CN113499441A - 一种药用糖包衣液及其制备方法 - Google Patents
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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Abstract
本发明公开了一种药用糖包衣液,由以下重量百分比的原料组成:硫酸钙30‑50份,蔗糖200~250份,纯化水150~300份,滑石粉60~100份,阿拉伯胶5~15份,色素0.1~1份。本发明还公开了该药用糖包衣液的制备方法,按配方分别称取各原料,首先提前将阿拉伯胶加水溶胀,然后将蔗糖加入纯化水搅拌溶解后,在搅拌下分别加入溶胀好的阿拉伯胶溶液、滑石粉、硫酸钙、色素,混匀即可。本发明药用糖包衣液具有可以进一步调节pH6.8介质与其它介质的溶出速度差异的包衣液的特点。
Description
技术领域
本发明涉及药物制剂技术领域,具体涉及一种药用糖包衣液,本发明还涉及该药用糖包衣液的制备方法。
背景技术
糖衣片是一种常用的制剂剂型,它适用于易稀释发霉,易挥发或遇光易变质的原料制剂。糖包衣可以实现以下功能:1)隔绝空气、避光、防潮、增加药物的稳定性;2)掩盖药物的酸苦等不良气味;3)包肠溶衣,避免药物对胃的刺激,防止胃酸或胃酶对药物的破坏;4)利用包衣技术,制备缓释或控释片剂,减少服药次数,降低不良反应;5)压片颗粒包衣使有配伍禁忌的药物隔离,避免相互作用;6)使片剂美观,且便于识别。
糖包衣的主要材料通常选用蔗糖,也可用其他糖及糖醇材料代替蔗糖,包括葡萄糖、乳糖、麦芽糖醇、山梨醇、甘露醇、异麦芽糖醇、木糖醇。其他主要的包衣成分包括粘合剂、填充剂、着色剂、矫味剂、润滑剂、抛光剂等。通常糖衣片在四种溶出介质中的溶出速度都相似,而在新药开发或仿制药研究中,往往需要片剂在不同的介质中具有不同的溶出速度,需要特定的糖包衣组合物来实现这一溶出特点。
发明内容
本发明的目的是提供一种药用糖包衣液,具有可以调节pH=6.8介质与其它介质的溶出速度差异的包衣液的特点。
本发明的另一个目的是提供一种药用糖包衣液的制备方法。
本发明所采用的技术方案是,一种药用糖包衣液,由以下重量百分比的原料组成:硫酸钙30-50份,蔗糖200~250份,纯化水150~300份,滑石粉60~100份,阿拉伯胶5~15份,色素0.1~1份。
优选地,所述硫酸钙和滑石粉粒径均小于100目。
优选地,所述硫酸钙包括二水硫酸钙。
优选地,所述色素为医药级色素或食品级色素中的一种。
本发明所采用的另一个技术方案是,一种药用糖包衣液的制备方法,具体包括以下步骤:
步骤1、按质量百分比分别称取:硫酸钙30-50份,蔗糖200~250份,纯化水150~300份,滑石粉60~100份,阿拉伯胶5~15份,色素0.1~1份;
步骤2、将阿拉伯胶加水溶胀,得到阿拉伯胶溶液;
步骤3、将蔗糖加入纯化水中,搅拌直至溶解;
步骤4、在搅拌下向步骤3得到的蔗糖溶液中分别加入阿拉伯胶溶液、滑石粉、硫酸钙、色素,继续搅拌混匀即得。
具体的,所述纯化水的温度为40℃-80℃。
具体的,所述步骤4中继续搅拌时间为40min。
本发明提供的一种药用糖包衣液,通过添加硫酸钙作为赋形剂,起到了调节制剂在pH=6.8介质中溶出速度的作用,通过硫酸钙比例的配比优化可以进一步调节pH=6.8介质与其它介质的溶出速度差异。此外,配方中加入了阿拉伯胶,可作为粘合剂,增大包衣层的粘合力和弹力,有助于避免芯料产生粉尘,同时改善塑性,减少包衣片的裂片。本发明的药用糖包衣液适用于混浆法包衣,相较于干撒滑石粉法,采用该包衣方法可以减少操作步骤、节省工时、节约辅料、降低劳动强度、提高糖衣片的质量稳定性。
本发明提供的一种药用糖包衣液的制备方法,按配方分别称取各原料,首先提前将阿拉伯胶加水溶胀,然后将蔗糖加入纯化水搅拌溶解后,在搅拌下分别加入溶胀好的阿拉伯胶溶液、滑石粉、硫酸钙、色素,混匀即可;本药用糖包衣液的制备方法操作简单,节约时间。
附图说明
图1是本发明不同比例硫酸钙包衣的糖衣片在PH=6.8介质中的溶出曲线图。
