CN104474518B - 一种治疗肺疾病的中药组合物及其制备方法 - Google Patents

一种治疗肺疾病的中药组合物及其制备方法 Download PDF

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CN104474518B
CN104474518B CN201410782982.4A CN201410782982A CN104474518B CN 104474518 B CN104474518 B CN 104474518B CN 201410782982 A CN201410782982 A CN 201410782982A CN 104474518 B CN104474518 B CN 104474518B
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刘群
谈宗华
昝琼
刘明莉
孙化富
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Tiansheng Pharmaceutical Group Co Ltd
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Abstract

本发明公开了一种治疗肺疾病的中药组合物，主要由以下中药原料组成：百部、香附、炙制百合、炮姜、砂仁、木香、川贝母、地黄、地骨皮、白芍、山药、山茱萸、茯芩、女贞子、北沙参、麦冬、泽泻、知母、蒸制五味子、制鳖甲、牛膝和黄芪。该中药组合物具有滋补肺肾，凉血除蒸功效，用于肺痨属肺肾不足，气阴两伤所致的咳喘少气，干咳少痰，潮热盗汗，形寒自汗，声嘶失音，心慌肢冷，形体消瘦的治疗。

Description

一种治疗肺疾病的中药组合物及其制备方法
技术领域
本发明属于中药领域，具体涉及一种治疗肺疾病的中药组合物及其制备方法。
背景技术
肺疾病主要包括慢性支气管炎、肺气肿、肺结核、矽肺、咳嗽、纤维化、胸膜炎等，在临床上属疑难病症，大多数西药只能针对病原体及对症治疗，而从根本上治疗肺系疾病，改善肺脏功能，抗肺纤维化及肺实变，保证呼吸系统的正常畅通，有赖于中医药的补充。从中医角度讲，通常的肺疾病属肺肾不足，气阴两伤所致，产生咳喘少气，干咳少痰，潮热盗汗症状。西医治疗肺疾病主要依靠平喘、抗菌、祛痰等化学药物治疗，副作用大，且只能治标，无法治本，而中药可以养肺理肺，清肺肃肺，解毒化痰，行瘀散结，健脾益肾，止咳平喘功能。通过扶正祛邪、标本兼治，杀灭病原体，改善肺功能，调节体内抗邪能力而达到治疗咳喘等肺疾病的目的，实现标本兼治。
发明内容
本发明之目的在于提供一种治疗肺疾病的中药组合物，该中药组合物具有滋补肺肾，凉血除蒸的功效。用于治疗肺痨属肺肾不足，气阴两伤所致的咳喘少气，干咳少痰，潮热盗汗，形寒自汗，声嘶失音，心慌肢冷，形体消瘦等。
本发明的治疗肺疾病的中药组合物，主要由以下重量份的中药原料组成：百部95～105份、香附95～105份、炙制百合95～105份、炮姜95～105份、砂仁95～105份、木香195～205份、川贝母95～105份、地黄505～515份、地骨皮505～515份、白芍505～515份、山药505～515份、山茱萸305～315份、茯芩305～315份、女贞子305～315份、北沙参195～205份、麦冬295～305份、泽泻195～205份、知母195～205份、蒸制五味子195～205份、制鳖甲195～205份、牛膝195～205份和黄芪195～205份。
优选的，本发明的治疗肺疾病的中药组合物，主要由以下重量份的中药原料组成：百部100份、香附100份、炙制百合100份、炮姜100份、砂仁100份、木香200份、川贝母100份、地黄500份、地骨皮500份、白芍500份、山药500份、山茱萸300份、茯芩300份、女贞子300份、北沙参200份、麦冬300份、泽泻200份、知母200份、蒸制五味子200份、制鳖甲200份、牛膝200份和黄芪200份。
