CN114848710B - 一种治疗慢性浆细胞乳腺炎的复方中药组合物的制备及应用 - Google Patents
一种治疗慢性浆细胞乳腺炎的复方中药组合物的制备及应用 Download PDFInfo
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Abstract
本发明提供一种治疗慢性浆细胞乳腺炎的复方中药组合物及其制备方法和用途,属于中医药技术领域。本发明的复方中药组合物由下述重量份配比的中药原料组成:当归5‑15份,蒲公英10‑20份,人参5‑15份,黄芪15‑25份,金银花5‑15份,连翘10‑20份,天花粉5‑15份,炙甘草5‑15份组成。经体内外试验和临床试验表明,本发明提供的复方中药组合物,配比科学合理,具有益气活血、散结消肿、托里透脓、调节免疫等功效,可以调控关键炎症免疫靶点,增强机体免疫,消除乳房红肿疼痛、消除淋巴结肿块并愈合瘘管创面,治疗慢性浆细胞乳腺炎的作用。
Description
技术领域
本发明属于中医药技术领域,具体涉及一种治疗慢性浆细胞乳腺炎的复方中药组合物制剂。
背景技术
浆细胞乳腺炎(Plasm cell mastitis, PCM)又称乳腺导管扩张症,是一种以导管扩张和浆细胞浸润为病变基础的乳腺炎症,以临床进展表现分为急性浆细胞乳腺炎以及慢性浆细胞乳腺炎。其中,慢性浆细胞乳腺炎临床上表现为乳头溢液,乳头内陷,乳晕周围肿块伴有疼痛,局部肿块持续不消长达数年,部分患者可继发感染形成乳腺脓肿。目前临床上缺乏治疗慢性浆细胞乳腺炎的方法,且浆细胞乳腺炎的病因尚不明确,有相关研究表明,浆细胞乳腺炎与自身免疫系统紊乱或自身免疫系统缺陷密切相关。我们在研究中也发现浆细胞乳腺炎的发生发展与炎症免疫关键通路密切相关,并建立了浆细胞乳腺炎分子靶标的知识图谱,以促进浆细胞乳腺炎治疗方法及治疗药物的开发。综上,浆细胞乳腺炎属于缺乏有效治疗手段的复杂性自身免疫系统疾病。
JAK2/STAT3是人体炎症以及自身免疫系统相关通路,磷酸化的JAK2和STAT3蛋白都是该通路被激活的重要标记,被激活后JAK2/STAT3以二聚体的形式进入细胞核调节目的基因表达。该信号通路的异常与自身免疫系统疾病的发生发展息息相关,与人体免疫系统功能密切相关。目前,已有相关研究表明,JAK2/STAT3通路的异常激活与浆细胞乳腺炎、炎症性肠病、银屑病等自身免疫系统疾病的病理进程密切相关。
中医药在治疗复杂性疾病方面具有独特的优势,以中药为代表的天然药物具有毒副作用小、耐受性好等特点。中医药理论强调辩证施治,一方面补人体之虚,从整体系统上对患者的免疫功能进行调控;另一方面解毒散结以治疗疾病,注重治病与调理的统一,改善患者的全身状态。目前,中医理论认为浆细胞乳腺炎的发生与肝郁胃热相关,即肝经郁热是该病症的主要发病机制。我们在慢性浆细胞乳腺炎的研究中并结合临床实践发现了一种复方中药组合制剂,用药量小且配比科学合理,可有效的治疗慢性浆细胞乳腺炎。此外,该组方制剂可以调控异常激活的JAK2/STAT3信号通路,下调磷酸化的JAK2和STAT3蛋白,进而调节浆细胞乳腺炎患者自身免疫系统及整体免疫功能,提升患者的自身免疫力,并消炎去肿,有望给慢性浆细胞乳腺炎的临床治疗提供一种低毒高效的治疗方法。
发明内容
针对上述问题,本发明提供一种治疗慢性浆细胞乳腺炎的复方中药组合物,本发明的另一个目的是提供该复方中药组合物的制备方法及其在制备治疗慢性浆细胞乳腺炎药物中的应用。
为了实现上述目的,本发明提供了如下技术方案。
