CN114699465B - 一种外用治疗皮肤炎症的沉香提取物及其应用 - Google Patents
一种外用治疗皮肤炎症的沉香提取物及其应用 Download PDFInfo
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
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- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
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- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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Abstract
本申请提供一种外用治疗皮肤炎症的沉香提取物及其应用。本申请通过水蒸气蒸馏法对沉香进行提取，发现其蒸馏液具有明显的抗炎和治疗湿疹的功效。
Description
技术领域
本申请涉及一种中药提取物及其应用，具体涉及一种沉香提取物及其在外用治疗皮肤炎症方面的新用途，属于中医药领域。
背景技术
从中医的角度来说，导致湿疹的原因可分为血热、风邪等外因因素，以及湿重、脾虚等内因因素，通常都是因为外因出现，进而诱发内因引起湿疹。所谓内因湿重、脾虚引起的湿疹，也就是大家常说的脾湿，是指胃肠功能不正常，导致食物无法充分消化吸收，使水湿停留在体内，当水湿跑到皮肤，就会形成湿疹。此外，情绪紧张、睡眠不足等内因因素，也会使身体免疫力变差，提高皮肤的敏感度，诱发异位性湿疹。湿疹在中医文献中拥有“浸淫疮”、“旋耳疮”、“绣球风”等多种别称，分发作部位及人群不同又有多种分类。近年来，湿疹的发病率呈现上升趋势，专家认为这与气候的变化、日常生活中大量化学制品的应用、都市生活饮食结构的改变等有密切联系。
沉香为瑞香科植物白木香Aquilaria sinensis(Lour.)Gilg含有树脂的木材。入脾、肾经，功效行气止痛，温中止呕，纳气平喘。主要化学成分包括木脂素类和挥发油类等，目前临床主要将其分为木脂素类和新木脂素类，以木脂素类来说，主要包括芳香丁内酯类、四氢呋喃类，芳香丁内酯类具有抗炎、镇痛及抗病毒的功效。挥发油类是一组成分较为复杂的混合物，特点为具有芳香气味，可以随着水蒸气蒸馏提取但不会与水相溶。挥发油类的成分主要包括芳香族化合物、萜类成分、色酮类，有临床研究通过蒸馏-萃取装置顺利提取了挥发油类中的17种成分，并且证明花姜酮是挥发油类的主要成分，可以占到64.7％，被认为是沉香的主要药效物质，挥发油类研究一直被临床广泛关注，研究发现挥发油类化合物可有效治疗癌症和心血管疾病，具有抗菌消炎、止咳平喘、健胃、解热和抗病毒的功效。目前针对沉香的研究主要集中于水蒸气蒸馏提取的挥发油成分，而对于蒸馏液研究较少。
发明内容
本申请的目的在于提供一种外用治疗皮肤炎症的沉香提取物及其应用。
作为本申请的一个方面，本申请提供一种外用治疗皮肤炎症的沉香提取物，所述提取物按如下方法制备：
取沉香药材，粉碎，采用水蒸气蒸馏法进行提取，收集蒸馏液，即为沉香提取物。
作为本申请的另一个方面，本申请提供所述沉香提取物在制备外用治疗皮肤炎症的药物中的应用。
其中，所述皮肤炎症包括湿疹、过敏性皮炎、荨麻疹、虫咬皮炎等。
作为本申请的第三个方面，本申请提供一种外用治疗皮肤炎症的中药制剂，所述制剂包括作为活性成分的沉香提取物和药学上可接受的载体，所述沉香提取物按如下方法制备：
取沉香药材，粉碎，采用水蒸气蒸馏法进行提取，收集蒸馏液，即为沉香提取物。
所述外用制剂包括喷雾剂、涂膜剂、搽剂、酊剂、乳化剂、悬浮液、纳米乳化剂、纳米悬浮液、脂质体、乳膏剂、软膏剂、糊剂、凝胶剂、贴剂、巴布剂、沐浴液(露)等；所述常规外用辅料包括表面活性剂、乳化剂、保湿剂、防腐剂、抗氧剂、增稠剂、增溶剂、抛射剂、透皮促进剂、矫味剂等。其中，表面活性剂包括硬脂酸、十二烷基苯磺酸钠、季铵化物、卵磷脂、氨基酸性、甜菜碱、脂肪酸甘油酯、脂肪酸山梨坦、聚山梨酯等；保湿剂包括丙三醇、丁二醇、聚乙二醇、丙二醇、木糖醇、聚丙二醇、山梨糖醇等；增稠剂包括甲基纤维素、羧甲基纤维素、羟乙基纤维素、羟丙基甲基纤维素、聚丙烯酸酯、明胶、海藻酸钠等；矫味剂包括卵磷脂、甘油、山梨醇、甘露醇、薄荷油、香精等。
