CN110960646A - 一种孕康口服液的制备方法 - Google Patents

一种孕康口服液的制备方法 Download PDF

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Publication number
CN110960646A
CN110960646A CN201911331252.1A CN201911331252A CN110960646A CN 110960646 A CN110960646 A CN 110960646A CN 201911331252 A CN201911331252 A CN 201911331252A CN 110960646 A CN110960646 A CN 110960646A
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China
Prior art keywords
filtrate
filtering
water
corii asini
colla corii
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CN201911331252.1A
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施金川
彭常春
彭启华
汪平元
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JIANGXI JIMINKEXIN JINSHUIBAO PHARMACEUTICAL CO Ltd
Jiangxi Jimin Kexin Pharmaceutical Co Ltd
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JIANGXI JIMINKEXIN JINSHUIBAO PHARMACEUTICAL CO Ltd
Jiangxi Jimin Kexin Pharmaceutical Co Ltd
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Priority to CN201911331252.1A priority Critical patent/CN110960646A/zh
Publication of CN110960646A publication Critical patent/CN110960646A/zh
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Abstract

本发明涉及一种孕康口服液及其制备方法，所述制备方法包括以下步骤：采用超临界萃取技术,将阿胶按上述药材重量份比例，投入超临界萃取装置中，萃取压力30‑35MPa，萃取温度30‑40℃，萃取速度1‑1.5L/min，萃取时间3小时。本发明进一步提供一种改善口服液澄明度技术，配方如下：配料后加入稳定剂0.10‰‑0.30‰EDTA‑2Na及过滤采用过滤纸板及微孔滤膜组合高级过滤技术进行过滤除杂技术改善产品的澄明度，包装，即得。

Description

一种孕康口服液的制备方法
技术领域
本发明属中药领域，本发明涉及一种孕康口服液及其制备方法，具体涉及一种治疗肾虚型和气血虚弱型先兆流产和习惯性流产的孕康口服液的制备方法中提取纯化工艺的改进。
背景技术
