CN116059154A - 一种藏药八味泷沐组合物 - Google Patents
一种藏药八味泷沐组合物 Download PDFInfo
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- CN116059154A CN116059154A CN202111279571.XA CN202111279571A CN116059154A CN 116059154 A CN116059154 A CN 116059154A CN 202111279571 A CN202111279571 A CN 202111279571A CN 116059154 A CN116059154 A CN 116059154A
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Abstract
本发明涉康复、养生领域，具体涉及一种含有多种植物成分的洗浴用产品，其组成可以是植物的有效部位、或药材饮片的粉碎颗粒、或经有效部位经糊精包合的速溶成分的一种或多种。八味泷沐方是由八种核心藏药汇集的一种外用产品或称制剂。它是由传统藏医泷沐洗浴方结合现代药理研究及使用经验创新而来。
Description
技术领域
本发明涉及一种药浴组合物，尤其涉及一种能改善痛风、类风湿、痹症患者症状的藏药药浴组合物。
背景技术
藏医药浴法，藏语称“泷沐”，是将全身或部分肢体浸泡于药物煮熬的水汁中，然后卧热炕发汗，使腠理开泄，祛风散寒、化瘀活络，达到治病目的的一种疗法。是藏族人民以土、水、火、风、空“五源”生命观和隆、赤巴、培根“三因”健康观及疾病观为指导，通过沐浴温泉或药物煮熬的水汁或蒸汽，调节身心平衡，实现生命健康和疾病防治的传统技能。
2018年11月中国“藏医药浴法”被正式列入联合国教科文组织人类非物质化遗产代表作名录。这一遗产项目既体现了相关社区民众通过沐浴防病、疗疾的民间经验，也是以《四部医典》为代表的传统藏医理论在当代健康实践中的继承和发展。
风湿性关节炎是一种常见的结缔组织炎症，，受累关节以大关节为主，多始于侵袭下肢关节者膝和踝关节最为常见，其次为肩、肘和腕。风湿性关节炎病变呈多发性和游走性，关节局部炎症明显，表现有红、肿、热、痛、压痛及活动受限，持续时间不长，但发作频繁且痛苦程度高。类风湿是一种病因尚未明了的慢性全身性炎症性疾病，一般认为为自身免疫病，以慢性关节炎和关节外病变为主要临床表现，多发于手、腕、足等小关节，反复发作。症状有关节红肿热痛和功能障碍、僵硬畸形、骨和骨骼肌的萎缩，处理不当经常导致残基。
风湿性关节炎和类风湿病时西医常用激素类以及非甾体抗炎药，此类药物副作用大，且疗效不稳定。中医一般认为治疗风湿痹毒思路为祛风、胜湿、温经散寒，经常使用雷公藤等毒性中药成分以毒攻毒，不能充分发挥中药毒副作用低的优点。
现代医学及传统医学中，外治治疗风湿性关节炎、类风湿的药物及方法虽然也较多，但民众仍需要方便、安全，且具有保健防病功能的药浴产品。
发明内容
本发明的目的在于提供一种能改善痛风、类风湿、痹症患者症状的药浴组合物。尤其是一种藏药八味药浴的组合物。因此，从新成分和给药途径上寻找开发更安全且有效的抗风湿关节炎非口服外用治疗的中药组合物很有必要。
为实现发明目的，本发明提供以下技术方案：由如下重量份的原料：诃子、独活、宽筋藤、红花、威灵仙、藏菖蒲、风毛菊、黑豆；制成药学上可接受的制剂，如口服片剂，外用散剂，熏蒸液、气雾剂、涂膜剂、淹渍药包。
本发明所述的药浴包，是由称取重量份的原料：诃子、独活、宽筋藤、红花、威灵仙、藏菖蒲、风毛菊、黑豆；经过净选、炮制、粉碎，混合，或再经发酵，干燥制成药浴包，以无纺布包装，即制成本发明所述的一种能改善痛风、类风湿、痹症患者症状的药浴组合物药浴包。
