CN109303325A - 一种预防或治疗干燥综合症的中药膏滋及其制备方法 - Google Patents
一种预防或治疗干燥综合症的中药膏滋及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种预防或治疗干燥综合症的中药膏滋及其制备方法。本发明提供了一种食品、功能食品或药物组合物，它是由下述重量配比的原料药制备而成：石斛4500‑5200份、天冬900‑1100份、麦冬900‑1100份。本发明还提供了所述组合物的制备方法和用途。本发明为药食同源中药材组成，临床应用效果明显，无毒副作用，本发明还具有生产工艺简单、口感好等优点。
Description
技术领域
本发明涉及一种预防或治疗干燥综合症的食品、功能食品或药物组合物及其制备方法。
技术背景
干燥综合症多发于春秋季节，而在寒冷的冬季北方家庭由于供暖的需求，室内变得干燥，加之当前气候环境恶化，雾霾天加重，人们因感受外感温热火燥或内生燥邪，临床表现为不同程度的口舌干燥、眼睛干涩、肌肤起皮脱屑、干咳、便秘等耗伤津液的症状日益增多；另外现代白领由于工作需要，长时间面对电脑也会产生眼睛干涩或其他不适症状，这种水液代谢异常，气阴生化受阻而发病的情况在中医属“燥证”、“内燥证”、“燥毒证”等范畴。燥邪损伤气血津液轻则空穴干燥、肢体疼痛，重则导致脏腑损害。其中燥热伤肺引起的咳嗽也是临床常见病症，相当于现代医学的急慢性咽炎、气管炎、肺炎等，若不及时治疗，病情常反复发作、迁延难愈甚则变生他病，威胁个体健康。
目前治疗有西医治疗与中医治疗，西医大多给予抗生素治疗，但频繁使用可导致机体免疫力降低，咳嗽经久不愈。中医认为，肺体属金，外合皮毛，不耐寒热，畏燥，咳嗽的辨证施治多以治肺为关键。治疗上应以润燥清热，滋阴生津为治疗大法。但市场上没有口感良好的预防或治疗干燥综合症的食品或功能食品。
发明内容
本发明的目的在于提供一种预防或治疗干燥综合症的食品、功能食品或药物组合物。本发明的另一目的在于提供所述组合物的制备方法及其用途。
本发明预防或治疗干燥综合症的组合物，它是由下述重量配比的原料药制备而成：石斛4500-5200份、天冬900-1100份、麦冬900-1100份。
优选地，它是由下述重量配比的原料药制备而成：石斛4800份、天冬960份、麦冬960份。
其中，所述石斛为金钗石斛、鼓槌石斛或流苏石斛。
优选地，所述石斛为金钗石斛。
其中，所述组合物是由所述原料药的原生粉末，或者水或有机溶剂提取物为活性成分，加上可接受的辅料或者辅助性成分制备成常用的制剂。
优选地，所述制剂为口服制剂。
进一步的，所述口服制剂为膏滋剂、颗粒剂、片剂、口服液。
本发明提供了所述组合物的制备方法，包括如下步骤：
a、金钗石斛剪段，粉碎，加入溶媒浸泡，过滤，药渣加入溶媒煎煮，合并煎液；
b、天冬、麦冬加水浸泡，煎煮三次，合并煎液；
c、金钗石斛的煎液与天冬、麦冬煎液合并，滤过，文火浓缩滤液成清膏；
d、清膏加炼蜜，浓缩，收膏，即得。
其中，步骤a中，所述溶媒为20倍量的90％乙醇。
其中，步骤c中，所述清膏密度为1.21～1.25。
其中，步骤d中，清膏与炼蜜的比例为1：1。
本发明提供了前述组合物在制备预防或/和治疗干燥综合症的功能食品或药品中的用途。
本发明还提供了前述组合物在制备具有滋阴润燥、清热生津或润肺止咳功效的功能食品或药品中的用途。
