CN108114149A - 一种蒙药苏龙嘎-4的制备方法 - Google Patents
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Abstract
本发明涉及一种蒙药成方新剂型的制备方法，具体涉及一种蒙药苏龙嘎‑4的制备方法，蒙药苏龙嘎‑4处方包括连翘、拳参、木通、麦冬，该制备方法包括如下步骤：A.取连翘捣碎，加水，蒸馏法提取挥发油，挥发油备用；B.连翘水溶液药渣与其余拳参、木通、麦冬三味药混合，水煎1‑3次，合并过滤，滤液浓缩得浸膏，低温干燥，粉碎，加入矫味剂和糊精，制成颗粒，干燥；C.加入所述挥发油或用有机溶剂溶解所述挥发油再喷入，混匀，即得颗粒剂。本发明通过合理的工艺筛选，经提取制成颗粒剂，疗效与原剂型一致。另外，通过本发明所获得的蒙药苏龙嘎‑4颗粒剂特别适用于儿童患者。
Description
技术领域
本发明涉及一种蒙药成方新剂型的制备方法，具体涉及一种蒙药苏龙嘎-4的制备方法。
背景技术
中华人民共和国卫生部制定药品标准蒙药分册(1998：106页)记载有苏龙嘎-4原剂型为药材直接粉碎、过筛、包装形成，口服原剂型，味苦涩、糊口、量大，有效活性成分难以完全溶出，影响药效的稳定性，特别对儿童患者尤为突出，是传统的汤剂。
发明内容
鉴于上述现有技术中所存在的问题，本发明提供一种蒙药苏龙嘎-4制备方法，克服了原剂型味苦涩、量大、糊口等问题。
具体技术方案如下：
一种蒙药苏龙嘎-4制备方法，蒙药苏龙嘎-4处方包括连翘、拳参、木通、麦冬，该制备方法包括如下步骤：
A.取连翘捣碎，加水，蒸馏法提取挥发油，挥发油备用；
B.连翘水溶液药渣与其余拳参、木通、麦冬三味药混合，水煎1-3次，合并过滤，滤液浓缩得浸膏，低温干燥，粉碎，加入矫味剂和糊精，制成颗粒，干燥；
C.加入所述挥发油或用有机溶剂溶解所述挥发油再喷入，混匀，即得颗粒剂。
在上述技术方案的基础上，还可增加以下技术特征进行进一步限定：
优选地，所述矫味剂的加入量为提取药粉重量的1～3％。
优选地，所述矫味剂选自蔗糖、甜蜜素、蛋白糖、甜菊素、山梨醇酸钾、阿司帕坦中的一种或多种。
优选地，所述糊精的加入量与提取药粉的重量比例为0.5～1.5：1。
优选地，在步骤B中，水煎1-3次，时间为各1～1.5小时。
优选地，在步骤B中，滤液浓缩至浸膏在50℃时的相对密度为1.3～1.6g/cm3。
优选地，在步骤B中，采用减压浓缩设备进行浓缩，温度控制在80℃以下。
优选地，在步骤B中，所述浸膏在95℃以下进行干燥。
本发明的有益效果如下：
本发明通过合理的工艺筛选，经提取制成颗粒剂，疗效与原剂型一致。另外，通过本发明所获得的蒙药苏龙嘎-4颗粒剂特别适用于儿童患者。
附图说明
图1示出了本发明的一个具体实施例的工艺流程图。
具体实施方式
下面结合附图和具体实例对本发明进行详细说明。
(1)本发明的工艺筛选过程如下：
①剂型确定
苏龙嘎-4原剂型为汤散剂，用于肠热、痢疾、腹痛、腹泻。由于是汤散剂味苦涩小儿拒绝吃药。经试验，原剂型提取后加适量糊精、矫味剂制成颗粒剂，口感改善，服用方便。
②工艺路线的确定
苏龙嘎-4颗粒剂的工艺路线是根据处方药物组成，所含有效成分的理化性质、生产实际等多方面因素，经反复试验研究、分析、比较而确定的。
连翘具有含多种活性成分，可做检测成分挥发油、连翘苷、连翘酯苷A等，拳参含有没食子酸、绿原酸，木通有原儿茶酸，麦冬有麦冬皂苷、麦冬黄酮。以上检测成分有较好的水溶性。从而确定苏龙嘎-4颗粒剂的基本工艺路线为加水提取，制成颗粒剂。
③水提条件考察
a连翘用水蒸气蒸馏法
经测定挥发油3h之前提取率高，之后提取率明显降低，6h后挥发油提尽。
表1连翘挥发油提取时间考察
b拳参、木通、麦冬水提工艺
表2因素水平
c试验方法
用正交试验对表2各因素进行考察，以绿原酸含量、浸膏率为考察指标，以权重系数计算综合评分。30/浸膏最大提取率×浸膏提取率，70/绿原酸最高提取率×绿原酸提取率(权重系数：浸膏0.3，绿原酸0.7)。
影响提取工艺影响因素：加水量>提取次数>浸泡时间>提取时间。综合评分方差分析结果：
A3B1C3D2(加12倍水，每次提取1h，提取3次，浸泡24h)
A2B1C2D3(加10倍水，每次提取1h，提取2次，浸泡48h)
