CN109512965A - 一种清热通痹片及其制备方法 - Google Patents
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Abstract
本发明属于医药技术领域，公开了一种清热通痹片及其制备方法，所述清热通痹片由雷公藤50～200g、麸炒苍术10～50g、防己10～50g、绵萆薢10～50g、黄柏10～50g、土茯苓20～100g、地龙10～50g、忍冬藤10～50g和川牛膝10～50g组成。本发明具有清热除湿，活血通络，消肿止痛的作用；本发明有效用于类风湿性关节炎、幼年性类风湿性关节炎湿热痹阻型。本发明具有抗炎镇痛及免疫抑制作用；具有抗病原微生物的作用，对多种致病性细菌有不同程度的抑制作用；本发明中含黄柏碱、巴马亭等具有降压活性成分。
Description
技术领域
本发明属于医药技术领域，尤其涉及一种清热通痹片及其制备方法。
背景技术
目前，业内常用的现有技术是这样的：
类风湿关节炎(RA)是一种病因未明的慢性、以炎性滑膜炎为主的系统性疾病。其特征是四肢大小关节的多关节、对称性、侵噬性关节炎，常伴有血清类风湿因子阳性及抗黄胍氨酸肽抗体阳性，如控制不佳可出现关节畸形功能丧失，甚者脏器受累危及生命。
目前类风湿关节炎的治疗以抗炎止痛、免疫抑制延缓病情发展，预防关节骨质破坏畸形，但长时间口服，副作用较大，常常引起脏器功能损伤；在使用消炎止痛药的过程中(非甾体消炎药、激素)，往往会带来比较明显的毒副作用，导致肝肾功能受损、血液系统受累、骨质疏松、消化性溃疡等新的问题。
现有技术存在的问题是：
1、在长期使用非甾体消炎药或激素过程中，患者往往会出现消化系统症状(恶心、呕吐、纳呆)，甚者严重可出现消化性溃疡；
2、目前RA的控制主要依靠免疫抑制剂(甲氨喋呤片、来氟米特片)，长期使用，患者会出现免疫力低下，特别容易诱发各种感染。
3、目前使用的中药制剂如白芍总苷胶囊、正清风痛宁胶囊虽然有一定的疗效，但是没有对病症分型治疗，用药宽泛，不能针对性治疗。
4、RA患者除疼痛可以使用抗炎止痛药缓解症状以外，晨僵、关节发热等症状不能很好得到解决。
解决缺陷：
1、在长期治疗过程中能够缓解疼痛，最大程度较少对消化道的毒副作用，而且对胃黏膜具有保护作用；
2、对于服用免疫抑制剂导致免疫力低下者，可以对免疫力进行双向调节；
3、整体治疗，除疼痛可以控制外，也可以兼顾合并症。
意义：
1、功补兼施，可长期口服：清热通痹片为复方制剂，除土茯苓、黄柏、雷公藤等具有清热利湿、通络止痛外，还配伍有炒苍术、绵萆薢等健脾化湿药物；长期口服攻划之药，可以耗伤气血，在使用过程中配伍健脾化湿之品，以补后天气血，使驱邪而不伤正，清热利湿而不伤阴，相得益彰。
2、辩证施治，达到精准治疗：辨明寒热、虚实是施治的基础，中药的使用是以中医理论为指导原则，才能做到精准治疗。
发明内容
针对现有技术存在的问题，本发明提供了一种清热通痹片及其制备方法。
本发明是这样实现的，一种清热通痹片按重量由雷公藤50～200g、麸炒苍术10～50g、防己10～50g、绵萆薢10～50g、黄柏10～50g、土茯苓20～100g、地龙10～50g、忍冬藤10～50g和川牛膝10～50g组成。
本发明的另一目的在于提供一种清热通痹片的制备方法，具体包括以下步骤：
步骤一：选取优质的雷公藤、麸炒苍术、防己、绵萆薢、黄柏、土茯苓、地龙、忍冬藤和川牛膝，除尘、去杂质，备用；
步骤二：取上述雷公藤(6％的量)、其他八味各三分之一量，干燥后粉碎，过100目筛，制得各原料精粉；
步骤三：剩余药材加水煎煮两次，每次2小时，合并煎液，滤过，滤液浓缩至适宜程度，加入上述细粉，混匀，制成颗粒，干燥，压制成1000片；
步骤四：制片后包糖衣，经杀菌、包装，制得清热通痹片。
进一步，所述步骤一中，去杂质，包括异物与金属残渣处理。
进一步，所述步骤三中，制片机使用前、后，需进行清洗及消毒，保证产品不被污染或混入杂质。
进一步，所述步骤四中，糖衣为普通药用糖衣，且符合国家标准。