孕康口服液由山药、当归、桑寄生、党参、阿胶、枸杞子、砂仁、黄芩、续断、狗脊、杜仲(炒)、茯苓、地黄、乌梅、益智、艾叶、黄芪、菟丝子、补骨脂、白术(焦)、山茱萸、白芍、苎麻根等多种中药材组成，具有健脾固肾、养血安胎的功效。用于肾虚型和气血虚弱型先兆流产和习惯性流产。处方中山药来源于薯蓣科植物薯蓣Dioscotea opposita Thunb.的干燥根茎，具有补脾养胃、生津益肺、补肾涩精，用于脾虚食少，久泻不止，肺虚喘咳，肾虚遗精，带下，尿频，虚热消渴；当归来源于伞形科植物当归Angelica sinensis(Oliv.)Diels的干燥根,具有补血活血、调经止痛、润肠通便，用于血虚萎黄，眩晕心悸，月经不调，经闭痛经，虚寒腹痛，风湿痹痛，跌扑损伤，痈疽疮疡，肠燥便秘；桑寄生来源于桑寄生科植物桑寄生Taxillus chinensis(DC.)Danser的干燥带叶茎枝，具有祛风湿、补肝肾、强筋骨、安胎元，用于风湿痹痛，腰膝酸软，筋骨无力，崩漏经多，妊娠漏血，胎动不安，头晕目眩；党参来源于桔梗科植物党参Codonopsis pilosula(Franch.)Nannf.、素花党参Codonopsis pilosulaNannf.var.modesta(Nannf.)L.T.Shen或川党参Codonopsis tangshen Oliv.的干燥根，具有健脾益肺、养血生津，用于脾肺气虚，食少倦怠，咳嗽虚喘，气血不足，面色萎黄，心悸气短，津伤口渴，内热消渴；阿胶来源于马科动物驴Equus asinm L.的干燥皮或鲜皮经煎煮、浓缩制成的固体胶，具有补血滋阴、润燥、止血，用于血虚萎黄，眩晕心悸，肌痿无力，心烦不眠，虚风内动，肺燥咳嗽，劳嗽咯血，吐血尿血，便血崩漏，妊娠胎漏；枸杞子来源于茄科植物宁夏枸杞Lycium barbarum L.的干燥成熟果实，具有滋补肝肾、益精明目，用于虚劳精亏，腰膝酸痛，眩晕耳鸣，阳萎遗精，内热消渴，血虚萎黄，目昏不明；砂仁来源于姜科植物阳春砂Amomum villosum Lour.、绿壳砂Amomum villosum our.var.xanthioides T.L.Wu etSenjen或海南砂Amomum longiligulare T.L.Wu的干燥成熟果实，具有化湿开胃、温脾止泻、理气安胎，用于湿浊中阻，脘痞不饥，脾胃虚寒，呕吐泄泻，妊娠恶阻，胎动不安；黄芩来源于唇形科植物黄芩Scutellaria baicalensis Georgi的干燥根，具有清热燥湿、泻火解毒、止血、安胎，用于湿温、暑湿，胸闷呕恶，湿热痞满，泻痢，黄疸，肺热咳嗽，高热烦渴，血热吐衄，痈肿疮毒，胎动不安；续断来源于川续断科植物川续断Dipsacus asper Wall.exHenry的干燥根，具有补肝肾、强筋骨、续折伤、止崩漏，用于肝肾不足，腰膝酸软，风湿痹痛，跌扑损伤，筋伤骨折，崩漏，胎漏；狗脊来源于蚌壳蕨科植物金毛狗脊Cibotium barometz(L.)J.Sm.的干燥根茎，具有祛风湿、补肝肾、强腰膝，用于风湿痹痛，腰膝酸软，下肢无力；杜仲来源于杜仲科植物杜仲Eucommia u1moides Oliv.的干燥树皮，具有补肝肾、强筋骨、安胎，用于肝肾不足，腰膝酸痛，筋骨无力，头晕目眩，妊娠漏血，胎动不安；茯苓来源于多孔菌科真菌茯苓Poria cocos(Schw.)Wolf的干燥菌核，具有利水渗湿、健脾、宁心，用于水肿尿少，痰饮眩悸，脾虚食少，便溏泄泻，心神不安，惊悸失眠；地黄来源于玄参科植物地黄Rehmannia glutinosa Libosch.的新鲜或干燥块根，具有清热凉血、养阴生津，用于热入营血，温毒发斑，吐血衄血，热病伤阴，舌绛烦渴，津伤便秘，阴虚发热，骨蒸劳热，内热消渴；乌梅来源于蔷薇科植物梅Prunus mume(Sieb.)Sieb.et Zucc.的干燥近成熟果实，具有敛肺、涩肠、生津、安蛔，用于肺虚久咳，久泻久痢，虚热消渴，蛔厥呕吐腹痛；益智姜科植物益智Alpinia oxyphylla Miq.