CN103127030B - Propylene glycol alginate sodium sulfate enteric capsule and preparation method thereof - Google Patents
Propylene glycol alginate sodium sulfate enteric capsule and preparation method thereof Download PDFInfo
- Publication number
- CN103127030B CN103127030B CN201310093377.1A CN201310093377A CN103127030B CN 103127030 B CN103127030 B CN 103127030B CN 201310093377 A CN201310093377 A CN 201310093377A CN 103127030 B CN103127030 B CN 103127030B
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- CN
- China
- Prior art keywords
- propylene glycol
- sodium sulfate
- enteric
- glycol alginate
- alginate sodium
- 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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- HDSBZMRLPLPFLQ-UHFFFAOYSA-N Propylene glycol alginate Chemical compound OC1C(O)C(OC)OC(C(O)=O)C1OC1C(O)C(O)C(C)C(C(=O)OCC(C)O)O1 HDSBZMRLPLPFLQ-UHFFFAOYSA-N 0.000 title claims abstract description 67
- PMZURENOXWZQFD-UHFFFAOYSA-L Sodium Sulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=O PMZURENOXWZQFD-UHFFFAOYSA-L 0.000 title claims abstract description 67
- 239000000770 propane-1,2-diol alginate Substances 0.000 title claims abstract description 67
- 235000010409 propane-1,2-diol alginate Nutrition 0.000 title claims abstract description 67
- 229910052938 sodium sulfate Inorganic materials 0.000 title claims abstract description 67
- 235000011152 sodium sulphate Nutrition 0.000 title claims abstract description 67
- 239000002775 capsule Substances 0.000 title claims abstract description 43
- 238000002360 preparation method Methods 0.000 title claims abstract description 18
- 239000008188 pellet Substances 0.000 claims abstract description 17
- 239000000463 material Substances 0.000 claims abstract description 14
- 239000002702 enteric coating Substances 0.000 claims abstract description 9
- 238000009505 enteric coating Methods 0.000 claims abstract description 9
- 239000000945 filler Substances 0.000 claims abstract description 8
- 239000004014 plasticizer Substances 0.000 claims abstract description 8
- 229920000623 Cellulose acetate phthalate Polymers 0.000 claims description 16
- 229940081734 cellulose acetate phthalate Drugs 0.000 claims description 16
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 12
- 235000010443 alginic acid Nutrition 0.000 claims description 12
- 229920000615 alginic acid Polymers 0.000 claims description 12
- 229910052708 sodium Inorganic materials 0.000 claims description 12
- 239000011734 sodium Substances 0.000 claims description 12
- FHVDTGUDJYJELY-UHFFFAOYSA-N 6-{[2-carboxy-4,5-dihydroxy-6-(phosphanyloxy)oxan-3-yl]oxy}-4,5-dihydroxy-3-phosphanyloxane-2-carboxylic acid Chemical compound O1C(C(O)=O)C(P)C(O)C(O)C1OC1C(C(O)=O)OC(OP)C(O)C1O FHVDTGUDJYJELY-UHFFFAOYSA-N 0.000 claims description 11
- 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 11
- 229940072056 alginate Drugs 0.000 claims description 11
- 150000005690 diesters Chemical class 0.000 claims description 11
- 239000007788 liquid Substances 0.000 claims description 6
- 239000000203 mixture Substances 0.000 claims description 6
- 239000011230 binding agent Substances 0.000 claims description 3
- 239000012467 final product Substances 0.000 claims description 3
- DOOTYTYQINUNNV-UHFFFAOYSA-N Triethyl citrate Chemical group CCOC(=O)CC(O)(C(=O)OCC)CC(=O)OCC DOOTYTYQINUNNV-UHFFFAOYSA-N 0.000 claims description 2
- 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 claims description 2
- 125000000311 mannosyl group Chemical group C1([C@@H](O)[C@@H](O)[C@H](O)[C@H](O1)CO)* 0.000 claims description 2
- 238000000034 method Methods 0.000 claims description 2
- 239000001069 triethyl citrate Substances 0.000 claims description 2
- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 claims description 2
- 235000013769 triethyl citrate Nutrition 0.000 claims description 2
- 230000000694 effects Effects 0.000 abstract description 8
- 239000010410 layer Substances 0.000 abstract 3
- 239000003795 chemical substances by application Substances 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 239000012530 fluid Substances 0.000 description 12
- 230000000968 intestinal effect Effects 0.000 description 12
- 238000004090 dissolution Methods 0.000 description 10
- 239000003814 drug Substances 0.000 description 9
- 230000002496 gastric effect Effects 0.000 description 7
- -1 Sodium Diester Chemical class 0.000 description 4
- 239000002253 acid Substances 0.000 description 4
