CN106236727A - 一种安乃近泡腾片及其制备方法 - Google Patents
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Abstract
一种安乃近泡腾片，由以下重量份的原料制备而成：安乃近200 ‑300份、枸橼酸90‑110份、碳酸氢钠90‑110份、甘露醇450‑550份、CMC45‑55份、麦芽糊精20‑30份。本发明提供的安乃近泡腾片，以枸橼酸为酸性崩解剂，以碳酸氢钠为碱性崩解剂，以甘露醇为稀释剂，以CMC和麦芽糊精为粘合剂，制得的安乃近泡腾片外观光滑美观、无斑点，泡腾崩解快，溶解完全，便于畜禽的口服给药。
Description
技术领域
本发明属于兽药加工技术领域，具体涉及一种安乃近泡腾片及其制备方法。
背景技术
安乃近为解热镇痛及非甾体抗炎镇痛药，安乃近溶于水，但是安乃近原料禁止在畜禽养殖业中直接使用，现有的安乃近片不溶于水，需要通过拌料的方式给药，不利于集约化养殖；泡腾片是以泡腾物料为崩解剂制成的一种片剂，遇水后产生二氧化碳，迅速崩解，溶于水中，具有使用方便、水中分布均匀、掩盖不良气味和生物利用度高等优点，兼顾了固体制剂和液体制剂的特点，是近年来国内外制药行业热衷开发的一种药物剂型。特别在兽药行业，这方面的研究相对比较滞后，专利CN201410623972.6公开了一种兽用安乃近泡腾片及其制备方法，其采用安乃近、泡腾剂、包裹剂、润滑剂、及其他辅料制备而成，其中润滑剂采用硬脂酸镁，由于金属镁离子有发生络合的危险，其应用受到一定的限制。
发明内容
本发明的目的就在于提供一种安乃近泡腾片及其制备方法。
本发明的目的是以下述方式实现的：
一种安乃近泡腾片，由以下重量份的原料制备而成：安乃近200 -300份、枸橼酸90-110份、碳酸氢钠90-110份、甘露醇450-550份、CMC45-55份、麦芽糊精20-30份。
优选的：由以下重量份的原料制备而成：安乃近250份、枸橼酸100份、碳酸氢钠100份、甘露醇500份、CMC50份、麦芽糊精25份。
如上所述的安乃近泡腾片的制备方法，包括以下步骤：
（1）将安乃近和其他原料粉碎过筛；
（2）酸性颗粒的制备：将安乃近、枸橼酸、甘露醇总量的45-55%、CMC、麦芽糊精按照组方量配制，混合均匀，以水为润湿剂，水的加入量为原料质量的5-10%，制粒，置于60℃-70℃条件下烘干，整粒，备用；
（3）碱性颗粒的制备：将碳酸氢钠、剩下的甘露醇按照组方量配制，混合均匀，以水为润湿剂，水的加入量为原料质量的5-10%，制粒，置于60℃-70℃条件下烘干，整粒，备用；
（4）压片：将酸性颗粒、碱性颗粒混合均匀，然后压片，车间湿度控制在40%以下。
步骤（1）中粉碎过80-120目筛。
本发明提供的安乃近泡腾片，以枸橼酸为酸性崩解剂，以碳酸氢钠为碱性崩解剂，以甘露醇为稀释剂，以CMC和麦芽糊精为粘合剂，制得的安乃近泡腾片外观光滑美观、无斑点，泡腾崩解快，溶解完全，便于畜禽的口服给药。
具体实施方式
实施例1
一种安乃近泡腾片，由以下重量份的原料制备而成：安乃近200 -300份、枸橼酸90-110份、碳酸氢钠90-110份、甘露醇450-550份、CMC45-55份、麦芽糊精20-30份。
如上所述的安乃近泡腾片的制备方法，包括以下步骤：
（1）将安乃近和其他原料粉碎过80-120目筛；
（2）酸性颗粒的制备：将安乃近、枸橼酸、甘露醇总量的45-55%、CMC、麦芽糊精按照组方量配制，混合均匀，以水为润湿剂，水的加入量为原料质量的5-10%，制粒，置于60℃-70℃条件下烘干，整粒，备用；
（3）碱性颗粒的制备：将碳酸氢钠、剩下的甘露醇按照组方量配制，混合均匀，以水为润湿剂，制粒，置于60℃-70℃条件下烘干，整粒，备用；
（4）压片：将酸性颗粒、碱性颗粒混合均匀，然后压片，车间湿度控制在40%以下。
试验例
根据安乃近的理化性质，经过预实验，稀释剂（甘露醇、乳糖），崩解剂（枸橼酸、NaHCO3），粘合剂（PVP-K30、CMC、麦芽糊精），初选四个组方（见表1），根据初选结果，确定安乃近泡腾片组方。
