CN111317725A - 一种阿莫西林制剂 - Google Patents
一种阿莫西林制剂 Download PDFInfo
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- CN111317725A CN111317725A CN201811535593.6A CN201811535593A CN111317725A CN 111317725 A CN111317725 A CN 111317725A CN 201811535593 A CN201811535593 A CN 201811535593A CN 111317725 A CN111317725 A CN 111317725A
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- amoxicillin
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- LSQZJLSUYDQPKJ-NJBDSQKTSA-N amoxicillin Chemical compound C1([C@@H](N)C(=O)N[C@H]2[C@H]3SC([C@@H](N3C2=O)C(O)=O)(C)C)=CC=C(O)C=C1 LSQZJLSUYDQPKJ-NJBDSQKTSA-N 0.000 title claims abstract description 40
- 229960003022 amoxicillin Drugs 0.000 title claims abstract description 40
- LSQZJLSUYDQPKJ-UHFFFAOYSA-N p-Hydroxyampicillin Natural products O=C1N2C(C(O)=O)C(C)(C)SC2C1NC(=O)C(N)C1=CC=C(O)C=C1 LSQZJLSUYDQPKJ-UHFFFAOYSA-N 0.000 title claims abstract description 40
- 238000002360 preparation method Methods 0.000 title claims abstract description 28
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 32
- 229920002472 Starch Polymers 0.000 claims abstract description 26
- 235000019698 starch Nutrition 0.000 claims abstract description 26
- 239000008107 starch Substances 0.000 claims abstract description 26
- 229920002261 Corn starch Polymers 0.000 claims abstract description 22
- 239000008120 corn starch Substances 0.000 claims abstract description 22
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims abstract description 16
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 claims abstract description 16
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 16
- 239000002002 slurry Substances 0.000 claims abstract description 16
- 239000011734 sodium Substances 0.000 claims abstract description 13
- 229910052708 sodium Inorganic materials 0.000 claims abstract description 13
- 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 claims abstract description 10
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims abstract description 9
- 238000000034 method Methods 0.000 claims abstract description 8
- 238000002156 mixing Methods 0.000 claims description 27
