CN116327885A - 一种用于防治甲状腺结节的药物组合物 - Google Patents
一种用于防治甲状腺结节的药物组合物 Download PDFInfo
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- CN116327885A CN116327885A CN202310612888.3A CN202310612888A CN116327885A CN 116327885 A CN116327885 A CN 116327885A CN 202310612888 A CN202310612888 A CN 202310612888A CN 116327885 A CN116327885 A CN 116327885A
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- platycodin
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Abstract
本发明提供了一种用于防治甲状腺结节的药物组合物，涉及药物组合物领域，该组合物包括：圆柚酮、香附烯酮、α‑香附酮、呋甾皂苷Ⅰ、螺甾皂苷、薤白皂苷、硫酸软骨素、鹿角盘胶原肽、贝母素甲、贝母素乙、β‑榄香烯、莪术烯、莪术醇、总磷脂、天冬多糖、洋菝契皂苷、桔梗皂苷D、桔梗皂苷D2、桔梗总黄酮、桔梗多酚、鳖甲胶、人参总皂苷，该组合物可用于制备防治甲状腺结节的药物，具有用药精准、高效，治疗效果优异且安全性高的优势。
Description
技术领域
本发明涉及药物组合物领域，具体涉及一种用于防治甲状腺结节的药物组合物。
背景技术
十味香鹿胶囊由香附、薤白、鹿角、贝母、莪术、蜈蚣、天冬、鳖甲、人参和桔梗组成，具有疏肝解郁，理气化痰，软坚散结。用于肝郁兼痰凝证所致乳腺疾病。症见：乳房肿块胀痛或刺痛，经前加重，经后缓解，伴胸胁胀闷，善郁易怒，胸闷不舒，身重倦怠或纳呆，或经行腹痛，舌质淡或淡红或有瘀点，苔白腻，脉弦或涩。
目前，并无十味香鹿胶囊治疗甲状腺结节的报道，但有报道认为：利用特定生物医学数据库，挖掘甲状腺结节、乳腺结节、子宫肌瘤3种疾病间的分子关联，这3种疾病的共有关键靶点相关154种中医症状，涉及血瘀、火热、痰湿等病机，病位主要在肝。甲状腺结节、乳腺结节、子宫肌瘤分属中医“瘿瘤”“乳核”“石瘕”范畴，皆为有形实体。
甲状腺结节是指在甲状腺内的肿块，可随吞咽动作随甲状腺而上下移动，是临床常见的病症，可由多种病因引起。临床上有多种甲状腺疾病，如甲状腺退行性变、炎症、自身免疫以及新生物等都可以表现为结节。甲状腺结节可以单发，也可以多发，多发结节比单发结节的发病率高，但单发结节甲状腺癌的发生率较高。
对于防治甲状腺结节的相关用药而言，文献：李雅慧, 杨文军, 徐云生. 基于数据挖掘的甲状腺结节中医临床用药规律分析[J]. 山东医药, 2019, 59(17):3.通过文献分析现代医家治疗甲状腺结节的处方用药，总结中医临床治疗甲状腺结节的用药规律。研究发现，其中使用频数≥15次的中药有夏枯草、浙贝母、柴胡、莪术、半夏、香附、牡蛎、茯苓、玄参、郁金、陈皮、厚朴、当归、皂角刺、白芍、白术、川芎、甘草、黄芪、枳壳共20味，药物归经方面最多是肝经，四气五味以寒、苦为主。
