CN114949058A - 一种通腑泻热解毒中药冻干粉及其制备方法 - Google Patents
一种通腑泻热解毒中药冻干粉及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种通腑泻热解毒中药冻干粉及其制备方法，属于医药技术领域。通过将连翘、枳实、蒲公英、金银花、厚朴、牡丹皮浸泡后，文火煎煮0.5～2小时，然后过滤，滤渣加入大黄继续煎煮，过滤，合并所得滤液后加入芒硝，并混匀药液，浓缩后冻干即得。本发明的通腑泻热解毒中药冻干粉具有清热解毒，通里攻下，活血止痛的功效，其具有良好的抗病毒、抗细菌、抗炎、抗休克的等药理作用，尤其是对腹腔感染及脓肿等相关疾病的炎症因子的过度分泌具有明显抑制作用，与现有的药物相比，避免了药材的浪费、储存时间短、药理活性的不稳定等缺陷。
Description
技术领域
本发明属于医药技术领域，具体涉及一种通腑泻热解毒中药冻干粉及其制备方法。
背景技术
腹腔脓肿是普外科的常见病、多发病，也是腹部术后最常见的严重并发症之一，在西医治疗上，一般主要采用手术治疗为主，由于传统的开腹切开引流术造成的创伤较大，不利于术后的恢复，经皮穿刺引流术被国内外广泛应用并获得了相对较好的治疗效果，同时辅以一定的营养支持和抗生素等的应用。但是以B超引导下穿刺引流术具有一定的局限性，比如说与周围血管以及脏器关系密切，位置较深的脓肿不易引流等，反而会引起一定程度的并发症。大多数的患者及家属多采取单一保守的抗生素治疗，整体的治疗效果较为一般。近年来，临床上采用中药进行辅助治疗，取得了较为不错的临床疗效。
中药复方具有多成分、多靶点、多效应的优势，但是传统的中药煎煮方式及药液储存方式，造成了药材的极大浪费，且不能长时间保存，药物原有的成分及稳定性遭受破坏，研究开发一种具有优良的生理活性及物理化学稳定性的通腑泻热解毒中药制剂成为当前亟待研究的重要课题。
发明内容
为了解决上述技术问题，本发明提供一种通腑泻热解毒中药冻干粉及其制备方法，采用该制备方法制得的冻干粉具有良好优良的生理活性及物理化学稳定性，可长时间储存，且易于吸收。
本发明涉及的中药具体信息如下：
【药名】大黄
【性味与归经】苦，寒；胃、脾、胃，大肠、肝、心包经。
【功效与主治】泻下攻积，清热泻火，凉血解毒，止血，逐瘀通经，利湿退黄。用于实热积滞，便秘，血热吐衄，目赤咽肿；痈肿疔疮，肠痈腹痛；瘀血经闭，产后瘀阻，跌打损伤；湿热痢疾，黄疸尿赤，淋证，水肿；烧烫伤；老痰壅塞，喘逆不得平卧，大便秘结。
【药名】连翘
【性味与归经】苦，微寒。胃、肺、心、小肠经。
【功效与主治】清热解毒；消肿散结；疏散风热，清心利尿。用于疮疡，痈疽，瘰疬，乳痈，丹毒；风热感冒，温病初起，温热入营，高热烦渴，神昏发斑；热淋涩痛。
【药名】枳实
【性味与归经】苦、辛酸、微寒。脾、胃经。
【功效与主治】破气消积；化痰散痞。用于积滞内停，痞满胀痛，泻痢后重，大便不通；痰阻气滞，胸痹，结胸；脏器下垂。
【药名】蒲公英
【性味与归经】苦、甘，寒；肝、胃经。
【功效与主治】清热解毒；消肿散结；利湿通淋；清肝明目。用于疔疮肿毒、乳痈，肺痈，肠痈，瘰疬；湿热黄疸，热淋涩痛；目赤肿痛。
【药名】金银花
【性味与归经】甘，寒；肺、心、胃经。
【功效与主治】清热解毒；疏散风热，凉血止痢，清暑解热。用于痈肿疔疮，喉痹，丹毒；风热感冒、温病发热；热毒血痢。
【药名】厚朴
【性味与归经】苦、辛，温；脾、胃、肺、大肠经。
【功效与主治】燥湿消痰；下气除满。用于湿滞伤中，脘痞吐泻；食积气滞、腹胀便秘；痰饮喘咳；梅核气。
