CN110946894A - 一种治疗肺动脉高压的藏药及其制备方法和应用 - Google Patents
一种治疗肺动脉高压的藏药及其制备方法和应用 Download PDFInfo
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Abstract
本发明公开了一种治疗肺动脉高压的藏药及其制备方法和应用。本发明藏药的活性组分包括丛菔、岩白菜、甘草、紫草茸。本发明藏药的制备方法是将所述活性组分与药学上可接受的辅料按照药剂学上的常规方法制成散剂、丸剂、颗粒剂、胶囊剂或片剂等。本发明的藏药可用于制备治疗泡肺动脉高压药物、保健品。本发明的藏药活性组分菔、岩白菜、甘草、紫草茸能够显著降低由低氧所引起的肺动脉高压，且药物的制备方法简便，用药成本较低，提高了肺动脉高压的治疗便利性。
Description
技术领域
本发明涉及医药技术领域，特别是涉及一种治疗肺动脉高压的藏药及其制备方法和应用。
背景技术
肺动脉高压( pulmonary arterial hypertension，PAH )是不同病因导致的以肺动脉压力和肺血管阻力升高为特点的一组疾病或临床综合征，其发病机制包括血管收缩、血管重构和血栓形成。国际原发性肺动脉高压专题研讨会提出的分类系统将肺动脉高压分成5种类型:1)与呼吸系统疾病和/或低氧血症有关的肺动脉高压；2)肺静脉高压；3)慢性血栓和/或栓塞性疾病；4)肺小动脉高压；5)直接影响肺血管组织疾病所致的肺动脉高压。如果PAH不加治疗，最终可导致右心衰竭、容量负荷增加而至死亡。目前，治疗肺动脉高压的药物主要是血管扩张剂，如α受体阻滞剂、钙拮抗剂血管紧张素转换酶抑制剂、磷酸二酯酶抑制剂、前列腺素类( PG)药物、硝基类血管扩张剂等。这些药物虽然具有改善患者呼吸困难、6分钟步行距离 (6MWD) 和肺血液动力学等方面的作用，但在治疗效果、制备和用药成本、治疗便利性方面均存在不同缺陷。
丛菔，为宽果丛菔Solms-Laubachia eurycarpa的干燥根茎，广泛用亍藏药复方中，具有清热解毒、清肺止咳、止血、消肿功效。岩白菜，为虎耳草科植物 Bergenia purpurascens全草，具有清热解毒、止咳止痛等功效，化学成分主要有岩白菜素、熊果苷、儿茶素、表儿茶素等。甘草，为豆科植物甘草(Glycyrrhiza uralensis、胀果甘草（Glycyrrhiza inflate) 及光果甘草（Glycyrrhiza glabral）的干燥根和根茎。具有补脾益气、祛痰止咳、清热解毒、缓急止痛、调和诸药之功效。其化学成分有甘草酸、甘草次酸、槲皮素等三萜皂苷类化合物、黄酮及其苷类、多糖等多种化学成分。紫草茸，为紫胶虫科昆虫紫胶虫在树枝上所分泌的胶质物，具有消毒、止血、活血化瘀的功效，主要含有虫胶质、蜡、及蒽醌类色素物质（Laccaicacid A-E）。尚无文献报道上述活性成分对于肺动脉高压的治疗有相关作用。
发明内容
基于此，有必要针对目前肺动脉高压药物治疗效果欠佳，药物制备和用药成本较高，治疗便利性不足的问题，提供一种以丛菔、岩白菜、甘草、紫草茸为活性组分的治疗药物。
一种治疗肺动脉高压的藏药，所述藏药的活性组分包括如下原料药：丛菔、岩白菜、甘草、紫草茸。
在其中一个实施例中，所述藏药的活性组分由如下重量份的原料药通过粉碎法或水提法或醇提法制成：丛菔200份、岩白菜160份、甘草100份、紫草茸100份。
在其中一个实施例中，将丛菔、岩白菜、甘草干燥根茎粉碎，用水或乙醇进行提取，提取液减压浓缩成浸膏并冷冻干燥，得药物提取物。
在其中一个实施例中，用水或乙醇进行提取过程中提取溶剂用量为药材重量的5-10倍；提取过程重复2-3次，每次提取时间为1-2小时；乙醇在0%-95%。
在其中一个实施例中，所述藏药由活性组分和药学上可接受的辅料制成。
本发明所述藏药的给药剂型可以是液体剂型、固体剂型或半固体剂型。液体剂型可以是溶液剂、乳剂、混悬剂、注射剂、滴眼剂、滴鼻剂、洗剂和搽剂等。固体剂型可以是片剂( 包括普通片、肠溶片、含片、分散片、咀嚼片、泡腾片、口腔崩解片)、胶囊剂( 包括硬胶囊、软胶囊、肠溶胶囊)、颗粒剂、散剂、微丸、滴丸、栓剂、膜剂、贴片、气( 粉) 雾剂、喷雾剂等；半固体剂型可以是软膏剂、凝胶剂、糊剂等。
