CN1907264A - Compound sulfanilamide suspension and preparation method thereof - Google Patents
Compound sulfanilamide suspension and preparation method thereof Download PDFInfo
- Publication number
- CN1907264A CN1907264A CN 200610040908 CN200610040908A CN1907264A CN 1907264 A CN1907264 A CN 1907264A CN 200610040908 CN200610040908 CN 200610040908 CN 200610040908 A CN200610040908 A CN 200610040908A CN 1907264 A CN1907264 A CN 1907264A
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- CN
- China
- Prior art keywords
- suspensoid
- liquid
- purified water
- weight portions
- sulfadiazine
- Prior art date
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- Granted
Links
- 229940124530 sulfonamide Drugs 0.000 title claims abstract description 29
- 238000002360 preparation method Methods 0.000 title claims description 12
- 239000000725 suspension Substances 0.000 title abstract description 56
- 150000001875 compounds Chemical class 0.000 title abstract description 8
- FDDDEECHVMSUSB-UHFFFAOYSA-N sulfanilamide Chemical compound NC1=CC=C(S(N)(=O)=O)C=C1 FDDDEECHVMSUSB-UHFFFAOYSA-N 0.000 title abstract description 4
- SEEPANYCNGTZFQ-UHFFFAOYSA-N sulfadiazine Chemical compound C1=CC(N)=CC=C1S(=O)(=O)NC1=NC=CC=N1 SEEPANYCNGTZFQ-UHFFFAOYSA-N 0.000 claims abstract description 27
- 229960004306 sulfadiazine Drugs 0.000 claims abstract description 26
- 229960005404 sulfamethoxazole Drugs 0.000 claims abstract description 23
- JLKIGFTWXXRPMT-UHFFFAOYSA-N sulphamethoxazole Chemical compound O1C(C)=CC(NS(=O)(=O)C=2C=CC(N)=CC=2)=N1 JLKIGFTWXXRPMT-UHFFFAOYSA-N 0.000 claims abstract description 23
- IEDVJHCEMCRBQM-UHFFFAOYSA-N trimethoprim Chemical compound COC1=C(OC)C(OC)=CC(CC=2C(=NC(N)=NC=2)N)=C1 IEDVJHCEMCRBQM-UHFFFAOYSA-N 0.000 claims abstract description 22
- 239000008213 purified water Substances 0.000 claims abstract description 21
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 21
- GPTONYMQFTZPKC-UHFFFAOYSA-N sulfamethoxydiazine Chemical compound N1=CC(OC)=CN=C1NS(=O)(=O)C1=CC=C(N)C=C1 GPTONYMQFTZPKC-UHFFFAOYSA-N 0.000 claims abstract description 19
- 229960002229 sulfametoxydiazine Drugs 0.000 claims abstract description 19
- 229960001082 trimethoprim Drugs 0.000 claims abstract description 15
- 239000003963 antioxidant agent Substances 0.000 claims abstract description 11
- 230000003078 antioxidant effect Effects 0.000 claims abstract description 11
- 239000000375 suspending agent Substances 0.000 claims abstract description 10
- 239000003381 stabilizer Substances 0.000 claims abstract description 9
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 8
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical group [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 36
- 239000007788 liquid Substances 0.000 claims description 27
- -1 compound sulfonamide Chemical class 0.000 claims description 19
- 238000003756 stirring Methods 0.000 claims description 17
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 12
- 239000000203 mixture Substances 0.000 claims description 12
- 238000013019 agitation Methods 0.000 claims description 9
- 230000002378 acidificating effect Effects 0.000 claims description 8
- 239000000796 flavoring agent Substances 0.000 claims description 8
- 235000013355 food flavoring agent Nutrition 0.000 claims description 8
- GEHJYWRUCIMESM-UHFFFAOYSA-L sodium sulfite Chemical compound [Na+].[Na+].[O-]S([O-])=O GEHJYWRUCIMESM-UHFFFAOYSA-L 0.000 claims description 8
- 239000000126 substance Substances 0.000 claims description 7
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 6
- 238000009835 boiling Methods 0.000 claims description 6
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims description 5
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 claims description 4
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims description 4
- 239000000661 sodium alginate Substances 0.000 claims description 4
- 235000010413 sodium alginate Nutrition 0.000 claims description 4
- 229940005550 sodium alginate Drugs 0.000 claims description 4
- 235000010265 sodium sulphite Nutrition 0.000 claims description 4
- UMGDCJDMYOKAJW-UHFFFAOYSA-N thiourea Chemical compound NC(N)=S UMGDCJDMYOKAJW-UHFFFAOYSA-N 0.000 claims description 4
- 239000003109 Disodium ethylene diamine tetraacetate Substances 0.000 claims description 3
