CN112237621B - 一种用于乳腺增生的中药乳膏及其制备方法 - Google Patents
一种用于乳腺增生的中药乳膏及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种用于乳腺增生的中药乳膏及其制备方法,涉及医药化工领域。一种用于乳腺增生的中药乳膏,由如下重量份数的原料药制成:莪术10‑25份、芒种花10‑35份、栗壳10‑25份、甜橙10‑20份、红泽兰10‑20份、漏芦5‑15份、白背枫5‑12份、玫瑰花5‑10份、青蒿5‑10份、艾叶1‑10份、花叶竹芋1‑10份、冰片1‑5份。本发明中药乳膏用于治疗乳腺增生,通过外用给药,能够使乳腺小叶体密度和腺泡比表面积显著下降,乳腺小叶间质体密度显著上升;大鼠血清中雌二醇水平显著下降,黄体酮水平显著升高,对乳腺增生具有显著的治疗作用。
Description
技术领域
本发明涉及医药化工领域,具体涉及一种用于乳腺增生的中药乳膏及其制备方法。
背景技术
乳腺增生是一种妇科常见疾病,它是以乳腺腺泡和导管的上皮细胞及结缔组织增生为主要病理变化的一类疾病的总称。它既非炎症,又非肿瘤,在临床上以乳房疼痛和肿块为特征,随月经周期和情绪变化而出现轻重变化。乳腺增生的发病率约占育龄妇女的40%,占乳腺疾病的75%,是最常见的乳房疾病。随着社会的进步、经济的发展和生态环境的变化,发病率呈明显上升趋势。流行病学资料表明乳腺癌的发生与乳腺增生性疾病有密切关系,特别是乳腺不典型增生。正常乳腺的上皮细胞向恶性转化,是在各种内外因素作用下发生的一个渐进过程,大约需15-35年。在这漫长的数十年中,通过人为的积极干预,如改善环境、行为干预、精神疏导、药物治疗等,对患者的免疫机能和内分泌功能起良性调节作用,有可能将病变逆转,从而减少和防止乳腺癌的发生。现代医学认为乳腺增生主要是内分泌功能紊乱,雌、孕激素比例失调所致,治疗上多采用激素制剂、维生素类药物及手术等治疗方法,手术只能切除局部病变,解除不了生成因素,其他部位仍可发生;激素替代疗法不能从根本上调整内分泌功能,长期使用产生严重的副作用,病人难以接受。
中医认为乳腺增生病的发生由肝郁气滞,或肝肾虚损,冲任失调,或痰凝血淤而成。中医治疗乳腺增生病,历史悠久,疗效确切且无明显毒副反应,复发率低。中医以整体观念对本病辨证论治,辨证与辨病相结合,整体与局部相结合,内治与外治相结合,长期治疗与短期治疗相结合,通过疏肝理气、活血化瘀、散结,从多方面、多角度起到调整内分泌,标本兼治的作用。尤其是中医外治法针对乳腺增生病患者以局部症状和体征为主的特点,采用集成外治治疗能直达病所,是治疗乳腺增生病的重要途径之一。
申请号为201310269365.X的专利文献提供了一种用于治疗乳腺增生病的外用中药,其原料药包括白芍、莪术、穿山甲、路路通、川楝子、筋骨草、没药、党参、昆布、皂角刺、肉苁蓉、郁金、马耳草、苦玄参、苦地丁、旋覆花、鸭儿芹、韩信草、柴胡、佛手和陈皮。该发明提供的外用中药组合物采用经皮局部给药的方法治疗乳腺增生病,疗效好,见效快,毒副作用小,使用方便,该发明给药方法采用外贴方式,辅以DP 照射,显示出良好的乳腺增生治疗效果。
申请号为201810508504.2的专利文献提供了一种活血通络用于乳腺增生治疗的中药透皮贴剂,包括粘胶层、能量层、永磁体、药膜层及背衬层,药膜层中的中药组分由以下重量份的药材原料制成:鹿衔草5~7份、蚤休6~10份、桃仁3~5份、红花2~4份、乳香3~5份、没药3~5份、茜草3~5份、葵蓬菜8~10份、柴胡3~5份、枳壳2~4份、蒲公英4~8份、三棱3~5份、莪术3~5份、漏芦2~4份、山慈菇2~4份、大黄3~5份、干姜2~4份、蜈蜙3~5份、青皮1~3份、全蝎4~6份、水蛭4~6份、雪上一枝蒿1~3份、秦艽1~3份、阿魏2~4份和血竭4~8份。该发明将中药组分包覆于由聚乳酸和聚3-羟基丁酸酯复合制得的高分子材料内,能够有效改善女性乳腺增生引起的乳房疼痛、乳房肿块、乳头溢液等症状,上述透皮贴剂制作方法繁琐,中药配伍复杂,疗效不明确。
发明内容
基于现有技术的不足,本发明所要解决的技术问题是提供一种用于乳腺增生的中药乳膏。
本发明所要解决的另一个技术问题是提供一种用于乳腺增生的中药乳膏的制备方法。
为解决上述技术问题,本发明所采用的技术方案如下:
一种用于乳腺增生的中药乳膏,由如下重量份数的原料药制成:莪术10-25份、芒种花10-35份、栗壳10-25份、甜橙10-20份、红泽兰10-20份、漏芦5-15份、白背枫5-12份、玫瑰花5-10份、青蒿5-10份、艾叶1-10份、花叶竹芋1-10份、冰片1-5份。
