CN1582911A - 一种新的硫普罗宁冻干粉针 - Google Patents
一种新的硫普罗宁冻干粉针 Download PDFInfo
- Publication number
- CN1582911A CN1582911A CN 03153760 CN03153760A CN1582911A CN 1582911 A CN1582911 A CN 1582911A CN 03153760 CN03153760 CN 03153760 CN 03153760 A CN03153760 A CN 03153760A CN 1582911 A CN1582911 A CN 1582911A
- Authority
- CN
- China
- Prior art keywords
- tiopronin
- glycine
- drug excipient
- injection
- 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.)
- Granted
Links
- 108010058907 Tiopronin Proteins 0.000 title claims abstract description 45
- YTGJWQPHMWSCST-UHFFFAOYSA-N Tiopronin Chemical compound CC(S)C(=O)NCC(O)=O YTGJWQPHMWSCST-UHFFFAOYSA-N 0.000 title claims abstract description 44
- 229960004402 tiopronin Drugs 0.000 title claims abstract description 44
- 239000000843 powder Substances 0.000 title claims abstract description 32
- 238000002347 injection Methods 0.000 title claims abstract description 27
- 239000007924 injection Substances 0.000 title claims abstract description 27
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 33
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 25
- 150000001413 amino acids Chemical class 0.000 claims abstract description 10
- 238000003756 stirring Methods 0.000 claims abstract description 10
- 229910019142 PO4 Inorganic materials 0.000 claims abstract description 6
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims abstract description 6
- 239000010452 phosphate Substances 0.000 claims abstract description 6
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims description 44
- 239000003814 drug Substances 0.000 claims description 27
- 239000004471 Glycine Substances 0.000 claims description 23
- 229940079593 drug Drugs 0.000 claims description 23
- 239000000243 solution Substances 0.000 claims description 19
- 235000001014 amino acid Nutrition 0.000 claims description 16
- 229940024606 amino acid Drugs 0.000 claims description 16
- 238000002360 preparation method Methods 0.000 claims description 15
- HXFCUMCLVYNZDM-UHFFFAOYSA-N 2-aminoacetic acid;sodium Chemical compound [Na].NCC(O)=O HXFCUMCLVYNZDM-UHFFFAOYSA-N 0.000 claims description 9
- 239000008215 water for injection Substances 0.000 claims description 9
- -1 amino acid salts Chemical class 0.000 claims description 8
- 229910000397 disodium phosphate Inorganic materials 0.000 claims description 6
- 235000019800 disodium phosphate Nutrition 0.000 claims description 6
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims description 5
- MTCFGRXMJLQNBG-REOHCLBHSA-N (2S)-2-Amino-3-hydroxypropansäure Chemical compound OC[C@H](N)C(O)=O MTCFGRXMJLQNBG-REOHCLBHSA-N 0.000 claims description 4
- WHUUTDBJXJRKMK-UHFFFAOYSA-N Glutamic acid Natural products OC(=O)C(N)CCC(O)=O WHUUTDBJXJRKMK-UHFFFAOYSA-N 0.000 claims description 4
- QNAYBMKLOCPYGJ-REOHCLBHSA-N L-alanine Chemical compound C[C@H](N)C(O)=O QNAYBMKLOCPYGJ-REOHCLBHSA-N 0.000 claims description 4
- CKLJMWTZIZZHCS-REOHCLBHSA-N L-aspartic acid Chemical compound OC(=O)[C@@H](N)CC(O)=O CKLJMWTZIZZHCS-REOHCLBHSA-N 0.000 claims description 4
- WHUUTDBJXJRKMK-VKHMYHEASA-N L-glutamic acid Chemical compound OC(=O)[C@@H](N)CCC(O)=O WHUUTDBJXJRKMK-VKHMYHEASA-N 0.000 claims description 4
- AGPKZVBTJJNPAG-WHFBIAKZSA-N L-isoleucine Chemical compound CC[C@H](C)[C@H](N)C(O)=O AGPKZVBTJJNPAG-WHFBIAKZSA-N 0.000 claims description 4
- AYFVYJQAPQTCCC-GBXIJSLDSA-N L-threonine Chemical compound C[C@@H](O)[C@H](N)C(O)=O AYFVYJQAPQTCCC-GBXIJSLDSA-N 0.000 claims description 4
