CN115518120A - 一种中药组合物在制备降低黏蛋白含量药物中的应用 - Google Patents
一种中药组合物在制备降低黏蛋白含量药物中的应用 Download PDFInfo
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Abstract
本发明公开了一种中药组合物在降低黏蛋白含量药物中的应用，本发明中药组合物主要由麻黄、石膏、连翘、黄芩、桑白皮、苦杏仁、前胡等药味组成，发挥复方中药的整体调节优势，具有多向性、多层面、多靶点的特点，经试验证实可以本发明药物对模型细胞MUC5AC分泌具有显著抑制作用（P<0.05）。
Description
技术领域
本发明涉及一种中药组合物在制备降低黏蛋白含量药物中的应用，属于中草药领域。
背景技术
黏蛋白是一类主要由黏多糖组成的糖蛋白，是一族高分子量，重糖基化 的蛋白（糖缀合物通常在大多数生物体的上皮组织中产生）。黏蛋白关键特征是其形成凝胶的能力; 因此它们是大多数凝胶状分泌物的关键组成部分，提供润滑，细胞信号通路及化学屏障的功能。目前至少有20人黏蛋白基因已经被区别在于基因的克隆-MUC1，MUC2，MUC3A，MUC3B，MUC4，MUC5AC，MUC5B，MUC6，MUC7，MUC8，MUC12，MUC13，MUC15，MUC16，MUC17，MUC19，MUC20，MUC21和MUC22。主要的分泌呼吸道黏蛋白是MUC5AC和MUC5B，而MUC2分泌主要在肠道，而且在气道。
本发明药物具有“化痰止咳”的作用特点，其组方融汇东汉张仲景麻杏石甘汤宣肺泄热和明代叶文龄清金化痰汤清热化痰，有助于减少痰液生成、降低痰液粘度、促进痰液排出，有效解决多种呼吸系统传染性或感染性疾病，及因病毒或细菌感染引起痰液阻滞气管，改善肺之通气换气功能，经试验证实本发明药物降低黏蛋白含量效果显著，特别是对黏蛋白MUC5AC抑制效果显著。
发明内容
本发明提供一种中药组合物制备降低黏蛋白含量药物中的应用，特别是对黏蛋白MUC5AC抑制效果显著。该中药组合物由下列重量份的原料药制成：
麻黄52-86；石膏194-324；连翘194-324；黄芩78-130；桑白皮194-324；苦杏仁78-130； 前胡78-130； 半夏78-130； 陈皮78-130； 贝母78-130；牛蒡子78-130； 金银花78-130； 大黄39-65； 桔梗46-76； 甘草39-65。
本发明中药组合物的原料药的重量份比优选为：
麻黄52；石膏324；连翘194；黄芩78；桑白皮194；苦杏仁130；前胡78；半夏130；陈皮78；贝母78；牛蒡子130；金银花130；大黄39；桔梗76；甘草65。
本发明中药组合物的原料药的重量份比还优选为：
麻黄86；石膏194；连翘324；黄芩130；桑白皮324；苦杏仁78；前胡130；半夏78；陈皮130；贝母130； 牛蒡子78；金银花78 ；大黄65；桔梗46； 甘草39。
本发明中药组合物的原料药的重量份比还优选为：
麻黄69；石膏259；连翘259；黄芩104；桑白皮259；苦杏仁104；前胡104；半夏104；陈皮104；贝母104； 牛蒡子104；金银花104；大黄52；桔梗61；甘草52。
本发明中药组合物的原料药的重量份比还优选为：
麻黄55；石膏254；连翘318；黄芩107；桑白皮203；苦杏仁107；前胡82；半夏105；陈皮84；贝母125； 牛蒡子122；金银花113；大黄42；桔梗60； 甘草50。