【药名】牡丹皮
【性味与归经】苦、辛，微寒；肝、肾经。
【功效与主治】清热凉血；活血化瘀。热入营血，温毒发斑，血热吐衄；温邪伤阴，阴虚发热，夜热早凉，无汗骨蒸；血滞经闭痛经，跌扑伤痛；痈肿疮毒。
【药名】芒硝
【性味与归经】咸、苦，寒；胃、大肠经。
【功效与主治】泻下通便；润燥软坚；清火消肿。实热积滞，腹满胀痛，大便燥结；肠痈腹痛；乳痈，痔疮肿痛，咽痛口疮，目赤肿痛。
本发明通过以下技术方案实现：
一种通腑泻热解毒中药冻干粉的制备方法，主要包括以下具体步骤：
(1)原料准备：按重量份称取以下中药材：大黄10～20份、连翘15～25份、枳实8～16份、蒲公英15～25份、金银花25～35份、厚朴10～20份、牡丹皮15～25份、芒硝1～10份；
(2)煎煮准备：将步骤(1)中的连翘、枳实、蒲公英、金银花、厚朴、牡丹皮放入烧瓶中；
(3)浸泡药材：向步骤(2)中的烧瓶内加入8～12倍于原料总质量的双蒸水后浸泡0.5～5小时；
(4)煎煮药材：将步骤(3)中的烧瓶连接热回流装置，并置于武火条件下煮沸后，文火煎煮0.5～2小时，然后过滤；
(5)将6～10倍于原料总质量的双蒸水加入到步骤(4)的残渣中并煎煮20～40分钟，然后加入大黄，再继续煮沸20～40分钟，过滤；
(6)加入芒硝后混匀药液：将步骤(4)和步骤(5)得到的滤液合并后加入芒硝，并混匀药液；
(7)将步骤(6)得到的药液浓缩至浓度在0.5～1.5g/ml之间；
(8)将步骤(7)浓缩后的药液经预冻后于冻干机中冻干即得。
进一步地，步骤(1)中大黄13～17份、连翘18～22份、枳实10～14份、蒲公英18～22份、金银花28～33份、厚朴13～17份、牡丹皮18～22份、芒硝3～7份。
进一步地，步骤(3)中加入10倍于原料总质量的双蒸水。
进一步地，步骤(4)和步骤(5)中所述的过滤使用6层脱脂纱布进行过滤。
进一步地，步骤(5)中加入8倍于原料总质量的双蒸水。
进一步地，步骤(7)中所述的浓缩的方式为使用旋转蒸发仪进行浓缩。
进一步地，步骤(8)的具体过程为：将步骤(7)浓缩后的药液置于-20～(-80)℃预冻10～24小时，然后于冻干机中持续冻干48～96小时，即得。
本发明另一方面提供上述制备方法制得的通腑泻热解毒中药冻干粉。
本发明还提供上述的通腑泻热解毒中药冻干粉在制备治疗腹腔脓肿的药物中的应用。
本发明相对于现有技术具有的有益效果如下：
1.本发明的通腑泻热解毒中药冻干粉具有清热解毒，通里攻下，活血止痛的功效，其具有良好的抗病毒、抗细菌、抗炎、抗休克的等药理作用，尤其是对腹腔感染及脓肿等相关疾病的炎症因子的过度分泌具有明显抑制作用，与现有的药物相比，避免了药材的浪费、储存时间短、药理活性的不稳定等缺陷。
2.本发明所述制备方法制得的复方中药冻干粉具有起效快，原料利用效率高，方便储存，易于运输等优点，在较长一段时间下仍能保持较好的物理、化学稳定性及药理活性，有望为相关基础科研探究甚至是胶囊等更高级的剂型方式奠定基础。
附图说明
为了更清楚地说明本发明实施例，下面将对实施例涉及的附图进行简单地介绍。
图1本发明的通腑泻热解毒中药冻干粉制备流程简图；
图2本发明的通腑泻热解毒中药冻干粉技术流程图；
图3本发明的通腑泻热解毒中药冻干粉的UHPLC/QTOFMS基峰色谱图。
具体实施方式
下面结合实施例对本发明进行详细的说明，但本发明的实施方式不限于此，显而易见地，下面描述中的实施例仅是本发明的部分实施例，对于本领域技术人员来讲，在不付出创造性劳动性的前提下，获得其他的类似的实施例均落入本发明的保护范围。
