boehringer Ingelheim International Gmbh | A xanthine derivative as dpp -4 inhibitor for use in the treatment of podocytes related disorders and/or nephrotic syndrome |
| US20130303554A1 (en) | 2012-05-14 | 2013-11-14 | Boehringer Ingelheim International Gmbh | Use of a dpp-4 inhibitor in sirs and/or sepsis |
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| EP2890370B1 (en) | 2012-08-31 | 2019-10-09 | The Regents of the University of California | Agents useful for treating obesity, diabetes and related disorders |
| CN103877054B (zh) * | 2012-12-21 | 2016-05-25 | 北大方正集团有限公司 | 一种苯甲酸阿格列汀片剂及其制备方法 |
| EP2769712A1 (en) * | 2013-02-21 | 2014-08-27 | Siegfried International AG | Pharmaceutical formulation comprising DPP-IV inhibitor agglomerates and DPP-IV inhibitor particles |
| CN103353491B (zh) * | 2013-06-29 | 2018-11-16 | 北京万全德众医药生物技术有限公司 | 一种用液相色谱法分离测定苯甲酸阿格列汀原料及其制剂的方法 |
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| CN104749269B (zh) * | 2013-12-31 | 2018-12-28 | 中美华世通生物医药科技（武汉）有限公司 | 一种利用hplc测定阿格列汀原料药及制剂中对映异构体杂质的方法 |
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