优选地,所述用于乳腺增生的中药乳膏,由如下重量份数的原料药制成:莪术10份、芒种花10份、栗壳10份、甜橙10份、红泽兰10份、漏芦5份、白背枫5份、玫瑰花5份、青蒿5份、艾叶1份、花叶竹芋1份、冰片1份。
优选地,所述用于乳腺增生的中药乳膏,由如下重量份数的原料药制成:莪术25份、芒种花35份、栗壳25份、甜橙20份、红泽兰20份、漏芦15份、白背枫12份、玫瑰花10份、青蒿10份、艾叶10份、花叶竹芋10份、冰片5份。
优选地,所述用于乳腺增生的中药乳膏,由如下重量份数的原料药制成:莪术15份、芒种花20份、栗壳15份、甜橙15份、红泽兰15份、漏芦10份、白背枫8份、玫瑰花8份、青蒿8份、艾叶6份、花叶竹芋5份、冰片3份。
上述用于乳腺增生的中药乳膏的制备方法,包括以下步骤:
(1)乙醇提取:将莪术、芒种花、栗壳、甜橙、红泽兰、漏芦、白背枫、玫瑰花、青蒿、艾叶和花叶竹芋混合粉碎,加入6-8倍量的95%乙醇,回流提取2-3次,每次1-2h,合并乙醇提取液,滤过,滤液减压浓缩至60℃时相对密度为1.3-1.4的浸膏,备用;
(2)水提取:将步骤(1)滤过所得药渣加入8-10倍量的纯化水,加热提取2-3次,每次2h,合并提取液,滤过,滤液减压浓缩至60℃时相对密度为1.3-1.4的浸膏,备用;
(3)油相制备:取油相基质,加热至75℃熔融,作为油相,保温备用;
(4)水相制备:取水相基质,加入蒸馏水,加热至75℃溶解,作为水相,保温备用;
(5)乳化:将步骤(1)的浸膏加入步骤(3)的油相中,搅拌均匀,得相Ⅰ;将步骤(2)的浸膏加入步骤(4)的水相中,搅拌均匀,得相Ⅱ;将相Ⅰ与相Ⅱ混合,在75℃下乳化30-40min,温度降至40℃时,加入5倍量乙醇溶解的冰片,搅拌均匀至室温,即得。
优选地,所述步骤(1)中混合粉碎的粒径为10-20目。
优选地,所述步骤(1)回流提取的温度为65-80℃。
优选地,所述步骤(2)中加热提取的温度为90-100℃。
优选地,所述油相基质为硬脂酸、单硬脂酸甘油酯、液体石蜡、十八醇、凡士林和羊毛脂的一种或两种以上的组合物。
优选地,所述水相基质为甘油、十二烷基硫酸钠、三乙醇胺和羟苯乙酯的一种或两种以上的组合物。
本发明治疗乳腺增生的中药乳膏的使用方法为:每日1-3次,涂擦患处,30天为一个疗程。
本发明中药乳膏中所用各种原料药的作用如下:
莪术:为姜科植物莪术的根茎。味辛、苦,性温;归肝、脾经。既善破血逐瘀,又擅行气止痛,用于癥瘕痞块,瘀血经闭,胸痹心痛,食积胀痛。《日华子本草》:“治一切气,开胃消食,通月经,消瘀血”。现代研究表明:本品主要含有挥发油,其主要成分为莪术呋喃酮、莪术烯醇、姜黄烯等20多种倍半萜,尚含棕榈酸、姜黄素等。挥发油中的莪术醇、莪术双酮不仅具有直接的抗癌作用,还可升高白细胞、使宿主特异性免疫功能增强而获得明显的免疫保护效应。其水提液可抑制血小板聚集,有抗血栓形成作用。
芒种花:为藤黄科植物金丝梅的全株。味苦,辛,寒;归肝;肾;膀胱经。清热解毒,利尿,行瘀。治肝炎,感冒,痢疾,淋病,疝气,筋骨疼痛,喉蛾,牙痛,鼻衄,黄水疮,跌打损伤。《贵州民间方药集》:根,破血去瘀。治便血,劳伤;舒筋活血,治牙痛,催乳;利尿,治五淋。《云南中草药》:清热解毒,舒筋活络,舒肝,止血。
栗壳:为壳斗科植物栗的外果皮。甘;涩;性平。降逆生津;化痰止咳;清热散结;止血。主反胃;呕哕;消渴;咳嗽痰多;百日咳;腮腺炎;瘰疬;衄血;便血。已知文献报道,板栗壳中主要含有有机酸、酚类、植物甾醇、三萜、黄酮、香豆素、糖、多糖和鞣质等化学成分(赵德义,高文海,花成文,等. 板栗壳化学成分的初步研究[J].陕西林业科技,2003,47(2):1-3)。
甜橙:为芸香科植物甜橙的成熟果实。归入厥阴肝经。行厥阴滞塞之气,止肝气左胁疼痛,下气消膨胀,行阳明乳汁不通。果实含黄酮甙、内酯、生物碱、有机酸等。黄酮甙中有橙皮甙、柚皮芸香甙、异樱花素-7-芦丁糖甙、柚皮素-4'-葡萄糖甙-7-芦丁糖甙、柚皮甙、柠檬素-3-β-D-葡萄糖甙和O-D-木糖基牡荆素。内酯中有双内酯苦味成分柠檬苦素即黄柏内酯及其衍生物柠檬苦素酸单内酯。生物碱为那可汀。有机酸中主要为柠檬酸和苹果酸。另含根皮酚-β-D-葡萄糖甙及糖类、维生素、钙、磷、铁等。果皮还含挥发油1.5-2%,其主要成分为正癸醛、柠檬醛、柠檬烯和辛醇等。
红泽兰:为爵床科植物垂序马蓝的全草。性苦微辛,温。《四川常用中草药》:“消瘀行水,舒肝散郁。治月经不调,产后淋漓腹痛,血晕,症瘕痈肿,跌打损伤及身面浮肿。”