- 239000000463 material Substances 0.000 claims description 23
- 239000002245 particle Substances 0.000 claims description 22
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- 238000004090 dissolution Methods 0.000 abstract description 11
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- 241000191940 Staphylococcus Species 0.000 description 3
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- 241000588724 Escherichia coli Species 0.000 description 2
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- JGSARLDLIJGVTE-MBNYWOFBSA-N Penicillin G Chemical compound N([C@H]1[C@H]2SC([C@@H](N2C1=O)C(O)=O)(C)C)C(=O)CC1=CC=CC=C1 JGSARLDLIJGVTE-MBNYWOFBSA-N 0.000 description 1
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- AGOYDEPGAOXOCK-KCBOHYOISA-N clarithromycin Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)C(=O)[C@H](C)C[C@](C)([C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)OC)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 AGOYDEPGAOXOCK-KCBOHYOISA-N 0.000 description 1
- 229960002626 clarithromycin Drugs 0.000 description 1
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- MJIHNNLFOKEZEW-UHFFFAOYSA-N lansoprazole Chemical compound CC1=C(OCC(F)(F)F)C=CN=C1CS(=O)C1=NC2=CC=CC=C2N1 MJIHNNLFOKEZEW-UHFFFAOYSA-N 0.000 description 1
- 229960003174 lansoprazole Drugs 0.000 description 1
- 229940049954 penicillin Drugs 0.000 description 1
- 208000020029 respiratory tract infectious disease Diseases 0.000 description 1
- 235000019333 sodium laurylsulphate Nutrition 0.000 description 1
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- 239000002904 solvent Substances 0.000 description 1
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- 231100000397 ulcer Toxicity 0.000 description 1
- 239000002132 β-lactam antibiotic Substances 0.000 description 1
- 229940124586 β-lactam antibiotics Drugs 0.000 description 1
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- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/425—Thiazoles
- A61K31/429—Thiazoles condensed with heterocyclic ring systems
- A61K31/43—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems
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Abstract