再如专利CN115300596A（国别：中国；公开日：2022.11.08）公开了一种防治甲状腺结节的微生态提取物及其制备方法，由按重量计的如下组分制得：猫爪草10-20份，夏枯草20-30份，莪术10-20份，浙贝10-20份，柴胡10-20份，郁金10-20份，青皮10-20份，生牡蛎30-50份，半夏10-20份，黄芪20-40份，陈皮10-20份，枳壳5-15份，茯苓10-15份，香附8-12份，桔梗8-12份，甘草8-12份，土木香8-12份，薤白8-12份，麦冬8-12份，王不留行8-12份，地榆8-12份，北沙参8-12份，药王茶8-12份，紫苏籽8-12份，钩藤8-12份，远志8-12份，OMEGA-3 0.1份，B-胡罗卜素0.001份，槲皮素0.05份，有机硒0.00005份。进一步将上述组分混合后加入胃蛋白酶进行酶解，再通过微生物进行微生态提取制得。最终制得的产品有毒成分低、人体吸收度高，且效果好、副作用少。另有专利CN114558096A（国别：中国；公开日：2022.05.31）公开了一种治疗甲状腺结节的中药组合物，由以下原料制得：黄芪、赤芍、当归、白术、茯苓、法半夏、浙贝母、生牡蛎、郁金、香附、鳖甲、夏枯草、川芎、昆布、甘草。该中药组合物对甲状腺结节的治疗具有显著效果。
但目前为止，有关十味香鹿胶囊的原材料以及其他中药药材组合在治疗甲状腺结节方面均有一定局限性，更多地在于对药材进行配伍或者将混合物进行进一步的提取利用，但以上方法通常难以精准控制用药，针对性较弱，或存在功效性差、安全性低的问题。针对以上问题，寻找一种高效、用药精准、效果优异且安全的防治甲状腺结节的组合物十分必要。
发明内容
本发明针对现有技术存在的问题，提供了一种用于防治甲状腺结节的药物组合物，该组合物可用于制备防治甲状腺结节的药物，具有用药精准、高效，治疗效果优异且安全性高的优势。
为实现上述目的，本发明采用的技术方案如下：
本发明提供了一种组合物，包括：圆柚酮、香附烯酮、α-香附酮、呋甾皂苷Ⅰ、螺甾皂苷、薤白皂苷、硫酸软骨素、鹿角盘胶原肽、贝母素甲、贝母素乙、β-榄香烯、莪术烯、莪术醇、总磷脂、天冬多糖、洋菝契皂苷、桔梗皂苷D、桔梗皂苷D2、桔梗总黄酮、桔梗多酚、鳖甲胶、人参总皂苷。
进一步地，所述的组合物，按重量份数计，包括：圆柚酮0.1-0.3份、香附烯酮1-2份、α-香附酮0.2-0.6份、呋甾皂苷Ⅰ 6-8份、螺甾皂苷 0.1-0.3份、薤白皂苷2-5份、硫酸软骨素1-3份、鹿角盘胶原肽30-36份、贝母素甲0.01-0.05份、贝母素乙0.01-0.05份、β-榄香烯0.3-0.8份、莪术烯1-1.5份、莪术醇0.2-0.6份、总磷脂8-15份、天冬多糖2-6份、洋菝契皂苷0.1-0.5份、桔梗皂苷D 0.2-0.6份、桔梗皂苷D2 0.2-0.6份、桔梗总黄酮0.2-0.8份、桔梗多酚0.1-0.5份、鳖甲胶2-4份、人参总皂苷8-12份。
优选地，所述的组合物，按重量份数计，包括：圆柚酮 0.1份、香附烯酮1.2份、α-香附酮0.3份、呋甾皂苷Ⅰ 7.5份、螺甾皂苷0.1份、薤白皂苷4份、硫酸软骨素1.6份、鹿角盘胶原肽32.8份、贝母素甲0.02份、贝母素乙0.015份、β-榄香烯0.4份、莪术烯1.1份、莪术醇0.3份、总磷脂10份、天冬多糖5份、洋菝契皂苷0.2份、桔梗皂苷D 0.4份、桔梗皂苷D2 0.4份、桔梗总黄酮0.5份、桔梗多酚0.2份、鳖甲胶2.5份、人参总皂苷10份。
进一步地，所述呋甾皂苷Ⅰ、硫酸软骨素和天冬多糖的重量比为6-8:1-3:2-6。优选为7.5:1.6:5。
优选地，所述鹿角盘胶原肽和鳖甲胶的重量比为30-36:2-4；优选为32.8:2.5。
进一步地，所述人参总皂苷包括人参皂苷Rg3、人参皂苷Re和人参皂苷Rb1中的一种或多种。
