CN115192673A - 一种治疗结节病的中药组合物及其制备方法 - Google Patents
一种治疗结节病的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗结节病的中药组合物,按照质量百分比由以下组份组成:三散草10.00%~27.56%、绞股蓝9.76%~24.59%、川蓼子7.50%~23.62%、三棱4.88%~16.39%、上甲5.00%~19.69%、白芥子4.76%~12.82%、合欢皮4.88%~16.39%、瓦楞子4.31%~12.71%、鸡内金2.44%~12.30%、水马1.44%~8.40%,以上各组份的质量百分比之和为100%;本发明还公开了该中药组合物的制备方法,即将上述成分经提取、浓缩、混合、干燥制得。该中药组合物疗效可靠、安全无毒,适合于结节病疗程长的用药特点,且可制备成便于患者服用的胶囊。
Description
技术领域
本发明属于中药技术领域,具体涉及一种治疗结节病的中药组合物,本发明还涉及该中药组合物的制备方法。
背景技术
结节病是一种非干酪样坏死性上皮细胞肉芽肿炎症性疾病,病因不明,身体任何器官均能受累,但以侵犯肺(肺结节)、甲状腺(甲状腺结节)等较为常见,结节病临床经过较为隐袭,且存在癌变风险,属于临床常见复杂病、疑难病,近年来发病率持续增加。
结节病患者需要定期随访和检查以观察结节的变化情况,但是,临床实践表明,对于结节病反复的影像学检查可能延误治疗时间和增加癌变风险,而无干预手段的随访也给患者造成了巨大心理压力和反复暗示。对于结节病患者,只有有效的消除结节病灶或控制结节不再进展才能彻底使患者消除恐惧和担忧而实现“临床治愈”。目前,对于结节病,现代医学主要采用药物干预和手术疗法,药物干预主要是采用口服激素、免疫调节和细胞毒等化学药物来控制或消除结节,但此类药物存在肝肾毒副作用大、胃肠道刺激、治标不治本、易于复发、患者耐受性低及难于长期给药的问题;手术疗法主要是通过传统手术或微创手术切除病灶来达到临床治愈的效果,但手术疗法存在指征严格、创伤大、并发症较多与易于复发的问题。
中医认为,结节病为有形之邪,为痰瘀相互搏凝结而成,中医根据实践经验提出了针对结节病的用药特点“积年陈疴,非旦夕速效可知矣”,指出其用药需要“久服丸药以缓图之,才能使峻药攻积而不伤正”,以达到“徐消默运”之效。因此开发一种疗效可靠、安全无毒、可长期服用的治疗结节病的中药组合物制剂,以满足对于日益增多的结节病的治疗,具有重要的临床应用价值和社会意义。
发明内容
本发明的目的是提供一种治疗结节病的中药组合物,该中药组合物对治疗结节病具有疗效可靠、安全无毒、可长期服用的特点。
本发明的另一目的是提供该中药组合物的制备方法。
本发明所采用的技术方案是,一种治疗结节病的中药组合物,按质量百分比由以下组份组成:三散草10.00%~27.56%,绞股蓝9.76%~24.59%,川蓼子7.50%~23.62%,三棱4.88%~16.39%,上甲5.00%~19.69%,白芥子4.76%~12.82%,合欢皮4.88%~16.39%,瓦楞子4.31%~12.71%,鸡内金2.44%~12.30%,水马1.44%~8.40%,各组份的质量百分比之和为100%。
本发明所采用的另一个技术方案是,一种治疗结节病的中药组合物的制备方法,包括以下步骤:
步骤1、按照质量百分比分别称取三散草10.00%~27.56%、绞股蓝9.76%~24.59%、川蓼子7.50%~23.62%、三棱4.88%~16.39%、上甲5.00%~19.69%、白芥子4.76%~12.82%、合欢皮4.88%~16.39%、瓦楞子4.31%~12.71%、鸡内金2.44%~12.30%、水马1.44%~8.40%,各组份的质量百分比之和为100%。
