CN104435154A - 治疗高血压ⅰ期的中药制剂及制法 - Google Patents
治疗高血压ⅰ期的中药制剂及制法 Download PDFInfo
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Abstract
本发明公开了一种治疗高血压Ⅰ期的中药制剂及制法,取下述重量配比的主要原料药制备而成:柴胡6-15,长春花5-10,黄芩8-16,代赭石4-8,党参10-16,荷叶10-20,茯苓9-16,生龙骨9-16,徐长卿6-10,生牡蛎9-16,广玉兰6-12,酒大黄7-13。本发明标本兼治、安全无毒副作用、不会产生依赖性、不反弹。
Description
技术领域
本发明涉及中医中药领域,特别是涉及一种治疗高血压Ⅰ期的中药制剂及制法。
背景技术
高血压定义为收缩压≥140mmHg和(或)舒张压≥90mmHg,根据血压升高水平,又进一步将高血压分为1~3级。1级高血压(轻度)收缩压140~159和/或舒张压90~99;2级高血压(中度)收缩压160~179和/或舒张压100~109;3级高血压(重度)收缩压≥180和/或舒张压≥140mmHg。收缩压≥140mmHg和舒张压<90mmHg单列为单纯性收缩期高血压。从医学上来说,高血压分为原发性和继发性两大类。高血压是常见的心血管疾病,以体循环动脉血压持续性增高为主要表现的临床综合征。继发性高血压是继发于肾、内分泌和神经系统疾病的高血压,多为暂时的,在原发的疾病治疗好了以后,高血压就会慢慢消失。病因:1、遗传因素。大约半数高血压患者有家族史。2、环境因素。3、其他:(1)体重:肥胖者发病率高。(2)避孕药。(3)睡眠呼吸暂停低通气综合征。(4)年龄:发病率着随年龄增长而增高的趋势,40岁以上者发病率高。(5)饮食:摄入食盐多者,高血压发病率高。高血压临床表现:1、头疼:部位多在后脑,并伴有恶心、呕吐等症状。若经常感到头痛,而且很剧烈,同时又恶心作呕,就可能是向恶性高血压转化的信号。2、眩晕:女性患者出现较多,可能会在突然蹲下或起立时有所感觉。3、耳鸣:双耳耳鸣,持续时间较长。4、心悸气短:高血压会导致心肌肥厚、心脏扩大、心肌梗死、心功能不全。这些都是导致心悸气短的症状。5、失眠:多为入睡困难、早醒、睡眠不踏实、易做噩梦、易惊醒。这与大脑皮质功能紊乱及自主神经功能失调有关。6、肢体麻木:常见手指、脚趾麻木或皮肤如蚁行感,手指不灵活。身体其他部位也可能出现麻木,还可能感觉异常,甚至半身不遂。
治疗:1.治疗目的及原则。降压治疗的最终目的是减少高血压患者心、脑血管病的发生率和死亡率。降压治疗应该确立血压控制目标值。另一方面,高血压常常与其他心、脑血管病的危险因素合并存在,例如高胆固醇血症、肥胖、糖尿病等,协同加重心血管疾病危险,治疗措施应该是综合性的。(1)改善生活行为:①减轻体重。②减少钠盐摄入。③补充钙和钾盐。④减少脂肪摄入。⑤增加运动。⑥戒烟、限制饮酒。(2)血压控制标准个体化:由于病因不同,高血压发病机制不尽相同,临床用药分别对待,选择最合适药物和剂量,以获得最佳疗效。(3)多重心血管危险因素协同控制:降压治疗后尽管血压控制在正常范围,血压升高以外的多种危险因素依然对预后产生重要影响。2.降压药物治疗。(1)降压药物种类:①利尿药。②β受体阻滞剂。③钙通道阻滞剂。④血管紧张素转换酶抑制剂。⑤血管紧张素II受体阻滞剂。(2)治疗方案:大多数无并发症或合并症患者可以单独或者联合使用噻嗪类利尿剂、β受体阻滞剂等。治疗应从小剂量开始,逐步递增剂量。临床实际使用时,患者心血管危险因素状况、靶器官损害、并发症、合并症、降压疗效、不良反应等,都会影响降压药的选择。2级高血压患者在开始时就可以采用两种降压药物联合治疗。
