CN1475275A - 注射用甘露聚糖肽冻干粉针制剂 - Google Patents
注射用甘露聚糖肽冻干粉针制剂 Download PDFInfo
- Publication number
- CN1475275A CN1475275A CNA031370705A CN03137070A CN1475275A CN 1475275 A CN1475275 A CN 1475275A CN A031370705 A CNA031370705 A CN A031370705A CN 03137070 A CN03137070 A CN 03137070A CN 1475275 A CN1475275 A CN 1475275A
- Authority
- CN
- China
- Prior art keywords
- mannatide
- freeze
- dried powder
- injection
- pharmaceutically acceptable
- 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
- 238000002347 injection Methods 0.000 title claims abstract description 42
- 239000007924 injection Substances 0.000 title claims abstract description 42
- 239000000843 powder Substances 0.000 title claims description 40
- 108090000765 processed proteins & peptides Proteins 0.000 title abstract description 7
- 229920000057 Mannan Polymers 0.000 title description 3
- 239000003708 ampul Substances 0.000 title 1
- 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 claims abstract description 9
- 229930195725 Mannitol Natural products 0.000 claims abstract description 9
- 239000000594 mannitol Substances 0.000 claims abstract description 9
- 235000010355 mannitol Nutrition 0.000 claims abstract description 9
- 238000000034 method Methods 0.000 claims abstract description 8
- 229920002307 Dextran Polymers 0.000 claims abstract description 5
- 108010010803 Gelatin Proteins 0.000 claims abstract description 5
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims abstract description 5
- 229930006000 Sucrose Natural products 0.000 claims abstract description 5
- 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 claims abstract description 5
- 239000008273 gelatin Substances 0.000 claims abstract description 5
- 229920000159 gelatin Polymers 0.000 claims abstract description 5
- 235000019322 gelatine Nutrition 0.000 claims abstract description 5
- 235000011852 gelatine desserts Nutrition 0.000 claims abstract description 5
- 239000008103 glucose Substances 0.000 claims abstract description 5
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims description 42
- 108010010998 polyactin A Proteins 0.000 claims description 26
- 235000017557 sodium bicarbonate Nutrition 0.000 claims description 21
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims description 21
- 238000002360 preparation method Methods 0.000 claims description 18
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 12
- 239000000203 mixture Substances 0.000 claims description 10
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 10
- 238000009472 formulation Methods 0.000 claims description 8
- 239000000243 solution Substances 0.000 claims description 8
- JGSARLDLIJGVTE-UHFFFAOYSA-N 3,3-dimethyl-7-oxo-6-[(2-phenylacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid Chemical compound O=C1N2C(C(O)=O)C(C)(C)SC2C1NC(=O)CC1=CC=CC=C1 JGSARLDLIJGVTE-UHFFFAOYSA-N 0.000 claims description 6
- 239000011780 sodium chloride Substances 0.000 claims description 6
- 239000008215 water for injection Substances 0.000 claims description 5
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 4
- 229930091371 Fructose Natural products 0.000 claims description 4
- 239000005715 Fructose Substances 0.000 claims description 4
- RFSUNEUAIZKAJO-ARQDHWQXSA-N Fructose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O RFSUNEUAIZKAJO-ARQDHWQXSA-N 0.000 claims description 4
- 102000008100 Human Serum Albumin Human genes 0.000 claims description 4
- 108091006905 Human Serum Albumin Proteins 0.000 claims description 4
- 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 4
- 239000002202 Polyethylene glycol Substances 0.000 claims description 4
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims description 4
- 239000008101 lactose Substances 0.000 claims description 4
- 238000005374 membrane filtration Methods 0.000 claims description 4
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims description 4
- 229920001223 polyethylene glycol Polymers 0.000 claims description 4
- 235000020183 skimmed milk Nutrition 0.000 claims description 4
- 239000005720 sucrose Substances 0.000 claims description 4
- 238000005303 weighing Methods 0.000 claims description 4
- 239000000811 xylitol Substances 0.000 claims description 4
- 235000010447 xylitol Nutrition 0.000 claims description 4
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims description 4
- 229960002675 xylitol Drugs 0.000 claims 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 claims description 3