本发明提供一种阿莫西林制剂，其特征在于，该制剂由阿莫西林、滑石粉、玉米淀粉、淀粉浆、羧甲淀粉钠、硬脂酸镁、十二烷基硫酸钠组成。该制剂处方重量百分比为：阿莫西林80‑99.9%、滑石粉0.02‑5%、玉米淀粉0.02‑5%、淀粉浆0.02‑4%、羧甲淀粉钠0.02‑3%、硬脂酸镁0.02‑3%、十二烷基硫酸钠0.02‑3%。本发明制剂工艺简单，操作方便，溶出度高。
Description
技术领域
本发明属于化药制剂领域，具体涉及一种阿莫西林制剂及制备工艺。
背景技术
阿莫西林是一种最常用的半合成青霉素类广谱β-内酰胺类抗生素，适用于敏感菌(不产β内酰胺酶菌株)所致的下列感染：1.溶血链球菌、肺炎链球菌、葡萄球菌或流感嗜血杆菌所致中耳炎、鼻窦炎、咽炎、扁桃体炎等上呼吸道感染。2.大肠埃希菌、奇异变形杆菌或粪肠球菌所致的泌尿生殖道感染。3.溶血链球菌、葡萄球菌或大肠埃希菌所致的皮肤软组织感染。4.溶血链球菌、肺炎链球菌、葡萄球菌或流感嗜血杆菌所致急性支气管炎、肺炎等下呼吸道感染。5.急性单纯性淋病。6.本品尚可用于治疗伤寒、伤寒带菌者及钩端螺旋体病；阿莫西林亦可与克拉霉素、兰索拉唑三联用药根除胃、十二指肠幽门螺杆菌，降低消化道溃疡复发率。
口服本品后迅速吸收，约75%~90%可自胃肠道吸收，食物对药物吸收影响不显著。口服0.25g和0.5g后血药峰浓度(Cmax)分别为3.5~5.0ml/L和5.5~7.5mg/L，达峰时间为1~2小时。本品在多数组织和体液中分布良好。其制剂有胶囊、片剂、颗粒剂等。
溶出度是指药物从片剂、胶囊等固体制剂在规定溶剂中溶出的速度和程度。溶出度是固体制剂质量控制的一个重要指标，对难溶性的药物一般都应作溶出度的检查。
阿莫西林制剂在生产出来（0天）溶出度较高，经放置一段时间后溶出度下降。
发明内容
本发明旨在提供一种工艺简单，溶出度高且稳定的阿莫西林制剂。
为实现上述发明目的，本发明一种阿莫西林制剂，具体实施方案为：
本发明所述一种阿莫西林制剂，该制剂由阿莫西林 、 滑石粉、 玉米淀粉、淀粉浆、羧甲淀粉钠、硬脂酸镁、 十二烷基硫酸钠组成。
本发明所述一种阿莫西林制剂，该制剂处方重量百分比为：阿莫西林80-99.9% 、滑石粉0.02-5%、 玉米淀粉0.02-5%、淀粉浆0.02-4%、羧甲淀粉钠0.02-3%、硬脂酸镁0.02-3%、 十二烷基硫酸钠0.02-3%。
本发明所述一种阿莫西林制剂，该制剂处方重量百分比为：阿莫西林90-99.9% 、滑石粉0.02-4%、 玉米淀粉0.02-4%、淀粉浆0.02-3%、羧甲淀粉钠0.02-2%、硬脂酸镁0.02-2%、 十二烷基硫酸钠0.02-2%。
本发明所述一种阿莫西林制剂，该制剂处方重量百分比为：阿莫西林96-99.9% 、滑石粉0.96-4%、 玉米淀粉0.96-4%、淀粉浆0.02-3%、羧甲淀粉钠0.58-2%、硬脂酸镁1.15-2%、 十二烷基硫酸钠0.30-2%。
本发明所述一种阿莫西林制剂，该制剂处方重量百分比为：阿莫西林96-99.9% 、滑石粉0.96-4%、 玉米淀粉0.96-4%、淀粉浆适量、羧甲淀粉钠0.58-2%、硬脂酸镁1.15-2%、十二烷基硫酸钠0.35-2%。
本发明所述一种阿莫西林制剂，该制剂为胶囊剂。
本发明所述一种阿莫西林制剂，该制剂制备工艺步骤为：制备辅料颗粒，制备辅料颗粒与原料颗粒总混，总混后的颗粒检测含量后按标示量进行胶囊填充，内包装，外包装。
进一步地，本发明的处方，按1000个制剂单位每个制剂单位含250mg(C16H19N3O5S)计算如下：
阿莫西林 250g(折纯)
滑石粉 2.5g
玉米淀粉 2.5g
淀粉浆 适量
羧甲淀粉钠 1.5g
硬脂酸镁 3.0g
十二烷基硫酸钠 0.7g
具体步骤和工艺参数如下：
a、称取部分玉米淀粉和纯化水，先将纯化水倒入冲浆锅内，再加入玉米淀粉，搅拌均匀后加热，边加热边搅拌，直至煮熟，将温度冷却至40～500C后，供制软材用；
b、将余下的玉米淀粉和滑石粉分别倒入混合制粒机内，干混20min，再加入适量粘合剂搅拌、切割10～20min，制粒时检查软材质量，待软材手捏成团推之即散后进行软材制粒，筛网目数为14目～18目，边制粒边铺盘，铺盘厚度1.5～2.5cm；
c、将装有湿颗粒的烤盘送入烘箱中进行烘烤，温度控制在60～800C之间，烘烤至物料6～7成干时翻料一次，以后每小时翻料一次，颗粒水分合格后停止烘烤，待颗粒温度降至室温时，装桶称重；
d、将颗粒用12目～60目筛网进行筛分后的中间产品装桶称重，填写物料标签，桶内桶外各放一张；
e、将羧甲淀粉钠、辅料粒子、硬脂酸镁、十二烷基硫酸钠加入混合机中，开机转动1min饱和设备后停机，按等量递加法加入阿莫西林，每次混合5min，最后一步加入阿莫西林时，总混30min，混合均匀后停机；将混合后的中间产品装入内衬洁净袋的周转桶内，称重，并在每桶的桶内、桶外各放一张物料标签；
f、等量递加法(指令中所有辅料数量为A)：第一步加入辅料A， 开机转动1min，第二步加入等量的原料A，混合5min，第三步加入原料2A，混合5min，第四步加入原料4A，混合5min，以此类推，当最后一步不足倍数时，按实际剩余量一次加入；
