CN116236544A - 缓解更年期综合征的中药组合物及其产品和制备方法 - Google Patents
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Abstract
本申请提供了一种缓解更年期综合征的中药组合物及其产品和制备方法。所述中药组合物按重量份计包括中药浓缩液100‑120份、中药挥发油18‑30份、辅料5‑20份；所述中药浓缩液由中药原料制成，所述中药原料按重量份计包括地黄60‑120份、枸杞子60‑120份、菟丝子50‑100份、当归30‑60份、麦冬30‑60份、黄连18‑36份、丹参18‑36份、龙骨40‑80份、川楝子30‑60份、女贞子50‑100份、淫羊藿40‑80份、茯苓25‑65份。本申请可以有效治疗更年期综合征，并且无毒副作用，适合长期服用；此外，可以实现多途径给药，在口服疗法的基础上结合吸嗅疗法，充分发挥所述中药组合物的疗效。
Description
技术领域
本申请涉及中药组合物领域，特别是一种缓解更年期综合征的中药组合物及其产品和制备方法。
背景技术
更年期综合征指妇女在更年期前后体内性激素波动变化所致的躯体及精神心理症状，例如月经失调、潮热、出汗、血压波动、心悸、心率不齐、睡眠障碍、激动易怒、焦虑、情绪低落、记忆和认知能力下降等。中医认为更年期综合征属于“妇女绝经期前后诸症”范畴，妇女绝经期前后，肾气渐衰，精血不足，冲任功能减退是导致一系列化症状的主要原因。其病位在肾，涉及的心肝及冲任脉，最常见的病理机制为：肾阴不足，心肝火旺。
中国发明专利CN1259955C提供了一种治疗妇女更年期综合征的中药制剂，该中药制剂由地黄、白芍、枸杞子、菟丝子、当归、麦冬、黄连、丹参和龙骨等制成，具有滋养肝肾、清热平肝、宁心安神的功能。
发明人通过分析现有技术发现如下问题：上述中药制剂仅通过口服吸收，给药方式单一，且药物代谢速度较快，作用时长较短，不能最大程度发挥疗效。
发明内容
鉴于所述问题，提出了本申请以便提供克服所述问题或者至少部分地解决所述问题的一种缓解更年期综合征的中药组合物及其产品和制备方法，包括：
一种缓解更年期综合征的中药组合物，按重量份计包括：中药浓缩液100-120份、中药挥发油18-30份、辅料5-20份；其中，所述中药浓缩液由中药原料制成，所述中药原料按重量份计包括：地黄60-120份、枸杞子60-120份、菟丝子50-100份、当归30-60份、麦冬30-60份、黄连18-36份、丹参18-36份、龙骨40-80份、川楝子30-60份、女贞子50-100份、淫羊藿40-80份、茯苓25-65份。
优选的，所述中药原料按重量份计还包括：小麦26-50份、大枣22-48份、甘草20-40份、陈皮20-40份、莲子心10-32份。
优选的，所述中药挥发油包括天竺葵挥发油、鼠尾草挥发油、薰衣草挥发油中的至少一种。
优选的，所述辅料包括蔗糖、葡萄糖浆、果糖糖浆、蜂蜜、甜菊苷中的至少一种。
优选的，按重量份计还包括：缓释剂3-5份；所述缓释剂包括多糖胶和改性海藻酸钠，其中，所述改性海藻酸钠的结构式为：
一种由上述任一项所述的中药组合物制备得到的中药产品，包括：瓶体和存储在所述瓶体内的所述中药组合物。
一种如上述任一项所述的中药组合物的制备方法，包括：
采用纯净水将所述中药原料浸泡第一时长；
将所述纯净水和所述中药原料煎煮第二时长；
加入纯净水，将所述纯净水和所述中药原料煎煮第三时长，得到中药水煎液；
将所述中药水煎液静置、离心、浓缩，得到所述中药浓缩液；
按配比加入所述中药挥发油和所述辅料，调节pH并静置、超滤、分装，得到所述中药组合物。
优选的，所述采用纯净水将所述中药原料浸泡第一时长的步骤，包括：
将所述中药原料碾磨至颗粒状，并采用20-35℃的纯净水将所述中药原料浸泡30-45min，浸泡的同时采用40-60kHz的超声波对所述中药原料进行超声处理。
优选的，所述将所述纯净水和所述中药原料煎煮第二时长的步骤，包括：
在35-90kpa压力下将所述纯净水和所述中药原料煎煮1-2h，煎煮的同时以20-50r/min的转速对所述纯净水和所述中药原料进行搅拌。
优选的，所述加入纯净水，将所述纯净水和所述中药原料煎煮第三时长的步骤，包括：
