CN106563110A - 一种治疗带状疱疹后遗神经痛的药物及制备方法 - Google Patents
一种治疗带状疱疹后遗神经痛的药物及制备方法 Download PDFInfo
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Abstract
本发明涉及医学及药物学领域,尤其涉及一种治疗带状疱疹后遗神经痛的药物及制备方法。本发明药物是由续断、杠板归、三七、大蒜、川芎、姜黄、草豆蔻、木香、刘寄奴、勒苋菜、红花、砂仁、白茅根、冰糖草、木芙蓉叶和七叶一枝花等结合传统中医药理论和最新药理学研究成果并利用现代工艺手段制备而成的口服制剂,优选胶囊、片剂和颗粒剂。经药效学实验研究表明,本发明药物对PHN具有理想的抑制作用,且本发明使用方便、安全性良好、不会产生药物依赖性;所有原料均来自天然药用植物,不含任何化学添加剂,长期服用安全、可靠,可从很大程度上提高患者的耐受性和依从性,从而为PHN患者的长期治疗提供了新选择方案,很适合目前临床需求。
Description
技术领域
本发明涉及医学及药物学领域,尤其涉及一种治疗带状疱疹后遗神经痛的药物及制备方法。
背景技术
带状疱疹是由水痘-带状疱疹病毒(varicella-zoster virus,VZV)引起的急性感染性皮肤病。带状疱疹病毒是一种嗜神经组织的疱疹病毒,通常是在患者儿童时期感染水痘时侵入感觉神经元,部分患者被感染后成为病毒携带者而不发生症状。由于该病毒具有亲神经性,感染后可长期潜伏于脊髓神经后根神经节的神经元内,当抵抗力低下或劳累、感染、感冒时,病毒可再次生长繁殖,并沿神经纤维移至皮肤,使受侵犯的神经和皮肤产生强烈的炎症,所引发的皮疹一般有单侧性和按神经节段分布的特点,由集簇性的疱疹组成,并伴有疼痛,年龄愈大,神经痛愈重。中医认为带状疱疹是因为肝胆火盛及脾湿郁久,外感毒邪而发。此病现代医学称为带状疱疹,民间称为蛇胆疮、缠腰龙等。
据报导,带状疱疹发病率为人群的1.4~4.8‰之间,约有20%的患者遗留有神经痛。50岁以上老年人是带状疱疹后遗神经痛的主要人群,约占受累人数的75%左右。在北美和欧洲地区,超过95%的青壮年呈VZV血清反应阳性,因此有患带状疱疹的风险,带状疱疹的年化发病率大约为3.4/1000;50岁以上人群中带状疱疹患病率陡然上升,到90岁年龄组患病率大约可达到11/1000。该病目前已成为医学界的疼痛难题,是中老年人健康潜在的杀手。
带状疱疹后遗神经痛(Postherpetic neuralgia,PHN)是最常见的带状疱疹慢性并发症,也是最常见的感染后神经痛类型。带状疱疹后遗神经痛是一种复合性神经病理性疼痛,这种疼痛是带状疱疹侵袭期外周神经持续损伤的直接结果,在带状疱疹急性期可观察到从皮肤至脊髓的神经组织都会发生病理性损伤。临床上认为带状疱疹皮损治愈后在原发疱疹部位出现的持续性的自发痛、轻触痛和感觉异常,且持续1个月以上者称为带状疱疹后遗神经痛,表现为局部阵发性或持续性的剧烈的顽固性疼痛,如灼痛、刺痛、跳痛、刀割痛、闪电痛、撕裂痛、摩擦痛、虫咬痛、紧痛、痒痛等,患者多有痛觉过敏和痛觉异常,风吹、轻触即可引起疼痛,而且疼痛可持续数周、数月甚至数年,严重影响患者的生活质量和身心健康,并可导致睡眠障碍、焦虑抑郁等精神症状。据报道带状疱疹患者中有9~18%发展为PHN,并且PHN的发生是年龄依赖性的:随年龄的增加发病率也增加,年龄大于60岁人群年龄组发病率明显增加。
带状疱疹后遗神经痛主要包括三种疼痛类型:1、激惹触痛型,临床表现以对痛觉超敏感为特征,轻轻的触摸即可产生剧烈的难以忍受的疼痛;2、痹痛型,临床表现以浅感觉减退和痛觉敏感为特征,触痛明显;3、中枢整合痛型,临床上可兼有以上两型的表现,由中枢继发性敏感化异常为主要特征,患者在就诊时将疼痛形象地描绘为火烧样痛、撕裂样痛、针刺样痛、刀割样痛、闪电样痛、绳索捆绑样绷紧痛等。