- FGUUSXIOTUKUDN-IBGZPJMESA-N C1(=CC=CC=C1)N1C2=C(NC([C@H](C1)NC=1OC(=NN=1)C1=CC=CC=C1)=O)C=CC=C2 Chemical compound C1(=CC=CC=C1)N1C2=C(NC([C@H](C1)NC=1OC(=NN=1)C1=CC=CC=C1)=O)C=CC=C2 FGUUSXIOTUKUDN-IBGZPJMESA-N 0.000 claims description 3
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 3
- 238000004108 freeze drying Methods 0.000 claims description 3
- FZWBNHMXJMCXLU-BLAUPYHCSA-N isomaltotriose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O)O1 FZWBNHMXJMCXLU-BLAUPYHCSA-N 0.000 claims description 3
- 239000008227 sterile water for injection Substances 0.000 claims description 3
- 241000143437 Aciculosporium take Species 0.000 claims description 2
- 238000012869 ethanol precipitation Methods 0.000 claims description 2
- 238000001556 precipitation Methods 0.000 claims description 2
- 238000001179 sorption measurement Methods 0.000 claims description 2
- TWNIBLMWSKIRAT-RWOPYEJCSA-N (1r,2s,3s,4s,5r)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol Chemical compound O1[C@@]2([H])OC[C@]1([H])[C@@H](O)[C@H](O)[C@@H]2O TWNIBLMWSKIRAT-RWOPYEJCSA-N 0.000 abstract description 4
- 230000008569 process Effects 0.000 abstract description 3
- 239000008267 milk Substances 0.000 abstract 1
- 235000013336 milk Nutrition 0.000 abstract 1
- 210000004080 milk Anatomy 0.000 abstract 1
- -1 pectose Chemical compound 0.000 abstract 1
- 229960004793 sucrose Drugs 0.000 abstract 1
- 239000003814 drug Substances 0.000 description 17
- 239000007788 liquid Substances 0.000 description 15
- 229940079593 drug Drugs 0.000 description 14
- 238000012360 testing method Methods 0.000 description 8
- 206010028980 Neoplasm Diseases 0.000 description 7
- 238000001914 filtration Methods 0.000 description 7
- 201000011510 cancer Diseases 0.000 description 6
- 230000000694 effects Effects 0.000 description 6
- 230000002401 inhibitory effect Effects 0.000 description 5
- 241001465754 Metazoa Species 0.000 description 4
- 230000005587 bubbling Effects 0.000 description 4
- 239000002552 dosage form Substances 0.000 description 4
- 238000011068 loading method Methods 0.000 description 4
- 241000699670 Mus sp. Species 0.000 description 3
- 230000037396 body weight Effects 0.000 description 3
- 230000003285 pharmacodynamic effect Effects 0.000 description 3
- 239000002504 physiological saline solution Substances 0.000 description 3
- 238000007086 side reaction Methods 0.000 description 3
- 230000001954 sterilising effect Effects 0.000 description 3
- 230000004083 survival effect Effects 0.000 description 3
- 239000002671 adjuvant Substances 0.000 description 2
- 238000003556 assay Methods 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 238000002512 chemotherapy Methods 0.000 description 2
- 238000011049 filling Methods 0.000 description 2
- 230000036737 immune function Effects 0.000 description 2
- 230000005847 immunogenicity Effects 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- 210000003205 muscle Anatomy 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- 238000001959 radiotherapy Methods 0.000 description 2
- 239000011265 semifinished product Substances 0.000 description 2
- 239000008223 sterile water Substances 0.000 description 2
- 238000004659 sterilization and disinfection Methods 0.000 description 2
- 206010008909 Chronic Hepatitis Diseases 0.000 description 1
- 238000003723 Smelting Methods 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 230000001413 cellular effect Effects 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000004821 distillation Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- FCZCIXQGZOUIDN-UHFFFAOYSA-N ethyl 2-diethoxyphosphinothioyloxyacetate Chemical compound CCOC(=O)COP(=S)(OCC)OCC FCZCIXQGZOUIDN-UHFFFAOYSA-N 0.000 description 1
- 239000000706 filtrate Substances 0.000 description 1
- 210000004907 gland Anatomy 0.000 description 1
- 208000006454 hepatitis Diseases 0.000 description 1
- 230000001900 immune effect Effects 0.000 description 1
- 230000036039 immunity Effects 0.000 description 1
- 239000012535 impurity Substances 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 238000010253 intravenous injection Methods 0.000 description 1
- 210000000265 leukocyte Anatomy 0.000 description 1
- 201000002364 leukopenia Diseases 0.000 description 1
- 231100001022 leukopenia Toxicity 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 210000000822 natural killer cell Anatomy 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 230000001360 synchronised effect Effects 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 230000000699 topical effect Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 230000002110 toxicologic effect Effects 0.000 description 1