加入60-95℃的纯净水，在35-90kpa压力下将所述纯净水和所述中药原料煎煮0.5-1h，煎煮的同时以20-50r/min的转速对所述纯净水和所述中药原料进行搅拌。
本申请具有以下优点：
在本申请的实施例中，相对于现有中药组合物不能最大程度发挥疗效的问题，本申请提供了吸嗅疗法和口服疗法相结合的解决方案，具体为：“一种缓解更年期综合征的中药组合物，按重量份计包括：中药浓缩液100-120份、中药挥发油18-30份、辅料5-20份；其中，所述中药浓缩液由中药原料制成，所述中药原料按重量份计包括：地黄60-120份、枸杞子60-120份、菟丝子50-100份、当归30-60份、麦冬30-60份、黄连18-36份、丹参18-36份、龙骨40-80份、川楝子30-60份、女贞子50-100份、淫羊藿40-80份、茯苓25-65份”。通过采用地黄、枸杞子、菟丝子、当归、麦冬、黄连、丹参、龙骨、川楝子、女贞子、淫羊藿等作为所述中药原料，可以有效治疗更年期综合征，并且，通过在所述中药原料中加入茯苓，使得不同组分间的药性得以调和，避免产生毒副作用，适合长期服用；此外，通过加入所述中药挥发油，可以实现多途径给药，在口服疗法的基础上结合吸嗅疗法，充分发挥所述中药组合物的疗效。
附图说明
为了更清楚地说明本申请的技术方案，下面将对本申请的描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1是本申请一实施例提供的一种中药产品的结构示意图；
图2是本申请一实施例提供的一种中药组合物的制备方法的步骤流程图。
说明书附图中的附图标记如下：
100、瓶体；110、瓶身；111、导热层；112、自热层；113、密封膜；120、瓶盖。
具体实施方式
为使本申请的所述目的、特征和优点能够更加明显易懂，下面结合附图和具体实施方式对本申请做进一步详细的说明。显然，所描述的实施例是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本申请保护的范围。
在本申请一实施例中，提供一种缓解更年期综合征的中药组合物，按重量份计包括：中药浓缩液100-120份、中药挥发油18-30份、辅料5-20份；其中，所述中药浓缩液由中药原料制成，所述中药原料按重量份计包括：地黄60-120份、枸杞子60-120份、菟丝子50-100份、当归30-60份、麦冬30-60份、黄连18-36份、丹参18-36份、龙骨40-80份、川楝子30-60份、女贞子50-100份、淫羊藿40-80份、茯苓25-65份。
需要说明的是，地黄含苯乙烯昔类成分，如毛蕊花糖昔等，还合有单糖、氨基酸、维生素A类物质等，具有补血滋阴，益精填髓的功效；枸杞子含有枸杞多糖、β-胡萝卜素、维生素E、硒及黄酮类等抗氧化物质，具有滋补肝肾，益精明目的功效；菟丝子主要含有黄酮类、有机酸类等成分，还含钙、钾、磷等微量元素及氨基酸，具有补益肝肾，固精缩尿，安胎，明目，止泻的功效；当归主要含蒙本内酷、当归酮、香荆芥酚、正丁烯味内酶、马鞭草烯酮，黄樟醚等挥发油，阿魏酸、香草酸、烟酸琥珀酸等有机酸成分，并含有当归多糖、氨基酸、维生素A等成分，具有补血活血，调经止痛，润肠通便的功效；麦冬含有皂昔类成分、高异黄酮类成分，还合多种氨基酸、微量元素，维生素A样物质，多糖等成分，具有润肺养阴，益胃生津，清心除烦的功效；黄连含有小檗碱、黄连碱、药根碱、巴马汀、棕榈碱、非洲防己碱、木兰碱、表小檗碱等喹啉类生物碱，还合有黄柏酮、黄柏内酯、阿魏酸、绿原酸等成分，具有清热燥湿，泻火解毒的功效；丹参含有醌类成分、原儿茶醛、原儿茶酸、乳酸、维生素E等成分，具有活血祛瘀，通经止痛，清心除烦，凉血消痛的功能；龙骨主要成分为磷灰石、粘土矿物、方解石等，具有镇心安神，平肝潜阳，固涩，收敛的功效；川楝子主要含有川楝素、生物碱、山奈醇等物质，具有疏肝泄热，行气止痛的功效；女贞子含有三萜类成分、环烯醚萜苷类成分、黄酮类成分、脂肪酸类成分，具有滋补肝肾、明目乌发的功效；淫羊藿含有黄酮类化合物，还含有木脂素，生物碱和挥发油等成分，具有补肾阳，强筋骨，祛风湿的功效；茯苓主要含多糖、三萜类成分、甾醇类成分，具有利水渗湿，健脾，宁心安神，调和药性的功效。