- QIVBCDIJIAJPQS-VIFPVBQESA-N L-tryptophane Chemical compound C1=CC=C2C(C[C@H](N)C(O)=O)=CNC2=C1 QIVBCDIJIAJPQS-VIFPVBQESA-N 0.000 claims description 4
- KZSNJWFQEVHDMF-BYPYZUCNSA-N L-valine Chemical compound CC(C)[C@H](N)C(O)=O KZSNJWFQEVHDMF-BYPYZUCNSA-N 0.000 claims description 4
- MTCFGRXMJLQNBG-UHFFFAOYSA-N Serine Natural products OCC(N)C(O)=O MTCFGRXMJLQNBG-UHFFFAOYSA-N 0.000 claims description 4
- AYFVYJQAPQTCCC-UHFFFAOYSA-N Threonine Natural products CC(O)C(N)C(O)=O AYFVYJQAPQTCCC-UHFFFAOYSA-N 0.000 claims description 4
- 239000004473 Threonine Substances 0.000 claims description 4
- QIVBCDIJIAJPQS-UHFFFAOYSA-N Tryptophan Natural products C1=CC=C2C(CC(N)C(O)=O)=CNC2=C1 QIVBCDIJIAJPQS-UHFFFAOYSA-N 0.000 claims description 4
- KZSNJWFQEVHDMF-UHFFFAOYSA-N Valine Natural products CC(C)C(N)C(O)=O KZSNJWFQEVHDMF-UHFFFAOYSA-N 0.000 claims description 4
- 235000004279 alanine Nutrition 0.000 claims description 4
- 235000003704 aspartic acid Nutrition 0.000 claims description 4
- OQFSQFPPLPISGP-UHFFFAOYSA-N beta-carboxyaspartic acid Natural products OC(=O)C(N)C(C(O)=O)C(O)=O OQFSQFPPLPISGP-UHFFFAOYSA-N 0.000 claims description 4
- 235000013922 glutamic acid Nutrition 0.000 claims description 4
- 239000004220 glutamic acid Substances 0.000 claims description 4
- AGPKZVBTJJNPAG-UHFFFAOYSA-N isoleucine Natural products CCC(C)C(N)C(O)=O AGPKZVBTJJNPAG-UHFFFAOYSA-N 0.000 claims description 4
- 229960000310 isoleucine Drugs 0.000 claims description 4
- 235000004400 serine Nutrition 0.000 claims description 4
- 159000000000 sodium salts Chemical class 0.000 claims description 4
- 239000004474 valine Substances 0.000 claims description 4
- 239000000470 constituent Substances 0.000 claims description 3
- 229910000403 monosodium phosphate Inorganic materials 0.000 claims description 3
- 235000019799 monosodium phosphate Nutrition 0.000 claims description 3
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 claims description 3
- ZPWVASYFFYYZEW-UHFFFAOYSA-L dipotassium hydrogen phosphate Chemical compound [K+].[K+].OP([O-])([O-])=O ZPWVASYFFYYZEW-UHFFFAOYSA-L 0.000 claims description 2
- 229910000402 monopotassium phosphate Inorganic materials 0.000 claims description 2
- 235000019796 monopotassium phosphate Nutrition 0.000 claims description 2
- PJNZPQUBCPKICU-UHFFFAOYSA-N phosphoric acid;potassium Chemical compound [K].OP(O)(O)=O PJNZPQUBCPKICU-UHFFFAOYSA-N 0.000 claims description 2
- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 claims description 2
- 150000003839 salts Chemical class 0.000 abstract description 4
- 230000001954 sterilising effect Effects 0.000 abstract description 4
- 238000004108 freeze drying Methods 0.000 abstract description 2
- 238000005303 weighing Methods 0.000 description 10
- 239000000047 product Substances 0.000 description 9
- 239000000203 mixture Substances 0.000 description 8
- 239000000126 substance Substances 0.000 description 8
- 238000009472 formulation Methods 0.000 description 6
- 239000007787 solid Substances 0.000 description 6
- 238000001914 filtration Methods 0.000 description 5
- 238000011835 investigation Methods 0.000 description 5
- 239000012982 microporous membrane Substances 0.000 description 5
- 238000012360 testing method Methods 0.000 description 5
- 238000001035 drying Methods 0.000 description 4
- 239000002510 pyrogen Substances 0.000 description 4
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 description 3
- 239000012535 impurity Substances 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 238000004659 sterilization and disinfection Methods 0.000 description 3