- 235000019301 disodium ethylene diamine tetraacetate Nutrition 0.000 claims description 3
- 239000007921 spray Substances 0.000 claims description 3
- BJEPYKJPYRNKOW-REOHCLBHSA-N (S)-malic acid Chemical compound OC(=O)[C@@H](O)CC(O)=O BJEPYKJPYRNKOW-REOHCLBHSA-N 0.000 claims description 2
- WHUUTDBJXJRKMK-UHFFFAOYSA-N Glutamic acid Natural products OC(=O)C(N)CCC(O)=O WHUUTDBJXJRKMK-UHFFFAOYSA-N 0.000 claims description 2
- XSQUKJJJFZCRTK-UHFFFAOYSA-N Urea Natural products NC(N)=O XSQUKJJJFZCRTK-UHFFFAOYSA-N 0.000 claims description 2
- 235000011054 acetic acid Nutrition 0.000 claims description 2
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 claims description 2
- 235000006708 antioxidants Nutrition 0.000 claims description 2
- 235000015165 citric acid Nutrition 0.000 claims description 2
- 235000013922 glutamic acid Nutrition 0.000 claims description 2
- 239000004220 glutamic acid Substances 0.000 claims description 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 2
- 229960003943 hypromellose Drugs 0.000 claims description 2
- 239000004310 lactic acid Substances 0.000 claims description 2
- 235000014655 lactic acid Nutrition 0.000 claims description 2
- 239000001630 malic acid Substances 0.000 claims description 2
- 235000011090 malic acid Nutrition 0.000 claims description 2
- 229920000609 methyl cellulose Polymers 0.000 claims description 2
- 239000001923 methylcellulose Substances 0.000 claims description 2
- 229960002900 methylcellulose Drugs 0.000 claims description 2
- 235000010981 methylcellulose Nutrition 0.000 claims description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 2
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 2
- AKHNMLFCWUSKQB-UHFFFAOYSA-L sodium thiosulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=S AKHNMLFCWUSKQB-UHFFFAOYSA-L 0.000 claims description 2
- 235000019345 sodium thiosulphate Nutrition 0.000 claims description 2
- 239000003814 drug Substances 0.000 abstract description 11
- 229940079593 drug Drugs 0.000 abstract description 6
- 230000000694 effects Effects 0.000 abstract description 6
- 241001465754 Metazoa Species 0.000 abstract description 4
- 206010067482 No adverse event Diseases 0.000 abstract description 2
- 229940100688 oral solution Drugs 0.000 abstract description 2
- 239000000463 material Substances 0.000 abstract 1
- 229940124531 pharmaceutical excipient Drugs 0.000 abstract 1
- 150000003456 sulfonamides Chemical class 0.000 description 13
- 230000000844 anti-bacterial effect Effects 0.000 description 6
- 238000011835 investigation Methods 0.000 description 6
- 238000012360 testing method Methods 0.000 description 6
- 238000002474 experimental method Methods 0.000 description 5
- 239000000273 veterinary drug Substances 0.000 description 5
- OVBPIULPVIDEAO-LBPRGKRZSA-N folic acid Chemical compound C=1N=C2NC(N)=NC(=O)C2=NC=1CNC1=CC=C(C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=C1 OVBPIULPVIDEAO-LBPRGKRZSA-N 0.000 description 4
- 239000002245 particle Substances 0.000 description 4
- 239000000843 powder Substances 0.000 description 4
- 238000004088 simulation Methods 0.000 description 4
- 238000013112 stability test Methods 0.000 description 4
- 210000001635 urinary tract Anatomy 0.000 description 4
- 208000015181 infectious disease Diseases 0.000 description 3
- 238000002347 injection Methods 0.000 description 3
- 239000007924 injection Substances 0.000 description 3
- 238000005259 measurement Methods 0.000 description 3
- 210000002345 respiratory system Anatomy 0.000 description 3
- 238000012552 review Methods 0.000 description 3
- 208000035143 Bacterial infection Diseases 0.000 description 2
- 208000003495 Coccidiosis Diseases 0.000 description 2
- 241000287828 Gallus gallus Species 0.000 description 2
- 206010023076 Isosporiasis Diseases 0.000 description 2
- OVBPIULPVIDEAO-UHFFFAOYSA-N N-Pteroyl-L-glutaminsaeure Natural products C=1N=C2NC(N)=NC(=O)C2=NC=1CNC1=CC=C(C(=O)NC(CCC(O)=O)C(O)=O)C=C1 OVBPIULPVIDEAO-UHFFFAOYSA-N 0.000 description 2
- 206010057190 Respiratory tract infections Diseases 0.000 description 2
- 230000001580 bacterial effect Effects 0.000 description 2
- 208000022362 bacterial infectious disease Diseases 0.000 description 2
- 230000000903 blocking effect Effects 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 229960000304 folic acid Drugs 0.000 description 2
- 235000019152 folic acid Nutrition 0.000 description 2