申请公布号 CN 102106979 A(申请号 201110040799.3)的中国专利文献公开了一种治疗高血压的药物,该药物是由茨实、熟地、芦根、钩藤、天麻、地龙、白芷、白芍、枝子、元胡、金钱草、茯苓、竹叶、大黄、灯蕊、甘草、板蓝根、山楂按传统中药制备工艺配制而成。申请公布号 CN 103599394 A(申请号 201310504570.X)的中国专利文献公开了一种治疗高血压的中药,该组合物包括如下组分:重量份杜仲10~30,重量份川芎20~40,重量份泽泻20~40,重量份苍术20~40,重量份川断20~40,重量份山芋肉10~30,重量份钩藤5~15,重量份天麻5~15,重量份生黄芪40~80,重量份丹参10~30,重量份麦冬20~40,重量份太子参10~20。申请公布号 CN 102940787 A(申请号 201210445851.8)的中国专利文献公开了一种治疗高血压的中药,该中药包括熟地5-10g、罗布麻叶5-10g,三七参叶5-8g,柿叶5-8g,葛根10-15g,红景天10-15g,胶股蓝10-15g,荷叶5-8g,当归10-15g、白芍10-15g、川芎10-15g、黄芪10-15g、党参10-15g、白术10-15g、茯苓5-10g、山木香5-10g、怀山药10-20g、杜仲10-15g、木通10-15g、菊花5-10g,山楂5-10g、丹参10-15g、桑叶5-10g、天麻10-15g和银杏叶5-10g。
服用西药,是长久以来高血压患者的传统降压手法。但是,西药治标不治本,因为它无法抑制病情恶化,不仅不能阻断并发症,反而会加剧并发症的发生。这是因为,由降压药产生的大量的药物代谢毒素会沉积在血管壁上,服用越多沉积的也就越多,最终导致血管硬化、变薄、变脆;再加上降压药是通过强力扩张血管以达到快速降压的,因此必然使原本已经硬化的血管变得更加脆弱,而这将会严重地损害心、脑、肝、肾等重要的人体器官,并加剧并发症的发生,最终危及人的生命。而且使用这类药物存在副作用,长期使用会产生依赖性,易反弹。
发明内容
针对现有技术的不足,本发明的目的是提供一种治疗高血压Ⅰ期的中药制剂及其制备方法。本发明标本兼治、安全无毒副作用、不会产生依赖性、不反弹。
本发明的技术方案是:
治疗高血压Ⅰ期的中药制剂,取下述重量配比的主要原料药制备而成:柴胡6-15,长春花5-10,黄芩8-16,代赭石4-8,党参10-16,荷叶10-20,茯苓9-16,生龙骨9-16,徐长卿6-10,生牡蛎9-16,广玉兰6-12,酒大黄7-13。
治疗高血压Ⅰ期的中药制剂,优选的方案是,取下述重量配比的主要原料药制备而成:柴胡8-13,长春花6-9,黄芩10-14,代赭石5-7,党参12-14,荷叶13-17,茯苓11-14,生龙骨11-15,徐长卿7-9,生牡蛎11-14,广玉兰8-11,酒大黄8-11。
治疗高血压Ⅰ期的中药制剂,更加优选的方案是,取下述重量配比的主要原料药制备而成:柴胡12,长春花7,黄芩12,代赭石6,党参13,荷叶15,茯苓12,生龙骨13,徐长卿8,生牡蛎12,广玉兰9,酒大黄9。
本发明还提供了将上述治疗高血压Ⅰ期的中药制剂制成药学上可接受的汤剂、丸剂、散剂和颗粒剂的制备方法。
所述汤剂的制备方法是:
(1)将大黄切成块,用黄酒喷淋拌匀,每100g大黄用黄酒18-30g(优选每100g大黄用黄酒24g),闷润1.7-3.4小时(优选闷润2.8小时),放在锅中炒18-34分钟(优选放在锅中炒30分钟),取出,晾干,放入研钵中研磨,筛得酒大黄粉末;
(2)将代赭石、生龙骨和生牡蛎放入砂锅中,加水,加水量为3种药物总重量的2.5-4.2倍(优选加水量为3种药物总重量的3.2倍),先用武火煮至沸腾,后转文火煎煮58-78分钟(优选后转文火煎煮68分钟),滤出药液;
(3)将柴胡、长春花、黄芩、党参、茯苓、徐长卿和广玉兰7味中药加入到步骤(2)盛有药渣的砂锅中,加水,加水量为7种药物总重量的3.5-5.2倍(优选加水量为7种药物总重量的4.5倍),先用武火煮至沸腾,后转文火煎煮35-55分钟(优选后转文火煎煮45分钟),加入荷叶,继续煎煮12-18分钟(优选继续煎煮15分钟),趁热将药液滤出后,将药渣用双层纱布包好,绞取药渣内剩余药液;
(4)合并三次药液,然后,将步骤(1)所得细粉加入即可。