步骤2、将步骤1称取的上甲、瓦楞子、鸡内金、水马各组份混合,干燥,粉碎,过筛,得到生药粉;
步骤3、将步骤1称取的三散草、绞股蓝、川蓼子、三棱、白芥子、合欢皮各组份混合后加入6~8倍量80~90%乙醇,浸泡,回流提取1次,得到醇提取液和药渣,将醇提取液回收乙醇至无醇味,得到醇提物;在药渣中加入8~10倍量纯化水,煎煮提取2次,将分次提取液合并,得到水提取液,浓缩至清膏,得到水提物;
步骤4、将步骤2所得生药粉与步骤3所得醇提物、水提物混合均匀,干燥,即得所述治疗结节病的中药组合物。
本发明的特征还在于,
还包括将所述中药组合物进行微粉化粉碎,得到微粉化药粉,经质检合格后装入胶囊,即得治疗结节病的中药组合物胶囊。
步骤2中的干燥温度为60±5℃。
步骤2中的过筛筛网孔径为60目。
步骤3中醇提过程浸泡时长为45min,回流提取时长为60min/次;水提过程煎煮提取时长为30min/次。
步骤4中干燥温度为65±5℃。
微粉化药粉粒径为150~250μm。
本发明的有益效果是:
1、本发明用于治疗结节病的中药组合物具有“消痰化瘀、攻毒散结、扶正袪邪”的功效,通过促进变异细胞凋亡、抑制病灶部位血管与淋巴管新生、提高机体免疫机能与阻止正常细胞癌变等途径而对结节病有着良好的治疗作用。
2、本发明中药组合物的组成中三散草、绞股蓝和鸡内金,在发挥对结节病药效的同时还具有良好的解毒、保肝、益肾、养胃的作用,有效地保护了患者的肝肾功能和消化功能。
3、本发明可制备微粉化中药组合物胶囊,具有掩盖中药组合物不良口感、携带服用方便、载药量大、疗效可靠与安全无毒等优点,符合结节病用药周期长的特点,因而患者依从性较高,可坚持用药治疗,对于当代人群高发结节病的治疗具有积极作用。
具体实施方式
下面结合具体实施例对本发明进行详细说明。
本发明一种治疗结节病的中药组合物,按照质量百分比由以下组份组成:三散草10.00%~27.56%,绞股蓝9.76%~24.59%,川蓼子7.50%~23.62%,三棱4.88%~16.39%,上甲5.00%~19.69%,白芥子4.76%~12.82%,合欢皮4.88%~16.39%,瓦楞子4.31%~12.71%,鸡内金2.44%~12.30%,水马1.44%~8.40%,各组份的质量百分比之和为100%。
各组份在本发明中药组合物中的功能如下:
三散草,具有攻毒散结、解毒化痰的功效,如《中药组合物材手册》记载:“治颈上瘰疬结核”,《广西中药组合物志》记载:“去火化痰结,治痰火瘰疬”;现代药理研究表明三散草对多种肿瘤具有显著的抑制作用,还具有抑菌与良好的保肝作用,因此,可用于瘰疬痰核、疔疮、结核与结节病等;
绞股蓝,具有益气健脾、化痰止咳与清热解毒的功效,如《中草药通讯》记载:“消炎解毒,止咳祛痰”,《临床中药组合物辞典》记载:“健脾理气,益气活血,生津止渴,解毒利尿”;现代药理研究表明绞股蓝具有增强机体免疫、抗肿瘤、保肝与防止正常细胞癌变的作用,因此,可用于体虚乏力、气津两虚、痰热咳喘与热毒癌瘤等;
川蓼子,具有软坚散结、活血化瘀、消积止痛的功效,如《本草衍义》记载:“治瘰疬,疮破者亦治”,《滇南本草》记载:“破血,治小儿痞块积聚,消年深坚积,疗妇人石瘕症”;现代药理研究表明川蓼子具有良好的抗癌、抑菌和利尿作用,因此,用于症瘕痞块、瘿瘤肿痛、食积不消与胃脘胀痛等;
三棱,具有破血祛瘀、行气止痛的功效,如《本草经疏》记载:“三棱,从血药则治血,从气药则治气。老癖症瘕积聚结块,未有不由血瘀、气结、食停所致,苦能泄而辛能散,甘能和而入脾,血属阴而有形,此所以能治一切凝结停滞有形之坚积也”,《开宝本草》记载:“主老癖症瘕结块”;现代药理研究表明三棱具有抗肿瘤、抗血栓等作用,因此,可用于症瘕积聚、气血凝滞、心腹疼痛与疮肿坚硬等;
