CN106344811A - 一种治疗风湿病的中药制剂及制备方法 - Google Patents
一种治疗风湿病的中药制剂及制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗风湿病的中药制剂及制备方法,由以下重量份的原料制成:白参200‑400份、红景天200‑400份、土鳖虫200‑400份、桑椹子200‑400份、当归400‑600份、女贞子400‑600份、蛤蚧50‑150份、海龙50‑150份、灵芝300‑500份、杜仲300‑500份、沙苑子300‑500份、地龙300‑500份、铁皮石斛50‑150份、白花蛇50‑150份、鸡血藤700‑900份、甘草200‑400份、川乌100‑200份、草乌100‑200份、细辛100‑300份、牛膝50‑150份、防己50‑150、丝瓜络200‑400份、甜菊糖0.001‑0.002份、苯甲酸钠0.001‑0.003份。本发明具有祛风湿、活络、补肾的功效,药效显著,可以长期服用,患者易于接受。
Description
技术领域
本发明涉及中药领域,特别是涉及一种治疗风湿病的中药制剂及制备方法。
背景技术
风湿病是一组侵犯关节、骨骼、肌肉、血管及有关软组织或结缔组织为主的疾病,其中多数为自身免疫性疾病,发病多较隐蔽而缓慢,病程较长,且大多具有遗传倾向,诊断及治疗均有一定难度,血液中多可检查出不同的自身抗体,可能与不同HLA亚型有关,对非甾类抗炎药(NSAID),糖皮质激素和免疫抑制剂有较好的短期或长期的缓解性反应,广义上认为凡是引起骨关节,肌肉疼痛的疾病皆可归属为风湿病,延续下来,至今在风湿病分类上,广义的已有100多种疾病,包括了感染性、免疫性、代谢性、内分泌性、遗传性、退行性、肿瘤性、地方性、中毒性等多种原因引起的疾病,狭义上应该仅限于内科与免疫相关范畴的几十种疾病,其中有些病还是跨学科的,如风湿病,骨性关节病,感染性关节炎等;目前中医药治疗风湿病研究报道日益增多,因其副作用小已为广大风湿病患者所接受,利用现代科技设备和方法,探讨风湿病病因病机,筛选验证有效药物,研制针对性强、疗效肯定、剂型简便的中药制剂,是当前亟待解决的关键问题。
发明内容
为解决上述技术问题,本发明提供一种治疗风湿病的中药制剂,由以下重量份的原料制成:白参200-400份、红景天200-400份、土鳖虫200-400份、桑椹子200-400份、当归400-600份、女贞子400-600份、蛤蚧50-150份、海龙50-150份、灵芝300-500份、杜仲300-500份、沙苑子300-500份、地龙300-500份、铁皮石斛50-150份、白花蛇50-150份、鸡血藤700-900份、甘草200-400份、川乌100-200份、草乌100-200份、细辛100-300份、牛膝50-150份、防己50-150、丝瓜络200-400份、甜菊糖0.001-0.002份、苯甲酸钠0.001-0.003份;
本发明还提供一种治疗风湿病的中药制剂的制备方法,其制备步骤为:
(1)取原料白参、红景天、土鳖虫、桑椹子、当归、女贞子用粉碎机粉碎,粉碎细度60-80目,得原料粉,备用;
(2)取原料蛤蚧、海龙、灵芝、杜仲、沙苑子、地龙、铁皮石斛、白花蛇、鸡血藤、甘草用粉碎机粉碎,粉碎细度80-100目,得原料粉,备用;
(3)取原料川乌、草乌、细辛、牛膝、防己、丝瓜络用粉碎机粉碎,粉碎细度100-120目,得原料粉,备用;
