CN104548043A - 一种治疗子宫肌瘤的中药制剂及其制备工艺 - Google Patents

一种治疗子宫肌瘤的中药制剂及其制备工艺 Download PDF

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CN104548043A
CN104548043A CN201510034536.XA CN201510034536A CN104548043A CN 104548043 A CN104548043 A CN 104548043A CN 201510034536 A CN201510034536 A CN 201510034536A CN 104548043 A CN104548043 A CN 104548043A
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段晓红
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Abstract

本发明公开了一种治疗子宫肌瘤的中药制剂,属于中医药技术领域。其由如下原料制得:当归、白术、干姜、熟地、茯苓、玄参、路路通、白芍、浙贝母、泽泻、全蝎、土鳖虫、蜈蚣、水蛭、香附、鬼箭羽、白花蛇舌草、牡蛎、枳壳、川断、甘草。与现有技术相比,发明中药制剂具有治疗效果好、不手术、标兼治、不易复发等治疗优势,并且其制备工艺简便易行、药效稳定、易于推广应用等技术优势。

Description

一种治疗子宫肌瘤的中药制剂及其制备工艺
技术领域
本发明涉及一种治疗子宫肌瘤的中药制剂,涉及中医药技术领域。
技术背景
子宫肌瘤是女性生殖器官中最常见的一种良性肿瘤,也是人体中最常见的肿瘤之一,又称为纤维肌瘤、子宫纤维瘤。由于子宫肌瘤主要是由子宫平滑肌细胞增生而成。
根据大量临床观察和实验结果表明子宫肌瘤是一种激素依赖性肿瘤。雌激素是促使肌瘤生长的主要因素,还有学者认为生长激素(GH)与肌瘤生长亦有关,GH能协同雌激素促进有丝分裂而促进肌瘤生长,并推测人胎盘催乳素(HPL)也能协同雌激素促有丝分裂作用,认为妊娠期子宫肌瘤生长加速除与妊娠期高激素环境有关外,可能HPL也参加了作用。
目前西医治疗子宫肌瘤多采用激素或手术的方法,副作用大并会给患者造成巨大创伤。
子宫肌瘤属于中医徵瘕范畴,“无瘀不成”,“气血不和,血瘀凝滞,以瘀成瘕”,故“坚者削之,客者除之,结者散之,留者攻之”。本病多由于郁怒伤肝,肝郁气滞,思虑伤脾,脾失健运,痰湿内蕴,以致肝脾痰气互结,瘀而成积块。现代医学研究表明,子宫肌瘤,慢性盆腔炎性包块,子宫内膜不规则脱之功血的发生均与体内分泌失调,免疫功能减退,代谢紊乱有关。故用活血化瘀,软坚散结法治疗子宫肌瘤有良效。
发明内容
本发明要解决的技术问题是开发一种对子宫肌瘤有较好治疗效果的中药组方,并利用现代制药技术将其开发成符合现代临床需要的成品制剂。
为了解决该技术问题,发明人将中药配伍理论、中医对子宫肌瘤的辨证认知和现代制药技术的特点综合起来,进行开发研究,并经过临床实验的调整和验证,最终发明一个全新的中药组方和其制备工艺,从临床试验的数据看对子宫肌瘤的治疗具有十分显著的效果。该中药组方为(以重量份计):
