CN110638847A - 中药处方纳米制剂再提纯增大疗效的新制剂方法 - Google Patents

中药处方纳米制剂再提纯增大疗效的新制剂方法 Download PDF

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CN110638847A
CN110638847A CN201910771757.3A CN201910771757A CN110638847A CN 110638847 A CN110638847 A CN 110638847A CN 201910771757 A CN201910771757 A CN 201910771757A CN 110638847 A CN110638847 A CN 110638847A
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李汉臣
沈毅
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Abstract

本发明中药处方纳米破壁制剂再提纯增大疗效的新制剂方法，解决了中医药处方传统高温煎熬而严重丢失维生素及生物医药元素造成的药效低、药效慢、疗程长的弊端；虽然有了把处方中药低温破壁粉碎成3000nm级超细粉而100％保留了两元素，但又发现其存在药渣子占位而不纯仍影响药效；本发明又创新地采取乙醇或纯水溶解萃取再提纯纳米药粉的新制剂工艺，将其不溶解的木质素和杂质静置沉淀，与上清药液分离，经加温乙醇挥发冷凝回收，把复方集中萃取提纯的药干粉制成胶囊、含片、口服液、冲剂、微颗粒等代替苦汤节材增效；也可广泛作为饮料食品的营养添加剂；更适用于所有中药处方办厂加工而增加了一个经济新亮点，填补了一项节材增效中药制剂技术空白。