(4)将步骤(1)所得原料粉和步骤(2)所得原料粉和(3)所得原料粉加入原料总重量的8-12倍的水,浸泡0.5-2小时,加热蒸馏2-6小时,得蒸馏液,药渣加入原料总重量的4-8倍的水煎煮1-2次,时间为0.4-0.8小时,合并煎煮液和蒸馏液,过滤得滤液,滤液浓缩至85-95℃测相对密度为1.00-1.05的清膏,冷却后加入85-95%乙醇适量,搅匀,0至6℃冷藏20-30小时,过滤,滤液减压回收乙醇至无醇味,滤液浓缩至50-60℃相对密度为1.15-1.25的浸膏,备用;
(5)将步骤(4)中所得浸膏放入配液罐内,加入浸膏重量3-6倍量的纯化水加热至沸腾,搅拌15-25分钟,微沸腾保温10-15分钟,形成药液,放置,冷却至室温,备用;
(6)取甜菊糖、苯甲酸钠分别粉碎成500-600目,备用;
(7)将步骤(5)中所得药液加入粉碎后的甜菊糖、苯甲酸钠溶解搅拌,使药液混合均匀,搅拌15-25分钟后用离心机进行过滤,在60-65℃,20-30MPa条件下进行两次均质,再调节pH为6.5-7.0,得到配液,备用;
(8)将步骤(7)中所得配液用洁净的玻璃瓶分装,采用超高温瞬时灭菌,即得治疗风湿病的中药制剂。
优选的方案中,所述的一种治疗风湿病的中药制剂,由以下重量份的原料制成:白参300份、红景天300份、土鳖虫300份、桑椹子300份、当归500份、女贞子500份、蛤蚧100份、海龙100份、灵芝400份、杜仲400份、沙苑子400份、地龙400份、铁皮石斛100份、白花蛇100份、鸡血藤800份、甘草300份、川乌150份、草乌150份、细辛200份、牛膝100份、防己100份、丝瓜络300份、甜菊糖0.0015份、苯甲酸钠0.002份;
其制备步骤为:
(1)取原料白参、红景天、土鳖虫、桑椹子、当归、女贞子用粉碎机粉碎,粉碎细度60目,得原料粉,备用;
(2)取原料蛤蚧、海龙、灵芝、杜仲、沙苑子、地龙、铁皮石斛、白花蛇、鸡血藤、甘草用粉碎机粉碎,粉碎细度80目,得原料粉,备用;
(3)取原料川乌、草乌、细辛、牛膝、防己、丝瓜络用粉碎机粉碎,粉碎细度100目,得原料粉,备用;
(4)将步骤(1)所得原料粉和步骤(2)所得原料粉和(3)所得原料粉加入原料总重量的12倍的水,浸泡0.5小时,加热蒸馏4小时,得蒸馏液,药渣加入原料总重量的8倍的水煎煮2次,时间为0.5小时,合并煎煮液和蒸馏液,过滤得滤液,滤液浓缩至85℃测相对密度为1.00的清膏,冷却后加入85%乙醇适量,搅匀,5℃冷藏20小时,过滤,滤液减压回收乙醇至无醇味,滤液浓缩至60℃相对密度为1.25的浸膏,备用;
(5)将步骤(4)中所得浸膏放入配液罐内,加入浸膏重量6倍量的纯化水加热至沸腾,搅拌15分钟,微沸腾保温10分钟,形成药液,放置,冷却至室温,备用;
(6)取甜菊糖、苯甲酸钠分别粉碎成600目,备用;
(7)将步骤(5)中所得药液加入粉碎后的甜菊糖、苯甲酸钠溶解搅拌,使药液混合均匀,搅拌15分钟后用离心机进行过滤,在60℃,20MPa条件下进行两次均质,再调节pH为7.0,得到配液,备用;
(8)将步骤(7)中所得配液用洁净的玻璃瓶分装,采用超高温瞬时灭菌,即得治疗风湿病的中药制剂。
本发明所用中药原料药的药理如下:
白参:性微温,味甘、苦,归心、脾、肺经;功能主治:大补元气,复脉固脱,补脾益肺,生津,安神;用于体虚欲脱,肢冷脉微,脾虚食少,肺虚喘咳,津伤口渴,内热消渴,久病虚羸,惊悸失眠,阳痿宫冷;心力衰竭,心原性休克。
红景天:性味:寒、甘、涩,归肺经,具有补气清肺、益智养心、收涩止血、散瘀消肿的功效;主气虚体弱,病后畏寒,气短乏力,肺热咳嗽,咯血,白带腹泻,跌打损伤,烫火伤,神经症,高原反应。
