CN106511484A - 一种复方金银花颗粒的提取制备工艺 - Google Patents
一种复方金银花颗粒的提取制备工艺 Download PDFInfo
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Abstract
本发明属于中医药技术领域,具体涉及一种复方金银花颗粒的提取制备工艺。提出的一种复方金银花颗粒的提取制备工艺为制备每1000g含糖复方金银花颗粒或500g不含糖复方金银花颗粒所需原料的质量为:金银花750g、连翘750g、黄芩250g,还加入有辅料;利用柠檬酸调节PH值至4~5的弱酸水对金银花进行提取得到金银花稠膏;利用与黄芩、连翘质量比为10~15:1的水提取得到黄芩、连翘稠膏;将辅料、金银花稠膏、黄芩连翘稠膏混合得到复方金银花干颗粒;将所收集的挥发油喷洒在复方金银花干颗粒上制得产品。本发明具有有效成分提取率高,溶媒用量及耗能小、低炭环保、提取温度低,收集的挥发油含水量小的特点。
Description
技术领域
本发明属于中医药技术领域,具体涉及一种复方金银花颗粒的提取制备工艺。
背景技术
复方金银花颗粒为***药品标准中药成方制剂第十册收载品种,具有清热解毒,凉血消肿之功;广泛用于风热感冒,咽炎,扁桃体炎,目痛,牙痛及痈肿疮疖。特别是在非典、手足口病、甲型流感流行期间更显示出化学药品所没有的独特疗效;部颁标准中收录的处方为:金银花750g、连翘750g、黄芩250g;制法:以上三味,金银花加水蒸馏,收集蒸馏液至规定量,另器保存。蒸馏后的水溶液滤过;药渣加水适量,蒸煮30分钟,滤过,合并两次滤液,浓缩至适量,加乙醇3倍量,搅拌,静置24小时,滤过,滤液浓缩至稠膏状。黄芩、连翘加水煎煮二次,每次1小时,合并煎液,滤过,滤液浓缩至适量,加乙醇3倍量,搅拌,静置24小时,滤过,滤液浓缩至稠膏状,加入金银花稠膏及蒸馏液与糖粉适量,混匀,制成颗粒,即得。
复方金银花颗粒现行生产工艺存在的缺陷:提取时间长、溶媒用量大,温度高,受热时间长;金银花挥发油在制备湿颗粒时加入,湿颗粒烘干过程中基本损殆尽。如金银花提取,第一遍,水蒸汽蒸馏法收集挥发油,通常需要2至2.5小时,第二遍再煎煮30分钟,提取时间长共3小时。溶媒用量大药材与溶媒比为1:22,黄芩、连翘提取同样存在,时间长、溶媒用量大,有效成分受热时间长的问题。且使后续醇沉除杂乙醇用量大,乙醇回收浓缩时间长,从而使有效成分损耗大,特别是热不稳定成分损失严重,致使提取效率低、能耗大;原工艺采用水蒸汽蒸馏法提取挥发油,得到的挥发油为白色油水混合物,含水多,只能选择在制湿颗粒工序加入,在湿颗粒的烘干过程中,由于蒸馏液均为挥发性成分随颗粒的干燥基本损失殆尽,使成品气微,没有了湿颗粒的浓郁香气。
由于以上原因,使生产企业在复方金银花颗粒生产中,为保证产品质量,不得不加大药材的投入量,而患者服用时为了达到更好的疗效,也不得不加大服用量,严重制约了患者的用药需求,造成中药材资源的严重浪费,阻碍了中药现代化、中药国际化的进程。
金银花相关提取工艺研究有多种方法,如醇提法,只考虑到绿原酸,忽略了挥发油的提取;超声法不适应于大生产;微波法,对设备要求高。均有不足之处。
