CN114452363A - 一种人参健脾片及其制备方法 - Google Patents
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- CN114452363A CN114452363A CN202011237455.7A CN202011237455A CN114452363A CN 114452363 A CN114452363 A CN 114452363A CN 202011237455 A CN202011237455 A CN 202011237455A CN 114452363 A CN114452363 A CN 114452363A
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Abstract
本发明提供了一种人参健脾片及其制备方法,所述人参健脾片由人参、白术、甘草、山药、莲子、白扁豆、木香、草豆蔻、陈皮、青皮、六神曲、谷芽、山楂、芡实、薏苡仁、当归和枳壳及适当辅料制备而成;通过冻干工艺以缩短超微粉碎时间,尽可能减少活性成分降解,并使药物提取更完全;同时通过对挥发油进行吸附、包覆等处理,确保药效更加稳定;此外,通过优化压片工艺及辅料,片剂的溶出度高、生物利用度好。
Description
技术领域
本发明涉及中医药领域,特别涉及一种人参健脾片及其制备方法。
背景技术
人参健脾片是一种具有补气健脾、开胃消食的中成药,临床上用于脾虚湿困所致的食少便溏、或吐或泻、脘腹胀满、四肢乏力、面色萎黄等症。常见制法为:人参、六神曲、草豆蔻、谷芽粉碎成细粉,过筛。木香、陈皮提取挥发油后,药渣加水煎煮一次,滤过;白扁豆、芡实、山楂、甘草、莲子、山药、薏苡仁加水煎煮二次,合并煎液,滤过;青皮、当归、白术、枳壳用60%乙醇进行渗漉,收集漉液,回收乙醇;合并以上各药液,减压浓缩成稠膏状,加入人参、六神曲等细粉及辅料适量,混匀,制成颗粒,60℃以下干燥,喷加木香、陈皮挥发油,混匀,压制,包糖衣,即得。
为了改善提取收率及生物利用度,更好的发挥药效,越来越多的现代提取工艺用于人参健脾片的制备。如申请号201310139008.1的中国专利公开了一种补气健脾的药物组合物,先粉碎至80-500目,在水煎或醇提之前,通过对不同的药物分组,并分别进行冻干预处理,从而破坏植物细胞壁以增加提取率;但该工艺仍存在由于粉碎后的颗粒较大,提取不完全;若超微粉碎至小粒径,某些易热解的物质或化学不稳定性成分也易被氧化、破坏,药材的有效成分损失巨大,严重影响了药物的疗效;同时加入挥发油容易逸散,难以留存,药效不稳定。
申请号201610272827.7的中国专利公开了一种人参健脾片及其制备方法,具体为以人参、白术、甘草、莲子、白扁豆、芡实和当归以超微细粉入药,以山药、六神曲和薏苡仁用复合酶酶解后煎煮入药,余下原料药进行超临界萃取,同时加入适量崩解剂,以改善崩解时间;由于人参等成分未经醇提、水煎等操作,进入人体后的生物利用度低。
因此,迫切需要寻找一种有效成分提取更完全、挥发性成分不易逸散的制备工艺,以更好地发挥人参健脾片这一经典方剂的药用价值。
发明内容
有鉴于此,针对现有技术中存在的不足,本发明旨在提出一种人参健脾片及制备方法,从而使有效成分提取更完全、存储稳定性优、生物利用度高,以更好地发挥该方的药用功效。
为达到上述目的,本发明的技术方案是这样实现的:
一种人参健脾片,所述人参健脾片包括下述组方:
优选的,所述人参健脾片包括下述组方:
进一步的,所述人参健脾片由以下方法制备:
(1)预处理将人参、白扁豆预粉碎至8-12μm,加1-2倍水(V/W)过夜浸泡、冻干,再超微粉碎至200-400nm;将白术、甘草、山药、山楂预粉碎至8-12μm,加1-2倍水(V/W)过夜浸泡、冻干,再超微粉碎至100-300nm;将莲子、青皮、芡实、薏苡仁粉碎至8-12μm,1-2倍水(V/W)混匀,酶解处理,得酶解物;将木香、陈皮、当归、枳壳粉碎至8-12μm后混匀;将草豆蔻、六神曲、谷芽超微粉碎至100-500nm后混匀;优选的,所述超微粉碎的操作温度为4-10℃。
(2)提取
木香、陈皮、当归、枳壳进行超临界CO2萃取,收集的挥发油进行再处理,得物料A;同时,药渣加入3-5倍(V/W)70%乙醇溶液提取、收集,得提取液Ⅰ;
向人参、白扁豆中加入提取液Ⅰ,浸渍5-10h,分离、收集渗漉液;同时,药渣加入2-4倍水(V/W)煎煮1-3h,滤过,与渗漉液合后浓缩,得提取物B;
将白术、甘草、山药、山楂加入6-10倍水(V/W)煎煮1-3h,滤过;将白术、甘草、山药、山楂的滤渣及人参、白扁豆的滤渣合并,再次用6-10倍水(V/W)煎煮1-3h,滤过,合并滤液并浓缩,得提取物C;
