CN1565448A - 尼群地平分散片及其制备方法 - Google Patents
尼群地平分散片及其制备方法 Download PDFInfo
- Publication number
- CN1565448A CN1565448A CN 03137976 CN03137976A CN1565448A CN 1565448 A CN1565448 A CN 1565448A CN 03137976 CN03137976 CN 03137976 CN 03137976 A CN03137976 A CN 03137976A CN 1565448 A CN1565448 A CN 1565448A
- Authority
- CN
- China
- Prior art keywords
- nitrendipine
- tablet
- dispersible tablet
- adjuvant
- micro powder
- 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
- PVHUJELLJLJGLN-INIZCTEOSA-N (S)-nitrendipine Chemical compound CCOC(=O)C1=C(C)NC(C)=C(C(=O)OC)[C@@H]1C1=CC=CC([N+]([O-])=O)=C1 PVHUJELLJLJGLN-INIZCTEOSA-N 0.000 title claims abstract description 104
- 229960005425 nitrendipine Drugs 0.000 title claims abstract description 101
- 238000000034 method Methods 0.000 title claims abstract description 19
- 239000006185 dispersion Substances 0.000 title abstract description 4
- 239000002245 particle Substances 0.000 claims abstract description 23
- 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 abstract description 11
- 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 abstract description 11
- 239000008101 lactose Substances 0.000 claims abstract description 11
- 239000011734 sodium Substances 0.000 claims abstract description 11
- 229910052708 sodium Inorganic materials 0.000 claims abstract description 11
- 239000007919 dispersible tablet Substances 0.000 claims description 61
- 239000003826 tablet Substances 0.000 claims description 45
- 239000003814 drug Substances 0.000 claims description 43
- 239000002671 adjuvant Substances 0.000 claims description 19
- 239000008187 granular material Substances 0.000 claims description 19
- 239000000843 powder Substances 0.000 claims description 18
- 229940079593 drug Drugs 0.000 claims description 16
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 13
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 13
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 12
- 229920002472 Starch Polymers 0.000 claims description 11
- 239000008107 starch Substances 0.000 claims description 11
- 235000019698 starch Nutrition 0.000 claims description 11
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 10
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims description 10
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 10
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 10
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 10
- 230000008569 process Effects 0.000 claims description 10
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 9
- 238000002360 preparation method Methods 0.000 claims description 9
- 239000004531 microgranule Substances 0.000 claims description 4
- 206010020772 Hypertension Diseases 0.000 abstract description 7
- 238000004519 manufacturing process Methods 0.000 abstract description 4
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 abstract description 2
- 239000001913 cellulose Substances 0.000 abstract 1
- 229920002678 cellulose Polymers 0.000 abstract 1
- 239000000463 material Substances 0.000 abstract 1
- 230000036772 blood pressure Effects 0.000 description 17
- 238000004090 dissolution Methods 0.000 description 14
- 230000035487 diastolic blood pressure Effects 0.000 description 13
- 230000000694 effects Effects 0.000 description 13
- 230000035488 systolic blood pressure Effects 0.000 description 11
- 238000012544 monitoring process Methods 0.000 description 8
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 8
- 230000007423 decrease Effects 0.000 description 7
- 238000006243 chemical reaction Methods 0.000 description 6
- 239000002552 dosage form Substances 0.000 description 6
- 238000012360 testing method Methods 0.000 description 6
- 239000000203 mixture Substances 0.000 description 5
- 238000011160 research Methods 0.000 description 5
- 238000002474 experimental method Methods 0.000 description 4
- 230000006872 improvement Effects 0.000 description 4
- 208000007530 Essential hypertension Diseases 0.000 description 3
- 206010019233 Headaches Diseases 0.000 description 3
- 230000003276 anti-hypertensive effect Effects 0.000 description 3
- 230000008901 benefit Effects 0.000 description 3