本品中主要成份金银花具有清热解毒、抗菌消炎、保肝利胆的功能, 是常用的中药材之一。 它所含的化学成分有绿原酸、异绿原酸、黄酮化合物、芳樟醇和双花醇等,其中绿原酸被认为是抗菌解毒、消炎利胆的主要有效成分;连翘中的主要成分连翘苷具有较强的抑菌、抗病毒作用;黄芩中的主要成分黄芩苷具有抗癌、抗菌、抗病毒、解热、清除氧自由基及抗氧化等作用。因此本品中挥发油的收集、加入方法及绿原酸、连翘苷、黄芩苷含量的高低直接影响产品的质量及、及疗效。
发明内容
为了解决现有提取工艺中有效成分损失严重、提取时间长、效率低下等不足,本发明提出了一种复方金银花颗粒的提取制备工艺。
本发明解决上述问题采用了如下技术方案:
一种复方金银花颗粒的提取制备工艺,所述的提取制备工艺为:
1)原料的准备:制备每1000g含糖复方金银花颗粒或500g不含糖复方金银花颗粒所需原料的质量为:金银花750g、连翘750g、黄芩250g,还加入有辅料;
2)原料的处理:金银花挑出非药用部分及杂质;黄芩快速用水洗去泥沙,蒸半小时,切薄片,干燥;连翘挑出非药用部分及杂质;辅料粉碎成100目细粉,备用;
3)金银花的提取:提取用水为用柠檬酸调节PH值至4~5的弱酸水,金银花、弱酸水与生物酶的质量比为1:10~15:0.001~0.0015;将金银花、生物酶放置在逆流提取机组中,再加入弱酸水;金银花、弱酸水及生物酶的质量比为1:5:0.001~0.0015;然后将逆流提取机组中药材及溶媒加热至50℃,并在50℃的温度下浸泡2小时;再将温度升高至80℃,并调节进水流速陆续加入剩余量弱酸水,逆流提取40分钟;逆流提取的过程中同时收集挥发油;待逆流提取完成后,药液滤过,浓缩至在50℃时测定相对密度为1.15~1.2的浸膏、放凉;加浸膏量3倍的乙醇,边加边搅拌,静置24小时,滤过,滤液回收乙醇并浓缩至相对密度为1.25~1.3的稠膏;提取后的金银花药渣离心甩干后弃去,清洗提取罐;
4)黄芩、连翘的提取:黄芩和连翘与水的质量比为1:10~15;将黄芩薄片与连翘一起置逆流提取机组中,加水5倍量,加热到50℃预浸2小时,再升温至80℃,并调节进水流速,陆续加入剩余量水,逆流提取1小时;药液滤过,浓缩至相对密度为1.15~1.2的浸膏,50℃测,放凉;加浸膏量3倍的乙醇,边加边搅拌,静置24小时,滤过,滤液回收乙醇并浓缩至相对密度为1.25~1.3的稠膏;提取后的黄芩、连翘药渣离心甩干后弃去,清洗逆流提取罐;
5)制粒:将所述辅料、金银花稠膏、黄芩连翘稠膏混合,于颗粒机中16目筛制粒,60℃沸腾干燥得到复方金银花干颗粒;将所收集的挥发油喷洒在复方金银花干颗粒上,用16目筛整粒,于不锈钢桶中闷润2小时,然后于二维混合机中,转速16转/分,总混30分钟,包装即得。
所述生物酶由β-葡聚糖酶、纤维素酶、木聚糖酶和果胶酶构成。
所述的辅料为蔗糖,辅料为蔗糖时重量为900g。
所述的辅料为糊精与阿司帕坦的组合物;辅料为糊精与阿司帕坦的组合物时,糊精为400g,阿司帕坦为2.5g。
本发明提出的一种复方金银花颗粒的提取工艺,采用上述技术方案,具有如下有益效果:
(1)采用生物酶加逆流提取技术,同时用柠檬酸调水的PH值4~5,酸性条件下更有利于细胞壁酶解破裂,利于挥发油的快速溶出;且在低酸度溶液中绿原酸电离过程被抑制,主要以分子形式存在,有利于绿原酸的溶出,从而大大提高挥发油及绿原酸的转移率;生物酶促进细胞破壁,有利于有效成分快速溶出;逆流可使药材与溶媒保持较高的浓度差,促进有效成分快速溶出;黄芩与连翘采用逆流提取技术,使连翘苷、黄芩苷提取率也有较大幅度提高。