目前对于带状疱疹后遗神经痛的治疗手段虽多种多样,但都具有各自的优缺点,主要的治疗手段包括:神经阻滞疗法、封闭疗法、药物治疗等。其中神经阻滞疗法和封闭疗法虽然能够缓解疼痛,但需要阻断交感神经,而神经被破坏后将会带来一系列的不良反应,并加大后续治疗的难度。药物治疗包括西药治疗和中药治疗,其中西药治疗包括口服药物三环类抗抑郁药阿米替林、去甲替林、丙咪嗪、地昔帕明、马普替林,抗惊厥药加巴喷丁、普瑞巴林,阿片类药物羟考酮、吗啡、美沙酮、曲马多,以及新型药物A型肉毒素(BTX-A);外用药辣椒素乳膏;局部用药利多卡因,但长期应用上述药物会导致许多不良反应,轻微的如呼吸抑制、恶心、呕吐、嗜睡、眩晕、口干、便秘、瘙痒、红疹、皮炎、皮肤刺激、体重增加、外周水肿等,随着剂量的加大,还可导致心肌梗死、心律不齐、药物依赖性等严重的不良事件,从而在很大程度上降低了患者的耐受性和依从性;中药治疗包括多种复方制剂,主要由扶正祛邪、活血化瘀、疏通经络、托毒祛腐、清热解毒、补气活血的中药组成,通过改善创面周围组织的微循环、增加局部血流、促进残存上皮细胞组织生长,进而起到阻截病毒蔓延、修复神经的作用,但上述中药复方制剂往往存在着服用不便、疗效不确切等缺陷。
综上,因PHN的病理机制尚不清楚,目前的各种治疗方法在实施过程中都具有很大的局限性,因此,仍有相当多的患者病情得不到有效地控制。而PHN本身又疼痛剧烈,持续时间长,可达数月甚至数年,给患者带来了巨大的身心痛苦。鉴于此,临床上急需一种疗效确切、安全性好、不良反应少的新治疗药物。
本发明在广泛检索、大规模筛选、重复验证的基础上获得了一种治疗PHN的新药物。经试验,本发明药物对PHN具有理想的抑制作用,且本发明质量易控、使用方便、安全性良好、不会产生药物依赖性;本发明药物所有原料均来自天然药用植物,不含任何化学添加剂,长期服用安全、可靠;本发明为口服剂型,便于携带和服用,可从很大程度上提高患者的耐受性和依从性,因此,本发明药物非常适合目前的临床需求,本发明的推广应用将会具有良好的市场前景并产生可观的经济及社会效益。
发明内容
解决的技术问题
本发明需要解决的问题是:因PHN的病理机制尚不清楚,目前的各种治疗方法在实施过程中都具有很大的局限性,例如西药不良反应多、易产生药物依赖性、患者耐受性和依从性差,中药复方制剂难于质控、服用不便、疗效不确切等,现有药物存在的上述问题使得相当多的PHN患者病情得不到有效地控制。
技术方案
本发明旨在提供一种治疗带状疱疹后遗神经痛的疗效确切、安全性好、不良反应少的新药物及其制备方法。
本发明的治疗带状疱疹后遗神经痛的药物,其特征在于它是由下述重量配比的原料制成的:
上述原料的重量配比优选:
上述原料的重量配比还优选:
上述原料的重量配比还优选:
本发明治疗带状疱疹后遗神经痛的药物可以是任何常规的药物剂型,优选胶囊剂、片剂、颗粒剂。
本发明治疗带状疱疹后遗神经痛的药物胶囊剂可通过以下方法制备而成:
1)将续断、杠板归、三七、川芎、姜黄、草豆蔻、乳香、没药、莪术、木香、刘寄奴、独活、荆芥、威灵仙、白芍、勒苋菜、红花、砂仁、白茅根、天麻、千里光、桂枝、甘草、冰糖草、木芙蓉叶和七叶一枝花药材混合、水漂洗、干燥、粉碎后加8-12倍量水,浸泡1小时后,煎煮1-3小时,药液滤过,滤液备用,在相同条件下将药渣重复煎煮2-3次,合并滤液,减压浓缩至小体积后得到混合药材提取物浓缩液;
2)将新鲜大蒜除去外皮,水漂洗后榨汁,所得榨汁液经离心后上清液利用截流分子量为500-1000的超滤膜进行超滤,所得滤渣经冷冻干燥得大蒜汁冻干粉备用;所得滤液与上述混合药材提取物浓缩液合并后进行喷雾干燥,得喷雾干燥粉备用;