优选地，所述人参总皂苷为重量比为2-3:1-2:1的人参皂苷Rg3、人参皂苷Re和人参皂苷Rb1。
进一步优选地，所述人参总皂苷为重量比为2:2:1的人参皂苷Rg3、人参皂苷Re和人参皂苷Rb1。
进一步地，本发明还提供了上述的组合物的制备方法，包括以下步骤：将圆柚酮、香附烯酮、α-香附酮、呋甾皂苷Ⅰ、螺甾皂苷、薤白皂苷、硫酸软骨素、鹿角盘胶原肽、贝母素甲、贝母素乙、β-榄香烯、莪术烯、莪术醇、总磷脂、天冬多糖、洋菝契皂苷、桔梗皂苷D、桔梗皂苷D2、桔梗总黄酮、桔梗多酚、鳖甲胶、人参总皂苷混合即得。
进一步地，本发明还提供了一种用于防治甲状腺结节的药物，包括上述的组合物和医学上可用的辅料。
进一步地，所述药物的剂型包括片剂、胶囊剂、颗粒剂、膏剂、液体剂、丸剂或混悬剂。
优选地，所述药物的剂型为胶囊剂。
本发明所取得的技术效果是：
本发明通过研究发现，通过对香附、薤白、鹿角、贝母、莪术、蜈蚣、天冬、鳖甲、人参和桔梗等有效成分进行提取并配合使用得到的药物组合物具有防治甲状腺结节的作用。在该组合物中，有效成分呋甾皂苷Ⅰ、硫酸软骨素和天冬多糖之间存在协同作用，鹿角盘胶原肽和鳖甲胶在满足一定的配比时也有较佳的效果。本发明的用药精准、高效，治疗效果优异且安全性高。
具体实施方式
以下通过特定的具体实例说明本发明的实施方式，本领域技术人员可由本说明书所揭露的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用，本说明书中的各项细节也可以基于不同观点与应用，在没有背离本发明的精神下进行各种修饰或改变。
在进一步描述本发明具体实施方式之前，应理解，本发明的保护范围不局限于下述特定的具体实施方案；还应当理解，本发明实施例中使用的术语是为了描述特定的具体实施方案，而不是为了限制本发明的保护范围。
当实施例给出数值范围时，应理解，除非本发明另有说明，每个数值范围的两个端点以及两个端点之间任何一个数值均可选用。除非另外定义，本文中使用的所有技术和科学术语具有与本发明所属技术领域的普通技术人员通常理解的相同意义。
值得说明的是，本发明中使用的原料均为普通市售产品，因此对其来源不做具体限定。
实施例1-3及对比例1-5：
表1 实施例1-3及对比例1-5的组方
| 原料 | 实施例1 | 实施例2 | 实施例3 | 对比例1 | 对比例2 | 对比例3 | 对比例4 | 对比例5 |
| 圆柚酮 | 0.1 | 0.3 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 |
| 香附烯酮 | 1 | 2 | 1.2 | 1.2 | 1.2 | 1.2 | 1.2 | 1.2 |
| α-香附酮 | 0.2 | 0.6 | 0.3 | 0.3 | 0.3 | 0.3 | 0.3 | 0.3 |
| 呋甾皂苷Ⅰ | 6 | 8 | 7.5 | 14.1 | - | - | 7.5 | 7.5(替换为等量薤白皂苷) |
| 螺甾皂苷 | 0.1 | 0.3 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 |
| 薤白皂苷 | 2 | 5 | 4 | 4 | 4 | 4 | 4 | 4 |
| 硫酸软骨素 | 1 | 3 | 1.6 | - | 14.1 | - | 1.6 | 1.6（替换为等量迷迭香酸） |
| 鹿角盘胶原肽 | 30 | 36 | 32.8 | 32.8 | 32.8 | 32.8 | 28.3 | 32.8 |