当归17-29份、白术8-20份、干姜8-18份、熟地16-28份、茯苓10-20份、玄参7-17份、路路通7-15份、白芍18-30份、浙贝母7-17份、泽泻7-19份、全蝎4-8份、土鳖虫4-6份、蜈蚣1-3份、水蛭4-7份、香附7-15份、鬼箭羽8-16份、白花蛇舌草10-22份、牡蛎20-32份、枳壳6-10份、川断8-18份、甘草9-15份。
从实践中总结出来的具有最佳疗效的3个优选配比为:
配比1:当归23份、白术14份、干姜13份、熟地22份、茯苓15份、玄参12份、路路通11份、白芍24份、浙贝母12份、泽泻13份、全蝎6份、土鳖虫5份、蜈蚣2份、水蛭5份、香附11份、鬼箭羽12份、白花蛇舌草16份、牡蛎26份、枳壳8份、川断13份、甘草12份。
配比2:当归25份、白术15份、干姜14份、熟地24份、茯苓14份、玄参13份、路路通12份、白芍23份、浙贝母11份、泽泻12份、全蝎5份、土鳖虫4份、蜈蚣2份、水蛭4份、香附10份、鬼箭羽14份、白花蛇舌草17份、牡蛎24份、枳壳7份、川断14份、甘草11份。
配比3:当归24份、白术16份、干姜12份、熟地21份、茯苓14份、玄参13份、路路通13份、白芍21份、浙贝母13份、泽泻12份、全蝎6份、土鳖虫6份、蜈蚣3份、水蛭6份、香附12份、鬼箭羽13份、白花蛇舌草15份、牡蛎28份、枳壳9份、川断14份、甘草13份。
将该组方做成成品制剂的制备工艺为以下步骤:
(1)按组方比例称取各味中药材,分别洗净,烘干,粉碎,备用;
(2)取当归、白术、枳壳、川断、甘草分别炒制,研磨,过120目筛,混合得细粉a,备用;
(3)取干姜、熟地、茯苓、玄参、路路通、白芍、浙贝母、泽泻、全蝎、土鳖虫、蜈蚣、水蛭、香附、鬼箭羽、白花蛇舌草、牡蛎,混合,加6-12倍的蒸馏水,浸泡8-16小时,回流煎煮3次,每次2-4小时,过滤,混合3次滤液,减压浓缩至65℃时所测相对密度为1.28-1.35,然后减压干燥得干浸膏,将干浸膏粉碎,研磨,过120目筛,得细粉b,备用;
(4)将细粉a、细粉b混合均匀,添加适当的辅料,利用现代通用的中药制剂技术制成临床所需求的剂型,如片剂、散剂、胶囊剂、颗粒剂、丸剂等剂型。
本发明所用中药材的来源、性味、归经及功效:
当归:本品为伞形科植物当归的干燥根。味甘、辛,性温;归肝、心、脾经;补血活血,调经止痛,润肠通便。
白术:本品为菊科植物白术的干燥根茎。味苦、甘,性温;归脾、胃经;健脾益气,燥湿利水,止汗,安胎。
干姜:本品为姜科植物姜的干燥根茎。味辛、性热;归脾、胃、肾、心、肺经;干姜温中散寒,回阳通脉,燥湿消痰。
熟地:本品为生地黄的炮制加工品。味甘,性微温;归肝、肾经;滋阴补血,益精填髓。
茯苓:本品为多孔菌科真菌茯苓的干燥菌核。味甘、淡,性平;归心、脾、肾经;渗湿利水、健脾和胃、宁心安神。
玄参:本品为玄参科植物玄参的干燥根。味甘、苦、咸,性微寒;归肺、胃、肾经;凉血滋阴,泻火解毒。
路路通:本品为金缕梅科植物枫香树的干燥成熟果序。味苦,性平;归肝、肾经;祛风活络,利水通经。
白芍:本品为毛茛科植物芍药的干燥根。味苦、酸,性微寒;归肝、脾经;平肝止痛,养血调经,敛阴止汗。
浙贝母:本品为百合科植物浙贝母的干燥鳞茎。味苦,性寒;归肺、心经;清热散结,化痰止咳。
泽泻:本品为泽泻科植物泽泻的干燥块茎。味甘,性寒;归肾、膀胱经;利小便,清湿热。
全蝎:本品为钳蝎科动物东亚钳蝎的干燥体。味辛,性平;归肝经;息风镇痉,攻毒散结,通络止痛。
土鳖虫:本品为鳖蠊科昆虫地鳖或冀地鳖的雌虫干燥体。捕捉后,置沸水中烫死,晒干或烘干。味咸,性寒;归肝经;破瘀血,续筋骨。