(2)通过采用生物酶加逆流提取工艺,大大缩短了提取、浓缩时间,节省了能耗,节约溶媒用量40%。
(3)提取温度低、时间短可减少挥发性成分、热敏成分的破坏,还减少了纤维、淀粉、粘液质等杂质的溶出,有利于下道工序的醇沉除杂。充分体现了高效、节能、环保的现代制药技术。
(4)由于生物酶的加入,提取温度低、时间短,收集到的挥发性成分,为油状物,含水少,可直接加入干颗粒中,避免干燥过程中损失;而原水蒸汽蒸馏法收集到的蒸馏液含水多,加在干颗粒中影响颗粒水分,只能在制湿颗粒时加入,湿颗粒干燥过程中又挥发损失掉。
(5)质量稳定性:经18个月的长期稳定性试验,各项质量指标与0月比无明显差别(相对标准偏差均小于3%),表明产品质量很稳定。
综上所述,本发明具有有效成分提取率高,溶媒用量及耗能小、低炭环保、提取温度低,收集的挥发油含水量小的特点;另外挥发油选择在制粒烘干后加入,不影响成品颗粒的水分,又避免烘干过程的损失。
具体实施方式
结合具体实施例对本发明加以说明:
实施例1
含蔗糖复方金银花颗粒100袋,每袋装10g由以下重量比的原辅料制成:金银花750g、连翘750g、黄芩250g、蔗糖900g。
其制备工艺过程如下:
1、金银花挑出非药用部分及杂质;黄芩快速用水洗去泥沙,蒸半小时,切薄片,干燥;连翘挑出非药用部分及杂质;蔗糖粉碎成细粉,备用。
2、金银花的提取:提取用水为用柠檬酸调节PH值至4~5的弱酸水,金银花、弱酸水与生物酶的质量比为1:10:0.001。将金银花放置在逆流提取机组中,先加入弱酸水及生物酶,金银花、弱酸水及生物酶的质量比为1:5:0.001;然后将逆流提取机组中药材及溶媒加热至50℃,并在50℃的温度下浸泡2小时;再将温度升高至80℃,并调节进水流速陆续加入剩余5倍量弱酸水,逆流提取40分钟;逆流提取的过程中同时收集挥发油;待药液逆流提取完成后,药液滤过,浓缩至相对密度为1.15~1.2的浸膏, 50℃时测定,放凉。加浸膏量3倍的乙醇,边加边搅拌,静置24小时,滤过,滤液回收乙醇并浓缩至相对密度为1.25~1.3的稠膏;提取后的金银花药渣离心甩干后弃去,清洗提取罐;
3、黄芩、连翘的提取:黄芩和连翘与水的质量比为1:10;将黄芩薄片与连翘一起置逆流提取机组中,加水5倍量,加热至50℃预浸2小时,再升温至80℃,并调节进水流速,陆续加入剩余5倍量水,逆流提取1小时;药液滤过,浓缩至相对密度为1.15~1.2的浸膏,50℃测,放凉;加浸膏量3倍的乙醇,边加边搅拌,静置24小时,滤过,滤液回收乙醇并浓缩至相对密度为1.25~1.3的稠膏;提取后的黄芩、连翘药渣离心甩干后弃去,清洗逆流提取罐;
3、金银花、黄芩、连翘浸膏与蔗糖粉混合,于颗粒机中16目筛制粒,60℃沸腾干燥。喷洒挥发油,16目筛整粒,于不锈钢桶中闷润2小时,于二维混合机中,转速16转/分,总混30分钟,包装(每袋装10g),即得。
实施例2
无蔗糖复方金银花颗粒100袋,每袋5g由以下重量比的原辅料制成:金银花750g、连翘750g、黄芩250g、糊精400g、阿司帕坦2.5g。
其制备工艺过程如下:
1、金银花挑出非药用部分及杂质;黄芩快速用水洗去泥沙,蒸半小时,切薄片,干燥;连翘挑出非药用部分及杂质;阿司帕坦粉碎成细粉,备用。