| 贝母素甲 | 0.01 | 0.05 | 0.02 | 0.02 | 0.02 | 0.02 | 0.02 | 0.02 |
| 贝母素乙 | 0.01 | 0.05 | 0.015 | 0.015 | 0.015 | 0.015 | 0.015 | 0.015 |
| β-榄香烯 | 0.3 | 0.8 | 0.4 | 0.4 | 0.4 | 0.4 | 0.4 | 0.4（替换为等量呋喃二烯） |
| 莪术烯 | 1 | 1.5 | 1.1 | 1.1 | 1.1 | 1.1 | 1.1 | 1.1 |
| 莪术醇 | 0.2 | 0.6 | 0.3 | 0.3 | 0.3 | 0.3 | 0.3 | 0.3 |
| 总磷脂 | 8 | 15 | 10 | 10 | 10 | 10 | 10 | 10 |
| 天冬多糖 | 2 | 6 | 5 | - | - | 14.1 | 5 | 5 |
| 洋菝契皂苷 | 0.1 | 0.5 | 0.2 | 0.2 | 0.2 | 0.2 | 0.2 | 0.2 |
| 桔梗皂苷D | 0.2 | 0.6 | 0.4 | 0.4 | 0.4 | 0.4 | 0.4 | 0.4 |
| 桔梗皂苷D2 | 0.2 | 0.6 | 0.4 | 0.4 | 0.4 | 0.4 | 0.4 | 0.4 |
| 桔梗总黄酮 | 0.2 | 0.8 | 0.5 | 0.5 | 0.5 | 0.5 | 0.5 | 0.5 |
| 桔梗多酚 | 0.1 | 0.5 | 0.2 | 0.2 | 0.2 | 0.2 | 0.2 | 0.2 |
| 鳖甲胶 | 2 | 4 | 2.5 | 2.5 | 2.5 | 2.5 | 7 | 2.5 |
| 人参总皂苷 | 8（重量比为2:1:1的人参皂苷Rg3、人参皂苷Re和人参皂苷Rb1） | 12（重量比为3:2:1的人参皂苷Rg3、人参皂苷Re和人参皂苷Rb1） | 10（重量比为2:2:1的人参皂苷Rg3、人参皂苷Re和人参皂苷Rb1） | 10（重量比为2:2:1的人参皂苷Rg3、人参皂苷Re和人参皂苷Rb1） | 10（重量比为2:2:1的人参皂苷Rg3、人参皂苷Re和人参皂苷Rb1） | 10（重量比为2:2:1的人参皂苷Rg3、人参皂苷Re和人参皂苷Rb1） | 10（重量比为2:2:1的人参皂苷Rg3、人参皂苷Re和人参皂苷Rb1） | 10（重量比为2:2:1的人参皂苷Rg3、人参皂苷Re和人参皂苷Rb1） |
表1中组合物的制备方法包括以下步骤：将圆柚酮、香附烯酮、α-香附酮、呋甾皂苷Ⅰ、螺甾皂苷、薤白皂苷、硫酸软骨素、鹿角盘胶原肽、贝母素甲、贝母素乙、β-榄香烯、莪术烯、莪术醇、总磷脂、天冬多糖、洋菝契皂苷、桔梗皂苷D、桔梗皂苷D2、桔梗总黄酮、桔梗多酚、鳖甲胶、人参总皂苷混合即得（对比例5根据实际情况进行原料替换）。
药效评价
开展药物组合物防治甲状腺结节的药效实验研究，观察本发明的药物组合物对甲状腺结节模型动物的影响，评价其对甲状腺结节的防治效果。
1实验材料及仪器
1.1 试验药物
十味香鹿胶囊：吉林华康药业股份有限公司提供，批准文号：国药准字号Z20120003，批号：20221001。临用时以等量蒸馏水分散开，用时摇匀，4℃保存。
对比例1-5、实施例1-3按上述配置，均由吉林华康药业股份有限公司提供，临用时以等量蒸馏水分散开，用时摇匀，4℃保存。
1.2 试验动物
（1）雄性Wistar大鼠，体重180-220g。购买自长春市亿斯实验动物技术有限责任公司，动物生产合格证号：SCXK（吉）-2020-0002。