土鳖虫:性味归经:咸,寒,有小毒,归肝经;功能主治:破瘀血,续筋骨;用于筋骨折伤,瘀血经闭,癥瘕痞块。
桑椹子:性味:味甘,性寒,归经:入心、肝、肾经;功能:滋阴补血,明目生津,润肠;主治:久病体虚,肝肾阴亏,腰膝酸软,目暗耳鸣,关节不利,肠燥便秘,津亏血少,潮热遗精,糖尿病等。
当归:性味归经:甘、辛,温,归肝、心、脾经;功能主治:补血活血,调经止痛,润肠通便;用于血虚萎黄,眩晕心悸,月经不调,经闭痛经,虚寒腹痛,肠燥便秘,风湿痹痛,跌扑损伤,痈疽疮疡。
女贞子:性味归经:甘、苦,凉,归肝、肾经;功能主治:滋补肝肾,明目乌发;用于眩晕耳鸣,腰膝酸软,须发早白,目暗不明。
蛤蚧:性味归经:咸,平,归肺、肾经;功能主治:补肺益肾,纳气定喘,助阳益精;用于虚喘气促,劳嗽咳血,阳萎遗精。
海龙:性味:咸甘,温,归肝经,肾经;功效:温肾壮阳;功能主治:补肾壮阳,治阳痿。
灵芝:性味归经:甘,平,归心、肺、肝、肾经;主治虚劳、咳嗽、气喘、失眠、消化不良,恶性肿瘤等。
杜仲:性味归经:甘,温,归肝、肾经;功能主治:补肝肾,强筋骨,安胎;用于肾虚腰痛,筋骨无力,妊娠漏血,胎动不安;高血压。
沙苑子:性味归经:甘,温,归肝、肾经;功效:温补肝肾,固精,缩尿,明目;用于肾虚腰痛,遗精早泄,白浊带下,小便余沥,眩晕目昏。
地龙:性味归经:咸,寒,归肝、脾、膀胱经;功能主治:清热定惊,通络,平喘,利尿;用于高热神昏,惊痫抽搐,关节痹痛,肢体麻木,半身不遂,肺热喘咳,尿少水肿,高血压。
铁皮石斛:性味归经:甘,微寒,归胃、肾经;功能主治:益胃生津,滋阴清热;用于阴伤津亏,口干烦渴,食少干呕,病后虚热,目暗不明。
白花蛇:性味归经:甘、咸,温;有毒,归肝经;功效:祛风湿,透筋骨,定惊搐;功能主治:祛风,通络,止痉;用于风湿顽痹,麻木拘挛,中风口歪,半身不遂,抽搐痉挛,破伤风,麻风疥癣,瘰疬恶疮。
鸡血藤:性味归经:苦、甘,温,归肝、肾经;功能主治:补血,活血,通络;用于月经不调,血虚萎黄,麻木瘫痪,风湿痹痛。
甘草:性平、味甘,归心、脾、肺、胃经;功效:补益;功能主治:补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药;用于脾胃虚弱,倦怠乏力,心悸气短,咳嗽痰多,脘腹、四肢挛急疼痛,痈肿疮毒,缓解药物毒性、烈性。
川乌:性味归经:辛、苦,热;有大毒,归心、肝、肾、脾经;功能主治:祛风除湿,温经止痛;用于风寒湿痹,关节疼痛,心腹冷痛,寒疝作痛,麻醉止痛。
草乌:性味归经:辛、苦,热;有大毒,归心、肝、肾、脾经;功能主治:祛风除湿,温经止痛;用于风寒湿痹,关节疼痛,心腹冷痛,寒疝作痛,麻醉止痛。
细辛:性味归经:辛,温,归心、肺、肾经;功能主治:祛风散寒,通窍止痛,温肺化饮;用于风寒感冒,头痛,牙痛,鼻塞鼻渊,风湿痹痛,痰饮喘咳。
牛膝:性味归经:苦、酸,平,归肝、肾经;功能主治:补肝肾,强筋骨,逐瘀通经,引血下行;用于腰膝酸痛,筋骨无力,经闭徵瘕,肝阳眩晕。
防己:性味归经:苦,寒,归膀胱、肺经;功能主治:利水消肿,祛风止痛;用于水肿脚气,小便不利,湿疹疮毒,风湿痹痛;高血压。
丝瓜络:性味:味甘,性平,归胃,肺,肝经;功能:有祛风,通络,活血,下乳的功效;主治:用于治疗痹痛拘挛、胸胁胀痛、乳汁不通,乳痈肿痛。
本发明的有益效果:具有祛风湿、活络、补肾的功效,药效显著,可以长期服用,患者易于接受。
具体实施方式
下面结合实施例和实验例详细说明本发明的技术方案,但保护范围不限于此。
实施例1
