CN109498577A - 易溶性复方磺胺氯达嗪钠粉 - Google Patents
易溶性复方磺胺氯达嗪钠粉 Download PDFInfo
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- CN109498577A CN109498577A CN201811579873.7A CN201811579873A CN109498577A CN 109498577 A CN109498577 A CN 109498577A CN 201811579873 A CN201811579873 A CN 201811579873A CN 109498577 A CN109498577 A CN 109498577A
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- 239000000843 powder Substances 0.000 title claims abstract description 34
- 150000001875 compounds Chemical class 0.000 title claims abstract description 18
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 title claims abstract description 15
- 239000011734 sodium Substances 0.000 title claims abstract description 15
- 229910052708 sodium Inorganic materials 0.000 title claims abstract description 15
- 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 25
- 229930006000 Sucrose Natural products 0.000 claims abstract description 25
- 229960004793 sucrose Drugs 0.000 claims abstract description 25
- 229960001082 trimethoprim Drugs 0.000 claims abstract description 24
- 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 24
- ODWMXYHUKDMPTR-UHFFFAOYSA-N sodium;(4-aminophenyl)sulfonyl-(6-chloropyridazin-3-yl)azanide Chemical compound [Na+].C1=CC(N)=CC=C1S(=O)(=O)[N-]C1=CC=C(Cl)N=N1 ODWMXYHUKDMPTR-UHFFFAOYSA-N 0.000 claims abstract description 20
- 239000005720 sucrose Substances 0.000 claims abstract description 17
- 239000000203 mixture Substances 0.000 claims abstract description 12
- 238000002156 mixing Methods 0.000 claims abstract description 4
- IIZVTUWSIKTFKO-UHFFFAOYSA-N 2-hydroxypropanoic acid;5-[(3,4,5-trimethoxyphenyl)methyl]pyrimidine-2,4-diamine Chemical compound CC(O)C(O)=O.COC1=C(OC)C(OC)=CC(CC=2C(=NC(N)=NC=2)N)=C1 IIZVTUWSIKTFKO-UHFFFAOYSA-N 0.000 claims description 5
- 229960001937 trimethoprim lactate Drugs 0.000 claims description 5
- 229940124530 sulfonamide Drugs 0.000 claims description 4
- FDDDEECHVMSUSB-UHFFFAOYSA-N sulfanilamide Chemical compound NC1=CC=C(S(N)(=O)=O)C=C1 FDDDEECHVMSUSB-UHFFFAOYSA-N 0.000 claims 2
- ZWMNTFJERFRROC-UHFFFAOYSA-N 2-benzyl-3-methoxypyridine Chemical compound COC1=CC=CN=C1CC1=CC=CC=C1 ZWMNTFJERFRROC-UHFFFAOYSA-N 0.000 claims 1
- ZAMOUSCENKQFHK-UHFFFAOYSA-N Chlorine atom Chemical compound [Cl] ZAMOUSCENKQFHK-UHFFFAOYSA-N 0.000 claims 1
- 239000000460 chlorine Substances 0.000 claims 1
- 229910052801 chlorine Inorganic materials 0.000 claims 1
- ZFBGNQYKWSPQDQ-UHFFFAOYSA-N piperazine;sodium Chemical compound [Na].C1CNCCN1 ZFBGNQYKWSPQDQ-UHFFFAOYSA-N 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract description 11