更优选的，本发明的治疗肺疾病的中药组合物，主要由以下中药原料组成：百部100g、香附100g、炙制百合100g、炮姜100g、砂仁100g、木香200g、川贝母100g、地黄500g、地骨皮500g、白芍500g、山药500g、山茱萸300g、茯芩300g、女贞子300g、北沙参200g、麦冬300g、泽泻200g、知母200g、蒸制五味子200g、制鳖甲200g、牛膝200g、黄芪200g。
上述本发明的中药组合物，进一步包括加入药用辅料形成片剂、口服液、糖浆剂、颗粒剂、散剂或丸剂。所述药用辅料包括填充剂、崩解剂、润滑剂、粘合剂、防腐剂、溶剂等，这些都是本领域常规的辅料，其制造方法也是本领域常用的。
上述本发明的中药组合物，其制剂形式优选为蜜丸。
本发明还提供了一种治疗肺疾病的密丸，包括上述本发明的中药组合物和炼蜜，其中，二者的重量比为1∶0.9～1。
所述密丸每丸重9g口服。一次1丸，一日1～2次。饭后服用。
本发明还提供了一种制备本发明的治疗肺疾病的密丸的方法，包括以下步骤：
1)将处方量的百合洗净、炙制，
2)将处方量的五味子洗净、蒸制，
3)将砂仁、川贝母、麦冬、女贞子、山茱萸、香附洗净、干燥，
4)将处方量的百部、炮姜、木香、地黄、地骨皮、白芍、山药、女贞子、北沙参、泽泻、知母、牛膝、黄芪洗净、湿润干燥；
5)将炮制鳖甲与步骤1)～4)的药材粉碎后混合，制得药粉，
6)将蜂蜜炼制后与上步的药粉混合，制丸，即得蜜丸，每丸重9g。
上述方法中，所述炙制百合、蒸制五味子和炮制鳖甲都是按照中国药典中描述的方法炮制而得。
本发明的中药组合物具有以下优势：
本发明药物选用植物中药材为原料，各组份符合中医学理论及现代医学理论，对人体无明显毒副作用；对病原体有清除杀灭作用，通过清肺肃肺，解毒化痰能够祛除外邪，抗击外邪，特别是结核杆菌有杀灭作用；直接作用于肺，通过养肺化痰，行瘀散结，止咳平喘，能够提高肺系抗邪能力，减轻或延缓病理产生和可进性改变的功效；滋补肺肾，凉血除蒸。对肺痨属肺肾不足，气阴两伤所致的咳喘少气，干咳少痰，潮热盗汗，形寒自汗，声嘶失音，心慌肢冷，形体消瘦有治疗效果。
本发明的治疗肺疾病的蜜丸，每丸重9g口服。一次1丸，一日1～2次。饭后服用。
具体实施方式
以下实施例用于进一步说明和理解本发明的实质，但不以此限制本发明的范围。
实施例1
治疗肺疾病的中药组合物，主要由以下重量份的中药原料组成：百部95份、香附105份、百合(炙)95份、炮姜105份、砂仁95份、木香195份、川贝母105份、地黄515份、地骨皮505份、白芍515份、山药515份、山茱萸305份、茯芩315份、女贞子305份、北沙参195份、麦冬305份、泽泻195份、知母205份、五味子(蒸)195份、鳖甲(制)205份、牛膝205份和黄芪195份。
蜜丸的制备，包括以下步骤：
1)将外处方量的百合洗净、炙制，
2)将处方量的五味子洗净、蒸制，
3)将砂仁、川贝母、麦冬、女贞子、山茱萸、香附洗净、干燥，
4)将处方量的百部、炮姜、木香、地黄、地骨皮、白芍、山药、女贞子、北沙参、泽泻、知母、牛膝、黄芪洗净、湿润干燥；
5)将炮制鳖甲与步骤1)～4)的药材粉碎后混合，制得药粉，
6)将蜂蜜炼制成炼蜜后与上步的药粉混合，其中，炼蜜与药粉的重量比为0.9～1.0∶1.0，制粒、即得蜜丸，每丸重9g。
实施例2
治疗肺疾病的中药组合物，主要由以下重量份的中药原料组成：百部105份、香附95份、百合(炙)105份、炮姜95份、砂仁105份、木香205份、川贝母95份、地黄505份、地骨皮515份、白芍5055份、山药505份、山茱萸315份、茯芩305份、女贞子315份、北沙参205份、麦冬295份、泽泻205份、知母195份、五味子(蒸)205份、鳖甲(制)195份、牛膝195份和黄芪205份。
蜜丸的制备参见实施例1
实施例3
治疗肺疾病的中药组合物，主要由以下重量份的中药原料组成：百部100份、香附100份、百合(炙)100份、炮姜100份、砂仁100份、木香200份、川贝母100份、地黄500份、地骨皮500份、白芍500份、山药500份、山茱萸300份、茯芩300份、女贞子300份、北沙参200份、麦冬300份、泽泻200份、知母200份、五味子(蒸)200份、鳖甲(制)200份、牛膝200份、黄芪200份。