实施例1
一种通腑泻热解毒中药冻干粉的制备方法，包括以下具体步骤：
(1)原料准备：按重量称重并准备以下中药材，主要原料组分及重量数如下：大黄45g、连翘60g、枳实36g、蒲公英60g、金银花90g、厚朴45g、牡丹皮60g、芒硝15g；
(2)煎煮准备：将步骤(1)中的连翘、枳实、蒲公英、金银花、厚朴、牡丹皮放入10000ml圆底烧瓶中；
(3)浸泡药材：向步骤(2)中的烧瓶内加入10倍于原料总质量的双蒸水(4110ml)后浸泡1小时；
(4)煎煮药材：将步骤(3)中的烧瓶连接热回流装置，并置于实验用调温型加热套武火煮沸(220v)后，文火(110v)煎煮1小时，然后用6层脱脂纱布过滤；
(5)随后将8倍于原料总质量的双蒸水(3288ml)添加到步骤(4)的残渣中并煎煮30分钟，然后加入大黄，再继续煮沸30分钟，用六层纱布过滤；
(6)加入芒硝后混匀药液：将步骤(4)和步骤(5)得到的滤液合并后加入芒硝，并混匀药液；
(7)使用旋转蒸发仪将步骤(6)得到的药液进行真空浓缩至原药浓度(1g/ml)；
(8)将步骤(7)浓缩后的药液分别分装到EP管并覆盖封口膜，将封口膜用锐器自内向外按间隔0.5厘米的距离按螺旋形针刺三层大小相同的小孔，然后将所有药液置于-80℃冷冻预冻24小时；
(9)将步骤(8)预冻的药液于冻干机中持续冻干96小时，冻干结束即得。
实施例2
一种通腑泻热解毒中药冻干粉的制备方法，包括以下具体步骤：
(1)原料准备：按重量称重并准备以下中药材，主要原料组分及重量数如下：大黄75g、连翘100g、枳实60g、蒲公英100g、金银花150g、厚朴75g、牡丹皮100g、芒硝25g；
(2)煎煮准备：将步骤(1)中的连翘、枳实、蒲公英、金银花、厚朴、牡丹皮放入10000ml圆底烧瓶中；
(3)浸泡药材：向步骤(2)中的烧瓶内加入10倍于原料总质量的双蒸水(6850ml)后浸泡1小时；
(4)煎煮药材：将步骤(3)中的烧瓶连接热回流装置，并置于实验用调温型加热套武火煮沸(220v)后，文火(110v)煎煮1小时，然后用6层脱脂纱布过滤；
(5)随后将8倍于原料总质量的双蒸水(5480ml)添加到步骤(4)的残渣中并煎煮30分钟，然后加入大黄，再继续煮沸30分钟，用六层纱布过滤；
(6)加入芒硝后混匀药液：将步骤(4)和步骤(5)得到的滤液合并后加入芒硝，并混匀药液；
(7)使用旋转蒸发仪将步骤(6)得到的药液进行真空浓缩至原药浓度(1g/ml)；
(8)将步骤(7)浓缩后的药液分别分装到EP管并覆盖封口膜，将封口膜用锐器自内向外按间隔0.5厘米的距离按螺旋形针刺三层大小相同的小孔，然后将所有药液置于-80℃冷冻预冻24小时；
(9)将步骤(8)预冻的药液于冻干机中持续冻干96小时，冻干结束即得。
实施例3
一种通腑泻热解毒中药冻干粉的制备方法，包括以下具体步骤：
(1)原料准备：按重量称重并准备以下中药材，主要原料组分及重量数如下：大黄15g、连翘20g、枳实12g、蒲公英20g、金银花30g、厚朴15g、牡丹皮20g、芒硝5g；
(2)煎煮准备：将步骤(1)中的连翘、枳实、蒲公英、金银花、厚朴、牡丹皮放入10000ml圆底烧瓶中；
(3)浸泡药材：向步骤(2)中的烧瓶内加入10倍于原料总质量的双蒸水(1370ml)后浸泡1小时；
(4)煎煮药材：将步骤(3)中的烧瓶连接热回流装置，并置于实验用调温型加热套武火煮沸(220v)后，文火(110v)煎煮1小时，然后用6层脱脂纱布过滤；
