CN110478459A - 一种阳虚型体质温肾强督、活血通痹的中药组合物 - Google Patents

一种阳虚型体质温肾强督、活血通痹的中药组合物 Download PDF

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CN110478459A
CN110478459A CN201910884958.4A CN201910884958A CN110478459A CN 110478459 A CN110478459 A CN 110478459A CN 201910884958 A CN201910884958 A CN 201910884958A CN 110478459 A CN110478459 A CN 110478459A
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丁群
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Guizhou Cimingtang Health Management Co Ltd
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Abstract

一种阳虚型体质温肾强督、活血通痹的中药组合物由下述重量份的药材配制而成：独活，桑寄生，土鳖虫，川芎，红花，川续断，莬丝子，巴戟天，穿山甲，王不留行，落得打，骨碎补，肉苁蓉，生地黄，熟地黄，生黄芪，蕲蛇，枸杞子，潼蒺藜，白蒺藜，太子参，生白术，枳实，野葡萄藤，蒲公英，菝葜，白茯苓，佛手，砂仁，蔻仁，路路通，生晒参，木香，虎杖。本中药组合物尤其适用于肾阳不足之督脉瘀滞型强直性脊柱的患者。

Description

一种阳虚型体质温肾强督、活血通痹的中药组合物
技术领域
本发明涉及一种阳虚型体质温肾强督、活血通痹的中药组合物，
具体为中药制备技术领域。
背景技术
强直性脊柱炎是一种主要累及脊柱中轴关节和骶髂关节的慢性进展性疾病，以受累组织炎性纤维化和骨化为病变特点，临床常以炎症性疼痛为首发症状，晚期可发生脊柱强直、畸形，常有不同程度的眼、肺、心血管、肾等多个器官的并发症。本病多见于青少年，发病年龄通常在 15 ～ 30 岁，男性发病率明显高于女性，约为 10.6:1。因该病有起病隐匿，病程长，缠绵难愈，误诊率高，致残率高等特点，常可危及患者身心健康和活动能力，严重影响 患者的生存质量。在强直性脊柱炎的临床治疗方面，目前西医尚没有较好的治疗方法，只是以减轻疼痛，控制病情进展为主要目的，临床上也无特效药，所用药物多为非甾体类抗炎 药、糖皮质激素、免疫抑制剂、慢作用抗风湿药等。由于服药时间较长，出现胃肠道损害，血液系统改变，肝肾功改变等，毒副作用较大，患者往往难以坚持接受治疗。
发明内容
本发明的目的在于提供一种阳虚型体质温肾强督、活血通痹的中药组合物。
为实现上述目的，本发明提供如下技术方案：一种阳虚型体质温肾强督、活血通痹的中药组合物由下述重量份的药材配制而成：独活10-120份，桑寄生100-300份，土鳖虫10-100份，川芎10-90份，红花10-100份，川续断10-150份，莬丝子100-300份，巴戟天100-200份，穿山甲10-90份，王不留行10-150份，落得打10-150份，骨碎补10-150份，肉苁蓉10-150份，生地黄10-150份，熟地黄10-150份，生黄芪10-150份，蕲蛇10-100份，枸杞子10-120份，潼蒺藜10-120份，白蒺藜10-120份，太子参100-300份，生白术10-120份，枳实100-300份，野葡萄藤100-300份，蒲公英100-300份，菝葜100-300份，白茯苓10-120份，佛手10-120份，砂仁5-60份，蔻仁5-60份，路路通10-100份，生晒参10-100份，木香10-90份，虎杖100-300份。
作为优选，所述的阳虚型体质温肾强督、活血通痹的中药组合物由下述重量份的药材配制而成：独活100份，桑寄生150份，土鳖虫80份，川芎80份，红花65份，川续断120份，莬丝子150份，巴戟天150份，穿山甲80份，王不留行120份，落得打120份，骨碎补120份，肉苁蓉120份，生地黄120份，熟地黄120份，生黄芪120份，蕲蛇80份，枸杞子100份，潼蒺藜100份，白蒺藜100份，太子参150份，生白术110份，枳实150份，野葡萄藤150份，蒲公英150份，菝葜150份，白茯苓80份，佛手80份，砂仁45份，蔻仁45份，路路通80份，生晒参80份，木香80份，虎杖200份。