在本申请的实施例中，相对于现有中药组合物不能最大程度发挥疗效的问题，本申请提供了吸嗅疗法和口服疗法相结合的解决方案，具体为：“一种缓解更年期综合征的中药组合物，按重量份计包括：中药浓缩液100-120份、中药挥发油18-30份、辅料5-20份；其中，所述中药浓缩液由中药原料制成，所述中药原料按重量份计包括：地黄60-120份、枸杞子60-120份、菟丝子50-100份、当归30-60份、麦冬30-60份、黄连18-36份、丹参18-36份、龙骨40-80份、川楝子30-60份、女贞子50-100份、淫羊藿40-80份、茯苓25-65份”。通过采用地黄、枸杞子、菟丝子、当归、麦冬、黄连、丹参、龙骨、川楝子、女贞子、淫羊藿等作为所述中药原料，可以有效治疗更年期综合征，并且，通过在所述中药原料中加入茯苓，使得不同组分间的药性得以调和，避免产生毒副作用，适合长期服用；此外，通过加入所述中药挥发油，可以实现多途径给药，在口服疗法的基础上结合吸嗅疗法，充分发挥所述中药组合物的疗效。
下面，将对本示例性实施例中一种缓解更年期综合征的中药组合物做进一步地说明。
本实施例中，所述中药浓缩液的相对密度为1.1-1.2，固含量为20％-40％；所述中药挥发油的含量为5％-10％(ml/g)。所述中药组合物中各组分配比合理，所述中药原料和所述中药挥发油可以相互配合充分发挥疗效。
本实施例中，所述中药原料按重量份计还包括：小麦26-50份、大枣22-48份、甘草20-40份、陈皮20-40份、莲子心10-32份。
需要说明的是，小麦含有淀粉、蛋白质、糖类、糊精、油酸、亚油酸、棕榈酸、硬脂酸、谷甾醇、卵磷脂、尿囊素、精氨酸等成分，具有养心，益肾，除热，止渴，治脏躁，烦热，消渴的功效；大枣含有大枣皂甙Ⅰ、Ⅱ、Ⅲ、酸枣仁皂甙B、光千金藤碱、葡萄糖、果糖、蔗糖、环磷腺苷、环磷乌苷等成分，具有补益脾胃，益气血，安心神，调营卫，调和药性的功效；甘草含有三酷皂首类和黄酮类等成分，具有益气补中，祛痰止咳，解毒，缓急止痛，调和药性的功效；陈皮含有橙皮甙、维生素B、C等成分，具有理气健脾，燥湿化痰的功效；莲子心主要含有莲心碱、异莲心碱、甲级莲心碱、荷叶碱、前荷叶碱、牛角花素、甲基紫堇杷灵、去甲基乌药碱等成分，具有清心安神，交通心肾，涩精止血的功效。
通过在地黄、枸杞子、菟丝子、当归、麦冬、黄连、丹参、龙骨、川楝子、女贞子、淫羊藿、茯苓中加小麦、大枣、甘草、陈皮、莲子心作为所述中药原料，可以提升所述中药组合物对更年期综合征的治疗效果，并且可以进一步调和药性，避免产生毒副作用。
本实施例中，所述中药挥发油包括天竺葵挥发油、鼠尾草挥发油、薰衣草挥发油中的至少一种。具体的，所述中药挥发油按重量份计包括：天竺葵挥发油20-40份、鼠尾草挥发油15-35份、薰衣草挥发油5-25份。
需要说明的是，天竺葵挥发油气味表现为浓郁、玫瑰香、青草味，尾香欧薄荷气息，带有玫瑰甜味，主要含有正二十四烷、1-十九烯、γ-谷甾醇、二十七烷和邻苯二甲酸二丁酯等成分，具有抗抑郁、抗出血、抗炎、杀菌、收敛、结瘢、利尿、杀真菌、肾上腺皮质刺激作用及补益的功效；鼠尾草挥发油气味表现为甜、温暖、草药味，带有烟味，主要含有α-崖柏酮、β-崖柏酮、樟脑、1,8-桉树脑、草烯、蒎烯、莰烯、苎烯、乙酸冰片酯等成分，具有抗抑郁、消炎、抗皮脂溢出、抗菌、解痉、收敛、杀菌、排气、结瘢、助消化、通经、降压、镇静、补益、缓解子宫平滑肌紧张的功效；薰衣草挥发油气味表现为水果味、草味、花香味、木质味和香脂味，主要含有乙酸芳樟酯、芳樟醇、石竹烯、桉叶油醇和4-松油醇等成分，具有止痛、抗惊厥、抗抑郁、抗风湿、解痉、抗毒素、醒脑、利胆、通经、降压、神经镇定、补益的功效。
通过采用天竺葵挥发油、鼠尾草挥发油、薰衣草挥发油中的至少一种作为所述中药挥发油，产生的中药挥发物经患者吸嗅后对更年期综合征的月经紊乱、情绪、血压、激素等变化引起的症状能起到很好的治疗作用，同时对女性子宫功能有着明显的改善作用。并且，经临床实验证明，所述中药挥发油与所述中药组合物配合使用后，相较于单一的口服疗法具有更为显著的疗效。
本实施例中，所述辅料包括蔗糖、葡萄糖浆、果糖糖浆、蜂蜜、甜菊苷中的至少一种，可以起到提升口感的作用。
本实施例中，所述辅料为蜂蜜。
需要说明的是，蜂蜜具有很强的调和药性的作用，可防止药物对人体，尤其是胃黏膜造成伤害。通过采用蜂蜜作为所述辅料，不仅可以提升所述中药组合物的口感，并且可以调和药性，避免产生毒副作用。
