CN114601816B - 一种羟苯磺酸钙胶囊组合物及其制备方法 - Google Patents
一种羟苯磺酸钙胶囊组合物及其制备方法 Download PDFInfo
- Publication number
- CN114601816B CN114601816B CN202111177147.4A CN202111177147A CN114601816B CN 114601816 B CN114601816 B CN 114601816B CN 202111177147 A CN202111177147 A CN 202111177147A CN 114601816 B CN114601816 B CN 114601816B
- Authority
- CN
- China
- Prior art keywords
- calcium dobesilate
- magnesium stearate
- capsule
- corn starch
- preparation
- 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.)
- Active
Links
- 229960005438 calcium dobesilate Drugs 0.000 title claims abstract description 61
- QGNBTYAQAPLTMX-UHFFFAOYSA-L calcium dobesilate Chemical compound [Ca+2].OC1=CC=C(O)C(S([O-])(=O)=O)=C1.OC1=CC=C(O)C(S([O-])(=O)=O)=C1 QGNBTYAQAPLTMX-UHFFFAOYSA-L 0.000 title claims abstract description 60
- 239000007963 capsule composition Substances 0.000 title claims abstract description 13
- 238000002360 preparation method Methods 0.000 title description 34
- 239000002775 capsule Substances 0.000 claims abstract description 43
- 229920002261 Corn starch Polymers 0.000 claims abstract description 26
- 239000008120 corn starch Substances 0.000 claims abstract description 26
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 16
- 238000001035 drying Methods 0.000 claims abstract description 10
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 68
- 235000019359 magnesium stearate Nutrition 0.000 claims description 34
- 238000002156 mixing Methods 0.000 claims description 27
- 238000011049 filling Methods 0.000 claims description 23
- 238000000034 method Methods 0.000 claims description 21
- 239000000463 material Substances 0.000 claims description 11
- 108010010803 Gelatin Proteins 0.000 claims description 9
- 229920000159 gelatin Polymers 0.000 claims description 9
- 239000008273 gelatin Substances 0.000 claims description 9
- 235000019322 gelatine Nutrition 0.000 claims description 9
- 235000011852 gelatine desserts Nutrition 0.000 claims description 9
- 239000008187 granular material Substances 0.000 claims description 8
- 239000002245 particle Substances 0.000 claims description 7
- 238000004090 dissolution Methods 0.000 abstract description 24
- 239000000314 lubricant Substances 0.000 abstract description 19
- 239000000945 filler Substances 0.000 abstract description 13
- 239000004480 active ingredient Substances 0.000 abstract description 2
- 239000000825 pharmaceutical preparation Substances 0.000 abstract description 2
- 239000000203 mixture Substances 0.000 description 18
- 239000003814 drug Substances 0.000 description 17
- 229940079593 drug Drugs 0.000 description 15
- 238000007908 dry granulation Methods 0.000 description 8
- 230000000052 comparative effect Effects 0.000 description 6
- 238000009472 formulation Methods 0.000 description 6
- 239000000523 sample Substances 0.000 description 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 4
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 4
- 238000004519 manufacturing process Methods 0.000 description 4
- 239000000047 product Substances 0.000 description 4
- 239000000126 substance Substances 0.000 description 4
- 238000005550 wet granulation Methods 0.000 description 4
- 238000005429 filling process Methods 0.000 description 3
- 229920002472 Starch Polymers 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 238000013441 quality evaluation Methods 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 235000019698 starch Nutrition 0.000 description 2
- 239000008107 starch Substances 0.000 description 2
- 206010067484 Adverse reaction Diseases 0.000 description 1
- 206010012689 Diabetic retinopathy Diseases 0.000 description 1
- 206010013710 Drug interaction Diseases 0.000 description 1
- 206010021143 Hypoxia Diseases 0.000 description 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 1
- 229920000881 Modified starch Polymers 0.000 description 1
- 229920002494 Zein Polymers 0.000 description 1
- 239000008186 active pharmaceutical agent Substances 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 230000006838 adverse reaction Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- -1 calcium dobesilate monohydrate Chemical class 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 239000012738 dissolution medium Substances 0.000 description 1
- 238000007922 dissolution test Methods 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 239000000706 filtrate Substances 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 125000002887 hydroxy group Chemical group [H]O* 0.000 description 1
- 230000007954 hypoxia Effects 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 238000009776 industrial production Methods 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 208000028867 ischemia Diseases 0.000 description 1
- 230000003907 kidney function Effects 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 230000003908 liver function Effects 0.000 description 1
- 238000011068 loading method Methods 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 1
- 239000008108 microcrystalline cellulose Substances 0.000 description 1
- 229940016286 microcrystalline cellulose Drugs 0.000 description 1
- 230000007576 microinfarct Effects 0.000 description 1
- 231100000989 no adverse effect Toxicity 0.000 description 1