一种治疗风湿病的中药制剂,由以下重量份的原料制成:白参400份、红景天400份、土鳖虫400份、桑椹子400份、当归600份、女贞子600份、蛤蚧150份、海龙150份、灵芝500份、杜仲500份、沙苑子500份、地龙500份、铁皮石斛150份、白花蛇150份、鸡血藤900份、甘草400份、川乌200份、草乌200份、细辛300份、牛膝150份、防己150份、丝瓜络400份、甜菊糖0.002份、苯甲酸钠0.003份;
其制备步骤为:
(1)取原料白参、红景天、土鳖虫、桑椹子、当归、女贞子用粉碎机粉碎,粉碎细度60-80目,得原料粉,备用;
(2)取原料蛤蚧、海龙、灵芝、杜仲、沙苑子、地龙、铁皮石斛、白花蛇、鸡血藤、甘草用粉碎机粉碎,粉碎细度80-100目,得原料粉,备用;
(3)取原料川乌、草乌、细辛、牛膝、防己、丝瓜络用粉碎机粉碎,粉碎细度100-120目,得原料粉,备用;
(4)将步骤(1)所得原料粉和步骤(2)所得原料粉和(3)所得原料粉加入原料总重量的8-12倍的水,浸泡0.5-2小时,加热蒸馏2-6小时,得蒸馏液,药渣加入原料总重量的4-8倍的水煎煮1-2次,时间为0.4-0.8小时,合并煎煮液和蒸馏液,过滤得滤液,滤液浓缩至85-95℃测相对密度为1.00-1.05的清膏,冷却后加入85-95%乙醇适量,搅匀,0至6℃冷藏20-30小时,过滤,滤液减压回收乙醇至无醇味,滤液浓缩至50-60℃相对密度为1.15-1.25的浸膏,备用;
(5)将步骤(4)中所得浸膏放入配液罐内,加入浸膏重量3-6倍量的纯化水加热至沸腾,搅拌15-25分钟,微沸腾保温10-15分钟,形成药液,放置,冷却至室温,备用;
(6)取甜菊糖、苯甲酸钠分别粉碎成500-600目,备用;
(7)将步骤(5)中所得药液加入粉碎后的甜菊糖、苯甲酸钠溶解搅拌,使药液混合均匀,搅拌15-25分钟后用离心机进行过滤,在60-65℃,20-30MPa条件下进行两次均质,再调节pH为6.5-7.0,得到配液,备用;
(8)将步骤(7)中所得配液用洁净的玻璃瓶分装,采用超高温瞬时灭菌,即得治疗风湿病的中药制剂。
用法:口服,每日2次,每次15ml。
实施例2
一种治疗风湿病的中药制剂,由以下重量份的原料制成:白参300份、红景天300份、土鳖虫300份、桑椹子300份、当归500份、女贞子500份、蛤蚧100份、海龙100份、灵芝400份、杜仲400份、沙苑子400份、地龙400份、铁皮石斛100份、白花蛇100份、鸡血藤800份、甘草300份、川乌150份、草乌150份、细辛200份、牛膝100份、防己100份、丝瓜络300份、甜菊糖0.0015份、苯甲酸钠0.002份;
其制备步骤为:
(1)取原料白参、红景天、土鳖虫、桑椹子、当归、女贞子用粉碎机粉碎,粉碎细度60-80目,得原料粉,备用;
(2)取原料蛤蚧、海龙、灵芝、杜仲、沙苑子、地龙、铁皮石斛、白花蛇、鸡血藤、甘草用粉碎机粉碎,粉碎细度80-100目,得原料粉,备用;
(3)取原料川乌、草乌、细辛、牛膝、防己、丝瓜络用粉碎机粉碎,粉碎细度100-120目,得原料粉,备用;
(4)将步骤(1)所得原料粉和步骤(2)所得原料粉和(3)所得原料粉加入原料总重量的8-12倍的水,浸泡0.5-2小时,加热蒸馏2-6小时,得蒸馏液,药渣加入原料总重量的4-8倍的水煎煮1-2次,时间为0.4-0.8小时,合并煎煮液和蒸馏液,过滤得滤液,滤液浓缩至85-95℃测相对密度为1.00-1.05的清膏,冷却后加入85-95%乙醇适量,搅匀,0至6℃冷藏20-30小时,过滤,滤液减压回收乙醇至无醇味,滤液浓缩至50-60℃相对密度为1.15-1.25的浸膏,备用;