本实施例中，按重量份计还包括：缓释剂3-5份；所述缓释剂包括重量比为2:1的多糖胶和改性海藻酸钠，其中，所述改性海藻酸钠的结构式为：
具体的，所述改性海藻酸钠由海藻酸钠和缩水甘油醚经下式反应生成：
由所述多糖胶与所述改性海藻酸钠混合得到的所述缓释剂具有较强的离子敏感性，当处于体外时，所述缓释剂呈低黏度的液体状态，当进入人体消化道后，所述缓释剂在胃液中的阳离子的作用下发生构象转变，形成凝胶状态，因而可以起到药物缓控释的作用，使得药物成分缓慢释放进入肠胃，增长药效时间。并且，由对所述海藻酸钠改性后得到的所述改性海藻酸钠兼具较好的亲水性和亲油性，可以起到提高体系稳定性的作用，使得所述中药组合物中的各类成分混合均匀，避免存储过程中发生沉淀。
本实施例中，所述中药原料由道地药材经低温干燥工艺制成。
需要说明的是，道地药材，又称为地道药材，是指质优效佳的药材，这一概念源于生产和中医临床实践，数千年来被无数的中医临床实践所证实，是源于古代的一项辨别优质中药材质量的独具特色的综合标准，也是中药学中控制药材质量的一项独具特色的综合判别标准，通俗地认为，道地药材就是指在一特定自然条件和生态环境的区域内所产的药材，并且生产较为集中，具有一定的栽培技术和采收加工方法，质优效佳，为中医临床所公认。
低温干燥工艺是在温度较低的情况下对药物进行干燥的一种方法，例如吸附干燥，真空干燥，降温干燥，升温干燥，真空喷雾干燥等，对于热稳定性差的药物，采用低温干燥工艺可以达到去除水分的目的，同时保留药物中有效成分的活性。
通过采用经低温干燥工艺制成的道地药材作为所述中药原料，可以保证药材活性，提升所述中药组合物的疗效。
所述中药组合物的服用方法为：先吸嗅10-30秒，再口服。
参照图1，示出了本申请一实施例提供的一种由上述任一实施例所述的中药组合物制备得到的中药产品，包括：瓶体100和存储在所述瓶体100内的所述中药组合物；
所述瓶体100包括瓶身110和与所述瓶身110活动连接的瓶盖120；所述瓶身110由内至外依次包括导热层111、自热层112和密封膜113；所述自热层112内存储有自热粉体。
在本申请的实施例中，相对于现有中药组合物直接服用可能造成用户胃肠不适的问题，本申请提供了自发热瓶体100的解决方案，具体为：“一种由上述任一实施例所述的中药组合物制备得到的中药产品，包括：瓶体100和存储在所述瓶体100内的所述中药组合物；所述瓶体100包括瓶身110和与所述瓶身110活动连接的瓶盖120；所述瓶身110由内至外依次包括导热层111、自热层112和密封膜113；所述自热层112内存储有自热粉体”通过设置所述导热层111、所述自热层112和所述密封膜113，可以根据需要对所述中药组合物进行加热，促进所述中药挥发油的挥发，便于患者吸嗅，同时提高所述中药组合物的温度，适于患者口服。
下面，将对本示例性实施例中一种由上述任一实施例所述的中药组合物制备得到的中药产品做进一步地说明。
本实施例中，所述自热粉体包括抗坏血酸钠、碳酸盐、二氧化硅、水、金属离子，其中，所述金属离子包括铜离子、亚铁离子或铁离子中的至少一种。
需要说明的是，抗坏血酸钠在铜离子、亚铁离子或铁离子的条件下，与空气中的氧气反应发出热量，且反应比较温和，发热温度适宜(最高不超过50℃)；同时，抗坏血酸钠与氧气反应后会生成二氧化碳气体，二氧化碳气体会稀释空气中渗入的氧气，保证反应温和稳定进行，尤其是二氧化硅起到分散作用，使反应中的热量分散均匀释放，避免热量集中造成局部温度过高。
通过采用抗坏血酸钠、碳酸盐、二氧化硅、水、金属离子作为所述自热粉体，可以实现对所述中药组合物的加热，并且可以避免加热温度过高，造成有效成分的破坏。
本实施例中，所述密封膜113的边缘设有撕拉条。通过拉动所述撕拉条可以快速撕下所述密封膜113，使得所述自热粉体与空气中的氧气进行反应。
本实施例中，所述瓶盖120包括盖体和与所述盖体连接的密封塞；所述密封塞设置在所述瓶身110的开口内。具体的，所述盖体表面设有环形的凹槽，便于手指扣入以将所述瓶盖120取出；所述密封塞表面设有环形的凸起，可以提升所述密封塞的密封性能。
所述中药产品的服用方法为：撕下所述密封膜113，打开所述瓶盖120，先对准所述瓶身110的开口处吸嗅10-30秒，再口服所述中药组合物。