一种阳虚型体质温肾强督、活血通痹的中药组合物的制备方法为：步骤一、将中药组合物按照重量份原料配比，将独活，桑寄生，土鳖虫，川芎，红花，川续断，莬丝子，巴戟天，穿山甲，王不留行，落得打，骨碎补，肉苁蓉，生地黄，熟地黄，生黄芪，蕲蛇，枸杞子，潼蒺藜，白蒺藜，太子参，生白术，枳实，野葡萄藤，蒲公英，菝葜，白茯苓，佛手，砂仁，蔻仁，路路通，生晒参，木香，虎杖全部粉碎成粉末，将粉碎的药材粉末全部投入超临界流体萃取反应釜中，然后加入改性剂乙醇0.3ml，萃取条件为压力34.5mPa，温度60℃，静态萃取时间10min，动态萃取量10ml，以水作为吸引，得到纯度很高的药粉；
步骤二、将药物浓缩粉放到干燥的器皿里，加入面粉，加入200ml热水，按1/5的药粉/面粉的比例，然后把药粉、面粉和热水进行人工搅拌均匀，热水温度设定为50-70℃，搅拌后得到药泥；
步骤三、将步骤二制备的药泥放入到药丸模型中进行模制成型，然后用烘干机进行烘干处理，温度设定为50℃，时间为10-15分钟，得到药丸； 每粒丸药重2g，药丸放入到微波杀菌设备中进行杀菌消毒处理，时间 为3-5分钟，杀菌温度为90-100℃；杀菌后的药丸放入到包装机内进行密封包装处理，得到药丸为 10g一袋。
本中药组合物中独活味辛苦，性温，归肾，膀胱经，具祛风湿，止痛之功；肉苁蓉味甘咸，性温，归肾经，具补肾助阳之能；二者共为君药，以温补肾阳，祛风湿，止痛。巴戟天、桑寄生、莬丝子、杜仲、续断、补肾脂、落得打、蕲蛇、生地黄、熟地黄、枸杞子、潼蒺藜、白蒺藜、野葡萄藤、菝葜、路路通等药，甘、温、入肾经，共具补肾阳，祛风湿，强筋骨，通络止痛之功，能辅助君药加强温补肾阳，祛风湿，止痛的作用，故为臣药。生黄芪、太子参、生白术、白茯苓、八月札、陈香橼、绿萼梅、佛手、砂仁、蔻仁、生晒参、川芎、红花、枳实、蒲公英、木香、虎杖、土鳖虫、穿山甲、王不留行合奏补脾胃，疏肝理气，活血，祛湿，止痛之功，用以协助君、臣药加强祛风湿，活血止痛之功，故俱为佐药。甘草缓和药性，调和诸药，为使药。全方具有温补肾阳，祛风湿，强督脉，强筋骨，活血止痛之功。
与现有技术相比，本发明的有益效果如下：本中药组合物尤其适用于肾阳不足之督脉瘀滞型强直性脊柱的患者。
具体实施方式
下面将结合本发明实施例中对本发明的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，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，都属于本发明保护的范围。
一种阳虚型体质温肾强督、活血通痹的中药组合物的制备方法为：步骤一、将中药组合物按照重量份原料配比，将独活10-120份，桑寄生100-300份，土鳖虫10-100份，川芎10-90份，红花10-100份，川续断10-150份，莬丝子100-300份，巴戟天100-200份，穿山甲10-90份，王不留行10-150份，落得打10-150份，骨碎补10-150份，肉苁蓉10-150份，生地黄10-150份，熟地黄10-150份，生黄芪10-150份，蕲蛇10-100份，枸杞子10-120份，潼蒺藜10-120份，白蒺藜10-120份，太子参100-300份，生白术10-120份，枳实100-300份，野葡萄藤100-300份，蒲公英100-300份，菝葜100-300份，白茯苓10-120份，佛手10-120份，砂仁5-60份，蔻仁5-60份，路路通10-100份，生晒参10-100份，木香10-90份，虎杖100-300份
全部粉碎成粉末，将粉碎的药材粉末全部投入超临界流体萃取反应釜中，然后加入改性剂乙醇0.3ml，萃取条件为压力34.5mPa，温度60℃，静态萃取时间10min，动态萃取量10ml，以水作为吸引，得到纯度很高的药粉；
步骤二、将药物浓缩粉放到干燥的器皿里，加入面粉，加入200ml热水，按1/5的药粉/面粉的比例，然后把药粉、面粉和热水进行人工搅拌均匀，热水温度设定为50-70℃，搅拌后得到药泥；
步骤三、将步骤二制备的药泥放入到药丸模型中进行模制成型，然后用烘干机进行烘干处理，温度设定为50℃，时间为10-15分钟，得到药丸； 每粒丸药重2g，药丸放入到微波杀菌设备中进行杀菌消毒处理，时间 为3-5分钟，杀菌温度为90-100℃；杀菌后的药丸放入到包装机内进行密封包装处理，得到药丸为 10g一袋。
实施例1：