本发明提供了一种治疗慢性浆细胞乳腺炎的复方中药组合物,其特征在于,所述的有效成分由下述重量份配比的中药原料的提取物组成:当归5-15份,蒲公英10-20份,人参5-15份,黄芪15-25份,金银花5-15份,连翘10-20份,天花粉5-15份,炙甘草5-15份。
进一步地,所述各原料药的重量份数配比是:当归10份,蒲公英15份,人参8份,黄芪20份,金银花10份,连翘15份,天花粉12份,炙甘草8份。
进一步地,所述组合物还包含药学上可接受的载体和/或赋形剂。
优选地,所述药学上可接受的载体和/或赋形剂选自脂质体、微晶纤维素、羧甲基淀粉钠、羧甲基纤维素钠、聚乙二醇、聚乙烯醇、丙烯酸酯类聚合物、甘油、丙二醇、山梨醇、β-环糊精、吐温-80、乳糖、淀粉、尤奇特S-100、尤奇特L-100、海藻酸钠、果胶、糊精中的一种或多种。
进一步地,如上所述组合物的剂型为颗粒剂、胶囊剂、口服液、片剂、丸剂、膏剂、汤剂、注射剂和微囊剂。
一种根据上述中任一项所述的一种治疗慢性浆细胞乳腺炎的复方中药组合物的制备方法,选自:
A:处方中药加水5-12倍量共煎煮,滤过,滤液浓缩;
B:处方中药加50-90%浓度的乙醇水溶液回流提取,滤过,滤液浓缩;
C:处方中药加水5-12倍量共煎煮,滤过;药渣加50-90%浓度乙醇水溶液回流提取,滤过,滤液合并浓缩。
进一步地,所述的乙醇水溶液回流提取操作中乙醇水溶液用量为药材重量8-10倍。
进一步地,如上所述的复方中药组合物在制备用于治疗慢性浆细胞乳腺炎的药物中的应用。
本发明所提供的调节肿瘤免疫并抗肿瘤的复方中药组合物的原料药功效如下。
当归性温味甘,归肝、心、脾经,具有补血活血、润肠通便、抗氧化并提高免疫力等功效。
蒲公英性寒微苦,归肝、胃经,具有清热解毒、消肿散结、利尿通淋,增强免疫细胞功能并抗肿瘤的功效。
人参性温味甘,归心、肺、脾、肾经,具有补元气、补脾益肾、生津安神,增强免疫细胞功能并抗肿瘤的功效。
黄芪性温味甘,归肺、脾经,具有补气升阳、利水消肿、生津养血、托毒排脓、提升免疫功效。
金银花性寒味甘,归心、肺、胃经,具有清热解毒、凉散风热、抗氧化、调节免疫的功效。
连翘性寒微苦,归肺经、心经,具有清热解毒、消肿散结、提升免疫并抗病毒的功效。
天花粉性寒味甘,归肺、胃经,具有消肿排脓、清热生津等功效。
炙甘草性温味甘,归心、肺、胃、脾经,具有补脾和胃、益气复脉的功效。
以上诸药合用以中医的“君臣佐使”理论为依据,合理配置,相互配伍。本发明中以金银花、蒲公英、连翘清热解毒、凉血消肿为君药;天花粉活血化瘀、散结消肿、排脓通乳为臣药;人参、黄芪、当归补气消肿、托毒排脓、提升免疫为佐药;炙甘草清热解毒,调和诸药为使药。八药合而为用,共奏诸药合用共奏清热解毒、活血止痛、提升免疫之功效。
与现有技术相比本发明的有益效果。
1. 本发明根据中医药理论,同时结合慢性浆细胞乳腺炎的最前沿研究结果,采用辩证论治全身调节的原则进行中药组方筛选,提供的复方中药组合物制剂可以调控多个炎症免疫靶点,对慢性浆细胞乳腺炎具有很好的治疗效果。
2. 实验结果表明本发明提供的治疗慢性浆细胞乳腺炎的复方中药组合物,具有益气活血、托里透脓的作用,同时可以调控异常的JAK2/STAT3信号通路,下调磷酸化的JAK2和STAT3蛋白,进而调节浆细胞乳腺炎患者自身免疫系统及整体免疫功能,发挥多靶点系统治疗慢性浆细胞乳腺炎的作用。临床实践表明,本发明提供的治疗慢性浆细胞乳腺炎的复方中药组合物安全性很高、而毒副作用很低。
3. 本发明提供的治疗慢性浆细胞乳腺炎的复方中药组合物可以利用药学载体/赋形剂等制备成多种剂型,患者服用方便。此外,本发明提供的治疗慢性浆细胞乳腺炎的复方中药组合物配比科学合理,用药量少,能较快发挥药效,制备工艺稳定,适合工业化大规模生产。
具体实施方式