- 239000011724 folic acid Substances 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 230000004060 metabolic process Effects 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 210000003491 skin Anatomy 0.000 description 2
- 229960002135 sulfadimidine Drugs 0.000 description 2
- 229960004257 sulfaguanidine Drugs 0.000 description 2
- BRBKOPJOKNSWSG-UHFFFAOYSA-N sulfaguanidine Chemical compound NC(=N)NS(=O)(=O)C1=CC=C(N)C=C1 BRBKOPJOKNSWSG-UHFFFAOYSA-N 0.000 description 2
- ASWVTGNCAZCNNR-UHFFFAOYSA-N sulfamethazine Chemical compound CC1=CC(C)=NC(NS(=O)(=O)C=2C=CC(N)=CC=2)=N1 ASWVTGNCAZCNNR-UHFFFAOYSA-N 0.000 description 2
- 229950003874 sulfamonomethoxine Drugs 0.000 description 2
- NHZLNPMOSADWGC-UHFFFAOYSA-N 4-amino-N-(2-quinoxalinyl)benzenesulfonamide Chemical compound C1=CC(N)=CC=C1S(=O)(=O)NC1=CN=C(C=CC=C2)C2=N1 NHZLNPMOSADWGC-UHFFFAOYSA-N 0.000 description 1
- MSTNYGQPCMXVAQ-KIYNQFGBSA-N 5,6,7,8-tetrahydrofolic acid Chemical compound N1C=2C(=O)NC(N)=NC=2NCC1CNC1=CC=C(C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=C1 MSTNYGQPCMXVAQ-KIYNQFGBSA-N 0.000 description 1
- 208000006400 Arbovirus Encephalitis Diseases 0.000 description 1
- 241000271566 Aves Species 0.000 description 1
- 206010008631 Cholera Diseases 0.000 description 1
- 208000035473 Communicable disease Diseases 0.000 description 1
- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical compound [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 description 1
- 206010052369 Encephalitis lethargica Diseases 0.000 description 1
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 1
- TYMRLRRVMHJFTF-UHFFFAOYSA-N Mafenide Chemical compound NCC1=CC=C(S(N)(=O)=O)C=C1 TYMRLRRVMHJFTF-UHFFFAOYSA-N 0.000 description 1
- 206010029148 Nephrolithiasis Diseases 0.000 description 1
- 241000283973 Oryctolagus cuniculus Species 0.000 description 1
- 206010035148 Plague Diseases 0.000 description 1
- CZPWVGJYEJSRLH-UHFFFAOYSA-N Pyrimidine Chemical compound C1=CN=CN=C1 CZPWVGJYEJSRLH-UHFFFAOYSA-N 0.000 description 1
- 208000007313 Reproductive Tract Infections Diseases 0.000 description 1
- 241000607142 Salmonella Species 0.000 description 1
- WMPXPUYPYQKQCX-UHFFFAOYSA-N Sulfamonomethoxine Chemical compound C1=NC(OC)=CC(NS(=O)(=O)C=2C=CC(N)=CC=2)=N1 WMPXPUYPYQKQCX-UHFFFAOYSA-N 0.000 description 1
- NHUHCSRWZMLRLA-UHFFFAOYSA-N Sulfisoxazole Chemical compound CC1=NOC(NS(=O)(=O)C=2C=CC(N)=CC=2)=C1C NHUHCSRWZMLRLA-UHFFFAOYSA-N 0.000 description 1
- PJSFRIWCGOHTNF-UHFFFAOYSA-N Sulphormetoxin Chemical compound COC1=NC=NC(NS(=O)(=O)C=2C=CC(N)=CC=2)=C1OC PJSFRIWCGOHTNF-UHFFFAOYSA-N 0.000 description 1
- 108010022394 Threonine synthase Proteins 0.000 description 1
- 208000037386 Typhoid Diseases 0.000 description 1
- 241000607479 Yersinia pestis Species 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000002924 anti-infective effect Effects 0.000 description 1
- 230000000845 anti-microbial effect Effects 0.000 description 1
- 239000004599 antimicrobial Substances 0.000 description 1
- 150000003851 azoles Chemical class 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000003115 biocidal effect Effects 0.000 description 1
- 210000004556 brain Anatomy 0.000 description 1
- 102000004419 dihydrofolate reductase Human genes 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 238000001033 granulometry Methods 0.000 description 1
- 230000002458 infectious effect Effects 0.000 description 1
- 208000028774 intestinal disease Diseases 0.000 description 1
- 229960003640 mafenide Drugs 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000010534 mechanism of action Effects 0.000 description 1
- 150000007523 nucleic acids Chemical class 0.000 description 1
- 102000039446 nucleic acids Human genes 0.000 description 1
- 108020004707 nucleic acids Proteins 0.000 description 1
- PBMSWVPMRUJMPE-UHFFFAOYSA-N phthalylsulfathiazole Chemical compound OC(=O)C1=CC=CC=C1C(=O)NC1=CC=C(S(=O)(=O)\N=C\2SC=CN/2)C=C1 PBMSWVPMRUJMPE-UHFFFAOYSA-N 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 229960003600 silver sulfadiazine Drugs 0.000 description 1
- 210000004872 soft tissue Anatomy 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 229960004673 sulfadoxine Drugs 0.000 description 1
- 229960000654 sulfafurazole Drugs 0.000 description 1
- KXRZBTAEDBELFD-UHFFFAOYSA-N sulfamethopyrazine Chemical compound COC1=NC=CN=C1NS(=O)(=O)C1=CC=C(N)C=C1 KXRZBTAEDBELFD-UHFFFAOYSA-N 0.000 description 1