上甲,具有养阴清热、平肝熄风、软坚散结的功效,如《本经》记载:“主心腹症瘕坚积、寒热,去痞、息肉、阴蚀,痔(核)、恶肉”,《药性论》记载:“主宿食、症块、痃癖气、冷瘕、劳瘦,下气,除骨热,骨节间劳热,结实壅塞”,《本草新编》记载:“上甲善能攻坚,又不损气,阴阳上下有痞滞不除者,皆宜用之。但宜研末调服,世人俱炙片入汤药中煮之,则不得其功矣”;现代药理研究表明上甲具有消除结块、保肝、抗突变与抗癌作用,因此,可用于劳热骨蒸、阴虚风动、症瘕痃癖等;
白芥子,具有利气散结、温肺豁痰、通络止痛的功效,如《本草经疏》记载:“白芥子味极辛,气温,能搜剔内外痰结及胸膈寒痰,冷涎壅塞者殊效”,《本草求真》记载:“能治胁下及皮里膜外之痰,非此不达”;现代药理研究表明白芥子具有良好的广谱抗菌、镇咳、祛痰和平喘的作用,因此,可用于痰湿阻滞经络、阴疽流注、肢体痹痛麻木与瘰疬痰核等;
合欢皮,具有解郁安神、和血消肿的功效,如《本经》记载:“主安五脏,和心志,令人欢乐无忧”,《分类草药性》记载:“消瘰疬”,《日华子本草》记载:“煎膏,消痈肿并续筋骨”;现代药理研究表明合欢皮具有镇静安神、抗抑郁与抗肿瘤的作用,因此,可用于心神不安、忧郁失眠、肺痈、痈肿、瘰疬等;
瓦楞子,具有消痰化瘀、软坚散结的功效,如《日华子本草》记载:“烧过醋淬,醋丸服,治一切血气,冷气,症癖”,《日用本草》记载:“消痰之功最大,凡痰隔病用之”,《医林集要》记载:“去一切痰积,血积,气块,破症瘕,攻瘰疬”;现代药理研究表明瓦楞子具有抗胃及十二指肠溃疡、抗癌的作用,因此,可用于顽痰积结、瘿瘤、瘰疬与症瘕痞块等;
鸡内金,具有消积滞、健脾胃的功效,如《陆川本草》记载:“生肌收口。治消化性溃疡”,《本草再新》记载:“化痰,理气,利湿”,《医学衷中参西录》记载:“鸡内金,鸡之脾胃也。不但能消脾胃之积,无论脏腑何处有积,鸡内金皆能消之,是以男子痃癖,女子癥瘕,久久服之,皆能治愈。又凡虚劳之证,其经络多瘀滞,加鸡内金于滋补药中,以化其绎络之疾滞,而病始可愈”;现代药理研究表明鸡内金具有增强脾胃消化功能、降血脂与抑制子宫肌瘤的作用,因此,可用于消化不良、饮食积滞、呕吐反胃、泌尿系结石及胆结石、症瘕经闭等;
水马,具有温肾壮阳、活血散结、消肿止痛的功效,如《本草纲目》记载:“暖水藏,壮阳道,消瘕块,治疔疮肿毒”,《品汇精要》记载:“调气和血”;现代药理研究表明水马具有增强抵抗力、抗衰老与抗血栓的作用,因此,可用于症瘕积聚、跌打损伤与痈疮肿毒等。
根据中医药关于“结节”的病理病机理论、现代医学研究结果以及临床一线治疗实践经验,不断优化调整上述药物组份的剂量从而形成本发明的中药组合物,其药味组成包括10.00%~27.56%的三散草、9.76%~24.59%的绞股蓝、7.50%~23.62%的川蓼子、4.88%~16.39%的三棱、5.00%~19.69%的上甲、4.76%~12.82%的白芥子、4.88%~16.39%的合欢皮、4.31%~12.71%的瓦楞子、2.44%~12.30%的鸡内金与1.44%~8.40%的水马。方中,三散草、川蓼子、上甲为君药,具有软坚散结、攻毒化痰的功效,对于症瘕痞块、瘰疬痰核与瘿瘤结节具有确切的作用;三棱、瓦楞子、水马、合欢皮为共为臣药,具有活血化瘀、通络止痛的功效,对于气血凝滞、症瘕积聚具有确切的作用,以助君药发挥软坚散结、解毒攻积的作用;以绞股蓝、鸡内金共为佐药,具有扶正的功效,通过健脾、强胃、消积起到扶正祛邪的作用;以辛散温通的白芥子为使药,以携诸药入“痰瘀窠囊”,达化痰消瘀、软坚散结的作用。