3)将上述各步骤制得的喷雾干燥粉和大蒜汁冻干粉混合,在搅拌机中充分混匀,制粒后过8-20目筛,干燥,用8-20目筛整粒,消毒后填充胶囊,包装,即得本药物胶囊剂;
本药物片剂和颗粒剂的制备方法为:步骤同上述1)、2)步,第3)步按本领域常规的制备片剂和颗粒剂的方法进行,制得本药物片剂和颗粒剂。
有益效果
本发明在广泛检索、大规模筛选、重复验证的基础上获得了一种治疗PHN的新药物。本发明治疗带状疱疹后遗神经痛的药物克服了现有的治疗药物中存在的一些不足,经试验,本发明药物对PHN具有理想的抑制作用,且本发明质量易控、使用方便、安全性良好、不会产生药物依赖性;本发明药物所有原料均来自天然药用植物,不含任何化学添加剂,长期服用安全、可靠;本发明为口服剂型,便于携带和服用,可从很大程度上提高患者的耐受性和依从性,从而为PHN患者的长期治疗提供了新选择方案;因此,本发明药物非常适合目前的临床需求,本发明的推广应用将会具有良好的市场前景并产生可观的经济及社会效益。
具体实施方式
以下通过特定的具体实例说明本发明的实施方式,本领域技术人员可由本说明书所揭露的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用,本说明书中的各项细节也可以基于不同观点与应用,在没有背离本发明的精神下进行各种修饰或改变。
在进一步描述本发明具体实施方式之前,应理解,本发明的保护范围不局限于下述特定的具体实施方案;还应当理解,本发明实施例中使用的术语是为了描述特定的具体实施方案,而不是为了限制本发明的保护范围;在本发明说明书和权利要求书中,除非文中另外明确指出,单数形式“一个”、“一”和“这个”包括复数形式。
当实施例给出数值范围时,应理解,除非本发明另有说明,每个数值范围的两个端点以及两个端点之间任何一个数值均可选用。除非另外定义,本发明中使用的所有技术和科学术语与本技术领域技术人员通常理解的意义相同。除实施例中使用的具体方法、设备、材料外,根据本技术领域的技术人员对现有技术的掌握及本发明的记载,还可以使用与本发明实施例中所述的方法、设备、材料相似或等同的现有技术的任何方法、设备和材料来实现本发明。
实施例1
一种治疗带状疱疹后遗神经痛的药物,本药物是由下述重量配比的原料制成的:
制备方法如下:
1)将续断、杠板归、三七、川芎、姜黄、草豆蔻、乳香、没药、莪术、木香、刘寄奴、独活、荆芥、威灵仙、白芍、勒苋菜、红花、砂仁、白茅根、天麻、千里光、桂枝、甘草、冰糖草、木芙蓉叶和七叶一枝花药材混合、水漂洗、干燥、粉碎后加8倍量水,浸泡1小时后,煎煮2小时,药液滤过,滤液备用,在相同条件下将药渣重复煎煮3次,合并滤液,减压浓缩至小体积后得到混合药材提取物浓缩液;
2)将新鲜大蒜除去外皮,水漂洗后榨汁,所得榨汁液经离心后上清液利用截流分子量为500的超滤膜进行超滤,所得滤渣经冷冻干燥得大蒜汁冻干粉备用;所得滤液与上述混合药材提取物浓缩液合并后进行喷雾干燥,得喷雾干燥粉备用;
3)将上述各步骤制得的喷雾干燥粉和大蒜汁冻干粉混合,在搅拌机中充分混匀,制粒后过12目筛,干燥,用14目筛整粒,消毒后填充胶囊,包装,即得本药物胶囊剂。
实施例2
一种治疗带状疱疹后遗神经痛的药物,本药物是由下述重量配比的原料制成的:
制备方法如下:
1)将续断、杠板归、三七、川芎、姜黄、草豆蔻、乳香、没药、莪术、木香、刘寄奴、独活、荆芥、威灵仙、白芍、勒苋菜、红花、砂仁、白茅根、天麻、千里光、桂枝、甘草、冰糖草、木芙蓉叶和七叶一枝花药材混合、水漂洗、干燥、粉碎后加10倍量水,浸泡1小时后,煎煮3小时,药液滤过,滤液备用,在相同条件下将药渣重复煎煮2次,合并滤液,减压浓缩至小体积后得到混合药材提取物浓缩液;
