CN112076171A - 一种复方脑蛋白水解物片及其制备工艺 - Google Patents
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Abstract
本发明公开一种复方脑蛋白水解物片及其制备工艺,涉及药品加工技术领域,按质量份数由以下组分制成:脑蛋白水解物60‑75份、谷氨酸6‑7份、硫酸软骨素钠6‑7份、微晶纤维11‑13份、维生素B 10‑12份、维生素B6 0.1‑0.3份、糊精7‑9份、碳酸钙8‑10份、玉米淀粉10‑12份,其中还包含用于包衣的硬脂酸镁3‑5份,蔗糖100‑130份和滑石粉60‑70份,将上原料依次通过制粒、干燥,整粒总混,压片,包衣后晾片制得,包衣分包隔离层、粉衣层和有色糖衣层三步进行,包衣原料均通过糖浆制的,加速了包衣的崩解时间,提高了药效时间,同时保证复方脑蛋白水解物的入口口感。
Description
技术领域
本公开属于药品加工技术领域,具体涉及一种复方脑蛋白水解物片及其制备工艺。
背景技术
脑蛋白水解物是由动物脑组织蛋白通过酶水解获得的多种氨基酸和低分子肽混合物的水溶液,是一种大脑所特有的肽能神经营养药物,能以多种方式作用于中枢神经,调节和改善神经元的代谢,促进突触的形成,诱导神经元的分化,并进一步保护神经细胞免受各种缺血和神经毒素的损害。用于改善失眠、头痛、记忆力下降、头晕及烦躁等症状,可促进脑外伤后遗症、脑血管疾病后遗症、脑炎后遗症、急性脑梗塞和急性脑外伤康复。
目前,常用的脑蛋白水解物制剂剂型主要有注射液、口服片剂等,其中口服片剂为薄膜衣片,通过将脑蛋白水解物与辅料等混合后经过喷雾制粒干燥、整粒、压片、包衣,包装等步骤制成,包衣的作用不仅起到药片的便于储藏,同时其崩解时间也直接影响药效作用,针对现有的包衣不易崩解的问题,我们提出一种复方脑蛋白水解物片及其制备工艺。
发明内容
针对现有技术的不足,本公开的目的在于提供一种复方脑蛋白水解物片及其制备工艺,以解决上述背景技术中提出的问题。
本公开的目的可以通过以下技术方案实现:一种复方脑蛋白水解物片,按质量份数由以下组分制成:脑蛋白水解物60-75份、谷氨酸6-7份、硫酸软骨素钠6-7份、微晶纤维11-13份、维生素B10-12份、维生素B60.1-0.3份、糊精7-9份、碳酸钙8-10份、玉米淀粉10-12份,其中还包含用于包衣的硬脂酸镁3-5份,蔗糖100-130份和滑石粉60-70份。
一种制备权利要求所述复方脑蛋白水解物片的制备工艺,包括以下步骤:
步骤1:配料
根据生产处方量分别称取:脑蛋白水解物60份、谷氨酸6.7份、硫酸软骨素钠6.7份、微晶纤维11.7份、维生素B10.33份、维生素B60.16份、糊精7份、碳酸钙8.5份、玉米淀粉10份各3份备用,称取50%乙醇30份,各3份备用;
步骤2:制粒
将步骤1所述原料加入到沸腾制粒机中,不包含50%乙醇,开启引风机使物料沸腾,在充分沸腾的状态下,开启蠕动泵和压缩空气,设定风机频率 40HZ,喷浆速度2.5,环境温度为25-32℃,空气湿度为25%-40%;
步骤3:干燥
打开加热装置,设定进风温度在70℃,温度控制范围:70±10℃,设定物料温度45℃,对物料进行干燥,干燥时间为3-4小时,重复以上操作二次;
步骤4:整粒、总混
将干燥好的颗粒倒入颗粒机中,用14目不锈钢筛网进行整粒,将整粒后的干颗粒加入混合机中,并将称取好的硬脂酸镁3份加入混合机内,混合时间60min;
步骤5:压片
取步骤4的颗粒放入模具中,调节压片机转速和压力进行压片。
步骤6:包衣
分别制备糖浆、有色糖浆和胶浆,将步骤5制成得压片放置在包衣锅中,依次加入胶浆、糖浆和有色糖浆,对压片依次包覆隔离层、粉衣层和有色糖衣层,然后进行表面抛光;