所述丸剂的制备方法是:
(1)将大黄切成块,用黄酒喷淋拌匀,每100g大黄用黄酒18-30g(优选每100g大黄用黄酒24g),闷润1.7-3.4小时(优选闷润2.8小时),放在锅中炒18-34分钟(优选放在锅中炒30分钟),取出,晾干,放入研钵中研磨,过120-140目筛(优选过130目筛),得酒大黄粉末;
(2)将除酒大黄、代赭石、生龙骨和生牡蛎外的其余8味中药共研成末,过120-140目筛(优选过130目筛);
(3)将代赭石、生龙骨和生牡蛎放入砂锅中,加水,加水量为3种药物总重量的3.5-5.5倍(优选加水量为3种药物总重量的4.8倍),先用武火煮至沸腾,后转文火煎煮60-75分钟(优选后转文火煎煮70分钟),滤出药液,静置3.2-4.8小时(优选静置4.2小时),得滤液;
(4)将步骤(1)和步骤(2)所得细粉搅拌,充分混匀,用步骤(3)所得滤液泛丸,制得的每丸的重量为0.3-0.6g(优选制得的每丸的重量为0.5g),在63-73℃的温度下干燥(优选在67℃的温度下干燥),使丸剂含水量控制在8%以内,即得。
所述散剂的制备方法是:
(1)将大黄切成块,用黄酒喷淋拌匀,每100g大黄用黄酒18-30g(优选每100g大黄用黄酒24g),闷润1.7-3.4小时(优选闷润2.8小时),放在锅中炒18-34分钟(优选放在锅中炒30分钟),取出,晾干,放入研钵中研磨,过150-170目筛(优选过160目筛),得酒大黄粉末;
(2)将代赭石、生龙骨和生牡蛎共研成末,过150-170目筛(优选过160目筛);
(3)将荷叶研成细粉,过150-170目筛(优选过160目筛);
(4)将除代赭石、生龙骨、生牡蛎、荷叶和酒大黄外的其余7位中药材共研成末,过150-170目筛(优选过160目筛);
(5)将步骤(1)、步骤(2)、步骤(3)和步骤(4)所得细粉充分混匀,无菌封装,每包0.4g,即得。
所述颗粒剂的制备方法是:
(1)将大黄切成块,用黄酒喷淋拌匀,每100g大黄用黄酒18-30g(优选每100g大黄用黄酒24g),闷润1.7-3.4小时(优选闷润2.8小时),放在锅中炒18-34分钟(优选放在锅中炒30分钟),取出,晾干,放入研钵中研磨,过130-150目筛(优选过140目筛),得酒大黄粉末;
(2)将除大黄外的各原料药分别研成细粉,过130-150目筛(优选过140目筛);
(3)将步骤(1)和步骤(2)所得细粉与辅料淀粉置容器内充分混匀,加水制成软材;
(4)将步骤(3)所得软材以挤压方式通过15-19目筛网(优选将步骤(3)所得软材以挤压方式通过17目筛网),制成均匀的颗粒;
(5)将步骤(4)所得颗粒在62℃-72℃的温度下干燥(优选将步骤(4)所得颗粒在66℃的温度下干燥),颗粒的含水量控制在2%以内,即得。
本发明提供的治疗高血压Ⅰ期的中药制剂简便易于使用。除此之外,本发明的优良效果还表现在:
1、作用持久;
2、方便安全,且无毒副用,易于高血压病人接受;
3、服用次数少,标本兼治、不复发;
4、有养阴清热、平肝镇逆、补中益气、凉血止血、健脾宁心、重镇安神等功效,使脑有所养,肝有所平,从而达到肝养风熄、血压得降的目的。
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。
本发明所用主要中药原料的药理如下:
柴胡:基原:为伞形科植物柴胡或狭叶柴胡的干燥根。药性:苦,微寒。归肝、胆经。 功用主治:和解表里,疏肝,升阳。用于感冒发热,寒热往来,胸胁胀痛,月经不调,子宫脱垂,脱肛。