(3)制粒将提取物B、C用高速搅拌机进行搅拌均匀,再加入草豆蔻、六神曲、谷芽的超细粉末及酶解物混匀,加入麦芽糖醇、50%羟丙基纤维素后制粒;
(4)压片湿颗粒干燥,再加入50%的羟丙基纤维素及物料A,混匀后压片、包衣。
由于超微粉碎至小粒径后,药材微粉不易压片,常需要加入大量的辅料来赋型,这样会造成主药含量低,服用量大,患者依从性差的问题。而申请人通过麦芽糖醇乙醇溶液代替上述辅料,从而无需添加常规辅料也可保证压片成型效果;同时,本发明通过乙醇溶液作为制软材的润湿剂,解决了活性成分高的提取物B、C遇水易结块的问题。同时,通过将羟丙甲基纤维素分成两份添加,使制粒的物料性质接近于羟丙基纤维素,更易混合均匀,崩解时间短,溶出度高。
进一步的,步骤(1)的冻干条件为:在2-5min内降温至-4℃,保温5-10min;然后5-10min降温至-20℃,保温20-35min;最后5-8min升温至30-35℃,保温5-10min后真空干燥。研究发现,传统的制备工艺中,药物粉碎后颗粒较大,导致水煎、醇提时间长,活性成分提取不充分且存在降解,收率不高;而当将药物直接粉碎至小粒径时,需要对药材长时间粉碎,不仅会造成重金属污染,同时粉碎使物料长时间处于高温、强烈的机械碰撞环境,也容易成破坏活性物质,导致提取收率不理想。申请人根据药材性质,针对性的采用不同提取工艺,同时创造性的将冻干处理与粉碎相结合,通过短时间内将浸泡后的预粉颗粒降至冰点以下,使植物细胞内的细胞液形成冰晶,从而破坏细胞壁、细胞膜成分,进而降低超微粉碎的处理难度,避免长时间的超微粉碎造成活性成分的降解,提高收率。
更进一步的,步骤(1)中酶解条件为:调pH至6.7-7.1后加热到50℃-55℃,加入0.7%(W/W)纤维素酶、1.5%(W/W)木瓜蛋白酶、1.2%(W/W)α-淀粉酶,恒温、搅拌酶解2-5h,灭活、浓缩干燥。申请人根据原料药有效成分的性质、特点,对莲子、青皮、芡实、薏苡仁四味药材在预粉碎后进行酶解处理后直接入药,既能避免繁杂的提取工艺导致收率有所损耗,同时有助于人体的吸收,生物利用度高;发明人对酶的种类及用量进行了考察,发现以7:15:12的纤维素酶、木瓜蛋白酶、α-淀粉酶比例组合的复合酶效果最佳,使莲子、青皮、芡实、薏苡仁更有助于人体的消化、吸收。
进一步的,所述超临界CO2萃取条件为:对萃取釜及分离釜a、b加热,当萃取釜温度为40~45℃,通入CO2至萃取釜,使分离釜a、b压力分别为10±1MPa、8.0±1MPa,调CO2的流量为16-18kg/h,进行恒温恒压循环萃取,2.5-3h后收集挥发油Ⅰ;升高温度,当萃取釜温度为65~70℃,调CO2的流量为12-15kg/h,恒温恒压萃取2-2.5h,收集挥发油Ⅱ,与挥发油Ⅰ合并。
更进一步的,所述步骤(2)的再处理包括:搅拌状态下,按1:1.5-2g/ml向挥发油中缓慢加入多孔淀粉,搅拌至挥发油被完全吸收。
进一步的,所述步骤(2)的再处理还包括:吸油后的多孔淀粉按1:4-15(W/W海藻酸钠)加入到0.8~2wt%的海藻酸钠水溶液,在搅拌下升温至30℃~35℃得到预混液;向上述预混液中缓慢滴入含0.1%(v/v)Tween80的1.0~2.0%(w/v)的氯化钙溶液,温度为20~50℃,静置20~100min,干燥,形成物料A。申请人通过研究发现,木香、陈皮、当归、枳壳均含有一定量挥发油,例如陈皮中约含1.5%挥发油,主要成分包括D-柠檬烯、β-月桂回烯、α-及β-蒎烯等,常作为作补气药之佐使,可使补而不滞;而当归中的挥发油中主要成分为藁本内酯、正丁烯基嗼内酯和当归酮等;现有技术中提取的挥发油直接入药,易逸散而导致药效下降。在此基础上,申请人采用超临界萃取技术,使得其有效成分不被破坏,挥发油提取更完全;同时对提取的挥发油进行吸附、固化等再处理,提高片剂存储的稳定性;为了进一步改善片剂的稳定性,申请人利用海藻酸钠具有生物相容性、安全性高的特点,对挥发油进行包覆,能够耐光、耐热,确保人参健脾片的药效稳定及存储期限。
进一步的,所述人参健脾片的规格为0.51g/片。本发明所制备的人参健脾片的单片片重适中,便于服用,患者的依从性好。
更进一步的,所述白术、甘草、山药、山楂的滤过采用下述方法:将水煎液降至25-30℃,静置5-8h后分层,上层清液采用离心,如3500rpm,进料流量100-1000L/h以尽量去除小颗粒物;下层沉淀中加入10%木香、陈皮、当归、枳壳的药渣,搅匀、过滤,与离心液合并。当超微粉碎至小粒径后,小分子颗粒物的释放进一步增加了固液分离的难度;单纯离心则需要高转速、长时间,不利于规模化生产;而常规的过滤操作需要加入助剂,而这无形加大后续水煎液体积,增加后续操作难度;申请人创造性的利用木香、陈皮、当归、枳壳的药渣作为助剂,既能提高过滤速度,同时实现了木香、陈皮、当归、枳壳的超临界萃取、醇提、水煎,从而充分提取活性成分,提高药效。
附图说明