步骤7:晾片
将步骤6的包衣片置晾片柜中晾12~16小时,环境温度为15-25℃,空气湿度为65%-80%;
步骤8:内包和外包,将步骤7制得药片封装在铝箔纸内,然后装入包装盒内;
步骤9:寄库待检,入库。
作为本公开进一步的方案,所述步骤3进行干燥时,在物料喷入50%乙醇30份。
作为本公开进一步的方案,所述步骤6中糖浆制备步骤如下:称取30-40 份纯化水倒入夹层锅中,称取100-120份蔗糖倒入夹层锅中充分搅拌,打开蒸汽阀门,加热至沸,抱持沸腾5-8分钟,制成75%糖浆,取23.2份糖浆制胶浆。
作为本公开进一步的方案,所述步骤6中制胶浆制备方法如下:称取明胶1-2份加入5-8份纯化水中,浸泡30min,煮沸后加入75%糖浆20-25份,搅拌均匀,温度保持60℃,制成胶浆。
作为本公开进一步的方案,所述步骤6中制粉浆制备方法如下:称取滑石粉50-60份加入75%糖浆99份中充分搅拌,制成粉浆。
作为本公开进一步的方案,所述步骤6中对压片包隔离层的步骤如下:分别向包衣锅加入105-115份片芯,加入胶浆9-13份片面润湿均匀后向锅内洒入滑石粉2-3份,设定转速为5—7转/分钟,设定进风温度45℃,出风温度40℃开启机器,包裹一层直至片面干燥。
作为本公开进一步的方案,所述步骤6中对压片包粉衣层的步骤如下:向包衣锅加粉浆50-60份进行包衣,设定转速为5—7转/分钟,设定进风温度 50℃,出风温度40℃开启机器;包裹15-18层直至外观无凹凸。
作为本公开进一步的方案,所述步骤6中对压片有色糖衣层的步骤如下:向包衣锅加入有色糖浆5-7份进行包衣,设定转速为5—7转/分钟,设定进风温度35℃,出风温度30℃,包裹10-15层直至外观圆整。
作为本公开进一步的方案,所述步骤6中的抛光步骤如下:在包衣锅加入300-350份虫白蜡(石蜡)均匀洒在压片表面,设定转速为5—7转/分钟,进风温度30℃,出风温度30℃,打光至片面光洁。
本公开的有益效果:包衣分包隔离层、粉衣层和有色糖衣层三步进行,包衣原料均通过糖浆制的,加速了包衣的崩解时间,提高了药效时间,同时保证复方脑蛋白水解物的入口口感。
附图说明
为了更清楚地说明本公开实施例或现有技术中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他的附图。
图1是本公开的工艺流程图;
具体实施方式
下面将结合本公开实施例中的附图,对本公开实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本公开一部分实施例,而不是全部的实施例。基于本公开中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其它实施例,都属于本公开保护的范围。
一种复方脑蛋白水解物片,按质量份数由以下组分制成:脑蛋白水解物 60-75份、谷氨酸6-7份、硫酸软骨素钠6-7份、微晶纤维11-13份、维生素B 10-12份、维生素B60.1-0.3份、糊精7-9份、碳酸钙8-10份、玉米淀粉10-12 份,其中还包含用于包衣的硬脂酸镁3-5份,蔗糖100-130份和滑石粉60-70 份。
一种制备权利要求所述复方脑蛋白水解物片的制备工艺,包括以下步骤:
步骤1:配料
根据生产处方量分别称取:脑蛋白水解物60份、谷氨酸6.7份、硫酸软骨素钠6.7份、微晶纤维11.7份、维生素B10.33份、维生素B60.16份、糊精7份、碳酸钙8.5份、玉米淀粉10份各3份备用,称取50%乙醇30份,各3份备用;
步骤2:制粒