长春花:基原:为夹竹桃科长春花属植物长春花,黄长春花的全草。成分:长春花中含有吲哚类生物碱70余种,包含长春碱、长春新碱、洛柯定碱、洛柯辛碱、去乙酰文朵尼定碱、长春花碱、长春尼定、洛柯宁碱等。根含生物碱,包括帽柱木碱、阿枯米辛碱、长春西定、洛柯文碱、硫酸卡文辛碱、硫酸留绕西文碱,阿模楷灵碱、硫酸派绕生等。药理:1.抗肿瘤作用:长春花含有的长春碱、长春新碱、环氧长春碱、异长春碱具有明显的抗肿瘤作用。2.抗肿瘤作用机理:长春花抗肿瘤作用与药物对微管蛋白结合的高亲和力直接有关,抑制核酸合成是它的另一机制。3.降血压与扩血管作用:长春花总生物碱不论灌胃、肌注或静注对麻醉犬均有降压作用,还有扩张冠状血管的作用。4.降血糖和降血脂作用:本品叶的水提取物对正常或四氧嘧啶糖尿病兔和犬有降低血糖作用。药性:苦,寒,有毒。功用主治:解毒抗癌,清热平肝。主治多种癌肿,高血压病,痈肿疮毒,烫伤。
黄芩:基原:为唇形科植物黄芩的干燥根。药性:苦,寒。归肺、胆、脾、大肠、小肠经。功用主治:清热燥湿,泻火解毒,止血,安胎。用于湿温、暑温胸闷呕恶,湿热痞满,泻痢,黄疸,肺热咳嗽,高热烦渴,血热吐衄,痈肿疮毒,胎动不安。
代赭石:又名须丸、赤土、丁头代赭、血师、紫朱、赭石、土朱、铁朱、钉头赭石、钉赭石、赤赭石、红石头、代赭,为氧化物类矿物赤铁矿的矿石。主要成分:主要含三氧化二铁,亦含少量的钛、镁、铝、锰、钙、硅和水分。药性:苦甘,平。归肝、胃、心包经。功用主治:平肝镇逆,凉血止血。治噫气呕逆,噎膈反胃,哮喘,惊痫,吐血,鼻衄,肠风,痔瘘,崩漏带下。
党参:基原:为桔梗科植物党参、素花党参、或川党参等的干燥根。党参含甾醇类有:α-菠菜甾醇、豆甾醇、α-菠菜甾醇-β-D-葡萄糖甙、豆甾醇-β-D-葡萄糖甙、α-菠菜甾酮、豆甾酮等。糖和甙类有:菊糖、果糖、四种含果糖的杂多糖。丁香甙、β-D-吡喃葡萄糖己醇甙、α-D-呋喃果糖乙醇甙。生物碱及含氮成分有:胆碱、正丁基脲基甲酸酯、党参酸、5-羟基-2-羟甲基吡啶、烟碱。挥发性成分有:己酸、庚酸、辛酸、壬酸、十二酸、壬二酸、十四酸、十五酸、十六酸、十八酸、十八碳二烯酸、2,4-壬二烯酸、正十五烷、α-姜黄烯、正十七烷、正十八烷、正十九烷、正廿一烷、正廿二烷、十四酸甲酯、十五酸甲酯、十六酸甲酯、硬脂酸甲酯、十八碳二烯酸甲酯、蒎烯、十六酸乙酯、辛酸甲酯。 尚含三萜类及其他成分:蒲公英萜醇、乙酰蒲公英萜醇、木栓酮;苍术内酯Ⅱ、Ⅲ;丁香醛、香荚兰酸、2-呋喃羟酸酯、党参内酯、5-羟甲基糠醛、5-甲氧基糠醛。此外,亦含铁、锌、铜、锰等14种无机元素及天冬氨酸、苏氨酸、丝氨酸、谷氨酸等17种氨基酸药性:甘,平。归脾、肺经。功用主治:补中益气,健脾益肺。用于脾肺虚弱,气短心悸,食少便溏,虚喘咳嗽,内热消渴。
荷叶:基原:为睡莲科植物莲的干燥叶。药性:苦,平。归肝、脾、胃经。功用主治:清热解暑,升发清阳,凉血止血。用于多种出血症及产后血晕。
茯苓:基原:为多孔菌科真菌茯苓的干燥菌核。药性:甘、淡,平。归心、肺、脾、肾经。功用主治:利水渗湿,健脾宁心。用于水肿尿少,痰饮眩悸,脾虚食少,便溏泄泻,心神不安,惊悸失眠。
生龙骨:基原:为古代哺乳动物如象类、犀牛类、三趾马等的骨骼的化石。主要成分:主要为碳酸钙、磷酸钙,亦含铁、钾、钠、氯、硫酸根等。药性:甘涩,平。归心、肝、肾、大肠经。功用主治:重镇安神镇惊安神,敛汗固精,止血涩肠,生肌敛疮。治惊痫癫狂,怔忡健忘,失眠多梦,自汗盗汗,遗精淋浊,吐衄便血,崩漏带下,泻痢脱肛,溃疡久不收口。
徐长卿:基原:为萝藦科植物徐长卿的根及根茎或带根全草。化学成分:全草含牡丹酚约l%。又找出有与肉珊瑚甙元、去酚牛皮消甙元、茸毛牛 奶藤甙元和去酰萝甙元极为相似的物质以及醋酸 、桂皮酸等。根含黄酮甙、糖类、氨基酸、牡丹酚。含C21甾类化合物。水解产物中含肉珊瑚甙元、去乙酰萝藦甙元、去乙酰牛皮消甙元及托曼甙元,尚含D-加拿大麻糖、D-洋地黄毒糖、L-夹竹桃糖和D-沙门糖。另有报道含C21变形甾甙类化合物,由芫花叶白前甙元D和不同糖链成的徐长卿甙A,B,C及芫花叶白前甙元B所形成的白薇甙B。此外还含牡丹酚、异丹皮酚、硬脂酸癸酯、蜂花烷、十六烯、β-谷甾醇和D-赤丝草醇。药性:辛,温。①《本经》:“味辛,温。”②《别录》:“无毒。”功用主治:镇痛,止咳,利水消肿,活血解毒。治胃痛,牙痛,风湿疼痛,经期腹痛,慢性气管炎,腹水,水肿,痢疾,肠炎,跌打损伤,湿疹,荨麻疹,毒蛇咬伤。