2、金银花的提取:提取用水为用柠檬酸调节PH值至4~5的弱酸水,金银花、弱酸水与生物酶的质量比为1:12:0.0012。将金银花放置在逆流提取机组中,先加入弱酸水及生物酶,金银花、弱酸水及生物酶的质量比为1:5:0.001;然后将逆流提取机组中药材及溶媒加热至50℃,并在50℃的温度下浸泡2小时;再将温度升高至80℃,并调节进水流速陆续加入剩余7倍量弱酸水,逆流提取40分钟;逆流提取的过程中同时收集挥发油;待药液逆流提取完成后,药液滤过,浓缩至相对密度为1.15-1.2的浸膏, 50℃时测定,放凉。加浸膏量3倍的乙醇,边加边搅拌,静置24小时,滤过,滤液回收乙醇并浓缩至相对密度为1.25~1.3的稠膏;提取后的金银花药渣离心甩干后弃去,清洗提取罐;
黄芩、连翘的提取:黄芩和连翘与水的质量比为1:12。将黄芩薄片与连翘一起置逆流提取机组中,加水5倍量,加热至50℃预浸2小时,再升温至80℃,并调节进水流速,陆续加入剩余7倍量水,逆流提取1小时;药液滤过,浓缩至相对密度为1.15-1.2的浸膏,50℃测,放凉;加浸膏量3倍的乙醇,边加边搅拌,静置24小时,滤过,滤液回收乙醇并浓缩至相对密度为1.25~1.3的稠膏;提取后的黄芩、连翘药渣离心甩干后弃去,清洗逆流提取罐;
3、金银花、黄芩、连翘浸膏与糊精、阿司帕坦于槽型混合机中混合15分钟,于颗粒机中16目筛制粒,60℃沸腾干燥,喷洒挥发油,16目筛整粒,于不锈钢桶中闷润2小时,于二维混合机中,转速16转/分,总混30分钟,包装(每袋装5g),即得。
实施例3
含蔗糖复方金银花颗粒100袋,每袋10g由以下重量比的原辅料制成:金银花750g、连翘750g、黄芩250g、蔗糖900g。
其制备工艺过程如下:
1、金银花挑出非药用部分及杂质;黄芩快速用水洗去泥沙,蒸半小时,切薄片,干燥;连翘挑出非药用部分及杂质;蔗糖粉碎成细粉,备用。
2、金银花的提取:提取用水为用柠檬酸调节PH值至4~5的弱酸水,金银花、弱酸水与生物酶的质量比为1:14:0.0015。将金银花放置在逆流提取机组中,先加入弱酸水及生物酶,金银花、弱酸水及生物酶的质量比为1:5:0.001;然后将逆流提取机组中药材及溶媒加热至50℃,并在50℃的温度下浸泡2小时;再将温度升高至80℃,并调节进水流速陆续加入剩余9倍量弱酸水,逆流提取40分钟;逆流提取的过程中同时收集挥发油;待药液逆流提取完成后,药液滤过,浓缩至相对密度为1.15~1.2的浸膏, 50℃时测定,放凉。加浸膏量3倍的乙醇,边加边搅拌,静置24小时,滤过,滤液回收乙醇并浓缩至相对密度为1.25~1.3的稠膏;提取后的金银花药渣离心甩干后弃去,清洗提取罐;
黄芩、连翘的提取:黄芩和连翘与水的质量比为1:14。将黄芩薄片与连翘一起置逆流提取机组中,加水5倍量,加热至50℃预浸2小时,再升温至80℃,并调节进水流速,陆续加入剩余9倍量水,逆流提取1小时;药液滤过,浓缩至相对密度为1.15~1.2的浸膏,50℃测,放凉;加浸膏量3倍的乙醇,边加边搅拌,静置24小时,滤过,滤液回收乙醇并浓缩至相对密度为1.25~1.3的稠膏;提取后的黄芩、连翘药渣离心甩干后弃去,清洗逆流提取罐;
3、金银花、黄芩、连翘浸膏与蔗糖粉混合,于颗粒机中16目筛制粒,60℃沸腾干燥。喷洒挥发油,16目筛整粒,于不锈钢桶中闷润2小时,于二维混合机中,转速16转/分,总混30分钟,包装(每袋装10g),即得。
自制品与市销售品质量对比