(5)将步骤(4)中所得浸膏放入配液罐内,加入浸膏重量3-6倍量的纯化水加热至沸腾,搅拌15-25分钟,微沸腾保温10-15分钟,形成药液,放置,冷却至室温,备用;
(6)取甜菊糖、苯甲酸钠分别粉碎成500-600目,备用;
(7)将步骤(5)中所得药液加入粉碎后的甜菊糖、苯甲酸钠溶解搅拌,使药液混合均匀,搅拌15-25分钟后用离心机进行过滤,在60-65℃,20-30MPa条件下进行两次均质,再调节pH为6.5-7.0,得到配液,备用;
(8)将步骤(7)中所得配液用洁净的玻璃瓶分装,采用超高温瞬时灭菌,即得治疗风湿病的中药制剂。
用法:口服,每日2次,每次15ml。
实施例3
一种治疗风湿病的中药制剂,由以下重量份的原料制成:白参200份、红景天200份、土鳖虫200份、桑椹子200份、当归400份、女贞子400份、蛤蚧50份、海龙50份、灵芝300份、杜仲300份、沙苑子300份、地龙300份、铁皮石斛50份、白花蛇50份、鸡血藤700份、甘草200份、川乌100份、草乌100份、细辛100份、牛膝50份、防己50份、丝瓜络200份、甜菊糖0.001份、苯甲酸钠0.001份;
其制备步骤为:
(1)取原料白参、红景天、土鳖虫、桑椹子、当归、女贞子用粉碎机粉碎,粉碎细度60-80目,得原料粉,备用;
(2)取原料蛤蚧、海龙、灵芝、杜仲、沙苑子、地龙、铁皮石斛、白花蛇、鸡血藤、甘草用粉碎机粉碎,粉碎细度80-100目,得原料粉,备用;
(3)取原料川乌、草乌、细辛、牛膝、防己、丝瓜络用粉碎机粉碎,粉碎细度100-120目,得原料粉,备用;
(4)将步骤(1)所得原料粉和步骤(2)所得原料粉和(3)所得原料粉加入原料总重量的8-12倍的水,浸泡0.5-2小时,加热蒸馏2-6小时,得蒸馏液,药渣加入原料总重量的4-8倍的水煎煮1-2次,时间为0.4-0.8小时,合并煎煮液和蒸馏液,过滤得滤液,滤液浓缩至85-95℃测相对密度为1.00-1.05的清膏,冷却后加入85-95%乙醇适量,搅匀,0至6℃冷藏20-30小时,过滤,滤液减压回收乙醇至无醇味,滤液浓缩至50-60℃相对密度为1.15-1.25的浸膏,备用;
(5)将步骤(4)中所得浸膏放入配液罐内,加入浸膏重量3-6倍量的纯化水加热至沸腾,搅拌15-25分钟,微沸腾保温10-15分钟,形成药液,放置,冷却至室温,备用;
(6)取甜菊糖、苯甲酸钠分别粉碎成500-600目,备用;
(7)将步骤(5)中所得药液加入粉碎后的甜菊糖、苯甲酸钠溶解搅拌,使药液混合均匀,搅拌15-25分钟后用离心机进行过滤,在60-65℃,20-30MPa条件下进行两次均质,再调节pH为6.5-7.0,得到配液,备用;
(8)将步骤(7)中所得配液用洁净的玻璃瓶分装,采用超高温瞬时灭菌,即得治疗风湿病的中药制剂。
用法:口服,每日2次,每次15ml。
本发明中药制剂治疗观察风湿病患者45例,临床报告如下:
1、一般资料
临床观察风湿病患者45例,其中男20例、女25例,年龄45-75岁,平均年龄60岁。
2、诊断标准
下面七项中符合四项就可以诊断是风湿病:
①晨僵至少一小时(>或=6周);②三个或三个以上关节肿(>或=6周);
③腕、掌指关节或近端指间关节肿(>或=6周);④对称性关节肿(>或=6周);⑤类风湿皮下结节;⑥手X线片改变(至少有骨质疏松和骨间隙的狭窄);
⑦类风湿因子阳性(滴度>1:32);
3、治疗方法
使用本发明中药制剂治疗,口服本发明中药制剂,每日2次,每次15ml,10天为一个疗程,疗程按照病的治疗快慢实际变化。
4、疗效评定
治愈:症状消失;
好转:临床症状减轻;