因此,本发明治疗结节病的中药组合物在上述配比范围内具有“消痰化瘀、攻毒散结、扶正袪邪”的功效,可通过促进变异细胞凋亡、抑制病灶部位血管与淋巴管新生、提高机体免疫机能与阻止正常细胞癌变等途径而对结节病有着良好的治疗作用。
上述治疗结节病的中药组合物的制备方法,具体按照以下步骤实施:
步骤1、按照质量百分比分别称取三散草10.00%~27.56%、绞股蓝9.76%~24.59%、川蓼子7.50%~23.62%、三棱4.88%~16.39%、上甲5.00%~19.69%、白芥子4.76%~12.82%、合欢皮4.88%~16.39%、瓦楞子4.31%~12.71%、鸡内金2.44%~12.30%、水马1.44%~8.40%,各组份的质量百分比之和为100%。
步骤2、将步骤1称取的上甲、瓦楞子、鸡内金、水马各组份混合,于60±5℃条件下干燥,粉碎,过筛,得到生药粉;
步骤3、将步骤1称取的三散草、绞股蓝、川蓼子、三棱、白芥子、合欢皮各组份混合后加入6~8倍量80~90%乙醇,浸泡45分钟,回流提取1次,每次60分钟,将得到的醇提取液回收乙醇至无醇味,得到醇提物;在醇提过程产生的药渣中加入8~10倍量纯化水,煎煮提取2次,每次30分钟,将2次水提取液合并,浓缩至清膏,得到水提物;
步骤4、将步骤2所得生药粉与步骤3所得醇提物、水提物混合均匀,于65±5℃条件下干燥,即得治疗结节病的中药组合物;
步骤5、将步骤4所得的中药组合物进行微粉化粉碎,控制粒子粒径为150~250μm,得到微粉化药粉,经质检合格后装入胶囊,即得治疗结节病的中药组合物胶囊。
本发明对于“血肉有情之品”的动物药材采用生药打粉(微粉化)入药,避免了提取过程可能对其中药组合物效成分的破坏损失与难于萃取完全的而影响药效问题;对于植物性药材采用高浓度乙醇和纯化水两种不同提取溶剂进行全成分提取,既保留了脂溶性活性部位又保留了水溶性活性部位,利于发挥中药组合物多成分、多靶点、多功效的综合作用特点。全成分提取后将上述动物药材和植物药材经混合干燥后进行微粉化处理,其微粉化粒子流动性高有助于胶囊填充,同时胶囊壳一方面可掩盖中药组合物的不良口感从而提高患者的依从性,另一方面能够在胃部快速崩解释放出药效成分,从而使患者快速吸收,提高了生物利用度。此外,该中药组合物中的三散草、绞股蓝和鸡内金,在发挥对结节病药效的同时还具有良好的解毒、保肝、益肾、养胃的作用,有效地保护了患者的肝肾功能和消化功能。
综上所述,本发明治疗结节病的中药组合物药性温和、攻补兼施、标本兼治,是一种疗效可靠、安全无毒、可长期服用的中药组合物制剂,可使结节病患者避免采用化学药物干预时存在的肝肾毒副作用、胃肠道刺激、难于长期给药等问题;或避免采用手术疗法时存在的指征严格、创伤大、并发症较多、易复发等问题;或避免无干预手段的随访给患者造成的巨大心理压力,进而导致结节病“恶变”风险增大的问题。
临床应用:
1、患者资料
纳入标准参照2018版《肺结节诊治中国专家共识》、2016版《中国肺部结节分类、诊断与治疗指南》与《中医病证诊断疗效标准》,选取25例多部位肺结节患者为研究对象,其中女性17例、男性8例,患者年龄28~60岁,其中14例合并甲状腺结节。排除标准:①合并严重肝肾功能不全,呼吸、心力衰竭,消化或血液系统疾病患者;②精神疾病患者;③孕妇及哺乳期患者。
2、治疗方法与疗效标准
(1)用法用量:温开水空腹或饭后口服本发明实施例3的中药组合物胶囊,每日3次,每次6粒,30天为一疗程,共治疗2个疗程。