- 229960003097 sulfaquinoxaline Drugs 0.000 description 1
- 229940072176 sulfonamides and trimethoprim antibacterials for systemic use Drugs 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 201000008297 typhoid fever Diseases 0.000 description 1
- 208000019206 urinary tract infection Diseases 0.000 description 1
- 210000002700 urine Anatomy 0.000 description 1
- 201000002498 viral encephalitis Diseases 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
A compound sulfanilamide suspensoid, it is by sulfadiazine, sulfamethoxazole, sulfamethoxydiazine, trimethoprim are regarded as the principal drug and mixed with the pharmaceutical adjuvant to make suspensoid; the suspension comprises the following components in percentage by weight: 8-12 parts of sulfadiazine, 4-8 parts of sulfamethoxazole, 2-6 parts of sulfamethoxydiazine, 2-6 parts of trimethoprim and the balance of pharmaceutical auxiliary materials; the pharmaceutical excipients comprise: pH regulator, suspending agent, sour agent, antioxidant, stabilizer and purified water; the compound sulfadiazine suspension belongs to a compound oral solution, is easy to take for animals, and has a prescription clinically used for many years, which is proved to have definite curative effect, safety and reliability, good stability and no adverse reaction.
Description
Technical field
The present invention relates generally to a kind of field of medicaments, relates in particular to a kind of compound sulfonamide suspensoid that is used for the treatment of disease in the animal body and preparation method thereof.
Background technology
Sulfonamides is the first kind chemotherapeutics that can effectively prevent and treat the general bacterial infection that the '30s is found.Now most of clinically by antibiotic and Du-6859a replacement, but because sulphonamides has some infectious disease (as epidemic encephalitis, the plague), to have curative effect good, easy to use, stable in properties, advantage such as cheap are so still account for certain status in the anti-infective medicine.
Sulfonamides and trimethoprim (TMP) trimethoprim share, and with 4: 1 or ratio use in 5: 1, clinical efficacy are obviously strengthened, and antibacterial effect strengthens several times to tens times.In recent years, abroad some sulfa drugss reflect that at home effect is fine, are the suspensoid of 40% sulfadiazine (SD), 8% trimethoprim (TMP) as " speed clothes peaceful " of French Virbac.
On the veterinary clinic there be sulfonamides commonly used now:
1. the sulphonamides that easily absorbs of enteral.
Short acting sulfonamide medicine such as sulfafurazole, sulfadimidine (SM2), sulfaquinoxaline etc., the half-life is in 10 hours.
Median acting sulfonamide medicine such as sulfadiazine (SD), Sulfamethoxazole (SMZ) etc., the half-life is in 10～24 hours.
First pyrimidine (SMM), sulfameter (SMD), fanasil (SDM), sulfalene (SMPZ) etc. between long-acting sulfonamide such as sulfanilamide.Half-life is more than 24 hours, the longlyest reaches 203 hours.
2. enteral is difficult for the sulphonamides of absorption, as sulfaguanidine (SG), phthalylsulfathiazole (PST).
3. part sulphonamides.As mafenide (SML), silver sulfadiazine (SD-Ag).
Though these three kinds of sulfonamides antimicrobial spectrums are similar, still have difference, and do not have incompatibility, be equipped with trimethoprim (TMP) after, better efficacy.The mechanism of action of trimethoprim (TMP) is to suppress the antibacterial dihydrofolate reductase, makes dihydrofoilic acid can not be reduced into tetrahydrofolic acid, stops the synthetic of bacterial nucleic acid.Share with sulphonamides, can make the folic acid metabolism of antibacterial suffer double blocking, the effect that strengthens sulphonamides reaches several times to tens times, even bactericidal action occurs, and can reduce the generation of Resistant strain.There is chemical sproof bacterial strain also can be suppressed to sulphonamides.Especially after Sulfamethoxazole (SMZ) and sulfameter (SMD) share with trimethoprim (TMP), effect significantly improved.Several drugs uses the toxicity that can reduce medicine simultaneously, and the dissolubility of sulfameter (SMD) in urine is better, is difficult for causing the kidney crystallization, and more single result of use is better.