2)将新鲜大蒜除去外皮,水漂洗后榨汁,所得榨汁液经离心后上清液利用截流分子量为800的超滤膜进行超滤,所得滤渣经冷冻干燥得大蒜汁冻干粉备用;所得滤液与上述混合药材提取物浓缩液合并后进行喷雾干燥,得喷雾干燥粉备用;
3)将上述各步骤制得的喷雾干燥粉和大蒜汁冻干粉混合,在搅拌机中充分混匀,然后按本领域常规的片剂制备方法制得本药物片剂。
实施例3
一种治疗带状疱疹后遗神经痛的药物,本药物是由下述重量配比的原料制成的:
制备方法如下:
1)将续断、杠板归、三七、川芎、姜黄、草豆蔻、乳香、没药、莪术、木香、刘寄奴、独活、荆芥、威灵仙、白芍、勒苋菜、红花、砂仁、白茅根、天麻、千里光、桂枝、甘草、冰糖草、木芙蓉叶和七叶一枝花药材混合、水漂洗、干燥、粉碎后加12倍量水,浸泡1小时后,煎煮1小时,药液滤过,滤液备用,在相同条件下将药渣重复煎煮2次,合并滤液,减压浓缩至小体积后得到混合药材提取物浓缩液;
2)将新鲜大蒜除去外皮,水漂洗后榨汁,所得榨汁液经离心后上清液利用截流分子量为1000的超滤膜进行超滤,所得滤渣经冷冻干燥得大蒜汁冻干粉备用;所得滤液与上述混合药材提取物浓缩液合并后进行喷雾干燥,得喷雾干燥粉备用;
3)将上述各步骤制得的喷雾干燥粉和大蒜汁冻干粉混合,在搅拌机中充分混匀,然后按照本领域常规的颗粒剂制备方法制得本药物颗粒剂。
药效学资料
本试验目的是观察并验证本发明中药组合物(实施例2中的药物)对带状疱疹后遗神经痛的治疗效果。
本试验所用试剂如下:
1.受试药物:中药组合物;提供单位:自制;性状及理化性质:棕黄色粉末。
2.阳性药物:加巴喷丁胶囊;生产单位:江苏恩华药业股份有限公司,批号:F20140523。
3.造模剂:已感染VZV的CV-1细胞(非洲绿猴肾母纤维细胞);提供单位:中国医学科学院皮肤病研究所。
4.灭菌注射用水,生产单位:山东齐都药业有限公司,批号:2A14150503。
实验动物:
动物种属:Sprague-Dawley大鼠(SD大鼠)
动物性别:雄性
动物等级:SPF级
动物周龄:实际给药开始时动物6~8周龄。
动物体重:给药开始时动物体重为183~206g(♂),161~190g(♀);动物体重在该性别动物平均体重的80%~120%之间。
动物数:36只
实验动物来源:北京维通利华实验动物技术有限公司;实验动物生产许可证号:SCXK(京)2012-0001;实验动物质量合格证编号:11400700103783;生产许可证签发单位:北京市科学技术委员会。
实验动物选择的理由:本试验选用SD大鼠是药物非临床研究中使用的标准动物,具有大量的背景数据,遗传背景清楚,对药物的反应比较稳定,个体差异较小,饲养方便,体形较小,便于试验操作,节省供试品,并且在研究相同或类似供试品时发现是合适的动物模型,没有其他已知可替代活体动物实验的方法。
供试品配制:
配制时间和频率:给药当天进行供试品的配制,溶媒1周配制1次。
受试药物配制方法:以水分别配制成浓度为25.0mg/ml,50.0mg/ml的混悬液。
阳性药物配制方法:将胶囊内容物以水配制成浓度为25.0mg/ml的混悬液。
造模方法:
先将36只大鼠禁食12小时,然后在每只大鼠左趾璞处皮下注射已感染VZV的CV-1细胞液0.1ml,从注射次日起观察大鼠缩爪阈值的变化,缩爪阈值由压力测痛仪测定。结果表明:所有大鼠的缩爪阈值于注射后第2天起开始持续下降,其中33只大鼠在注射后第12~14天时缩爪阈值降至较低水平并稳定于这一痛阈水平,说明此PHN模型已造模成功。
试验分组:
从33只造模成功的大鼠中选择体重相近的30只大鼠,随机分为3组(1~3组),即阳性对照组(以加巴喷丁混悬液灌胃)、供试品低剂量组(以中药组合物低剂量混悬液灌胃)、供试品高剂量组(以中药组合物高剂量混悬液灌胃)。
给药方法:
给药途径:口服灌胃给药。
给药频次和周期:每天给药2次,连续给药21天。
给药方式与剂量:低剂量组:125mg/kg体重,高剂量组:250mg/kg体重,均按0.1ml/10g体重给药,每日早晚称量体重后,分别给予供试品混悬液。阳性药组:125mg/kg体重,按0.1ml/10g体重给药,每日早晚称量体重后,分别给予加巴喷丁混悬液。
动物活体检测指标:
一般临床观察:包括但不限于死亡情况、精神状态、行为活动、发病、呼吸、分泌物、粪便以及饮食和饮水情况等。
详细临床观察:包括但不限于精神状态、行为活动、皮肤、被毛、眼睛、耳朵、鼻、腹部、外生殖器、肛门、四肢、足和呼吸。
体重:所有动物在接收后和分组前测定体重,并在动物濒死安乐死前测定体重。
缩爪阈值检测:
检测时间:造模前、首次给药前和首次给药后D4、D7、D14、D21。
检测方法:压力测痛仪测定。
测定数值:每次测定均重复测三次取平均值;造模前测定所有大鼠的缩爪阈值取平均值作为参考正常阈值。
试验结果:高、低剂量供试品组和阳性药组均表现出显著的抑制PHN作用,试验期间,各组动物缩爪阈值的改变主要表现为给药后D4、D7均明显升高,随着给药次数的增加,升高幅度降低,其中,D21低剂量组和阳性药组已接近正常阈值、高剂量组则已完全达到正常阈值。
表1各试验组动物给药前后缩爪阈值表
注:表中所示值为Mean±SD,n=10;
“*”表示与同组给药前相比较P≤0.05;
“**”表示与同组给药前相比较P≤0.001。
从各试验组动物给药前后缩爪阈值结果看,与给药前缩爪阈值相比,首次给药后D4、D7各组动物的缩爪阈值均明显升高,随着给药次数的增加,各组的阈值均保持着持续升高的趋势,但升高幅度有所降低,D21的测定结果表明,低剂量组和阳性药组的阈值已接近了造模前的参考正常阈值,而高剂量组则已完全达到并略高于参考正常阈值,但三个试验组之间并没有显著地统计学差异。
试验结论:
供试品高、低剂量组和阳性药组均具有显著的抑制PHN作用,主要表现在:分别以高、低剂量中药组合物、阳性药物给小鼠灌胃,连续给药21天,在给药4天后各组就表现出非常明显的抑制PHN作用,到给药7天时,各组动物的缩爪阈值均明显升高,继续给药时,缩爪阈值持续升高但升幅有所降低,待21天给药结束时,低剂量组和阳性药组的阈值已接近了造模前的参考正常阈值,而高剂量组则已完全达到并略高于参考正常阈值,各组的阈值与给药前阈值均具有极显著差异(P≤0.001),但三个试验组之间并没有显著地统计学差异。说明本中药组合物与阳性药加巴喷丁均具有显著的抑制PHN作用,其作用强度相仿,本中药组合物高剂量组作用略强于低剂量组。
临床试验
本试验目的是观察并验证本发明药物(实施例2中的药物)对带状疱疹后遗神经痛的治疗效果。
一、病例选择与分组
全部60例,随机分为治疗组和对照组,每组各30例。
两组年龄、性别、病程、临床表现及病情严重程度比较差异均无统计学意义(p>0.05)。
二、诊断依据及纳入标准
(1)年龄要求18-65周岁;
(2)近2年内曾有带状疱疹病史;
(3)神经痛症状持续时间大于1个月;
(4)试验前3天内未服用其他止痛药;
(5)无其他严重脏器疾病;
(6)同意参加本试验,并已签署知情同意书。
三、排除标准
(1)年龄在18周岁以下或65周岁以上者;
(2)妊娠期或哺乳期妇女;
(3)对加巴喷丁有过敏史,或过敏体质者;
(4)合并有心血管、肝、肾或造血系统等严重原发性疾病者;
(5)精神疾病患者。
四、治疗方法
治疗组:本发明药物(实施例2)制备的片剂,每次1.5克,每日3次,15天1疗程;