的干燥成熟果实，具有暖肾固精缩尿、温脾止泻摄唾，用于肾虚遗尿，小便频数，遗精白浊，脾寒泄泻，腹中冷痛，口多唾涎；艾叶来源于菊科植物艾Artemisiaargyi levl.et Vant.的干燥叶，具有温经止血、散寒止痛，用于吐血，衄血，崩漏，月经过多，胎漏下血，少腹冷痛，经寒不调，宫冷不孕；黄芪来源于豆科植物蒙古黄芪Astragalusmembranaceus(Fisch.)Bge.var.mongholicus(Bge.)Hsiao或膜荚黄芪Astragalusmembranaceus(Fisch.)Bge.的干燥根，具有补气升阳、固表止汗、利水消肿、生津养血、行滞通痹、托毒排脓、敛疮生肌，用于气虚乏力，食少便溏，中气下陷，久泻脱肛，便血崩漏，表虚自汗，气虚水肿，内热消渴，血虚萎黄，半身不遂，痹痛麻木，痈疽难溃，久溃不敛；菟丝子来源于旋花科植物南方菟丝子Cuscuta australis R.Br.或菟丝子Cuscuta chinensis Lam.的干燥成熟种子，具有补益肝肾、固精缩尿、安胎，明目、止泻，用于肝肾不足，腰膝酸软，阳痿遗精，遗尿尿频，肾虚胎漏，胎动不安，目昏耳鸣，脾肾虚泻；补骨脂来源于豆科植物补骨脂Psoralea corylifolia L.的干燥成熟果实，具有温肾助阳、纳气平喘、温脾止泻，用于肾阳不足，阳痿遗精，遗尿尿频，腰膝冷痛，肾虚作喘，五更泄泻；白术菊科植物白术Atractylodes macrocephala Koidz.的干燥根茎，具有健脾益气、燥湿利水、止汗、安胎，用于脾虚食少，腹胀泄泻，痰饮眩悸，水肿，自汗，胎动不安；山茱萸来源于山茱萸科植物山茱萸Cornus officinalis Sieb.et Zucc.的干燥成熟果肉，具有补益肝肾、收涩固脱，用于眩晕耳鸣，腰膝酸痛，阳痿遗精，遗尿尿频，崩漏带下，大汗虚脱，内热消渴；白芍来源于毛茛科植物芍药Paeonia lactiflora Pall.的干燥根，具有养血调经、敛阴止汗、柔肝止痛、平抑肝阳，用于血虚萎黄，月经不调，自汗，盗汗，胁痛，腹痛，四肢挛痛，头痛眩晕。诸药合用，具有健脾固肾、养血安胎之功效，是一副著名经验用方，具有疗效确切、无明显副作用和应用方便等优点。
孕康口服液配方和制备收载于《中国药典》2015年版一部817页。配方如下：山药125g、当归75g、桑寄生50g、党参75g、阿胶25g、枸杞子100g、砂仁50g、黄芩50g、续断75g、狗脊100g、杜仲(炒)75g、茯苓100g、地黄100g、乌梅50g、益智50g、艾叶8.3g、黄芪100g、菟丝子75g、补骨脂75g、白术(焦)75g、山茱萸75g、白芍75g、苎麻根75g、蜂蜜83g、蔗糖88g、苯甲酸钠3.0g。
中药口服液原料药材品种多，来源复杂，故提取液是多种成分的混合，既含有所需的有效成分,也含有一些高分子物质,如鞣质、淀粉、蛋白质、树胶、粘液质、多糖、色素等，在生产的过程中经常出现得膏率异常、澄明度不合格的问题，传统工艺的弊端在于造成很多有效成分的损失，导致该方的疗效降低，治愈率低，疗效不稳定。本发明结合参考各药所含成分的理化性质，充分应用现代科学技术和手段，进行制备方法的设计和筛选。
本发明的目的在于提供一种养血安胎孕康口服液新的制备方法。
发明内容
本发明的目的是这样实现的：采用用超临界萃取技术提取阿胶，通过优化提取参数，使提取更充分。在配制过程中，辅料蔗糖变更为甜菊素，辅料和清膏混合后，加入稳定剂0.1‰-0.30‰EDTA-2Na，最后采用过滤纸板及微孔滤膜组合过滤技术，得到质量优良的孕康口服液。