漏芦:味苦,性寒;归胃经。本品既长于清热解毒、消散痈肿,治热毒疮痈,尤为治乳痈之要药。又能通乳,治热壅乳房作胀、乳汁不下。《神农本草经》:“主皮肤热,恶疮疽痔,湿痹,下乳汁”。《本草纲目》:“下乳汁,消热毒,排脓,止血,生肌、杀虫,故东垣以为手、足阳明药,而古方治痈疽发背,以漏芦汤为首称也”。漏芦含有的化学成分主要包括植物蜕皮激素类、三萜类和噻吩类,其次还有黄酮和挥发油等成分,研究证明其具有抗氧化、调血脂、抗肿瘤、抗炎、镇痛等广泛的药理活性。
白背枫:为马钱科醉鱼草属植物狭叶醉鱼草的全株。性辛,苦,温。有小毒。祛风利湿,行气活血。用于妇女产后头风痛、胃寒作痛,风湿关节痛,跌打损伤,骨折;外用治皮肤湿痒、阴囊湿疹、无名肿毒。
玫瑰花:味甘、微苦,性温;归肝、胃经。既入血分,又入气分,具有行气活血、散瘀止痛之功,常用治肝郁气滞、经脉不通之月经不调、经前乳房胀痛等证。《药性考》:“行血破积,损伤瘀痛”。《本草纲目拾遗》:“和血行气,理气,治风痹、噤口痢、乳痈、肿毒初起、肝胃气痛”。本品主要含有挥发油,油中主要为香茅醇、牻牛醇、橙花醇、丁香油酚、苯乙醇等,尚含有槲皮苷、苦味素、鞣质、脂肪油、有机酸等。所含挥发油对人体免疫缺陷病病毒、白血病病毒和T细胞白血病病毒均有抑制作用。
青蒿:为菊科一年生草本植物黄花蒿的干燥地上部分。其性寒、味苦,归肝、胆经,具有抗菌、平喘、解热、止咳等功效。常用于温邪伤阴、夜热早凉、阴虚发热、骨蒸劳热、暑邪发热、疟疾寒热、湿热黄疸。青蒿的化学成分主要有挥发油类、香豆素类、萜类、黄酮类、苯丙酸类及其他类成分。
艾叶:性辛、苦,性温;归肝、脾、肾经。具有温经止血,散寒止痛之功;外用祛湿止痒。用于吐血,衄血,崩漏,月经过多,胎漏下血,少腹冷痛,经寒不调,宫冷不孕;外治皮肤瘙痒。醋艾炭温经止血,用于虚寒性出血。《名医别录》:“主灸百病。可作煎,止下痢,吐血,下部慝疮,妇人漏血。利阴气,生肌肉,辟风寒,使人有子”。《本草纲目》:“温中,逐冷,除湿”。现代药学研究表明:艾叶含有挥发油、三萜、黄酮、多糖等化学成分。艾叶水浸剂及煎剂对多种致病菌及真菌、病毒有抑制作用,能抑制血小板聚集。尚有强心、镇静、利胆等作用。
花叶竹芋:性苦;辛;性寒;小毒。归心经。清热解毒;散结消肿。主痈疽;疮疡;无名肿毒;跌打损伤;瘀血肿痛。
冰片:味辛、苦,性微寒;归心、脾、肺经。具开窍醒神,清热止痛之功,用于热病神昏、惊厥,中风痰厥,气郁暴厥,中恶昏迷,胸痹心痛,目赤,口疮,咽喉肿痛,耳道流脓。《本草纲目》:“疗喉痹,脑痛,鼻瘜,齿痛,伤寒舌出,小儿痘陷,通诸窍,散郁火”。本品局部应用能轻微刺激感觉神经,有一定的止痛及温和的防腐作用。现代用50%冰片醇溶液外用,治疗晚期肿瘤疼痛有效,尤对肺癌、乳腺癌的止痛效果较好。单独使用可用于抗炎、抗菌、镇痛、保护脑缺血等。在传统中医药中,冰片常作为一味佐药,即冰片与其他药物配伍可提高临床治疗效果,即“独行则势弱,佐使则有功”。冰片的配伍作用,主要是通过增加血脑屏障的通透性、提高药物在血液内的浓度以及促透皮吸收等方式,促进药物吸收,从而提高其他药物的生物利用度,以此达到增强治疗效果的目的。
乳腺增生病在中医属“乳癖”范畴,又名“乳痞”、“乳中结核”、“奶脾”、“奶积”等。肾气亏虚、冲任失调、水不涵木、肝失所养肝气郁结、乳络痰滞、癖滞生疾是乳腺增生之因,是病之本;而气滞、血瘀、痰凝所造成的乳房肿块和疼痛,是其果,是病之标。本病的病机既有肝肾不足之本虚,又有气滞、血瘀、痰凝之标实。所以,乳腺增生是一种本虚标实、虚实夹杂的疾病。目前中医治疗离不开一“气”字,多以疏肝理气为主,佐以化痰散结,调理冲任,活血止痛、软坚散结,以期恢复女性的正常生理平衡,从而达到治疗乳腺增生的目的。由于乳腺增生属慢性病,复杂难治,传统的治疗方法可能难以奏效。比如汤剂便于临床加减用药,所以临床治疗上多以汤剂为主,但是汤剂剂型不利于患者长期坚持用药。临床上专用方制成胶囊或冲剂服药方便,适应了乳腺增生病程较长而需长期服药的特点,利于患者坚持用药治疗。但长期口服中药又会引起肝肾受损的副作用。中医药外治法疗程短、见效快、操作简单且价格便宜,符合患者的要求,则更具有优势。采用中药外治法,理论依据为“外治之理,即内治之理,外治之药,亦即内治之药,所异者,法耳”,药物通过透皮吸收而起到治疗作用,它不但可避免肝脏的首过效应,而且可降低患者个体间及个体内差异,维持稳定血药浓度。为了克服上述现代医学和中药口服治疗乳腺增生的不足,本发明采用现代制药工艺提取方法,将提取的中药有效成分制成高渗透的外用乳剂,直达病所,病人容易接受和坚持、携带方便、确切、生物相容性好又不污染衣物。通过小鼠实验表明,外用给药30d后,与模型组比较,本发明实验组的乳腺小叶体密度和腺泡比表面积显著下降(P<0.05),乳腺小叶间质体密度显著上升(P<0.05);大鼠血清中雌二醇水平显著下降,黄体酮水平显著升高,表明它可通过调控性激素水平对乳腺增生起到保护或治疗作用,并能够改善相关脏器指数(P<0.05)。
