CN101284123A - 一种阳和汤口服制剂及其制备方法 - Google Patents
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Abstract
本发明涉及一种由熟地等7味中药制备而得的阳和汤药物口服制剂及其制备方法，以白熟地、白芥子、鹿角胶、肉桂、姜炭、麻黄、甘草的混合提取物(浸膏或干粉和挥发油)为原料，与作为基质的药学上可接受的载体或赋形剂一起按常规工艺制备而成，该制剂主治阳虚血弱，寒凝痰滞之阴疽证，该处方长期临床应用显示，对阳虚寒凝，营血虚滞，痰湿凝滞于骨节，经络等之阴疽具有很好的疗效。
Description
技术领域
本发明属于医药技术领域，涉及一种主治阳虚血弱，寒凝痰滞之阴疽的药物口服制剂及其制备方法，特别涉及以阳和汤传统中药成方的提取物为药物活性成分的口服制剂。
背景技术
“阳和汤”为清·王维德《外科证治全生集》中创制的，历来作为阳虚寒凝，营血虚滞，痰湿凝滞于骨节，经络等之阴疽的常用方，由熟地，白芥子，鹿角胶，肉桂，姜炭，麻黄，甘草所组成，具有温阳补血，散寒通滞的功效，主治阳虚血弱，寒凝痰滞之阴疽证。该处方长期临床应用显示，对阳虚寒凝，营血虚滞，痰湿凝滞于骨节，经络等之阴疽具有很好的疗效，并具有广泛的应用，也未发现明显的毒副发应。
阳和汤中所提到的中药材的来源如下：
熟地：为玄参科植物地黄的块根。有补血滋阴，益精填髓的功效。
白芥子：为十字花科植物白芥或芥的干燥成热种子。有通行经络，温中开胃，发汗散寒，利气豁痰，消肿止痛的功效。
鹿角胶：为鹿科动物梅花鹿或马鹿的角煎熬而成的胶块。有补血，益精的功效。
肉桂：为樟科植物肉桂的干燥树皮。有补火助阳，引火归源，散寒止痛，活血通经的功效。
姜炭：为姜科植物姜的干燥根茎的炮制品。有温中止痛止血之作用。
麻黄：为草麻黄、中麻黄或木贼麻黄的干燥草质茎。具有发汗散寒，宣肺平喘，利水消肿，祛痰，解热，抗菌，抗病毒，兴奋中枢神经，升高血压等作用。
甘草：为豆科植物干草，胀果干草或光果干草的干燥根及根茎。有补脾益气，清热解毒，祛痰止咳，缓急止痛和调和诸药的功效。
方中熟地滋肾补血，鹿角胶养血助阳，强壮筋骨；肉桂、炮姜温通阳气，散寒邪；麻黄开腠理祛寒邪；白芥子散寒凝，祛皮里膜外之痰；甘草调和诸药。全方共奏温阳补血，散寒祛痰，宣通血脉之功。
古代阳和汤只有汤剂，需要购买饮片后煎煮服用，携带服用都很不方便，我们经过研究，通过指标成分进行定量控制制成现代中药口服制剂，产品剂量准确、质量稳定，方便服用，适用于商品化大生产，克服了中药汤剂用量大、用量不准确、携带服用不方便、无法商品化等缺点，方便临床治疗和家庭使用的需要。
发明内容
本发明的目的在于按照现代中药的制备方法，通过指标成分进行定量控制制成现代中药口服制剂，将阳和汤开发成产品剂量准确、质量稳定，方便服用，适用于商品化大生产的中成药，方便临床治疗和家庭使用。
本发明所涉及口服制剂的药物由熟地，白芥子，鹿角胶，肉桂，姜炭，麻黄，甘草提取物和适量药用辅料经特定的工艺制备而成。采用以下的技术方案进行制备，即可得到本发明所涉及的阳和汤口服制剂。
本发明处方中各药味以及重量分数(单位为g或kg)为：