构成本发明的一部分的附图用来提供对本发明的进一步理解,本发明的示意性实施例及其说明用于解释本发明,并不构成对本发明的不当限定。在附图中:
图1为本发明实施例所述的提取浓缩罐的结构示意图;
图2为本发明实施例所述的回流设备的整体示意图;
图3为本发明实施例所述的回流设备的剖面示意图;
图4为本发明实施例所述的传动结构的结构示意图;
图5为本发明实施例所述反转件的结构示意图。
附图标记说明:
1-罐体;2-搅拌系统;3-回流设备;31-传动结构;311-第一齿轮;312-第一双联齿轮;313-第一齿轮轴;314-第二齿轮;315-第二齿轮轴;316-第二双联齿轮;317-第三齿轮;318-第一驱动轴;319-第二驱动轴;32-混合组件;321-下筒体;3211-凸起;3212-第一下料口;322-盖设件;3221-第一上料口;323-反转件;3231-杆体;3232-密封轴承;3233-容纳腔;3234-固定座;3235-第一混合段;3236-第二混合段;3237-第三混合段;3238-叶片;33-主动轴;4-驱动电机;5-投料口;6-加热层;7-输送泵;8-回流管。
本发明人通过以下试验考察不同工艺步骤及参数对本发明中药片剂的影响。需要说明的是:以下试验只是本发明研制过程中众多试验中的举例性试验,并未涵盖和穷尽了发明人为本发明所做的所有实验,目的仅仅在于用数据来阐述本发明制备方法筛选优化的部分过程及结果。
实验例1
1.1预处理工艺的选择
以200g人参为例,分别按照表1的方法进行预处理,其中粉碎采用XDW-15A型超微粉碎机,冻干条件为:用2倍水(V/W)过夜浸泡,离心分离;3min内将湿粉降温至-4℃,保温10min;然后10min降温至-20℃,保温35min,然后5min升温至30℃,保温10min后真空干燥,HPLC测定人参皂苷Re、Rg1、Rc、Rd、Rb1、Rh1的总含量;之后粉末用6倍70%乙醇溶液渗漉提取10h,滤渣用5倍水煎煮提取2h,计算单步提取得率及提取总得率。
表1预处理操作对人参皂苷的提取得率的影响
由表1可知,相较于醇提操作,通过醇提、水煎两步操作可有效提高人参中活性成分的提取得率;相比于直接超微粉碎,将预粉碎的物料进行冻干处理,利用植物细胞内产生冰晶破坏细胞壁,有效缩短超微粉碎的时间,提高提取总得率;相对于常温下超微粉碎,在低温下超微粉碎能够有效避免活性成分降解,提高最终人参皂苷的总得率。
1.2挥发油的处理
参照实施例1的制备方法,取等量挥发油分别按照表2的条件进行处理,制备片剂。将制备的片剂在温度45±2℃、湿度75%±5%条件下放置30天,以D-柠檬烯为例,在第0天、15天、30天取样,测定片剂中挥发油的损失率;所述D-柠檬烯的检测为现有技术。
表2不同操作对片剂中挥发油的影响
由表2可知,随着对挥发油的处理工艺的增加,最终片剂中挥发油的含量有所降低;通过对挥发油进行吸附以及二次包覆,片剂中挥发油的损失率更低,存储时间产,药效稳定。
1.3压片工艺优化
参照实施例1的制备方法,取制备的物料A、B、C、草豆蔻、六神曲、谷芽的超细粉末及酶解物分别按照下述表3的方法进行制粒、压片,观察压片效果,检测的崩解度、硬度和脆碎度,采用FDA推荐的相似因子法评价其溶出度。
表3不同操作方式对压片、溶出的影响
由表3可知,本发明采用乙醇溶液作为制软材的润湿剂,解决了提取物B、C及酶解物、微粉等遇水易结块的问题;本发明中将麦芽糖醇溶于乙醇溶液中,制粒工艺中用麦芽糖醇乙醇溶液将提取物B、C及酶解物、微粉粘合起来制成软材用于后续制粒,其中麦芽糖醇不仅起到粘合作用,还能提高片剂具备一定的硬度。而相对于羟丙甲基纤维素的一次添加,分成两份在制粒时、压片时添加,能够有效改善片剂的溶出度。
实验例2
申请人研究发现,人参、白扁豆进行水提时的设备的混合性能也能影响最终的提取收率,为此通常需要进行高转速、长时间搅拌。为了确保提取完全并降低能耗,申请人对现有设备进行了如下改进:
如图1所述,一种搅拌罐,包括罐体1、搅拌系统2、投料口5、加热层6,所述罐体1的顶部设有投料口5,所述搅拌系统2包括贯穿所述罐体1且设在所述罐体1的中轴线上的搅拌轴以及设在所述搅拌轴下端部的搅拌桨叶。所述加热层6位于所述罐体1的中下部,环绕的设在所述罐体1的外周侧。所述罐体1内还设有回流设备3,所述回流设备3通过回流管8与输送泵7的出口端相连,所述输送泵7的进口端与所述罐体1的底部相连,用于将罐体1内的物料输送至回流设备3内。优选的,所述回流设备3的上方依次设有驱动电机4,用于驱动所述回流设备3转动。