Abroad about this product research present situation and approval and operating position: be mainly used in the control chicken colibacillosis, Salmonella infects.No. (1999) 03, the compound sulfadiazine suspension of producing as France dimension gram pharmaceutical factory limited company, its content specification is 200ml: sulfadiazine 80g+ trimethoprim 16g.
Domestic about this product research present situation and approval and operating position:
(1) tablet, sulphadiazine tablet is being a choice drug aspect the treatment brain bacterial infection, and the Sulfamethoxazole sheet is mainly used in urinary tract, respiratory tract infection, and the sulfameter sheet is mainly used in urinary tract, respiratory tract, digestive tract, skin, reproductive tract infection.Also can be used for the treatment of coccidiosis, compound sulfonamide strengthens antibacterial efficacy to the Sulfamonomethoxine sheet folic acid metabolism of double blocking antibacterial then.Be used for infection such as urinary tract, respiratory tract and skin soft tissue.These some Chinese veterinary drug allusion quotations one one of version in 2000 is all recorded.
(2) aqueous injection is mainly used in urinary tract, respiratory tract infection, and Jiangsu Province's provincial standard is also recorded, as Fu side's Sulfamethoxazole injection.
(3) powder mainly is applicable to aspects such as domestic animal respiratory tract, urinary tract infection and young stock infectious intestinal disease and Pullorum Disease, avian typhoid, fowl cholera.Can be used as the prevention and the treatment of chicken, rabbit coccidiosis simultaneously.Jiangsu Province's provincial standard is also recorded, as compound sulfonamide-5-Sulfamonomethoxine powder; Be used for the antimicrobial drug aspect, as Fu side's Sulfamethoxazole powder.
Domestic most preparation producer all produces its various preparations, as tablet, injection, powder etc.Comparatively wide in clinical use, but also do not have manufacturer production sulfanilamide suspending agent.
Summary of the invention
The object of the invention provide a kind of stability better, the compound sulfonamide suspensoid that is easy to take and preparation method thereof.
In order to achieve the above object, the present invention can be implemented by the following technical programs:
A kind of compound sulfonamide suspensoid, it is for being that principal agent is equipped with the formulated suspensoid of excipient substance with sulfadiazine, Sulfamethoxazole, sulfameter, trimethoprim.
The percentage by weight of each composition is in the described suspensoid: sulfadiazine 8～12, Sulfamethoxazole 4～8, sulfameter 2～6, trimethoprim 2～6, all the other are excipient substance.
Described excipient substance comprises: acidity-basicity regulator, suspending agent, acidic flavoring agent, antioxidant, stabilizing agent and purified water.
Described acidity-basicity regulator is a sodium hydroxide, and the purity of described sodium hydroxide is greater than 96%.
Described suspending agent is a kind of or two or more at least mixture in sodium alginate, methylcellulose, hypromellose, the polyvinylpyrrolidone.
Described acidic flavoring agent is a kind of or two or more at least mixture in citric acid, lactic acid, acetic acid, malic acid, the glutamic acid.
Described antioxidant is a kind of or two or more at least mixture in sodium sulfite, antioxidant, sodium thiosulfate, the thiourea.
Described stabilizing agent is one or both mixture in ethylenediaminetetraacetic acid, the disodium EDTA.
The percentage by weight of each composition is in the described suspensoid: sulfadiazine 8～12, Sulfamethoxazole 4～8, sulfameter 2～6, trimethoprim 2～6, acidity-basicity regulator 4～5, suspending agent 0.6～1, acidic flavoring agent 0.8～1.2, antioxidant 0.25～0.5, stabilizing agent 0.05～0.1, all the other are purified water.
The present invention can also further be implemented by the following technical programs:
A kind of preparation method of compound sulfonamide suspensoid, it comprises the steps:
(1) get the suspending agent of 0.6～1 weight portion, the stabilizing agent of 0.05～0.1 weight portion, the purified water that adds 20 weight portions is soaked, dissolve A liquid
(2) get the purified water of 28 weight portions, the sodium hydroxide stirring and dissolving that adds 3.5～4 weight portions, add the sulfadiazine of 8～12 weight portions, the Sulfamethoxazole of 4～8 weight portions, the sulfameter of 2～6 weight portions respectively, heat while stirring to dissolving fully, water-bath is cooled to room temperature, gets B liquid;
(3) get the purified water of 40 weight portions and add the acidic flavoring agent of 0.8～1.2 weight portion, the antioxidant stirring and dissolving of 0.25～0.5 weight portion, add the trimethoprim of 2～6 weight portions again, be heated to boiling after, keep boiling 5～10 minutes, C liquid;
(4) sodium hydroxide of getting 0.5～1 weight portion adds the purified water stirring and dissolving of 1 weight portion, D liquid;
(5) described A liquid is added Agitation Tank and stirring;
(6) the described C liquid of temperature at 70～80 ℃ is joined in the Agitation Tank, and sprays immediately or drip described D liquid, continue to stir and be cooled to 40 ℃ after add described B liquid;
(7) adding purified water to the liquid in the Agitation Tank reaches 100 weight portions and promptly obtains described suspensoid.