Description

中药处方纳米制剂再提纯增大疗效的新制剂方法
技术领域 本发明涉及中药处方纳米制剂再提纯增大疗效的新制剂方法。中华医药自古 以来药食同源，采用植物、动物、矿物等天然材料中所富含的营养维生素和生物医药元素， 对人体的发育成长不断地给予营养补偿！对于人体发生的伤病给予及时有效的预防和治疗！ 因此，对其采用的原材料，必须针对不同的疫情和病痛进行辩证配伍及其制剂加工后服用； 本发明就是针对传统的中医药处方制剂的方法及其服用方式，在继承发扬其传统优势的同时， 对其一直沿用的高温度煎煮熬蒸的加工制剂、喝苦汤吃苦丸的方式方法进行改革和创新，以 提高其疗效；因此采用已出现的新的低温纳米超细粉制剂的基础上，再进一步采用现代生物 医学的萃取提纯技术去杂留精的改良创新，从而更多地保留药材内含的天然维生素和天然生 物医药元素，力争达到节材增效，治慢病、治未病、防大病、保健康促长寿的更高效的医疗 水平！
背景技术 中华医药自神农氏尝百草、黄帝内经至李时珍《本草纲目》，历经五千年的实 践发展，繁衍壮大至今14亿人挺立于世界之巅！
只要把世世代代无数的中医大师对中华民族生死存亡的保驾护航的高超医术继承下来，把 救死扶伤的生物、食品，及其神通广大的中药材的五千年来的治病救命的经验积累的巨大医 术成果，急需运用现代生物技术进行总结升华！
据统计报道，已知有12807种中药材，其中，药用植物约占87％、药用动物约占12％、矿 用药约占1％，近代又发展了药食同用的菌藻类。但是，中药材内究竟是那些生物元素名称及 其成分和分子量在治病疗伤、保健康促长寿？以及古今药典内外记载和民间流传的千万个处 方方剂如古方、御方、验方、奇方、秘方、良方等，若能全部完成检测、检验、普查，并快 速鉴别提升到极为准确性的生物化医学科学完整准确的立案大典！
必须坚定地维护中医药的天然性(非化学合成)、组合型(复方多味合力)、联动性(凉与 热、泻与补、阴阳调配)、标本同治、治疗和养生调理结合、辨证施治等的经验、医术、理论， 都要庄重而完整地编写入中华医药学新大典！
西药的药素萃取和提纯技术应尽早创新地用于中医药的制剂提纯增效；自古以来，中医药 的传统制剂方法和服用方式，至今仍沿用每一付药须经100度高温煎熬2至3次，倒出苦汤， 扔弃药渣，致使百分之百的维生素几乎全部丢失！热敏药素也受到损失！所以就会出现药力 不足、疗效低、疗效慢、疗程长、费药材、花钱多的落后方法，应予创新和改进！
目前已出现了把中药处方多味全草在低温条件下，经集中破壁粉碎成纳米超细药粉，其粒 度已达3000nm以上，折合5万目左右，可以说能百分之百地保留了中医药材内含的全部维生 素和生物医药元素，从而达到节材增效的目的；但经试验，虽然疗效有所提高，却发现服用 量大时，会产生便秘，说明纳米超细粉连药渣子也打进去了，而中药传统煎熬法是把药渣子 扔掉不用的；本发明就是要把纳米超细粉中的渣滓提除，就更能提高其疗效！其渣滓也能变 废为宝另有用途？！
发明内容 本发明《中医药处方纳米制剂再提纯增大疗效的新制剂方法》，就是要把传统 的高温煎熬蒸煮的中医药处方的单剂或复方剂材料，改为低温破壁超细粉碎的纳米干粉，再 采用生物化学物理萃取提纯技术，把纳米干粉中存留的药渣子(如植物木质素、纤维素等) 分离出来，力争使其药粉里所含的维生素和生物医药元素最大量最纯净地去杂留精，用于安 全服用、提高疗效！
但是，目前生物化学物理的萃取提纯技术，多用于每一种物料，只能一次性萃取出其中 一个元素后就丢弃了，须再换新料提取，非常浪费材料，增加了成本！而中药处方多是复合 方剂，内含数十种维生素和药素，不适宜一味一提取的工艺方法，需要先用一种适宜的溶剂， 低温溶解纳米粉，把其中的杂质澄清分离出来，然后再把剩余的富含多种维生素和医药元素 的复合纯溶剂，一次性集中恢复到原来的纳米干药粉状态；
所用的溶剂必须无毒副作用，并易挥发；萃取工艺仍坚持低温操作，再恢复到提取前的 纳米超细干粉的含水率4％的指标，以防储存中霉变；中医认为酒就是第一药素，既能药借酒 力，酒助药效，更能消毒杀菌，所以用食用的高度乙醇做溶剂较好；但是也可用洁净的清水 做溶剂湿法提纯；
在提纯的工艺上，要将乙醇溶剂与药粉倒入透明搅拌釜(罐)搅拌均匀→静置溶解沉淀 →分层提纯→酒精溶剂略给加温(不超过摄氏50度)促其挥发气化→釜上部打开气流阀门→ 通入冷凝器回收液体乙醇→打开釜下出料阀回收药料→送入晾干室干燥至4％→取样质检→ 包装贴标→入库。所有工艺及其器械，都要采用无毒材质制作！
如果采用蒸馏水或纯净水做溶剂(不适用矿泉水或有氯气的自来水)，适于冷冻真空辐射 低温干燥设备进行提纯生产。
具体实施方案：
本发明《中医药处方纳米制剂再提纯增大疗效的新制剂方法》的实施方案，设计了两条工艺 路线：
第一条提纯路线：选用乙醇“70度以上的食用酒精”，作为中药纳米破壁超细干粉的溶剂， 进一步落实如下的提纯实施方案。
工艺步骤1“选料”：请一位老中医帮助从中医药典中任意选择一个依靠传统高温蒸煮煎熬的 有效处方，其药物味数不限，但必须是地道的无污染、无农残、无霉变的传统中草药材料13公斤；
工艺步骤2“快速净化、切段、低温脱水干燥”：把所需的药材经手选去杂、用水池浸没十分 钟捞出再用水管冲洗浮土泥沙→净化后用脱水机甩掉浮水→低温风干或晾干至含水量4％→用切段机切至5公分左右长→计量11公斤左右；(场地必须干净)；