本发明所述藏药可以制成普通制剂、也可以是缓释制剂、控释制剂、靶向制剂及各种微粒给药系统。
在其中一个实施例中，所述藏药的剂型为散剂、丸剂、颗粒剂、胶囊剂或片剂等。
本发明所述藏药的给药途径可为经胃肠道或非经胃肠道，如口服、肺、鼻腔、皮下、舌下、皮肤、肌肉、直肠等，优选口服给药。
本发明所述藏药的给药剂量取决于许多因素，例如所要预防或治疗疾病的性质和严重程度，患者或动物的性别、年龄、体重、性格及个体反应，给药途径、给药次数、治疗目的，因此本发明的治疗剂量可以有大范围的变化。本发明的药物组合物可单独服用，或与其他治疗药物或对症药物合并使用并调整剂量。
在其中一个实施例中，所述活性组分占药物总重量的0.1～99％。
为达到用药目的，增强治疗效果，本发明的藏药可用任何公知的给药方法给药。
此外，如需要，也可以向药物制剂中添加着色剂、防腐剂、香料、矫味剂、甜味剂或其他材料。
本发明还提供了所述的治疗肺动脉高压的藏药在制备治疗肺动脉高压的药物、保健品中的应用。
附图说明
图1为本发明实施例中不同组别大鼠动脉压的测量结果比较示意图；
图2为本发明实施例中不同组别大鼠肺组织的HE染色图；
图3为本发明实施例中不同组别大鼠肺组织血管壁厚所占比示意图。
具体实施方式
为使本发明的上述目的、特征和优点能够更加明显易懂，下面结合附图对本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施，本领域技术人员可以在不违背本发明内涵的情况下做类似改进，因此本发明不受下面公开的具体实施例的限制。
一种治疗肺动脉高压的藏药，所述藏药的活性组分包括如下原料药：丛菔、岩白菜、甘草、紫草茸。
优选地，所述活性组分由如下重量份的原料药通过粉碎法或水提法或醇提法制成：丛菔200份、岩白菜160份、甘草100份、紫草茸100份。
优选地，所述藏药由活性组分和药学上可接受的辅料制成。
优选地，所述藏药的剂型为散剂、丸剂、颗粒剂、胶囊剂或片剂等。
优选地，所述活性组分占药物总重量的0.1～99％。
一种治疗肺动脉高压的藏药的制备方法，包括如下步骤：将所述活性组分与药学上可接受的辅料按照药剂学上的常规方法制成散剂、丸剂、颗粒剂、胶囊剂或片剂等。
上述治疗肺动脉高压的藏药在制备治疗肺动脉高压的药物、保健品中的应用。
本发明与现有技术相比具有如下优点：
本发明的藏药活性组分菔、岩白菜、甘草、紫草茸能够显著降低由低氧所引起的肺动脉高压，且药物的制备方法简便，用药成本较低，提高了肺动脉高压的治疗便利性。
实施例
药物活性组分的制备：
采用干燥丛菔、岩白菜、甘草根茎、紫草茸作为原生药，按2:1.6:1:1的重量比混合粉碎后以水回流提取3 次，每次用量为原生药重量的5 倍，提取时间为每次1.5 小时，将提取液合并后过滤，滤液减压浓缩得浸膏，经冷冻干燥后得到药物提取物。
采用干燥丛菔、岩白菜、甘草根茎、紫草茸作为原生药，按2:1.6:1:1的重量比混合粉碎后以95%乙醇回流提取3 次，每次用量为原生药重量的5 倍，提取时间为每次1.5 小时，将提取液合并后过滤，滤液减压浓缩得浸膏，经冷冻干燥后得到药物提取物。
降低肺动脉压作用药理活性实验：
实验动物：健康雄性Sprague-Dawley（SD）大鼠，购置于西安交通大学动物实验中心（实验动物使用许可证号SCXK(陕)2017-003），6-8周龄，体重为250-300 g。
实验仪器：电子枰：SHANGPING(YP601N)、Biopac多导生理记录仪、转轮式切片机（徕卡-2016，德国）；TSJ-Ⅱ型全自动封闭式组织脱水机（常州市中威电子仪器有限公司）；BMJ-Ⅲ型包埋机（常州郊区中威电子仪器厂）；PHY-Ⅲ型病理组织漂烘仪（常州市中威电子仪器有限公司）；数码三目摄像显微镜（BA400 Digital，麦克奥迪实业集团有限公司）等；图像分析软件Motic Images Advanced。
肺动脉高压模型复制SD 大鼠随机分为3组，每组 6 只，分别为：①常氧组（Control）：大鼠于当天用20%乌拉坦腹腔麻醉（0.5 ml/0.1kg）并测定肺动脉压，仰卧固定后打开胸腔，将心肺快速取出，取材留样；②低氧组（Hypoxia）：大鼠置于低压氧舱内饲养（海拔5000米）30 天，复制大鼠PAH模型；③低氧给予药物组（SBG）：大鼠低氧暴露后，每天灌胃给药生药材剂量为2.74 g/Kg，连续给予30 天。