与现有技术相比,本发明的有益效果如下:
本发明用于乳腺增生的外用乳膏是以莪术、甜橙和芒种花为君药,其中莪术性温,既善破血逐瘀,又擅行气止痛;甜橙性微温,可条达肝气而疏肝解郁;芒种花清热解毒,舒肝行瘀,这三味药合用,重在疏肝解郁、行气止痛。以红泽兰、白背枫、栗壳、漏芦和青蒿为臣药。其中红泽兰性温,消瘀行水,舒肝散郁;白背枫性温,功善祛风止痛;栗壳性平,清热化痰,宽胸散结;漏芦性寒,清热散结;青蒿性寒,清热,消痰,益气。五药合用,在增加君药利气的基础上,增加消肿散结、通络止痛之功。以玫瑰花、艾叶、花叶竹芋为佐药,其中玫瑰花散瘀止痛,艾叶散寒止痛,花叶竹芋解毒消肿,这三味药药性温和,既能活血行气,又能化瘀止痛。以冰片为使药,既能散郁火止痛,又能促透皮吸收,提高药物生物利用度。诸药配伍共奏疏肝理气、消肿散结、止痛之功。
乳腺增生病位浅表,采用外治疗法确有一定的临床疗效。首先,本发明的乳膏安全可靠系数大,由于皮肤、粘膜屏障自我保护功能及使用的多为天然药物,使得其基本没有或极少有毒副作用;其次,本发明的乳膏通过局部用药,直达病所,疏通气血、化痰散结通络,可使药物浓度高度集中于疾病患处,用药疗程短,见效快;同时,具有用药方便,可自行操作,病人容易接受和坚持等优点;此外,价格相对低廉,可减轻患者经济负担。
具体实施方式
为了更好地理解本发明,下面结合实施例进一步清楚阐述本发明的内容,但本发明的保护内容不仅仅局限于下面的实施例。在下文的描述中,给出了大量具体的细节以便提供对本发明更为彻底的理解。然而,对于本领域技术人员来说显而易见的是,本发明可以无需一个或多个这些细节而得以实施。
本发明提供一种用于乳腺增生的中药乳膏,由如下重量份数的原料药制成:莪术10-25份、芒种花10-35份、栗壳10-25份、甜橙10-20份、红泽兰10-20份、漏芦5-15份、白背枫5-12份、玫瑰花5-10份、青蒿5-10份、艾叶1-10份、花叶竹芋1-10份、冰片1-5份。本发明上述重量份具体可以为g、kg或其他本领域常用计量单位。作为本发明的一种具体实施方案:以g计,莪术可以为10g、11g、12g、13g、14g、15g、16g、17g、18g、19g、20g、21g、22g、23g、24g或25g;芒种花为10g、11g、12g、13g、14g、15g、16g、17g、18g、19g、20g、21g、22g、23g、24g、25g、26g、27g、28g、29g、30g、31g、32g、33g、34g或35g;栗壳为10g、11g、12g、13g、14g、15g、16g、17g、18g、19g、20g、21g、22g、23g、24g或25g;甜橙为10g、11g、12g、13g、14g、15g、16g、17g、18g、19g或20g;红泽兰为10g、11g、12g、13g、14g、15g、16g、17g、18g、19g或20g;漏芦为5g、6g、7g、8g、9g、10g、11g、12g、13g、14g或15g;白背枫为5g、6g、7g、8g、9g、10g、11g或12g;玫瑰花为5g、6g、7g、8g、9g或10g;青蒿为5g、6g、7g、8g、9g或10g;艾叶为1g、2g、3g、4g、5g、6g、7g、8g、9g或10g;花叶竹芋为1g、2g、3g、4g、5g、6g、7g、8g、9g或10g;冰片为1g、2g、3g、4g或5g。
上述用于乳腺增生的中药乳膏的制备方法,包括以下步骤:
(1)乙醇提取:将莪术、芒种花、栗壳、甜橙、红泽兰、漏芦、白背枫、玫瑰花、青蒿、艾叶和花叶竹芋混合粉碎,加入6-8倍量的95%乙醇,回流提取2-3次,每次1-2h,合并乙醇提取液,滤过,滤液减压浓缩至60℃时相对密度为1.3-1.4的浸膏,备用;
(2)水提取:将步骤(1)滤过所得药渣加入8-10倍量的纯化水,加热提取2-3次,每次2h,合并提取液,滤过,滤液减压浓缩至60℃时相对密度为1.3-1.4的浸膏,备用;
(3)油相制备:取油相基质,加热至75℃熔融,作为油相,保温备用;
(4)水相制备:取水相基质,加入蒸馏水,加热至75℃溶解,作为水相,保温备用;
(5)乳化:将步骤(1)的浸膏加入步骤(3)的油相中,搅拌均匀,得相Ⅰ;将步骤(2)的浸膏加入步骤(4)的水相中,搅拌均匀,得相Ⅱ;将相Ⅰ与相Ⅱ混合,在75℃下乳化30-40min,温度降至40℃时,加入5倍量乙醇溶解的冰片,搅拌均匀至室温,即得。
