CN109692162A - 一种头孢拉定药物制剂 - Google Patents
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Abstract
本发明一种头孢拉定药物制剂,其特征在于该药物制剂处方重量份数计为:头孢拉定200‑300份,辅料是:滑石粉40‑50份、淀粉40‑50份、淀粉浆适量、羧甲淀粉钠1‑5份、滑石粉1‑5份、硬脂酸镁1‑5份、十二烷基硫酸钠0.1‑3份。上述各种有效成分针对敏感菌所致的感染具有显著疗效,使患者很快见效,药效明显,治疗时间短,疗效显著。其生产工艺解决了现有湿法制粒工艺中头孢拉定受高温高湿影响而降解的缺陷。
Description
技术领域
本发明属于药物制剂领域,具体涉及一种头孢拉定药物制剂。
背景技术
头孢拉定为第一代头孢菌素,对不产青霉素酶和产青霉素酶金黄色葡萄球菌、凝固酶阴性葡萄球菌、A组溶血性链球菌、肺炎链球菌和草绿色链球菌等革兰阳性球菌的部分菌株具良好抗菌作用。储存要求阴凉贮存(20℃以下)。在日常流通过程,往往头孢拉定胶囊储存差异较大,受环境温度、湿度等因素影响明显,如发生上述情况时,其主要表现在头孢拉定胶囊活性成分会降解,从而影响药效与治疗效果。本发明公开了一种头孢拉定胶囊制剂生产工艺改进方法,其解决了现有湿法制粒工艺中头孢拉定受高温高湿影响而降解的缺陷。它主要包括辅料制粒、原辅料总混、全自动胶囊机充填、铝塑泡罩包装机铝包、外包装等工序。
发明内容
本发明旨在提供一种不受高温高湿影响而降解的头孢拉定药物制剂。
为实现上述发明目的,本发明技术方案为:
本发明所述一种头孢拉定药物制剂,该药物制剂包括头孢拉定和药用辅料。
本发明所述一种头孢拉定药物制剂,该药物制剂处方重量份数计为:头孢拉定200-300份,辅料是:滑石粉40-50份、淀粉40-50份、淀粉浆适量、羧甲淀粉钠1-5份、滑石粉1-5份、硬脂酸镁1-5份、十二烷基硫酸钠0.1-3份。
本发明所述一种头孢拉定药物制剂,其特征在于该药物制剂制备方法为:
(1)粘合剂制备:取玉米淀粉和纯化水,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40~50℃后,供制软材用;
(2)软材制备:玉米淀粉和滑石粉(内加)按先后顺序倒入湿法制粒机内,干混,再加入适量粘合剂搅拌、切割,进行软材制粒,筛网目数为18目~20目;
(3)软材干燥:温度控制在60~80℃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,备用;
(4)整粒、筛分:选择12目筛网,将干燥颗粒置于摇摆式颗粒机内进行整粒;
(5)总混:第一步将约1/2的辅料粒子加入混合机中,开机转动1min饱和设备,第二步加入羧甲淀粉钠、滑石粉、硬脂酸镁、十二烷基硫酸钠、约1/5的原料,混合,第三步将剩余原料和辅料粒子全部加入,混合,混合均匀后充填即得。
本发明生产工艺分析:
1. 本发明原料不再加粘合剂经湿法制粒制成颗粒干燥总混后灌装,而是先将辅料制粒干燥,再将原料与辅料总混灌装。
2. 原料未经过高温高湿的制粒干燥过程而直接总混灌装,含量下降小,杂质少,灌装时装量稳定,装量差异符合质量标准。
3. 生产全过程中严格控制环境温湿度要求,使其相对湿度低于产品临界湿度,以降低成品水分指标。
4. 生产全过程中避免本品烘烤干燥(超过35℃),使其保持低温状态,以降低温度对活性成分的降解。
本发明有益效果:
本发明采取全粉末灌装工艺,将头孢拉定与处方量辅料总混均匀后,直接使用全自动胶囊充填机灌装成胶囊,制剂过程未经历高温高湿,产品不易开环降解,杂质少,且节约了人工和能耗。
本发明的头孢拉定胶囊的药理如下:本发明的头孢拉定胶囊为第一代头孢菌素,对不产青霉素酶和产青霉素酶金黄色葡萄球菌、凝固酶阴性葡萄球菌、A组溶血性链球菌、肺炎链球菌、草绿色链球菌等革兰阳性球菌的部分菌株具有良好的抗菌作用。厌氧革兰阳性菌对本产品敏感,脆弱拟杆菌对本产品呈现耐药性。耐甲氧西林葡萄球菌属、肠球菌属对本产品呈现耐药性。本产品对革兰阳性菌与革兰阴性菌的作用与头孢氨苄相似。本产品对淋病奈瑟菌有一定作用,对产酶淋病奈瑟菌也具活性,对流感嗜血杆菌的活性较差。作用机制与其他头孢菌素相同,作用机制为抑制细菌细胞壁的合成。上述各种有效成分针对敏感菌所致的感染具有显著疗效,使患者很快见效,药效明显,治疗时间短,疗效显著。
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
处方:头孢拉定250份,辅料是:滑石粉45份、淀粉45份、淀粉浆适量、羧甲淀粉钠3份、滑石粉3份、硬脂酸镁4份、十二烷基硫酸钠1份。
制备工艺:
(1)粘合剂制备:取玉米淀粉和纯化水,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40~50℃0C后,供制软材用;
(2)软材制备:玉米淀粉和滑石粉(内加)按先后顺序倒入湿法制粒机内,干混20min,再加入适量粘合剂搅拌、切割10~20min,进行软材制粒,筛网目数为18目~20目;