The invention has the beneficial effects as follows: compound sulfadiazine suspension belongs to the compound oral solution, and it is easy to take for animal, and its prescription uses for many years clinically, is proved to be determined curative effect, and safe and reliable, good stability has no adverse reaction.
The specific embodiment
Embodiment 1:
A kind of compound sulfonamide suspensoid, its prescription is:
Sulfadiazine (SD) 10kg
Sulfamethoxazole (SMZ) 6kg
Sulfameter (SMD) 4kg
Trimethoprim (TMP) 4kg
Sodium alginate 0.8kg
Citric acid 1kg
Sodium hydroxide (1) (purity 96%) 3.9kg
Sodium hydroxide (2) (purity 96%) 0.6kg
Sodium sulfite 0.25kg
Disodium EDTA 0.05kg
Purified water adds to 100L
The preparation method of described compound sulfonamide suspensoid comprises the steps:
(1) gets sodium alginate, the EDTA-2Na that measures in the prescription, add 20 liters of soaked overnight of purified water, dissolving---A liquid
(2) get sodium hydroxide (1) stirring and dissolving that 28 liters of purified water add amount in the prescription, the sulfadiazine (SD), Sulfamethoxazole (SMZ), the sulfameter (SMD) that add amount in the prescription respectively, heat while stirring to dissolving fully, water-bath is cooled to room temperature, and is standby---B liquid
(3) get 40 liters of citric acid, sodium sulfite stirring and dissolving that add amount in the prescription of purified water, after the trimethoprim (TMP) of amount is heated to boiling in the adding prescription, keep boiling 5 minutes.---C liquid
(4) getting the sodium hydroxide of measuring in the prescription (2), to add 1 liter of stirring and dissolving of purified water standby---D liquid
(5) A liquid adding Agitation Tank, startup blender are stirred;
(6) the described C liquid of temperature at 70～80 ℃ is joined in the Agitation Tank, and sprays immediately or drip described D liquid, continue to stir and be cooled to 40 ℃ after add described B liquid;
(7) adding purified water to the liquid in the Agitation Tank reaches 100 weight portions and promptly obtains described suspensoid.
The following is the stability test that described compound sulfonamide suspensoid is carried out, comprise that exposure experiments to light, accelerated test and room temperature keep sample to investigate test, concrete testing data sees the following form:
1, influence factor's test---exposure experiments to light
Sample source: laboratory products
Sample requirement: 3 batches, the simulation commercially available back
Sample products lot number: 20020818,20020819,20020820.
Investigation project: determine that according to " crude drug and preparation stability high spot reviews repertory " in " the veterinary drug stability test technical specification (trying) " of the Ministry of Agriculture's promulgation investigation project of this product is character, content, settling volume ratio, fineness of the particles, catabolite.
At ambient temperature, this product is removed outer package sample is poured in the plate, under 4500 ± 500lx light intensity, place, and sampling after 5,10 days, measurement result sees Table 1.
Table 1. exposure experiments to light result (4500 ± 500lx)
| Lot number | Time (my god) | Character | The volume settling ratio | Catabolite | Content % | |||
| Sulfadiazine | Sulfamethoxazole | Sulfameter | Trimethoprim | |||||
| 2002081 8 | 0 5 10 | White suspension white suspension white suspension | 0.98 0.98 0.99 | -- - | 99.2％ 99.6％ 98.9％ | 99.2％ 99.6％ 100.2％ | 99.9％ 98.3％ 99.4％ | 99.2％ 99.6％ 98.7％ |
| 2002081 9 | 0 5 10 | White suspension white suspension white suspension | 0.97 0.98 0.97 | -- - | 99.9％ 99.2％ 100.0％ | 99.5％ 99.2％ 100.0％ | 98.3％ 99.2％ 100.0％ | 99.9％ 99.2％ 100.0％ |
| 2002082 0 | 0 5 10 | White suspension white suspension white suspension | 0.97 0.94 0.98 | -- - | 99.8％ 99.2％ 100.0％ | 97.9％ 99.2％ 99.0％ | 98.6％ 99.2％ 98.6％ | 97.8％ 98.6％ 98.2％ |
2, accelerated test
Sample source: laboratory products
Sample requirement: 3 batches, the simulation commercially available back
Sample products lot number: 20020912,20020913,20020914.