生牡蛎:基原:为牡蛎科动物长牡蛎、大连湾牡蛎或近江牡蛎的贝壳。药性:咸,微寒。归肝、胆、肾经。功用主治:重镇安神,潜阳补阴,软坚散结,收敛固涩。用于惊悸失眠,眩晕耳鸣,瘰疬痰核,癥瘕痞块,自汗盗汗,遗精崩带,胃痛吞酸。
广玉兰:基原:为木兰科木兰属植物荷花玉兰的花和树皮。成分:皮部含生物碱:木兰花碱,白栝楼碱;糖苷类:广玉兰立定苷,广玉兰赖宁苷,广玉兰西丁苷,丁香苷,无梗五加苷B等。药性:《湖南药物志》:“微辛,温,无毒。”功用主治:祛风散寒,行气止痛。主治外感风寒,头痛鼻塞,脘腹胀痛,呕吐腹泻,高血压病,偏头痛。
大黄:基原:为家科植物掌叶大黄、唐古特大黄或药用大黄的干燥根及根茎。药性:苦,寒。归脾、胃、大肠、肝、心包经。功用主治:泻热通肠,凉血解毒,逐瘀通经。用于实热便秘,积滞腹痛,泻痢不爽,湿热黄值,血热吐衄,目赤,咽肿,肠痈腹痛,痈肿疗疮,瘀血经闭,跌扑损伤,外治水火烫伤;上消化道出血。酒大黄是属于大黄药材炮制品中的一种,将大黄切成块,用黄酒喷淋拌匀,闷润,放在锅中炒,取出,晾干,放入研钵中研磨,筛得酒大黄粉末。酒大黄善清上焦血分热毒。用于目赤咽肿.齿龈肿痛。注意孕妇及月经期、哺乳期慎用。
实施例1治疗高血压Ⅰ期的中药制剂,取下述重量份的主要原料药制备而成(每份为80g):柴胡6份,长春花5份,黄芩8份,代赭石4份,党参10份,荷叶10份,茯苓9份,生龙骨9份,徐长卿6份,生牡蛎9份,广玉兰6份,酒大黄7份。
上述治疗高血压Ⅰ期的中药制剂汤剂的制备方法是:
(1)将大黄切成块,用黄酒喷淋拌匀,每100g大黄用黄酒18g,闷润1.7小时,放在锅中炒18分钟,取出,晾干,放入研钵中研磨,筛得酒大黄粉末;
(2)将代赭石、生龙骨和生牡蛎放入砂锅中,加水,加水量为3种药物总重量的2.5倍,先用武火煮至沸腾,后转文火煎煮58分钟,滤出药液;
(3)将柴胡、长春花、黄芩、党参、茯苓、徐长卿和广玉兰7味中药加入到步骤(2)盛有药渣的砂锅中,加水,加水量为7种药物总重量的3.5倍,先用武火煮至沸腾,后转文火煎煮35分钟,加入荷叶,继续煎煮12分钟,趁热将药液滤出后,将药渣用双层纱布包好,绞取药渣内剩余药液;
(4)合并三次药液,然后,将步骤(1)所得细粉加入即可。
本发明汤剂使用方法:口服,每日两次,每次260mL(温热)。
实施例2治疗高血压Ⅰ期的中药制剂,取下述重量份的主要原料药制备而成(每份为80g):柴胡15份,长春花10份,黄芩16份,代赭石8份,党参16份,荷叶20份,茯苓16份,生龙骨16份,徐长卿10份,生牡蛎16份,广玉兰12份,酒大黄13份。
上述治疗高血压Ⅰ期的中药制剂丸剂的制备方法是:
(1)将大黄切成块,用黄酒喷淋拌匀,每100g大黄用黄酒24g,闷润2.8小时,放在锅中炒30分钟,取出,晾干,放入研钵中研磨,过130目筛,得酒大黄粉末;
(2)将除酒大黄、代赭石、生龙骨和生牡蛎外的其余8味中药共研成末,过130目筛;
(3)将代赭石、生龙骨和生牡蛎放入砂锅中,加水,加水量为3种药物总重量的4.8倍,先用武火煮至沸腾,后转文火煎煮70分钟,滤出药液,静置4.2小时,得滤液;
(4)将步骤(1)和步骤(2)所得细粉搅拌,充分混匀,用步骤(3)所得滤液泛丸,制得的每丸的重量为0.5g,在67℃的温度下干燥,使丸剂含水量控制在8%以内,即得。
典型病例一:王XX,女,47岁。既往有高血压病史7年,最高血压155/95mmHg,曾先后服过洛汀新、降压0号等药物治疗,血压一直控制不佳。2个月前,每天加用氨氯地平5 mg治疗,血压有波动,故来诊。血压:149/95 mmHg,各瓣膜听诊区未闻及杂音,心率76次/分,肝、脾未触及,双肾区无叩击痛,双下肢无水肿。血生化指标正常。尿常规正常。诊断为高血压病Ⅰ期。服用本实施例所得治疗高血压Ⅰ期的中药制剂丸剂,每日三次,每次8丸。服用6天,血压恢复至正常值。随访至今血压平稳,未反弹。
实施例3治疗高血压Ⅰ期的中药制剂,取下述重量份的主要原料药制备而成(每份为80g):柴胡8份,长春花6份,黄芩10份,代赭石5份,党参12份,荷叶13份,茯苓11份,生龙骨11份,徐长卿7份,生牡蛎11份,广玉兰8份,酒大黄8份。