热地15-50份，白芥子1-8份，鹿角胶3-15份，肉桂1-8份，姜炭0.1-5份，麻黄1-5份，甘草1-5份
本发明最佳优选处方中各味以及重量分数(单位为g或kg)为：
熟地30份，白芥子6份，鹿角胶9份，肉桂3份，姜炭2份，麻黄2份，甘草3份
本发明阳和汤中药原料药物的提取工艺方法如下：
(1)将各味药材净选，按最佳份量称取各药材并加入8～20倍量水浸泡2-12小时，加热提取2-3次，提取液合并，收集挥发油；
(2)水提取液静置12-48小时，过滤取上清液，减压浓缩得浸膏为水提取物；
(3)水取物加挥发油与药学上可接受的载体或赋形剂组合按常规工艺制成各种口服固体或液体制剂。其中所述的药学上的载体或辅料根据不同的剂型而选择，所用的这些载体或赋形剂对于制药领域的普通技术人员是可以决定的。
本发明药物，其中剂型包括口服固体制剂和口服液体制剂，其中口服固体制剂包括：片剂、硬胶囊、液体型胶囊、颗粒剂、软胶囊、滴丸、丸剂、微丸剂、缓释制剂；口服液体制剂包括：口服液、糖浆剂、酒剂；其中颗粒剂、口服液体制剂、硬胶囊以及片剂辅料选自淀粉、碳酸氢钠、糖粉、乳糖、可压性淀粉、微晶纤维素、无机盐类主要是一些无机钙盐，如硫酸钙、枸橼酸、磷酸氢钙及药用碳酸钙、甘露醇、淀粉浆、羧甲基纤维素钠、羟丙基纤维素、甲基纤维素和乙基纤维素、羟丙基甲基纤维素、羟丙甲纤维素、其它粘合剂、干淀粉、羧甲基淀粉钠、低取代羟丙基纤维素、聚乙烯比咯烷酮、交联羧甲基纤维素钠、硬脂酸镁、微粉硅胶、滑石粉、氧化植物油、聚乙二醇类(聚乙二醇2000-6000)与月挂醇硫酸镁以及木糖醇中的一种或多种；其中软胶囊剂、液体型胶囊和滴丸剂的辅料选自聚乙二醇(聚乙二醇200-6000)、丙二醇、蜂蜡、虫胶、聚氧乙烯单硬脂酸脂、甘油、乙醇、(吐温20、40、60、65、80)、司盘类(司盘20、40、60、65、80)、大豆油、茶油、红花油、月见草油、橄榄油、C5-C14的甘油三酯、油酸乙酯中的一种或几种，还可以填加抗氧化剂，选自α-生育酚、抗坏血酸棕榈酸酯、丁基羟基茴香醚(BHA)、二丁基羟基甲苯(BHT)中的一种或几种。
本发明药物制剂，其中还可以含芳香剂和防腐剂，其中芳香剂包括橘子香精、香蕉香精、草莓香精、奶油香精中的一种或几种，防腐剂包括尼泊金酯类、苯甲酸类中的一种或几种。
阳和汤提取物制备方法如下：
处方：熟地30份，白芥子6份，鹿角胶9份，肉桂3份，姜炭2份，麻黄2份，甘草3份
制法：将处方各味药材净选，称取处方量各药材加入8～20倍量水浸泡2-12小时，加热提取2-3次，提取液合并，收集挥发油；水提取液静置12-48小时，过滤取上清液，减压浓缩得浸膏或喷雾干燥为干粉为水提取物备用。
制备阳和汤口服液和糖浆剂
阳和汤提取物与矫味剂、防腐剂和水制成口服液，其中矫味剂选自蔗糖、糖精钠、环己基氨基磺酸钠、甜菊糖苷、天门冬酰苯甲氨酸甲酯、薄荷油(醇)中的一种或几种；防腐剂选自山梨酸甲酯、苯甲酸类、你泊金类等中的一种或几种。
口服液和糖浆剂的制备方法如下：阳和汤提取物加水调剂至制备量，加入矫味剂、防腐剂混合均匀，经灭菌、灌装、检验、包装等工艺，即得济川煎口服液以及糖浆剂。
其中加入的重量百分比含量为：阳和汤提取物5-80％、矫味剂0.05-5％、防腐剂0.001-2％、水10-90％.