本发明提供一种孕康口服液的制备方法，其中所述孕康口服液的配方如下：山药125g、当归75g、桑寄生50g、党参75g、阿胶25g、枸杞子100g、砂仁50g、黄芩50g、续断75g、狗脊100g、杜仲(炒)75g、茯苓100g、地黄100g、乌梅50g、益智50g、艾叶8.3g、黄芪100g、菟丝子75g、补骨脂75g、白术(焦)75g、山茱萸75g、白芍75g、苎麻根75g、蜂蜜83g、甜菊素1.8g、苯甲酸钠3.0g。
本发明所述的制备方法，包括以下步骤：
阿胶投入超临界萃取装置中萃取，萃取压力30-35MPa，萃取温度30-40℃，萃取速度1-1.5L/min，萃取时间3小时。
本发明所述的制备方法，还包括辅料蔗糖变更为甜菊素、配料后加入稳定剂0.1‰-0.30‰EDTA-2Na及过滤采用过滤纸板及微孔滤膜组合技术进行过滤除杂的步骤。
本发明优选的制备方法，步骤如下：
6、以上二十三味，阿胶放入粉碎机中粉碎成粒径为40-60目的原料粉末，放入超临界萃取装置中，以30-35MPa压力，萃取温度30-40℃，1.5L/min，萃取3小时得到阿胶萃取物，萃取液备用，其余山药等二十二味药材加4倍量温水温浸4h后，滤过，滤液备用，药渣再加4倍量水煎煮三次，第一次2h，第二次1h，第三次0.5h，合并4次滤液，滤液和阿胶萃取液浓缩成每1ml含生药1g的清膏；清膏放冷，加乙醇使含醇量达70％，搅拌，放置24小时，取上清液，滤过，滤液回收乙醇至无醇味，加入蜂蜜83g、甜菊素1.8g、苯甲酸钠3.0g及水适量，混匀，加氢氧化钠试液调pH至5～6，再加入0.3‰EDTA-2Na，加热煮沸30分钟，搅匀，加水至1000ml，通过0.65um微孔滤膜加纸板的板框过滤机过滤，滤液灌封，灭菌，即得。
采用本发明所述的原料制成的口服液，与原工艺相比，阿胶采用超临界萃取技术提取，配料时加入稳定剂，配制后的药液通过0.65um微孔滤膜加纸板的板框过滤机过滤，不仅能除去液体中较小固体粒子，而且可截留多糖、蛋白质等大分子物质，且具有一次过滤完全，节省过滤时间，便于操作，且过滤效果更佳的优点。本法继承了现有处方的优势，保留了全方的有效成分，提高了药物的质量和稳定性，降低了生产成本，保证了药物的疗效；
下述实验例和实施例用于进一步说明但不限于本发明。
1、矫味剂的选择
由于孕康口服液处方中大部分药材都具有苦味，且最终的口服液也具有较重的苦味，患者很难下咽，因此必须加入一定的甜味剂以改善患者顺应性，同时又要兼顾糖尿病及肥胖症患者的特殊要求。口服液中常用的甜味剂包括天然的和合成的两大类。天然的甜味剂除蔗糖和单糖浆以外，还有甜菊素。而合成的甜味剂有糖精钠、阿斯帕坦。由于甜菊素来源于植物中，且具有不产生热量，甜度约为蔗糖250倍，水溶液中稳定的优点，因此我们选择蜂蜜、甜菊素作为孕康口服液的矫味剂。
2、提取方法的选择
中药口服液原料药材品种多，来源复杂，故提取液是多种成分的混合，既含有所需的有效成分,也含有一些高分子物质,如鞣质、淀粉、蛋白质、树胶、粘液质、多糖、色素等，按照传统的提取方法提取配料后产品的质量不稳定，得膏率时高时低，在生产贮存过程中经常出现沉淀，出现消费者投诉的情况，严重影响产品的销量，解决孕康口服液澄明度的问题迫在眉睫。超临界萃取技术是一种高效的新型分离技术，与传统的萃取方法如压蒸馏、水蒸汽蒸馏和溶剂萃取等相比，其工艺简单，先择性好、产品纯度高，提取温度低，提取时间短，是当前提取中草药有效成分的一个发展方向，而且产品不产生有害物质污染环境，保证了100％的纯天然性，符合当今寻找各开发节能环保的“绿色化学技术”的潮流。
