CN114601816A - 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
- CN114601816A CN114601816A CN202111177147.4A CN202111177147A CN114601816A CN 114601816 A CN114601816 A CN 114601816A CN 202111177147 A CN202111177147 A CN 202111177147A CN 114601816 A CN114601816 A CN 114601816A
- Authority
- CN
- China
- Prior art keywords
- calcium dobesilate
- composition
- 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.)
- Granted
Links
- 229960005438 calcium dobesilate Drugs 0.000 title claims abstract description 66
- 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 65
- 239000007963 capsule composition Substances 0.000 title claims abstract description 13
- 238000002360 preparation method Methods 0.000 title claims description 36
- 239000002775 capsule Substances 0.000 claims abstract description 41
- 239000000314 lubricant Substances 0.000 claims abstract description 27
- 229920002261 Corn starch Polymers 0.000 claims abstract description 26
- 239000008120 corn starch Substances 0.000 claims abstract description 26
- 239000000945 filler Substances 0.000 claims abstract description 19
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 17
- 238000001035 drying Methods 0.000 claims abstract description 10
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical group [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 64
- 235000019359 magnesium stearate Nutrition 0.000 claims description 32
- 238000002156 mixing Methods 0.000 claims description 27
- 239000000203 mixture Substances 0.000 claims description 26
- 238000011049 filling Methods 0.000 claims description 23
- 238000000034 method Methods 0.000 claims description 19
- 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
- 239000002245 particle Substances 0.000 claims description 8
- 238000004090 dissolution Methods 0.000 abstract description 24
- 239000004480 active ingredient Substances 0.000 abstract description 2
- 239000000825 pharmaceutical preparation Substances 0.000 abstract description 2
- 239000003814 drug Substances 0.000 description 16
- 229940079593 drug Drugs 0.000 description 14
- 238000007908 dry granulation Methods 0.000 description 8
- 239000008187 granular material Substances 0.000 description 7
- 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
- 206010002660 Anoxia Diseases 0.000 description 1
- 241000976983 Anoxia Species 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
- 230000007953 anoxia 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
- 238000012377 drug delivery 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
- 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
Abstract
Description
Claims (9)
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)
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---|---|---|---|
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 true CN114601816A (zh) | 2022-06-10 |
CN114601816B CN114601816B (zh) | 2022-09-02 |
Family
ID=81857706
Family Applications (1)
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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 |
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Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1744891A (zh) * | 2002-11-29 | 2006-03-08 | 埃斯特韦实验室有限公司 | 2,5-二羟基苯磺酸化合物在治疗以减损一氧化氮产生和/或减损edhf功能调节为基础的疾病中的用途 |
CN1826107A (zh) * | 2003-07-30 | 2006-08-30 | 埃斯特韦实验室有限公司 | 含2,5-二羟基苯磺酸化合物和钾离子通道调制剂的活性物质组合物 |
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 |
CN104622842A (zh) * | 2014-12-23 | 2015-05-20 | 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 |
CN110290784A (zh) * | 2017-02-22 | 2019-09-27 | 博拉克投资有限公司 | 呈个性化供应单元形式的包含2,5-二羟基苯磺酸或其药学上可接受的盐的药物组合物和相应的制造方法 |
-
2021
- 2021-10-09 CN CN202111177147.4A patent/CN114601816B/zh active Active
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1744891A (zh) * | 2002-11-29 | 2006-03-08 | 埃斯特韦实验室有限公司 | 2,5-二羟基苯磺酸化合物在治疗以减损一氧化氮产生和/或减损edhf功能调节为基础的疾病中的用途 |
CN1826107A (zh) * | 2003-07-30 | 2006-08-30 | 埃斯特韦实验室有限公司 | 含2,5-二羟基苯磺酸化合物和钾离子通道调制剂的活性物质组合物 |
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 |
CN104622842A (zh) * | 2014-12-23 | 2015-05-20 | 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 |
CN110290784A (zh) * | 2017-02-22 | 2019-09-27 | 博拉克投资有限公司 | 呈个性化供应单元形式的包含2,5-二羟基苯磺酸或其药学上可接受的盐的药物组合物和相应的制造方法 |
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CN114601816B (zh) | 2022-09-02 |
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Legal Events
Date | Code | Title | Description |
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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. |
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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 |
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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PE01 | Entry into force 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 |