将步骤1所述原料加入到沸腾制粒机中,不包含50%乙醇,开启引风机使物料沸腾,在充分沸腾的状态下,开启蠕动泵和压缩空气,设定风机频率 40HZ,喷浆速度2.5,环境温度为25-32℃,空气湿度为25%-40%;
步骤3:干燥
打开加热装置,设定进风温度在70℃,温度控制范围:70±10℃,设定物料温度45℃,对物料进行干燥,干燥时间为3-4小时,重复以上操作二次;
步骤4:整粒、总混
将干燥好的颗粒倒入颗粒机中,用14目不锈钢筛网进行整粒,将整粒后的干颗粒加入混合机中,并将称取好的硬脂酸镁3份加入混合机内,混合时间60min;
步骤5:压片
取步骤4的颗粒放入模具中,调节压片机转速和压力进行压片。
步骤6:包衣
分别制备糖浆、有色糖浆和胶浆,将步骤5制成得压片放置在包衣锅中,依次加入胶浆、糖浆和有色糖浆,对压片依次包覆隔离层、粉衣层和有色糖衣层,然后进行表面抛光;
步骤7:晾片
将步骤6的包衣片置晾片柜中晾12~16小时,环境温度为15-25℃,空气湿度为65%-80%;
步骤8:内包和外包,将步骤7制得药片封装在铝箔纸内,然后装入包装盒内;
步骤9:寄库待检,入库。
优选地,所述步骤3进行干燥时,在物料喷入50%乙醇30份,乙醇吸收物料内的水分,加快了干燥效果,提高了加工效率。
优选地,所述步骤6中糖浆制备步骤如下:称取30-40份纯化水倒入夹层锅中,称取100-120份蔗糖倒入夹层锅中充分搅拌,打开蒸汽阀门,加热至沸,抱持沸腾5-8分钟,制成75%糖浆,取23.2份糖浆制胶浆。
优选地,所述步骤6中制胶浆制备方法如下:称取明胶1-2份加入5-8份纯化水中,浸泡30min,煮沸后加入75%糖浆20-25份,搅拌均匀,温度保持 60℃,制成胶浆。
优选地,所述步骤6中制粉浆制备方法如下:称取滑石粉50-60份加入 75%糖浆99份中充分搅拌,制成粉浆。
优选地,所述步骤6中对压片包隔离层的步骤如下:分别向包衣锅加入105-115份片芯,加入胶浆9-13份片面润湿均匀后向锅内洒入滑石粉2-3份,设定转速为5—7转/分钟,设定进风温度45℃,出风温度40℃开启机器,包裹一层直至片面干燥。
优选地,所述步骤6中对压片包粉衣层的步骤如下:向包衣锅加粉浆50-60 份进行包衣,设定转速为5—7转/分钟,设定进风温度50℃,出风温度40℃开启机器;包裹15-18层直至外观无凹凸。
优选地,所述步骤6中对压片有色糖衣层的步骤如下:向包衣锅加入有色糖浆5-7份进行包衣,设定转速为5—7转/分钟,设定进风温度35℃,出风温度30℃,包裹10-15层直至外观圆整。
优选地,所述步骤6中的抛光步骤如下:在包衣锅加入300-350份虫白蜡 (石蜡)均匀洒在压片表面,设定转速为5—7转/分钟,进风温度30℃,出风温度30℃,打光至片面光洁。
本公开实施例制得的药片各项性能参数如下表所示:
通过小白鼠喂养试验研究表明,对小白鼠无副作用损伤,服用一周小白鼠精力充沛,无低迷嗜睡等现象。
对于本领域技术人员而言,可以理解在不脱离本公开的原理和精神的情况下可以对这些实施例进行多种变化、修改、替换和变型。因此,从任意一处来说,都应将实施例看作是指导性的,而且是非限制性的,本公开的范围由所附权利要求而不是上述说明限定,本公开的较佳实施例而已,并不用以限制本公开,凡在本公开的精神和原则之内,所有的任何修改、等同替换、改进等,均应包含在本公开的保护范围之内。
Claims (10)
1.一种复方脑蛋白水解物片,其特征在于,按质量份数由以下组分制成:脑蛋白水解物60-75份、谷氨酸6-7份、硫酸软骨素钠6-7份、微晶纤维11-13份、维生素B10-12份、维生素B60.1-0.3份、糊精7-9份、碳酸钙8-10份、玉米淀粉10-12份,其中还包含用于包衣的硬脂酸镁3-5份,蔗糖100-130份和滑石粉60-70份。