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 239000007864 aqueous solution Substances 0.000 description 2
- 238000002425 crystallisation Methods 0.000 description 2
- 230000008025 crystallization Effects 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 239000003937 drug carrier Substances 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 230000005496 eutectics Effects 0.000 description 2
- 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 description 2
- 239000007788 liquid Substances 0.000 description 2
- 239000002932 luster Substances 0.000 description 2
- 238000013112 stability test Methods 0.000 description 2
- 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 description 1
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 description 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 description 1
- 229920002307 Dextran Polymers 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108010010803 Gelatin Proteins 0.000 description 1
- 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 description 1
- 206010019668 Hepatic fibrosis Diseases 0.000 description 1
- 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 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- 108010009736 Protein Hydrolysates Proteins 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 239000002671 adjuvant Substances 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- 239000004411 aluminium Substances 0.000 description 1
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 1
- LFVGISIMTYGQHF-UHFFFAOYSA-N ammonium dihydrogen phosphate Chemical compound [NH4+].OP(O)([O-])=O LFVGISIMTYGQHF-UHFFFAOYSA-N 0.000 description 1
- 239000000427 antigen Substances 0.000 description 1
- 108091007433 antigens Proteins 0.000 description 1
- 102000036639 antigens Human genes 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 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 description 1
- 235000012970 cakes Nutrition 0.000 description 1
- 239000001110 calcium chloride Substances 0.000 description 1
- 229910001628 calcium chloride Inorganic materials 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 229940119744 dextran 40 Drugs 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 238000004821 distillation Methods 0.000 description 1
- 235000021463 dry cake Nutrition 0.000 description 1
- 230000002255 enzymatic effect Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 238000013467 fragmentation Methods 0.000 description 1
- 238000006062 fragmentation reaction Methods 0.000 description 1
- 239000008273 gelatin Substances 0.000 description 1
- 229920000159 gelatin Polymers 0.000 description 1
- 235000019322 gelatine Nutrition 0.000 description 1
- 235000011852 gelatine desserts Nutrition 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 235000001727 glucose Nutrition 0.000 description 1
- 230000036039 immunity Effects 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 230000003908 liver function Effects 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 230000002503 metabolic effect Effects 0.000 description 1
- 231100000252 nontoxic Toxicity 0.000 description 1
- 230000003000 nontoxic effect Effects 0.000 description 1
- 230000001473 noxious effect Effects 0.000 description 1
- YTJSFYQNRXLOIC-UHFFFAOYSA-N octadecylsilane Chemical compound CCCCCCCCCCCCCCCCCC[SiH3] YTJSFYQNRXLOIC-UHFFFAOYSA-N 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 230000003449 preventive effect Effects 0.000 description 1