Investigation project: determine that according to " crude drug and preparation stability high spot reviews repertory " in " the veterinary drug stability test technical specification (trying) " of the Ministry of Agriculture's promulgation investigation project of this product is character, content, settling volume ratio, fineness of the particles, catabolite.
The simulation commercially available back is under 75 ± 5% the condition, to examine 6 months at 40 ± 2 ℃, relative humidity (RH), and measurement result sees Table 2.
Table 2. accelerated test result (40 ± 2 ℃ of RH75 ± 5%)
| Lot number | Time (my god) | Character | The volume settling ratio | Catabolite | Content % | |||
| Sulfadiazine | Sulfamethoxazole | Sulfameter | Trimethoprim | |||||
| 2002091 2 | 1 2 3 4 5 6 | White suspension white suspension white suspension white suspension white suspension white suspension | 1.00 0.98 0.98 0.99 0.97 0.98 | -- - | 99.2％ 99.6％ 100.2％ 99.2％ 99.6％ 97.9％ | 98.2％ 99.6％ 100.2％ 99.2％ 99.6％ 97.8％ | 97.9％ 99.2％ 99.6％ 100.2％ 98.3％ 98.1％ | 97.2％ 99.6％ 100.2％ 98.2％ 99.6％ 98.2％ |
| 2002091 3 | 1 2 3 4 5 6 | White suspension white suspension white suspension white suspension white suspension white suspension | 0.99 0.98 0.99 0.95 0.97 0.95 | -- - | 97.8％ 99.6％ 100.2％ 99.2％ 99.6％ 99.2％ | 98.2％ 99.6％ 100.2％ 99.2％ 99.6％ 98.2％ | 97.9％ 99.2％ 99.6％ 100.2％ 98.3％ 99.2％ | 99.1％ 99.6％ 100.2％ 99.2％ 99.6％ 99.0％ |
| 2002091 4 | 1 2 3 4 5 6 | White suspension white suspension white suspension white suspension white suspension white suspension | 1.00 0.97 0.99 0.99 0.99 0.96 | -- - | 98.2％ 99.6％ 98.2％ 99.2％ 99.6％ 98.2％ | 99.9％ 99.6％ 101.2％ 99.2％ 99.6％ 98.8％ | 98.9％ 99.2％ 99.6％ 100.2％ 98.3％ 98.2％ | 98.6％ 99.6％ 100.2％ 99.2％ 97.6％ 98.0％ |
3, long-term experiment
Sample source: laboratory products
Sample requirement: 3 batches, the simulation commercially available back
Sample products lot number: 20010802,20010803,20010804.
Investigation project: determine that according to " crude drug and preparation stability high spot reviews repertory " in " the veterinary drug stability test technical specification (trying) " of the Ministry of Agriculture's promulgation investigation project of this product is character, content, settling volume ratio, fineness of the particles, catabolite.
This product is simulated commercially available back, is under 60 ± 5% the condition, to examine 36 months at 25 ± 2 ℃, relative humidity (RH), and measurement result sees Table 3.
Table 3. long-term experiment is investigated result (25 ± 2 ℃ of RH 60 ± 5%)
| Lot number | Time (moon) | Character | The volume settling ratio | Catabolite | Content % | |||
| Sulfadiazine | Huang An Jia Evil azoles | Sulfameter | Trimethoprim | |||||
| 20010802 | 0 3 6 9 12 18 24 36 | White suspension white suspension white suspension white suspension white suspension white suspension white suspension white suspension | 0.99 0.95 1.00 0.98 0.98 0.99 0.97 0.98 | --- | 99.1％ 98.6％ 100.2％ 98.2％ 99.6％ 97.8％ 99.6％ 100.2％ | 98.2％ 97.6％ 100.2％ 97.2％ 99.6％ 100.2％ 98.2％ 99.6％ | 100.2％ 98.3％ 99.6％ 97.9％ 99.2％ 97.8％ 99.6％ 99.6％ | 98.9％ 99.2％ 99.6％ 100.2％ 98.3％ 97.2％ 99.6％ 100.2％ |
| 20010803 | 0 3 6 9 12 18 24 36 | White suspension white suspension white suspension white suspension white suspension white suspension white suspension white suspension | 1.00 0.98 0.98 0.99 0.97 0.98 0.95 1.00 | --- | 100.2％ 99.2％ 97.8％ 99.6％ 99.6％ 97.8％ 99.6％ 100.2 | 98.6％ 99.6％ 101.2％ 99.2％ 97.6％ 99.6％ 97.8％ 99.6 | 97.9％ 99.2％ 99.6％ 100.2％ 98.3％ 99.2％ 99.6％ 99.2％ | 99.2％ 99.6％ 100.2％ 99.2％ 99.6％ 98.2％ 99.6％ 97.8％ |
| 20010804 | 0 3 6 9 12 18 24 36 | White suspension white suspension white suspension white suspension white suspension white suspension white suspension white suspension | 1.00 0.94 1.00 0.98 0.98 0.99 0.97 0.98 | --- | 99.2％ 97.6％ 98.2％ 100.2％ 99.6％ 97.2％ 99.6％ 100.2％ | 101.3％ 99.6％ 101.2％ 99.2％ 99.6％ 99.2％ 97.8％ 99.6％ | 97.2％ 99.6％ 100.2％ 98.2％ 99.6％ 99.2％ 97.8％ 99.6％ | 98.2％ 99.6％ 100.2％ 99.2％ 99.6％ 100.2％ 97.2％ 99.6％ |
Wherein: RH is a humidity;
Annotate: measure according to the 62nd page of granulometry of appendix of Chinese veterinary drug allusion quotation version in 2000, the test sample fineness of the particles of above-mentioned three kinds of situations is all at 0.1-100um.
