CN102688188B - 马来酸桂哌齐特注射液及其制备方法 - Google Patents
马来酸桂哌齐特注射液及其制备方法 Download PDFInfo
- Publication number
- CN102688188B CN102688188B CN201210194527.3A CN201210194527A CN102688188B CN 102688188 B CN102688188 B CN 102688188B CN 201210194527 A CN201210194527 A CN 201210194527A CN 102688188 B CN102688188 B CN 102688188B
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- CN
- China
- Prior art keywords
- injection
- cinepazide
- cinepazide maleate
- maleate
- preparation
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- 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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- 229960004201 cinepazide Drugs 0.000 title claims abstract description 72
- 238000002347 injection Methods 0.000 title claims abstract description 53
- 239000007924 injection Substances 0.000 title claims abstract description 53
- XSTJTOKYCAJVMJ-GVTSEVKNSA-N (z)-but-2-enedioic acid;(e)-1-[4-(2-oxo-2-pyrrolidin-1-ylethyl)piperazin-1-yl]-3-(3,4,5-trimethoxyphenyl)prop-2-en-1-one Chemical compound OC(=O)\C=C/C(O)=O.COC1=C(OC)C(OC)=CC(\C=C\C(=O)N2CCN(CC(=O)N3CCCC3)CC2)=C1 XSTJTOKYCAJVMJ-GVTSEVKNSA-N 0.000 title claims abstract description 51
- 238000002360 preparation method Methods 0.000 title claims abstract description 22
- RCUDFXMNPQNBDU-VOTSOKGWSA-N cinepazide Chemical compound COC1=C(OC)C(OC)=CC(\C=C\C(=O)N2CCN(CC(=O)N3CCCC3)CC2)=C1 RCUDFXMNPQNBDU-VOTSOKGWSA-N 0.000 claims abstract description 21
- 238000000034 method Methods 0.000 claims abstract description 4
- 239000000243 solution Substances 0.000 claims description 15
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims description 13
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims description 13
- 235000010356 sorbitol Nutrition 0.000 claims description 13
- 229960002920 sorbitol Drugs 0.000 claims description 13
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 13
- 230000001954 sterilising effect Effects 0.000 claims description 10
- 239000008215 water for injection Substances 0.000 claims description 10
- SHWNNYZBHZIQQV-UHFFFAOYSA-J EDTA monocalcium diisodium salt Chemical compound [Na+].[Na+].[Ca+2].[O-]C(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O SHWNNYZBHZIQQV-UHFFFAOYSA-J 0.000 claims description 8
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 6
- 239000003610 charcoal Substances 0.000 claims description 6
- 229940105082 medicinal charcoal Drugs 0.000 claims description 6
- 238000003756 stirring Methods 0.000 claims description 6
- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 claims description 5
- 230000008901 benefit Effects 0.000 claims description 5
- 235000017281 sodium acetate Nutrition 0.000 claims description 5
- 239000001632 sodium acetate Substances 0.000 claims description 5
- 239000012467 final product Substances 0.000 claims description 4
- 239000011521 glass Substances 0.000 claims description 4
- 238000009413 insulation Methods 0.000 claims description 4
- 239000000706 filtrate Substances 0.000 claims description 3
- 239000002738 chelating agent Substances 0.000 abstract description 14
- 239000003381 stabilizer Substances 0.000 abstract description 14
- 230000007774 longterm Effects 0.000 abstract description 5
- 239000002994 raw material Substances 0.000 abstract description 3
- 238000012360 testing method Methods 0.000 description 13
- 238000005516 engineering process Methods 0.000 description 7
- 239000000523 sample Substances 0.000 description 7
- 239000000047 product Substances 0.000 description 5
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 4
- 229930195725 Mannitol Natural products 0.000 description 4
- 229940079593 drug Drugs 0.000 description 4
- 239000003814 drug Substances 0.000 description 4
- 235000010355 mannitol Nutrition 0.000 description 4
- 239000000594 mannitol Substances 0.000 description 4
- 238000012216 screening Methods 0.000 description 4
- 238000013112 stability test Methods 0.000 description 4
- 230000001988 toxicity Effects 0.000 description 4
- 231100000419 toxicity Toxicity 0.000 description 4
- 241000283973 Oryctolagus cuniculus Species 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000002474 experimental method Methods 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 238000010521 absorption reaction Methods 0.000 description 2
- OIRDTQYFTABQOQ-KQYNXXCUSA-N adenosine Chemical compound C1=NC=2C(N)=NC=NC=2N1[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O OIRDTQYFTABQOQ-KQYNXXCUSA-N 0.000 description 2
- 238000011835 investigation Methods 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 239000003002 pH adjusting agent Substances 0.000 description 2
- 238000005070 sampling Methods 0.000 description 2
- 230000000638 stimulation Effects 0.000 description 2
- 238000010998 test method Methods 0.000 description 2
- 239000002126 C01EB10 - Adenosine Substances 0.000 description 1
- BHPQYMZQTOCNFJ-UHFFFAOYSA-N Calcium cation Chemical compound [Ca+2] BHPQYMZQTOCNFJ-UHFFFAOYSA-N 0.000 description 1