(5)随后将8倍于原料总质量的双蒸水(1096ml)添加到步骤(4)的残渣中并煎煮30分钟，然后加入大黄，再继续煮沸30分钟，用六层纱布过滤；
(6)加入芒硝后混匀药液：将步骤(4)和步骤(5)得到的滤液合并后加入芒硝，并混匀药液；
(7)使用旋转蒸发仪将步骤(6)得到的药液进行真空浓缩至原药浓度(1g/ml)；
(8)将步骤(7)浓缩后的药液分别分装到EP管并覆盖封口膜，将封口膜用锐器自内向外按间隔0.3厘米的距离按螺旋形针刺三层大小相同的小孔，然后将所有药液置于-80℃冷冻预冻12小时；
(9)将步骤(8)预冻的药液于冻干机中持续冻干72小时，冻干结束即得。
精确称重冻干后冻干粉1.0g，用50ml甲醇/水(1:1,v/v)超声萃取30min，将萃取后的样品使用高速离心机在4℃13000rpm/min条件下离心10min，吸取其上清液，并使用0.22μm过滤器过滤，滤液上机待分析。
色谱条件如下：
正离子模式：
色谱柱：Waters BEH C8柱(规格：50mm×2.1mm,1.7μm)(Waters,Milford,MA)，柱温：60℃，流速：0.4ml/min；
流动相：水添加0.1％甲酸(A相)和乙腈添加0.1％甲酸(B相)；
梯度：起始梯度为5％B，维持0.5min，随后在1.5min内线性增至40％B，在6min内又线性增至100％B并维持2min，在10.1min处降回初始梯度5％B，平衡2min。
负离子模式：
色谱柱：ACQUITY UPLC HSS T3(规格：50mm×2.1mm,1.8μm)(Waters,Milford,MA)；
柱温：60℃，流速：0.4ml/min；
流动相：A相为水添加6.5mM NH4HCO3；B相为含95％甲醇和6.5mM NH4HCO3水溶液。
梯度：起始梯度为2％B，维持0.5min，在2min内增至40％B，随后在6min内线性增加到100％B并维持2min，在10.1min处降回初始梯度2％B，平衡2min。
质谱检测采用Agilent 6530b四极杆飞行时间质谱仪进行。采用双喷针电喷雾离子源，正负离子扫描模式进行检测。操作参数如下：干燥气(氮气)流速均为10L/min，温度分别为350℃和325℃；雾化气(氮气)压力为35psig；鞘气流速均为12L/min，温度分别为400℃和350℃；碎裂电压均为120V；Skimmer为65V；八极杆射频为750V；毛细管电压分别设定为4kV和-3.5kV；喷嘴电压分别为+500V和-1000V；质量扫描范围为50-1100m/z。在质量扫描范围m/z 50-1000条件下采集获取一级质谱图，如图3所示。并使用MassHunter B.06.00工作站软件进行处理，具体分析的结果如表1所示。
表1通腑泻热解毒中药冻干粉化学成分结果及成分归属表
RRR，Rhei Radix et Rhizoma(大黄)；GF，Gardeniae Fructus(栀子)；FF，Forsythlae Fructus(连翘)；CM，Moutan Cortex(牡丹皮)；LJF，Lonicerae JaponicaeFlos(金银花)；MOREW，Magnoliae Offininalis Cortex(厚朴)。
最后应说明的是：以上各实施例仅用以说明本发明的技术方案，而非对其限制；尽管参照前述各实施例对本发明进行了详细的说明，本领域的普通技术人员应当理解：其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分或者全部技术特征进行等同替换；而这些修改或者替换，并不使相应技术方案的本质脱离本发明各实施例技术方案的范围。