其中诃子，为使君子科植物诃子Terminalia chebula Retz.或绒毛诃子Terminalia chebula Retz.var.tomentella Kurt.的干燥成熟果实。一般去果核后使用。
独活：为伞形科植物重齿毛当归Angelica pubescens Maxim.f.biserrata Shanet Yuan的干燥根。
宽筋藤，为防己科青牛胆属植物中华青牛胆Tinospora sinensis(Lour.)Merr.，以藤茎入药。洗净切碎，晒干。
红花、为菊科植物红花Carthamus tinctorius L.的干燥花。夏季花由黄变红时采摘取管状花，注意勿伤基部的子房，除去杂质，阴干或微火烘干，此时质较软，色深红最佳。或为为鸢尾科植物番红花Crocus sativus L.的花朵上部及柱头。
威灵仙、本品为毛茛科植物威灵仙Clematis chinensis Osbeck、棉团铁线莲(山蓼)Clematis hexapetala Pall.或东北铁线莲(黑薇)Clematis manshurica Rupr.的干燥根及根茎。秋季采挖，除去泥沙，晒干。
风毛菊，为菊科风毛菊属植物风毛菊Saussurea japonica(Thunb.)DC.，以全草入药。夏秋采收，鲜用或晒干。
藏菖蒲：为天南星科植物藏菖蒲Acorus calamus L.的干燥根茎。秋冬二季采挖，除去须根及泥沙，晒干。
黑豆：为豆科植物大豆Glycinemax(L.)Merr.的干燥成熟种子。黑豆味甘，性平，归脾、肾经，具有益精明目、养血祛风、利水、解毒的功效。
优选地，所述药浴组合物由如下重量份的原料制备得到：诃子10-25份、独活20-30份、宽筋藤20-25份、红花1-15份、威灵仙20-25份、藏菖蒲20-30份、风毛菊10-20份、黑豆20-350份。
本发明改善痛风、类风湿、痹症患者症状的药浴组合物的制备方法包括如下步骤：取诃子10-25份、独活20-30份、宽筋藤20-25份、红花1-15份、威灵仙20-25份、藏菖蒲20-30份、风毛菊10-20份，黑豆20-350份，按比例称取原料药，粉碎成微粉，加水煎煮至药粉吸干水分，加青稞粉及酒曲适量，30-45℃发酵1-7日，晾晒，干燥，加适当辅料压制成球形、片剂型。
与现有技术相比，本发明具有的有益效果为对皮肤刺激性小，能较快缓解类风湿关节炎晨僵及关节疼痛，痛风关节红肿，坚持洗浴可延缓关节变形的发生。
具体实施方式
下面结合具体实施方式，对本发明的技术方案作进一步的详细说明，但不构成对本发明的任何限制。
实施例1
取诃子150g、独活250g、宽筋藤250g、红花50g、威灵仙150g、藏菖蒲250g、风毛菊150g、黑豆1800g。粉碎，装入无纺布药浴包，封装即得。使用时，拆去外包装，取无纺布药包，在锅内温水浸泡20-30分钟，再兑入足量沸水，将水温调节至35-65℃，将药水倒入浴缸或澡盆供患者或顾客泷沐药浴所用。
实施例2
取诃子、独活、宽筋藤、红花、威灵仙、藏菖蒲、风毛菊、及50％重量份的黑豆粉碎，提取水蒸气蒸馏提取挥发油，用预胶化淀粉、β-环糊精包合所制备的挥发油，制成挥发油固态包合物，药渣干燥与其余黑豆份及挥发油包合物混合；装入无纺布药浴包，封装即得。使用时，拆去外包装，无纺布药包，在锅内温水浸泡20-30分钟，再兑入沸水，将水温调节至35-65℃，将药水倒入浴缸或澡盆供泷沐所用。
以上所述仅为本发明的部分实施例，凡在本发明的精神和原则范围内所作的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。
实施例3：