(2)肺结节危险程度分级:根据《中国肺部结节分类、诊断与治疗指南》将肺结节分为低危、中危、高危结节,低危结节包括:直径<5mm的纯磨玻璃结节、直径<5mm的实性结节;中危结节包括:直径≥5mm的纯磨玻璃结节、直径介于5~15mm且无明显恶性CT征象的肺实性结节、直径≤8mm的混合结节;高危结节包括:直径≥15mm的实性结节、直径介于8~15mm且含明显恶性CT征象(毛刺征、分叶征等)的实性结节、直径>8mm的混合结节。当患者存在多个肺结节时,选取恶性程度最高的肺结节评估危险分级。
(3)疗效评判标准:①治愈:胸部CT示结节消失;②显效:胸部CT示结节变小、变淡、变少,最大径面的面积(面积和)减小率≥50%;③有效:胸部CT示结节变小、变淡、变少,最大径面的面积(面积和)减小率<50%;④无效:胸部CT示结节大小、密度、数量稳定无明显变化或进展。总有效率(%)=(治愈例数+显效例数+有效例数)/总例数×100%。
3、治疗结果
经过系统治疗后,治愈13例,治愈率为52%;显效9例,显效率为36%;有效3例,有效率为12%;无效0例;总有效率为100%。其中,14例合并甲状腺结节患者,治疗后甲状腺结节也全部治愈,结节病灶消失。治疗后统计,患者反映在治疗过程中药组合物物服用方便,未出现不良反应与不适感,患者心情舒畅无负面情绪。因此,表明本发明处方组成合理、功效显著,对于结节病具有良好的治疗效果,同时,安全无毒、无不良反应,适合于结节病防治需要疗程长的特点。
实施例1
一种治疗结节病的中药组合物,按照质量百分比由以下组份组成:三散草10.00%、绞股蓝16.69%、川蓼子23.62%、三棱4.88%、上甲5.00%、白芥子12.82%、合欢皮4.88%、瓦楞子12.71%、鸡内金3.15%、水马6.25%,各组份的质量百分比之和为100%。
上述中药组合物的制备方法包括如下步骤:
步骤1、根据制剂所需,称取上述质量百分比的三散草、绞股蓝、川蓼子、三棱、上甲、白芥子、合欢皮、瓦楞子、鸡内金、水马;
步骤2、将步骤1称取的上甲、瓦楞子、鸡内金、水马混合,于60±5℃条件下干燥,粉碎,过60目筛网,得到生药粉;
步骤3、将步骤1称取的三散草、绞股蓝、川蓼子、三棱、白芥子、合欢皮混合后加入上述混合物6倍量、浓度为90%的乙醇,浸泡45分钟,回流提取1次,每次60分钟,得到醇提取液和药渣,将醇提取液中的乙醇回收至上述提取液无醇味,得到醇提物;在药渣中加入其质量10倍量的纯化水,煎煮提取2次,每次30分钟,将2次水提取液合并,减压浓缩至清膏,得到水提物;
步骤4、将步骤2所得生药粉与步骤3所得醇提物、水提物混合均匀,于65±5℃条件下干燥,即得治疗结节病的中药组合物;
步骤5、将步骤4所得的中药组合物进行微粉化粉碎,控制粒子粒径为150~250μm,得到微粉化药粉,经质检合格后装入胶囊,即得治疗结节病的中药组合物胶囊。
实施例2
一种治疗结节病的中药组合物,按照质量百分比由以下组份组成:三散草27.56%、绞股蓝9.76%、川蓼子7.50%、三棱16.39%、上甲13.07%、白芥子4.76%、合欢皮6.17%、瓦楞子7.51%、鸡内金5.84%、水马1.44%,各组份的质量百分比之和为100%。
上述中药组合物的制备方法包括如下步骤:
步骤1、根据制剂所需,称取上述质量百分比的三散草、绞股蓝、川蓼子、三棱、上甲、白芥子、合欢皮、瓦楞子、鸡内金、水马;
步骤2、将步骤1称取的上甲、瓦楞子、鸡内金、水马混合,于60±5℃条件下干燥,粉碎,过60目筛网,得到生药粉;
步骤3、将步骤1称取的三散草、绞股蓝、川蓼子、三棱、白芥子、合欢皮混合后加入上述混合物8倍量、浓度为80%的乙醇,浸泡45分钟,回流提取1次,每次60分钟,得到醇提取液和药渣,将醇提取液中的乙醇回收至上述提取液无醇味,得到醇提物;在药渣中加入其质量8倍量的纯化水,煎煮提取2次,每次30分钟,将2次水提取液合并,减压浓缩至清膏,得到水提物;