蜈蚣:本品为蜈蚣科动物少棘巨蜈蚣的干燥体。味辛,性温;归肝经;息风镇痉,功毒散结,通络止痛。
水蛭:本品为水蛭科动物蚂蟥、水蛭或柳叶蚂蟥的干燥体。味咸、苦,性平;归肝经;破血,逐瘀,通经。
香附:本品为莎草科植物莎草的干燥根茎。味辛、微苦、微甘,性平;归肝、脾、三焦经;行气解郁,调经止痛。
鬼箭羽:为卫矛科植物卫矛的具翅状物的枝条或翅状附属物。味苦,性寒;归肝经;破血通经;解毒消肿;杀虫。
白花蛇舌草:本品为茜草科耳草属植物白花蛇舌草的全草。味甘、淡,性凉;入胃、大肠、小肠经;清热解毒,利尿消肿,活血止痛。
牡蛎:本品为牡蛎科动物长牡蛎、大连湾牡蛎或近江牡蛎的贝壳。味咸,性微寒;归肝、胆、肾经;重镇安神,潜阳补阴,软坚散结。
枳壳:本品为芸香科植物酸橙及其栽培变种的干燥未成熟果实。味苦、辛、酸,性温;归脾、胃经。理气宽中,行滞消胀。
川断:本品为川续断科植物川续断的干燥根。味苦、辛,性微温;归肝、肾经;补肝肾,强筋骨,续折伤,止崩漏。
甘草:本品为豆科植物甘草、胀果甘草或光果甘草的干燥根。味甘,性平;归心、肺、脾、胃经;补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。
本发明中药组方的方解:
该中药组方是以当归、熟地、白芍、牡蛎、白花蛇舌草、茯苓为君药,活血调经、滋阴补血、软坚散结、清热解毒、渗湿利水;以白术、干姜、泽泻、鬼箭羽、川断为臣药,健脾益气、回阳通脉、解毒消肿、补肾止崩;以路路通、全蝎、土鳖虫、蜈蚣、水蛭为佐药,利水通经、攻毒散结、破血逐瘀、通络止痛;以玄参、浙贝母、香附、枳壳为使药,凉血滋阴、清热散结、行气解郁、行滞消胀;以甘草调和诸药性,使诸药阴阳和谐,调治结合,共同达到滋阴补血、软坚散结、解毒消肿、补肾止崩、攻毒散结、破血逐瘀、清热散结、行气解郁等功效,对子宫肌瘤具有十分显著的治疗效果。
与现有技术相比,本发明中药制剂具有治疗效果好、不手术、标本兼治、不易复发等治疗优势,并且其制备工艺简便易行、药效稳定、易于推广应用等技术优势。
具体实施方式
实施例1
按本发明中药组方的优选配比1的比例生产颗粒剂:
(1)按组方比例称取:当归2300g、白术1400g、干姜1300g、熟地2200g、茯苓1500g、玄参1200g、路路通1100g、白芍2400g、浙贝母1200g、泽泻1300g、全蝎600g、土鳖虫500g、蜈蚣200g、水蛭500g、香附1100g、鬼箭羽1200g、白花蛇舌草1600g、牡蛎2600g、枳壳800g、川断1300g、甘草1200g,分别洗净,烘干,粉碎,备用;
(2)取当归、白术、枳壳、川断、甘草分别炒制,研磨,过120目筛,混合得细粉a,备用;
(3)取干姜、熟地、茯苓、玄参、路路通、白芍、浙贝母、泽泻、全蝎、土鳖虫、蜈蚣、水蛭、香附、鬼箭羽、白花蛇舌草、牡蛎,混合,加9倍的蒸馏水,浸泡12小时,回流煎煮3次,每次3小时,过滤,混合3次滤液,减压浓缩至65℃时所测相对密度为1.28-1.35,然后减压干燥得干浸膏,将干浸膏粉碎,研磨,过120目筛,得细粉b,备用;
(4)将细粉a、细粉b混合均匀,添加适当的辅料,利用现代通用的中药制剂技术制成颗粒剂,规格:折合生药0.33g生药/g颗粒剂。
实施例2
按本发明中药组方的优选配比2的比例生产颗粒剂:
(1)按组方比例称取:当归2500g、白术1500g、干姜1400g、熟地2400g、茯苓1400g、玄参1300g、路路通1200g、白芍2300g、浙贝母1100g、泽泻1200g、全蝎500g、土鳖虫400g、蜈蚣200g、水蛭400g、香附1000g、鬼箭羽1400g、白花蛇舌草1700g、牡蛎2400g、枳壳700g、川断1400g、甘草1100g,分别洗净,烘干,粉碎,备用;
(2)取当归、白术、枳壳、川断、甘草分别炒制,研磨,过120目筛,混合得细粉a,备用;
(3)取干姜、熟地、茯苓、玄参、路路通、白芍、浙贝母、泽泻、全蝎、土鳖虫、蜈蚣、水蛭、香附、鬼箭羽、白花蛇舌草、牡蛎,混合,加9倍的蒸馏水,浸泡12小时,回流煎煮3次,每次3小时,过滤,混合3次滤液,减压浓缩至65℃时所测相对密度为1.28-1.35,然后减压干燥得干浸膏,将干浸膏粉碎,研磨,过120目筛,得细粉b,备用;
(4)将细粉a、细粉b混合均匀,添加适当的辅料,利用现代通用的中药制剂技术制成颗粒剂,规格:折合生药0.33g生药/g颗粒剂。
实施例3
按本发明中药组方的优选配比3的比例生产颗粒剂:
(1)按组方比例称取:当归2400g、白术1600g、干姜1200g、熟地2100g、茯苓1400g、玄参1300g、路路通1300g、白芍2100g、浙贝母1300g、泽泻1200g、全蝎600g、土鳖虫600g、蜈蚣300g、水蛭600g、香附1200g、鬼箭羽1300g、白花蛇舌草1500g、牡蛎2800g、枳壳900g、川断1400g、甘草1300g,分别洗净,烘干,粉碎,备用;
(2)取当归、白术、枳壳、川断、甘草分别炒制,研磨,过120目筛,混合得细粉a,备用;
(3)取干姜、熟地、茯苓、玄参、路路通、白芍、浙贝母、泽泻、全蝎、土鳖虫、蜈蚣、水蛭、香附、鬼箭羽、白花蛇舌草、牡蛎,混合,加9倍的蒸馏水,浸泡12小时,回流煎煮3次,每次3小时,过滤,混合3次滤液,减压浓缩至65℃时所测相对密度为1.28-1.35,然后减压干燥得干浸膏,将干浸膏粉碎,研磨,过120目筛,得细粉b,备用;
(4)将细粉a、细粉b混合均匀,添加适当的辅料,利用现代通用的中药制剂技术制成颗粒剂,规格:折合生药0.33g生药/g颗粒剂。
实施例4
按本发明中药组方的最小范围的比例生产颗粒剂:
(1)按组方比例称取:当归1700g、白术800g、干姜800g、熟地1600g、茯苓1000g、玄参700g、路路通700g、白芍1800g、浙贝母700g、泽泻700g、全蝎400g、土鳖虫400g、蜈蚣100g、水蛭400g、香附700g、鬼箭羽800g、白花蛇舌草1000g、牡蛎2000g、枳壳600g、川断800g、甘草900g,分别洗净,烘干,粉碎,备用;
(2)取当归、白术、枳壳、川断、甘草分别炒制,研磨,过120目筛,混合得细粉a,备用;
(3)取干姜、熟地、茯苓、玄参、路路通、白芍、浙贝母、泽泻、全蝎、土鳖虫、蜈蚣、水蛭、香附、鬼箭羽、白花蛇舌草、牡蛎,混合,加9倍的蒸馏水,浸泡12小时,回流煎煮3次,每次3小时,过滤,混合3次滤液,减压浓缩至65℃时所测相对密度为1.28-1.35,然后减压干燥得干浸膏,将干浸膏粉碎,研磨,过120目筛,得细粉b,备用;
(4)将细粉a、细粉b混合均匀,添加适当的辅料,利用现代通用的中药制剂技术制成颗粒剂,规格:折合生药0.33g生药/g颗粒剂。
实施例5
按本发明中药组方的最大范围的比例生产颗粒剂:
