CN105920016B - 一种头孢氨苄片剂组合物 - Google Patents
一种头孢氨苄片剂组合物 Download PDFInfo
- Publication number
- CN105920016B CN105920016B CN201610470724.1A CN201610470724A CN105920016B CN 105920016 B CN105920016 B CN 105920016B CN 201610470724 A CN201610470724 A CN 201610470724A CN 105920016 B CN105920016 B CN 105920016B
- Authority
- CN
- China
- Prior art keywords
- cefalexin
- magnesium silicate
- aluminum magnesium
- starch
- lactose
- 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.)
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Links
- ZAIPMKNFIOOWCQ-UEKVPHQBSA-N cephalexin Chemical compound C1([C@@H](N)C(=O)N[C@H]2[C@@H]3N(C2=O)C(=C(CS3)C)C(O)=O)=CC=CC=C1 ZAIPMKNFIOOWCQ-UEKVPHQBSA-N 0.000 title claims abstract description 43
- 229940106164 cephalexin Drugs 0.000 title claims abstract description 43
- 239000007916 tablet composition Substances 0.000 title claims abstract description 9
- 229940009868 aluminum magnesium silicate Drugs 0.000 claims abstract description 31
- WMGSQTMJHBYJMQ-UHFFFAOYSA-N aluminum;magnesium;silicate Chemical compound [Mg+2].[Al+3].[O-][Si]([O-])([O-])[O-] WMGSQTMJHBYJMQ-UHFFFAOYSA-N 0.000 claims abstract description 31
- 238000002360 preparation method Methods 0.000 claims abstract description 14
- 239000000463 material Substances 0.000 claims abstract description 13
- 239000000203 mixture Substances 0.000 claims abstract description 9
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 32
- 229920002472 Starch Polymers 0.000 claims description 23
- 239000008107 starch Substances 0.000 claims description 23
- 235000019698 starch Nutrition 0.000 claims description 23
- 235000019359 magnesium stearate Nutrition 0.000 claims description 16
- 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 description 15
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 15
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 15
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 15
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 15
- 239000008101 lactose Substances 0.000 claims description 15
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 9
- 239000011734 sodium Substances 0.000 claims description 9
- 229910052708 sodium Inorganic materials 0.000 claims description 9
- 238000000227 grinding Methods 0.000 claims description 4
- 239000002245 particle Substances 0.000 claims description 4
- 238000004806 packaging method and process Methods 0.000 claims description 3
- 239000003795 chemical substances by application Substances 0.000 abstract description 4
- 238000007908 dry granulation Methods 0.000 abstract description 3
- 239000000853 adhesive Substances 0.000 abstract description 2
- 230000001070 adhesive effect Effects 0.000 abstract description 2
- 239000000945 filler Substances 0.000 abstract description 2
- 239000000314 lubricant Substances 0.000 abstract description 2
- 238000004519 manufacturing process Methods 0.000 abstract description 2
- 229940032147 starch Drugs 0.000 description 15
- 239000002775 capsule Substances 0.000 description 7
- 229940080313 sodium starch Drugs 0.000 description 6
- 238000004090 dissolution Methods 0.000 description 5
- 239000000126 substance Substances 0.000 description 5
- 241000894006 Bacteria Species 0.000 description 4
- 239000008187 granular material Substances 0.000 description 4
- 238000000034 method Methods 0.000 description 3
- 239000000047 product Substances 0.000 description 3
- 229930006000 Sucrose Natural products 0.000 description 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 2
- 230000000844 anti-bacterial effect Effects 0.000 description 2
- 235000013339 cereals Nutrition 0.000 description 2
- 230000000052 comparative effect Effects 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- DKXULEFCEORBJK-UHFFFAOYSA-N magnesium;octadecanoic acid Chemical compound [Mg].CCCCCCCCCCCCCCCCCC(O)=O DKXULEFCEORBJK-UHFFFAOYSA-N 0.000 description 2
- 230000000873 masking effect Effects 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- 239000005720 sucrose Substances 0.000 description 2
- 206010002383 Angina Pectoris Diseases 0.000 description 1
- 229930186147 Cephalosporin Natural products 0.000 description 1
- 206010035664 Pneumonia Diseases 0.000 description 1
- 206010062255 Soft tissue infection Diseases 0.000 description 1
- 206010001093 acute tonsillitis Diseases 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- 229910021529 ammonia Inorganic materials 0.000 description 1
- QGZKDVFQNNGYKY-UHFFFAOYSA-N ammonia Natural products N QGZKDVFQNNGYKY-UHFFFAOYSA-N 0.000 description 1
- 230000003115 biocidal effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 206010006451 bronchitis Diseases 0.000 description 1
- 210000002421 cell wall Anatomy 0.000 description 1
- 230000001413 cellular effect Effects 0.000 description 1
- 229940124587 cephalosporin Drugs 0.000 description 1
- 150000001780 cephalosporins Chemical class 0.000 description 1
- 238000004581 coalescence Methods 0.000 description 1
- 238000010960 commercial process Methods 0.000 description 1
- 239000013065 commercial product Substances 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- 230000029087 digestion Effects 0.000 description 1