本发明由金钗石斛、天冬、麦冬三种原料药组成，天冬、麦冬在治疗燥咳、口渴咽干、鼻燥、便秘方面有良效，而石斛是具有滋阴补益功效的名贵药材，被誉为“滋阴圣品”，其作用在《神农本草经》及《本草纲目》中所述甚广，《中国药典》2015年版确定石斛主治为“益胃生津，滋阴清热。用于热病津伤，口干烦渴，胃阴不足，食少干呕，病后虚热不退，阴虚火旺，骨蒸劳热，目暗不明，筋骨痿软”。全方具有滋阴润燥，清热生津，润肺止咳功效，针对阴伤津亏，口干烦渴，病后虚热，目暗不明，燥伤肺津或阴虚肺热引起的咳嗽、鼻干咽痛及阴虚证有很好的疗效。
本发明药物组合物在海军舰艇官兵中试用，官兵普遍反映本发明药物组合物石斛润燥膏对于缓解海上作战条件下出现的肌肤及眼睛不适症状有着重要作用。
针对干燥综合症为常见病症，且市场上没有此类用于预防或治疗干燥综合症的功能食品，本发明填补市场空白。本发明为药食同源中药材组成，临床应用效果明显，无毒副作用，本发明还具有生产工艺简单、口感好等优点。
根据本发明的上述内容，按照本发明相关领域的普通技术知识和惯用手段，在不脱离本发明上述基本技术思想前提下，还可以做出其它多种形式的修改、替换或变更。
具体实施方式
实施例1本发明组合物制备方法
1.原料：金钗石斛4800g、天冬960g、麦冬960g。
2.制备方式：a、金钗石斛剪段，粉碎，加入20倍量的90％乙醇，浸泡24h后85℃加热煎煮3小时，过滤，药渣加入20倍量溶媒继续煎煮3小时，合并煎液；b、天冬、麦冬加水浸泡，煎煮三次，合并煎液；c、金钗石斛的煎液与天冬、麦冬煎液合并，滤过，文火浓缩滤液成相对密度为1.21～1.25的清膏；d、清膏加炼蜜，混匀，煮沸收膏即得。
实施例2本发明组合物制备方法
1.原料：金钗石斛4500g、天冬910g、麦冬920g。
2.制备方式：a、金钗石斛剪段，粉碎，加入20倍量的90％乙醇，浸泡24h后85℃加热煎煮3小时，过滤，药渣加入20倍量溶媒继续煎煮3小时，合并煎液；b、天冬、麦冬加水浸泡，煎煮三次，合并煎液；c、金钗石斛的煎液与天冬、麦冬煎液合并，滤过，文火浓缩滤液成相对密度为1.21～1.25的清膏；d、清膏加炼蜜，混匀，煮沸收膏即得。
实施例3本发明组合物制备方法
1.原料：金钗石斛5200g、天冬1000g、麦冬1100g。
2.制备方式：a、金钗石斛剪段，粉碎，加入20倍量的90％乙醇，浸泡24h后85℃加热煎煮3小时，过滤，药渣加入20倍量溶媒继续煎煮3小时，合并煎液；b、天冬、麦冬加水浸泡，煎煮三次，合并煎液；c、金钗石斛的煎液与天冬、麦冬煎液合并，滤过，文火浓缩滤液成相对密度为1.21～1.25的清膏；d、清膏加炼蜜，混匀，煮沸收膏即得。
以下通过具体临床试验证明本发明的有益效果：
实验例1本发明组合物的临床疗效
1.临床资料
1.1诊断标准：
将210例干燥综合症患者，其中包括燥热伤肺型咳嗽、便秘及口眼干燥症状的患者，随机分为治疗组70例，对照组Ⅰ70例，对照组Ⅱ70例。3组患者的性别、年龄、病程无差异(P＞0.05)，具有可比性。
1.2纳入标准
符合1.1节诊断标准的病例均纳入。
2、治疗方法
治疗组：给予本发明实施例1的药物。
具体给药方法为：
治疗组应用本发明组合物9g，每日2次，口服，连续服用一个月；
对照组Ⅰ应用传统中成药二冬膏9g，每日2次，口服，连续服用一个月；