- 238000000034 method Methods 0.000 abstract description 6
- 239000006185 dispersion Substances 0.000 abstract 1
- 239000003595 mist Substances 0.000 description 5
- 238000004090 dissolution Methods 0.000 description 3
- 238000003756 stirring Methods 0.000 description 3
- BEYVZYCEXAARDO-UHFFFAOYSA-N [Na].N1=NC=CC=C1.[Cl] Chemical compound [Na].N1=NC=CC=C1.[Cl] BEYVZYCEXAARDO-UHFFFAOYSA-N 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 150000003456 sulfonamides Chemical class 0.000 description 2
- PCFUWBOSXMKGIP-UHFFFAOYSA-N 2-benzylpyridine Chemical compound C=1C=CC=NC=1CC1=CC=CC=C1 PCFUWBOSXMKGIP-UHFFFAOYSA-N 0.000 description 1
- XECFTMDGCOUEKX-UHFFFAOYSA-N C(C1=CC=CC=C1)C1=NC=CC=C1.[O] Chemical compound C(C1=CC=CC=C1)C1=NC=CC=C1.[O] XECFTMDGCOUEKX-UHFFFAOYSA-N 0.000 description 1
- 241000588724 Escherichia coli Species 0.000 description 1
- 206010061126 Escherichia infection Diseases 0.000 description 1
- 206010034107 Pasteurella infections Diseases 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 229960000074 biopharmaceutical Drugs 0.000 description 1
- 238000004821 distillation Methods 0.000 description 1
- 239000012153 distilled water Substances 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 208000020612 escherichia coli infection Diseases 0.000 description 1
- 244000144972 livestock Species 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 125000000956 methoxy group Chemical group [H]C([H])([H])O* 0.000 description 1
- 201000005115 pasteurellosis Diseases 0.000 description 1
- 244000144977 poultry Species 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 239000000273 veterinary drug Substances 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/63—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
- A61K31/635—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g. sulfadiazine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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Abstract
本发明涉及本发明涉及一种易溶性复方磺胺氯达嗪钠粉。所述的配方为磺胺氯达嗪钠、甲氧苄啶、蔗糖按质量比60‑65：10‑15：20‑30的混合物。其混合方法是将甲氧苄啶和蔗糖粉混合后，将混合物通过气流粉碎机粉碎至粒度小于1μm，再与磺胺氯达嗪钠粉混合配制成产品。采用本发明的技术方案解决了产品水溶性差，部分药粉漂浮在水面，不易在水中分散问题；解决市场的需求，提供高质量的产品。
Description
技术领域
本发明提供一种易溶性复方磺胺氯达嗪钠粉，属于生物制药技术领域。
背景技术
复方磺胺氯达嗪钠粉是中国药典收载的兽药制剂品种，是有磺胺氯哒嗪钠、甲氧苄啶及蔗糖三种原辅料配制而成，主要用于畜禽大肠杆菌和巴氏杆菌感染。以前曾试生产了部分产品，产品水溶性极差，部分药粉漂浮在水面，不易在水中分散；按照市场的需求，需要提供高质量的产品，首要解决产品水溶性问题，对复方磺胺氯达嗪钠粉原辅料水溶解性的分析了解，是由于甲氧苄啶不溶于水的性质造成产品水溶性较差的问题，通过试验，为解决生产的复方磺胺氯达嗪钠粉水溶性问题提供方法。
发明内容