- 239000012738 dissolution medium Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 239000012535 impurity Substances 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 238000000691 measurement method Methods 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 239000008363 phosphate buffer Substances 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 208000025301 tympanitis Diseases 0.000 description 1
- 208000019206 urinary tract infection Diseases 0.000 description 1
- 235000020985 whole grains Nutrition 0.000 description 1
Classifications
-
- 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
- A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
- A61K31/542—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with heterocyclic ring systems
- A61K31/545—Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine
-
- 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
- A61K9/2009—Inorganic compounds
-
- 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
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
对照例1 | 实施例1 | 实施例2 | 实施例3 | 实施例4 | 实施例5 | 实施例6 | |
臭味 | 重 | 淡 | 几乎无 | 几乎无 | 几乎无 | 几乎无 | 几乎无 |
休止角(°) | 45.3 | 38.7 | 32.3 | 28.9 | 30.6 | 29.8 | 34.5 |
40目筛粒粉比 | 1:3.3 | 1.5:1 | 2.8:1 | 3.0:1 | 3.1:1 | 2.8:1 | 2.2:1 |
对照例1 | 实施例1 | 实施例2 | 实施例3 | 实施例4 | 实施例5 | 实施例6 | |
室温,0天 | 95.64 | 98.86 | 99.86 | 99.37 | 99.58 | 99.62 | 99.73 |
60℃,10天 | 90.32 | 97.56 | 98.56 | 98.62 | 98.78 | 98.82 | 97.98 |
对照例1 | 实施例1 | 实施例2 | 实施例3 | 实施例4 | 实施例5 | 实施例6 | |
0天 | 0.253 | 0.237 | 0.241 | 0.238 | 0.240 | 0.237 | 0.236 |
60℃,5天 | 0.321 | 0.253 | 0.257 | 0.379 | 0.256 | 0.248 | 0.253 |
60℃,10天 | 0.644 | 0.310 | 0.321 | 0.510 | 0.303 | 0.299 | 0.306 |
Claims (5)
Priority Applications (1)
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CN201610470724.1A CN105920016B (zh) | 2016-06-27 | 2016-06-27 | 一种头孢氨苄片剂组合物 |
Applications Claiming Priority (1)
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CN201610470724.1A CN105920016B (zh) | 2016-06-27 | 2016-06-27 | 一种头孢氨苄片剂组合物 |
Publications (2)
Publication Number | Publication Date |
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CN105920016A CN105920016A (zh) | 2016-09-07 |
CN105920016B true CN105920016B (zh) | 2019-06-07 |
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CN201610470724.1A Active CN105920016B (zh) | 2016-06-27 | 2016-06-27 | 一种头孢氨苄片剂组合物 |
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CN (1) | CN105920016B (zh) |
Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN110613697A (zh) * | 2019-10-30 | 2019-12-27 | 长春迪瑞制药有限公司 | 一种头孢氨苄胶囊及制备方法 |
CN111956622B (zh) * | 2020-09-15 | 2022-11-15 | 北京福元医药股份有限公司 | 一种达格列净丙二醇水合物药物制剂 |
CN112206217A (zh) * | 2020-10-21 | 2021-01-12 | 迪沙药业集团有限公司 | 一种头孢拉定药物组合物及其制备方法 |
CN112451491A (zh) * | 2020-12-03 | 2021-03-09 | 迪沙药业集团有限公司 | 一种头孢氨苄颗粒药物合物 |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105106166A (zh) * | 2015-09-17 | 2015-12-02 | 华北制药河北华民药业有限责任公司 | 一种头孢氨苄片及其制备方法 |
-
2016
- 2016-06-27 CN CN201610470724.1A patent/CN105920016B/zh active Active
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105106166A (zh) * | 2015-09-17 | 2015-12-02 | 华北制药河北华民药业有限责任公司 | 一种头孢氨苄片及其制备方法 |
Also Published As
Publication number | Publication date |
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Legal Events
Date | Code | Title | Description |
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C06 | 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 | ||
TR01 | Transfer of patent right |
Effective date of registration: 20191114 Address after: 264205 No. 1 South Qingdao Road, Weihai economic and Technological Development Zone, Shandong, China Co-patentee after: Dijia Pharmaceutical Group Co.,Ltd. Patentee after: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Co-patentee after: WEIHAI DISU PHARMACEUTICAL Co.,Ltd. Address before: 264205 No. 1 South Qingdao Road, Weihai economic and Technological Development Zone, Shandong, China Co-patentee before: WEIHAI DISU PHARMACEUTICAL Co.,Ltd. Patentee before: DISHA PHARMACEUTICAL GROUP Co.,Ltd. |
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TR01 | Transfer of patent right | ||
TR01 | Transfer of patent right |
Effective date of registration: 20210707 Address after: No.1 Qingdao South Road, Weihai Economic and Technological Development Zone, Shandong Province Patentee after: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Patentee after: Dijia Pharmaceutical Group Co.,Ltd. Address before: No.1 Qingdao South Road, Weihai Economic and Technological Development Zone, Shandong Province Patentee before: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Patentee before: Dijia Pharmaceutical Group Co.,Ltd. Patentee before: WEIHAI DISU PHARMACEUTICAL Co.,Ltd. |
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TR01 | Transfer of patent right | ||
PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: Cephalexin tablet composition Effective date of registration: 20220721 Granted publication date: 20190607 Pledgee: Bank of China Limited Weihai Branch Pledgor: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Registration number: Y2022980010828 |
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PE01 | Entry into force of the registration of the contract for pledge of patent right |