综上所述，本发明的优点及积极效果为：本发明具有清热除湿，活血通络，消肿止痛的作用；本发明有效用于类风湿性关节炎、幼年性类风湿性关节炎湿热痹阻型。
本发明具有抗炎镇痛及免疫抑制作用；具有抗病原微生物的作用，对多种致病性细菌有不同程度的抑制作用；本发明中含黄柏碱、巴马亭等具有降压活性成分。
附图说明
图1是本发明实施例提供的清热通痹片的制备方法流程图。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅用以解释本发明，并不用于限定本发明。
本发明实施例提供的清热通痹片按重量由雷公藤50～200g、麸炒苍术10～50g、防己10～50g、绵萆薢10～50g、黄柏10～50g、土茯苓20～100g、地龙10～50g、忍冬藤10～50g和川牛膝10～50g组成。
下面结合附图对本发明的应用原理做详细描述。
如图1所示，本发明实施例提供的清热通痹片的制备方法，具体包括以下步骤：
S101：选取优质的雷公藤、麸炒苍术、防己、绵萆薢、黄柏、土茯苓、地龙、忍冬藤和川牛膝，除尘、去杂质，备用；
S102：取上述雷公藤(6％的量)、其他八味各三分之一量，干燥后粉碎，过100目筛，制得各原料精粉；
S103：剩余药材加水煎煮两次，每次2小时，合并煎液，滤过，滤液浓缩至适宜程度，加入上述细粉，混匀，制成颗粒，干燥，压制成1000片；
S104：制片后包糖衣，经杀菌、包装，制得清热通痹片。
步骤S101中，本发明实施例提供的去杂质，包括异物与金属残渣处理。
步骤S103中，本发明实施例提供的制片机使用前、后，需进行清洗及消毒，保证产品不被污染或混入杂质。
步骤S104中，本发明实施例提供的糖衣为普通药用糖衣，且符合国家标准。
下面结合具体的药理作用对本发明的应用原理进行进一步详细说明；
本发明具有抗炎镇痛及免疫抑制作用；具有抗病原微生物的作用，对多种致病性细菌有不同程度的抑制作用；本发明中含黄柏碱、巴马亭等具有降压活性成分。
下面结合各药效对本发明的应用原理进行进一步详细说明；
雷公藤，性味苦、辛，凉。有大毒。功能主治祛风，解毒，杀虫。外用治风湿性关节炎，皮肤发痒。
麸炒苍术，辛、苦，温；归脾、胃、肝经；具有燥湿健脾、祛风散寒、明目功能；用于脘腹胀满、泄泻、水肿、风湿痹痛、风寒感冒、夜盲。
防己，苦，辛，寒；归膀胱经、肾经、脾经；具有祛风湿，止痛，利水的功能；主治风湿关节疼痛；湿热肢体疼痛；水肿；小便不利；脚气湿肿。
绵萆薢，性味苦，平；归肾、胃经；功能主治利湿去浊，祛风通痹。用于淋病白浊，白带过多，湿热疮毒，腰膝痹痛。
黄柏，味苦，性寒。清热解毒，泻火燥湿。主治急性细菌性痢疾、急性肠炎、急性黄疸型肝炎、泌尿系统感染等炎症。外用治火烫伤、中耳炎、急性结膜炎等。
土茯苓，性味甘、淡，平；归肝、胃经；功能主治除湿，解毒，通利关节；用于湿热淋浊，带下，痈肿，瘰疬，疥癣，梅毒及汞中毒所致的肢体拘挛，筋骨疼痛。
地龙，咸、寒，功能：清热熄风，平肝降压，洛络通痹，清肺平喘，利尿通淋。
忍冬藤，性味甘，寒；归肺、胃经；功能主治清热解毒，疏风通络；用于温病发热，热毒血痢，痈肿疮疡，风湿热痹，关节红肿热痛。
川牛膝，味甘、微苦，性平；归肝、肾经；逐瘀通经，通利关节，利尿通淋；用于经闭症瘕，胞衣不下，跌扑损伤，风湿痹痛，足痿筋挛，尿血血淋等证。
下面结合临床实施例对本发明的应用效果作详细的描述。
实施例一：常某，男，44岁。
于2018年8月13日因四肢关节肿痛入院就诊，结果回报：中医诊断：尪痹，湿热痹阻型；西医诊断：类风湿关节炎。
诊查：营养中等，发育良好，形体适中，表情痛苦；心电图示，窦性心动过缓。中医治清热除湿、活血通络为法，方用宣痹汤合三妙散，配合清热通痹片(每日3次，每次2片)口服治疗。患者四肢关节肿痛较前减轻，病情好转出院。
实施例二：选取82位符合类风湿关节炎属急性活动期、X线分期为早、中期，并且于治疗3个月后复查的病人作为研究对象。82例病人，随机分成治疗组50例，对照组32例。其中男性26例，女性56例；病程1～15年，平均7.49±3.68年；年龄15岁～61岁，平均年龄30.64±7.62岁。随机分成治疗组50例(平均病程7.46±3.70，年龄30.69±7.58)；对照组32例(平均病程7.51±3.62，年龄了30.57±7.63)。两组性别，平均病程、年龄等临床资料比较无统计学差异(P＞0.05),具有可比性。