参照图2，示出了本申请一实施例提供的一种如上述任一实施例所述的中药组合物的制备方法，包括：
S110、采用纯净水将所述中药原料浸泡第一时长；
S120、将所述纯净水和所述中药原料煎煮第二时长；
S130、加入纯净水，将所述纯净水和所述中药原料煎煮第三时长，得到中药水煎液；
S140、将所述中药水煎液静置、离心、浓缩，得到所述中药浓缩液；
S150、按配比加入所述中药挥发油和所述辅料，调节pH并静置、超滤、分装，得到所述中药组合物。
在本申请的实施例中，相对于现有中药组合物药物提取效率较低，制备成本较高的问题，本申请提供了先浸泡再煎煮的解决方案，具体为：“一种根据上述任一实施例所述的中药组合物的制备方法，包括：采用纯净水将所述中药原料浸泡第一时长；将所述纯净水和所述中药原料煎煮第二时长；加入纯净水，将所述纯净水和所述中药原料煎煮第三时长，得到中药水煎液；将所述中药水煎液静置、离心、浓缩，得到所述中药浓缩液；按配比加入所述中药挥发油和所述辅料，调节pH并静置、超滤、分装，得到所述中药组合物”。通过采用纯净水将所述中药原料浸泡第一时长，有利于所述中药原料中的有效成分的溶解和浸出，提高了药物提取效率，降低了制备成本。
下面，将对本示例性实施例中一种根据上述任一实施例所述的中药组合物的制备方法做进一步地说明。
如所述步骤S110所述，采用纯净水将所述中药原料浸泡第一时长。
将所述中药原料碾磨至颗粒状，并采用20-35℃的纯净水将所述中药原料浸泡30-45min，浸泡的同时采用40-60kHz的超声波对所述中药原料进行超声处理。
通过将所述中药原料碾磨至颗粒状，增大了所述中药原料的表面积，有利于所述中药原料中的有效成分的溶解和浸出；通过采用超声波对所述中药原料进行超声处理，可以促进所述中药原料中的有效成分快速溶解和浸出，提高了药物提取效率。
如所述步骤S120所述，将所述纯净水和所述中药原料煎煮第二时长。
在35-90kpa压力下将所述纯净水和所述中药原料煎煮1-2h，煎煮的同时以20-50r/min的转速对所述纯净水和所述中药原料进行搅拌。
通过在高压下对所述中药原料进行煎煮，有利于所述中药原料中的有效成分快速溶解和浸出，提高了药物提取效率；通过对所述纯净水和所述中药原料进行搅拌，可以避免煎煮过程中所述中药原料的局部温度过高，造成所述中药原料中有效成分的破坏。
如所述步骤S130所述，加入纯净水，将所述纯净水和所述中药原料煎煮第三时长。
加入60-95℃的纯净水，在35-90kpa压力下将所述纯净水和所述中药原料煎煮0.5-1h，煎煮的同时以20-50r/min的转速对所述纯净水和所述中药原料进行搅拌。
通过在高压下对所述中药原料进行煎煮，有利于所述中药原料中的有效成分快速溶解和浸出，提高了药物提取效率；通过对所述纯净水和所述中药原料进行搅拌，可以避免煎煮过程中所述中药原料的局部温度过高，造成所述中药原料中有效成分的破坏。
如所述步骤S140所述，将所述中药水煎液静置、离心、浓缩，得到所述中药浓缩液。
将所述中药水煎液静置，在转速为7320r/min、载流量300L/hr条件下离心，在压力为0.07MP、温度为60-70℃条件下浓缩，得到所述中药浓缩液。
如所述步骤S150所述，按配比加入所述中药挥发油和所述辅料，调节pH并静置、超滤、分装，得到所述中药组合物。
按配比加入所述中药挥发油和所述辅料(在一些实施例中，同时加入所述缓释剂)，调节pH至7.3-7.5，并静置，在压力为0.15Mpa条件下超滤，超滤截流分子量≤35000，以10ml/支的标准分装，得到所述中药组合物，每支所述中药组合物含相当生药量为5.06g。
以下是本申请的毒理、药理及临床实验结果：
一、毒理研究结果
1.急性毒性实验
对小鼠单次经口、鼻给予45.4g浸膏/kg(相当于生药125.6g/kg)剂量的本申请，大鼠单次经口、鼻给予27.2g浸膏/kg(相当于生药75.3g/kg)剂量的本申请，均未引起动物任何不良反应和死亡，体重也随实验时间的延长而增加。
在上述实验剂量条件下，小鼠单次经口、鼻给予的最大容量大于45.4g浸膏/kg(相当于生药125.6g/kg)，大鼠单次经口、鼻给予的最大容量大于27.2g浸膏/kg(相当于生药75.3g/kg)。
2.长期毒性实验