作为本发明的一种优选实施方案,上述步骤(1)中混合粉碎的粒径为10-20目,以提高原料与溶媒的接触面积,缩短提取时间,提高有效成分转移率,提高原料的综合利用度。
作为本发明的一种优选实施方案,上述步骤(1)回流提取的温度为65-80℃。本发明首先采用乙醇回流提取,通过优选提取参数,能够更全面地提取有效成分,提取效率高,简便易操作,同时乙醇在提取后容易除去。
作为本发明的一种优选实施方案,上述步骤(2)中加热提取的温度为90-100℃。本发明在乙醇提取的基础上,将滤渣中的成分进行再提取,从而增加有效成分的溶出。
作为本发明的一种优选实施方案,上述油相基质为硬脂酸、单硬脂酸甘油酯、液体石蜡、十八醇、凡士林和羊毛脂的一种或两种以上的组合物。作为本发明的一种优选实施方案,所述水相基质为甘油、十二烷基硫酸钠、三乙醇胺和羟苯乙酯的一种或两种以上的组合物。通过油相基质和水相基质的合理搭配,乳膏具有适宜的润滑性和湿润性,易于涂抹,乳膏细腻,体感舒适。更优选地,油相基质由如下原料制成:硬脂酸5-10g、单硬脂酸甘油酯0-10g、液体石蜡30-50g、十八醇0-30g、凡士林0-30g和羊毛脂0-10g;水相基质由如下原料制成:甘油100g、十二烷基硫酸钠0-20g、三乙醇胺0-30g和羟苯乙酯0-5g。
实施例1
一种用于乳腺增生的中药乳膏,由如下原料药制成:莪术15g、芒种花20g、栗壳15g、甜橙15g、红泽兰15g、漏芦10g、白背枫8g、玫瑰花8g、青蒿8g、艾叶6g、花叶竹芋5g、冰片3g。
上述用于乳腺增生的中药乳膏的制备方法,包括以下步骤:
(1)乙醇提取:将莪术、芒种花、栗壳、甜橙、红泽兰、漏芦、白背枫、玫瑰花、青蒿、艾叶和花叶竹芋混合粉碎,粒径为10-20目,加入7倍量的95%乙醇,回流提取3次,每次1.5h,合并乙醇提取液,滤过,滤液减压浓缩至60℃时相对密度为1.32的浸膏,备用;
(2)水提取:将步骤(1)滤过所得药渣加入9倍量的纯化水,加热提取2次,每次2h,合并提取液,滤过,滤液减压浓缩至60℃时相对密度为1.31的浸膏,备用;
(3)油相制备:取油相基质,加热至75℃熔融,作为油相,保温备用;
(4)水相制备:取水相基质,加入蒸馏水,加热至75℃溶解,作为水相,保温备用;
(5)乳化:将步骤(1)的浸膏加入步骤(3)的油相中,搅拌均匀,得相Ⅰ;将步骤(2)的浸膏加入步骤(4)的水相中,搅拌均匀,得相Ⅱ;将相Ⅰ与相Ⅱ混合,在75℃下乳化35min,温度降至40℃时,加入5倍量乙醇溶解的冰片,搅拌均匀至室温,即得。
步骤(1)回流提取的温度为80℃。
步骤(2)中加热提取的温度为100℃。
油相基质为硬脂酸8g、单硬脂酸甘油酯1g、液体石蜡50g、十八醇10g、凡士林25g和羊毛脂8g。
水相基质为甘油100g、十二烷基硫酸钠5g、三乙醇胺10g和羟苯乙酯1g。
实施例2
一种用于乳腺增生的中药乳膏,由如下原料药制成:莪术25g、芒种花35g、栗壳25g、甜橙20g、红泽兰20g、漏芦15g、白背枫12g、玫瑰花10g、青蒿10g、艾叶10g、花叶竹芋10g、冰片5g。
上述用于乳腺增生的中药乳膏的制备方法,包括以下步骤:
(1)乙醇提取:将莪术、芒种花、栗壳、甜橙、红泽兰、漏芦、白背枫、玫瑰花、青蒿、艾叶和花叶竹芋混合粉碎,粒径为10-20目,加入8倍量的95%乙醇,回流提取3次,每次1h,合并乙醇提取液,滤过,滤液减压浓缩至60℃时相对密度为1.4的浸膏,备用;
(2)水提取:将步骤(1)滤过所得药渣加入10倍量的纯化水,加热提取3次,每次2h,合并提取液,滤过,滤液减压浓缩至60℃时相对密度为1.4的浸膏,备用;
(3)油相制备:取油相基质,加热至75℃熔融,作为油相,保温备用;
(4)水相制备:取水相基质,加入蒸馏水,加热至75℃溶解,作为水相,保温备用;
(5)乳化:将步骤(1)的浸膏加入步骤(3)的油相中,搅拌均匀,得相Ⅰ;将步骤(2)的浸膏加入步骤(4)的水相中,搅拌均匀,得相Ⅱ;将相Ⅰ与相Ⅱ混合,在75℃下乳化40min,温度降至40℃时,加入5倍量乙醇溶解的冰片,搅拌均匀至室温,即得。
步骤(1)回流提取的温度为75℃。
步骤(2)中加热提取的温度为95℃。
油相基质为硬脂酸10g、单硬脂酸甘油酯5g、液体石蜡30g、十八醇30g、凡士林30g和羊毛脂5g。
水相基质为甘油100g、十二烷基硫酸钠20g、三乙醇胺30g和羟苯乙酯5g。
实施例3
一种用于乳腺增生的中药乳膏,由如下原料药制成:莪术10g、芒种花10g、栗壳10g、甜橙10g、红泽兰10g、漏芦5g、白背枫5g、玫瑰花5g、青蒿5g、艾叶1g、花叶竹芋1g、冰片1g。