本发明中药组合物中，所述苦杏仁为炒苦杏仁、贝母为浙贝母、金银花为山银花、半夏为清半夏。
本发明中药组合物主要由麻黄、石膏、连翘、黄芩、桑白皮等组成，发挥复方中药的整体调节优势，具有多向性、多层面、多靶点的特点，经实验证实对黏蛋白MUC5AC抑制效果显著。。
本发明所述中药可以被有相同或相似功效的中药代替，并且这些药材均可以按照《全国中药炮制规范》或《中药大辞典》炮制。
本发明中药组合物的活性成分由以下步骤制成:
A、按组方比例称取浙贝母，粉碎成细粉，备用；
B、按组方比例称取麻黄、连翘、炒苦杏仁、清半夏、牛蒡子、大黄加40-70%乙醇回流提取2次，每次1-4小时，第一次加8-10倍量，第二次加6-9倍量，提取液合并，滤过，滤液减压回收乙醇，浓缩至60℃热测相对密度为1.14-1.16的清膏，备用；
C、按组方比例称取石膏、桑白皮、前胡、陈皮、山银花、桔梗、甘草，加水煎煮两次，每次1-4小时，第一次加9-11倍量，第二次加7-9倍量，煎液合并，滤过，浓缩至60℃热测相对密度为1.14-1.16的清膏，与步骤B所得的清膏合并，备用；
步骤A所得细粉和步骤C所得合并后的清膏共同构成该药物组合物的活性成分。
本发明药物的剂型为胶囊剂、片剂、散剂、颗粒剂、口服液、软胶囊、丸剂、酊剂、糖浆剂、栓剂、凝胶剂、喷雾剂或注射剂。
为使上述剂型能够实现，需在制备这些剂型时加入药学可接受的辅料，例如：填充剂、崩解剂、润滑剂、助悬剂、粘合剂、甜味剂、矫味剂、防腐剂、基质等。填充剂包括：淀粉、预胶化淀粉、乳糖、甘露醇、甲壳素、微晶纤维素、蔗糖等；崩解剂包括：淀粉、预胶化淀粉、微晶纤维素、羧甲基淀粉钠、交联聚乙烯吡咯烷酮、低取代羟丙纤维素、交联羧甲基纤维素钠等；润滑剂包括：硬脂酸镁、十二烷基硫酸钠、滑石粉、二氧化硅等；助悬剂包括：聚乙烯吡咯烷酮、微晶纤维素、蔗糖、琼脂、羟丙基甲基纤维素等；粘合剂包括，淀粉浆、聚乙烯吡咯烷酮、羟丙基甲基纤维素等；甜味剂包括：糖精钠、阿斯帕坦、蔗糖、甜蜜素、甘草次酸等；矫味剂包括：甜味剂及各种香精；防腐剂包括：尼泊金类、苯甲酸、苯甲酸钠、山梨酸及其盐类、苯扎溴铵、醋酸氯乙定、桉叶油等；基质包括：PEG6000，PEG4000，虫蜡等。
其中片剂由如下步骤制成：
A、按组方比例称取浙贝母，粉碎成细粉，备用；
B、按组方比例称取麻黄、连翘、炒苦杏仁、清半夏、牛蒡子、大黄加40-70%乙醇回流提取2次，每次1-4小时，第一次加8-10倍量，第二次加6-9倍量，提取液合并，滤过，滤液减压回收乙醇，浓缩至60℃热测相对密度为1.14-1.16的清膏，备用；
C、按组方比例称取石膏、桑白皮、前胡、陈皮、山银花、桔梗、甘草，加水煎煮两次，每次1-4小时，第一次加9-11倍量，第二次加7-9倍量，煎液合并，滤过，浓缩至60℃热测相对密度为1.14-1.16的清膏，与步骤B所得的清膏合并，备用；
D、将步骤C所得合并的清膏，喷雾干燥，收集喷雾粉备用；
E、步骤D所得喷雾粉与步骤A所得细粉，以乙醇为黏合剂制软材，过筛制粒；按药学常规方法压片即得。
优选的片剂的制备方法为：
A、按组方比例称取浙贝母，粉碎成细粉，备用；
B、按组方比例称取麻黄、连翘、炒苦杏仁、清半夏、牛蒡子、大黄加50%乙醇回流提取2次，每次3小时，第一次加10倍量，第二次加6倍量，提取液合并，滤过，滤液减压回收乙醇，浓缩至60℃热测相对密度为1.15的清膏，备用；
C、按组方比例称取石膏、桑白皮、前胡、陈皮、山银花、桔梗、甘草，加水煎煮两次，每次2小时，第一次加10倍量，第二次加7倍量，煎液合并，滤过，浓缩至60℃热测相对密度为1.15的清膏，与步骤B所得的清膏合并，备用；