步骤4、将步骤2所得生药粉与步骤3所得醇提物、水提物混合均匀,于65±5℃条件下干燥,即得治疗结节病的中药组合物;
步骤5、将步骤4所得的中药组合物进行微粉化粉碎,控制粒子粒径为150~250μm,得到微粉化药粉,经质检合格后装入胶囊,即得治疗结节病的中药组合物胶囊。
实施例3
一种治疗结节病的中药组合物,按照质量百分比由以下组份组成:三散草17.02%、绞股蓝17.01%、川蓼子13.61%、三棱10.20%、上甲10.20%、白芥子8.16%、合欢皮8.16%、瓦楞子6.80%、鸡内金5.44%、水马3.40%,各组份的质量百分比之和为100%。
上述中药组合物的制备方法包括如下步骤:
步骤1、根据制剂所需,称取上述质量百分比的三散草、绞股蓝、川蓼子、三棱、上甲、白芥子、合欢皮、瓦楞子、鸡内金、水马;
步骤2、将步骤1称取的上甲、瓦楞子、鸡内金、水马混合,于60±5℃条件下干燥,粉碎,过60目筛网,得到生药粉;
步骤3、将步骤1称取的三散草、绞股蓝、川蓼子、三棱、白芥子、合欢皮混合后加入上述混合物7倍量、浓度为85%的乙醇,浸泡45分钟,回流提取1次,每次60分钟,得到醇提取液和药渣,将醇提取液中的乙醇回收至上述提取液无醇味,得到醇提物;在药渣中加入其质量9倍量的纯化水,煎煮提取2次,每次30分钟,将2次水提取液合并,减压浓缩至清膏,得到水提物;
步骤4、将步骤2所得生药粉与步骤3所得醇提物、水提物混合均匀,于65±5℃条件下干燥,即得治疗结节病的中药组合物;
步骤5、将步骤4所得的中药组合物进行微粉化粉碎,控制粒子粒径为150~250μm,得到微粉化药粉,经质检合格后装入胶囊,即得治疗结节病的中药组合物胶囊。
实施例4
一种治疗结节病的中药组合物,按照质量百分比由以下组份组成:三散草17.34%、绞股蓝12.72%、川蓼子12.63%、三棱5.57%、上甲7.51%、白芥子9.79%、合欢皮16.39%、瓦楞子4.31%、鸡内金12.3%、水马1.44%,各组份的质量百分比之和为100%。
上述中药组合物的制备方法包括如下步骤:
步骤1:根据制剂所需,称取上述质量百分比的三散草、绞股蓝、川蓼子、三棱、上甲、白芥子、合欢皮、瓦楞子、鸡内金、水马;
步骤2、将步骤1称取的上甲、瓦楞子、鸡内金、水马混合,于60±5℃条件下干燥,粉碎,过60目筛网,得到生药粉;
步骤3、将步骤1称取的三散草、绞股蓝、川蓼子、三棱、白芥子、合欢皮混合后加入上述混合物8倍量、浓度为85%的乙醇,浸泡45分钟,回流提取1次,每次60分钟,得到醇提取液和药渣,将醇提取液中的乙醇回收至上述提取液无醇味,得到醇提物;在药渣中加入其质量8倍量的纯化水,煎煮提取2次,每次30分钟,将2次水提取液合并,减压浓缩至清膏,得到水提物;
步骤4、将步骤2所得生药粉与步骤3所得醇提物、水提物混合均匀,于65±5℃条件下干燥,即得治疗结节病的中药组合物;
步骤5、将步骤4所得的中药组合物进行微粉化粉碎,控制粒子粒径为150~250μm,得到微粉化药粉,经质检合格后装入胶囊,即得治疗结节病的中药组合物胶囊。
实施例5
一种治疗结节病的中药组合物,按照质量百分比由以下组份组成:三散草10.16%、绞股蓝24.59%、川蓼子7.50%、三棱8.32%、上甲19.69%、白芥子4.76%、合欢皮9.83%、瓦楞子4.31%、鸡内金2.44%、水马8.40%,各组份的质量百分比之和为100%。
上述中药组合物的制备方法包括如下步骤:
步骤1、根据制剂所需,称取上述质量百分比的三散草、绞股蓝、川蓼子、三棱、上甲、白芥子、合欢皮、瓦楞子、鸡内金、水马;