上述用于乳腺增生的中药乳膏的制备方法,包括以下步骤:
(1)乙醇提取:将莪术、芒种花、栗壳、甜橙、红泽兰、漏芦、白背枫、玫瑰花、青蒿、艾叶和花叶竹芋混合粉碎,粒径为10-20目,加入6倍量的95%乙醇,回流提取2次,每次2h,合并乙醇提取液,滤过,滤液减压浓缩至60℃时相对密度为1.3的浸膏,备用;
(2)水提取:将步骤(1)滤过所得药渣加入8倍量的纯化水,加热提取2次,每次2h,合并提取液,滤过,滤液减压浓缩至60℃时相对密度为1.3的浸膏,备用;
(3)油相制备:取油相基质,加热至75℃熔融,作为油相,保温备用;
(4)水相制备:取水相基质,加入蒸馏水,加热至75℃溶解,作为水相,保温备用;
(5)乳化:将步骤(1)的浸膏加入步骤(3)的油相中,搅拌均匀,得相Ⅰ;将步骤(2)的浸膏加入步骤(4)的水相中,搅拌均匀,得相Ⅱ;将相Ⅰ与相Ⅱ混合,在75℃下乳化30min,温度降至40℃时,加入5倍量乙醇溶解的冰片,搅拌均匀至室温,即得。
步骤(1)回流提取的温度为65℃。
步骤(2)中加热提取的温度为90℃。
油相基质为硬脂酸5g、单硬脂酸甘油酯10g、液体石蜡40g、十八醇20g、凡士林20g和羊毛脂10g。
水相基质为甘油100g、十二烷基硫酸钠10g、三乙醇胺20g和羟苯乙酯1g。
实施例4
一种用于乳腺增生的中药乳膏,由如下原料药制成:莪术12g、芒种花12g、栗壳12g、甜橙10g、红泽兰10g、漏芦7g、白背枫7g、玫瑰花6g、青蒿6g、艾叶3g、花叶竹芋3g、冰片2g。
上述用于乳腺增生的中药乳膏的制备方法,参阅实施例1,其中:
步骤(1)回流提取的温度为70℃。
步骤(2)中加热提取的温度为92℃。
油相基质为硬脂酸8g、液体石蜡35g、凡士林15g。
水相基质为甘油100g、十二烷基硫酸钠10g、三乙醇胺20g。
实施例5
一种用于乳腺增生的中药乳膏,由如下原料药制成:莪术20g、芒种花25g、栗壳20g、甜橙18g、红泽兰18g、漏芦12g、白背枫10g、玫瑰花9g、青蒿9g、艾叶8g、花叶竹芋8g、冰片4g。
上述用于乳腺增生的中药乳膏的制备方法,参阅实施例1,其中:
油相基质为硬脂酸10g、单硬脂酸甘油酯2g、液体石蜡40g、十八醇10g、羊毛脂5g。
水相基质为甘油100g、三乙醇胺15g和羟苯乙酯2g。
实施例6
一种用于乳腺增生的中药乳膏,由如下原料药制成:莪术23g、芒种花30g、栗壳23g、甜橙20g、红泽兰20g、漏芦15g、白背枫11g、玫瑰花10g、青蒿9g、艾叶9g、花叶竹芋9g、冰片3g。
上述用于乳腺增生的中药乳膏的制备方法,参阅实施例1,其中:
油相基质为硬脂酸5g、单硬脂酸甘油酯10g、液体石蜡50g、羊毛脂5g。
水相基质为甘油100g、十二烷基硫酸钠15g、羟苯乙酯1g。
实施例7
本实施例描述的用于乳腺增生的中药乳膏,与实施例1不同的是:
油相基质为硬脂酸10g、液体石蜡50g。
水相基质为甘油100g。
对比例1:一种用于乳腺增生的中药乳膏,通过如下制备方法获得:
(1)水提取:将莪术、芒种花、栗壳、甜橙、红泽兰、漏芦、白背枫、玫瑰花、青蒿、艾叶和花叶竹芋混合粉碎,粒径为10-20目,加入10倍量的纯化水,加热至90℃,提取3次,每次2h,合并提取液,滤过,滤液减压浓缩至60℃时相对密度为1.32的浸膏,备用;
(2)油相制备:取油相基质,加热至75℃熔融,作为油相,保温备用;
(3)水相制备:取水相基质,加入蒸馏水,加热至75℃溶解,作为水相,保温备用;
(4)乳化:将步骤(1)的浸膏、步骤(2)的油相、步骤(3)的水相混合,搅拌均匀,在75℃下乳化45min,温度降至40℃时,加入5倍量乙醇溶解的冰片,搅拌均匀至室温,即得。
其中,油相基质与水相基质同实施例1。
对比例2:一种用于乳腺增生的中药乳膏由如下原料药制成:莪术30g、芒种花20g、栗壳15g、红泽兰15g、漏芦10g、白背枫8g、玫瑰花8g、青蒿8g、艾叶6g、花叶竹芋5g、冰片3g。
对比例3:一种用于乳腺增生的中药乳膏由如下原料药制成:莪术35g、栗壳15g、甜橙15g、红泽兰15g、漏芦10g、白背枫8g、玫瑰花8g、青蒿8g、艾叶6g、花叶竹芋5g、冰片3g。
对比例4:一种用于乳腺增生的中药乳膏由如下原料药制成:芒种花25g、栗壳15g、甜橙25g、红泽兰15g、漏芦10g、白背枫8g、玫瑰花8g、青蒿8g、艾叶6g、花叶竹芋5g、冰片3g。
上述对比例2-4的制备方法均参阅实施例1。
效果评价:
1、本发明乳膏的安全性试验