D、将步骤C所得合并的清膏，喷雾干燥，收集喷雾粉备用；
E、步骤D所得喷雾粉与步骤A所得细粉，以乙醇为黏合剂制软材，过筛制粒干燥后整粒，加入羧甲淀粉钠、微晶纤维素、硬脂酸镁，混匀，压片即得。本发明药物其他剂型的制备方法为：按比例称取原料药，采用常规的制备方法制备，例如，范碧亭《中药药剂学》（上海科学出版社1997年12月第1版）记载的制备工艺，制成药剂学可接受的常规剂型。
本发明药物降低黏蛋白含量优选为呼吸道黏蛋白，更优选为黏蛋白MUC5AC或MUC5B。
本发明药物也可以通过降低黏蛋白含量来治疗支气管炎、支气管痉挛、感冒、咳嗽、发烧、祛痰、平喘、肺损伤。
附图说明：
图1：LHQK对模型细胞MUC5AC分泌的作用结果，其中LHQK为本发明药物的简称。
具体实施方式
下述实施例用于举例说明本发明药物的制备，但其不能对本发明的范围构成任何限制。
实施例1
处方：
麻黄52克；石膏324克；连翘194克；黄芩78克；桑白皮194克；苦杏仁130克；前胡78克；半夏130克；陈皮78克；浙贝母78克；牛蒡子130克；山银花130克；大黄39克；桔梗76克；甘草65克。
制备方法：
A、按组方比例称取浙贝母，粉碎成细粉，备用；
B、按组方比例称取麻黄、连翘、苦杏仁、半夏、牛蒡子、大黄加50%乙醇回流提取2次，每次3小时，第一次加10倍量，第二次加6倍量，提取液合并，滤过，滤液减压回收乙醇，浓缩至60℃热测相对密度为1.15的清膏，备用；
C、按组方比例称取石膏、桑白皮、前胡、陈皮、山银花、桔梗、甘草，加水煎煮两次，每次2小时，第一次加10倍量，第二次加7倍量，煎液合并，滤过，浓缩至60℃热测相对密度为1.15的清膏，与步骤B所得的清膏合并，备用；
D、将步骤C所得合并的清膏，喷雾干燥，收集喷雾粉备用；
E、步骤D所得喷雾粉，步骤A所得细粉，以80%乙醇为黏合剂制备软材，过筛制粒，60度干燥后，整粒。加入羧甲基淀粉钠、微晶纤维素、硬脂酸镁混匀，按常规制剂方法制成片剂，即得。
实施例2
处方：
麻黄86克；石膏194克；连翘324克；黄芩130克；桑白皮324克；炒苦杏仁78克；前胡130克；半夏78克；陈皮130克；贝母130克； 牛蒡子78克；山银花78克 ；大黄65克；桔梗46克；甘草39克。
制备方法：
A、按组方比例称取贝母，粉碎成细粉，备用；
B、按组方比例称取麻黄、连翘、炒苦杏仁、半夏、牛蒡子、大黄加40%乙醇回流提取2次，每次4小时，第一次加8倍量，第二次加9倍量，提取液合并，滤过，滤液减压回收乙醇，浓缩至60℃热测相对密度为1.14的清膏，备用；
C、按组方比例称取石膏、桑白皮、前胡、陈皮、山银花、桔梗、甘草，加水煎煮两次，每次4小时，第一次加9倍量，第二次加7倍量，煎液合并，滤过，浓缩至60℃热测相对密度为1.16的清膏，与步骤B所得的清膏合并，备用；
D、将步骤C所得合并的清膏，喷雾干燥，收集喷雾粉备用；
E、步骤D所得喷雾粉，步骤A所得细粉，以80%乙醇为黏合剂制备软材，过筛制粒，60度干燥后，整粒。加入羧甲基淀粉钠、微晶纤维素、硬脂酸镁混匀，按常规制剂方法制成片剂，即得。
实施例3
处方：
麻黄69克；石膏259克；连翘259克；黄芩104克；桑白皮259克；炒苦杏仁104克；前胡104克；清半夏104克；陈皮104克；浙贝母104克； 牛蒡子104克；山银花104克；大黄52克；桔梗61克；甘草52克。
制备方法：
A、按组方比例称取浙贝母，粉碎成细粉，备用；
B、按组方比例称取麻黄、连翘、炒苦杏仁、清半夏、牛蒡子、大黄加70%乙醇回流提取2次，每次1小时，第一次加10倍量，第二次加6倍量，提取液合并，滤过，滤液减压回收乙醇，浓缩至60℃热测相对密度为1.16的清膏，备用；