Claims (9)
1.一种通腑泻热解毒中药冻干粉的制备方法，其特征在于，主要包括以下具体步骤：
(1)原料准备：按重量份称取以下中药材：大黄10～20份、连翘15～25份、枳实8～16份、蒲公英15～25份、金银花25～35份、厚朴10～20份、牡丹皮15～25份、芒硝1～10份；
(2)煎煮准备：将步骤(1)中的连翘、枳实、蒲公英、金银花、厚朴、牡丹皮放入烧瓶中；
(3)浸泡药材：向步骤(2)中的烧瓶内加入8～12倍于原料总质量的双蒸水后浸泡0.5～5小时；
(4)煎煮药材：将步骤(3)中的烧瓶连接热回流装置，并置于武火条件下煮沸后，文火煎煮0.5～2小时，然后过滤；
(5)将6～10倍于原料总质量的双蒸水加入到步骤(4)的残渣中并煎煮20～40分钟，然后加入大黄，再继续煮沸20～40分钟，过滤；
(6)加入芒硝后混匀药液：将步骤(4)和步骤(5)得到的滤液合并后加入芒硝，并混匀药液；
(7)将步骤(6)得到的药液浓缩至浓度在0.5～1.5g/ml之间；
(8)将步骤(7)浓缩后的药液经预冻后于冻干机中冻干即得。
2.根据权利要求1所述的制备方法，其特征在于，步骤(1)中大黄13～17份、连翘18～22份、枳实10～14份、蒲公英18～22份、金银花28～33份、厚朴13～17份、牡丹皮18～22份、芒硝3～7份。
3.根据权利要求1所述的制备方法，其特征在于，步骤(3)中加入10倍于原料总质量的双蒸水。
4.根据权利要求1所述的制备方法，其特征在于，步骤(4)和步骤(5)中所述的过滤使用6层脱脂纱布进行过滤。
5.根据权利要求1所述的制备方法，其特征在于，步骤(5)中加入8倍于原料总质量的双蒸水。
6.根据权利要求1所述的制备方法，其特征在于，步骤(7)中浓缩的方式为使用旋转蒸发仪进行浓缩。
7.根据权利要求1所述的制备方法，其特征在于，步骤(8)的具体过程为：将步骤(7)浓缩后的药液置于-20～(-80)℃预冻10～24小时，然后于冻干机中持续冻干48～96小时，即得。
8.权利要求1-7任一项所述的制备方法制得的通腑泻热解毒中药冻干粉。
9.权利要求8所述的通腑泻热解毒中药冻干粉在制备治疗腹腔脓肿的药物中的应用。
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| CN102949533A (zh) * | 2012-11-20 | 2013-03-06 | 西安福安创意咨询有限责任公司 | 一种用于慢性阑尾炎的中药分散片及其制备方法 |
| CN113750054A (zh) * | 2021-05-27 | 2021-12-07 | 北京康仁堂药业有限公司 | 一种冻干粉的制备方法 |
| CN113975354A (zh) * | 2021-11-09 | 2022-01-28 | 刘彦宏 | 一种中药冻干粉冲剂及其制备方法 |
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| CN113750054A (zh) * | 2021-05-27 | 2021-12-07 | 北京康仁堂药业有限公司 | 一种冻干粉的制备方法 |
| CN113975354A (zh) * | 2021-11-09 | 2022-01-28 | 刘彦宏 | 一种中药冻干粉冲剂及其制备方法 |
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