1)皮肤急性毒性试验:取健康白色家兔12只,雌雄各半,动物在受试前24h,对称剪去脊柱两侧毛约5×10cm2,依体重性别随机分为3组,即空白对照组、完整皮肤组、破损皮肤组,每组4只。空白对照组将基质2.0g涂布于家兔背部脱毛区,完整皮肤组将中药乳膏2.0g涂布于家兔背部脱毛区完整皮肤,破损皮肤组将中药乳膏2.0g涂布于家兔背部脱毛区破损皮肤。24h后用温水洗去残留的受试药物。连续观察7d,观察家兔全身表现和中毒死亡情况。
结果显示:各组动物在给药后24h及7d观察期间无死亡,各组家兔外观、活动状态、精神状态、摄食、饮水、皮毛、呼吸、口眼鼻耳分泌物、大、小便情况均无异常。表明中药乳膏对动物无明显毒性。
2)急性皮肤刺激性试验:取健康白色家兔12只,雌雄各半,采用同体左右侧自身对比,随机分为完整皮肤组和破损皮肤组,每组6只。家兔破损皮肤用消毒针头对消毒皮肤做“#”字形划痕,以轻微渗血为度。左侧背部涂以中药乳膏0.5g,右侧背涂以基质0.5g,各组家兔均用消毒纱布覆盖,胶布固定脱毛区。每只动物分笼饲养,24h后用温水洗去残留的受试药物。于清除受试物后的1、24、48和72h观察涂抹部位皮肤反应,按表1进行皮肤反应评分,以受试家兔的平均值进行综合评价,根据24、48和72h各观察时点最高积分均值,按表2判定皮肤刺激强度。
结果显示:家兔完整皮肤和破损皮肤接触相同剂量的乳膏和基质后不同时间,动物均未见局部红斑和水肿及色素沉着、出血点、皮肤粗糙或皮肤菲薄等情况,同体左右侧比较未见异常反应,见表3。
表1皮肤刺激反应评分标准
表2皮肤刺激强度分级标准
表3皮肤刺激性试验结果(n=6)
从表3中看出,本发明治疗乳腺增生的中药乳膏刺激强度评价小于0.5,均为无刺激性。
2、本发明乳膏对乳腺增生模型小鼠的治疗作用
1)实验动物:雌性C57BL/6J小鼠96只,体质量22±2g,8周龄,SPF级,购于广州中医药大学实验动物中心,动物合格证号:SCXK(粤)2018-0034。饲养湿度为30%-60%,温度20-25℃。所有小鼠均自由取食,常规饲养1周后进行实验。
2)动物分组及药物:96只雌性小鼠随机分为空白组、模型组、对照组、对比1组、对比2组、对比3组、对比4组及实验组各12只。除空白组外,各组小鼠前25d给予经橄榄油稀释的苯甲酸雌二醇注射液(0.5mg·kg-1),肌肉注射25d;第26天改为橄榄油稀释的黄体酮注射液(5mg·kg-1),连续肌肉注射5d,以建立乳腺增生模型。同时,空白组和模型组小鼠灌胃给予生理盐水;对照组给予乳癖消片(沈阳红药)1.0g/kg,每天灌胃1次;对比1组给予小鼠乳房部涂抹对比例1外用乳膏0.5g,每天1次;对比2组给予小鼠乳房部涂抹对比例2外用乳膏0.5g,每天1次;对比3组给予小鼠乳房部涂抹对比例3外用乳膏0.5g,每天1次;对比4组给予小鼠乳房部涂抹对比例4外用乳膏0.5g,每天1次;实验组给予小鼠乳房部涂抹本发明外用乳膏0.5g,每天1次;连续30d。
3)实验结果
统计学方法:采用SPSS16.0统计学软件,计量资料以均数±标准差(±s)表示,组间两两比较采用t检验。P<0.05为差异有统计学意义。
3.1立体定量分析法的测定:使用100g·L-1的水合氯醛麻醉各组小鼠后,摘下各组小鼠乳房,4%甲醛溶液固定,脱水,包埋,以5μm连续切片,常规脱蜡至水,选取每张病理切片3个不同的视野,对每个视野进行立体计量学测定乳腺小叶体密度、乳腺小叶间质体密度及腺泡比表面积。
表1各组乳腺小叶体密度、乳腺小叶间质体密度及腺泡比表面积比较
注:与空白组比较,*P<0.01;与模型组比较,#P<0.05;与对照组比较,△P<0.05。
表1显示,与空白组比较,模型组乳腺小叶体密度和腺泡比表面积显著上升(P<0.01),乳腺小叶间质体密度显著下降(P<0.01),说明模型建立成功。与模型组比较,实验组乳腺小叶体密度和腺泡比表面积均明显下降(P<0.05),乳腺小叶间质体密度显著上升(P<0.05)。与对照组比较,实验组乳腺小叶体密度、乳腺小叶间质体密度和腺泡比表面积无显著差异,说明实验组获得了与乳癖消片基本一致的效果,且从上述参数来看,实验组的效果要略优于乳癖消片。
3.2酶联免疫法的测定:小鼠采用100g·L-1的水合氯醛给予麻醉,腹主动脉取血,将血液放置室温30min静置后,4℃3500r·min-1,离心半径12cm,离心5min,上清取血清,ELISA法测定雌二醇和黄体酮的水平。
表2各组雌二醇和黄体酮比较
注:与空白组比较,*P<0.01;与模型组比较,#P<0.05;与对照组比较,△P<0.05。
表2显示,与空白组比较,模型组雌二醇水平显著升高(P<0.01),血清黄体酮水平显著降低(P<0.01)。与模型组比较,实验组雌二醇显著下降(P<0.05),血清黄体酮水平显著上升(P<0.05)。