无效:临床症状无改善或加重。
5、治疗结果
临床治疗风湿病患者45例中,治愈27例占60%,好转15例占33.3%,无效3例占6.7%,总有效率为93.3%。
6、典型病例
病例1:女,45岁,因发热、游走性关节痛、出红斑3天,前6天开始发热、畏寒、体温达39.5℃,但不规则,伴全身疲乏,食欲减退、大量出汗和心慌,前5天出现双膝、踝关节发热、肿痛、行走困难,口服本发明中药制剂一个疗程,病人症状明显减轻,又口服中药制剂两个疗程,临床治愈。
病例2:男,66岁,3年前无明显诱因出现双足趾、双膝关节疼痛,渐出现周身关节肿痛,伴发热,四肢关节肿痛一个月加重伴发热,皮肤紫癜10余天,发病以来,精神倦怠、纳差、伴脱发,口服本发明中药制剂一个疗程,病人症状明显减轻,又口服中药制剂两个疗程,关节疼痛好转,又口服本发明中药制剂两个疗程,临床治愈。
病例3:女,69岁,因外伤诱发类风湿性关节炎,至今8年有余,期间曾辗转国内多家医院诊治,效果不见明显,四肢关节疼痛肿胀,情绪非常低落,口服本发明中药制剂一个疗程,病人症状明显减轻,又口服中药制剂两个疗程,关节疼痛好转,又口服本发明中药制剂三个疗程,临床治愈。
应当指出的是,具体实施方式只是本发明比较有代表性的例子,显然本发明的技术方案不限于上述实施例,还可以有很多变形;本领域的普通技术人员,以本发明所明确公开的或根据文件的书面描述毫无异议的得到的,均应认为是本专利所要保护的范围。
Claims (6)
1.一种治疗风湿病的中药制剂,其特征在于:由以下重量份的原料制成:白参200-400份、红景天200-400份、土鳖虫200-400份、桑椹子200-400份、当归400-600份、女贞子400-600份、蛤蚧50-150份、海龙50-150份、灵芝300-500份、杜仲300-500份、沙苑子300-500份、地龙300-500份、铁皮石斛50-150份、白花蛇50-150份、鸡血藤700-900份、甘草200-400份、川乌100-200份、草乌100-200份、细辛100-300份、牛膝50-150份、防己50-150、丝瓜络200-400份、甜菊糖0.001-0.002份、苯甲酸钠0.001-0.003份。
2.根据权利要求1所述的一种治疗风湿病的中药制剂的制备方法,其特征在于:其制备步骤为:
(1)取原料白参、红景天、土鳖虫、桑椹子、当归、女贞子用粉碎机粉碎,粉碎细度60-80目,得原料粉,备用;
(2)取原料蛤蚧、海龙、灵芝、杜仲、沙苑子、地龙、铁皮石斛、白花蛇、鸡血藤、甘草用粉碎机粉碎,粉碎细度80-100目,得原料粉,备用;
(3)取原料川乌、草乌、细辛、牛膝、防己、丝瓜络用粉碎机粉碎,粉碎细度100-120目,得原料粉,备用;
(4)将步骤(1)所得原料粉和步骤(2)所得原料粉和(3)所得原料粉加入原料总重量的8-12倍的水,浸泡0.5-2小时,加热蒸馏2-6小时,得蒸馏液,药渣加入原料总重量的4-8倍的水煎煮1-2次,时间为0.4-0.8小时,合并煎煮液和蒸馏液,过滤得滤液,滤液浓缩至85-95℃测相对密度为1.00-1.05的清膏,冷却后加入85-95%乙醇适量,搅匀,0至6℃冷藏20-30小时,过滤,滤液减压回收乙醇至无醇味,滤液浓缩至50-60℃相对密度为1.15-1.25的浸膏,备用;
(5)将步骤(4)中所得浸膏放入配液罐内,加入浸膏重量3-6倍量的纯化水加热至沸腾,搅拌15-25分钟,微沸腾保温10-15分钟,形成药液,放置,冷却至室温,备用;
(6)取甜菊糖、苯甲酸钠分别粉碎成500-600目,备用;
