JP2635009C

JP2635009C -

Info

Publication number: JP2635009C
Authority: JP; Japan
Prior art keywords: elcatonin; aqueous solution; preparation; reference example; ionic strength
Prior art date: 1999-10-04
Legal status : Expired - Lifetime

Application number

Other languages

English (en)

Japanese (ja)

Original Assignee

旭化成工業株式会社

Publication date

1999-10-04

Links

JYSJVJJVLNYRKL-QPHHPWFVSA-N Elcatonin Chemical compound N([C@H](C(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC=1NC=NC=1)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](C(C)C)C(=O)NCC(=O)N[C@@H](C)C(=O)NCC(=O)N[C@@H]([C@@H](C)O)C(=O)N1[C@@H](CCC1)C(N)=O)C(C)C)C(=O)C1CCCCCC(=O)OC[C@H](N)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)O)C(=O)N1 JYSJVJJVLNYRKL-QPHHPWFVSA-N 0.000 claims description 64
229960000756 Elcatonin Drugs 0.000 claims description 64
239000007864 aqueous solution Substances 0.000 claims description 33
239000000203 mixture Substances 0.000 claims description 31
238000002360 preparation method Methods 0.000 claims description 26
239000003708 ampul Substances 0.000 claims description 23
JVTAAEKCZFNVCJ-UHFFFAOYSA-M lactate Chemical compound CC(O)C([O-])=O JVTAAEKCZFNVCJ-UHFFFAOYSA-M 0.000 claims description 14
239000003513 alkali Substances 0.000 claims description 11
239000004480 active ingredient Substances 0.000 claims description 10
239000005388 borosilicate glass Substances 0.000 claims description 7
UIIMBOGNXHQVGW-UHFFFAOYSA-M buffer Substances [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims description 7
102000004190 Enzymes Human genes 0.000 claims 1
108090000790 Enzymes Proteins 0.000 claims 1
239000007972 injectable composition Substances 0.000 claims 1
239000011780 sodium chloride Substances 0.000 description 20
239000007924 injection Substances 0.000 description 19
FAPWRFPIFSIZLT-UHFFFAOYSA-M sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 18
239000000243 solution Substances 0.000 description 17
239000011521 glass Substances 0.000 description 16
238000002347 injection Methods 0.000 description 16
KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 12
150000003839 salts Chemical class 0.000 description 11
239000004310 lactic acid Substances 0.000 description 10
235000014655 lactic acid Nutrition 0.000 description 10
230000000052 comparative effect Effects 0.000 description 7
WCUXLLCKKVVCTQ-UHFFFAOYSA-M potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 description 6
159000000000 sodium salts Chemical class 0.000 description 6
QZNNVYOVQUKYSC-JEDNCBNOSA-N (2S)-2-amino-3-(1H-imidazol-5-yl)propanoic acid;hydron;chloride Chemical compound Cl.OC(=O)[C@@H](N)CC1=CN=CN1 QZNNVYOVQUKYSC-JEDNCBNOSA-N 0.000 description 5
230000000694 effects Effects 0.000 description 5
238000009472 formulation Methods 0.000 description 5
VEXZGXHMUGYJMC-UHFFFAOYSA-N HCl Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 4
150000001875 compounds Chemical class 0.000 description 4
239000003814 drug Substances 0.000 description 4
XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 4
229940001447 Lactate Drugs 0.000 description 3
QTBSBXVTEAMEQO-UHFFFAOYSA-N acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 3
239000007853 buffer solution Substances 0.000 description 3
125000003178 carboxy group Chemical group [H]OC(*)=O 0.000 description 3
239000007979 citrate buffer Substances 0.000 description 3
239000001103 potassium chloride Substances 0.000 description 3
235000011164 potassium chloride Nutrition 0.000 description 3
VMHLLURERBWHNL-UHFFFAOYSA-M sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 description 3
239000001632 sodium acetate Substances 0.000 description 3
235000017281 sodium acetate Nutrition 0.000 description 3
HEMHJVSKTPXQMS-UHFFFAOYSA-M sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
BFNBIHQBYMNNAN-UHFFFAOYSA-N Ammonium sulfate Chemical compound N.N.OS(O)(=O)=O BFNBIHQBYMNNAN-UHFFFAOYSA-N 0.000 description 2
QWCKQJZIFLGMSD-VKHMYHEASA-N L-α-aminobutyrate zwitterion Chemical compound CC[C@H](N)C(O)=O QWCKQJZIFLGMSD-VKHMYHEASA-N 0.000 description 2
229940005581 Sodium Lactate Drugs 0.000 description 2
NGSFWBMYFKHRBD-UHFFFAOYSA-M Sodium lactate Chemical compound [Na+].CC(O)C([O-])=O NGSFWBMYFKHRBD-UHFFFAOYSA-M 0.000 description 2
KDYFGRWQOYBRFD-UHFFFAOYSA-N Succinic acid Chemical compound OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 description 2
229910052921 ammonium sulfate Inorganic materials 0.000 description 2
235000011130 ammonium sulphate Nutrition 0.000 description 2
239000003795 chemical substances by application Substances 0.000 description 2