C、按组方比例称取石膏、桑白皮、前胡、陈皮、山银花、桔梗、甘草，加水煎煮两次，每次1小时，第一次加11倍量，第二次加7倍量，煎液合并，滤过，浓缩至60℃热测相对密度为1.14的清膏，与步骤B所得的清膏合并，备用；
D、将步骤C所得合并的清膏，喷雾干燥，收集喷雾粉备用；
E、步骤D所得喷雾粉，步骤A所得细粉，以80%乙醇为黏合剂制备软材，过筛制粒，60度干燥后，整粒。加入羧甲基淀粉钠、微晶纤维素、硬脂酸镁混匀，按常规制剂方法制成片剂，即得。
实施例4：
原料药配方为：
麻黄55克；石膏254克；连翘318克；黄芩107克；桑白皮203克；炒苦杏仁107克；前胡82克；半夏105克；陈皮84克；浙贝母125克； 牛蒡子122克；山银花113克；大黄42克；桔梗60克； 甘草50克。
制备方法：
A、按组方比例称取浙贝母，粉碎成细粉，备用；
B、按组方比例称取麻黄、连翘、炒苦杏仁、半夏、牛蒡子、大黄加60%乙醇回流提取2次，每次2小时，第一次加9倍量，第二次加7倍量，提取液合并，滤过，滤液减压回收乙醇，浓缩至60℃热测相对密度为1.15的清膏，备用；
C、按组方比例称取石膏、桑白皮、前胡、陈皮、山银花、桔梗、甘草，加水煎煮两次，每次2.5小时，第一次加10倍量，第二次加7倍量，煎液合并，滤过，浓缩至60℃热测相对密度为1.14的清膏，与步骤B所得的清膏合并，备用；
D、将步骤C所得合并的清膏，喷雾干燥，收集喷雾粉备用；
E、步骤D所得喷雾粉，步骤A所得细粉，以80%乙醇为黏合剂制备软材，过筛制粒，60度干燥后，整粒。加入羧甲基淀粉钠、微晶纤维素、硬脂酸镁混匀，按常规制剂方法制成片剂，即得。
实施例5：
麻黄62克 石膏220克 连翘256克 黄芩90克 桑白皮300克
苦杏仁90克 前胡90克 半夏90克 陈皮100克 贝母100克 牛蒡子100克 金银花100克 大黄50克 桔梗66克 甘草50克
以上药材，按常规方法制成胶囊剂即得。
实施例6：
麻黄68克 石膏215克 连翘215克 黄芩100克 桑白皮220克
苦杏仁90克 前胡90克 半夏90克 陈皮90克 贝母90克
牛蒡子90克 金银花90克 大黄50克 桔梗50克 甘草50克
以上药材，按常规方法制成颗粒剂即得。
实施例7：
麻黄50克 石膏200克 连翘300克 黄芩100克 桑白皮250克
苦杏仁100克 前胡100克 半夏100克 陈皮100克 贝母100克
牛蒡子100克 金银花100克 大黄50克 桔梗50克 甘草50克
以上药材，按常规方法制成注射剂即得。
实施例8：
麻黄60克 石膏200克 连翘200克 黄芩95克 桑白皮230克
苦杏仁95克 前胡95克 半夏95克 陈皮95克 贝母95克
牛蒡子95克 金银花95克 大黄50克 桔梗50克 甘草50克
以上药材，按常规方法制成丸剂即得。
试验例：
为证实本发明中药组合物具有降低黏蛋白含量的疗效，用按本发明药物组合物实施例3制备方法，压片前的颗粒作为供试品（以下称本发明药物或LHQK）。
一、试验方法：采用脂多糖（LPS）损伤人支气管上皮细胞（16HBE）24 h构建气道炎症模型，检测本发明药物对模型细胞黏蛋白MUC5AC的分泌的影响。
二、检测方法：试剂盒为上海生工，货号D711278，具体步骤如下：
1. 样品收集：将细胞培养基移至无菌离心管，在4° C条件下 1000 g离心20 min，除去杂质及细胞碎片。取上清检测。