A2B3C1D2(加10倍水，每次提取2h，提取1次，浸泡24h)
A2B2C3D1(加10倍水，每次提取1.5h，提取3次，浸泡12h)
依据上述分析，对提取工艺选择有利于工业化生产、降低成本因素搭配，即A2B2C2D2(加10倍水，每次提取1.5h，提取2次，浸泡24h)为最佳因素提取工艺。
d最佳提取工艺验证
称取连翘480g，提取挥发油，药渣与拳参420g、木通420g、麦冬300g混合，加10倍水，浸泡24h，每次提取1.5h，提取2次。依法测定绿原酸含量、浸膏提取率。绿原酸含量0.102％，浸膏提取率21.5％，与正交试验结果基本一致，说明该工艺条件基本稳定、合理。
表3 L9(34)表及试验结果
表4方差分析
临界值F1-0.1(2，2)＝9 F1-0.05(2，2)＝19.以B因素离差作为误差，检验因素的显著性,方差分析。
④浓缩、干燥、粉碎
为防止有效成分长时间受热破坏，本工艺采用减压浓缩设备进行浓缩，温度控制在80℃以下，浓缩至浸膏比重1.4～1.5(50℃)，浸膏在95℃以下进行干燥。
表5水提浸膏收率及出粉率
⑤辅料的筛选
矫味剂选择：以蔗糖、甜蜜素、蛋白糖、甜菊素、山梨醇酸钾、阿司帕坦作为矫味剂，考察矫味效果。蛋白糖、阿司帕坦矫味效果好，进一步考察，阿司帕坦2：100矫味效果比较好。
表6甜味素用量试验(g)
注–口感差 +口感一般 ++口感好
糊精、乙醇：试验不同比例糊精用量及湿润剂乙醇浓度，以制粒是否粘筛、颗粒均匀性、成粒率及颗粒休止角为指标综合考察，最终选定糊精用量为药粉与糊精1：1；乙醇浓度75％。制成的颗粒粒度均匀，成粒率高、硬度适宜、溶化性好。
表7制粒成粒率、休止角
⑥服用量的确定
连翘727g、拳参636g、木通636g、麦冬455g(合计2454g)，出膏490-510g(膏-药材1︰5)，加490-510g糊精，矫味剂20g，合计成品1000g。每2g颗粒剂相当于药材5g，原剂型服5g，颗粒剂服2g。
(2)中试资料
结果表明，苏龙嘎-4颗粒剂装量、粒度、绿原酸含量、水份、微生物限度检查均符合要求，工艺稳定、可行，适合工业生产。
表8苏龙嘎-4颗粒剂中试生产数据
综上所述，本发明经过了深入工艺确定，确定了最佳的工艺过程和参数，且获得的颗粒剂疗效和口服感均佳，值得推广。
Claims (10)
1.一种蒙药苏龙嘎-4的制备方法，蒙药苏龙嘎-4处方包括连翘、拳参、木通、麦冬，其特征在于：
A.取连翘捣碎，加水，蒸馏法提取挥发油，挥发油备用；
B.连翘水溶液药渣与其余拳参、木通、麦冬三味药混合，加水浸泡，水煎1-3次，合并过滤，滤液浓缩得浸膏，低温干燥，粉碎，加入矫味剂和糊精，制成颗粒，干燥；
C.加入所述挥发油或用有机溶剂溶解所述挥发油再喷入，混匀，即得颗粒剂。
2.根据权利要求1所述的蒙药苏龙嘎-4的制备方法，其特征在于：所述矫味剂的加入量为步骤B中粉碎获得的提取药粉重量的1～3％。
3.根据权利要求1或2任一所述的蒙药苏龙嘎-4的制备方法，其特征在于：所述矫味剂选自蔗糖、甜蜜素、蛋白糖、甜菊素、山梨醇酸钾、阿司帕坦中的一种或多种。
4.根据权利要求1所述的蒙药苏龙嘎-4的制备方法，其特征在于：所述糊精的加入量与步骤B中粉碎获得的提取药粉的重量比例为0.5～1.5：1。
5.根据权利要求1所述的蒙药苏龙嘎-4的制备方法，其特征在于：在步骤B中，水煎2次，时间各为1～1.5小时。
6.根据权利要求1所述的蒙药苏龙嘎-4的制备方法，其特征在于：所述连翘水溶液药渣与其余拳参、木通、麦冬三味药混合后的加水量为10-12倍。
7.根据权利要求1所述的蒙药苏龙嘎-4的制备方法，其特征在于：在步骤B中，滤液浓缩至浸膏比重为在50℃时的相对密度为1.3～1.6g/cm3。
8.根据权利要求1所述的蒙药苏龙嘎-4的制备方法，其特征在于：在步骤A中，所述挥发油的提取时间为3～6小时。
9.根据权利要求1所述的蒙药苏龙嘎-4的制备方法，其特征在于：在步骤B中，采用减压浓缩设备进行浓缩，温度控制在80℃以下。
10.根据权利要求1所述的蒙药苏龙嘎-4的制备方法，其特征在于：在步骤B中，所述浸膏在95℃以下进行干燥。
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