- 239000003795 chemical substances by application Substances 0.000 description 3
- 150000001875 compounds Chemical class 0.000 description 3
- 238000009826 distribution Methods 0.000 description 3
- 230000003203 everyday effect Effects 0.000 description 3
- 231100000869 headache Toxicity 0.000 description 3
- 239000000725 suspension Substances 0.000 description 3
- 229940127291 Calcium channel antagonist Drugs 0.000 description 2
- 208000007271 Substance Withdrawal Syndrome Diseases 0.000 description 2
- 238000009825 accumulation Methods 0.000 description 2
- LSQZJLSUYDQPKJ-NJBDSQKTSA-N amoxicillin Chemical compound C1([C@@H](N)C(=O)N[C@H]2[C@H]3SC([C@@H](N3C2=O)C(O)=O)(C)C)=CC=C(O)C=C1 LSQZJLSUYDQPKJ-NJBDSQKTSA-N 0.000 description 2
- 238000003556 assay Methods 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 239000000945 filler Substances 0.000 description 2
- 238000010579 first pass effect Methods 0.000 description 2
- 239000012530 fluid Substances 0.000 description 2
- 238000011010 flushing procedure Methods 0.000 description 2
- 230000001077 hypotensive effect Effects 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 239000002547 new drug Substances 0.000 description 2
- 239000008194 pharmaceutical composition Substances 0.000 description 2
- QYSPLQLAKJAUJT-UHFFFAOYSA-N piroxicam Chemical compound OC=1C2=CC=CC=C2S(=O)(=O)N(C)C=1C(=O)NC1=CC=CC=N1 QYSPLQLAKJAUJT-UHFFFAOYSA-N 0.000 description 2
- 230000000630 rising effect Effects 0.000 description 2
- 239000007901 soft capsule Substances 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- UESHVCAYLZYGOX-FFHNEAJVSA-N (4r,4ar,7s,7ar,12bs)-9-methoxy-3-methyl-2,4,4a,7,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinoline-7-ol;2-acetyloxybenzoic acid Chemical compound CC(=O)OC1=CC=CC=C1C(O)=O.C([C@H]1[C@H](N(CC[C@@]112)C)C3)=C[C@H](O)[C@@H]1OC1=C2C3=CC=C1OC UESHVCAYLZYGOX-FFHNEAJVSA-N 0.000 description 1
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 1
- BSYNRYMUTXBXSQ-UHFFFAOYSA-N Aspirin Chemical compound CC(=O)OC1=CC=CC=C1C(O)=O BSYNRYMUTXBXSQ-UHFFFAOYSA-N 0.000 description 1
- 208000019505 Deglutition disease Diseases 0.000 description 1
- 229920001353 Dextrin Polymers 0.000 description 1
- 239000004375 Dextrin Substances 0.000 description 1
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 229960001138 acetylsalicylic acid Drugs 0.000 description 1
- 229960003022 amoxicillin Drugs 0.000 description 1
- 229940121363 anti-inflammatory agent Drugs 0.000 description 1
- 239000002260 anti-inflammatory agent Substances 0.000 description 1
- 230000000767 anti-ulcer Effects 0.000 description 1
- 239000002220 antihypertensive agent Substances 0.000 description 1
- 229940127088 antihypertensive drug Drugs 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 235000013409 condiments Nutrition 0.000 description 1
- 208000029078 coronary artery disease Diseases 0.000 description 1
- 239000006184 cosolvent Substances 0.000 description 1
- 235000019425 dextrin Nutrition 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000000839 emulsion Substances 0.000 description 1
- 239000004744 fabric Substances 0.000 description 1
- 239000007948 fast release tablet Substances 0.000 description 1
- 229940065410 feldene Drugs 0.000 description 1
- 239000007903 gelatin capsule Substances 0.000 description 1
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 238000000227 grinding Methods 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 239000007970 homogeneous dispersion Substances 0.000 description 1
- 230000001631 hypertensive effect Effects 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 238000004137 mechanical activation Methods 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 238000002483 medication Methods 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 230000000422 nocturnal effect Effects 0.000 description 1
- 239000006186 oral dosage form Substances 0.000 description 1
- 229940100688 oral solution Drugs 0.000 description 1
- LSQZJLSUYDQPKJ-UHFFFAOYSA-N p-Hydroxyampicillin Natural products O=C1N2C(C(O)=O)C(C)(C)SC2C1NC(=O)C(N)C1=CC=C(O)C=C1 LSQZJLSUYDQPKJ-UHFFFAOYSA-N 0.000 description 1
- 230000003285 pharmacodynamic effect Effects 0.000 description 1