制备阳和汤颗粒剂、丸剂、微丸剂、胶囊剂、片剂
颗粒剂、丸剂、微丸剂、胶囊剂、及片剂，制成浓缩颗粒剂或丸剂或片剂所用的辅料包括稀释剂、粘合剂、润滑剂；稀释剂选自淀粉、乳糖、糊精、微晶纤维素种的一种或几种；粘合剂包括水、高分子材料和乙醇的一种或几种；润滑剂包括硬脂酸镁、滑石粉、硬脂酸中的一种或几种。
颗粒剂、丸剂、微丸剂、胶囊剂、及片剂的制备方法如下：
将阳和汤提取物与适量药用辅料混匀，加入粘合剂等制成软材，用制粒机制成颗粒剂，干燥、整粒即得颗粒剂，或泛制成丸剂，或经胶囊填充机制成胶囊剂，或经压片制成片剂。
颗粒剂、丸剂、微丸剂、胶囊剂、及片剂，其中每克颗粒相当于含有0.1-10克的生药量。
制备阳和汤软胶囊
将阳和汤提取物与辅料稀释剂、抗氧化剂、防腐剂、助悬剂，其中稀释剂选自聚乙二醇、丙二醇、植物油、矿物油中的一种或几种；抗氧化剂选自甘氨酸、维生素E及其衍生物、抗坏血酸、焦亚硫酸纳、焦亚硫酸钾中的一种或几种；防腐剂包括山梨酸甲酯、苯甲酸类、你泊金类等中的一种或几种；助悬剂选自甲壳素、纤维素类、琼脂、蜂蜡中的一种或几种。
制备方法如下：阳和汤提取物5-50％，加入适量稀释剂、抗氧化剂、防腐剂、助悬剂混合均匀、按常规工艺制备而成，其中每克软胶囊相当于含有0.1-10克的生药量。
具体实施例
实施例一：阳和汤提取物(浸膏和挥发油)制备方法
处方：熟地30份，白芥子6份，鹿角胶9份，肉桂3份，姜炭2份，麻黄2份，甘草3份
制法：将处方备味药材净选，按处方量称取各药材，加入8～12倍量水浸泡2-10小时，加热微沸提取2-3次，提取液合并，收集挥发油；水提取液静置12-48小时，过滤取上清液，减压浓缩得浸膏为水提取物约17.5g，挥发油约0.2g。
实施例二：阳和汤口服固体制剂制备方法
(一)制备阳和汤颗粒剂
处方：
阳和汤提取物 10-90％
淀粉 5.0-70％
糊精 2.0-20％
木糖醇 5.0-20％
山梨酸甲酯 0.001-2.0％
优选处方：
阳和汤提取物 17.7g
淀粉 8.0g
糊精 8.0g
木糖醇 4.0g
山梨酸甲酯 0.002g
制法：按实施例一中的方法制备柴阳和汤提取物，加入处方量辅料按常规方法制成颗粒剂，挥发油用适量乙醇溶解，均匀喷洒在颗粒剂上，低温干燥，包装即得，每袋10g。
(二)制备阳和汤泡腾片
处方：阳和汤提取物 17.7
淀粉 5g
糊精 5g
微晶纤维素 3g
滑石粉 0.1g
硬脂酸镁 0.1g
无水柠檬酸 5.0g
碳酸氢钠 5.0g
乳糖 5.0g
水 适量
制法：按实施例一中的方法制备柴阳和汤提取物，加入处方量辅料按常规方法制成颗粒剂，挥发油用适量乙醇溶解，均匀喷洒在颗粒剂上，低温干燥，压片即得。
(三)制备阳和汤丸剂
处方：
阳和汤提取物 17.7g
淀粉 10g
硬酯酸镁 0.5g
糊精 5g
水 适量
制法：按实施例一中的方法制备柴阳和汤提取物，加入处方量辅料按常规方法制成颗粒剂，挥发油用适量乙醇溶解，均匀喷洒在颗粒剂上，低温干燥，压丸即得。
(四)制备阳和汤软胶囊
内容物处方：
阳和汤提取物 17.7g
植物油 20g
聚氧乙烯单硬脂酸脂 2.5g
对羟基苯甲酸乙酯 0.02g
蜂蜡 6g
制法：按实施例一中的方法制备阳和汤提取物，加入优选处方百分量的植物油、蜂蜡、聚氧乙烯单硬脂酸脂、对羟基苯甲酸乙酯按常规工艺制备而成。
(五)制备阳和汤胶囊剂
处方：
阳和汤提取物 10-95％
淀粉 5-55％
硬酯酸镁 0.1-5％
优选处方：
阳和汤提取物2 17.7g
淀粉 10g
硬酯酸镁 1.5g
制法：按实施例一中的方法制备柴阳和汤提取物，加入处方量辅料按常规方法制成颗粒剂，挥发油用适量乙醇溶解，均匀喷洒在颗粒剂上，低温干燥，灌装即得。
实施例三：阳和汤口服液体制剂制备方法
(一)口服液制备
处方：阳和汤提取物 5-80％
蔗糖 5.0-50％
环己基氨基磺酸钠 5.0-40％
山梨酸甲酯 0.001-2％
司盘20 5.0-40％
蒸馏水 10-90％.
优选处方：
阳和汤提取物 17.7g
蔗糖 5.0g
环己基氨基磺酸钠 1.5g
司盘20 2.5g
山梨酸甲酯 0.02g
蒸馏水定容至60ml.
