CN111494454B - 一种治疗间质性肺病的药物组合物 - Google Patents
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Abstract
本发明涉及一种治疗间质性肺病的药物组合物及其制备方法。该组合物由黄芪10‑15、生甘草10‑15、地龙6‑10、野菊花5‑8和瓜蒌1‑5组成。组方简单，利于产品质量控制以及生产成本的降低，同时还能止咳化痰，有效改善患者呼吸功能、提高患者生存质量，延缓病症进展，且无明显副作用。
Description
技术领域
本发明涉及中药领域，更具体地，一种治疗间质性肺病的药物组合物。
背景技术
间质性肺病又称肺间质病、弥漫性实质性肺病或侵袭性肺病，由一大组异质性肺病组成，包括原因已明和原因不明两大类。原因已明类主要包括因职业环境引起的尘肺病、外源性过敏性肺炎等，或药物诱发引起。原因不明类则包括特发性肺间质纤维化、肺出血肾炎综合征、结节病等。临床表现通常为进行性呼吸困难、干咳、喘息等，胸部X射线表现为双肺弥漫性的网状、结节状或细结节状浸润性阴影，组织学特点显示非肿瘤性的炎症性改变或伴有血管炎性肉芽肿性的炎症性改变。由于间质性肺病是一种进展性的疾病，不论是早期还是晚期，一旦确诊都应立即进行治疗，方可阻止疾病发展。目前尚无任何药物治疗手段可以确切逆转或改变间质性肺病进程。在常规治疗方案中，常用的药物有糖皮质激素、免疫抑制剂、抗纤维化及抗氧化等药物，但这些药物的副作用有目共睹，且不适合终身使用。肺移植是目前唯一能够治愈间质性肺病的手段，但难以找到匹配的器官，术后器官排异问题也层出不穷。
由于间质性肺病既可是肺组织病变的一类单独疾病，又可是由多***疾病累及肺组织损伤的一类综合征，运用中医的整体观疗法应更适合。现代中医学者认为间质性肺病当归属于中医学的肺痹、肺痿、喘证等范畴。肺痿以气虚为根本病机，病性证素以痰、热最为多见，病位责之在肺、胃为主，可累及脾肾，分为寒热两类，阴虚内热、阳虚生寒是其内在机制，证候特点多以虚实夹杂为主。肺痹以实证为主，虚证则以肺肾气虚多见，亦可表现为虚实夹杂证，以气虚为本，气闭为标。临证当辨其虚实矛盾的主次而施治。截至目前，已有各大医家在临床实践中提出多种用于治疗或缓解间质性肺病的组方，组方用药各有长短。
CN104147517A公开了一种治疗特发性肺间质纤维化的中药组合物，包括太子参、南沙参、麦冬、玄参、黄芪、党参、苍术等16味药材，认为该组合物具有益气养阴、活血化瘀、开胸利气的作用。
CM109806349A公开了一种治疗肺间质纤维化的中药组合物，包括黄芪、党参、红参、白术、清半夏、茯苓、陈皮等27味药材，此外还可包括忍冬藤、白芍等6个成分，认为该组合物具有健脾补肺、化痰活血、止咳平喘的功效，可用于治疗肺间质纤维化。
然而，间质性肺病种类繁多、机制复杂，对间质性肺病机制与有效治疗的探索渐成为国内外研究热点。本申请的发明人通过研究，提出一种可用于间质性肺病的药物组合物，简化了组合物的组方，利于产品质量控制、降低生产成本，同时还能有效改善患者呼吸功能、提高患者生存质量，延缓病症进展，由此得到本申请。
发明内容
本申请提供了一种治疗间质性肺病的药物组合物及其制备方法。该组合物由黄芪10-15、生甘草10-15、地龙6-10、野菊花5-8和瓜蒌1-5组成。
该药物组合物中，各药材的用量为：黄芪12-15、生甘草12-15、地龙8-10、野菊花6-8和瓜蒌3-5。
优选的药物组合物是：黄芪15、生甘草15、地龙10、野菊花8和瓜蒌3。
本申请还提供了一种药物制剂，将上述药物组合物通过常规制药方法制得汤剂、颗粒剂、胶囊剂、片剂、滴丸等常规剂型产品。