- 231100000027 toxicology Toxicity 0.000 description 1
- 230000009466 transformation Effects 0.000 description 1
- 230000017105 transposition Effects 0.000 description 1
- 230000004614 tumor growth Effects 0.000 description 1
- 238000010792 warming Methods 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Description
Claims (6)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN 03137070 CN1205996C (zh) | 2002-12-16 | 2003-06-18 | 注射用甘露聚糖肽冻干粉针制剂 |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN02155497 | 2002-12-16 | ||
CN02155497.8 | 2002-12-16 | ||
CN 03137070 CN1205996C (zh) | 2002-12-16 | 2003-06-18 | 注射用甘露聚糖肽冻干粉针制剂 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1475275A true CN1475275A (zh) | 2004-02-18 |
CN1205996C CN1205996C (zh) | 2005-06-15 |
Family
ID=34195498
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN 03137070 Expired - Lifetime CN1205996C (zh) | 2002-12-16 | 2003-06-18 | 注射用甘露聚糖肽冻干粉针制剂 |
Country Status (1)
Country | Link |
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CN (1) | CN1205996C (zh) |
Cited By (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN100408088C (zh) * | 2003-12-31 | 2008-08-06 | 西安亨通光华制药有限公司 | 一种治疗口腔溃疡的药物 |
CN100413510C (zh) * | 2005-01-05 | 2008-08-27 | 成都利尔药业有限公司 | 甘露聚糖肽注射剂及其制备方法 |
CN100577149C (zh) * | 2006-12-21 | 2010-01-06 | 北京民海生物科技有限公司 | 一种治疗用a型肉毒毒素冻干粉针剂新型冻干保护剂配方 |
CN1965848B (zh) * | 2005-11-14 | 2010-04-21 | 王锦 | 一种灯盏花素冻干粉针剂及其制备工艺 |
CN102698256A (zh) * | 2012-06-18 | 2012-10-03 | 贵州神奇集团控股有限公司 | 治疗肿瘤的药物组合物及其制备方法 |
CN103651809A (zh) * | 2012-09-03 | 2014-03-26 | 贵州神奇集团控股有限公司 | 一种营养保健奶及其制备方法 |
WO2014101743A1 (zh) * | 2012-12-26 | 2014-07-03 | Li Hewei | 一种冻干赋型制剂及其制备方法 |
CN106729661A (zh) * | 2016-12-02 | 2017-05-31 | 广东天普生化医药股份有限公司 | 人尿激肽原酶的新用途及含有人尿激肽原酶的药物组合物 |
-
2003
- 2003-06-18 CN CN 03137070 patent/CN1205996C/zh not_active Expired - Lifetime
Cited By (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN100408088C (zh) * | 2003-12-31 | 2008-08-06 | 西安亨通光华制药有限公司 | 一种治疗口腔溃疡的药物 |
CN100413510C (zh) * | 2005-01-05 | 2008-08-27 | 成都利尔药业有限公司 | 甘露聚糖肽注射剂及其制备方法 |
CN1965848B (zh) * | 2005-11-14 | 2010-04-21 | 王锦 | 一种灯盏花素冻干粉针剂及其制备工艺 |
CN100577149C (zh) * | 2006-12-21 | 2010-01-06 | 北京民海生物科技有限公司 | 一种治疗用a型肉毒毒素冻干粉针剂新型冻干保护剂配方 |
CN102698256A (zh) * | 2012-06-18 | 2012-10-03 | 贵州神奇集团控股有限公司 | 治疗肿瘤的药物组合物及其制备方法 |
CN103651809A (zh) * | 2012-09-03 | 2014-03-26 | 贵州神奇集团控股有限公司 | 一种营养保健奶及其制备方法 |
CN103651809B (zh) * | 2012-09-03 | 2017-10-31 | 贵州神奇集团控股有限公司 | 一种营养保健奶及其制备方法 |
WO2014101743A1 (zh) * | 2012-12-26 | 2014-07-03 | Li Hewei | 一种冻干赋型制剂及其制备方法 |
CN106729661A (zh) * | 2016-12-02 | 2017-05-31 | 广东天普生化医药股份有限公司 | 人尿激肽原酶的新用途及含有人尿激肽原酶的药物组合物 |
Also Published As
Publication number | Publication date |
---|---|
CN1205996C (zh) | 2005-06-15 |
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Owner name: JILIN A-THINK PHARMACEUTICAL CO., LTD. Free format text: FORMER NAME OR ADDRESS: CHANGCHUN LIERFAN PHARMACEUTICAL CO., LTD. |
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Address after: 130616, No. 1, No. 1, industrial economic development zone, Shuangyang sika deer, Jilin, Changchun Patentee after: Jilin A-Think Pharmaceutical Co.,Ltd. Address before: 130022 No. 168 Renmin Street, Jilin, Changchun Patentee before: Changchun Lierfan Pharmaceutical Co.,Ltd. |
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Owner name: JILIN YIXIN PHARMACEUTICAL CO., LTD. Free format text: FORMER NAME OR ADDRESS: JILIN A-THINK PHARMACEUTICAL CO., LTD. |
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Address after: No. 1, one heart road, Shuangyang Economic Development Zone, Jilin, Changchun Patentee after: Jilin Yixin pharmaceutical Limited by Share Ltd. Address before: No. 1, one heart road, Shuangyang deer Industrial Economic Development Zone, Changchun, Jilin Patentee before: Jilin A-Think Pharmaceutical Co.,Ltd. |
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Owner name: GUOYAO YIXIN PHARMACEUTICAL CO., LTD. Free format text: FORMER NAME: JILIN YIXIN PHARMACEUTICAL CO., LTD. |
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CP01 | Change in the name or title of a patent holder |
Address after: 130616 Jilin province Changchun Shuangyang Economic Development Zone on the road No. 1 Patentee after: SINOPHARM A-THINK PHARMACEUTICAL Co.,Ltd. Address before: 130616 Jilin province Changchun Shuangyang Economic Development Zone on the road No. 1 Patentee before: Jilin Yixin pharmaceutical Limited by Share Ltd. |
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Granted publication date: 20050615 |