（2）动物饲养及实验均在吉林大学基础医学院实验动物中心进行，全部过程符合动物伦理审查要求，动物饲喂普通维持饲料，自由饮食水。
1.3 试剂
丙基硫氧嘧啶（propylthiouracil，PTU），深圳市中联制药有限公司；
生理盐水：四川科伦药业股份有限公司；
水合氯醛，美国默克公司；
大鼠促甲状腺激素（thyrotropin，TSH）ELISA试剂盒，江西艾博因公司；
大鼠游离三碘甲腺原氨酸（free triiodothyronine，FT3）ELISA试剂盒，江西艾博因公司；
大鼠游离甲状腺素（free thyroxine，FT4）ELISA试剂盒，江西艾博因公司。
1.4 仪器
DGX-9003B型烘箱，上海福玛实验设备有限公司；
电热恒温水箱，上海跃进仪器厂；
XSP-C20型普通光学显微镜，重庆光电仪器有限公司；
80-2型离心机，上海云楼医用仪器厂；
AG204型电子天平，北京京科伟业实验器材有限公司。
2.方法
2.1实验动物分组与模型建立
采用随机数字表法，将大鼠随机分为正常组、模型组、十味香鹿胶囊组（即对照组）、对比例1组、对比例2组、对比例3组、对比例4组、对比例5组、实施例1-高剂量组、实施例1-中剂量组、实施例1-低剂量组、实施例2组、实施例3组，每组10只，记录大鼠体重。正常组灌服给予生理盐水，其余各组均分别灌服给予浓度为0.1 %的PTU溶液，每日早上8:00灌胃1次，各组均连续灌服8周。
2.2给药方法
（1）给药剂量
实施例1-高剂量组给药140mg/次，实施例1-中剂量组给药70mg/次，实施例1-低剂量组给药35mg/次，十味香鹿胶囊组给药130mg/次，其余各组给药量与实施例1-低剂量组一致，正常组灌胃给予等量蒸馏水。
（2）给药方法
第9周起，实施例1-3以及对比例1-5分别按照相应剂量灌胃给药，对照组灌胃给予十味香鹿胶囊，正常组及模型组灌胃给予蒸馏水。每日早上8:00灌胃1次，各组均连续灌服8周。
2.3 指标检测
灌胃给药8周后，大鼠禁食12 h，禁水2 h。给予10%水合氯醛腹腔麻醉成功后，使用剪刀在大鼠甲状软骨上方剪断，提起大鼠，将血液收集至5 mL促凝管中，采血量为2 mL。随后，将大鼠固定在鼠台上切开皮肤，暴露气管，找到甲状腺组织（精细化剥离结节组织），完整分离后去除周围其他组织，称量组织质量。
将收集到的血液静置2 h后，低温离心10 min分离血清，各收集0.5 mL血清于1.5mL EP管中，于-20℃冰箱保存备用。严格按照ELISA试剂盒说明书检测血清TSH、FT3和FT4含量。
3.统计学分析
本研究中的全部实验结果以x（平均值）±s（标准差）表示；组间数据显著性差异用SPSS统计软件进行单因素方差分析t-检验。P<0.05显示具有统计学差异，P<0.01显示统计学差异显著。
二、结果
1、甲状腺组织质量
表2 各组甲状腺组织质量
注：##与正常组比较：P＜0.01；**与模型组比较：P＜0.01；
○与实施例1低剂量比较：P＜0.05，○○与实施例1低剂量比较：P＜0.01；
●与实施例2比较：P＜0.05，●●与实施例2比较：P＜0.01；
◇与实施例3比较：P＜0.05，◇◇与实施例3比较：P＜0.01。
2、血清TSH、FT3和FT4含量
表3 各组血清TSH、FT3和FT4含量
注：##与正常组比较：P＜0.01；**与模型组比较：P＜0.01；
○与实施例1低剂量比较：P＜0.05，○○与实施例1低剂量比较：P＜0.01；
●与实施例2比较：P＜0.05，●●与实施例2比较：P＜0.01；