上述治疗高血压Ⅰ期的中药制剂散剂的制备方法是:
(1)将大黄切成块,用黄酒喷淋拌匀,每100g大黄用黄酒24g,闷润2.8小时,放在锅中炒30分钟,取出,晾干,放入研钵中研磨,过160目筛,得酒大黄粉末;
(2)将代赭石、生龙骨和生牡蛎共研成末,过160目筛;
(3)将荷叶研成细粉,过160目筛;
(4)将除代赭石、生龙骨、生牡蛎、荷叶和酒大黄外的其余7位中药材共研成末,过160目筛;
(5)将步骤(1)、步骤(2)、步骤(3)和步骤(4)所得细粉充分混匀,无菌封装,每包0.4g,即得。
典型病例二:石XX,女,56岁。主诉:劳累后头痛3年,加重1周。现病史:3年前体检时发现血压偏高,收缩压150mmHg、舒张压95mmHg,无明显自觉症状,偶感劳累后头痛,无头晕、乏力、失眠、多梦等症状。3年来一直坚持药物治疗,口服络活喜5mg,每日1次,血压一直控制在130-145mmHg、舒张压85-95mmHg左右。患者体态偏胖,不喜欢活动,经常在外就餐,偶饮少量红葡萄酒,自发病以来未接受过正规的饮食指导,近1周来因连续加夜班,导致头疼加重求治。查T 37.5℃,BP 148/97mmHg。诊断为高血压病Ⅰ期。服用本实施例所得治疗高血压Ⅰ期的中药制剂散剂,每日两次,每次0.4g。服用3天,头痛症状明显减轻。继续服用5天,诸症消失,血压降至正常值。随访未反弹。
实施例4治疗高血压Ⅰ期的中药制剂,取下述重量份的主要原料药制备而成(每份为80g):柴胡13份,长春花9份,黄芩14份,代赭石7份,党参14份,荷叶17份,茯苓14份,生龙骨15份,徐长卿9份,生牡蛎14份,广玉兰11份,酒大黄11份。
上述治疗高血压Ⅰ期的中药制剂颗粒剂的制备方法是:
(1)将大黄切成块,用黄酒喷淋拌匀,每100g大黄用黄酒24g,闷润2.8小时,放在锅中炒30分钟,取出,晾干,放入研钵中研磨,过140目筛,得酒大黄粉末;
(2)将除大黄外的各原料药分别研成细粉,过140目筛;
(3)将步骤(1)和步骤(2)所得细粉与辅料淀粉置容器内充分混匀,加水制成软材;
(4)将步骤(3)所得软材以挤压方式通过17目筛网,制成均匀的颗粒;
(5)将步骤(4)所得颗粒在66℃的温度下干燥,颗粒的含水量控制在2%以内,即得。
典型病例三:丁XX,男,62岁。主诉:血压偏高10年,头晕、头痛两月余。血压偏高10年,并无其他体征,先后口服过尼莫地平片、得高宁片、阿司匹林肠溶片等,血压忽高忽低始终不稳。近来感觉头晕,目眩加重,故来就诊。查:T 37℃,BP 147/98mmHg。诊断为高血压病Ⅰ期。服用本实施例所得治疗高血压Ⅰ期的中药制剂颗粒剂,每日三次,每次10g。服用2天,头晕、头痛症状明显减轻。继续服用5天,诸症消失,血压恢复正常。随访未反弹。
实施例5治疗高血压Ⅰ期的中药制剂,取下述重量份的主要原料药制备而成(每份为80g):柴胡12份,长春花7份,黄芩12份,代赭石6份,党参13份,荷叶15份,茯苓12份,生龙骨13份,徐长卿8份,生牡蛎12份,广玉兰9份,酒大黄9份。
上述治疗高血压Ⅰ期的中药制剂汤剂的制备方法是:
(1)将大黄切成块,用黄酒喷淋拌匀,每100g大黄用黄酒24g,闷润2.8小时,放在锅中炒30分钟,取出,晾干,放入研钵中研磨,筛得酒大黄粉末;
(2)将代赭石、生龙骨和生牡蛎放入砂锅中,加水,加水量为3种药物总重量的3.2倍,先用武火煮至沸腾,后转文火煎煮68分钟,滤出药液;
(3)将柴胡、长春花、黄芩、党参、茯苓、徐长卿和广玉兰7味中药加入到步骤(2)盛有药渣的砂锅中,加水,加水量为7种药物总重量的4.5倍,先用武火煮至沸腾,后转文火煎45分钟,加入荷叶,继续煎煮15分钟,趁热将药液滤出后,将药渣用双层纱布包好,绞取药渣内剩余药液;
(4)合并三次药液,然后,将步骤(1)所得细粉加入即可。