- 241000700199 Cavia porcellus Species 0.000 description 1
- 206010018910 Haemolysis Diseases 0.000 description 1
- 206010020751 Hypersensitivity Diseases 0.000 description 1
- 229960005305 adenosine Drugs 0.000 description 1
- 239000002671 adjuvant Substances 0.000 description 1
- 230000002009 allergenic effect Effects 0.000 description 1
- 230000003042 antagnostic effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N butenedioic acid Chemical compound OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 1
- 229910001424 calcium ion Inorganic materials 0.000 description 1
- -1 cinnamoyl Chemical group 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 230000002526 effect on cardiovascular system Effects 0.000 description 1
- 210000003743 erythrocyte Anatomy 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000008588 hemolysis Effects 0.000 description 1
- 230000002949 hemolytic effect Effects 0.000 description 1
- 239000012535 impurity Substances 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 239000006101 laboratory sample Substances 0.000 description 1
- 238000011031 large-scale manufacturing process Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 210000005259 peripheral blood Anatomy 0.000 description 1
- 239000011886 peripheral blood Substances 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 238000009781 safety test method Methods 0.000 description 1
- 231100000041 toxicology testing Toxicity 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
Claims (2)
Priority Applications (1)
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CN201210194527.3A CN102688188B (zh) | 2012-06-13 | 2012-06-13 | 马来酸桂哌齐特注射液及其制备方法 |
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CN201210194527.3A CN102688188B (zh) | 2012-06-13 | 2012-06-13 | 马来酸桂哌齐特注射液及其制备方法 |
Publications (2)
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CN102688188A CN102688188A (zh) | 2012-09-26 |
CN102688188B true CN102688188B (zh) | 2016-06-22 |
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CN201210194527.3A Active CN102688188B (zh) | 2012-06-13 | 2012-06-13 | 马来酸桂哌齐特注射液及其制备方法 |
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Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
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CN105832662A (zh) * | 2016-05-12 | 2016-08-10 | 河北仁合益康药业有限公司 | 一种马来酸桂哌齐特注射液组合物及其制备方法 |
CN108309929A (zh) * | 2017-01-15 | 2018-07-24 | 湖南格制药有限公司 | 一种马来酸桂哌齐特注射液及其制备方法 |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101058565A (zh) * | 2006-04-21 | 2007-10-24 | 孟宪慧 | 稳定的桂哌齐特水溶性盐 |
CN101058567A (zh) * | 2006-04-21 | 2007-10-24 | 郭维城 | 桂哌齐特的新的药学上可接受的盐 |
CN101204372A (zh) * | 2007-12-17 | 2008-06-25 | 车冯升 | 马来酸桂哌齐特注射液及其制备方法 |
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2012
- 2012-06-13 CN CN201210194527.3A patent/CN102688188B/zh active Active
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101058565A (zh) * | 2006-04-21 | 2007-10-24 | 孟宪慧 | 稳定的桂哌齐特水溶性盐 |
CN101058567A (zh) * | 2006-04-21 | 2007-10-24 | 郭维城 | 桂哌齐特的新的药学上可接受的盐 |
CN101204372A (zh) * | 2007-12-17 | 2008-06-25 | 车冯升 | 马来酸桂哌齐特注射液及其制备方法 |
Non-Patent Citations (1)
Title |
---|
马来酸桂哌齐特氯化钠注射液的研究;候怀信;《中国优秀硕士学位论文全文数据库》;20120315(第3期);第E079-26页 * |
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CN102688188A (zh) | 2012-09-26 |
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Effective date of registration: 20160503 Address after: 224200 Jiangsu Province, Yancheng City Dongtai City Ho duo Road No. 18 Applicant after: JIANGSU SHENLONG PHARMACEUTICAL Co.,Ltd. Address before: 224200 Jiangsu Province, Yancheng City Dongtai City Ho duo Road No. 18 Applicant before: JIANGSU SHENLONG PHARMACEUTICAL Co.,Ltd. Applicant before: JIANGSU CHENGCHUANG NEW DRUG R&D CO.,LTD. |
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Address after: 224200 Jiangsu Province, Yancheng City Dongtai City Ho duo Road No. 18 Patentee after: JIANGSU SHENLONG PHARMACEUTICAL CO.,LTD. Address before: 224200 Jiangsu Province, Yancheng City Dongtai City Ho duo Road No. 18 Patentee before: JIANGSU SHENLONG PHARMACEUTICAL Co.,Ltd. |
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CP01 | Change in the name or title of a patent holder | ||
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Address after: 224200, No. 18 North Road, Dongtai, Jiangsu, Yancheng City Patentee after: JIANGSU SHENLONG PHARMACEUTICAL Co.,Ltd. Address before: 224200, No. 18 North Road, Dongtai, Jiangsu, Yancheng City Patentee before: JIANGSU SHENLONG PHARMACEUTICAL Co.,Ltd. |
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Address after: No.15 Weiba Road, Dongtai City, Yancheng City, Jiangsu Province 224200 Patentee after: JIANGSU SHENLONG PHARMACEUTICAL Co.,Ltd. Address before: 224200, No. 18 North Road, Dongtai, Jiangsu, Yancheng City Patentee before: JIANGSU SHENLONG PHARMACEUTICAL Co.,Ltd. |
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