本申请的有益效果：
1、获得了一种新的外用治疗皮肤炎症的沉香提取物(即沉香纯露)。本申请意外发现以水蒸气蒸馏法对沉香进行提取获得的蒸馏液具有明显的治疗皮肤炎症的功效。这是现有技术没有公开的。
2、方法简便，提取率高。本申请以水蒸气蒸馏法制备沉香纯露，水蒸气蒸馏法提取装置简便且无污染，50g沉香药材可以得到60ml左右的纯露，而仅能得到0.7ml左右的精油。可见，纯露的获得率大大高于精油，能够更充分的利用沉香。
3、提高了沉香的利用率：沉香是传统名贵药材和名贵的天然香料，但是由于国内沉香种植面积小，加之种香容易产香难，天然沉香不可再生性。诸多提取沉香精油的方法中，水蒸气蒸馏是最传统也最为最常见的一种。水蒸气蒸馏法可获得沉香精油、蒸馏液和药渣三部分，针对沉香的研究以往多集中在挥发油成分，而蒸馏液和药渣则被弃去，造成了沉香资源的浪费。而本申请意外发现以水蒸气蒸馏法对沉香进行提取获得的蒸馏液具有明显的抗炎和外用治疗湿疹的功效。这一发现大大了提高沉香的利用率。
附图说明
图1为各组小鼠耳变应评分。
图2为沉香纯露GC-MS色谱图。
图3为沉香精油GC-MS色谱图。
具体实施方式
下面对本发明的实施例作详细说明，本实施例在以本发明技术方案为前提下进行实施，给出了详细的实施方式和具体的操作过程，但本发明的保护范围不限于下述的实施例。
实施例1沉香提取物的制备
称取沉香50g，粉碎，加入适量蒸馏水至所得沉香粗粉中，水蒸气蒸馏五小时，分别收集挥发油和蒸馏液。
共得到挥发油(沉香精油)0.7ml和蒸馏液(沉香纯露)60ml。
实施例2药效实验
1实验药物
实验药物：实施例1制备的沉香纯露、沉香精油。
阳性对照药：复方醋酸地塞米松乳膏。
2动物分组及造模
实验动物购至斯贝福(北京)生物技术有限公司。SPF级雄性昆明小鼠50只，体质量(20±2)g。50只小鼠按体质量随机分成5组，每组10只：①正常组、②模型组、③沉香纯露组、④沉香精油组、⑤阳性药组，适应性饲养3天后，小剂量反复涂抹DNCB(二硝基氯苯)建立湿疹模型。
造模：除去正常组之外，其余40只小鼠在实验前1天于腹部去毛，面积约为2.0cm×2.0cm，实验第1天，用移液枪吸取7％DNCB溶液25uL，涂抹于小鼠腹部剪毛区致敏，第2天再次致敏1次，第5天开始在小鼠右耳双面涂抹0.1％DNCB溶液5uL致敏，每隔两天进行1次，共4次。观察各组动物的行为状态，出现皮肤粗糙，干燥，小鼠有明显的烦躁不安，即为造模成功。末次激发后，从抓挠、水肿、红斑三个方面对小鼠右耳变应反应评分，最高分值8分，取每组平均值，评分表见表1。
表1耳变应反应评分表
| 评分项目 | 反应强度 | 分值 |
| 抓挠 | 无 | 0 |
| 有 | 1 | |
| 水肿 | 无水肿 | 0 |
| 轻微水肿 | 1 | |
| 中度水肿 | 2 | |
| 严重水肿 | 3 | |
| 红斑 | 无红斑 | 0 |
| 轻微红斑 | 1 | |
| 中度红斑 | 2 | |
| 中度红斑伴有结痂 | 3 | |
| 严重红斑伴有结痂 | 4 |
给药：末次致敏24h后给药，正常组和模型组予以1ml生理盐水涂抹双耳及腹部致敏区，沉香纯露组予以1ml涂抹双耳及腹部致敏区，沉香精油组予以1ml涂抹双耳及腹部致敏区，阳性药组予以复方醋酸地塞米松乳膏50mg涂抹双耳及腹部致敏区，连续给药14天，根据体质量变化情况，随时调整给药剂量。末次给药1h后，昆明小鼠取血，测定血清中IL-6炎症因子的浓度。使用直径8mm打孔器在左右耳中部同一部位打孔取圆形耳片，立即用电子分析天平称量耳片质量，并计算肿胀度、肿胀率及肿胀抑制率。肿胀度＝右耳重量-左耳重量；肿胀率＝肿胀度/左耳重量；肿胀抑制率(％)＝[(模型组平均肿胀度-给药组平均肿胀度)/模型组平均肿胀度]×100％。
3实验结果