本发明的目的就是提供一种易溶性复方磺胺氯达嗪钠粉配制的方法，解决公司生产的复方磺胺氯达嗪钠粉水溶性差问题。本发明提供的技术方案是：
易溶性复方磺胺氯达嗪钠粉，所述的配方为磺胺氯达嗪钠、甲氧苄啶、蔗糖按质量比60-65：10-15：20-30的混合物。
进一步优选方案中所述的配方为磺胺氯达嗪钠、甲氧苄啶、蔗糖按质量比 62.5：12.5：25的混合物。
易溶性复方磺胺氯达嗪钠粉在配制过程中，将甲氧苄啶和蔗糖粉混合后，将混合物通过气流粉碎机粉碎至粒度小于0.05μm，再与磺胺氯达嗪钠粉混合配制成产品。
本发明的技术方案中，62.5g磺胺氯达嗪钠+37.5g甲氧苄啶与蔗糖(微粉混合物)的水溶性优于礼来产品水溶性效果，在试制本发明所述的“复方磺胺氯哒嗪钠粉”时，可将甲氧苄啶和蔗糖粉按配方比例混合后，将混合物通过气流粉碎机粉碎，再与磺胺氯达嗪钠粉混合配制成产品，水溶性效果最好。
附图说明
图1为62.5g磺胺氯达嗪钠+12.5g甲氧苄啶+25g蔗糖溶解效果图。
图2为62.5g磺胺氯达嗪钠+12.5g甲氧苄啶(微粉)+25g蔗糖粉溶解效果图。
图3为62.5g磺胺氯达嗪钠+12.5g乳酸甲氧苄啶+25g蔗糖溶解效果图。
图4为62.5g磺胺氯达嗪钠+37.5g甲氧苄啶与蔗糖(混合物微粉化物)溶解效果图。
图5为礼来产品溶解效果图。
图6为礼来产品搅拌溶解静置后的效果图。
具体实施方式
实施例1
试验原辅料：
磺胺氯达嗪钠粉、甲氧苄啶、乳酸甲氧苄啶、蔗糖粉，复方磺胺氯哒嗪钠粉配制试验方法：
(1)、原料微粉化：
1.甲氧苄啶1kg使用气流粉碎机粉碎微粉化至0.01-0.05μm，待用。
2.0.5kg甲氧苄啶+1kg蔗糖粉使用气流粉碎机粉碎微粉化至0.01-0.05μm，待用。
3.分别取1g甲氧苄啶+2g糖粉、1g甲氧苄啶(微粉至0.01-0.05μm)+2g 糖粉、3g(甲氧苄啶+蔗糖)微粉至0.01-0.05μm、1g乳酸甲氧苄啶+2g蔗糖，分别加入100ml蒸馏水溶解，搅拌后静置，观察溶解效果。
溶解、分散性效果对比(3g→100ml)：
(2)、混合配制：
配方：磺胺氯达嗪钠：62.5％，甲氧苄啶12.5％，蔗糖：25.0％
1.样品1：62.5g磺胺氯达嗪钠+12.5g甲氧苄啶+25g蔗糖粉，充分混合待用。
2.样品2：62.5g磺胺氯达嗪钠+12.5g甲氧苄啶(微粉至0.01-0.05μm)+25g 蔗糖粉，充分混合待用。
3.样品3：62.5g磺胺氯达嗪钠+12.5g乳酸甲氧苄啶+25g蔗糖，充分混合待用。
4.样品4：62.5g磺胺氯达嗪钠+37.5g甲氧苄啶与蔗糖(混合物微粉化至 0.01-0.05μm，其中甲氧苄啶12.5g，蔗糖25g)，充分混合待用。
5、以礼来产品康舒秘作为对照。
分别称取样品1、样品2、样品3、样品4、礼来产品各1g，分别加入100ml 蒸馏水溶解，搅拌后静置，观察溶解效果。
溶解、分散性效果对比(1g→100ml)：
Claims (4)
1.易溶性复方磺胺氯达嗪钠粉，其特征在于，所述的配方为磺胺氯达嗪钠、甲氧苄啶、蔗糖按质量比60-65：10-15：20-30的混合物。
2.根据权利要求1所述的易溶性复方磺胺氯达嗪钠粉，其特征在于，所述的配方为磺胺氯达嗪钠、甲氧苄啶、蔗糖按质量比62.5：12.5：25的混合物。
3.根据权利要求1或2所述的易溶性复方磺胺氯达嗪钠粉，其特征在于，将甲氧苄啶和蔗糖粉混合后，将混合物通过气流粉碎机粉碎至粒度小于0.05μm，再与磺胺氯达嗪钠粉混合配制成产品。
4.根据权利要求1或2所述的易溶性复方磺胺氯达嗪钠粉，其特征在于，所述的甲氧苄啶还可以为乳酸甲氧苄啶。
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101468025A (zh) * | 2007-12-26 | 2009-07-01 | 天津瑞普生物技术集团有限公司 | 一种用于防治禽大肠杆菌病的可溶性粉 |
| WO2011150481A1 (pt) * | 2010-06-01 | 2011-12-08 | Universidade Federal De Ouro Preto | Composição nanoparticulada contendo antibióticos para administração intramamária de uso animal |
| CN106880603A (zh) * | 2015-12-15 | 2017-06-23 | 北大方正集团有限公司 | 一种含有托匹司他的口腔崩解片及其制备方法 |
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2018
- 2018-12-24 CN CN201811579873.7A patent/CN109498577A/zh active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101468025A (zh) * | 2007-12-26 | 2009-07-01 | 天津瑞普生物技术集团有限公司 | 一种用于防治禽大肠杆菌病的可溶性粉 |
| WO2011150481A1 (pt) * | 2010-06-01 | 2011-12-08 | Universidade Federal De Ouro Preto | Composição nanoparticulada contendo antibióticos para administração intramamária de uso animal |
| CN106880603A (zh) * | 2015-12-15 | 2017-06-23 | 北大方正集团有限公司 | 一种含有托匹司他的口腔崩解片及其制备方法 |
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