试验例1 实施例5所得治疗高血压Ⅰ期的中药制剂的临床应用:2009年1月-2010年12月,在6所医院筛选288例高血压Ⅰ期患者,其中男158例,女130例,年龄34-72岁,平均年龄54.5岁。随机分为两组,实验组和对照组(每组144人)。实验组男80例,女性64例,年龄34-72岁,平均年龄54.5岁。对照组男78例,女性66例,年龄34-72岁,平均年龄54.5岁。以上两组患者在年龄结构、性别组成、疾病严重程度、患者一般情况等方面比较无显著性差异(P>0.05),病例资料具有可比性。实验组使用本实施例5所得产品,使用方法:口服,每日两次,每次260mL(温热)。对照组使用常规治疗高血压的药品(如美托洛尔、阿替洛尔、普萘洛尔、利尿剂和钙拮抗剂等)。 高血压疗效判定标准:治愈:服药后的血压恢复至正常值,临床症状全部消失;显效:服药后的血压比服药前降低,接近正常值,临床症状明显改善;无效:服药前后血压没有明显变化,临床症状无改善。总有效包括治愈和显效。治疗七天后,结果如表1所示。
表1:实施例5所得治疗高血压Ⅰ期的中药制剂效果验证
治疗效果:治愈100例(69.44%),显效40例(27.78%),无效4例(2.78%),总有效率97.22%。效果明显优于对照组。
本发明选择柴胡、长春花、黄芩和代赭石等进行配伍,制成治疗高血压Ⅰ期的中药制剂。方中柴胡和解表里,疏肝,升阳。长春花解毒抗癌,清热平肝。黄芩养阴清热。代赭石平肝镇逆,凉血止血。党参补中益气,健脾益肺。荷叶清热解暑,升发清阳,凉血止血。茯苓利水渗湿,健脾宁心。生龙骨重镇安神、镇惊安神,敛汗固精,止血涩肠,生肌敛疮。徐长卿镇痛,止咳,利水消肿,活血解毒。生牡蛎重镇安神,潜阳补阴,软坚散结,收敛固涩。广玉兰祛风散寒,行气止痛。酒大黄善清上焦血分热毒。诸药合用,有养阴清热、平肝镇逆、补中益气、凉血止血、健脾宁心、重镇安神等功效,对于治疗高血压Ⅰ期效果显著。
最后应说明的是,实施例只是本发明最优的具体实施方式而已,并不用于限制本发明,尽管参照前述实施例对本发明进行了详细的说明,对于本领域的技术人员来说,其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分技术特征进行等同替换。凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (10)
1.治疗高血压Ⅰ期的中药制剂,其特征在于,取下述重量配比的主要原料药制备而成:柴胡6-15,长春花5-10,黄芩8-16,代赭石4-8,党参10-16,荷叶10-20,茯苓9-16,生龙骨9-16,徐长卿6-10,生牡蛎9-16,广玉兰6-12,酒大黄7-13。
2.如权利要求1所述的治疗高血压Ⅰ期的中药制剂,其特征在于,取下述重量配比的主要原料药制备而成:柴胡8-13,长春花6-9,黄芩10-14,代赭石5-7,党参12-14,荷叶13-17,茯苓11-14,生龙骨11-15,徐长卿7-9,生牡蛎11-14,广玉兰8-11,酒大黄8-11。
3.如权利要求1所述的治疗高血压Ⅰ期的中药制剂,其特征在于,取下述重量配比的主要原料药制备而成:柴胡12,长春花7,黄芩12,代赭石6,党参13,荷叶15,茯苓12,生龙骨13,徐长卿8,生牡蛎12,广玉兰9,酒大黄9。
4.如权利要求1~3任一所述的治疗高血压Ⅰ期的中药制剂,其特征在于,将该治疗高血压Ⅰ期的中药制剂制成药学上可接受的汤剂,所述汤剂的制备方法是:
(1)将大黄切成块,用黄酒喷淋拌匀,每100g大黄用黄酒18-30g(优选每100g大黄用黄酒24g),闷润1.7-3.4小时(优选闷润2.8小时),放在锅中炒18-34分钟(优选放在锅中炒30分钟),取出,晾干,放入研钵中研磨,筛得酒大黄粉末;
(2)将代赭石、生龙骨和生牡蛎放入砂锅中,加水,加水量为3种药物总重量的2.5-4.2倍(优选加水量为3种药物总重量的3.2倍),先用武火煮至沸腾,后转文火煎煮58-78分钟(优选后转文火煎煮68分钟),滤出药液;