制法：按实施例一中的方法制备阳和汤提取物，加入处方各辅料和蒸馏水，再经超滤器超滤，超滤液灌装，灭菌，即得。
Claims (6)
1、一种由熟地等7味中药制备而得的主治阳虚血弱，寒凝痰滞之阴疽的阳和汤药物口服制剂及其制备方法，以白熟地、白芥子、鹿角胶、肉桂、姜炭、麻黄、甘草的混合提取物(浸膏或干粉和挥发油)为原料，与作为基质的药学上可接受的载体或赋形剂一起按常规工艺制备而成，其中：
1.1处方中各药味以及重量分数(单位为g或kg)为：
熟地15-50份，白芥子1-8份，鹿角胶3-15份，肉桂1-8份，姜炭0.1-5份，麻黄1-5份，甘草1-5份
优选处方中各味以及重量分数(单位为g或kg)为：
熟地30份，白芥子6份，鹿角胶9份，肉桂3份，姜炭2份，麻黄2份，甘草3份
1.2基质：药剂书中制备口服固体和液体制剂中的常用药用辅料；
1.3配比：提取物(包括水提取物：浸膏或干粉和挥发油)∶基质＝9∶1～1∶9。
2、根据权利要求1中的阳和汤提取物，其制备工艺如下：
1.1将各味药材净选，按最佳份量称取各药材并加入8～20倍量水浸泡2-12小时，加热提取2-3次，提取液合并，收集挥发油；
1.2水提取液静置12-48小时，过滤取上清液，减压浓缩得浸膏或喷雾干燥得干粉为水提取物；
1.3阳和汤水提取物和挥发油与药学上的载体或辅料根组合按常规工艺制成各种口服固体或液体制剂，其中所用的这些载体或赋形剂对于制药领域的普通技术人员是可以决定的。
3、根据权利要求1-2中的阳和汤口服药物制剂，其中剂型包括片剂、硬胶囊、颗粒剂、软胶囊、滴丸以及口服液体制剂，其中：
1.1颗粒剂、片剂、硬胶囊以及口服液液体制剂基质选自淀粉、碳酸氢钠、糖粉、乳糖、可压性淀粉、微晶纤维素、无机盐类(主要是一些无机钙盐，如硫酸钙、枸橼酸、磷酸氢钙及药用碳酸钙)、甘露醇、淀粉浆、羧甲基纤维素钠、羟丙基纤维素、甲基纤维素和乙基纤维素、羟丙基甲基纤维素、羟丙甲纤维素、其它粘合剂、干淀粉、羧甲基淀粉钠、低取代羟丙基纤维素、交联聚乙烯比咯烷酮、交联羧甲基纤维素钠、硬脂酸镁、微粉硅胶、滑石粉、氢化植物油、聚乙二醇类(聚乙二醇2000-6000)与月挂醇硫酸镁以及木糖醇中的一种或多种。
1.2软胶囊剂和滴丸的基质选自聚乙二醇(聚乙二醇200-6000)、丙二醇、蜂蜡、虫胶、聚氧乙烯单硬脂酸脂、甘油、乙醇、(吐温20、40、60、65、80)、司盘类(司盘20、40、60、65、80)、大豆油、茶油、红花油、月见草油、橄榄油、C5-C14的甘油三酯、油酸乙酯中的一种或几种。
4、根据权利要求1-3中的药物制剂，还可以填加抗氧化剂，选自α-生育酚、抗坏血酸棕榈酸酯、丁基羟基茴香醚(BHA)、二丁基羟基甲苯(BHT)中的一种或几种。
5、根据权利要求1-4中的药物制剂，其中还可以含芳香剂和防腐剂，其中芳香剂包括橘子香精、香蕉香精、草莓香精、奶油香精中的一种或几种，防腐剂包括尼泊金酯类、苯甲酸类中的一种或几种。
6、根据权利要求1-5中的阳和汤药物口服制剂，主治阳虚血弱，寒凝痰滞之阴疽证，该处方长期临床应用显示，对阳虚寒凝，营血虚滞，痰湿凝滞于骨节，经络等之阴疽具有很好的疗效。
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| CN102641493A (zh) * | 2012-04-22 | 2012-08-22 | 李承平 | 一组温阳补血散寒通滞的药物组合 |
| CN114129702A (zh) * | 2021-12-16 | 2022-03-04 | 王芝 | 一种治疗流痰初期的穴位贴 |
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| CN102641493A (zh) * | 2012-04-22 | 2012-08-22 | 李承平 | 一组温阳补血散寒通滞的药物组合 |
| CN114129702A (zh) * | 2021-12-16 | 2022-03-04 | 王芝 | 一种治疗流痰初期的穴位贴 |
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