步骤2、将步骤1称取的上甲、瓦楞子、鸡内金、水马混合,于60±5℃条件下干燥,粉碎,过60目筛网,得到生药粉;
步骤3、将步骤1称取的三散草、绞股蓝、川蓼子、三棱、白芥子、合欢皮混合后加入上述混合物7倍量、浓度为80%的乙醇,浸泡45分钟,回流提取1次,每次60分钟,得到醇提取液和药渣,将醇提取液中的乙醇回收至上述提取液无醇味,得到醇提物;在药渣中加入其质量10倍量的纯化水,煎煮提取2次,每次30分钟,将2次水提取液合并,减压浓缩至清膏,得到水提物;
步骤4、将步骤2所得生药粉与步骤3所得醇提物、水提物混合均匀,于65±5℃条件下干燥,即得治疗结节病的中药组合物;
步骤5、将步骤4所得的中药组合物进行微粉化粉碎,控制粒子粒径为150~250μm,得到微粉化药粉,经质检合格后装入胶囊,即得治疗结节病的中药组合物胶囊。
Claims (8)
1.一种治疗结节病的中药组合物,其特征在于,按质量百分比由以下组份组成:三散草10.00%~27.56%,绞股蓝9.76%~24.59%,川蓼子7.50%~23.62%,三棱4.88%~16.39%,上甲5.00%~19.69%,白芥子4.76%~12.82%,合欢皮4.88%~16.39%,瓦楞子4.31%~12.71%,鸡内金2.44%~12.30%,水马1.44%~8.40%,以上各组份的质量百分比之和为100%。
2.根据权利要求1所述治疗结节病的中药组合物的制备方法,其特征在于,包括以下步骤:
步骤1、按照质量百分比分别称取三散草10.00%~27.56%、绞股蓝9.76%~24.59%、川蓼子7.50%~23.62%、三棱4.88%~16.39%、上甲5.00%~19.69%、白芥子4.76%~12.82%、合欢皮4.88%~16.39%、瓦楞子4.31%~12.71%、鸡内金2.44%~12.30%、水马1.44%~8.40%,以上各组份的质量百分比之和为100%;
步骤2、将步骤1称取的上甲、瓦楞子、鸡内金、水马混合,干燥,粉碎,过筛,得到生药粉;
步骤3、将步骤1称取的三散草、绞股蓝、川蓼子、三棱、白芥子、合欢皮混合后加入上述混合物6~8倍量、浓度为80%~90%的乙醇,浸泡,回流提取1次,得到醇提取液和药渣,将醇提取液中的乙醇回收至上述提取液无醇味,得到醇提物;在药渣中加入其质量8~10倍量的纯化水,煎煮提取2次,将分次提取液合并,得到水提取液,浓缩至清膏,得到水提物;
步骤4、将步骤2所得生药粉与步骤3所得醇提物、水提物混合均匀,干燥,即得所述治疗结节病的中药组合物。
3.根据权利要求2所述的治疗结节病的中药组合物的制备方法,其特征在于,还包括将所述中药组合物进行微粉化粉碎,得到微粉化药粉,经质检合格后装入胶囊,即得治疗结节病的中药组合物胶囊。
4.根据权利要求2所述的治疗结节病的中药组合物的制备方法,其特征在于,所述步骤2中的干燥温度为60±5℃。
5.根据权利要求2所述的治疗结节病的中药组合物的制备方法,其特征在于,所述步骤2中的过筛筛网孔径为60目。
6.根据权利要求2所述的治疗结节病的中药组合物的制备方法,其特征在于,所述步骤3中醇提过程浸泡时长为45min,回流提取时长为60min/次;水提过程煎煮提取时长为30min/次。
7.根据权利要求2所述的治疗结节病的中药组合物的制备方法,其特征在于,所述步骤4中干燥温度为65±5℃。
8.根据权利要求3所述的治疗结节病的中药组合物的制备方法,其特征在于,所述微粉化药粉粒径为150~250μm。
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