(3)将柴胡、长春花、黄芩、党参、茯苓、徐长卿和广玉兰7味中药加入到步骤(2)盛有药渣的砂锅中,加水,加水量为7种药物总重量的3.5-5.2倍(优选加水量为7种药物总重量的4.5倍),先用武火煮至沸腾,后转文火煎煮35-55分钟(优选后转文火煎煮45分钟),加入荷叶,继续煎煮12-18分钟(优选继续煎煮15分钟),趁热将药液滤出后,将药渣用双层纱布包好,绞取药渣内剩余药液;
(4)合并三次药液,然后,将步骤(1)所得细粉加入即可。
5.如权利要求1~3任一所述的治疗高血压Ⅰ期的中药制剂,其特征在于,将该治疗高血压Ⅰ期的中药制剂制成药学上可接受的丸剂,所述丸剂的制备方法是:
(1)将大黄切成块,用黄酒喷淋拌匀,每100g大黄用黄酒18-30g(优选每100g大黄用黄酒24g),闷润1.7-3.4小时(优选闷润2.8小时),放在锅中炒18-34分钟(优选放在锅中炒30分钟),取出,晾干,放入研钵中研磨,过120-140目筛(优选过130目筛),得酒大黄粉末;
(2)将除酒大黄、代赭石、生龙骨和生牡蛎外的其余8味中药共研成末,过120-140目筛(优选过130目筛);
(3)将代赭石、生龙骨和生牡蛎放入砂锅中,加水,加水量为3种药物总重量的3.5-5.5倍(优选加水量为3种药物总重量的4.8倍),先用武火煮至沸腾,后转文火煎煮60-75分钟(优选后转文火煎煮70分钟),滤出药液,静置3.2-4.8小时(优选静置4.2小时),得滤液;
(4)将步骤(1)和步骤(2)所得细粉搅拌,充分混匀,用步骤(3)所得滤液泛丸,制得的每丸的重量为0.3-0.6g(优选制得的每丸的重量为0.5g),在63-73℃的温度下干燥(优选在67℃的温度下干燥),使丸剂含水量控制在8%以内,即得。
6.如权利要求1~3任一所述的治疗高血压Ⅰ期的中药制剂,其特征在于,将该治疗高血压Ⅰ期的中药制剂制成药学上可接受的散剂,所述散剂的制备方法是:
(1)将大黄切成块,用黄酒喷淋拌匀,每100g大黄用黄酒18-30g(优选每100g大黄用黄酒24g),闷润1.7-3.4小时(优选闷润2.8小时),放在锅中炒18-34分钟(优选放在锅中炒30分钟),取出,晾干,放入研钵中研磨,过150-170目筛(优选过160目筛),得酒大黄粉末;
(2)将代赭石、生龙骨和生牡蛎共研成末,过150-170目筛(优选过160目筛);
(3)将荷叶研成细粉,过150-170目筛(优选过160目筛);
(4)将除代赭石、生龙骨、生牡蛎、荷叶和酒大黄外的其余7位中药材共研成末,过150-170目筛(优选过160目筛);
(5)将步骤(1)、步骤(2)、步骤(3)和步骤(4)所得细粉充分混匀,无菌封装,每包0.4g,即得。
7.如权利要求1~3任一所述的治疗高血压Ⅰ期的中药制剂,其特征在于,将该治疗高血压Ⅰ期的中药制剂制成药学上可接受的颗粒剂,所述颗粒剂的制备方法是:
(1)将大黄切成块,用黄酒喷淋拌匀,每100g大黄用黄酒18-30g,闷润1.7-3.4小时(优选闷润2.8小时),放在锅中炒18-34分钟(优选放在锅中炒30分钟),取出,晾干,放入研钵中研磨,过130-150目筛(优选过140目筛),得酒大黄粉末;
(2)将除大黄外的各原料药分别研成细粉,过130-150目筛(优选过140目筛);
(3)将步骤(1)和步骤(2)所得细粉与辅料淀粉置容器内充分混匀,加水制成软材;
(4)将步骤(3)所得软材以挤压方式通过15-19目筛网,制成均匀的颗粒;
(5)将步骤(4)所得颗粒在62℃-72℃的温度下干燥,颗粒的含水量控制在2%以内,即得。
8.如权利要求7所述的治疗高血压Ⅰ期的中药制剂的制备方法,其特征在于,步骤(1)中每100g大黄用黄酒24g。
9.如权利要求7所述的治疗高血压Ⅰ期的中药制剂的制备方法,其特征在于,步骤(4)中将步骤(3)所得软材以挤压方式通过17目筛网。
10.如权利要求7所述的治疗高血压Ⅰ期的中药制剂的制备方法,其特征在于,步骤(5)中优选将步骤(4)所得颗粒在66℃的温度下干燥。
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