一种阳虚型体质温肾强督、活血通痹的中药组合物由下述重量份的药材配制而成：独活10份，桑寄生100份，土鳖虫10份，川芎10份，红花10份，川续断10份，莬丝子100份，巴戟天100份，穿山甲10份，王不留行10份，落得打10份，骨碎补10份，肉苁蓉10份，生地黄10份，熟地黄10份，生黄芪10份，蕲蛇10份，枸杞子10份，潼蒺藜10份，白蒺藜10份，太子参100份，生白术10份，枳实100份，野葡萄藤100份，蒲公英100份，菝葜100份，白茯苓10份，佛手10份，砂仁5份，蔻仁5份，路路通10份，生晒参10份，木香10份，虎杖100份。
实施例2：
一种阳虚型体质温肾强督、活血通痹的中药组合物由下述重量份的药材配制而成：独活120份，桑寄生300份，土鳖虫100份，川芎90份，红花100份，川续断150份，莬丝子300份，巴戟天200份，穿山甲90份，王不留行150份，落得打150份，骨碎补150份，肉苁蓉150份，生地黄150份，熟地黄150份，生黄芪150份，蕲蛇100份，枸杞子120份，潼蒺藜120份，白蒺藜120份，太子参300份，生白术120份，枳实300份，野葡萄藤300份，蒲公英300份，菝葜300份，白茯苓120份，佛手120份，砂仁60份，蔻仁60份，路路通100份，生晒参100份，木香90份，虎杖300份。
实施例3：
一种阳虚型体质温肾强督、活血通痹的中药组合物由下述重量份的药材配制而成：独活100份，桑寄生150份，土鳖虫80份，川芎80份，红花65份，川续断120份，莬丝子150份，巴戟天150份，穿山甲80份，王不留行120份，落得打120份，骨碎补120份，肉苁蓉120份，生地黄120份，熟地黄120份，生黄芪120份，蕲蛇80份，枸杞子100份，潼蒺藜100份，白蒺藜100份，太子参150份，生白术110份，枳实150份，野葡萄藤150份，蒲公英150份，菝葜150份，白茯苓80份，佛手80份，砂仁45份，蔻仁45份，路路通80份，生晒参80份，木香80份，虎杖200份。
疗效检测方法
为表明本发明药物的治疗效果，本发明经过 120 例颈椎酸痛和强直性脊柱炎患者进行系统的临床研究；中医诊断参照《中药新药临床研究指导原则》中有关肝肾不足证强直性脊柱炎的诊断标准确诊。患者临床以腰痛引项脊尻背，僵硬畸形，肌肉瘦削，屈伸不利，手部不温，畏寒喜暖，或腰膝酸软，滑精，阳痿等，舌质淡，苔白少津，脉沉弱或细数。
治疗组：按就诊顺序根据随机数字表法选取 60 例，在原治疗基础上，停用所有治疗药物，单纯服用本发明药物治疗3个月。
对照组：按就诊顺序根据随机数字表法选取60例，口服全天麻胶囊+扶他林片，治疗3个月。
两组在病情、性别、年龄、病程等方面经统计学处理差异无统计学意义。
服用方法 ：治疗组 ：每日早晚各一次服用本发明组合物5g，疗程为 3 个月。
对照组 ：口服全天麻胶囊，0. 5g/粒，每次口服4粒，每天3次。
疗效判定标准：痊愈 ：患者症状消失，关节、脊柱功能活动恢复正常 ；
显效 ：症状明显缓解，关节、脊柱功能活动范围增加 ；
有效 ：症状基本减轻，关节、脊柱功能活动范围稍有增加 ；
无效 ：症状及 关节、脊柱功能活动无变化。
表1
实验组 临床治愈 显效 有效 无效
治疗组 49 10 1 0
对照组 30 10 10 10
实验组治疗颈椎酸痛和强直性脊柱炎明显优于对照组，且未发现本中药组合物具有明显的不良反应。因此，可判定本中药组合物是一种疗效确切而安全的药物。
案型病例 ：
梁某，男，28 岁，2017年 10 月来诊。主诉“腰骶部疼痛 3 年，加重半月”。1 年前患者无明显诱因出现腰骶部疼痛，晨起发僵，略作活动可好转，未予重视。半月前腰骶部疼痛加重，夜间翻身困难，弯腰受限。腰背部怕凉。骶髂关节 CT 示 ：双侧骶髂关节关节面毛糙，关节间隙略狭窄。诊断强直性脊柱炎，采用本发明中药制剂，先服 1个疗程，症状明显好转，继而又服用 2 疗程，半年后复诊， 腰背疼痛消失，腰背活动度较前好转，晨僵不明显。
冯某，女，40岁，患者两年前无明显诱因，出现腰骶部酸痛不适，在医院检查确诊为强直性脊椎炎，曾服用柳氮磺吡啶片、沙利度胺片等药，但因疗效欠佳而停用。患者舌淡，苔薄白，脉细弱，往有慢性胃窦炎和胆囊切除病史，此乃肾虚督寒。外邪入侵，日久成淤，闭阻经络，不通则痛故证，肾虚督寒，淤血内阻，患者服用本方一个月后，腰骶部酸痛，下坠感和足跟疼痛明显减轻，舌淡红，苔薄白，脉细，继续服用，两个月后痊愈。
尽管已经示出和描述了本发明的实施例，对于本领域的普通技术人员而言，可以理解在不脱离本发明的原理和精神的情况下可以对这些实施例进行多种变化、修改、替换和变型，本发明的范围由所附权利要求及其等同物限定。