- 229960002702 piroxicam Drugs 0.000 description 1
- 239000011505 plaster Substances 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 230000005180 public health Effects 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 235000015424 sodium Nutrition 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 229960005404 sulfamethoxazole Drugs 0.000 description 1
- JLKIGFTWXXRPMT-UHFFFAOYSA-N sulphamethoxazole Chemical compound O1C(C)=CC(NS(=O)(=O)C=2C=CC(N)=CC=2)=N1 JLKIGFTWXXRPMT-UHFFFAOYSA-N 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 239000007916 tablet composition Substances 0.000 description 1
- 229940125725 tranquilizer Drugs 0.000 description 1
- 239000003204 tranquilizing agent Substances 0.000 description 1
- 230000002936 tranquilizing effect Effects 0.000 description 1
- 230000032258 transport Effects 0.000 description 1
- 239000004565 water dispersible tablet Substances 0.000 description 1
- 238000005550 wet granulation Methods 0.000 description 1
Images
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
Claims (9)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN 03137976 CN1291716C (zh) | 2003-06-16 | 2003-06-16 | 尼群地平分散片及其制备方法 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN 03137976 CN1291716C (zh) | 2003-06-16 | 2003-06-16 | 尼群地平分散片及其制备方法 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1565448A true CN1565448A (zh) | 2005-01-19 |
CN1291716C CN1291716C (zh) | 2006-12-27 |
Family
ID=34470558
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN 03137976 Expired - Fee Related CN1291716C (zh) | 2003-06-16 | 2003-06-16 | 尼群地平分散片及其制备方法 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN1291716C (zh) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN100402060C (zh) * | 2005-02-25 | 2008-07-16 | 山东省医学科学院药物研究所 | 益心酮分散片及其制备方法 |
CN1732952B (zh) * | 2005-09-02 | 2010-04-07 | 姚俊华 | 一种治疗高血压的复方分散片 |
CN108743553A (zh) * | 2018-08-09 | 2018-11-06 | 河北赛克药业有限公司 | 一种尼群地平片及其制备方法 |
CN109985013A (zh) * | 2019-05-10 | 2019-07-09 | 河北赛克药业有限公司 | 一种尼群地平分散片及其制备方法 |
-
2003
- 2003-06-16 CN CN 03137976 patent/CN1291716C/zh not_active Expired - Fee Related
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN100402060C (zh) * | 2005-02-25 | 2008-07-16 | 山东省医学科学院药物研究所 | 益心酮分散片及其制备方法 |
CN1732952B (zh) * | 2005-09-02 | 2010-04-07 | 姚俊华 | 一种治疗高血压的复方分散片 |
CN108743553A (zh) * | 2018-08-09 | 2018-11-06 | 河北赛克药业有限公司 | 一种尼群地平片及其制备方法 |
CN109985013A (zh) * | 2019-05-10 | 2019-07-09 | 河北赛克药业有限公司 | 一种尼群地平分散片及其制备方法 |
CN109985013B (zh) * | 2019-05-10 | 2021-08-10 | 河北君圣药业有限公司 | 一种尼群地平分散片及其制备方法 |
Also Published As
Publication number | Publication date |
---|---|
CN1291716C (zh) | 2006-12-27 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
C06 | Publication | ||
PB01 | Publication | ||
C10 | Entry into substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
C14 | Grant of patent or utility model | ||
GR01 | Patent grant | ||
C17 | Cessation of patent right | ||
CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20061227 Termination date: 20120616 |
|
C49 | Reinstatement of patent right or utility model | ||
RR01 | Reinstatement of patent right |
Former decision: cessation of patent right due to non-payment of the annual fee Former decision publication date: 20130814 |
|
PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: Nitrendipine dispersion tablet and method for making same Effective date of registration: 20191119 Granted publication date: 20061227 Pledgee: Industrial and Commercial Bank of China Limited Lincheng sub branch Pledgor: HEBEI SAIKE PHARMACEUTICAL Co.,Ltd. Registration number: Y2019130000009 |
|
PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
CP01 | Change in the name or title of a patent holder |
Address after: 054300 North Lincheng Industrial Park, Haonan highway, Xingtai City, Hebei Province Patentee after: Hebei Junsheng Pharmaceutical Co.,Ltd. Address before: 054300 North Lincheng Industrial Park, Haonan highway, Xingtai City, Hebei Province Patentee before: HEBEI SAIKE PHARMACEUTICAL Co.,Ltd. |
|
CP01 | Change in the name or title of a patent holder | ||
CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20061227 |
|
CF01 | Termination of patent right due to non-payment of annual fee |