对大鼠每天经口、鼻给予22、18和14g生药/(kg·d)剂量的本申请，实验时间六个月，在整个实验期间所有大鼠均未出现任何明显的毒副反应，也未引起动物死亡。三个剂量组对大鼠体重增长无明显影响，均随实验时间的延长而增加，对摄食量有轻度减少作用，对饮水量无明显影响，仅表现不规则的增减作用，基本与对照组相同。给药三个月、六个月(停药次日)和恢复期结束(停药一个月)检查，三个剂量组对各阶段的血液学、血液生化学指标均无明显影响。对各阶段的脏器系数也无明显影响，大体观察和病理组织学检查也均未见任何病理形态学和组织学改变，与对照组相同。
在上述实验剂量条件下，大鼠连续六个月经口、鼻给予相当人临床用剂量55倍的本申请仍未明显出现毒副反应和未明显显示中毒靶器官。无毒(影响)剂量大于22g生药(8g浸膏)/(kg·d)。
二、药理研究结果
1.具有调节内分泌功能作用。
1.1.能显著增加12月龄雌性大鼠血清E2含量；
1.2.能显著降低12月龄去卵巢雌性大鼠血清FSH和TSH的含量；
1.3.能显著增加12月龄去卵巢雌性大鼠的动情期发生率；
1.4.能显著增加12月龄去卵巢雌性大鼠子宫的重量；
1.5.能显著增加12月龄雌性大鼠的卵巢重量：
1.6.能显著增加24-26周龄雌性小鼠的子宫及卵巢重量。
2.具有提高免疫力作用。
2.1.提高细胞免疫：能显著提高强的松致25-26周龄小鼠免疫功能低下时，T淋巴细胞的转化率：
2.2.提高体液免疫：能显著增加强的松致25-26周龄小鼠免疫功能低下时，鸡RBC作免疫原的溶血素含量：
2.3.提高非特异性免疫：能显著增加强的松致24-26周龄小鼠免疫功能低下时，单核吞噬功能和免疫器官(胸腺)的重量。
3.能提高12月龄雌性大鼠的骨钙和血钙含量。
4.具有安定和调节中枢神经系统作用，能延长小鼠戊巴比妥钠的睡眠时间，减少自发活动，对抗中枢神经兴奋剂所致的惊厥，延长惊厥潜伏期，减少死亡率。
5.能改善因中枢兴奋、内分泌失调所致的各种症状。
6.能明显改善阴虚模型动物的阴虚症状，增强耐高温能力。
以上药效学实验结果为本申请临床用于治疗更年期综合征提供了一定的药理学依据。
三、临床实验结果
实施例一
一种缓解更年期综合征的中药组合物，按重量份计包括：中药浓缩液100份、中药挥发油18份、蜂蜜5份；其中，所述中药浓缩液由中药原料制成，所述中药原料按重量份计包括：地黄60份、枸杞子60份、菟丝子50份、当归30份、麦冬30份、黄连18份、丹参18份、龙骨40份、川楝子30份、女贞子50份、淫羊藿40份、茯苓25份；所述中药挥发油按重量份计包括：天竺葵挥发油20份、鼠尾草挥发油15份、薰衣草挥发油5份。
实施例二
一种缓解更年期综合征的中药组合物，按重量份计包括：中药浓缩液110份、中药挥发油24份、蜂蜜12份；其中，所述中药浓缩液由中药原料制成，所述中药原料按重量份计包括：地黄90份、枸杞子90份、菟丝子75份、当归45份、麦冬45份、黄连27份、丹参27份、龙骨60份、川楝子45份、女贞子75份、淫羊藿60份、茯苓45份；所述中药挥发油按重量份计包括：天竺葵挥发油30份、鼠尾草挥发油25份、薰衣草挥发油15份。
实施例三
一种缓解更年期综合征的中药组合物，按重量份计包括：中药浓缩液120份、中药挥发油30份、蜂蜜20份；其中，所述中药浓缩液由中药原料制成，所述中药原料按重量份计包括：地黄120份、枸杞子120份、菟丝子100份、当归60份、麦冬60份、黄连36份、丹参36份、龙骨80份、川楝子60份、女贞子100份、淫羊藿80份、茯苓65份、小麦50份、大枣48份、甘草40份、陈皮40份、莲子心32份；所述中药挥发油按重量份计包括：天竺葵挥发油40份、鼠尾草挥发油35份、薰衣草挥发油25份。
实施例四
一种缓解更年期综合征的中药组合物，按重量份计包括：中药浓缩液100份、中药挥发油18份、蜂蜜5份；其中，所述中药浓缩液由中药原料制成，所述中药原料按重量份计包括：地黄60份、枸杞子60份、菟丝子50份、当归30份、麦冬30份、黄连18份、丹参18份、龙骨40份、川楝子30份、女贞子50份、淫羊藿40份、茯苓25份；所述中药挥发油按重量份计包括：天竺葵挥发油20份、鼠尾草挥发油15份、薰衣草挥发油5份。
实施例五