- 238000011835 investigation Methods 0.000 description 4
- 210000004369 blood Anatomy 0.000 description 3
- 239000008280 blood Substances 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- 239000002671 adjuvant Substances 0.000 description 2
- 239000011248 coating agent Substances 0.000 description 2
- 238000000576 coating method Methods 0.000 description 2
- 208000029078 coronary artery disease Diseases 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 229940096978 oral tablet Drugs 0.000 description 2
- 239000007935 oral tablet Substances 0.000 description 2
- 229920001282 polysaccharide Polymers 0.000 description 2
- 239000005017 polysaccharide Substances 0.000 description 2
- 208000002874 Acne Vulgaris Diseases 0.000 description 1
- 206010065559 Cerebral arteriosclerosis Diseases 0.000 description 1
- 206010008088 Cerebral artery embolism Diseases 0.000 description 1
- 206010008132 Cerebral thrombosis Diseases 0.000 description 1
- 206010008190 Cerebrovascular accident Diseases 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 206010018367 Glomerulonephritis chronic Diseases 0.000 description 1
- 229920001499 Heparinoid Polymers 0.000 description 1
- 208000031226 Hyperlipidaemia Diseases 0.000 description 1
- 201000001429 Intracranial Thrombosis Diseases 0.000 description 1
- 208000006011 Stroke Diseases 0.000 description 1
- 206010061373 Sudden Hearing Loss Diseases 0.000 description 1
- 208000032109 Transient ischaemic attack Diseases 0.000 description 1
- 206010000496 acne Diseases 0.000 description 1
- 239000000783 alginic acid Substances 0.000 description 1
- 229960001126 alginic acid Drugs 0.000 description 1
- 150000004781 alginic acids Chemical class 0.000 description 1
- 230000002429 anti-coagulating effect Effects 0.000 description 1
- 230000002785 anti-thrombosis Effects 0.000 description 1
- 239000003146 anticoagulant agent Substances 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 229920002301 cellulose acetate Polymers 0.000 description 1
- 230000015271 coagulation Effects 0.000 description 1
- 238000005345 coagulation Methods 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 230000003111 delayed effect Effects 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- IZEKFCXSFNUWAM-UHFFFAOYSA-N dipyridamole Chemical compound C=12N=C(N(CCO)CCO)N=C(N3CCCCC3)C2=NC(N(CCO)CCO)=NC=1N1CCCCC1 IZEKFCXSFNUWAM-UHFFFAOYSA-N 0.000 description 1
- 239000012738 dissolution medium Substances 0.000 description 1
- 238000011978 dissolution method Methods 0.000 description 1
- 230000032050 esterification Effects 0.000 description 1
- 238000005886 esterification reaction Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 235000011389 fruit/vegetable juice Nutrition 0.000 description 1
- 210000004211 gastric acid Anatomy 0.000 description 1
- 210000004051 gastric juice Anatomy 0.000 description 1
- 210000001156 gastric mucosa Anatomy 0.000 description 1
- 239000002554 heparinoid Substances 0.000 description 1
- 230000007062 hydrolysis Effects 0.000 description 1
- 238000006460 hydrolysis reaction Methods 0.000 description 1
- 230000031891 intestinal absorption Effects 0.000 description 1
- 201000005851 intracranial arteriosclerosis Diseases 0.000 description 1
- 201000010849 intracranial embolism Diseases 0.000 description 1
- 230000000302 ischemic effect Effects 0.000 description 1
- 238000011031 large-scale manufacturing process Methods 0.000 description 1
- 208000019423 liver disease Diseases 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000005457 optimization Methods 0.000 description 1
- 229940100691 oral capsule Drugs 0.000 description 1
- 210000005259 peripheral blood Anatomy 0.000 description 1
- 239000011886 peripheral blood Substances 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 230000001603 reducing effect Effects 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 238000006277 sulfonation reaction Methods 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 201000010875 transient cerebral ischemia Diseases 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
Description
? | 30min | 1h | 2h | 3h | 4h |
Embodiment 1 | 6.5% | 7.5% | 9.7% | 10.4% | 11.4% |
Embodiment 2 | 7.6% | 9.4% | 10.1% | 11.8% | 12.9% |
Embodiment 3 | 5.6% | 6.1% | 8.2% | 9.8% | 11.7% |
Embodiment 4 | 7.4% | 8.4% | 9.8% | 11.2% | 12.0% |
Embodiment 5 | 5.2% | 5.7% | 6.3% | 7.2% | 8.4% |
Embodiment 6 | 8.5% | 9.8% | 10.2% | 11.3% | 12.3% |
? | 5min | 10min | 15min | 20min | 30min | 40min | 50min | 60min |