g、总混后的颗粒检测含量后按标示量进行胶囊填充（或压片，或颗粒分装），包装即得。
本发明的优点：
工艺简单，操作方便，溶出度高。
具体实施方式
下面实施例只为进一步说明本发明，不以任何形式限制本发明范围。
实施例1：本发明的处方，按1000个制剂单位每个制剂单位含250mg(C16H19N3O5S)计算如下：
阿莫西林 250g(折纯)
滑石粉 2.5g
玉米淀粉 2.5g
淀粉浆 适量
羧甲淀粉钠 1.5g
硬脂酸镁 3.0g
十二烷基硫酸钠 0.7g
实施例2：本发明的处方，按1000个制剂单位每个制剂单位含250mg(C16H19N3O5S)计算如下：
阿莫西林 250g(折纯)
滑石粉 2g
玉米淀粉 2g
淀粉浆 适量
羧甲淀粉钠 1g
硬脂酸镁 2g
十二烷基硫酸钠 0.5g
实施例3：本发明的处方，按1000个制剂单位每个制剂单位含250mg(C16H19N3O5S)计算如下：
阿莫西林 250g(折纯)
滑石粉 3g
玉米淀粉 3g
淀粉浆 适量
羧甲淀粉钠 2g
硬脂酸镁 2g
十二烷基硫酸钠 1g
实施例1-3的具体步骤和工艺参数如下：
a、称取部分玉米淀粉和纯化水，先将纯化水倒入冲浆锅内，再加入玉米淀粉，搅拌均匀后加热，边加热边搅拌，直至煮熟，将温度冷却至40～500C后，供制软材用。
b、将余下的玉米淀粉和滑石粉分别倒入混合制粒机内，干混20min，再加入适量粘合剂搅拌、切割10～20min，制粒时检查软材质量，待软材手捏成团推之即散后进行软材制粒，筛网目数为14目～18目，边制粒边铺盘，铺盘厚度1.5～2.5cm。
、将装有湿颗粒的烤盘送入烘箱中进行烘烤，温度控制在60～800C之间，烘烤至物料6～7成干时翻料一次，以后每小时翻料一次，颗粒水分合格后停止烘烤，待颗粒温度降至室温时，装桶称重。
d、将颗粒用12目～60目筛网进行筛分后的中间产品装桶称重，填写物料标签，桶内桶外各放一张。
、将羧甲淀粉钠、辅料粒子、硬脂酸镁、十二烷基硫酸钠加入混合机中，开机转动1min饱和设备后停机，按等量递加法加入阿莫西林，每次混合5min，最后一步加入阿莫西林时，总混30min，混合均匀后停机。将混合后的中间产品装入内衬洁净袋的周转桶内，称重，并在每桶的桶内、桶外各放一张物料标签。
、等量递加法(指令中所有辅料数量为A)：第一步加入辅料A， 开机转动1min，第二步加入等量的原料A，混合5min，第三步加入原料2A，混合5min，第四步加入原料4A，混合5min，以此类推，当最后一步不足倍数时，按实际剩余量一次加入。
、总混后的颗粒检测含量后按标示量进行胶囊填充（或压片，或颗粒分装），包装即得。
本发明技术实施例1-3与改进前样品加速试验溶出度（中国药典标准≥80%）对比数据如下：
结论：以上结果表明，本发明所制得的阿莫西林胶囊体外溶出度好，生物利用度高。
Claims (5)
1.一种阿莫西林制剂，其特征在于，该制剂由阿莫西林 、 滑石粉、 玉米淀粉、淀粉浆、羧甲淀粉钠、硬脂酸镁、 十二烷基硫酸钠组成。
2.根据权利要求1所述一种阿莫西林制剂，其特征在于，该制剂处方重量百分比为：阿莫西林80-99.9% 、 滑石粉0.02-5%、 玉米淀粉0.02-5%、淀粉浆0.02-4%、羧甲淀粉钠0.02-3%、硬脂酸镁0.02-3%、 十二烷基硫酸钠0.02-3%。
3.根据权利要求1所述一种阿莫西林制剂，其特征在于，该制剂处方重量百分比为：阿莫西林90-99.9% 、 滑石粉0.02-4%、 玉米淀粉0.02-4%、淀粉浆0.02-3%、羧甲淀粉钠0.02-2%、硬脂酸镁0.02-2%、 十二烷基硫酸钠0.02-2%。
4.根据权利要求1-3任一项所述一种阿莫西林制剂，其特征在于，该制剂为胶囊剂。
5.根据权利要求1-3任一项所述一种阿莫西林制剂，其特征在于，该制剂制备工艺步骤为：制备辅料颗粒，制备辅料颗粒与原料颗粒总混，总混后的颗粒检测含量后按标示量进行胶囊填充，内包装，外包装。
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| CN104856972A (zh) * | 2015-03-27 | 2015-08-26 | 华北制药股份有限公司 | 阿莫西林胶囊及其制备方法 |
| CN104887645A (zh) * | 2015-06-15 | 2015-09-09 | 吉林万通药业集团梅河药业股份有限公司 | 阿莫西林胶囊及其制备方法 |
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| CN101146828A (zh) * | 2005-03-23 | 2008-03-19 | Bpsi控股有限公司 | 聚结的淀粉组合物 |
| CN104856972A (zh) * | 2015-03-27 | 2015-08-26 | 华北制药股份有限公司 | 阿莫西林胶囊及其制备方法 |
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