本发明还提供了上述药物制剂的制备方法，包括：取黄芪、生甘草、野菊花和瓜蒌，加入10-15倍量蒸馏水，浸泡20-30分钟，煎煮至水量剩余一半时，倒出药液，再加入10-15倍量蒸馏水，煎煮至水量剩余一半，倒出药液，与之前药液混合，得汤剂。
本发明还提供了上述药物制剂的制备方法，包括：取黄芪、生甘草、野菊花和瓜蒌，加3-5倍量的50-80％乙醇回流提取1-3次，每次2小时，滤过，滤液合并，得滤液1，药渣待用；另取地龙，加3-5倍量0.9％氯化钠溶液提取1-2次，每次2小时，滤过，滤液合并，得滤液2，药渣待用；取前述所得的全部药渣，合并后用3-5倍量水煎煮提取1-3次，提取液过滤，得滤液3；合并滤液1-3，减压浓缩至相对密度为1.15-1.25的稠膏，进一步减压干燥，得到干膏，按照常规方法将干膏制备为颗粒剂、胶囊剂、片剂等。
更具体地，该方法包括如下步骤：取黄芪、生甘草、野菊花和瓜蒌，加5倍量的75％乙醇回流提取2次，每次2小时，滤过，滤液合并，得滤液1，药渣待用；另取地龙，加5倍量0.9％氯化钠溶液提取2次，每次2小时，滤过，滤液合并，得滤液2，药渣待用；取前述所得的全部药渣，合并后用3倍量水煎煮提取2次，提取液过滤，得滤液3；合并滤液1-3，减压浓缩至相对密度为1.15-1.25的稠膏，进一步减压干燥，得到干膏，按照常规方法将干膏制备为颗粒剂、胶囊剂、片剂等。
本申请的药物组合物仅由5味中药材组成，组方简单，利于产品质量控制以及生产成本的降低，同时还能止咳化痰，有效改善患者呼吸功能、提高患者生存质量，延缓病症进展，且无明显副作用。
具体实施方式
为使本发明实施例的目的、技术方案和优点更加清楚，下面将对本申请的技术方案作更进一步的详细说明。显然，本申请的保护范围不受具体实施例的任何限制，本领域普通技术人员在没有做出创造性劳动下所得到的所有其他实施例，都落入本申请的保护范围内。
间质性肺病患者的症状大多是进行性呼吸困难、干咳或有浓痰、胸痛等。其中进行性呼吸困难是最具有特征性的症状，最初发生于大量运动期间，随着病情进展，呼吸困难也可发生于静息期间，极大降低患者日常的生活质量。从肺功能角度，绝大多数间质性肺病患者均出现限制性通气障碍和弥散功能降低，表现为肺活量、肺总量、功能残气量和残气量减少，FEV1/FVC正常或偏高，一氧化碳弥散率和动脉血氧分压降低。
1.临床资料：选择间质性肺病患者68例，按照随机数字表法分为对照组和本发明药物组，每组各34例。对照组34例中男24例、女10例，年龄35-68岁，病程2m-2y；本发明药物组34例中男26例、女8例，年龄39-65岁，病程1m-3y。2组患者基线资料无统计学差异，可进行比较。
2.方法：对照组患者接受常规治疗，本发明药物组患者除接受常规治疗外还服用本发明实施例1的汤剂(一日两次，服药2周)。
观察指标：①观察2组患者治疗前后的肺功能变化；②观察2组患者治疗前后生活质量评分。采用SGRQ评分表进行，对日常生活、活动能力及症状的影响，总分为100分，总评分越低，表示生活质量越高。
统计学方法 计量资料采用t检验，P＜0.05为差异具有统计学意义。
3.结果：
3.1肺功能检测
表1治疗前后2组患者的肺功能情况
注：t、P为2组组内比较检验值，t1、P1为2组治疗前比较检验值，t2、P2为2组治疗后比较检验值。
结果显示，治疗前2组患者肺功能无显著性差异(P＞0.05)；治疗后本发明药物组患者的肺功能显著优于对照组，差异有显著性(P＜0.05)。
3.2 SGRQ评分
表2
结果显示，治疗前2组患者生活质量总评分比较无统计学差异(P＞0.05)；治疗后本发明药物组生活质量总评分均显著低于治疗前及对照组，显示生活质量得到极大改善，有统计学差异(P＜0.05)。
4.小结