Embodiment 1 | 15.6% | 40.3% | 55.4% | 64.6% | 73.1% | 79.0% | 82.2% | 84.1% |
Embodiment 2 | 14.2% | 38.7% | 50.9% | 62.2% | 71.0% | 78.5% | 83.7% | 85.2% |
Embodiment 3 | 16.3% | 45.8% | 60.0% | 71.2% | 76.3% | 79.4% | 80.2% | 82.6% |
Embodiment 4 | 13.5% | 33.6% | 48.3% | 60.6% | 71.2% | 76.2% | 78.4% | 80.0% |
Embodiment 5 | 17.7% | 44.9% | 60.2% | 72.8% | 83.4% | 86.2% | 89.0% | 91.4% |
Embodiment 6 | 16.7% | 40.2% | 54.8% | 65.9% | 74.6% | 80.1% | 82.5% | 84.4% |
? | 30min | 1h | 2h | 3h | 4h |
Embodiment 7 | 5.5% | 6.5% | 7.2% | 8.0% | 9.6% |
Embodiment 8 | 4.3% | 5.1% | 5.9% | 6.7% | 7.0% |
Embodiment 9 | 6.1% | 7.0% | 7.8% | 9.0% | 9.6% |
Embodiment 10 | 5.2% | 5.7% | 6.3% | 7.2% | 8.4% |
Embodiment 11 | 6.8% | 8.1% | 9.2% | 10.0% | 10.9% |
Embodiment 12 | 7.2% | 8.4% | 9.7% | 10.4% | 11.6% |
Embodiment 13 | 7.0% | 7.9% | 8.7% | 9.9% | 11.0% |
? | 5min | 10min | 15min | 20min | 30min | 40min | 50min | 60min |
Embodiment 7 | 17.0% | 41.2% | 55.3% | 68.9% | 73.2% | 80.0% | 85.3% | 88.9% |
Embodiment 8 | 19.3% | 56.6% | 70.2% | 78.3% | 84.1% | 88.9% | 91.3% | 95.2% |
Embodiment 9 | 18.0% | 48.9% | 65.4% | 75.8% | 80.3% | 84.2% | 88.7% | 92.5% |
Embodiment 10 | 17.7% | 44.9% | 60.2% | 72.8% | 83.4% | 86.2% | 89.0% | 91.4% |
Embodiment 11 | 16.1% | 46.8% | 56.8% | 67.3% | 73.1% | 79.5% | 83.6% | 86.7% |
Embodiment 12 | 15.5% | 40.2% | 57.8% | 66.8% | 74.2% | 78.9% | 82.4% | 86.8% |
Embodiment 13 | 16.0% | 43.7% | 59.0% | 69.3% | 76.1% | 79.5% | 84.1% | 89.6% |
Claims (4)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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CN201310093377.1A CN103127030B (en) | 2013-03-21 | 2013-03-21 | Propylene glycol alginate sodium sulfate enteric capsule and preparation method thereof |
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Application Number | Priority Date | Filing Date | Title |
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CN201310093377.1A CN103127030B (en) | 2013-03-21 | 2013-03-21 | Propylene glycol alginate sodium sulfate enteric capsule and preparation method thereof |
Publications (2)
Publication Number | Publication Date |
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CN103127030A CN103127030A (en) | 2013-06-05 |
CN103127030B true CN103127030B (en) | 2014-05-21 |
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CN201310093377.1A Active CN103127030B (en) | 2013-03-21 | 2013-03-21 | Propylene glycol alginate sodium sulfate enteric capsule and preparation method thereof |
Country Status (1)
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CN (1) | CN103127030B (en) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN110960511A (en) * | 2019-12-30 | 2020-04-07 | 无锡市儿童医院 | Polysaccharide sulfate sustained-release capsule and application thereof in treating cerebral ischemia reperfusion injury |
-
2013
- 2013-03-21 CN CN201310093377.1A patent/CN103127030B/en active Active
Non-Patent Citations (4)
Title |
---|
中药肠溶制剂研究进展;尹进朝等;《中成药》;20110228;第33卷(第2期);第315-318页 * |
尹进朝等.中药肠溶制剂研究进展.《中成药》.2011,第33卷(第2期),第315-318页. |
藻酸双醋钠引起胃出血一例报告分析;郭云欣等;《山东医药工业》;20001231;第19卷(第2期);第55-56页 * |
郭云欣等.藻酸双醋钠引起胃出血一例报告分析.《山东医药工业》.2000,第19卷(第2期),第55-56页. |
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Address after: 266103 Qingdao economic and Technological Development Zone, unity Road, No. 3601, Shandong Applicant after: Qingdao Zhengda Haier Pharmaceutical Co.,Ltd. Address before: 266103 Haier Road, Shandong, Qingdao, No. 1 Applicant before: Qingdao Zhengda Haier Pharmaceutical Co.,Ltd. |
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Address after: 266103 3601 Tuen Jie Road, Qingdao economic and Technological Development Zone, Shandong Patentee after: CP PHARMACEUTICAL (QINGDAO) Co.,Ltd. Address before: 266103 3601 Tuen Jie Road, Qingdao economic and Technological Development Zone, Shandong Patentee before: Qingdao Zhengda Haier Pharmaceutical Co.,Ltd. |
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CP01 | Change in the name or title of a patent holder | ||
CP03 | Change of name, title or address |
Address after: No.3601 Tuanjie Road, Qingdao Economic and Technological Development Zone, Shandong Province 266426 Patentee after: Qingdao Guoxin Pharmaceutical Co.,Ltd. Country or region after: China Address before: No. 3601 Tuanjie Road, Qingdao Economic and Technological Development Zone, Shandong Province Patentee before: CP PHARMACEUTICAL (QINGDAO) Co.,Ltd. Country or region before: China |
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