(1)按组方比例称取:当归2900g、白术2000g、干姜1800g、熟地2800g、茯苓2000g、玄参1700g、路路通1500g、白芍3000g、浙贝母1700g、泽泻1900g、全蝎800g、土鳖虫600g、蜈蚣300g、水蛭700g、香附1500g、鬼箭羽1600g、白花蛇舌草2200g、牡蛎3200g、枳壳1000g、川断1800g、甘草1500g,分别洗净,烘干,粉碎,备用;
(2)取当归、白术、枳壳、川断、甘草分别炒制,研磨,过120目筛,混合得细粉a,备用;
(3)取干姜、熟地、茯苓、玄参、路路通、白芍、浙贝母、泽泻、全蝎、土鳖虫、蜈蚣、水蛭、香附、鬼箭羽、白花蛇舌草、牡蛎,混合,加9倍的蒸馏水,浸泡12小时,回流煎煮3次,每次3小时,过滤,混合3次滤液,减压浓缩至65℃时所测相对密度为1.28-1.35,然后减压干燥得干浸膏,将干浸膏粉碎,研磨,过120目筛,得细粉b,备用;
(4)将细粉a、细粉b混合均匀,添加适当的辅料,利用现代通用的中药制剂技术制成颗粒剂,规格:折合生药0.33g生药/g颗粒剂。
实施例6
按本发明中药组方范围内的任一比例生产颗粒剂:
(1)按组方比例称取:当归1700g、白术2000g、干姜800g、熟地2800g、茯苓1000g、玄参1700g、路路通1500g、白芍1800g、浙贝母700g、泽泻1900g、全蝎400g、土鳖虫600g、蜈蚣100g、水蛭700g、香附700g、鬼箭羽1600g、白花蛇舌草1000g、牡蛎3200g、枳壳600g、川断1800g、甘草900g,分别洗净,烘干,粉碎,备用;
(2)取当归、白术、枳壳、川断、甘草分别炒制,研磨,过120目筛,混合得细粉a,备用;
(3)取干姜、熟地、茯苓、玄参、路路通、白芍、浙贝母、泽泻、全蝎、土鳖虫、蜈蚣、水蛭、香附、鬼箭羽、白花蛇舌草、牡蛎,混合,加9倍的蒸馏水,浸泡12小时,回流煎煮3次,每次3小时,过滤,混合3次滤液,减压浓缩至65℃时所测相对密度为1.28-1.35,然后减压干燥得干浸膏,将干浸膏粉碎,研磨,过120目筛,得细粉b,备用;
(4)将细粉a、细粉b混合均匀,添加适当的辅料,利用现代通用的中药制剂技术制成颗粒剂,规格:折合生药0.33g生药/g颗粒剂。
本发明中药制剂的动物毒性试验
1、急性毒性试验
(1)受试药物:本发明实施例1-6所制造的颗粒剂,加纯化水,调制成稀糊,备用。
(2)试验动物:昆明种小鼠,体重20g±5g,雌雄各半,雌性小鼠均无孕。
(3)小鼠灌胃本发明中药颗粒剂配制的稀糊,当灌胃剂量达到685.4g生药/kg剂量时,给药后小鼠出现轻微活动减少,2小时左右恢复正常,给药后连续观察7天,无一动物死亡,其全身状况、饮食、摄水、小便和体重增长均正常。
(4)试验结果表明:小鼠灌胃实施例1-6所制造的颗粒剂的最大给药量为685.4g生药/kg/d(LD50>685.4g生药/kg)。本发明的中药制剂每日临床用药总量为0.22g生药/kg/d;按体重计,小鼠灌胃A-F颗粒剂的耐受量为临床病人的3115.5倍。提示该药急性毒性极低,临床用药安全。
2、动物长期毒性试验
(1)受试药物:本发明实施例1-6所得中药颗粒剂,加纯化水,调制成稀糊,备用。
(2)试验动物:普通级SD大鼠,体重216g±12g,雌雄各半,雌性大鼠均无孕。
(3)方法与结果:
6种中药颗粒剂:均分为高、中、低三个剂量组,单位体重给药量分别为患者服用量的180、60、20倍;