一种缓解更年期综合征的中药组合物，按重量份计包括：中药浓缩液110份、中药挥发油24份、蜂蜜12份；其中，所述中药浓缩液由中药原料制成，所述中药原料按重量份计包括：地黄90份、枸杞子90份、菟丝子75份、当归45份、麦冬45份、黄连27份、丹参27份、龙骨60份、川楝子45份、女贞子75份、淫羊藿60份、茯苓45份、小麦38份、大枣35份、甘草30份、陈皮30份、莲子心21份；所述中药挥发油按重量份计包括：天竺葵挥发油30份、鼠尾草挥发油25份、薰衣草挥发油15份。
实施例六
一种缓解更年期综合征的中药组合物，按重量份计包括：中药浓缩液120份、中药挥发油30份、蜂蜜20份；其中，所述中药浓缩液由中药原料制成，所述中药原料按重量份计包括：地黄120份、枸杞子120份、菟丝子100份、当归60份、麦冬60份、黄连36份、丹参36份、龙骨80份、川楝子60份、女贞子100份、淫羊藿80份、茯苓65份、小麦50份、大枣48份、甘草40份、陈皮40份、莲子心32份；所述中药挥发油按重量份计包括：天竺葵挥发油40份、鼠尾草挥发油35份、薰衣草挥发油25份。
对比例一
一种组合物(安慰剂)，按重量份计包括：洋李脯汁100份、杏仁挥发油18份。
对比例二
一种组合物(安慰剂)，按重量份计包括：洋李脯汁110份、杏仁挥发油24份。
对比例三
一种组合物(安慰剂)，按重量份计包括：洋李脯汁120份、杏仁挥发油30份。
对比例四
一种中药组合物，与实施例一区别在于不含中药挥发油。
对比例五
一种中药组合物，与实施例二区别在于不含中药挥发油。
对比例六
一种中药组合物，与实施例三区别在于不含中药挥发油。
实验例一
选取患有更年期综合征中月经失调症状的测试者300名(性别女，年龄45-55岁)，将300名测试者随机分为12组，每组25人，第1组测试者服用实施例一的中药组合物，第2组测试者服用实施例二的中药组合物，第3组测试者服用实施例三的中药组合物，第4组测试者服用实施例四的中药组合物，第5组测试者服用实施例五的中药组合物，第6组测试者服用实施例六的中药组合物，第7组测试者服用对比例一的安慰剂，第8组测试者服用对比例二的安慰剂，第9组测试者服用对比例三的安慰剂，第10组测试者服用对比例四的中药组合物，第11组测试者服用对比例五的中药组合物，第12组测试者服用对比例六的中药组合物，第1-9组的服用方法为先吸嗅20秒再口服，第10-12组的服用方法为直接口服。每位测试者每天服用40ml，早、晚各20ml，在经期的1至7天停服。在实验开始后的第1，2，3，4，5和6月分别对测试者的月经失调症状的改善情况进行记录。各情况对应的人数记录如表1所示：
表1
由表1可知，从第3月开始，第1-6组测试者的情况明显优于第7-9组，可以明显看出，本申请提供的所述中药组合物在服用3月后，可以有效缓解更年期综合征中月经失调的症状。
并且，从第3月开始，第1-3组测试者的情况明显优于第10-12组，可以明显看出，本申请提供的所述中药组合物通过结合吸嗅疗法和口服疗法，相较于单一的口服疗法具有更为显著的疗效。
此外，将第1-6组测试者在实验前后的血液和尿液检验结果进行对比，在激素水平、细胞成份等方面均无变化，可以看出，本申请提供的所述中药组合物有很好的耐受性，无副作用。
实验例二
选取患有更年期综合征中潮热出汗症状的测试者225名(性别女，年龄45-55岁)，将225名测试者随机分为9组，每组25人，第1组测试者服用实施例一的中药组合物，第2组测试者服用实施例二的中药组合物，第3组测试者服用实施例三的中药组合物，第4组测试者服用实施例四的中药组合物，第5组测试者服用实施例五的中药组合物，第6组测试者服用实施例六的中药组合物，第7组测试者服用对比例一的组合物，第8组测试者服用对比例二的组合物，第9组测试者服用对比例三的组合物，服用方法均为先吸嗅20秒再口服。每位测试者每天服用40ml，早、晚各20ml，在经期的1至7天停服。在实验开始后的第1，2，3，4，5和6月分别对测试者的潮热出汗症状的改善情况进行记录。各情况对应的人数记录如表2所示：
表2
由表2可知，从第3月开始，第1-6组测试者的情况明显优于第7-9组，可以明显看出，本申请提供的所述中药组合物在服用3月后，可以有效缓解更年期综合征中潮热出汗的症状。