(7)将步骤(5)中所得药液加入粉碎后的甜菊糖、苯甲酸钠溶解搅拌,使药液混合均匀,搅拌15-25分钟后用离心机进行过滤,在60-65℃,20-30MPa条件下进行两次均质,再调节pH为6.5-7.0,得到配液,备用;
(8)将步骤(7)中所得配液用洁净的玻璃瓶分装,采用超高温瞬时灭菌,即得治疗风湿病的中药制剂。
3.根据权利要求2所述的一种治疗风湿病的中药制剂的制备方法,其特征在于:其制备步骤为:
(1)取原料白参、红景天、土鳖虫、桑椹子、当归、女贞子用粉碎机粉碎,粉碎细度60目,得原料粉,备用;
(2)取原料蛤蚧、海龙、灵芝、杜仲、沙苑子、地龙、铁皮石斛、白花蛇、鸡血藤、甘草用粉碎机粉碎,粉碎细度80目,得原料粉,备用;
(3)取原料川乌、草乌、细辛、牛膝、防己、丝瓜络用粉碎机粉碎,粉碎细度100目,得原料粉,备用;
(4)将步骤(1)所得原料粉和步骤(2)所得原料粉和(3)所得原料粉加入原料总重量的12倍的水,浸泡0.5小时,加热蒸馏4小时,得蒸馏液,药渣加入原料总重量的8倍的水煎煮2次,时间为0.5小时,合并煎煮液和蒸馏液,过滤得滤液,滤液浓缩至85℃测相对密度为1.00的清膏,冷却后加入85%乙醇适量,搅匀,5℃冷藏20小时,过滤,滤液减压回收乙醇至无醇味,滤液浓缩至60℃相对密度为1.25的浸膏,备用;
(5)将步骤(4)中所得浸膏放入配液罐内,加入浸膏重量6倍量的纯化水加热至沸腾,搅拌15分钟,微沸腾保温10分钟,形成药液,放置,冷却至室温,备用;
(6)取甜菊糖、苯甲酸钠分别粉碎成600目,备用;
(7)将步骤(5)中所得药液加入粉碎后的甜菊糖、苯甲酸钠溶解搅拌,使药液混合均匀,搅拌15分钟后用离心机进行过滤,在60℃,20MPa条件下进行两次均质,再调节pH为7.0,得到配液,备用;
(8)将步骤(7)中所得配液用洁净的玻璃瓶分装,采用超高温瞬时灭菌,即得治疗风湿病的中药制剂。
4.根据权利要求1所述的一种治疗风湿病的中药制剂,其特征在于:由以下重量份的原料制成:白参300份、红景天300份、土鳖虫300份、桑椹子300份、当归500份、女贞子500份、蛤蚧100份、海龙100份、灵芝400份、杜仲400份、沙苑子400份、地龙400份、铁皮石斛100份、白花蛇100份、鸡血藤800份、甘草300份、川乌150份、草乌150份、细辛200份、牛膝100份、防己100份、丝瓜络300份、甜菊糖0.0015份、苯甲酸钠0.002份。
5.根据权利要求1所述的一种治疗风湿病的中药制剂,其特征在于:由以下重量份的原料制成:白参400份、红景天400份、土鳖虫400份、桑椹子400份、当归600份、女贞子600份、蛤蚧150份、海龙150份、灵芝500份、杜仲500份、沙苑子500份、地龙500份、铁皮石斛150份、白花蛇150份、鸡血藤900份、甘草400份、川乌200份、草乌200份、细辛300份、牛膝150份、防己150份、丝瓜络400份、甜菊糖0.002份、苯甲酸钠0.003份。
6.根据权利要求1所述的一种治疗风湿病的中药制剂,其特征在于:由以下重量份的原料制成:白参200份、红景天200份、土鳖虫200份、桑椹子200份、当归400份、女贞子400份、蛤蚧50份、海龙50份、灵芝300份、杜仲300份、沙苑子300份、地龙300份、铁皮石斛50份、白花蛇50份、鸡血藤700份、甘草200份、川乌100份、草乌100份、细辛100份、牛膝50份、防己50份、丝瓜络200份、甜菊糖0.001份、苯甲酸钠0.001份。
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