导管法测量右心室收缩压：于30天后，将各组大鼠用 10 g/L 的戊巴比妥钠（40mg/kg）麻醉后，固定于手术台，分离出右颈外静脉，结扎远心端，动脉夹阻断近心端，使用聚乙烯导管（导管内充满 0.5％肝素溶液）行右颈静脉插管术，连接压力换能器和生理记录仪。导管进入血管后，缓慢推进，并同时观测记录仪显示，待显示右心室动脉压力曲线后，固定导管，并记录 30 s 压力曲线。经记录仪分析软件计算出右心室收缩末期压力（right-ventricular systolic pressure，RVSP)。
右心室肥厚指数的测量：将 mPAP测量完毕后，立即剪开大鼠胸腔，并确定导管位置在右心室，取出心脏，剪去左右心房组织，并沿室间隔边缘剪下右心室组织，分别称重。计算出右心室与左心室加室间隔比值（RV/LV+S），即右心室肥厚指数（right ventricularhypertrophy index，RVHI），以此确定右心室有无肥厚。
组织取材及固定：肺小血管重塑观察及图像处理，大鼠左侧肺组织经中性缓冲福尔马林固定，石蜡包埋切片，HE染色，光镜下观察肺小血管重塑情况。取直径100μm左右的肺动脉, 用图像分析系统进行形态计量分析, 以血管壁横断面积占血管横断面积比值(WT%)作为衡量缺氧性肺血管重塑的指标。
统计分析：实验结果以均数±标准差（mean±SEM)表示，数据使用 SPSS13.0 软件分析。组间差异使用 One-way ANOVA 分析，P<0.05 有统计学差异。
实验结果：药物对低氧刺激下大鼠肺动脉压的影响如图1所示：与常氧组比较，低氧使大鼠肺动脉压增加明显（30.04±1.98 vs 22±1.55 mmHg），同时右心室肥厚指数也明显增加（0.35±0.08 vs 0.55±0.12）；药物干预后使这两个指标都有明显降低（22.17±1.83 vs 0.42±0.07），具体数据见表1。
表1
| mPAP | 右心肥厚指数 | |
| Control | 22±1.55 | 0.35±0.08 |
| Hypoxia | 30.04±1.98 | 0.55±0.12 |
| SBG | 22.17±1.83 | 0.42±0.07 |
不同组别大鼠肺组织的HE染色结果如图2所示：其中A为常氧组、B为低氧组、C为低氧给予药物组，可见本发明药物对低氧所致肺小动脉血管重构产生了影响：低氧导致了肺小动脉壁的明显增厚，同时导致了肺动脉平滑肌层面积的显著增加，而药物干预后明显减轻了肺小动脉血管壁的增厚。
取直径100 μm左右的肺动脉，用图像分析系统进行形态计量分析，以血管壁横断面积占血管横断面积比值（WT%）作为衡量缺氧性肺血管重塑的指标，结果如图3所示：与常氧组相比，低氧组WT%的值增加到了46.3%，低氧给予药物组WT%的值28.5%（与低氧组相比，p< 0.05），明显抑制肺小血管的重构。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。
Claims (7)
1.一种治疗肺动脉高压的藏药，其特征在于，所述藏药的活性组分包括如下原料药：丛菔、岩白菜、甘草、紫草茸。
2.根据权利要求1所述的治疗肺动脉高压的藏药，其特征在于，所述活性组分由如下重量份的原料药通过粉碎法或水提法或醇提法制成：丛菔200份、岩白菜160份、甘草100份、紫草茸100份。
3.根据权利要求1或2所述的治疗肺动脉高压的藏药，其特征在于，所述藏药由活性组分和药学上可接受的辅料制成。
4.根据权利要求3所述的治疗肺动脉高压的藏药，其特征在于，所述藏药的剂型为散剂、丸剂、颗粒剂、胶囊剂或片剂等。
5.根据权利要求3所述的治疗肺动脉高压的藏药，其特征在于，所述活性组分占药物总重量的0.1～99％。
6.根据权利要求3所述的治疗肺动脉高压的藏药的制备方法，其特征在于，包括如下步骤：将所述活性组分与药学上可接受的辅料按照药剂学上的常规方法制成散剂、丸剂、颗粒剂、胶囊剂或片剂等。
7.根据权利要求1-5任一项所述的治疗肺动脉高压的藏药在制备治疗肺动脉高压的药物、保健品中的应用。
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