下面结合具体实施例对本发明做详细的说明。以下实施例将有助于对本发明的了解,但这些实施例仅为了对本发明加以说明,本发明并不限于这些内容。在实施例中的操作方法均为本技术领域常规操作方法。
实施例1
按重量份数取原料药,取当归15克,蒲公英20克,人参15克,黄芪25克,金银花15克,连翘20克,天花粉15克,炙甘草15克。按照复方中药的重量加水12倍即1680mL共煎煮,提取3次,每次2小时,120目不锈钢网自然滤过,浓缩物上大孔吸附树脂柱,洗脱后进一步减压浓缩成测定相对密度为1.20-1.30的浸膏,真空干燥后,低温超微粉碎得细粉,加入稀释剂乳糖以及玉米淀粉混合均匀,装入肠溶胶囊并制备成复方中药的胶囊剂(批号:C001)。
实施例2
按重量份数取原料药,取当归10克,蒲公英15克,人参10克,黄芪20克,金银花10克,连翘15克,天花粉10克,炙甘草10克。按照复方中药的重量加水10倍即1000mL水共煎煮,提取3次,每次2小时,120目不锈钢网自然滤过, 浓缩物上大孔吸附树脂柱,洗脱后进一步减压浓缩成测定相对密度为1.20-1.30的浸膏,真空干燥后,低温超微粉碎得细粉,加入微晶纤维素、羧甲基淀粉钠,并加入润滑剂硬脂酸镁,混合均匀后,压片制备成片剂(批号:C002)。
实施例3
按重量份数取原料药,取当归5克,蒲公英10克,人参5克,黄芪15克,金银花5克,连翘10克,天花粉5克,炙甘草5克。按照复方中药的重量加水8倍即480mL水共煎煮,120目不锈钢网自然滤过,药渣加入10倍重量份的50%乙醇600mL回流提取,120目不锈钢网自然滤过,将过滤液合并,浓缩物上大孔吸附树脂柱,洗脱后进一步减压浓缩成测定相对密度为1.20-1.30的浸膏,真空干燥后,低温超微粉碎得细粉,加入甘油及山梨醇等赋形剂制备成内服的复方中药膏剂(批号:C003)。
实施例4
按重量份数取原料药,取当归10克,蒲公英15克,人参8克,黄芪20克,金银花10克,连翘15克,天花粉12克,炙甘草8克。按照复方中药的重量加8倍70%的乙醇溶液即784mL乙醇溶液回流提取,提取3次,每次2小时,120目不锈钢网自然滤过,浓缩物上大孔吸附树脂柱,洗脱后进一步减压浓缩成测定相对密度为1.20-1.30的浸膏,真空干燥后,低温超微粉碎得细粉,加入丙烯酸酯类聚合物、聚乙二醇等赋形剂及粘结剂,采用融溶法制备成复方中药的滴丸剂型(批号:C004)。
实施例5
按重量份数取原料药,取当归10克,蒲公英15克,人参8克,黄芪20克,金银花10克,连翘15克,天花粉12克,炙甘草8克。按照复方中药的重量加10倍的90%的乙醇溶液即980mL乙醇溶液回流提取,提取3次,每次2小时,120目不锈钢网自然滤过,浓缩物上大孔吸附树脂柱,洗脱后进一步减压浓缩成测定相对密度为1.20-1.30的浸膏,真空干燥后,低温超微粉碎得细粉,加入海藻酸钠、低聚木糖及果胶,经微囊化包埋,并利用喷雾干燥技术处理,制备成复方中药的微囊剂(批号:C005)。
实施例6
按重量份数取原料药,取当归10克,蒲公英15克,人参8克,黄芪20克,金银花10克,连翘15克,天花粉12克,炙甘草8克。按照复方中药的重量加水10倍即980mL水共煎煮,120目不锈钢网自然滤过,药渣加入8倍重量份的50%乙醇784mL回流提取,120目不锈钢网自然滤过,将过滤液合并,浓缩物上大孔吸附树脂柱,洗脱后得到浓缩液。将浓缩液置于配液罐中,向中药浓缩液中缓慢加入苯甲酸乙醇溶液和山梨酸乙醇溶液,同时加入调味剂,制备得到复方中药的口服液(批号:C006)。
实施例7