对照组Ⅱ应用中药石斛9g，每日2次，煎服，连续服用一个月。
3、疗效观察
3.1疗效标准：
治愈：咳嗽、便秘及口眼干燥症状消失；
好转：咳嗽、便秘及口眼干燥症状缓解；
未愈：咳嗽、便秘及口眼干燥症状无改善。
3.2治疗结果
如表1所示：
| 组别 | 治愈/％ | 好转/％ | 未愈/％ | 有效率 |
| a治疗组(70人) | 41/58.57％ | 25/35.71％ | 4/5.71％ | 94.29％ |
| b对照组Ⅰ(70人) | 26/37.14％ | 36/51.43％ | 8/11.43％ | 88.57％ |
| c对照组Ⅱ(70人) | 25/35.71％ | 33/47.14％ | 12/17.14％ | 82.86％ |
Pa vs b＝0.036 Pb vs c＝0.622 Pa vs c＝0.011
结果：对实验结果(表1)进行统计学处理，表明患者服用本发明组合物后，治疗效果与服用中药石斛组(c对照组Ⅱ)比较差异有统计学意义(P＜0.05)；与服用二冬膏组(b对照组Ⅰ)比较差异亦有统计学意义(P＜0.05)；而服用中药石斛组(c对照组Ⅱ)与服用二冬膏组(b对照组Ⅰ)比较差异无统计学意义。说明本发明组合物的疗效优于对照组传统养阴润燥剂二冬膏及中药石斛组，证明该方组方合理，可以提高患者的生活质量，值得临床推广应用。
综上，本发明为药食同源中药材组成，在临床上针对干燥综合症，治疗效果良好，无副作用，生产工艺简单、口感好，作为功能性食品填补了市场空白。
Claims (10)
1.一种食品、功能食品或药品组合物，其特征在于：它是由下述重量配比的原料药制备而成：石斛4500-5200份、天冬900-1100份、麦冬900-1100份。
2.根据权利要求1所述组合物，其特征在于：它是由下述重量配比的原料药制备而成：石斛4800份、天冬960份、麦冬960份。
3.根据权利要求1或2所述组合物，其特征在于：所述石斛为金钗石斛、鼓槌石斛或流苏石斛；优选地，所述石斛为金钗石斛。
4.根据权利要求1-3任意一项所述组合物，其特征在于：所述组合物是由所述原料药的原生粉末，或者水或有机溶剂提取物为活性成分，加上可接受的辅料或者辅助性成分制备成常用的制剂。
5.根据权利要求4所述组合物，其特征在于：所述制剂为口服制剂。
6.根据权利要求5所述组合物，其特征在于：所述口服制剂为膏滋剂、颗粒剂、片剂、口服液。
7.一种权利要求1-6任意一项所述组合物的制备方法，其特征在于：包括如下步骤：
a、金钗石斛剪段，粉碎，加入溶媒浸泡，过滤，药渣加入溶媒煎煮，合并煎液；
b、天冬、麦冬加水浸泡，煎煮三次，合并煎液；
c、金钗石斛的煎液与天冬、麦冬煎液合并，滤过，文火浓缩滤液成清膏；
d、清膏加炼蜜，浓缩，收膏，即得。
8.根据权利要求7所述制备方法，其特征在于：步骤a中，所述溶媒为20倍量的90％乙醇；步骤c中，所述清膏密度为1.21～1.25；步骤d中，所述清膏与炼蜜的比例为1：1。
9.根据权利要求1-6任意一项所述组合物在制备预防或/和治疗干燥综合症的功能食品或药品中的用途。
10.根据权利要求1-6任意一项所述组合物在制备具有滋阴润燥、清热生津或润肺止咳功效的功能食品或药品中的用途。
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