如图2、图3所示,所述回流设备3包括由上自下依次相连的主动轴33、传动结构31、混合组件32,所述主动轴33通过传动结构31驱动混合组件32转动。作为优选,所述主动轴33通过传动结构31同时驱动所述反转件323、下筒体321互为反向转动。也就是说:所述反转件323为顺时针转动,同时所述下筒体321为逆时针转动;或者所述反转件323为逆时针转动,同时所述下筒体321为顺时针转动。具体的,如图4所示,所述传动结构31包括依次啮合相连的第一齿轮311、第一双联齿轮312、第二齿轮314,所述第一齿轮311位于主动轴33的下部,所述第一齿轮311与所述主动轴33驱动相连,所述第一双联齿轮312套设在所述第一齿轮轴313的外周侧,所述第二齿轮314的下方设有第一驱动轴318,所述第一驱动轴318用于驱动所述反转件323的转动;所述传动结构31还包括依次啮合相连第二双联齿轮316、第三齿轮317,所述第二双联齿轮316套设在所述第二齿轮轴315的外周侧,所述第二双联齿轮316与第一双联齿轮312传动相连,所述第三齿轮317位于所述第二齿轮314的下部的,所述第二驱动轴319的内部中空,所述第一驱动轴318设在所述第二驱动轴319内,所述第二驱动轴319用于驱动所述下筒体321的转动。所述第一双联齿轮312、第一齿轮轴313、第二双联齿轮316、第二齿轮轴315均为二个,分别对称的设在所述主动轴33的两侧。所述传动结构31还包括外壳,所述第一齿轮轴313、第二齿轮轴315插装在所述外壳体相应位置的轴孔内。
第一驱动轴318与第二驱动轴319的转向关系为:
主动轴33正转→第一齿轮311正转→第一双联齿轮312反转→第二齿轮314正转→第一驱动轴318正转;同样的,当主动轴33反转时,也会使第一驱动轴318反转。
主动轴33正转→第一齿轮311正转→第一双联齿轮312反转→第二双联齿轮316正转→第三齿轮317反转→第二驱动轴319反转;同样的,当主动轴33反转时,也会使第一驱动轴318正转。
当料液进入混合组件32后,在反转件323的作用下向周侧旋转运动以分散人参、白扁豆微粉颗粒及提取液组成的料液,当与反向运动的下筒体321接触,尤其是下筒体321上的凸起3211接触后,料液中的颗粒物由于瞬间受到极大的差速而被进一步撕裂、分散,从而促进提取液进入植物细胞间隙,最终在回流设备3及搅拌系统2在相对低转速下实现快速提取的效果,更加节能、安全。
所述混合组件32包括下筒体321、盖设件322、反转件323。优选的,所述盖设件322与所述筒体1为固定连接,所述下筒体321与盖设件322之间转动相连,形成的容纳空间内设有所述反转件323;优选的,所述盖设件322上设有加强筋3221,所述回流管8通过所述加强筋3221之间的间隙向回流设备3内输入物料;所述下筒体321的内壁面上设有多个凸起3211,所述下筒体321的底部开口形成第一下料口3212,进入回流设备3内的物料通过所述凸起3211进行摩擦、混合后通过所述第一下料口3212进入所述罐体1内,随着驱动电机4的转动,带动混合组件32高速转动产生的离心作用,人参、白扁豆与醇提液在混合组件32内充分混合,大幅改善二者的混合效果,提取效率更高。优选的,如图3所述,所述反转件323包括依次相连的杆体3231、密封轴承3232、固定座3234,所述固定座3234与所述盖设件322可拆卸的连接,例如螺接、卡接、插接等。所述密封轴承3232在远离所述杆体3231的一端与所述第一驱动轴318驱动相连。如图5所示,所述杆体3231的侧壁上设有倾斜向上或向下设置的叶片3238,可以是常规的叶片,如涡轮式叶片、平桨式叶片、斜桨式叶片、螺带式叶片等等。优选的,所述叶片3238为倾斜向上设置的螺带式叶片,能够产生向上的驱动力;优选的,所述杆体3231包括从上至下依次连接的第一混合段3235、第二混合段3236、第三混合段3237,所述第一混合段3235的侧壁与下筒体321之间的距离、第二混合段3236的侧壁与下筒体321之间的距离、第三混合段3237的侧壁与下筒体321之间的距离依次增大。从第一上料口3221进入的物料在重力的作用下向下移动,当反转件323转动时,可对混合组件32内的物料产生向上的驱动力,对物料向上挤压,因此位于混合组件32上部的物料受到的压力较大,流量也较大;从所述下筒体321的上端至下端,所述叶片3238的直径逐渐减小,其产生的驱动力也越小,从而使延长物料在所述混合组件32内的停留时间。除此之外,申请人还对反转件323的的杆体3231、固定座3234进行了进一步改进,所述杆体3231内设置容纳腔3233,所述容纳腔3233的开口方向朝向所述固定座3234的一侧,所述固定座3234上固定设置有连接管路,所述容纳腔3233用于对所述连接管路进行容纳,当需要清洗,可通过连接管路向混合组件内通入相应物质。
具体实施方式
需要说明的是,在不冲突的情况下,本发明中的实施例及实施例中的特征可以相互组合。
下面将参考附图并结合实施例来详细说明本发明。
实施例1