将实验鼠随机分成19组,其中18组分别灌胃6种三个剂量的颗粒剂溶液,剩余一组灌胃生理盐水(患者服用量的20倍);所有19组均连续灌胃180天,观察动物全身毒性反应及严重程度,处死后按操作规程检查各部位,并进行血液学,ALT、BUN及心、肝、脾、肺、肾、胃等主要脏器的病理学检查;
经过长期喂食,19组大鼠均未出现毒性反应。发育良好。肉眼外观及主要脏器未见异常。外周血象及血清ALT、BUN与对照组比较无病理性改变。病理报告心、肝、脾、肺、肾、胃等均未有意义的改变,因此,认为经病理证实,6种中药颗粒剂对动物无慢性毒性表现。
通过以上两个毒性实验,证明本发明按实施例1-6制作的中药颗粒剂是安全的,无毒副作用的,可以被患者服用。
本发明临床效果试验
1、试验基本资料
此次临床试验的受试者均由某市人民医院提供,该市与2011年6月至2014年5月共收治子宫肌瘤患者731例,从中筛选出适合并且自愿参与本次临床试验的患者200例,这些患者年龄22-47岁,病程2-13年,将所有受试者按年龄、病情等平均分成4个组,使这4个组在统计学意义上具有可比性,每组50例,4个组分别编号为:对照组、试验1、试验2、试验3。
2、试验用药
对照药:桂枝茯苓胶囊,规格:0.31g*60粒,国药准字Z10950005,江苏康缘药业股份有限公司。
试验药:本发明实施例1-3所制造的颗粒剂,规格:折合生药0.33g生药/g颗粒剂。
3、试验方法
对照组患者口服桂枝茯苓胶囊,每日3次,每次3粒,经期停止服药;试验1-3组患者分别口服实施例1-3所制造颗粒剂,每日2次,每次20g,经期停止服药;4周为一个疗程,连续治疗3个疗程。
4、评价标准
试验前对每个患者进行B超检测,记录瘤体大小和数量,试验结束后重新检测检测瘤体大小和数量。
治愈:瘤体完全消失,月经恢复正常;
显效:月经正常,瘤体数量减少或瘤体缩小>0.5cm;
有效:临床症状消失或减轻,瘤体略有缩小或无变化;
无效:瘤体体积不变或增大,相关临床症状不变或者更加严重。
5、试验结果
试验结果统计分析如表1所示:
表1 试验结果统计分析表
6、试验结论
与对照组相比,试验组的平均治愈率为45.3%,是对照组的2.06倍;试验组的平均总有效率为95.3%,比对照组高13.3个百分点,且在显效的比较中试验组也显著占有优势。因此,本发明中药制剂与现有技术相比具有十分显著的技术优势,获得了新的、创造性的突破。

Claims (6)

1.一种治疗子宫肌瘤的中药制剂,其特征在于由如下重量份的原料制得:当归17-29份,白术8-20份,干姜8-18份,熟地16-28份,茯苓10-20份,玄参7-17份,路路通7-15份,白芍18-30份,浙贝母7-17份,泽泻7-19份,全蝎4-8份,土鳖虫4-6份,蜈蚣1-3份,水蛭4-7份,香附7-15份,鬼箭羽8-16份,白花蛇舌草10-22份,牡蛎20-32份,枳壳6-10份,川断8-18份,甘草9-15份。
2.如权利要求1所述的一种治疗子宫肌瘤的中药制剂,其特征在于由如下重量份的原料制得:当归23份,白术14份,干姜13份,熟地22份,茯苓15份,玄参12份,路路通11份,白芍24份,浙贝母12份,泽泻13份,全蝎6份,土鳖虫5份,蜈蚣2份,水蛭5份,香附11份,鬼箭羽12份,白花蛇舌草16份,牡蛎26份,枳壳8份,川断13份,甘草12份。