具体实施方式
下面将对本发明的技术方案进行清楚、完整的描述,显然,所描述的实施例是本发明的一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动的前提下所获得的所有其他实施例,都属于本发明保护的范围。
硫酸钙微溶于酸,溶于400份水中,因此其在不同的溶出介质中溶解度有一定的差异。
图1是本发明用含不同比例硫酸钙的包衣液进行糖包衣,包衣片在pH=6.8的磷酸盐缓冲液中的溶出结果。其中不同处方的包衣液根据硫酸钙的比例调整了蔗糖比例,其它成分含量一致,且各包衣片的包衣增重相同。由图1可知,不同比例硫酸钙的包衣液在pH=6.8的介质中的溶出曲线不同;由于通常糖衣片在四种溶出介质中的溶出速度都相似,因此,通过硫酸钙比例的配比优化可以进一步调节pH=6.8介质与其它介质的溶出速度差异。
实施例一
步骤1、按质量百分比分别称取:二水硫酸钙30份,蔗糖230份,纯化水150份,滑石粉80份,阿拉伯胶9份,色素1份;
步骤2、将阿拉伯胶加水溶胀,得到阿拉伯胶溶液;
步骤3、将蔗糖加入40℃-80℃的纯化水中,搅拌直至溶解;
步骤4、在搅拌下向步骤3得到的蔗糖溶液中分别加入阿拉伯胶溶液、滑石粉、硫酸钙、色素,继续搅拌40min混匀即得。
实施例二
步骤1、按质量百分比分别称取:二水硫酸钙35份,蔗糖214.8份,纯化水300份,滑石粉90份,阿拉伯胶10份,色素0.2份;
步骤2、将阿拉伯胶加水溶胀,得到阿拉伯胶溶液;
步骤3、将蔗糖加入40℃-80℃的纯化水中,搅拌直至溶解;
步骤4、在搅拌下向步骤3得到的蔗糖溶液中分别加入阿拉伯胶溶液、滑石粉、硫酸钙、色素,继续搅拌40min混匀即得。
实施例三
步骤1、按质量百分比分别称取:二水硫酸钙30份,蔗糖210份,纯化水160份,滑石粉85份,阿拉伯胶14份,色素1份;
步骤2、将阿拉伯胶加水溶胀,得到阿拉伯胶溶液;
步骤3、将蔗糖加入40℃-80℃的纯化水中,搅拌直至溶解;
步骤4、在搅拌下向步骤3得到的蔗糖溶液中分别加入阿拉伯胶溶液、滑石粉、硫酸钙、色素,继续搅拌40min混匀即得。
实施例四
步骤1、按质量百分比分别称取:二水硫酸钙50份,蔗糖210.5份,纯化水300份,滑石粉80份,阿拉伯胶10份,色素0.5份;
步骤2、将阿拉伯胶加水溶胀,得到阿拉伯胶溶液;
步骤3、将蔗糖加入40℃-80℃的纯化水中,搅拌直至溶解;
步骤4、在搅拌下向步骤3得到的蔗糖溶液中分别加入阿拉伯胶溶液、滑石粉、硫酸钙、色素,继续搅拌40min混匀即得。
综上所述,上述各实施例仅为本发明的较佳实施例而已,并不用以限定本发明的保护范围,凡在本发明的精神和原则之内,所做的任何修改、等同替换、改进等,皆应包含在本发明的保护范围内。
Claims (7)
1.一种药用糖包衣液,其特征在于,由以下重量百分比的原料组成:硫酸钙30-50份,蔗糖200~250份,纯化水150~300份,滑石粉60~100份,阿拉伯胶5~15份,色素0.1~1份。
2.如权利要求1所述的一种药用糖包衣液,其特征在于,所述硫酸钙和滑石粉粒径均小于100目。
3.如权利要求1所述的一种药用糖包衣液,其特征在于,所述硫酸钙包括二水硫酸钙。
4.如权利要求1所述的一种药用糖包衣液,其特征在于,所述色素为医药级色素或食品级色素中的一种。
5.一种药用糖包衣液的制备方法,其特征在于,具体包括以下步骤:
步骤1、按质量百分比分别称取:硫酸钙30-50份,蔗糖200~250份,纯化水150~300份,滑石粉60~100份,阿拉伯胶5~15份,色素0.1~1份;
步骤2、将阿拉伯胶加水溶胀,得到阿拉伯胶溶液;
步骤3、将蔗糖加入纯化水中,搅拌直至溶解;
步骤4、在搅拌下向步骤3得到的蔗糖溶液中分别加入阿拉伯胶溶液、滑石粉、硫酸钙、色素,继续搅拌混匀即得。
6.如权利要求4所述的制备方法,其特征在于,所述纯化水的温度为40℃-80℃。
7.如权利要求4所述的制备方法,其特征在于,所述步骤4中继续搅拌时间为40min。
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