依据其病因病机以及临床表现，我们在临床实践中选用八味泷沐药浴方，外用相结合常规治疗退行性关节病92例，其中颈椎退行性病变28例，腰椎退行性病变41例，膝关节退行性病变23例，获效显著。以上病例全部经X光照片或CT、磁共振检查明确诊断。
治疗方法：1、八味泷沐药浴散，细粉，30g，温水化开，浸泡双足及湿敷患处。15天为一个疗程，中间休息2天，连续观察两个疗程。
疗效评定：1、显效：骨节疼痛消失，活动功能恢复正常，X线检查示骨质改变恢复。2、有效：骨关节疼痛减轻，活动功能好转，X线检查示骨质改变有好转。3、无效：骨节疼痛未减，X线检查骨质改变无改善。
治疗结果：196例患者，经一个疗程治疗显效76％，有效12％，无效12％，两个疗程治疗后显效87％，有效10％，无效3％。收效显著，且未发现任何毒副作用，尤其没有出现胃肠道的反应。
临床总结：退行性骨关节病属于中医骨痹范畴。主要成因有三：一是风寒湿邪欠羁，侵入骨骼，气血运行不畅，骨失充养。二是骨质受损、负重太过。三是老年体衰、肝肾亏虚，精血不足，骨髓不充，以致骨质脆弱。总以寒湿阻滞，气血失运，经络受阻而见骨骼关节疼痛，活动受限，久则变形。是一种常见病和多发病，严重的影响了人们的身心健康。
八味泷沐药浴散，具有很好的祛风通络、柔筋活血、消肿止痛作用。八味药中，辛能散邪，苦能燥湿，咸能软坚，甘能缓急，温以通络，实属治疗骨关节病的最佳组合。
实施例4：
赵某刚，男，22岁，学生。因为每天需做实验早出晚归，睡觉时间少，身体虚弱。脚关节肿痛，频繁失眠。使用本发明药浴包后，进行泡脚，据本人反应脚关节疼痛明显改善，疲劳度减少，睡眠质量有所改善，精神更充沛，明显改善无力状况。
实施例5：
姚某芮，女，48岁，学生。红斑狼疮面容，容易失眠、惊醒，常出虚汗。坚持每天使用八味泷沐药浴散，每天50g，隔日一次，坚持使用两周时间，皮损面容有了极大改善，入睡快，睡眠质量也变高，极少有夜梦、虚汗等现象，精神状态也好了很多。
实例6：
齐某茵，女，38岁，教师。身体较虚弱，睡眠质量差，容易失眠，罹患系统性硬化症，经多个医院治疗，不能有效缓解。后坚持每天使用本发明八味泷沐药浴组合物全身药浴，熏蒸，三日一次，坚持使用28天时间，双手及双肩硬化症明显改善，睡眠质量有所改善，且明显改善吞咽困难的症状。
实施例7
取诃子、独活、宽筋藤、红花、威灵仙、藏菖蒲、风毛菊、黑豆，预胶化淀粉50份、β-环糊精20份；其中取诃子、独活、宽筋藤、红花、威灵仙、宽筋藤、风毛菊将其粉碎再加预胶化淀粉、β-环糊精；然后用纱布将药物包好，在锅内浸泡20-30分钟，先用大火将水煮沸，再用小火煎煮30分钟即可，煮好后将药水倒入浴缸或澡盆，加入适量热水即可。
实施例8
本发明八味泷沐药浴包的有两种常用使用方法为患部或全身熏蒸：取八味泷沐药浴包，将其粉碎；然后用纱布将药物包好，在锅内浸泡20-30分钟，先用大火将水煮沸，再用小火煎煮保持沸腾，引导药物蒸汽到肢体或患病部位。
所述八味泷沐药浴包，按比例称取除黑豆的另七味原料药，诃子、独活、宽筋藤、红花、威灵仙、藏菖蒲、风毛菊、，粉碎，制成微粉，加水1.2倍量，蒸煮至药粉吸干水分，加黑豆粉及酒曲适量，30-45℃发酵3日，晾晒，干燥，加适当辅料压制成球形，无纺布包装即得。
实施例9
本发明八味泷沐药浴包用于治疗高尿酸血症并发痹症的使用观察：
根据八味泷沐药浴包组方特点，我们于2018年7月～2019年1月运用该药包用于中医痹症兼有血尿酸、血肌酐、尿素检测异常异常的患者120例，取得显著使用效果：
1临床资料：
1.1诊断标准：参照《中药新药临床研究指导原则》制定。凡具备以下者列为观察对象：
1.1.1西医诊断标准：
高尿酸血症诊断标准：非同日两次空腹血尿酸水平男性高于420μmol/L，女性高于360μmol/L，即称为高尿酸血症。