Claims (3)

1.一种阳虚型体质温肾强督、活血通痹的中药组合物，其特征在于：所述的中药组合物由下述重量份的药材配制而成：独活10-120份，桑寄生100-300份，土鳖虫10-100份，川芎10-90份，红花10-100份，川续断10-150份，莬丝子100-300份，巴戟天100-200份，穿山甲10-90份，王不留行10-150份，落得打10-150份，骨碎补10-150份，肉苁蓉10-150份，生地黄10-150份，熟地黄10-150份，生黄芪10-150份，蕲蛇10-100份，枸杞子10-120份，潼蒺藜10-120份，白蒺藜10-120份，太子参100-300份，生白术10-120份，枳实100-300份，野葡萄藤100-300份，蒲公英100-300份，菝葜100-300份，白茯苓10-120份，佛手10-120份，砂仁5-60份，蔻仁5-60份，路路通10-100份，生晒参10-100份，木香10-90份，虎杖100-300份。
2.根据权利要求1所述的一种阳虚型体质温肾强督、活血通痹的中药组合物，其特征在于：所述的中药组合物由下述重量份的药材配制而成：独活100份，桑寄生150份，土鳖虫80份，川芎80份，红花65份，川续断120份，莬丝子150份，巴戟天150份，穿山甲80份，王不留行120份，落得打120份，骨碎补120份，肉苁蓉120份，生地黄120份，熟地黄120份，生黄芪120份，蕲蛇80份，枸杞子100份，潼蒺藜100份，白蒺藜100份，太子参150份，生白术110份，枳实150份，野葡萄藤150份，蒲公英150份，菝葜150份，白茯苓80份，佛手80份，砂仁45份，蔻仁545份，路路通80份，生晒参80份，木香80份，虎杖200份。
3.一种阳虚型体质温肾强督、活血通痹的中药组合物的制备方法，其特征在于：具体制备方法为：步骤一、将中药组合物按照重量份原料配比，将独活，桑寄生，土鳖虫，川芎，红花，川续断，莬丝子，巴戟天，穿山甲，王不留行，落得打，骨碎补，肉苁蓉，生地黄，熟地黄，生黄芪，蕲蛇，枸杞子，潼蒺藜，白蒺藜，太子参，生白术，枳实，野葡萄藤，蒲公英，菝葜，白茯苓，佛手，砂仁，蔻仁，路路通，生晒参，木香，虎杖全部粉碎成粉末，将粉碎的药材粉末全部投入超临界流体萃取反应釜中，然后加入改性剂乙醇0.3ml，萃取条件为压力34.5mPa，温度60℃，静态萃取时间10min，动态萃取量10ml，以水作为吸引，得到纯度很高的药粉；
步骤二、将药物浓缩粉放到干燥的器皿里，加入面粉，加入200ml热水，按1/5的药粉/面粉的比例，然后把药粉、面粉和热水进行人工搅拌均匀，热水温度设定为50-70℃，搅拌后得到药泥；
步骤三、将步骤二制备的药泥放入到药丸模型中进行模制成型，然后用烘干机进行烘干处理，温度设定为50℃，时间为10-15分钟，得到药丸； 每粒丸药重2g，药丸放入到微波杀菌设备中进行杀菌消毒处理，时间 为3-5分钟，杀菌温度为90-100℃；杀菌后的药丸放入到包装机内进行密封包装处理，得到药丸为 10g一袋。
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