人参健脾片,由下述原料组成:人参16g、白术55g、甘草55g、山药70g、莲子30g、白扁豆55g、木香9g、草豆蔻30g、陈皮20g、青皮65g、六神曲30g、谷芽45g、山楂50g、芡实60g、薏苡仁80g、当归60g、枳壳20g、麦芽糖醇70g、羟丙基纤维素50g。
制备方法为:
(1)预处理将人参、白扁豆预粉碎至D90=10-12μm,加入2倍水(V/W)过夜浸泡,3000rpm离心分离,将湿粉进行冻干,即5min内降温至-4℃,保温10min;然后10min降温至-20℃,保温35min,然后5min升温至30℃,保温10min后45℃真空干燥;再超微粉碎至D90=300-400nm,备用;将白术、甘草、山药、山楂预粉碎至D90=10-12μm,加入1倍水(V/W)过夜浸泡,3000rpm离心分离,将湿粉进行冻干:即3min内降温至-4℃,保温5min;然后5min降温至-20℃,保温20min,然后8min升温至35℃,保温5min后40℃下真空干燥,再超微粉碎至100-200nm,备用;将莲子、青皮、芡实、薏苡仁粉碎至D90=8-10μm,加入8倍水(V/W)搅拌、混匀,调pH至6.7后加热到50℃,加入0.7%(W/W)纤维素酶、1.5%(W/W)木瓜蛋白酶、1.2%(W/W)α-淀粉酶,恒温、搅拌酶解5h,灭活、50℃真空浓缩,得酶解物;将木香、陈皮、当归、枳壳粉碎至D90=8-12μm后混匀,备用;将草豆蔻、六神曲、谷芽超微粉碎至D90=300-500nm后混匀,备用;
(2)提取
将粉状的木香、陈皮、当归、枳壳进行超临界CO2萃取,即对萃取釜及分离釜a、b加热,当萃取釜温度为45℃,通入CO2至萃取釜,使分离釜a、b压力分别为10.2MPa、8.3MPa,调CO2的流量为17kg/h,进行恒温恒压循环萃取,2.5h后收集挥发油Ⅰ;升高温度,当萃取釜温度为65℃,调CO2的流量为12kg/h,恒温恒压萃取2h,收集挥发油Ⅱ,与挥发油Ⅰ合并,搅拌状态下,按1:2g/ml向挥发油Ⅰ、Ⅱ中缓慢加入多孔淀粉,搅拌至挥发油被吸收完全;吸油后的多孔淀粉按照1:4(W/W海藻酸钠)加至2wt%海藻酸钠水溶液,搅拌、升温至35℃,得预混液;向上述预混液中缓慢滴入含0.1%(v/v)Tween80的2.0%(w/v)的氯化钙溶液,温度为20℃,静置20min,干燥,形成物料A。
向木香、陈皮、当归、枳壳的药渣加入5倍(V/W)70%乙醇溶液45℃提取3h,收集得提取液Ⅰ;将提取液Ⅰ加入到人参、白扁豆的超微粉,浸渍5h,收集渗漉液;同时,药渣加入4倍水(V/W)煎煮2h,滤过,与渗漉液合并后45℃真空浓缩,得提取物B;
将粉状的白术、甘草、山药、山楂加入6倍水(V/W)煎煮3h,滤过;将白术、甘草、山药、山楂的药渣及人参、白扁豆的滤渣合并,再次用10倍水(V/W)煎煮2h;滤过,合并滤液,45℃真空浓缩,得提取物C;
(3)制粒
将提取物B、C用高速搅拌机进行搅拌均匀,再加入超微粉状的草豆蔻、六神曲、谷芽及莲子、青皮、芡实、薏苡仁形成的酶解物,加入麦芽糖醇乙醇溶液后混匀、制粒;
(4)压片
湿颗粒在60℃下真空干燥8h,加入羟丙基纤维素及物料A,混合均匀,压1000片,包薄膜衣,即得,每片重0.51g。
实施例2
人参健脾片,由下述原料组成:人参20g、白术70g、甘草20g、山药40g、莲子40g、白扁豆45g、木香14g、草豆蔻20g、陈皮35g、青皮55g、六神曲55g、谷芽40g、山楂40g、芡实40g、薏苡仁100g、当归50g、枳壳30g、麦芽糖醇30g、羟丙基纤维素20g。
制备方法为:
(1)预处理将人参、白扁豆预粉碎至D90=10-12μm,加入1.5倍水(V/W)过夜浸泡,3000rpm离心分离,将湿粉进行冻干,即3min内降温至-4℃,保温8min;然后6min降温至-20℃,保温30min;再在6min升温至35℃,保温8min后45℃真空干燥;再超微粉碎至D90=200-300nm,备用;将白术、甘草、山药、山楂预粉碎至D90=10-12μm,加入1.2倍水(V/W)过夜浸泡,3000rpm离心分离,将湿粉进行冻干-即5min内降温至-4℃,保温9min;然后8min降温至-20℃,保温25min,然后7min升温至35℃,保温10min后40℃下真空干燥,再超微粉碎至100-200nm,备用;将莲子、青皮、芡实、薏苡仁粉碎至D90=8-10μm,加入10倍水(V/W)搅拌、混匀,调pH至7.1后加热到52℃,加入0.7%(W/W)纤维素酶、1.5%(W/W)木瓜蛋白酶、1.2%(W/W)α-淀粉酶,恒温、搅拌酶解3h,灭活、得酶解物;将木香、陈皮、当归、枳壳粉碎至D90=8-12μm后混匀,备用;将草豆蔻、六神曲、谷芽超微粉碎至D90=100-400nm后混匀,备用;
(2)提取