(1)病史尿酸异常大于6个月，或伴有血肌酐＞110μmol/L，而血尿素＞7.5mmol/L。
(2)症状
主症 关节肿胀，疼痛，晨僵。
次症 下雨前及阴天关节不适感加重，或下肢浮肿。
证候
(1)湿热证
主症 关节疼痛，或伴有咽痛，咽部干燥不利。
次症 发热，口渴。
检查 咽粘膜红或鲜红，悬壅垂红肿，咽后壁淋巴滤泡增生。
舌象 舌质尖红苔薄白或薄黄。
脉象 濡数。
1.2排除标准：
(1)有食物或药物过敏者。
(2)因麻疹，猩红热，流感及粒细胞缺乏症，传染性单核细胞增多症，白血病等引起的咽部症状或炎症。
(3)妊娠及意向妊娠或哺乳期妇女。
(4)合并有心、肝、肾和造血系统严重原发性疾病，精神病患者。
1.3一般资料120例，男75例、女35例，随机分为两组。
治疗组(本发明制剂，按本发明实施例2制备)80例，男62例、年龄44～68岁；女28例、年龄51～73岁。
对照组(艾叶、红花、鸡血藤、桑枝、伸筋草各35g，黑豆180g)40例，男23例、年龄43～65岁；女17例、年龄51～62岁。两组患者无显著差异(P＞0.05)，有可比性。
治疗方法：
2.1治疗组：本发明八味泷沐药浴包，每2～3日药浴一次，每次30-45分钟。
对照组：用艾叶、红花、鸡血藤桑枝、伸筋草各35g，黑豆180g制成模拟制剂，每2～3日药浴一次，每次30-45分钟。
3疗效观察：
3.1疗效判定标准参照有关文献按临床痊愈、显效、有效、无效4级评定：
3.1.1中医痹症疗效判定标准
(1)临床痊愈药浴3次以内症状减轻，7次以内临床症状及体征消失。
(2)显效用药10次以内症状、体征明显改善。
(3)有效用药15次以内症状减轻，部分体征消失。
(4)无效用药25次以内症状及体征无明显改善。
3.1.2单项症状、体征疗效评定标准
(1)临床痊愈尿酸水平恢复正常，血肌酐，尿素水平明显下降，并下肢浮肿明显减轻。
(2)显效尿酸水平下降，接近恢复正常，血肌酐，尿素水平有所下降，并下肢浮肿减轻。
(3)有效尿酸水平下降，。
(4)无效尿酸无改变。
3.2治疗结果
3.2.1两组临床疗效见表1，
表1治疗组与对照组疗效比较
| 组别 | 例数 | 临床痊愈 | 显效 | 有效 | 无效 |
| 治疗组1 | 80例 | 26 | 22 | 23 | 9 |
| 对照组 | 40例 | 8 | 13 | 15 | 4 |
采用T检验，治疗组与对照组总显效率比较P＜0.05，具有显著性意义。
实验例10
取诃子、独活、宽筋藤、红花、威灵仙、藏菖蒲、风毛菊粉碎，二氧化碳超临界提取挥发油备用；提取挥发油所剩药渣干燥粉碎，与黑豆粗粉拌匀、润湿；投入足量酒曲拌匀，35-42℃发酵48小时后，取除放凉、干燥，然后用粗布将药物包好备用。使用时，将药包在锅内浸泡25分钟，先用大火将水煮沸，再用小火煎煮10分钟即可，煮好后将药水倒入浴缸或澡盆，加入适量热水以备药浴。
实验例11
取独活20份、宽筋藤20份、红花1份、威灵仙20份、藏菖蒲20份、风毛菊10份、粉碎，二氧化碳超临界提取挥发油备用；提取挥发油所剩药渣干燥粉碎，与黑豆150份粗粉拌匀、纯净水润湿药粉；投入足量酒曲拌匀，35-42℃发酵48小时后，取除放凉、干燥，压制成直径15mm的片剂，即为八味泷沐汤浴片剂。
取八味泷沐汤浴片剂约1.5g，加入丙酮80ml，加热回流30分钟，过滤，滤液蒸干，残渣用水溶解并稀释至10ml，冰箱(5～10℃)放置1小时，取出，通过孔径为0.45μm的微孔滤膜，滤液作为供试品溶液；另取没食子酸对照品溶液，作为对照品溶液；再取诃子对照药材约0.5g，按供试品溶液制备的方法操作，制成对照药材溶液。