蜜丸的制备参见实施例1
实施例4
治疗肺疾病的中药组合物，主要由以下中药原料组成：百部100g、香附100g、百合(炙)100g、炮姜100g、砂仁100g、木香200g、川贝母100g、地黄500g、地骨皮500g、白芍500g、山药500g、山茱萸300g、茯芩300g、女贞子300g、北沙参200g、麦冬300g、泽泻200g、知母200g、五味子(蒸)200g、鳖甲(制)200g、牛膝200g、黄芪200g。
蜜丸的制备，包括以下步骤：
1)将外处方量的百合洗净、炙制，
2)将处方量的五味子洗净、蒸制，
3)将砂仁、川贝母、麦冬、女贞子、山茱萸、香附洗净、干燥，
4)将处方量的百部、炮姜、木香、地黄、地骨皮、白芍、山药、女贞子、北沙参、泽泻、知母、牛膝、黄芪洗净、湿润干燥；
5)将炮制鳖甲与步骤1)～4)的药材粉碎后混合，制得药粉，
6)将蜂蜜炼制成炼蜜后与上步的药粉混合，其中，炼蜜与药粉的重量比为1.0∶1.0，制粒、即得蜜丸，每丸重9g
实施例5
临床疗效试验
试验患者
80例肺疾病患者，其中，男性60例，女性20例，平均年龄50岁，入选标准：咳嗽或气喘反复发作6个月以上，伴有干咳少痰，潮热盗汗，形寒自汗，声嘶失音，心慌肢冷，形体消瘦、咯血、胸闷、胸痛、气促、出汗或少气等临床症状。其中慢性支气管炎57例，肺结核10例，肺气肿13例，其中2种或2种以上合并较多。
给药方案：
给每位患者口服实施例4的蜜丸，每次9g，每日1次，30天为一疗程，一般1～3个疗程，必要时加服1～2个疗程，孕妇慎用，忌烟酒。
观察临床症状：
临床症状：观察咳嗽发作的长短、性质、咳声，咯痰的量、色、质，气喘的虚实，咯血的量、色、质，胸闷气促的原因，是否有潮热盗汗，形寒自汗，声嘶失音，心慌肢冷，形体消瘦等症状以及其他全身状况，舌苔脉象。
疗效判断标准
显效——症状全部消失
有效——症状基本消失
无效——症状无改变
试验结果：
咳嗽咯痰症状逐步消失，治疗前咳嗽咯痰症状占100％，而治疗后咳嗽咯痰症状大部分消失。80例患者服药一月内有70例(占87.5％)，明显好转，治疗3个月后，仅4例患者尚有轻度咳嗽，其余患者均已消失，其消失率为95％。气喘症状明显好转，治疗前气喘症状明显者40例，占总数的50％。经服药一月有36例明显好转(占90％)，服药3个月后，仅1例患者尚有明显气喘症状，其余患者均有不同程度减轻或消失。其好转率为97.5％。
总的治疗结果：
总的80例患者中，显效75例，有效4例，无效1例，总有效为98.7％。
其他症状改善：
99％的患者的咯痰、咯血、胸闷、胸痛、气促、出汗、少气、倦怠乏力、头昏、潮热盗汗，形寒自汗，声嘶失音，心慌肢冷，形体消瘦等症状均消失或明显改善。
经临床试验，实施例1-3的中药组合物与实施例4的组合物有相当的疗效。
在本发明的实质精神下进行处方量的成倍增减或简单的改变，也属于本发明的保护范围。

Claims (3)

1.一种滋补肺肾的中药组合物，由以下重量份的中药原料组成：百部100份、香附100份、炙制百合100份、炮姜100份、砂仁100份、木香200份、川贝母100份、地黄500份、地骨皮500份、白芍500份、山药500份、山茱萸300份、茯苓300份、女贞子300份、北沙参200份、麦冬300份、泽泻200份、知母200份、蒸制五味子200份、制鳖甲200份、牛膝200份和黄芪200份。
2.如权利要求1所述的中药组合物，由以下中药原料组成：百部100g、香附100g、炙制百合100g、炮姜100g、砂仁100g、木香200g、川贝母100g、地黄500g、地骨皮500g、白芍500g、山药500g、山茱萸300g、茯苓 300g、女贞子300g、北沙参200g、麦冬300g、泽泻200g、知母200g、蒸制五味子200g、制鳖甲200g、牛膝200g、黄芪200g。
3.如权利要求1或2所述的中药组合物，进一步包括加入药用辅料形成口服液、糖浆剂、颗粒剂、散剂或丸剂。
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