- 239000003960 organic solvent Substances 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N phenol group Chemical group C1(=CC=CC=C1)O ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 description 1
- 238000005498 polishing Methods 0.000 description 1
- 239000011251 protective drug Substances 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 239000012488 sample solution Substances 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 230000001502 supplementing effect Effects 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
- 239000005019 zein Substances 0.000 description 1
- 229940093612 zein Drugs 0.000 description 1
Classifications
-
- 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
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
-
- 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
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
-
- 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
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Diabetes (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Obesity (AREA)
- Emergency Medicine (AREA)
- Hematology (AREA)
- Endocrinology (AREA)
- Urology & Nephrology (AREA)
- Vascular Medicine (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Description
Claims (3)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202111177147.4A CN114601816B (zh) | 2021-10-09 | 2021-10-09 | 一种羟苯磺酸钙胶囊组合物及其制备方法 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202111177147.4A CN114601816B (zh) | 2021-10-09 | 2021-10-09 | 一种羟苯磺酸钙胶囊组合物及其制备方法 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN114601816A CN114601816A (zh) | 2022-06-10 |
CN114601816B true CN114601816B (zh) | 2022-09-02 |
Family
ID=81857706
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN202111177147.4A Active CN114601816B (zh) | 2021-10-09 | 2021-10-09 | 一种羟苯磺酸钙胶囊组合物及其制备方法 |
Country Status (1)
Country | Link |
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CN (1) | CN114601816B (zh) |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN104434873A (zh) * | 2014-11-18 | 2015-03-25 | 成都医路康医学技术服务有限公司 | 一种羟苯磺酸钙胶囊 |
Family Cites Families (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ES2208124B1 (es) * | 2002-11-29 | 2005-10-01 | Laboratorios Del Dr. Esteve, S.A. | Uso de los compuestos 2,5-dihidroxibencenosulfonicos para la fabricacion de un medicamento. |
ES2222831B2 (es) * | 2003-07-30 | 2006-02-16 | Laboratorios Del Dr. Esteve, S.A. | Combinacion de principio activo que comprende un compuesto 2,5-dihidroxibencenosulfonico y un modulador de los canales de k+. |
CN104622842B (zh) * | 2014-12-23 | 2017-06-06 | 北京京丰制药集团有限公司 | 一种羟苯磺酸钙胶囊及其制备方法 |
CN106619564A (zh) * | 2016-12-23 | 2017-05-10 | 北京满格医药科技有限公司 | 一种羟苯磺酸钙胶囊及制备方法 |
ES2680293B1 (es) * | 2017-02-22 | 2019-08-22 | Belac Invest S L | Composición farmacéutica que comprende ácido 2,5 - dihidroxibencenosulfónico o una de sus sales farmacéuticamente aceptables en forma de unidades individualizadas de suministro y procedimiento de fabricación correspondiente |
-
2021
- 2021-10-09 CN CN202111177147.4A patent/CN114601816B/zh active Active
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN104434873A (zh) * | 2014-11-18 | 2015-03-25 | 成都医路康医学技术服务有限公司 | 一种羟苯磺酸钙胶囊 |
Also Published As
Publication number | Publication date |
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CN114601816A (zh) | 2022-06-10 |
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Legal Events
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PB01 | Publication | ||
PB01 | Publication | ||
SE01 | Entry into force of request for substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
GR01 | Patent grant | ||
GR01 | Patent grant | ||
CP01 | Change in the name or title of a patent holder |
Address after: 100025 1703, 14th floor, No.97 Sili, Balizhuang, Chaoyang District, Beijing Patentee after: Beijing huizhiheng Biotechnology Co.,Ltd. Patentee after: Jilin Huisheng Biopharmaceutical Co.,Ltd. Address before: 100025 1703, 14th floor, No.97 Sili, Balizhuang, Chaoyang District, Beijing Patentee before: Beijing huizhiheng Biotechnology Co.,Ltd. Patentee before: Jilin Huisheng biopharmaceutical Co.,Ltd. |
|
CP01 | Change in the name or title of a patent holder | ||
PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: A calcium hydroxybenzenesulfonate capsule composition and its preparation method Effective date of registration: 20231013 Granted publication date: 20220902 Pledgee: Jilin Bank Co.,Ltd. Tonghua Meihekou Branch Pledgor: Jilin Huisheng Biopharmaceutical Co.,Ltd. Registration number: Y2023220000102 |
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PC01 | Cancellation of the registration of the contract for pledge of patent right | ||
PC01 | Cancellation of the registration of the contract for pledge of patent right |
Granted publication date: 20220902 Pledgee: Jilin Bank Co.,Ltd. Tonghua Meihekou Branch Pledgor: Jilin Huisheng Biopharmaceutical Co.,Ltd. Registration number: Y2023220000102 |
|
PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: A calcium hydroxybenzenesulfonate capsule composition and its preparation method Granted publication date: 20220902 Pledgee: Industrial and Commercial Bank of China Limited Meihekou Branch Pledgor: Jilin Huisheng Biopharmaceutical Co.,Ltd. Registration number: Y2024220000070 |