吸取上述供试品溶液与对照品及对照药材溶液各20μl，照高效液相色谱法(中国药典2015年版一部附录)试验，用十八烷基硅烷键合硅胶为固定相，A0.05M磷酸溶液-0.05M磷酸二氢钾溶液(1∶1)；B甲醇；C醋酸乙酯，按下表进行梯度洗脱，检测波长为280nm，供试品色谱应呈现与对照品保留时间相同的色谱峰，应与对照药材的色谱基本一致。
| 时间 | 流动相A％ | 流动相B％ | 流动相C％ |
| 0 | 94 | 6 | 0 |
| 5 | 95 | 4 | 1 |
| 15 | 92 | 2 | 5 |
| 20 | 88 | 6 | 6 |
| 35 | 53 | 42 | 5 |
实验例11
取独活20份、宽筋藤20份、红花1份、威灵仙20份、藏菖蒲20份、风毛菊10份、粉碎，二氧化碳超临界提取挥发油备用；提取挥发油所剩药渣干燥粉碎，与黑豆150份粗粉拌匀、纯净水润湿药粉；投入足量酒曲拌匀，35-42℃发酵48小时后，取除放凉、干燥，压制成直径15mm的片剂，备用。使用时，将片剂在锅内浸泡25分钟，先用大火将水煮沸，再用小火煎煮10分钟即可，煮好后将药水倒入浴缸或澡盆，加入适量热水以备药浴。
实验例12
取诃子8.95kg、独活8.25kg、宽筋藤8.25g、番红花2.64kg、威灵仙4.95kg、藏菖蒲8.25g、风毛菊4.95g、黑豆53.75g。粉碎，装入无纺布药浴包，封装即得。使用时，拆去外包装，取无纺布药包，在锅内温水浸泡20-30分钟，再兑入足量沸水，将水温调节至35-65℃，将药水倒入浴缸或澡盆供患者或顾客泷沐药浴所用。
实验例13
张某发：67岁，男，下肢浮肿，伴有全身乏力、腰酸不适，贫血，夜间排尿次数增多半年，2019年6月经诊断为肾炎氮质血症一期：氮质血症期。服用尿毒清颗粒、发酵虫草菌丝粉，水肿及肾功有改善，但下肢浮肿明显，且劳累或停药后加重。
2019年12月开始，应用本发明藏药八味泷沐药浴包，煎煮，取药液足量装于壶中，保持药液温度35-62℃，每次30-45分钟，每2～3日足部及下肢淋渫法药浴一次，具体淋渫方法：即双足踩于木凳上，药液从膝关节，淋洗至足面。经5次治疗，下肢水肿明显减轻且劳累后不复发。
Claims (8)
1.一种藏药八味泷沐组合物，其特征在于，由以下原料药制备得到：诃子、独活、宽筋藤、红花、威灵仙、藏菖蒲、风毛菊、黑豆。
2.根据权利要求1所述的一种藏药八味泷沐组合物，其特征在于，由以下重量份的原料药制备得到：诃子10-25份、独活20-30份、宽筋藤20-25份、红花1-15份、威灵仙20-25份、藏菖蒲20-30份、风毛菊10-20份、黑豆20-350份。
3.根据权利要求2所述的一种藏药八味泷沐组合物，其特征在于，由以下重量份的原料药制备得到：诃子15份、独活25份、宽筋藤25份、红花5份、威灵仙15份、藏菖蒲25份、风毛菊15份、黑豆180份。
4.一种藏药八味泷沐组合物，其特征在于，其有效成分包含权利要求1-3任一项所述的药浴组合物，还包括医学上可接受的添加剂，制成便于应用的药浴包、药浴液、熏蒸液、气雾剂、涂膜剂、淹渍药包。
5.一种藏药八味泷沐组合物药浴包的制备方法，其特征在于，所述药浴包为微粉速崩固体剂药芯及无纺布药袋组成，其中药芯的制备步骤如下：按比例称取除黑豆的另七味原料药，粉碎，制成微粉，加水1.2倍量，蒸煮至药粉吸干水分，加黑豆粉及酒曲适量，30-45℃发酵1-7日，晾晒，干燥，加适当辅料压制成球形、片剂。
6.权利要求1-5任一项所述的藏药八味泷沐组合物在制备治疗类风湿药物中的应用。
7.权利要求1-5任一项所述的藏药八味泷沐组合物在制备治疗痛风药物中的应用。
8.权利要求1-5任一项所述的藏药八味泷沐组合物在制备治疗氮质血症下肢水肿药物中的应用。
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