拟采用以下两种提取方法进行研究：(1)以上二十三味，阿胶放入粉碎机中粉碎成粒径为40-60目的原料粉末，放入超临界萃取装置中，以30-35MPa压力，萃取温度30-40℃，1.5L/min，萃取3小时得到阿胶萃取物，萃取液备用，其余山药等二十二味药材加4倍量温水温浸4h后，滤过，滤液备用，药渣再加4倍量水煎煮三次，第一次2h，第二次1h，第三次0.5h，合并4次滤液，滤液和阿胶萃取液浓缩成每1ml含生药1g的清膏；清膏放冷，加乙醇使含醇量达70％，搅拌，放置24小时，取上清液，滤过，滤液回收乙醇至无醇味；(2)以上二十三味，阿胶放入热水中溶化，溶化液备用，其余山药等二十二味药材加4倍量温水温浸4h后，滤过，滤液备用，药渣再加4倍量水煎煮三次，第一次2h，第二次1h，第三次0.5h，合并4次滤液，滤液和阿胶溶化液浓缩成每1ml含生药1g的清膏；清膏放冷，加乙醇使含醇量达70％，搅拌，放置24小时，取上清液，滤过，滤液回收乙醇至无醇味。考察结果如下：
表1三种提取方法的考察结果
Figure BDA0002329633700000061
结论：根据以上两种提取方法考察结果，方法二采用超临界萃取技术的样品更为理想，得膏率、清膏的沉淀量各检测指标考察结果最优。
3、过滤工艺优化
在本发明的制备方法中，所述过滤选自：微孔滤膜加过滤纸板过滤，其筛选过程如下：
3.1过滤介质的考察
使用板框压滤机进行过滤，并对微孔滤膜、帆布及过滤纸板三种介质进行考察。
将按配好待过滤的孕康口服液，平均分成三份(编号1，2，3)，分别通过以0.65μm微孔滤膜、帆布、过滤纸板为过滤介质的板框压滤机过滤，考察药液过滤后液体的澄明度、鉴别、PH值、过滤的难易程度，结果见表2。(说明：澄明度的考察为样品经离心机4000转/min，离心10min后观察试管底部的沉淀情况。过滤难易程度的考察指标以过滤时板框压滤机的压力来判定，当过滤压力低于0.2MPa为容易过滤，在0.2MPa-0.25MPa时为较难过滤，超过0.25MPa为很难过滤。)
表2过滤介质选择试验样品的质量检测情况
Figure BDA0002329633700000062
结果表明经微孔滤膜过滤后药液的澄明度均较好，但是比较难过滤，而较易过滤的过滤纸板和帆布过滤后的药液澄明度较差。各种过滤介质对药液的质量情况没有影响。
3.2微孔滤膜孔径的筛选
针对以上这种情况我们考虑将经过过滤纸板的药液平均分成两份(编号：4，5)分别通过以0.45μm微孔滤膜、0.65μm微孔滤膜为介质的过滤板框压滤机再次过滤，考察药液过滤后液体的澄明度、PH值、过滤的难易程度，结果见表3。(说明：澄明度的考察为样品经离心机4000转/min，离心10min后观察试管底部的沉淀情况。过滤难易程度的考察指标以过滤时板框压滤机的压力来判定，当过滤压力低于0.2MPa为容易过滤，在0.2MPa-0.25MPa时为较难过滤，超过0.25MPa为很难过滤。)
表3微孔滤膜选择试验样品的质量检测情况
编号 鉴别 相对密度 PH值 过滤难易 澄明度
4 符合规定 1.14 5.75 较难过滤 无可见异物
5 符合规定 1.14 5.75 容易过滤 无可见异物
结果表明用过滤纸板过滤后再经微孔滤膜过滤后药液的澄明度均较好，而通过0.65μm的微孔滤膜过滤比较容易。
3.3组合过滤技术考察
由于过滤纸板及微孔滤膜均适合同一板框压滤机，因此我们考虑将微孔滤膜与纸板组合，将药液一次通过两种介质过滤，以期达到过滤速度及澄明度均好的效果。
将孕康口服液，通过以0.65μm微孔滤膜加过滤纸板为过滤介质的板框压滤机过滤，考察用先通过微孔滤膜加过滤纸板过滤效果(编号6)与先通过纸板再通过微孔滤膜的过滤效果(编号7)的药液液体的澄明度、PH值、过滤的难易程度，并将结果进行比较，结果见表4。(说明：澄明度的考察为样品经离心机4000转/min，离心10min后观察试管底部的沉淀情况。过滤难易程度的考察指标以过滤时板框压滤机的压力来判定，当过滤压力低于0.2MPa为容易过滤，在0.2MPa-0.25MPa时为较难过滤，超过0.25MPa为很难过滤。)
表4过滤纸板选择试验样品的的质量检测情况
Figure BDA0002329633700000071