根据表2所示组方考察结果：组方1、3外观有斑点，组方4崩解时限相对于组方2有些短，因此可知，选择甘露醇做稀释剂，泡腾片外观光滑无斑点，选择CMC和麦芽糊精崩解速度合适，溶解完全，因此选择组方2为本发明最佳组方。组方中不含金属离子，应用广泛。
实施例2
一种安乃近泡腾片，由以下重量份的原料制备而成：安乃近250份、枸橼酸100份、碳酸氢钠100份、甘露醇500份、CMC50份、麦芽糊精25份。
如上所述的安乃近泡腾片的制备方法，包括以下步骤：
（1）将安乃近和其他原料粉碎过100目筛；
（2）酸性颗粒的制备：将安乃近、枸橼酸、甘露醇总量的50%、CMC、麦芽糊精按照组方量配制，混合均匀，以水为润湿剂，水的加入量为原料质量的8%，制粒，置于65℃条件下烘干，整粒，备用；
（3）碱性颗粒的制备：将碳酸氢钠、剩下的甘露醇按照组方量配制，混合均匀，以水为润湿剂，制粒，置于65℃条件下烘干，整粒，备用；
（4）压片：将酸性颗粒、碱性颗粒混合均匀，然后压片，车间湿度控制在40%以下。
实施例3
一种安乃近泡腾片，由以下重量份的原料制备而成：安乃近250份、枸橼酸100份、碳酸氢钠95份、甘露醇500份、CMC48份、麦芽糊精20份。
如上所述的安乃近泡腾片的制备方法，包括以下步骤：
（1）将安乃近和其他原料粉碎过80目筛；
（2）酸性颗粒的制备：将安乃近、枸橼酸、甘露醇总量的45%、CMC、麦芽糊精按照组方量配制，混合均匀，以水为润湿剂，水的加入量为原料质量的5%，制粒，置于60℃条件下烘干，整粒，备用；
（3）碱性颗粒的制备：将碳酸氢钠、剩下的甘露醇按照组方量配制，混合均匀，以水为润湿剂，制粒，置于70℃条件下烘干，整粒，备用；
（4）压片：将酸性颗粒、碱性颗粒混合均匀，然后压片，车间湿度控制在40%以下。
实施例4
一种安乃近泡腾片，由以下重量份的原料制备而成：安乃近250份、枸橼酸110份、碳酸氢钠100份、甘露醇480份、CMC50份、麦芽糊精25份。
如上所述的安乃近泡腾片的制备方法，包括以下步骤：
（1）将安乃近和其他原料粉碎过120目筛；
（2）酸性颗粒的制备：将安乃近、枸橼酸、甘露醇总量的55%、CMC、麦芽糊精按照组方量配制，混合均匀，以水为润湿剂，水的加入量为原料质量的10%，制粒，置于70℃条件下烘干，整粒，备用；
（3）碱性颗粒的制备：将碳酸氢钠、剩下的甘露醇按照组方量配制，混合均匀，以水为润湿剂，制粒，置于70℃条件下烘干，整粒，备用；
（4）压片：将酸性颗粒、碱性颗粒混合均匀，然后压片，车间湿度控制在40%以下。
本发明实施例5-18安乃近泡腾片配方见表3-4，其他同实施例2。
以上所述的仅是本发明的优选实施方式，应当指出，对于本领域的技术人员来说，在不脱离本发明整体构思前提下，还可以作出若干改变和改进，这些也应该视为本发明的保护范围。
Claims (4)
1.一种安乃近泡腾片，其特征在于由以下重量份的原料制备而成：安乃近200 -300份、枸橼酸90-110份、碳酸氢钠90-110份、甘露醇450-550份、CMC45-55份、麦芽糊精20-30份。
2.如权利要求1所述的安乃近泡腾片，其特征在于由以下重量份的原料制备而成：安乃近250份、枸橼酸100份、碳酸氢钠100份、甘露醇500份、CMC50份、麦芽糊精25份。
3.如权利要求1-2任一项所述的安乃近泡腾片的制备方法，其特征在于包括以下步骤：
（1）将安乃近和其他原料粉碎过筛；
（2）酸性颗粒的制备：将安乃近、枸橼酸、甘露醇总量的45-55%、CMC、麦芽糊精按照组方量配制，混合均匀，以水为润湿剂，水的加入量为原料质量的5-10%，制粒，置于60℃-70℃条件下烘干，整粒，备用；
（3）碱性颗粒的制备：将碳酸氢钠、剩下的甘露醇按照组方量配制，混合均匀，以水为润湿剂，水的加入量为原料质量的5-10%，制粒，置于60℃-70℃条件下烘干，整粒，备用；
（4）压片：将酸性颗粒、碱性颗粒混合均匀，然后压片，车间湿度控制在40%以下。
4.如权利要求3所述的安乃近泡腾片的制备方法，其特征在于步骤（1）中粉碎过80-120目筛。
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