本申请药物组合物能很好地调动机体自身抗病能力，在改善间质性肺炎患者临床症状、提高生活质量等方面具有独到优势。对于目前尚无有效治疗方案的间质性患者来说，意义重大。
具体实施方式
实施例1
取黄芪15g、生甘草15g、地龙10g、野菊花8g和瓜蒌3g，加入10倍量蒸馏水，浸泡30分钟，煎煮至水量剩余一半时，倒出药液，再加入10倍量蒸馏水，煎煮至水量剩余一半，倒出药液，与之前药液混合，得汤剂。
实施例2
取黄芪1500g、生甘草1500g、野菊花800g和瓜蒌300g，加5倍量的75％乙醇回流提取2次，每次2小时，滤过，滤液合并，得滤液1，药渣待用；另取地龙1000g，加5倍量0.9％氯化钠溶液提取2次，每次2小时，滤过，滤液合并，得滤液2，药渣待用；取前述所得的全部药渣，合并后用3倍量水煎煮提取2次，提取液过滤，得滤液3；合并滤液1-3，减压浓缩至相对密度为1.15-1.25的稠膏，进一步减压干燥，得到干膏，按照常规方法将干膏制备为颗粒剂。
实施例3
取黄芪1300g、生甘草1300g、野菊花800g和瓜蒌300g，加3倍量的80％乙醇回流提取3次，每次2小时，滤过，滤液合并，得滤液1，药渣待用；另取地龙900g，加5倍量0.9％氯化钠溶液提取2次，每次2小时，滤过，滤液合并，得滤液2，药渣待用；取前述所得的全部药渣，合并后用3倍量水煎煮提取3次，提取液过滤，得滤液3；合并滤液1-3，减压浓缩至相对密度为1.15-1.25的稠膏，进一步减压干燥，得到干膏，按照常规方法将干膏制备为片剂。
Claims (8)
1.一种治疗间质性肺病的药物组合物，其特征在于由用量配比黄芪12-15、生甘草12-15、地龙8-10、野菊花6-8和瓜蒌3-5组成。
2.如权利要求1所述的药物组合物，其特征在于由用量配比黄芪15、生甘草15、地龙10、野菊花8和瓜蒌3组成。
3.一种药物制剂，其特征在于将权利要求1-2任一项所述的药物组合物通过常规制药方法制得汤剂、颗粒剂、胶囊剂、片剂。
4.如权利要求3所述的药物制剂的制备方法，其特征在于由如下方法制得：取黄芪、生甘草、地龙、野菊花和瓜蒌，加入10-15倍量蒸馏水，浸泡20-30分钟，煎煮至水量剩余一半时，倒出药液，再加入10-15倍量蒸馏水，煎煮至水量剩余一半，倒出药液，与之前药液混合，得汤剂。
5.如权利要求3所述的药物制剂的制备方法，其特征在于包括如下步骤：取黄芪、生甘草、野菊花和瓜蒌，加3-5倍量的50-80％乙醇回流提取1-3次，每次2小时，滤过，滤液合并，得滤液1，药渣待用；另取地龙，加3-5倍量0.9％氯化钠溶液提取1-2次，每次2小时，滤过，滤液合并，得滤液2，药渣待用；取前述所得的全部药渣，合并后用3-5倍量水煎煮提取1-3次，提取液过滤，得滤液3；合并滤液1-3，减压浓缩至相对密度为1.15-1.25的稠膏，进一步减压干燥，得到干膏，按照常规方法将干膏制备为颗粒剂、胶囊剂、片剂。
6.如权利要求5所述的制备方法，其特征在于包括如下步骤：
取黄芪、生甘草、野菊花和瓜蒌，加5倍量的75％乙醇回流提取2次，每次2小时，滤过，滤液合并，得滤液1，药渣待用；另取地龙，加5倍量0.9％氯化钠溶液提取2次，每次2小时，滤过，滤液合并，得滤液2，药渣待用；取前述所得的全部药渣，合并后用3倍量水煎煮提取2次，提取液过滤，得滤液3；合并滤液1-3，减压浓缩至相对密度为1.15-1.25的稠膏，进一步减压干燥，得到干膏，按照常规方法将干膏制备为颗粒剂、胶囊剂、片剂。
7.如权利要求1-2任一项所述的药物组合物或权利要求3所述的药物制剂在制备治疗间质性肺病的药物中的用途。
8.如权利要求4-6任一项所述的方法制得的药物制剂在制备治疗间质性肺病的药物中的用途。
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