复方金银花颗粒现行部颁标准(WS3-B-1985-95),由于颁布年代较早,没有含测指标,但公司为了加强本品的质量控制,制订了企业内控标准,性状项下增加了“有浓郁香气”,含测项下增加了“绿原酸、连翘苷、黄芩苷的含测指标”。
本发明复方金银花颗粒实施例产品与市售其它公司产品有效成分质量比较,检测标准依据我公司注册标准下的内控标准,结果如下:
表1 本发明复方金银花颗粒实施例与市售品质量比较
本发明复方金银花颗粒(实施例1、2、3)的长期稳定性实验数据见表2、表3、表4。
表2 实施例1的长期稳定性实验
表3 实施例2的长期稳定性实验
表4 实施例3的长期稳定性实验
Claims (4)
1.一种复方金银花颗粒的提取制备工艺,其特征在于:所述的提取制备工艺为:
1)原料的准备:制备每1000g含糖复方金银花颗粒或500g不含糖复方金银花颗粒所需原料的质量为:金银花750g、连翘750g、黄芩250g,还加入有辅料;
2)原料的处理:金银花挑出非药用部分及杂质;黄芩快速用水洗去泥沙,蒸半小时,切薄片,干燥;连翘挑出非药用部分及杂质;辅料粉碎成100目细粉,备用;
3)金银花的提取:提取用水为用柠檬酸调节PH值至4~5的弱酸水,金银花、弱酸水与生物酶的质量比为1:10~15:0.001~0.0015;将金银花、生物酶放置在逆流提取机组中,再加入弱酸水;金银花、弱酸水及生物酶的质量比为1:5:0.001~0.0015;然后将逆流提取机组中药材及溶媒加热至50℃,并在50℃的温度下浸泡2小时;再将温度升高至80℃,并调节进水流速陆续加入剩余量弱酸水,逆流提取40分钟;逆流提取的过程中同时收集挥发油;待逆流提取完成后,药液滤过,浓缩至在50℃时测定相对密度为1.15~1.2的浸膏、放凉;加浸膏量3倍的乙醇,边加边搅拌,静置24小时,滤过,滤液回收乙醇并浓缩至相对密度为1.25~1.3的稠膏;提取后的金银花药渣离心甩干后弃去,清洗提取罐;
4)黄芩、连翘的提取:黄芩和连翘与水的质量比为1:10~15;将黄芩薄片与连翘一起置逆流提取机组中,加水5倍量,加热到50℃预浸2小时,再升温至80℃,并调节进水流速,陆续加入剩余量水,逆流提取1小时;药液滤过,浓缩至相对密度为1.15~1.2的浸膏,50℃测,放凉;加浸膏量3倍的乙醇,边加边搅拌,静置24小时,滤过,滤液回收乙醇并浓缩至相对密度为1.25~1.3的稠膏;提取后的黄芩、连翘药渣离心甩干后弃去,清洗逆流提取罐;
5)制粒:将所述辅料、金银花稠膏、黄芩连翘稠膏混合,于颗粒机中16目筛制粒,60℃沸腾干燥得到复方金银花干颗粒;将所收集的挥发油喷洒在复方金银花干颗粒上,用16目筛整粒,于不锈钢桶中闷润2小时,然后于二维混合机中,转速16转/分,总混30分钟,包装即得。
2.如权利要求1所述的一种复方金银花颗粒的提取制备工艺,其特征在于:所述生物酶由β-葡聚糖酶、纤维素酶、木聚糖酶和果胶酶构成。
3.如权利要求1所述的一种复方金银花颗粒的提取制备工艺,其特征在于:所述的辅料为蔗糖,辅料为蔗糖时重量为900g。
4.如权利要求1所述的一种复方金银花颗粒的提取制备工艺,其特征在于:所述的辅料为糊精与阿司帕坦的组合物;辅料为糊精与阿司帕坦的组合物时,糊精为400g,阿司帕坦为2.5g。
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