治疗组：口服清热通痹片每次4片(400mg)每日3次；由湖北省洪湖市中医医院制药厂提供。
对照组：口服美洛昔康片(江苏亚邦爱普生药业有限公司国药准字H2010108)，每次1片(7.5mg)每日2次；来氟米特片(爱若华，苏州长征一欣凯制药有限公司，国药准字H20000550)，治疗的前3天根据病人年龄给予负荷剂量即每天3-5片(30mg-50mg)，每日1次；后每日1次每次1片(10mg)。两组以3个月为1疗程并进行统计学处理，观察两组疗效。
结果：治疗组50例，效果显著者共计13例，有效者共计26例，进步者共计8例，无效者3例，合计总有效者47例；实验组32例，效果显著者共计4例，有效者共计14例，进步者共计5例，无效者9例，合计总有效者23例；清热通痹片治疗尪痹(湿热痹阻证)优于美洛昔康片与来氟米特片联合用药。
实施例三：选取95例风湿病科住院患者，随机分为2组。治疗组61例，其中男22例，女39例；年龄23—68岁。平均年龄(45.23±7.05)岁。对照组34例，其中男10例，女24例；年龄25—64岁。平均年龄(44.38±6.23)岁。两组患者性别，年龄等一般资料比较均无明显统计学差异(p＞0.05)，具有可比性。
治疗组：采用内服清热通痹片和外敷止痛散治疗。该2种药均由我院制剂室生产。(1)清热通痹片组方：雷公藤、苍术(麸炒)、防己、萆薢、黄柏、土茯苓、地龙、忍冬藤、川牛膝等。每次3片，日3次，饭后服，10天为一疗程(2)外敷止痛散：由透骨草、乳香、没药、赤芍、红花、自然铜、雷公藤等组成。先将外敷药粉倒入容器内，加入适量的白酒或醋搅拌均匀，和成稀泥状，根据患者病变部位大小，取适中调好的药泥外敷于患处，外裹一层塑料纸后，用纱布固定，24小时换药一次，10天为一疗程，或肿胀消失后停用。有皮肤溃烂，外伤化脓者不宜敷用。
对照组：采用口服尼美舒利胶囊(广州白云山制药有限股份公司生产)，每次0.18g，每日2次，10天为1疗程。2个疗程后观察两组疗效。
结果：治疗组共计61例，治愈者12例，显效者24例，好转者21例，无效者4例，总有效率93.44％；实验组共计34例，治愈者4例，显效者11例，好转者13例，无效者6例，总有效率82.35％；治疗组疗效明显优于对照组。
本发明实施例提供的性状为：本发明为糖衣片，除去糖衣后显棕褐色，味苦微甜。
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。
Claims (5)
1.一种清热通痹片，其特征在于，所述清热通痹片由雷公藤50～200g、麸炒苍术10～50g、防己10～50g、绵萆薢10～50g、黄柏10～50g、土茯苓20～100g、地龙10～50g、忍冬藤10～50g和川牛膝10～50g组成。
2.一种如权利要求1所述清热通痹片的制备方法，其特征在于，所述清热通痹片的制备方法包括以下步骤：
步骤一：选取雷公藤、麸炒苍术、防己、绵萆薢、黄柏、土茯苓、地龙、忍冬藤和川牛膝，除尘、去杂质，备用；
步骤二：取上述雷公藤6％的量、其他八味各三分之一量，干燥后粉碎，过100目筛，制得各原料精粉；
步骤三：剩余药材加水煎煮两次，每次2小时，合并煎液，滤过，滤液浓缩至适宜程度，加入上述细粉，混匀，制成颗粒，干燥，压制成1000片；
步骤四：制片后包糖衣，经杀菌、包装，制得清热通痹片。
3.如权利要求2所述的清热通痹片的制备方法，其特征在于，所述步骤一中，去杂质，包括异物与金属残渣处理。
4.如权利要求2所述的清热通痹片的制备方法，其特征在于，所述步骤三中，制片机使用前、后，需进行清洗及消毒。
5.如权利要求2所述的清热通痹片的制备方法，其特征在于，所述步骤四中，糖衣为普通药用糖衣。
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