从末次激发到最后处死小鼠共计进行评分6次。结果见图1，与空白组相比DNCB刺激的各组小鼠耳变应评分均有增加；与模型组相比，沉香纯露组、沉香精油组及阳性药组小鼠的耳变应评分有不同程度的降低，且阳性药优于沉香纯露，沉香纯露优于沉香精油。
通过左右耳对比，模型组小鼠右耳明显肿胀，质量明显比左耳增加，具有显著统计学差异(P<0.05)；与模型组相比，阳性药组小鼠右耳无充血现象，能够显著抑制小鼠耳肿胀，有显著统计学差异(P<0.05)；沉香纯露组小鼠右耳可见明显发红，有轻微肿胀现象，有显著统计学差异(P<0.05)；沉香精油组小鼠右耳可见明显发红，有轻微肿胀现象，有显著统计学差异(P<0.05)。结果见表2。
表2各组动物肿胀度与肿胀率(n＝10)
| 肿胀度 | 肿胀率 | 肿胀抑制率(％) | |
| 正常组 | - | - | - |
| 模型组 | 14.83±3.26* | 1.22±0.31* | - |
| 沉香纯露组 | 9.85±3.28△ | 0.75±0.22△ | 33.58 |
| 沉香精油组 | 10.19±2.97△ | 0.80±0.23△ | 31.29 |
| 阳性药组 | 7.44±3.16△ | 0.57±0.23△ | 49.81 |
注：*，模型组与对照组比较P＜0.05；△给药组与模型组比较P＜0.05
与正常组相比，模型组血清中IL-6水平显著升高，差异具有统计学意义(P<0.05)。与模型组相比，阳性药组、沉香纯露组及沉香精油组小鼠血清中IL-6水平显著下降，差异具有统计学意义(P<0.05)。结果见表3。
表3各组动物IL-6水平(n＝10)
| IL-6(pg/ml) | |
| 正常组 | 2.93±0.98 |
| 模型组 | 18.91±2.80* |
| 沉香纯露组 | 10.82±2.96△ |
| 沉香精油组 | 11.01±3.26△ |
| 阳性药组 | 6.85±1.15△ |
注：*，模型组与对照组比较P＜0.05；△给药组与模型组比较P＜0.05实施例3沉香纯露和沉香精油主要成分比较
取实施例1制备的沉香精油和沉香纯露，采用GC-MS方法测定其主要成分。
检测方法：
色谱柱为Agilent 19091S-433UI HP-5ms超高惰性色谱柱(30m×250μm×0.25μm)；初始温度50℃，以10℃/min升温至130℃。以2℃/min升温至170℃。以3℃/min升温至230℃，维持10min。载气为高纯氦气(99.999％)；载气流量1.0mL/min；分流比10:1；离子源为EI源；离子源温度230℃；四级杆温度150℃；电子能量70eV；传输线温度250℃；质量范围m/z：50-600。
检测结果：
结果见图2、3和表4、5。可见，沉香纯露和沉香精油在相同条件下的相同保留时间没有共有峰，说明二者成分显著不同。通过色谱峰归属沉香纯露的组成成分主要是脂肪族成分，而沉香精油则是色酮类成分，二者在主要成分组成上有明显区别。
表4沉香纯露主要成分
表5沉香精油主要成分
实施例4喷雾剂的制备
取实施例1制备的沉香纯露，加入樟脑、薄荷脑及冰片以及适量乙醇混匀，静置，滤过，灌装，封口，充入抛射剂适量，即得。
实施例5贴敷剂的制备
取实施例1制备的沉香纯露，加入0.5％OW340B，8％1,3—丁二醇，68.8％去离子水，防腐剂混合均匀，浸于无纺布类纤维织物，放入包装物中，密封，即得。
实施例6涂膜剂的制备
取实施例1制备的沉香纯露，将10％硅酸铝镁胶体加水溶胀后，边搅拌，边依次加入沉香纯露、5％聚氧乙烯甘油椰油酸酯，10％乙醇(96％)，15％米淀粉，57％去离子水，防腐剂，搅拌均匀，形成胶体即可。
实施例7乳膏剂的制备
取实施例1制备的沉香纯露，硬脂酸、单甘油酯、白凡士林、羊毛脂、液体石蜡、三乙醇胺、蒸馏水、樟脑适量，按常规制剂工艺制成乳膏剂。
Claims (1)
1.一种沉香提取物在制备外用治疗皮肤炎症的药物中的应用；其特征在于，所述皮肤炎症为湿疹；
所述沉香提取物按如下方法制备：取沉香药材，粉碎，加入适量蒸馏水至沉香粗粉中，水蒸气蒸馏五小时，收集蒸馏液，即为沉香提取物。
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