238000007796 conventional method Methods 0.000 description 2
229940079593 drugs Drugs 0.000 description 2
238000004128 high performance liquid chromatography Methods 0.000 description 2
238000011081 inoculation Methods 0.000 description 2
238000005259 measurement Methods 0.000 description 2
239000006174 pH buffer Substances 0.000 description 2
238000007911 parenteral administration Methods 0.000 description 2
102000004196 processed proteins & peptides Human genes 0.000 description 2
108090000765 processed proteins & peptides Proteins 0.000 description 2
AYRVGWHSXIMRAB-UHFFFAOYSA-M sodium acetate trihydrate Chemical compound O.O.O.[Na+].CC([O-])=O AYRVGWHSXIMRAB-UHFFFAOYSA-M 0.000 description 2
239000001540 sodium lactate Substances 0.000 description 2
235000011088 sodium lactate Nutrition 0.000 description 2
RAHZWNYVWXNFOC-UHFFFAOYSA-N sulphur dioxide Chemical compound O=S=O RAHZWNYVWXNFOC-UHFFFAOYSA-N 0.000 description 2
239000004094 surface-active agent Substances 0.000 description 2
238000005406 washing Methods 0.000 description 2
241000972773 Aulopiformes Species 0.000 description 1
206010020583 Hypercalcaemia Diseases 0.000 description 1
208000003393 Mammary Paget's Disease Diseases 0.000 description 1
229940100656 Nasal Solution Drugs 0.000 description 1
208000010191 Osteitis Deformans Diseases 0.000 description 1
208000001132 Osteoporosis Diseases 0.000 description 1
229960001304 POTASSIUM LACTATE Drugs 0.000 description 1
PHZLMBHDXVLRIX-UHFFFAOYSA-M Potassium lactate Chemical compound [K+].CC(O)C([O-])=O PHZLMBHDXVLRIX-UHFFFAOYSA-M 0.000 description 1
HELHAJAZNSDZJO-UHFFFAOYSA-L Sodium tartrate Chemical compound [Na+].[Na+].[O-]C(=O)C(O)C(O)C([O-])=O HELHAJAZNSDZJO-UHFFFAOYSA-L 0.000 description 1
229960002167 Sodium tartrate Drugs 0.000 description 1
238000010521 absorption reaction Methods 0.000 description 1
230000003139 buffering Effects 0.000 description 1
BBBFJLBPOGFECG-VJVYQDLKSA-N calcitonin Chemical compound N([C@H](C(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC=1NC=NC=1)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)NCC(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H]([C@@H](C)O)C(=O)N1[C@@H](CCC1)C(N)=O)C(C)C)C(=O)[C@@H]1CSSC[C@H](N)C(=O)N[C@@H](CO)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)O)C(=O)N1 BBBFJLBPOGFECG-VJVYQDLKSA-N 0.000 description 1
229960003773 calcitonin (salmon synthetic) Drugs 0.000 description 1
238000001514 detection method Methods 0.000 description 1
239000012153 distilled water Substances 0.000 description 1
238000010828 elution Methods 0.000 description 1
239000003623 enhancer Substances 0.000 description 1
230000002708 enhancing Effects 0.000 description 1
230000002349 favourable Effects 0.000 description 1
230000000148 hypercalcaemia Effects 0.000 description 1
150000002500 ions Chemical class 0.000 description 1
239000007951 isotonicity adjuster Substances 0.000 description 1
238000004519 manufacturing process Methods 0.000 description 1
230000003000 nontoxic Effects 0.000 description 1
231100000252 nontoxic Toxicity 0.000 description 1
239000001521 potassium lactate Substances 0.000 description 1
235000011085 potassium lactate Nutrition 0.000 description 1
159000000001 potassium salts Chemical class 0.000 description 1
230000002335 preservative Effects 0.000 description 1
239000003755 preservative agent Substances 0.000 description 1
235000019515 salmon Nutrition 0.000 description 1
KEAYESYHFKHZAL-UHFFFAOYSA-N sodium Chemical compound [Na] KEAYESYHFKHZAL-UHFFFAOYSA-N 0.000 description 1
239000011734 sodium Substances 0.000 description 1
229910052708 sodium Inorganic materials 0.000 description 1
239000001433 sodium tartrate Substances 0.000 description 1
235000011004 sodium tartrates Nutrition 0.000 description 1
239000003381 stabilizer Substances 0.000 description 1
238000003860 storage Methods 0.000 description 1
239000007785 strong electrolyte Substances 0.000 description 1
239000000126 substance Substances 0.000 description 1
239000001384 succinic acid Substances 0.000 description 1
QAOWNCQODCNURD-UHFFFAOYSA-L sulfate Chemical compound [O-]S([O-])(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 description 1
NINIDFKCEFEMDL-UHFFFAOYSA-N sulfur Chemical compound [S] NINIDFKCEFEMDL-UHFFFAOYSA-N 0.000 description 1
239000011593 sulfur Substances 0.000 description 1
229910052717 sulfur Inorganic materials 0.000 description 1
239000003440 toxic substance Substances 0.000 description 1
DTQVDTLACAAQTR-UHFFFAOYSA-N trifluoroacetic acid Chemical compound OC(=O)C(F)(F)F DTQVDTLACAAQTR-UHFFFAOYSA-N 0.000 description 1
238000004506 ultrasonic cleaning Methods 0.000 description 1