Figure BDA0002329633700000081
结果表明用微孔滤膜加过滤纸板过滤效果与先通过纸板再通过微孔滤膜两次过滤的效果无差别，该技术可行。
4、稳定剂用量考察
EDTA-2Na是强效螯合剂，防腐剂和抗氧化剂，能与碱金属以外的绝大多数大分子物质生成的络合物。EDTA-2Na的用量进行筛选，见表5
表5-EDTA-2Na的用量
Figure BDA0002329633700000082
从上表的结果可以看出，加入极少量的EDTA-2Na对孕康口服液澄明度有明显澄清效果，当加入的量在0.1‰～0.30‰澄明度效果最好而且药液最澄清，随着量的增大，颜色变浅。
表6，和现有技术相比本发明的优点如下
Figure BDA0002329633700000083
具体实施方式
实施例1：
按下述配比称取原料：
Figure BDA0002329633700000091
将上述各组份制成本发明药物的生产方法是：
1、【制法】以上二十三味，阿胶放入粉碎机中粉碎成粒径为40-60目的原料粉末，放入超临界萃取装置中，以30-35MPa压力，萃取温度30-40℃，1.5L/min，萃取3小时得到阿胶萃取物，萃取液备用，其余山药等二十二味药材加4倍量温水温浸4h后，滤过，滤液备用，药渣再加4倍量水煎煮三次，第一次2h，第二次1h，第三次0.5h，合并4次滤液，滤液和阿胶萃取液浓缩成每1ml含生药1g的清膏；清膏放冷，加乙醇使含醇量达70％，搅拌，放置24小时，取上清液，滤过，滤液回收乙醇至无醇味，加入蜂蜜83g、甜菊素1.8g、苯甲酸钠3.0g及水适量，混匀，加氢氧化钠试液调pH至5～6，再加入0.1‰EDTA-2Na，加热煮沸30分钟，搅匀，加水至1000ml，通过0.65um微孔滤膜加纸板的板框过滤机过滤，滤液灌封，灭菌，即得。
实施例2：
按下述配比称取原料：
Figure BDA0002329633700000092
将上述各组份制成本发明药物的生产方法是：
2、【制法】以上二十三味，阿胶放入粉碎机中粉碎成粒径为40-60目的原料粉末，放入超临界萃取装置中，以30-35MPa压力，萃取温度30-40℃，1.5L/min，萃取3小时得到阿胶萃取物，萃取液备用，其余山药等二十二味药材加4倍量温水温浸4h后，滤过，滤液备用，药渣再加4倍量水煎煮三次，第一次2h，第二次1h，第三次0.5h，合并4次滤液，滤液和阿胶萃取液浓缩成每1ml含生药1g的清膏；清膏放冷，加乙醇使含醇量达70％，搅拌，放置24小时，取上清液，滤过，滤液回收乙醇至无醇味，加入蜂蜜83g、甜菊素1.8g、苯甲酸钠3.0g及水适量，混匀，加氢氧化钠试液调pH至5～6，再加入0.2‰EDTA-2Na，加热煮沸30分钟，搅匀，加水至1000ml，通过0.65um微孔滤膜加纸板的板框过滤机过滤，滤液灌封，灭菌，即得。
实施例3：
按下述配比称取原料：
Figure BDA0002329633700000101
将上述各组份制成本发明药物的生产方法是：
3、【制法】以上二十三味，阿胶放入粉碎机中粉碎成粒径为40-60目的原料粉末，放入超临界萃取装置中，以30-35MPa压力，萃取温度30-40℃，1.5L/min，萃取3小时得到阿胶萃取物，萃取液备用，其余山药等二十二味药材加4倍量温水温浸4h后，滤过，滤液备用，药渣再加4倍量水煎煮三次，第一次2h，第二次1h，第三次0.5h，合并4次滤液，滤液和阿胶萃取液浓缩成每1ml含生药1g的清膏；清膏放冷，加乙醇使含醇量达70％，搅拌，放置24小时，取上清液，滤过，滤液回收乙醇至无醇味，加入蜂蜜83g、甜菊素1.8g、苯甲酸钠3.0g及水适量，混匀，加氢氧化钠试液调pH至5～6，再加入0.3‰EDTA-2Na，加热煮沸30分钟，搅匀，加水至1000ml，通过0.65um微孔滤膜加纸板的板框过滤机过滤，滤液灌封，灭菌，即得。