3.3胸腺指数和子宫指数的测定:100g·L-1的水合氯醛麻醉各组小鼠后,摘下各组的胸腺和子宫,并测量胸腺指数和子宫指数。
胸腺指数和子宫指数的计算:用滤纸吸干残血后,对胸腺和子宫分别进行称重(mg),分别除以小鼠体重(g),再乘以10,分别得到胸腺指数和子宫指数,即:
胸腺指数=(胸腺重量/小鼠体重)×10;
子宫指数=(子宫重量/小鼠体重)×10
表3各组雌二醇和黄体酮比较
注:与空白组比较,*P<0.05;与模型组比较,#P<0.05;与对照组比较,△P<0.05。
表3显示,与对照组比较,模型组胸腺指数明显增大(P<0.05),子宫指数明显减小(P<0.05)。与模型组比较,实验组胸腺指数和子宫指数明显改善。
上述实验结果显示,本发明外用乳膏以莪术、甜橙和芒种花为君药,重在疏肝解郁、行气止痛;以红泽兰、白背枫、栗壳、漏芦和青蒿为臣药,在增加君药利气的基础上,增加消肿散结、通络止痛之功;以玫瑰花、艾叶、花叶竹芋为佐药,既能活血行气,又能化瘀止痛;以冰片为使药,既能散郁火止痛,又能促透皮吸收,提高药物生物利用度。诸药配伍共奏疏肝理气、消肿散结、止痛之功。与模型组比较,外用给药30d后,实验组的乳腺小叶体密度和腺泡比表面积显著下降(P<0.05),乳腺小叶间质体密度显著上升(P<0.05);大鼠血清中雌二醇水平显著下降,黄体酮水平显著升高,表明它可通过调控性激素水平对乳腺增生起到保护或治疗作用,并能够改善相关脏器指数(P<0.05)。
综上所述,以上均是本发明优选实施方式,在不脱离本发明原理的条件下,还可以做出若干修饰和改造,均包含在本发明的保护范围之内。
Claims (5)
1.一种用于乳腺增生的中药乳膏,其特征在于,由如下重量份数的原料药制成:莪术10-25份、芒种花10-35份、栗壳10-25份、甜橙10-20份、红泽兰10-20份、漏芦5-15份、白背枫5-12份、玫瑰花5-10份、青蒿5-10份、艾叶1-10份、花叶竹芋1-10份、冰片1-5份;
所述的用于乳腺增生的中药乳膏的制备方法,包括以下步骤:
(1)乙醇提取:将莪术、芒种花、栗壳、甜橙、红泽兰、漏芦、白背枫、玫瑰花、青蒿、艾叶和花叶竹芋混合粉碎,加入6-8倍量的95%乙醇,65-80℃条件下回流提取2-3次,每次1-2h,合并乙醇提取液,滤过,滤液减压浓缩至60℃时相对密度为1.3-1.4的浸膏,备用;
(2)水提取:将步骤(1)滤过所得药渣加入8-10倍量的纯化水,90-100℃条件下加热提取2-3次,每次2h,合并提取液,滤过,滤液减压浓缩至60℃时相对密度为1.3-1.4的浸膏,备用;
(3)油相制备:取油相基质,加热至75℃熔融,作为油相,保温备用;
所述油相基质由如下原料制成:硬脂酸5-10重量份、单硬脂酸甘油酯0-10重量份、液体石蜡30-50重量份、十八醇0-30重量份、凡士林0-30重量份和羊毛脂0-10重量份;
(4)水相制备:取水相基质,加入蒸馏水,加热至75℃溶解,作为水相,保温备用;
所述水相基质由如下原料制成:甘油100重量份、十二烷基硫酸钠0-20重量份、三乙醇胺0-30重量份和羟苯乙酯0-5重量份;
(5)乳化:将步骤(1)的浸膏加入步骤(3)的油相中,搅拌均匀,得相Ⅰ;将步骤(2)的浸膏加入步骤(4)的水相中,搅拌均匀,得相Ⅱ;将相Ⅰ与相Ⅱ混合,在75℃下乳化30-40min,温度降至40℃时,加入5倍量乙醇溶解的冰片,搅拌均匀至室温,即得。
2.根据权利要求1所述的用于乳腺增生的中药乳膏,其特征在于,由如下重量份数的原料药制成:莪术10份、芒种花10份、栗壳10份、甜橙10份、红泽兰10份、漏芦5份、白背枫5份、玫瑰花5份、青蒿5份、艾叶1份、花叶竹芋1份、冰片1份。
3.根据权利要求1所述的用于乳腺增生的中药乳膏,其特征在于,由如下重量份数的原料药制成:莪术25份、芒种花35份、栗壳25份、甜橙20份、红泽兰20份、漏芦15份、白背枫12份、玫瑰花10份、青蒿10份、艾叶10份、花叶竹芋10份、冰片5份。
4.根据权利要求1所述的用于乳腺增生的中药乳膏,其特征在于,由如下重量份数的原料药制成:莪术15份、芒种花20份、栗壳15份、甜橙15份、红泽兰15份、漏芦10份、白背枫8份、玫瑰花8份、青蒿8份、艾叶6份、花叶竹芋5份、冰片3份。
5.根据权利要求1-4任一项所述的用于乳腺增生的中药乳膏,其特征在于,所述步骤(1)中混合粉碎的粒径为10-20目。
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