按重量份数取原料药,取当归10克,蒲公英15克,人参8克,黄芪20克,金银花10克,连翘15克,天花粉12克,炙甘草8克。按照复方中药的重量加水10倍即980mL水共煎煮,120目不锈钢网自然滤过,药渣加入10倍重量份的70%乙醇980mL回流提取,提取3次,每次2小时,120目不锈钢网自然滤过,将过滤液合并,浓缩物上大孔吸附树脂柱,洗脱后进一步减压浓缩成测定相对密度为1.20-1.30的浸膏,真空干燥后,低温超微粉碎得细粉,加入糊精,喷雾制得复方中药的颗粒剂(批号:C007)。
实施例8
通过脂多糖(LPS)刺激诱导的乳腺炎细胞模型来评估本发明实施例制备得到的复方中药组合物制剂对JAK2/STAT3信号通路及人体免疫系统功能的调控作用。JAK2/STAT3是人体自身免疫系统相关通路,该信号通路的异常与自身免疫系统疾病的发生发展息息相关, 与人体免疫系统功能密切相关。体外培养小鼠巨噬细胞Raw264.7,利用1μg /mL浓度的脂多糖作用于小鼠巨噬细胞Raw264.7刺激诱导建立体外乳腺炎细胞模型。将诱导后的细胞用胰酶进行消化、计数、制成浓度为6×104个/mL的细胞悬液。将96孔板中每孔加入100μL细胞悬液(每孔6×103个细胞),然后置于培养箱中培养24小时。将上述实施例1-7中的组方中药制剂配制成50mg/mL的水溶液;AG-490是一种经典的JAK2/STAT3通路的小分子抑制剂,用DMSO将AG-490配制成50mg/mL的溶液,混合均匀后将这些药物溶液加入2μL到96孔白色酶标板中。JAK2抗体以及磷酸化JAK2抗体(p-JAK2),STAT3抗体以及磷酸化STAT3抗体(p-STAT3)均购自Abcam公司。利用Western技术并结合ImageJ等软件定量计算确定药物处理细胞后p-JAK2/JAK2的含量比例以及p-STAT3/STAT3的含量比例。处理后如果这两个比例降低,则说明药物有效地下调了JAK2/STAT3信号通路及相关靶点,进而对自身免疫系统以及免疫功能起到调控作用。组别分成缓冲液(9%的Saline溶液)、AG-490对照药物组、以及七组本发明实施例制备得到的中药组合物制剂的处理组。
表1. 中药组合物制剂对JAK2/STAT3信号通路及免疫系统功能的调控作用评估
。
本实验表明,批号C004-007的复方组合物制剂对JAK2/STAT3信号通路的调控作用要强于批号C001-003的复方组合物制剂,证明批号C004-007的组方配较优。此外,批号C004-007的复方组合物制剂对JAK2/STAT3信号通路的调控作用接近于对照药物AG-490的调控作用,证明复方中药组合物制剂对免疫系统功能以及整体免疫有较好的调控作用。
实施例9
通过临床试验研究来评估本发明的复方中药组方产品的治疗慢性浆细胞乳腺炎作用。采用开放、随机对照设计,共纳入50例慢性浆细胞乳腺炎患者。受试者年龄在20-60岁,入选标准符合慢性浆细胞乳腺炎患者的女性患者,诊断标准如下:1. 乳腺B超、钼靶、MRI在组织病理学上诊断为慢性浆细胞乳腺炎;2. 发病以乳头内陷、一侧或双侧乳晕周围有肿块并伴有疼痛、局部肿块持续不消长达数年等慢性浆细胞乳腺炎的病理表现;3. 形成乳漏。经病理组织学证实为慢性浆细胞乳腺炎患者。凡有以下情况之一,则不能参加临床试验研究:1. 入组前1个月使用过激素及免疫抑制治疗;2. 有严重基础疾病患者、例如糖尿病、心血管疾病、造血系统疾病等;3. 怀孕期或者哺乳期女性患者;4. 对中药不耐受或者依从性差;5. 近期服用过抗抑郁药和其他精神类药物者。
入组患者每日服用复方中药组方制剂产品(实施例产品批号: C007),每次10g/袋,每天两次。每3周为1周期,总计6周期。每个周期复查彩超评价治疗疗效,临床观察评估复方中药组方产品的治疗效果;每2个周期采集外周血检测炎症免疫指标,利用流式细胞术及ELISA试剂盒检测炎症免疫细胞因子包括IL-1β,TNF-α等在治疗前后的含量变化,用来评估复方中药组方产品的治疗效果。