将粉状的木香、陈皮、当归、枳壳进行超临界CO2萃取,即对萃取釜及分离釜a、b加热,当萃取釜温度为45℃,通入CO2至萃取釜,使分离釜a、b压力分别为9.8MPa、7.9MPa,调CO2的流量为16kg/h,进行恒温恒压循环萃取,3h后收集挥发油Ⅰ;升高温度,当萃取釜温度为70℃,调CO2的流量为15kg/h,恒温恒压萃取2h,收集挥发油Ⅱ;合并挥发油Ⅰ、Ⅱ,搅拌状态下,按1:1.5g/ml向挥发油Ⅰ、Ⅱ中缓慢加入多孔淀粉,搅拌至挥发油被吸收完全;吸油后的多孔淀粉按照1:15(W/W海藻酸钠)加入到2wt%海藻酸钠水溶液,在搅拌下升温至30℃得到预混液;向上述预混液中缓慢滴入含0.1%(v/v)Tween80的1.0%(w/v)的氯化钙溶液,40℃下静置60min,60℃真空干燥6h,制得物料A。
向木香、陈皮、当归、枳壳的药渣加入3倍(V/W)70%乙醇溶液提取、收集、得提取液Ⅰ;向人参、白扁豆的超微粉中加入提取液Ⅰ,浸渍10h,收集渗漉液;同时,分离的药渣加入2倍水(V/W)煎煮2h,滤过,与渗漉液合并后45℃真空浓缩,得提取物B;
将粉状的白术、甘草、山药、山楂加入10倍水(V/W)煎煮1h,滤过;将白术、甘草、山药、山楂的药渣及人参、白扁豆的滤渣合并,再加入8倍水(V/W)煎煮3h;滤过,合并滤液,45℃真空浓缩,得提取物C;
(3)制粒
将提取物B、C用高速搅拌机进行搅拌均匀,再加入超微粉状的草豆蔻、六神曲、谷芽及莲子、青皮、芡实、薏苡仁的酶解物,加入麦芽糖醇乙醇溶液、50%羟丙基纤维素后混匀、制粒;
(4)压片
湿颗粒在60℃下干燥8h,加入50%的羟丙基纤维素及物料A,混合均匀,压1000片,包薄膜衣,即得,每片重0.51g。
实施例3
人参健脾片,由下述原料组成:人参18g、白术60g、甘草45g、山药60g、莲子35g、白扁豆50g、木香12g、草豆蔻25g、陈皮30g、青皮60g、六神曲40g、谷芽55g、山楂55g、芡实50g、薏苡仁90g、当归70g、枳壳25g、麦芽糖醇50g、羟丙基纤维素40g。
制备方法为:
(1)预处理将人参、白扁豆预粉碎至D90=10-12μm,加入2倍水(V/W)过夜浸泡,3500rpm离心分离,将湿粉进行冻干,即4min内降温至-4℃,保温10min;然后10min降温至-20℃,保温25min;再在8min升温至32℃,保温10min后45℃真空干燥;再超微粉碎至D90=200-300nm,备用;将白术、甘草、山药、山楂预粉碎至D90=8-10μm,加入1.5倍水(V/W)过夜浸泡,3500rpm离心分离,将湿粉进行冻干,即3min内降温至-4℃,保温6min;然后10min降温至-20℃,保温30min,然后8min升温至35℃,保温8min后40℃下真空干燥,再超微粉碎至200-300nm,备用;将莲子、青皮、芡实、薏苡仁粉碎至D90=8-10μm,加入12倍水(V/W)搅拌、混匀,调pH至6.9后加热到50℃,加入0.7%(W/W)纤维素酶、1.5%(W/W)木瓜蛋白酶、1.2%(W/W)α-淀粉酶,恒温、搅拌酶解5h,灭活、得酶解物;将木香、陈皮、当归、枳壳粉碎至D90=8-11μm后混匀,备用;将草豆蔻、六神曲、谷芽超微粉碎至D90=200-400nm后混匀,备用;
(2)提取
将粉状的木香、陈皮、当归、枳壳超临界CO2萃取,即对萃取釜及分离釜a、b加热,当萃取釜温度为40℃,通入CO2至萃取釜,使分离釜a、b压力分别为9.5MPa、7.7MPa,调CO2的流量为18kg/h,进行恒温恒压循环萃取,3h后收集挥发油Ⅰ;升高温度,当萃取釜温度为68℃,调CO2的流量为12kg/h,恒温恒压萃取2.5h,收集挥发油Ⅱ;合并挥发油Ⅰ、Ⅱ,搅拌状态下,按1:1.8g/ml向挥发油Ⅰ、Ⅱ中缓慢加入多孔淀粉,搅拌至挥发油被吸收完全;吸油后的多孔淀粉按照1:8(W/W海藻酸钠)加入到0.8wt%海藻酸钠水溶液,在搅拌下升温至32℃得到预混液;向上述预混液中缓慢滴入含0.1%(v/v)Tween80的1.5%(w/v)的氯化钙溶液,温度为50℃,静置100min,55℃干燥4h,形成物料A。
向木香、陈皮、当归、枳壳的药渣加入5倍(V/W)70%乙醇溶液提取,收集、得提取液Ⅰ;向提取液Ⅰ加入到人参、白扁豆的超微粉,浸渍5h后渗漉提取,收集渗漉液;同时,人参、白扁豆提取后的药渣加入4倍水(V/W)煎煮2h,滤过,与渗漉液合并后45℃真空浓缩,得提取物B;
将粉状的白术、甘草、山药、山楂加入6倍水(V/W)煎煮3h,滤过;将白术、甘草、山药、山楂的药渣及人参、白扁豆的滤渣合并,再次用10倍水(V/W)煎煮1h;滤过,合并滤液,45℃真空浓缩,得提取物C;
(3)制粒
将提取物B、C用高速搅拌机进行搅拌均匀,再加入超微粉状的草豆蔻、六神曲、谷芽及莲子、青皮、芡实、薏苡仁的酶解物,加入麦芽糖醇乙醇溶液、50%羟丙基纤维素后混匀、制粒;
(4)压片
湿颗粒在60℃下干燥5h,加入50%的羟丙基纤维素及物料A,混合均匀,压1000片,包薄膜衣,即得,每片重0.51g。