2.一种制备权利要求所述复方脑蛋白水解物片的制备工艺,其特征在于,包括以下步骤:
步骤1:配料
根据生产处方量分别称取:脑蛋白水解物60份、谷氨酸6.7份、硫酸软骨素钠6.7份、微晶纤维11.7份、维生素B10.33份、维生素B60.16份、糊精7份、碳酸钙8.5份、玉米淀粉10份各3份备用,称取50%乙醇30份,各3份备用;
步骤2:制粒
将步骤1所述原料加入到沸腾制粒机中,不包含50%乙醇,开启引风机使物料沸腾,在充分沸腾的状态下,开启蠕动泵和压缩空气,设定风机频率40HZ,喷浆速度2.5,环境温度为25-32℃,空气湿度为25%-40%;
步骤3:干燥
打开加热装置,设定进风温度在70℃,温度控制范围:70±10℃,设定物料温度45℃,对物料进行干燥,干燥时间为3-4小时,重复以上操作二次;
步骤4:整粒、总混
将干燥好的颗粒倒入颗粒机中,用14目不锈钢筛网进行整粒,将整粒后的干颗粒加入混合机中,并将称取好的硬脂酸镁3份加入混合机内,混合时间60min;
步骤5:压片
取步骤4的颗粒放入模具中,调节压片机转速和压力进行压片。
步骤6:包衣
分别制备糖浆、有色糖浆和胶浆,将步骤5制成得压片放置在包衣锅中,依次加入胶浆、糖浆和有色糖浆,对压片依次包覆隔离层、粉衣层和有色糖衣层,然后进行表面抛光;
步骤7:晾片
将步骤6的包衣片置晾片柜中晾12~16小时,环境温度为15-25℃,空气湿度为65%-80%。
3.根据权利要求1所述的一种复方脑蛋白水解物片的制备工艺,其特征在于,所述步骤3进行干燥时,在物料喷入50%乙醇30份。
4.根据权利要求1所述的一种复方脑蛋白水解物片的制备工艺,其特征在于,所述步骤6中糖浆制备步骤如下:称取30-40份纯化水倒入夹层锅中,称取100-120份蔗糖倒入夹层锅中充分搅拌,打开蒸汽阀门,加热至沸,抱持沸腾5-8分钟,制成75%糖浆,取23.2份糖浆制胶浆。
5.根据权利要求4所述的一种复方脑蛋白水解物片的制备工艺,其特征在于,所述步骤6中制胶浆制备方法如下:称取明胶1-2份加入5-8份纯化水中,浸泡30min,煮沸后加入75%糖浆20-25份,搅拌均匀,温度保持60℃,制成胶浆。
6.根据权利要求5所述的一种复方脑蛋白水解物片的制备工艺,其特征在于,所述步骤6中制粉浆制备方法如下:称取滑石粉50-60份加入75%糖浆99份中充分搅拌,制成粉浆。
7.根据权利要求6所述的一种复方脑蛋白水解物片的制备工艺,其特征在于,所述步骤6中对压片包隔离层的步骤如下:分别向包衣锅加入105-115份片芯,加入胶浆9-13份片面润湿均匀后向锅内洒入滑石粉2-3份,设定转速为5—7转/分钟,设定进风温度45℃,出风温度40℃开启机器,包裹一层直至片面干燥。
8.根据权利要求7所述的一种复方脑蛋白水解物片的制备工艺,其特征在于,所述步骤6中对压片包粉衣层的步骤如下:向包衣锅加粉浆50-60份进行包衣,设定转速为5—7转/分钟,设定进风温度50℃,出风温度40℃开启机器;包裹15-18层直至外观无凹凸。
9.根据权利要求8所述的一种复方脑蛋白水解物片的制备工艺,其特征在于,所述步骤6中对压片有色糖衣层的步骤如下:向包衣锅加入有色糖浆5-7份进行包衣,设定转速为5—7转/分钟,设定进风温度35℃,出风温度30℃,包裹10-15层直至外观圆整。
10.根据权利要求9所述的一种复方脑蛋白水解物片的制备工艺,其特征在于,所述步骤6中的抛光步骤如下:在包衣锅加入300-350份虫白蜡(石蜡)均匀洒在压片表面,设定转速为5—7转/分钟,进风温度30℃,出风温度30℃,打光至片面光洁。
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