2. 预先计算好所需的板条数，实验前30 min，拿出试剂盒，恢复至室温。
3. 标准品梯度稀释：标准品于10000g 离心1 min，加入标准品&样品稀释液1.0mL至冻干标准品中，旋紧管盖，静置10 min，上下颠倒数次，待其充分溶解后，轻轻混匀，配成20ng/mL的标准品工作液。配制成以下浓度：10, 5, 2.5, 1.25, 0.63, 0.31, 0.16, 0ng/mL。
4.每个反应孔中加入100 μl标准品工作液及检测样本，封板后于37° C孵箱孵育90min。
5. 弃去液体，甩干，每个反应孔中加入100 μl生物素标记粘蛋白5AC抗体工作液（稀释液SD2 100：1稀释）至反应孔中，封板后于37° C 孵箱孵育60 min。
6.洗涤：弃去液体，甩干，每个反应孔中加入350 μl 洗涤液，浸泡1-2 min，甩干洗涤液。重复4次。
7.每个反应孔中加入100 μl HRP 标记链霉亲和素工作液（用稀释液SD3 100：1稀释）至反应孔中，封板后于37° C孵箱孵育30 min。
8.洗涤：每个反应孔中加入300 μl 洗涤液，间隔30 s，甩干洗涤液。重复4次。
9.每个反应孔中加入90 μl 显色剂（避光）至反应孔中，封板后于37° C避光显色15 min左右。
10.每个反应孔中加入50 μl 终止液，即刻用酶标仪450 nm波长下测量OD值（5min内）。
11.用酶标仪450 nm波长测定OD值。
12.根据标准品及样品OD值计算样品浓度。
三、试验结果：本发明药物(LHQK)（0.025-250ug/ml）对模型细胞MUC5AC分泌具有显著抑制作用（P<0.05），且具有剂量依赖性。
Claims (14)
1.一种中药组合物在制备降低黏蛋白含量药物中的应用，其特征在于所述中药组合物由下列重量份的原料药制成：
麻黄52-86 ；石膏194-324； 连翘194-324 ；黄芩78-130 ；桑白皮194-324；苦杏仁78-130； 前胡78-130； 半夏78-130； 陈皮78-130； 贝母78-130； 牛蒡子78-130； 金银花78-130； 大黄39-65； 桔梗46-76； 甘草39-65。
2.根据权利要求1所述的应用，其特征在于由下列重量份的原料药制成：
麻黄52； 石膏 324； 连翘194； 黄芩78； 桑白皮194； 苦杏仁130； 前胡78； 半夏130；陈皮78； 贝母78； 牛蒡子130； 金银花130； 大黄39； 桔梗76； 甘草65。
3.根据权利要求1所述的应用，其特征在于由下列重量份的原料药制成：
麻黄86；石膏194；连翘324；黄芩130；桑白皮324；苦杏仁78；前胡130；半夏78；陈皮130；贝母130； 牛蒡子78；金银花78 ；大黄65；桔梗46； 甘草39。
4.根据权利要求1所述的应用，其特征在于由下列重量份的原料药制成：
麻黄69；石膏259；连翘259；黄芩104；桑白皮259；苦杏仁104；前胡104；半夏104；陈皮104；贝母104； 牛蒡子104；金银花104；大黄52；桔梗61；甘草52。
5.根据权利要求1所述的应用，其特征在于由下列重量份的原料药制成：
麻黄55；石膏254；连翘318；黄芩107；桑白皮203；苦杏仁107；前胡82；半夏105；陈皮84；贝母125； 牛蒡子122；金银花113；大黄42；桔梗60； 甘草50。
6.根据权利要求1-5任一项所述的应用，其特征在于所述苦杏仁为炒苦杏仁、贝母为浙贝母、金银花为山银花、半夏为清半夏。
7.根据权利要求1-5任一项所述的应用，其特征在于所述药物的活性成分由以下步骤制成：