工艺步骤3“纳米破壁粉碎与传统煎熬制剂同时进行计量试验”：
(1)需购进一台每六小时可低温破壁粉碎10公斤的纳米粉碎机，粒度按需调整，可达3万～10万目→分次或一次放入净化的药料→低温产出5万目已破壁的超细干 粉；
(2)准备一个较大的熬药的砂锅→将1公斤的净化药料放入砂锅→加入1.5公斤的清水→中火熬煮1小时左右倒出第一次的药汤越500克→再向砂锅内加入清水1 公斤→再熬煮50分钟后越有500克药汤→将两次药汤合并搅匀送质检室化验检测 →把药渣另存待用；
工艺步骤4“将乙醇溶剂与干纳米药粉按2比1混合”：即20公斤70多度的食用酒精与10 公斤的超细干粉药料倒入透明的玻璃罐(釜)→搅匀静置沉淀2～3小时左右， 可观测到液体沉淀分层至少显示出三层时，底层达到明显浑浊，中层半透明，上 层较透明，即已达标；
工艺步骤5“分离、提取上清液”：用吸管或吸盘将中层和上层溶液吸出流入可上下封闭的夹 层不锈钢蒸发罐里；
工艺步骤6“再溶解提纯”：将玻璃罐里的第三层浑浊液按其高度再加入一倍的酒精→搅拌后 净置2小时左右→将其上中层清液吸出兑入工艺步骤5的溶液搅拌均匀；
工艺步骤7“蒸发、冷凝、回收”：将加温到50度的热水送入不锈钢罐的夹层里→罐内慢速 搅拌吸热(搅拌器必须是硬杂木，不会碰出火星引起酒精爆燃)→进热水前就 应打开罐顶的放气阀门接通气流管道→受热挥发的乙醇气体将流入冷凝器→回 收冷凝成乙醇液体的酒精→防火存储，下次再用；
工艺步骤8“回收不锈钢罐底部已提纯的纳米超细粉”：将反应釜中的乙醇气体挥发完后→打 开罐底的阀门管道口→将其无酒液的药粉自行落入塑料袋回收→送入消毒包装 车间→取样送质检室检验粒度和含水量→达标后分装贴标→验收登记，存入商 品库；
工艺步骤9“送检对比”：
(1)从产出的已提纯的中药纳米干粉中取样100克→送质检室检测其维生素和药素的含量数据；
(2)再从煎熬的制剂药汤总量1000克中取出10％计100克药液(相当于百分之10的纳米干粉)送质检室化验检测其维生素和药素含量数据；
(3)将以上两项的数据检测结果相对照，就可获知中药新旧制剂技术的优劣；及其治疗效果能对比预知了；照此每次纳米超细粉的数据都要标注入说明书；
工艺步骤10“包装成易服用的药品”：胶囊、口服液、口含片、冲剂、微颗粒等。
2、第二条技术工艺路线：采用纯水作为安全溶剂湿法提纯：
工艺步骤1：在净化中药处方材料脱水切段后不用干燥，可直接投入纳米破壁粉碎机湿法粉 碎成超细湿粉；
工艺步骤2：按超细湿粉与清水1∶1.5的比率，送入透明或有观察孔的反应搅拌釜或罐里， 搅匀后，静置沉淀3小时左右，显示出三层时，底层达到明显浑浊，中层半透明， 上层较透明，即已达标；
工艺步骤3：用吸管或吸盘将上两层清液吸出流入另一储存罐内；
工艺步骤4：按搅拌釜或罐中沉淀的第三层浑浊液的高度，再注入高过1倍的清水→搅拌均 匀→静置沉淀分明三层→把上两层清液吸出→并入工艺步骤3的罐内搅匀；留下的 第三层浑浊液取出另做废物利用，增加收入，杜绝生态环境污染；
工艺步骤5：把储存的全部上清液送入真空冷冻辐射升华干燥机干燥度达到4％；
工艺步骤6“包装成易服用的药品”：胶囊、口服液、口含片、冲剂、微颗粒等。
结论：经以上两项新工艺技术生产的处方药剂提纯技术有共同优势，也各存不足：
第一条提纯工艺路线：用干法破壁粉碎制干纳米粉、采用高度食用酒精作溶剂分层提纯去杂留 精，工艺简便、设备省钱，药效提高；在同类药物料加工中，回收的酒精可反复使用；但必 须要有防火的措施！
第二条提纯工艺路线：用湿法破壁粉碎制干纳米粉、用清水作溶剂，工艺简便、无失火风险； 但去湿提纯干粉的机械设备及工本较高！
其共同优势是：虽然溶剂不同，但都能达到给纳米级超细粉再去杂留精提纯，达到大幅 度提高了防疫治病、保健康、促长寿的高效新制剂的改革创新！将彻底放弃几千年来多种中 药处方因用高温煎煮喝苦汤的落后的制剂方法，避免了丢失患者大量急需的维生素和医药元 素，丢失的结果是药力不足、药效低、疗效慢、疗程长，停留在病情加重时一再加大药材用 量，进入所谓的“慢慢调理吧”的被动局面！而延误病情及时好转！本专利的中医药处方新 制剂技术是不是一次有革命性意义的创新改革呢？！因为能大幅度地节省药材、减少天然维 生素和医药元素的损失、口服方便、吸收快，大幅度提高了疗效，保健康促长寿，更优质地 服务于全人类！
另外，经去杂留精提纯的纳米超细粉，还可作为缺乏营养的各种饮料食品的营养添加剂： 比如油炸方便面、凉皮、矿泉水、各种冰激凌、饼干等饮料食品，甚至毫无营养的白酒，都 可将此提纯的药食两用的纳米超细粉作为营养添加剂，转换成治未病、重养生的营养美食入 口，健康国民。
分层分离萃取提纯纳米超细粉之后的杂质，主要是占位20～30％的木质素和纤维素居多， 不能丢弃，还可废物利用，制成有价值的化工产品，从而能降低中药纳米纯干药粉的生产成 本，也有利于降低药价利于患者。同时也为广开处方药纳米提纯中药制品加工厂，增加了一 个经济新亮点，填补了一项制药技术空白！
总之力争做到现代中医药有较好的综合防治作用、服药安全、作用靶点多、长效性强、 克服服用剂量大、成分质量不稳定的缺点，本中药处方纳米制剂再提纯增大疗效的新制剂方 法，就是慢性病、治未病、保健养生长寿最佳的选择。