- 230000022558 protein metabolic process Effects 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 235000002639 sodium chloride Nutrition 0.000 description 1
- BKHJWWRUVITKEE-UHFFFAOYSA-M sodium;2-(2-sulfanylpropanoylamino)acetate Chemical compound [Na+].CC(S)C(=O)NCC([O-])=O BKHJWWRUVITKEE-UHFFFAOYSA-M 0.000 description 1
- 238000011003 system suitability test Methods 0.000 description 1
- 239000012085 test solution Substances 0.000 description 1
Abstract
Description
药品批号 | 贮存时间(月) | 考察日期 | ||||||
性状 | 酸 度(PH) | 澄明度 | 有关物质 | 热原 | 干燥失重% | 含量% | ||
020801 | 0 | 白色粉末 | 2.25 | 符合规定 | 符合规定 | 符合规定 | 1.25 | 98.52 |
3 | 白色粉末 | 2.26 | 符合规定 | 符合规定 | 符合规定 | 1.23 | 98.46 | |
6 | 白色粉末 | 2.23 | 符合规定 | 符合规定 | 符合规定 | 1.27 | 98.75 | |
9 | 白色粉末 | 2.28 | 符合规定 | 符合规定 | 符合规定 | 1.22 | 98.61 | |
12 | 白色粉末 | 2.27 | 符合规定 | 符合规定 | 符合规定 | 1.24 | 98.58 |
药品批号 | 贮存时间(月) | 考察日期 | ||||||
性状 | 酸度(PH) | 澄明度 | 有关物质 | 热原 | 干燥失重% | 含量% | ||
020801 | 0 | 白色粉末 | 2.25 | 符合规定 | 符合规定 | 符合规定 | 1.25 | 98.52 |
1 | 白色粉末 | 2.24 | 符合规定 | 符合规定 | 符合规定 | 1.25 | 98.54 | |
2 | 白色粉末 | 2.26 | 符合规定 | 符合规定 | 符合规定 | 1.28 | 98.68 | |
9 | 白色粉末 | 2.27 | 符合规定 | 符合规定 | 符合规定 | 1.26 | 98.71 | |
12 | 白色粉末 | 2.23 | 符合规定 | 符合规定 | 符合规定 | 1.24 | 98.59 |
Claims (9)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CNB03153760XA CN100393310C (zh) | 2003-08-20 | 2003-08-20 | 一种新的硫普罗宁冻干粉针 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CNB03153760XA CN100393310C (zh) | 2003-08-20 | 2003-08-20 | 一种新的硫普罗宁冻干粉针 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1582911A true CN1582911A (zh) | 2005-02-23 |
CN100393310C CN100393310C (zh) | 2008-06-11 |
Family
ID=34597851
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CNB03153760XA Expired - Fee Related CN100393310C (zh) | 2003-08-20 | 2003-08-20 | 一种新的硫普罗宁冻干粉针 |
Country Status (1)
Country | Link |
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CN (1) | CN100393310C (zh) |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN100356912C (zh) * | 2005-07-08 | 2007-12-26 | 王建标 | 一种硫普罗宁冻干制剂及其制备方法 |
CN100389764C (zh) * | 2005-04-13 | 2008-05-28 | 广州名冠医药科技有限公司 | 一种含硫普罗宁的冻干组合物及其制备方法 |
CN100436411C (zh) * | 2006-05-18 | 2008-11-26 | 武汉远大制药集团有限公司 | 硫普罗宁氨基酸盐及其制备方法 |
CN1880301B (zh) * | 2006-05-11 | 2012-11-07 | 沈阳药科大学 | 硫普罗宁赖氨酸及其制备方法和用途 |
CN104644569A (zh) * | 2013-11-25 | 2015-05-27 | 蚌埠丰原涂山制药有限公司 | 一种硫普罗宁冻干粉针及其制备方法 |
Family Cites Families (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1404827A (zh) * | 2002-10-08 | 2003-03-26 | 河南省新谊药业股份有限公司 | 硫普罗宁制剂 |
-
2003
- 2003-08-20 CN CNB03153760XA patent/CN100393310C/zh not_active Expired - Fee Related
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN100389764C (zh) * | 2005-04-13 | 2008-05-28 | 广州名冠医药科技有限公司 | 一种含硫普罗宁的冻干组合物及其制备方法 |
CN100356912C (zh) * | 2005-07-08 | 2007-12-26 | 王建标 | 一种硫普罗宁冻干制剂及其制备方法 |
CN1880301B (zh) * | 2006-05-11 | 2012-11-07 | 沈阳药科大学 | 硫普罗宁赖氨酸及其制备方法和用途 |
CN100436411C (zh) * | 2006-05-18 | 2008-11-26 | 武汉远大制药集团有限公司 | 硫普罗宁氨基酸盐及其制备方法 |
CN104644569A (zh) * | 2013-11-25 | 2015-05-27 | 蚌埠丰原涂山制药有限公司 | 一种硫普罗宁冻干粉针及其制备方法 |
CN104644569B (zh) * | 2013-11-25 | 2018-01-02 | 马鞍山丰原制药有限公司 | 一种硫普罗宁冻干粉针及其制备方法 |
Also Published As
Publication number | Publication date |
---|---|
CN100393310C (zh) | 2008-06-11 |
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Owner name: JIANGXI OUSHI PHARMACEUTICAL CO.,LTD. Free format text: FORMER OWNER: SHENGPUHUA MEDICINE SCIENCE-TECHNOLOGY DEVELOPMET CO., LTD., BEIJING Effective date: 20060818 |
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