A、按组方比例称取贝母，粉碎成细粉，备用；
B、按组方比例称取麻黄、连翘、苦杏仁、半夏、牛蒡子、大黄加40-70%乙醇回流提取2次，每次1-4小时，第一次加8-10倍量，第二次加6-9倍量，提取液合并，滤过，滤液减压回收乙醇，浓缩至60℃热测相对密度为1.14-1.16的清膏，备用；
C、按组方比例称取石膏、桑白皮、前胡、陈皮、金银花、桔梗、甘草，加水煎煮两次，每次1-4小时，第一次加9-11倍量，第二次加7-9倍量，煎液合并，滤过，浓缩至60℃热测相对密度为1.14-1.16的清膏，与步骤B所得的清膏合并，备用；
步骤A所得细粉和步骤C所得合并后的清膏共同构成该药物组合物的活性成分。
8.根据权利要求1-5任一项所述的应用，其特征在于所述药物剂型为片剂、胶囊剂、散剂、颗粒剂、口服液、丸剂、酊剂、糖浆剂、栓剂、凝胶剂、喷雾剂或注射剂。
9.根据权利要求8所述的应用，其特征在于所述片剂由以下步骤制成：
A、按组方比例称取贝母，粉碎成细粉，备用；
B、按组方比例称取麻黄、连翘、苦杏仁、半夏、牛蒡子、大黄加40-70%乙醇回流提取2次，每次1-4小时，第一次加8-10倍量，第二次加6-9倍量，提取液合并，滤过，滤液减压回收乙醇，浓缩至60℃热测相对密度为1.14-1.16的清膏，备用；
C、按组方比例称取石膏、桑白皮、前胡、陈皮、金银花、桔梗、甘草，加水煎煮两次，每次1-4小时，第一次加9-11倍量，第二次加7-9倍量，煎液合并，滤过，浓缩至60℃热测相对密度为1.14-1.16的清膏，与步骤B所得的清膏合并，备用；
D、将步骤C所得合并的清膏，喷雾干燥，收集喷雾粉备用；
E、步骤D所得喷雾粉与步骤A所得细粉，以乙醇为黏合剂制软材，过筛制粒；按药学常规方法压片即得。
10.根据权利要求9所述的应用，其特征在于所述片剂由以下步骤制成：
A、按组方比例称取贝母，粉碎成细粉，备用；
B、按组方比例称取麻黄、连翘、苦杏仁、半夏、牛蒡子、大黄加50%乙醇回流提取2次，每次3小时，第一次加10倍量，第二次加6倍量，提取液合并，滤过，滤液减压回收乙醇，浓缩至60℃热测相对密度为1.15的清膏，备用；
C、按组方比例称取石膏、桑白皮、前胡、陈皮、金银花、桔梗、甘草，加水煎煮两次，每次2小时，第一次加10倍量，第二次加7倍量，煎液合并，滤过，浓缩至60℃热测相对密度为1.15的清膏，与步骤B所得的清膏合并，备用；
D、将步骤C所得合并的清膏，喷雾干燥，收集喷雾粉备用；
E、步骤D所得喷雾粉与步骤A所得细粉，以乙醇为黏合剂制软材，过筛制粒干燥后整粒，加入羧甲淀粉钠、微晶纤维素、硬脂酸镁，混匀，压片即得。
11.根据权利要求1-5任一项所述的应用，其特征在于所述黏蛋白为呼吸道黏蛋白。
12.根据权利要求1-5任一项所述的应用，其特征在于所述黏蛋白为黏蛋白MUC5AC或MUC5B。
13.根据权利要求12所述的应用，其特征在于本发明药物在治疗支气管炎、支气管痉挛、感冒、咳嗽、发烧、祛痰、平喘药物中的应用。
14.根据权利要求12所述的应用，其特征在于本发明药物在治疗肺损伤药物中的应用。
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| 曾玉珍, 等: "中西医结合治疗小儿支原体肺炎", 光明中医, vol. 26, no. 07, 20 July 2011 (2011-07-20), pages 1435 - 1436 * |
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