(3)软材干燥:温度控制在60~80℃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,备用;
(4)整粒、筛分:选择12目筛网,将干燥颗粒置于摇摆式颗粒机内进行整粒;
(5)总混:第一步将约1/2的辅料粒子加入混合机中,开机转动1min饱和设备,第二步加入羧甲淀粉钠、滑石粉、硬脂酸镁、十二烷基硫酸钠、约1/5的原料,混合20min,第三步将剩余原料和辅料粒子全部加入,混合40min,混合均匀后胶囊充填即得。
实施例2
处方:头孢拉定200份,辅料是:滑石粉40份、淀粉40份、淀粉浆适量、羧甲淀粉钠1份、滑石粉1份、硬脂酸镁1份、十二烷基硫酸钠0.1份。
制备工艺:
(1)粘合剂制备:取玉米淀粉和纯化水,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40~50℃后,供制软材用;
(2)软材制备:玉米淀粉和滑石粉(内加)按先后顺序倒入湿法制粒机内,干混20min,再加入适量粘合剂搅拌、切割10~20min,进行软材制粒,筛网目数为18目;
(3)软材干燥:温度控制在60~80℃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,备用;
(4)整粒、筛分:选择12目筛网,将干燥颗粒置于摇摆式颗粒机内进行整粒;
(5)总混:第一步将约1/2的辅料粒子加入混合机中,开机转动1min饱和设备,第二步加入羧甲淀粉钠、滑石粉、硬脂酸镁、十二烷基硫酸钠、约1/5的原料,混合20min,第三步将剩余原料和辅料粒子全部加入,混合40min,混合均匀后胶囊充填即得。
实施例3
处方:头孢拉定300份,辅料是:滑石粉50份、淀粉50份、淀粉浆适量、羧甲淀粉钠5份、滑石粉5份、硬脂酸镁5份、十二烷基硫酸钠3份。
制备工艺:
(1)粘合剂制备:取玉米淀粉和纯化水,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40~50℃后,供制软材用;
(2)软材制备:玉米淀粉和滑石粉(内加)按先后顺序倒入湿法制粒机内,干混20min,再加入适量粘合剂搅拌、切割10~20min,进行软材制粒,筛网目数为18目;
(3)软材干燥:温度控制在60~80℃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,备用;
(4)整粒、筛分:选择12目筛网,将干燥颗粒置于摇摆式颗粒机内进行整粒;
(5)总混:第一步将约1/2的辅料粒子加入混合机中,开机转动1min饱和设备,第二步加入羧甲淀粉钠、滑石粉、硬脂酸镁、十二烷基硫酸钠、约1/5的原料,混合20min,第三步将剩余原料和辅料粒子全部加入,混合40min,混合均匀后胶囊充填即得。
头孢拉定胶囊实施例1-3检测结果见下表:
。
Claims (3)
1.一种头孢拉定药物制剂,其特征在于该药物制剂包括头孢拉定和药用辅料。
2.根据权利要求1所述一种头孢拉定药物制剂,其特征在于该药物制剂处方重量份数计为:头孢拉定200-300份,辅料是:滑石粉40-50份、淀粉40-50份、淀粉浆适量、羧甲淀粉钠1-5份、滑石粉1-5份、硬脂酸镁1-5份、十二烷基硫酸钠0.1-3份。
3.根据权利要求1所述一种头孢拉定药物制剂,其特征在于该药物制剂制备方法为:
(1)粘合剂制备:取玉米淀粉和纯化水,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40~50℃后,供制软材用;
(2)软材制备:玉米淀粉和滑石粉(内加)按先后顺序倒入湿法制粒机内,干混,再加入适量粘合剂搅拌、切割,进行软材制粒,筛网目数为18目~20目;
(3)软材干燥:温度控制在60~80℃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,备用;
(4)整粒、筛分:选择12目筛网,将干燥颗粒置于摇摆式颗粒机内进行整粒;
(5)总混:第一步将约1/2的辅料粒子加入混合机中,开机转动1min饱和设备,第二步加入羧甲淀粉钠、滑石粉、硬脂酸镁、十二烷基硫酸钠、约1/5的原料,混合,第三步将剩余原料和辅料粒子全部加入,混合,混合均匀后充填即得。
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CN112972416A (zh) * | 2021-03-30 | 2021-06-18 | 海南海力制药有限公司 | 一种头孢拉定胶囊的制备方法 |
CN113081988A (zh) * | 2021-05-10 | 2021-07-09 | 河北医科大学 | 一种头孢拉定分散片及其制备方法 |
CN113081988B (zh) * | 2021-05-10 | 2022-07-12 | 河北医科大学 | 一种头孢拉定分散片及其制备方法 |
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