对照组:加巴喷丁,每次0.3g,每日3次,15天1疗程。
五、观测指标及疗效判定标准
观测指标:
临床指标:试验期间逐日观察临床症状、体征变化,并密切监测各种不良反应的发生时间、表现、程度、处理及结果。
实验室指标:试验前和停药后检查血、尿、便常规,肝、肾功能。
疗效评估分级:
根据临床症状、体征的总体改善程度分为四级:
痊愈:临床症状、体征均恢复正常;
显效:病情明显好转,但尚未完全恢复正常;
改善:病情有好转,但不够明显;
无效:病情无好转或加重者。
六、治疗结果
治疗组和对照组分别治疗15天后,临床疗效统计结果参见下表2。从表2中可以看出,采用本发明药物治疗带状疱疹后遗神经痛,其中痊愈病例数、显效病例数和总有效率均高于对照药加巴喷丁,从而证明利用本发明药物治疗带状疱疹后遗神经痛可以比使用加巴喷丁获得更理想的治疗效果,而且其服用安全性也有了显著的提高。
表2治疗组与对照组治疗15天后疗效对照表
组别 | 例数 | 痊愈 | 显效 | 改善 | 无效 | 总有效率 |
治疗组 | 30 | 10 | 10 | 7 | 3 | 90.0% |
对照组 | 30 | 9 | 6 | 8 | 7 | 76.7% |
典型病例
男59岁,十余年前患带状疱疹,后屡次复发,约一年前复发治愈后在原发疱疹部位出现持续性的触痛,表现为局部阵发性的灼痛、摩擦痛,疼痛剧烈,轻触即可引起疼痛,疼痛持续近半年,期间曾服用多种止痛药物,效果均不理想,停药后疼痛依旧,后期睡眠、情绪、精神状态均受到严重影响。在服用了本发明药物2周后,疼痛明显缓解,睡眠、精神好转,继续服药2周,疼痛感完全消失,停药后随访半年,未再出现疼痛症状,健康状况也得到了明显改善。
以上对本发明优选的具体实施方式和实施例作了详细说明,但是本发明并不限于上述实施方式和实施例,在本领域技术人员所具备的知识范围内,还可以在不脱离本发明构思的前提下作出各种变化。
Claims (6)
1.一种治疗带状疱疹后遗神经痛的药物,其特征在于它是由下述重量配比的原料制成的:
2.如权利要求1所述的治疗带状疱疹后遗神经痛的药物,其中各原料的重量配比是:
3.如权利要求1所述的治疗带状疱疹后遗神经痛的药物,其中各原料的重量配比是:
4.如权利要求1所述的治疗带状疱疹后遗神经痛的药物,其中各原料的重量配比是:
5.如权利要求1-4任一项所述的治疗带状疱疹后遗神经痛的药物,其特征在于所述药物为胶囊剂、片剂或颗粒剂。
6.权利要求5所述治疗带状疱疹后遗神经痛的药物的制备方法,其特征在于包括以下步骤:
1)将续断、杠板归、三七、川芎、姜黄、草豆蔻、乳香、没药、莪术、木香、刘寄奴、独活、荆芥、威灵仙、白芍、勒苋菜、红花、砂仁、白茅根、天麻、千里光、桂枝、甘草、冰糖草、木芙蓉叶和七叶一枝花药材混合、水漂洗、干燥、粉碎后加8-12倍量水,浸泡1小时后,煎煮1-3小时,药液滤过,滤液备用,在相同条件下将药渣重复煎煮2-3次,合并滤液,减压浓缩至小体积后得到混合药材提取物浓缩液;
2)将新鲜大蒜除去外皮,水漂洗后榨汁,所得榨汁液经离心后上清液利用截流分子量为500-1000的超滤膜进行超滤,所得滤渣经冷冻干燥得大蒜汁冻干粉备用;所得滤液与上述混合药材提取物浓缩液合并后进行喷雾干燥,得喷雾干燥粉备用;
3)将上述各步骤制得的喷雾干燥粉和大蒜汁冻干粉混合,在搅拌机中充分混匀,制粒后过8-20目筛,干燥,用8-20目筛整粒,消毒后填充胶囊,包装,即得本药物胶囊剂;
本药物片剂和颗粒剂的制备方法为:步骤同上述1)、2)步,第3)步按本领域常规的制备片剂和颗粒剂的方法进行,制得本药物片剂和颗粒剂。
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