Claims (10)
1, a kind of compound sulfonamide suspensoid is characterized in that: it is for being that principal agent is equipped with the formulated suspensoid of excipient substance with sulfadiazine, Sulfamethoxazole, sulfameter, trimethoprim.
2, compound sulfonamide suspensoid according to claim 1; It is characterized in that: the percentage by weight of each composition is in the described suspensoid: sulfadiazine 8～12, Sulfamethoxazole 4～8, sulfameter 2～6, trimethoprim 2～6, all the other are excipient substance.
3, compound sulfonamide suspensoid according to claim 1 is characterized in that: described excipient substance comprises: acidity-basicity regulator, suspending agent, acidic flavoring agent, antioxidant, stabilizing agent and purified water.
4, compound sulfonamide suspensoid according to claim 3 is characterized in that: described acidity-basicity regulator is a sodium hydroxide, and the purity of described sodium hydroxide is greater than 96%.
5, compound sulfonamide suspensoid according to claim 3 is characterized in that: described suspending agent is a kind of or two or more at least mixture in sodium alginate, methylcellulose, hypromellose, the polyvinylpyrrolidone.
6, compound sulfonamide suspensoid according to claim 3 is characterized in that: described acidic flavoring agent is a kind of or two or more at least mixture in citric acid, lactic acid, acetic acid, malic acid, the glutamic acid.
7, compound sulfonamide suspensoid according to claim 3 is characterized in that: described antioxidant is a kind of or two or more at least mixture in sodium sulfite, antioxidant, sodium thiosulfate, the thiourea.
8, compound sulfonamide suspensoid according to claim 3 is characterized in that: described stabilizing agent is one or both mixture in ethylenediaminetetraacetic acid, the disodium EDTA.
9, compound sulfonamide suspensoid according to claim 3, it is characterized in that: the percentage by weight of each composition is in the described suspensoid: sulfadiazine 8～12, Sulfamethoxazole 4～8, sulfameter 2～6, trimethoprim 2～6, acidity-basicity regulator 4～5, suspending agent 0.6～1, acidic flavoring agent 0.8～1.2, antioxidant 0.25～0.5, stabilizing agent 0.05～0.1, all the other are purified water.
10, a kind of preparation method of compound sulfonamide suspensoid, it is characterized in that: it comprises the steps:
(1) get the suspending agent of 0.6～1 weight portion, the stabilizing agent of 0.05～0.1 weight portion, the purified water that adds 20 weight portions is soaked, dissolve A liquid
(2) get the purified water of 28 weight portions, the sodium hydroxide stirring and dissolving that adds 3.5～4 weight portions, add the sulfadiazine of 8～12 weight portions, the Sulfamethoxazole of 4～8 weight portions, the sulfameter of 2～6 weight portions respectively, heat while stirring to dissolving fully, water-bath is cooled to room temperature, gets B liquid;
(3) get the purified water of 40 weight portions and add the acidic flavoring agent of 0.8～1.2 weight portion, the antioxidant stirring and dissolving of 0.25～0.5 weight portion, add the trimethoprim of 2～6 weight portions again, be heated to boiling after, keep boiling 5～10 minutes, C liquid;
(4) sodium hydroxide of getting 0.5～1 weight portion adds the purified water stirring and dissolving of 1 weight portion, D liquid;
(5) described A liquid is added Agitation Tank and stirring;
(6) the described C liquid of temperature at 70～80 ℃ is joined in the Agitation Tank, and sprays immediately or drip described D liquid, continue to stir and be cooled to 40 ℃ after add described B liquid;
(7) adding purified water to the liquid in the Agitation Tank reaches 100 weight portions and promptly obtains described suspensoid.
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