实施例4
人参健脾片,由下述原料组成:人参18g、白术60g、甘草45g、山药55g、莲子35g、白扁豆50g、木香12g、草豆蔻28g、陈皮20g、青皮55g、六神曲48g、谷芽48g、山楂45g、芡实50g、薏苡仁90g、当归50g、枳壳20g、麦芽糖醇70g、羟丙基纤维素60g、微晶纤维素20g。
制备方法为:
(1)预处理将人参、白扁豆预粉碎至D90=10-12μm,加入1.8倍水(V/W)过夜浸泡,3000rpm离心分离,将湿粉进行冻干,即在5min内降温至-4℃,保温5min;然后10min降温至-20℃,保温25min;再在8min升温至35℃,保温10min后40℃真空干燥;再超微粉碎至D90=200-300nm,备用;将白术、甘草、山药、山楂预粉碎至D90=10-12μm,用2倍水(V/W)过夜浸泡,3000rpm离心分离,将湿粉进行冻干:5min内降温至-4℃,保温6min;然后10min降温至-20℃,保温35min,然后5min升温至30℃,保温10min后40℃下真空干燥,再超微粉碎至100-200nm,备用;将莲子、青皮、芡实、薏苡仁粉碎至D90=8-10μm,加入8倍水(V/W)搅拌、混匀,调pH至6.7后加热至50℃,加入0.7%(W/W)纤维素酶、1.5%(W/W)木瓜蛋白酶、1.2%(W/W)α-淀粉酶,恒温、搅拌酶解5h,灭活、得酶解物;将木香、陈皮、当归、枳壳粉碎至D90=10-12μm后混匀,备用;将草豆蔻、六神曲、谷芽超微粉碎至D90=100-200nm后混匀,备用;
(2)提取
将粉状的木香、陈皮、当归、枳壳进行超临界CO2萃取,即对萃取釜及分离釜a、b加热,当萃取釜温度为42℃,通入CO2至萃取釜,使分离釜a、b压力分别为10.5MPa、8.3MPa,调CO2的流量为18kg/h,进行恒温恒压循环萃取,2.7h后收集挥发油Ⅰ;升高温度,当萃取釜温度为68℃,调CO2的流量为14kg/h,恒温恒压萃取2h,收集挥发油Ⅱ,与挥发油Ⅰ合并;搅拌状态下,按1:1.5g/ml向挥发油Ⅰ、Ⅱ中缓慢加入多孔淀粉,搅拌至挥发油被吸收完全;将吸附后的多孔淀粉按照1:8(W/W海藻酸钠)加入到1.5wt%海藻酸钠水溶液,在搅拌下升温至32℃得到预混液;向上述预混液中缓慢滴入含0.1%(v/v)Tween80的1.8%(w/v)的氯化钙溶液,温度为35℃,静置100min,干燥,形成物料A。
向木香、陈皮、当归、枳壳的药渣加入5倍(V/W)70%乙醇溶液提取,收集得提取液Ⅰ;将提取液Ⅰ加入到人参、白扁豆的超微粉中,浸渍5h,收集渗漉液;同时,将人参、白扁豆提取后的药渣投入到实验例2所述的提取设备中,加入4倍水(V/W)循环回流、煎煮2h,滤过,与渗漉液合并后45℃真空浓缩,得提取物B;
将粉状的白术、甘草、山药、山楂加入8倍水(V/W)煎煮1h,降温至25-30℃,静置5-8h后分层,上层清液采用3500rpm离心,流量500L/h;下层沉淀中加入10%木香、陈皮、当归、枳壳的药渣,搅拌10min混匀、过滤,合并过滤液。将白术、甘草、山药、山楂的药渣及人参、白扁豆的滤渣合并,再用6倍水(V/W)煎煮3h;滤过,合并滤液,45℃真空浓缩,得提取物C;
(3)制粒
将提取物B、C用高速搅拌机进行搅拌均匀,再加入超微粉状的草豆蔻、六神曲、谷芽及莲子、青皮、芡实、薏苡仁形成的酶解物,加入麦芽糖醇乙醇溶液、50%羟丙基纤维素后混匀、制粒;
(4)压片
湿颗粒在60℃下干燥7h,加入微晶纤维素及50%的羟丙基纤维素及物料A,混合均匀,压1000片,包薄膜衣,即得,每片重0.51g。
实施例5
采用实施例1相同的方法及工艺参数,区别在于,提取的挥发油不经包覆处理直接喷洒制备片剂。
对比例1
采用申请号201610272827.7中实施例1的方法制备,共压制1000片;
对比例2
采用申请号201310139008.1中实施例1的方法制备,共压制1000片;
为验证本发明制备人参健脾片的治疗效果,申请人对临床上其药效学进行研究,具体方法及结果如下:
肠易激综合征(IBS)属于中医的“腹痛”、“腹泻”范畴,多由于感受外邪、饮食所伤、脾胃虚弱等而致,尤以脾胃虚弱最为常见,临床上以而腹泻型最多见。根据罗马Ⅲ标准,所有病例均符合IBS标准,即:在最近的3个月内,每个月至少有3d具有反复发作的腹痛或不适症状,并具有下列中的2项或以上:(1)排便后症状改善;(2)排便频率增加;(3)大便稀溏、不成形或水样便比例≥25%。在此基础上便常规、潜血、镜检、腹部B超、结肠镜检查排除可引起这些症状的器质性疾病;及其他胃肠道功能性疾病;内分泌疾病;合并心脑血管、肝、肾和造血系统等严重疾病;孕、产妇,精神病患者,系统严重病患者,以126例腹泻型IBS患者为对象,随机分为7组,分别口服实施例1-5、对比例1-2制备的人参健脾片,2片/次,2次/d,疗程均为两周,评价治疗效果,结果见表4。