3.如权利要求1所述的一种治疗子宫肌瘤的中药制剂,其特征在于由如下重量份的原料制得:当归25份,白术15份,干姜14份,熟地24份,茯苓14份,玄参13份,路路通12份,白芍23份,浙贝母11份,泽泻12份,全蝎5份,土鳖虫4份,蜈蚣2份,水蛭4份,香附10份,鬼箭羽14份,白花蛇舌草17份,牡蛎24份,枳壳7份,川断14份,甘草11份。
4.如权利要求1所述的一种治疗子宫肌瘤的中药制剂,其特征在于由如下重量份的原料制得:当归24份,白术16份,干姜12份,熟地21份,茯苓14份,玄参13份,路路通13份,白芍21份,浙贝母13份,泽泻12份,全蝎6份,土鳖虫6份,蜈蚣3份,水蛭6份,香附12份,鬼箭羽13份,白花蛇舌草15份,牡蛎28份,枳壳9份,川断14份,甘草13份。
5.一种制备如权利要求1所述治疗子宫肌瘤的中药制剂的方法,其特征在于包括如下工艺步骤:
(1)按比例称取各味中药材,分别洗净,烘干,粉碎,备用;
(2)取当归、白术、枳壳、川断、甘草分别炒制,研磨,过120目筛,混合得细粉a,备用;
(3)取干姜、熟地、茯苓、玄参、路路通、白芍、浙贝母、泽泻、全蝎、土鳖虫、蜈蚣、水蛭、香附、鬼箭羽、白花蛇舌草、牡蛎,混合,加6-12倍的蒸馏水,浸泡8-16小时,回流煎煮3次,每次2-4小时,过滤,混合3次滤液,减压浓缩至65℃时所测相对密度为1.28-1.35,然后减压干燥得干浸膏,将干浸膏粉碎,研磨,过120目筛,得细粉b,备用;
(4)将细粉a、细粉b混合均匀,添加适当的辅料,利用现代通用的中药制剂技术制成临床所需求的剂型。
6.如权利要求1所述治疗子宫肌瘤的中药制剂,其特征在于:所述中药制剂为片剂、散剂、胶囊剂、颗粒剂或丸剂。
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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104887805A (zh) * 2015-07-06 2015-09-09 苗怡文 一种治疗骨结核的中药制剂及其制备方法
CN106074894A (zh) * 2016-06-17 2016-11-09 王玉云 一种结合超声介入治疗子宫肌瘤的中药及其制备方法

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102949698A (zh) * 2012-11-29 2013-03-06 广西东兴市创新特色医药科技发展有限公司 一种治疗子宫肌瘤的药物及其制备方法

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102949698A (zh) * 2012-11-29 2013-03-06 广西东兴市创新特色医药科技发展有限公司 一种治疗子宫肌瘤的药物及其制备方法

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104887805A (zh) * 2015-07-06 2015-09-09 苗怡文 一种治疗骨结核的中药制剂及其制备方法
CN106074894A (zh) * 2016-06-17 2016-11-09 王玉云 一种结合超声介入治疗子宫肌瘤的中药及其制备方法

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