Claims (4)

1.中医药处方纳米制剂再提纯增大疗效的新制剂方法，其技术特征在于，任意选择一个曾用传统高温煎熬的中药方剂及其材料，经净化、切段、计量后，采用两条工艺技术路线实施该节材增效的新制剂方法：
(1)第一条技术工艺路线采用70度食用酒精作溶剂：
①把净化和低温干燥到4％的药材原料，投入纳米破壁超细粉碎机，进行低温粉碎，达到能破壁的3000nm左右粒度即5000目左右的纳米超细粉时停机，将酒精与干药粉按2∶1一同送入透明或有观察孔的反应搅拌釜或罐里，搅匀后，静置沉淀2～3小时左右，显示出三层时，底层达到明显浑浊，中层半透明，上层较透明，即已达标；
②用吸管或吸盘，将中层和上层溶液吸出流入可上下封闭的夹层不锈钢蒸发罐里；
③将搅拌罐里的第三层浑浊液，按其高度再加入一倍的食用高度酒精，搅拌后净置2小时左右，将其上中层清液吸出来，再送入夹层不锈钢蒸发罐里混合搅拌均匀；
④将加温限制在50度的热水，通过管道送入不锈钢蒸发罐的夹层里，与热水源不停循环，罐内慢速不停地搅拌吸热→同时打开罐顶的放气阀门接通气流管道，受热挥发的乙醇气体将源源不断地进入冷凝器里，还原为液体酒精；→防火存储，下次再用；
⑤将反应釜中的乙醇气体挥发完后，打开罐底的阀门通道口→已无酒液的药粉自行落入塑料回收袋中，送入消毒包装车间再干至4％；
⑥质检室取样检验粒度、水量；检验提纯后的维生素和药元素的数据，达标后分装贴标→验收登记，入包装库生产商品胶囊、含片、口服液、冲剂、微颗粒等产品待销；
(2)第二条技术工艺路线：采用纯水作为安全溶剂提纯：
工艺步骤1：在净化中药处方材料脱水切段后不用干燥，可直接投入纳米破壁粉碎机湿法粉碎成超细湿粉；
工艺步骤2：按超细湿粉与清水1∶1.5的比率，送入透明或有观察孔的反应搅拌釜或罐里，搅匀后，静置沉淀2～3小时左右，显示出三层时，底层达到明显浑浊，中层半透明，上层较透明，即已达标；
工艺步骤3：用吸管或吸盘将上两层清液吸出流入另一储存罐内；
工艺步骤4：按搅拌釜或罐中沉淀的第三层浑浊液的高度，再注入高过1倍的清水→搅拌均匀→静置沉淀分明三层→把上两层清液吸出→并入工艺步骤3的罐内搅匀；留下的第三层浑浊液取出另做废物利用，增加收入；
工艺步骤5：把储存的全部上清液送入真空冷冻辐射升华干燥机干燥度达到4％；
工艺步骤6：将其干燥的药粉进行维生素、药素含量及其干湿度检测→合格后送入包装库→包装成易服用的成品药：胶囊、口服液、口含片、冲剂、微颗粒等，入库待销。
2.根据权利要求1所述的中医药处方纳米制剂再提纯增大疗效的新制剂方法，其技术特征在于，凡自古至今所有有效无害的中医药古方、御方、验方、奇方、秘方、良方，只要是一直采用高温煎熬蒸煮喝苦汤吃苦丸的方剂，都适用本发明的中医药处方纳米制剂再提纯增大疗效的新制剂方法提高疗效。
3.根据权利要求1及2所述的中医药处方纳米制剂再提纯增大疗效的新制剂方法的技术，其技术特征，创办中医药处方纳米制剂再提纯的专业制药厂，生产胶囊、口服液、口含片、冲剂、微颗粒等纳米超细粉再提纯的节材增疗效的系列新产品。
4.根据权利要求1的技术特征：把中医药多味处方方剂的中药药材，集中一起破壁粉碎、一起加入溶剂分解、一次性集中提纯出几十种维生素和药素，大大超过了西医一味材料只能提取一种元素的萃取提纯方法。
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