Claims (5)

1.一种孕康口服液的制备方法，所述孕康口服液配方如下：山药125g、当归75g、桑寄生50g、党参75g、阿胶25g、枸杞子100g、砂仁50g、黄芩50g、续断75g、狗脊100g、杜仲(炒)75g、茯苓100g、地黄100g、乌梅50g、益智50g、艾叶8.3g、黄芪100g、菟丝子75g、补骨脂75g、白术(焦)75g、山茱萸75g、白芍75g、苎麻根75g、蜂蜜83g、甜菊素1.8g、苯甲酸钠3.0g；其特征在于，包括以下步骤：
阿胶投入超临界萃取装置中萃取，萃取压力30-35MPa，萃取温度30-40℃，萃取速度1-1.5L/min，萃取时间3小时。
2.根据权利要求1所述的制备方法，其特征在于，还包括配料后加入稳定剂0.1‰-0.30‰EDTA-2Na及过滤采用过滤纸板及微孔滤膜组合技术进行过滤除杂的步骤。
3.权利要求1所述的制备方法，其特征在于，步骤如下：阿胶放入粉碎机中粉碎成粒径为40-60目的原料粉末，放入超临界萃取装置中，以30-35MPa压力，萃取温度30-40℃，1.0-1.5L/min，萃取3小时得到阿胶萃取物，萃取液备用；其余山药等二十二味药材加4倍量温水温浸4h后，滤过，滤液备用，药渣再加4倍量水煎煮三次，第一次2h，第二次1h，第三次0.5h，合并4次滤液，滤液和阿胶萃取液浓缩成每1ml含生药1g的清膏；清膏放冷，加乙醇使含醇量达70％，搅拌，放置24小时，取上清液，滤过，滤液回收乙醇至无醇味，加入蜂蜜83g、甜菊素1.8g、苯甲酸钠3.0g及水适量，混匀，加氢氧化钠试液调pH至5～6，再加入0.1‰EDTA-2Na，加热煮沸30分钟，搅匀，加水至1000ml，通过0.65um微孔滤膜加纸板的板框过滤机过滤，滤液灌封，灭菌，即得。
4.权利要求1所述的制备方法，其特征在于，步骤如下：阿胶放入粉碎机中粉碎成粒径为40-60目的原料粉末，放入超临界萃取装置中，以30-35MPa压力，萃取温度30-40℃，1.0-1.5L/min，萃取3小时得到阿胶萃取物，萃取液备用；其余山药等二十二味药材加4倍量温水温浸4h后，滤过，滤液备用，药渣再加4倍量水煎煮三次，第一次2h，第二次1h，第三次0.5h，合并4次滤液，滤液和阿胶萃取液浓缩成每1ml含生药1g的清膏；清膏放冷，加乙醇使含醇量达70％，搅拌，放置24小时，取上清液，滤过，滤液回收乙醇至无醇味，加入蜂蜜83g、甜菊素1.8g、苯甲酸钠3.0g及水适量，混匀，加氢氧化钠试液调pH至5～6，再加入0.2‰EDTA-2Na，加热煮沸30分钟，搅匀，加水至1000ml，通过0.65um微孔滤膜加纸板的板框过滤机过滤，滤液灌封，灭菌，即得。
5.权利要求1所述的制备方法，其特征在于，步骤如下：阿胶放入粉碎机中粉碎成粒径为40-60目的原料粉末，放入超临界萃取装置中，以30-35MPa压力，萃取温度30-40℃，1.0-1.5L/min，萃取3小时得到阿胶萃取物，萃取液备用；其余山药等二十二味药材加4倍量温水温浸4h后，滤过，滤液备用，药渣再加4倍量水煎煮三次，第一次2h，第二次1h，第三次0.5h，合并4次滤液，滤液和阿胶萃取液浓缩成每1ml含生药1g的清膏；清膏放冷，加乙醇使含醇量达70％，搅拌，放置24小时，取上清液，滤过，滤液回收乙醇至无醇味，加入蜂蜜83g、甜菊素1.8g、苯甲酸钠3.0g及水适量，混匀，加氢氧化钠试液调pH至5～6，再加入0.3‰EDTA-2Na，加热煮沸30分钟，搅匀，加水至1000ml，通过0.65um微孔滤膜加纸板的板框过滤机过滤，滤液灌封，灭菌，即得。
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