◇与实施例3比较：P＜0.05，◇◇与实施例3比较：P＜0.01。
三、结论
本发明的组合物对模型动物的甲状腺结节具有治疗作用；可以有效增加大鼠甲状腺组织的质量，减少大鼠甲状腺肿的质量，逆转其发展，可以降低血清中TSH含量，升高血清中FT3和FT4含量；总体来看，其中实施例效果优于对比例和十味香鹿胶囊组，实施例1高、中剂量优于其他组别，同剂量下以实施例3最优；而对比例和十味香鹿胶囊组效果相当。
最后应当说明的是，以上内容仅用以说明本发明的技术方案，而非对本发明保护范围的限制，本领域的普通技术人员对本发明的技术方案进行的简单修改或者等同替换，均不脱离本发明技术方案的实质和范围。
Claims (10)
1.一种组合物，其特征在于：包括：圆柚酮、香附烯酮、α-香附酮、呋甾皂苷Ⅰ、螺甾皂苷、薤白皂苷、硫酸软骨素、鹿角盘胶原肽、贝母素甲、贝母素乙、β-榄香烯、莪术烯、莪术醇、总磷脂、天冬多糖、洋菝契皂苷、桔梗皂苷D、桔梗皂苷D2、桔梗总黄酮、桔梗多酚、鳖甲胶、人参总皂苷。
2.根据权利要求1所述的组合物，其特征在于：按重量份数计，包括：圆柚酮0.1-0.3份、香附烯酮1-2份、α-香附酮0.2-0.6份、呋甾皂苷Ⅰ 6-8份、螺甾皂苷0.1-0.3份、薤白皂苷2-5份、硫酸软骨素1-3份、鹿角盘胶原肽30-36份、贝母素甲0.01-0.05份、贝母素乙0.01-0.05份、β-榄香烯0.3-0.8份、莪术烯1-1.5份、莪术醇0.2-0.6份、总磷脂8-15份、天冬多糖2-6份、洋菝契皂苷0.1-0.5份、桔梗皂苷D 0.2-0.6份、桔梗皂苷D2 0.2-0.6份、桔梗总黄酮0.2-0.8份、桔梗多酚0.1-0.5份、鳖甲胶2-4份、人参总皂苷8-12份。
3.根据权利要求2所述的组合物，其特征在于：按重量份数计，包括：圆柚酮0.1份、香附烯酮1.2份、α-香附酮0.3份、呋甾皂苷Ⅰ 7.5份、螺甾皂苷0.1份、薤白皂苷4份、硫酸软骨素1.6份、鹿角盘胶原肽32.8份、贝母素甲0.02份、贝母素乙0.015份、β-榄香烯0.4份、莪术烯1.1份、莪术醇0.3份、总磷脂10份、天冬多糖5份、洋菝契皂苷0.2份、桔梗皂苷D 0.4份、桔梗皂苷D2 0.4份、桔梗总黄酮0.5份、桔梗多酚0.2份、鳖甲胶2.5份、人参总皂苷10份。
4.根据权利要求1所述的组合物，其特征在于：所述呋甾皂苷Ⅰ、硫酸软骨素和天冬多糖的重量比为6-8:1-3:2-6。
5.根据权利要求1所述的组合物，其特征在于：所述鹿角盘胶原肽和鳖甲胶的重量比为30-36:2-4。
6.根据权利要求1所述的组合物，其特征在于：所述人参总皂苷包括人参皂苷Rg3、人参皂苷Re和人参皂苷Rb1中的一种或多种。
7.根据权利要求6所述的组合物，其特征在于：所述人参总皂苷为重量比为2-3:1-2:1的人参皂苷Rg3、人参皂苷Re和人参皂苷Rb1。
8.如权利要求1-7任一项所述的组合物的制备方法，其特征在于：包括以下步骤：将圆柚酮、香附烯酮、α-香附酮、呋甾皂苷Ⅰ、螺甾皂苷、薤白皂苷、硫酸软骨素、鹿角盘胶原肽、贝母素甲、贝母素乙、β-榄香烯、莪术烯、莪术醇、总磷脂、天冬多糖、洋菝契皂苷、桔梗皂苷D、桔梗皂苷D2、桔梗总黄酮、桔梗多酚、鳖甲胶、人参总皂苷混合即得。
9.一种用于防治甲状腺结节的药物，其特征在于：包括权利要求1-7任一项所述的组合物和医学上可用的辅料。
10.根据权利要求9所述的药物，其特征在于：所述药物的剂型包括片剂、胶囊剂、颗粒剂、膏剂、液体剂、丸剂或混悬剂。
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