总有效=显效+有效。
疗效评价标准
显效:2周后全部症状消失,随诊1个月无复发;有效:原有症状全部减轻;无效:症状无改变仍腹痛腹泻。
表4治疗2周后临床疗效对比
组别 | 例数 | 显效 | 有效 | 无效 | 总有效率,% |
1 | 18 | 9 | 4 | 5 | 72.2 |
2 | 18 | 10 | 4 | 4 | 77.8 |
3 | 18 | 12 | 3 | 3 | 83.3 |
4 | 18 | 13 | 4 | 2 | 94.4 |
5 | 18 | 9 | 3 | 6 | 66.7 |
6 | 18 | 7 | 2 | 9 | 50.0 |
7 | 18 | 8 | 2 | 8 | 55.6 |
由表4可知,本申请制备的人参健脾片中人参、陈皮补中益气;白术、薏苡仁、白扁豆、山药、草豆蔻健脾化湿、消食调中;莲子、芡实健脾补胃、补脾止泻、止泻固精;木香、青皮行气止痛、调中导滞;当归活血化瘀、通脉疏络;陈皮理气燥湿;甘草健脾益气,调和诸药;通过优化工艺,能够有效提取药材中的活性成分,疗效更优。
以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (10)
3.一种权利要求1或2所述的人参健脾片的制备方法,其特征在于,由以下方法制备:
(1)预处理将人参、白扁豆预粉碎至8-12μm,加1-2倍水(V/W)过夜浸泡、冻干,再超微粉碎至200-400nm;将白术、甘草、山药、山楂预粉碎至8-12μm,加1-2倍水(V/W)过夜浸泡、冻干,再超微粉碎至100-300nm;将莲子、青皮、芡实、薏苡仁粉碎至8-12μm,加1-2倍水(V/W)混匀、酶解,得酶解物;将木香、陈皮、当归、枳壳粉碎至8-12μm后混匀;将草豆蔻、六神曲、谷芽超微粉碎至100-500nm后混匀;
(2)提取
木香、陈皮、当归、枳壳进行超临界CO2萃取,收集的挥发油进行再处理,得物料A;同时,药渣加入3-5倍(V/W)70%乙醇溶液提取、收集,得提取液Ⅰ;
向人参、白扁豆中加入提取液Ⅰ,浸渍5-10h,分离、收集渗漉液;同时,药渣加入2-4倍水(V/W)煎煮1-3h,滤过,与渗漉液合并后浓缩,得提取物B;
将白术、甘草、山药、山楂加入6-10倍水(V/W)煎煮1-3h,滤过;将白术、甘草、山药、山楂的滤渣及人参、白扁豆的滤渣合并,再加入6-10倍水(V/W)煎煮1-3h;滤过,合并滤液并浓缩,得提取物C;
(3)制粒
将提取物B、C用高速搅拌机进行搅拌均匀,再加入草豆蔻、六神曲、谷芽的超细粉末及酶解物混匀,加入麦芽糖醇、50%羟丙基纤维素后制粒;
(4)压片
湿颗粒干燥,再加入50%的羟丙基纤维素及物料A,混匀、压片、包衣。
4.根据权利要求3所述的人参健脾片的制备方法,其特征在于,步骤(1)的冻干条件为:在5-15min内降温至-4℃,保温5-10min;然后5-10min降温至-20℃,保温20-35min,最后5-8min升温至30-35℃,保温5-10min后40-55℃真空干燥。
5.根据权利要求3所述的人参健脾片的制备方法,其特征在于,步骤(1)中酶解条件为:调pH至6.7-7.1后加热到50℃-55℃,加入0.7%(W/W)纤维素酶、1.5%(W/W)木瓜蛋白酶、1.2%(W/W)α-淀粉酶,恒温、搅拌酶解2-5h,灭活、浓缩干燥。
6.根据权利要求3所述的人参健脾片的制备方法,其特征在于,所述超临界CO2萃取条件为:对萃取釜及分离釜a、b加热,当萃取釜温度为40~45℃,通入CO2至萃取釜,使分离釜a、b压力分别为10±1MPa、8.0±1MPa,调CO2的流量为16-18kg/h,进行恒温恒压循环萃取,2.5-3h后收集挥发油Ⅰ;升高温度,当萃取釜温度为65~70℃,调CO2的流量为12-15kg/h,恒温恒压萃取2-2.5h,收集挥发油Ⅱ,挥发油Ⅰ合并。
7.根据权利要求6所述的人参健脾片的制备方法,其特征在于,所述步骤(2)的再处理包括:搅拌状态下,按1:1.5-2g/ml向挥发油中缓慢加入多孔淀粉,搅拌至挥发油被完全吸收。
8.根据权利要求3所述人参健脾片的制备方法,其特征在于,所述人参健脾片的规格为0.51g/片。
9.根据权利要求3所述的人参健脾片的制备方法,其特征在于,所述白术、甘草、山药、山楂的滤过采用下述方法:将水煎液降至25-30℃,静置5-8h后分层,上层清液进行离心;下层沉淀中加入10%木香、陈皮、当归、枳壳的药渣,搅匀、过滤,与离心液合并。
10.根据权利要求3所述的人参健脾片的制备方法,其特征在于,所述超微粉碎的操作温度为4-10℃。
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