临床观察及疗效标准
根据浆细胞乳腺炎的中医辨证标准以及《中药新药临床指导原则》制定浆细胞乳腺炎的病理症状,并依据病理体征将疗效划分为痊愈、基本痊愈、显效、有效、无效五个等级:A. 痊愈:乳房红肿疼痛完全消失、淋巴结肿块完全消失,乳腺B超、钼靶、MRI等技术在组织病理学上诊断为痊愈;B. 基本痊愈:乳房红肿疼痛基本消失、淋巴结肿块基本消失、瘘管基本愈合;C. 显效:乳房红肿疼痛显著减轻、有淋巴结肿块、瘘管大部分愈合;D. 有效:乳房红肿疼痛有减轻、有淋巴结肿块,瘘管创面等开始愈合;E. 无效:没有治疗效果或病变范围扩大。
表2. 临床观察复方中药组方产品治疗前后的疗效评价结果
。
结果表明,复方中药组方产品治疗后,慢性浆细胞乳腺炎患者患者达到痊愈或基本痊愈的比例达到82%,达到有效或显效的比例达到12%。
表3. 治疗周期后采集患者外周血检测炎症免疫指标的结果
。
结果表明,利用本发明的复方中药组方制剂产品治疗后,慢性浆细胞乳腺炎患者患者的炎症细胞因子的含量显著下降,表示复方中药组方制剂产品有效地调控了患者的炎症免疫通路,治疗效果良好。
Claims (6)
1.一种治疗慢性浆细胞乳腺炎的复方中药组合物,其特征在于,所述中药组合物由下述重量份配比的中药原料制成:当归10份,蒲公英15份,人参8份,黄芪20份,金银花10份,连翘15份,天花粉12份,炙甘草8份,所述复方中药组合物的制备方法,选自:A:处方中药加水5-12倍量共煎煮,滤过,滤液浓缩;B:处方中药加50-90%浓度的乙醇水溶液回流提取,滤过,滤液浓缩,所述乙醇水溶液回流提取操作中乙醇水溶液用量为药材重量8-10倍;C:处方中药加水5-12倍量共煎煮,滤过;药渣加50-90%浓度乙醇水溶液回流提取,滤过,滤液合并浓缩,所述乙醇水溶液回流提取操作中乙醇水溶液用量为药材重量8-10倍,所述复方中药组合物具有益气活血、托里透脓的作用,同时调控异常的JAK2/STAT3信号通路,下调磷酸化的JAK2和STAT3蛋白,进而调节浆细胞乳腺炎患者自身免疫系统。
2.根据权利要求1所述的一种治疗慢性浆细胞乳腺炎的复方中药组合物,其特征在于,所述组合物还包含药学上可接受的载体。
3.根据权利要求2所述的一种治疗慢性浆细胞乳腺炎的复方中药组合物,其特征在于,所述药学上可接受的载体选自脂质体、微晶纤维素、羧甲基淀粉钠、羧甲基纤维素钠、聚乙二醇、聚乙烯醇、丙烯酸酯类聚合物、甘油、丙二醇、山梨醇、β-环糊精、吐温-80、乳糖、淀粉、尤奇特S-100、尤奇特L-100、海藻酸钠、果胶、糊精中的一种或多种。
4.根据权利要求1所述的一种治疗慢性浆细胞乳腺炎的复方中药组合物,其特征在于,所述组合物的剂型为颗粒剂、胶囊剂、口服液、片剂、丸剂、膏剂或微囊剂。
5.根据权利要求1-4中任一项所述的一种治疗慢性浆细胞乳腺炎的复方中药组合物的制备方法,选自:A:处方中药加水5-12倍量共煎煮,滤过,滤液浓缩;B:处方中药加50-90%浓度的乙醇水溶液回流提取,滤过,滤液浓缩,所述乙醇水溶液回流提取操作中乙醇水溶液用量为药材重量8-10倍;C:处方中药加水5-12倍量共煎煮,滤过;药渣加50-90%浓度乙醇水溶液回流提取,滤过,滤液合并浓缩,所述乙醇水溶液回流提取操作中乙醇水溶液用量为药材重量8-10倍。
6.根据权利要求1-4中任一项所述的复方中药组合物在制备用于治疗慢性浆细胞乳腺炎的药物中的应用。
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