此外，将第1-6组测试者在实验前后的血液和尿液检验结果进行对比，在激素水平、细胞成份等方面均无变化，可以看出，本申请提供的所述中药组合物有很好的耐受性，无副作用。
尽管已描述了本申请实施例的优选实施例，但本领域内的技术人员一旦得知了基本创造性概念，则可对这些实施例做出另外的变更和修改。所以，所附权利要求意欲解释为包括优选实施例以及落入本申请实施例范围的所有变更和修改。
最后，还需要说明的是，在本文中，诸如第一和第二等之类的关系术语仅仅用来将一个实体或者操作与另一个实体或操作区分开来，而不一定要求或者暗示这些实体或操作之间存在任何这种实际的关系或者顺序。而且，术语“包括”、“包含”或者其任何其他变体意在涵盖非排他性的包含，从而使得包括一系列要素的过程、方法、物品或者终端设备不仅包括那些要素，而且还包括没有明确列出的其他要素，或者是还包括为这种过程、方法、物品或者终端设备所固有的要素。在没有更多限制的情况下，由语句“包括一个……”限定的要素，并不排除在包括所述要素的过程、方法、物品或者终端设备中还存在另外的相同要素。
以上对本申请所提供的一种缓解更年期综合征的中药组合物及其产品和制备方法，进行了详细介绍，本文中应用了具体个例对本申请的原理及实施方式进行了阐述，以上实施例的说明只是用于帮助理解本申请的方法及其核心思想；同时，对于本领域的一般技术人员，依据本申请的思想，在具体实施方式及应用范围上均会有改变之处，综上所述，本说明书内容不应理解为对本申请的限制。
Claims (10)
1.一种缓解更年期综合征的中药组合物，其特征在于，按重量份计包括：中药浓缩液100-120份、中药挥发油18-30份、辅料5-20份；其中，所述中药浓缩液由中药原料制成，所述中药原料按重量份计包括：地黄60-120份、枸杞子60-120份、菟丝子50-100份、当归30-60份、麦冬30-60份、黄连18-36份、丹参18-36份、龙骨40-80份、川楝子30-60份、女贞子50-100份、淫羊藿40-80份、茯苓25-65份。
2.根据权利要求1所述的中药组合物，其特征在于，所述中药原料按重量份计还包括：小麦26-50份、大枣22-48份、甘草20-40份、陈皮20-40份、莲子心10-32份。
3.根据权利要求1所述的中药组合物，其特征在于，所述中药挥发油包括天竺葵挥发油、鼠尾草挥发油、薰衣草挥发油中的至少一种。
4.根据权利要求1所述的中药组合物，其特征在于，所述辅料包括蔗糖、葡萄糖浆、果糖糖浆、蜂蜜、甜菊苷中的至少一种。
5.根据权利要求1所述的中药组合物，其特征在于，按重量份计还包括：缓释剂3-5份；所述缓释剂包括多糖胶和改性海藻酸钠，其中，所述改性海藻酸钠的结构式为：
6.一种由权利要求1-5任一项所述的中药组合物制备得到的中药产品，其特征在于，包括：瓶体和存储在所述瓶体内的所述中药组合物。
7.一种如权利要求1-5任一项所述的中药组合物的制备方法，其特征在于，包括：
采用纯净水将所述中药原料浸泡第一时长；
将所述纯净水和所述中药原料煎煮第二时长；
加入纯净水，将所述纯净水和所述中药原料煎煮第三时长，得到中药水煎液；
将所述中药水煎液静置、离心、浓缩，得到所述中药浓缩液；
按配比加入所述中药挥发油和所述辅料，调节pH并静置、超滤、分装，得到所述中药组合物。
8.根据权利要求7所述的制备方法，其特征在于，所述采用纯净水将所述中药原料浸泡第一时长的步骤，包括：
将所述中药原料碾磨至颗粒状，并采用20-35℃的纯净水将所述中药原料浸泡30-45min，浸泡的同时采用40-60kHz的超声波对所述中药原料进行超声处理。
9.根据权利要求7所述的制备方法，其特征在于，所述将所述纯净水和所述中药原料煎煮第二时长的步骤，包括：
在35-90kpa压力下将所述纯净水和所述中药原料煎煮1-2h，煎煮的同时以20-50r/min的转速对所述纯净水和所述中药原料进行搅拌。
10.根据权利要求7所述的制备方法，其特征在于，所述加入纯净水，将所述纯净水和所述中药原料煎煮第三时长的步骤，包括：
加入60-95℃的纯净水，在35-90kpa压力下将所述纯净水和所述中药原料煎煮0.5-1h，煎煮的同时以20-50r/min的转速对所述纯净水和所述中药原料进行搅拌。
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