CN104474102A - 一种治疗心悸的药物及其制备方法 - Google Patents
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Abstract
一种治疗心悸的药物及其制备方法，它是由龙眼肉、酸枣仁、山萸肉、柏子仁、生龙骨、生牡蛎、乳香、没药按照一定比例配伍而成。本发明中药组合物能够镇惊定志，养心安神，补血养心，益气安神；滋阴清火，养心安神，温补心阳，安神定悸；活血化瘀，理气通络；振奋心阳，化气行水，对治疗心脏神经官能症心悸失眠有切实疗效，且无毒副作用。
Description
技术领域
本发明涉及一种由中草药为原料药的中药组合物及其制备方法，具体的说是涉及一种治疗心悸的药物及其制备方法。
背景技术
心悸包括惊悸和怔忡，是一种自觉心脏跳动的不适感或心慌感。当心率加快时感到心脏跳动不适，心率缓慢时感到搏动有力。心悸时，心率可快，可慢，也可有心率失常，心率和心律正常者也可以有心悸。
心悸是许多疾病的一个共同表现，临床上，心悸可分为两类：
一种是器质性病变引起心悸。西医学之各种原因引起的心律失常，心力衰竭、某些器质性或功能性疾病如冠心病、风湿性心脏病、高血压性心脏病、肺源性心脏病、各种心律失常，以及贫血、低钾血症、心脏神经官能症等出现心悸。
一类是心脏神经官能症心悸。一些心悸的患者并非是器质性病变引起，在日常诊治病人中，常遇到一些患者，主诉胸闷、心慌、胸痛，自认为患了“心脏病”，忧心忡忡地来院就诊。但大多病人经检查：X摄片、心电图及超声心电图检查均正常。这并非是器质心脏病，而是一种以心血管症状为主的功能性失调的心脏神经官能症（即心脏植物神经功能紊乱症）。心脏为何有神经官能症呢？由于焦虑、紧张、情绪激动、精神创伤等因素的作用，中枢的兴奋和抑制过程发生障碍，受植物神经调节的心血管系统也随着发生紊乱，引起了一系列交感神经张力过高的症状。此外，过度劳累，体力活动过少，循环系统缺乏适当锻炼，以致稍有活动或少许劳累即不能适应，因而产生过度的心血管反应而致该病。心脏神经官能症是全身神经官能症的一种（即植物神经功能紊乱在心血官系统的表现），其症状表现是多种多样的，最普通的自觉症状是心悸、呼吸不畅、心前区疼痛和全身乏力等，还有容易激动、失眠、多汗、发抖、眩晕、多梦等表现。该病虽没有生命之虞，但病情时好时坏，迁延不愈，严重者甚至不能正常生活和工作，使患者饱受痛苦。由于该病患者心脏并无器质性病理改变，长期来往往得不到足够重视，有关研究报道不多。临床上由于其缺乏有效的诊断手段和治疗措施，造成漏诊和误治情况并不少见，尤其是当该病有少量早搏或ST－T改变时，如果不再做进一步检查排除，患者常会被误作病毒性心肌炎或冠心病等。
发明内容
本发明从临床医疗用药需求及中医组方辩证原则出发，提出一种主治心脏神经官能症心悸的药物及其制备方法。它是由以下重量份数配比的原料药制备而成的药剂：龙眼肉13-17g、酸枣仁8-12g、山萸肉8-12g、柏子仁3-7g、生龙骨13-17g、生牡蛎13-17g、乳香2-5g、没药2-5g。优选配比为：龙眼肉15g、酸枣仁10g、山萸肉10g、柏子仁5g、生龙骨15g、生牡蛎15g、乳香3g、没药3g。所述药剂为汤剂、胶囊剂、片剂或丸剂。
所述胶囊剂、片剂、丸剂的制备方法步骤如下：
（1）取方中龙眼肉、酸枣仁、山萸肉、柏子仁、生龙骨、生牡蛎、乳香、没药粉碎筛析；
（2）将步骤（1）中筛制的混合物加水煎煮2-3次，合并煎液、过滤，将虑液浓缩成70-80度时，胶囊、丸剂相对密度为1.0-1.6的稠膏，片剂相对密度为1.0-1.4的稠膏；
（3）制作胶囊、丸剂时：
将稠膏分离纯化、干燥，制成干颗粒；将干颗粒混合均匀，填充胶囊内即制成胶囊；将干颗粒喷加炼蜜、混合均匀，制成小丸即制成丸剂；
制作片剂时：
将2-4份淀粉与步骤（2）中的稠膏混合均匀，制成颗粒、干燥，制成干颗粒，将干颗粒压制成片剂，包糖衣，即制成片剂。
步骤（2）中所述的混合物，加水煎煮的优选次数为2次，第一次为60-80分钟，第二次为40-60分钟。
本发明药物原料药的药理如下：
龙眼肉：具有益气补血，增强记忆，安神定志，养血安胎，抗菌，抑制癌细胞，降脂护心，延缓衰老的功效；现代医学证实，龙眼肉中含有大量的铁、钾等元素，能促进血红蛋白的再生以治疗因贫血造成的心悸、心慌、失眠、健忘；可降血脂，增加冠状动脉血流量。
酸枣仁：归心经、脾经、肝经、胆经，具有宁心安神，养肝，敛汗功效；主治：虚烦不眠；惊悸怔忡；体虚自汗、盗汗；现代药理证实，酸枣仁具有镇静催眠作用，对戊四氮引起的惊厥有对抗作用，能对抗咖啡因。
山萸肉：具有补益肝肾，收敛固脱功效，主治腰头晕目眩，耳聋耳鸣，腰膝酸软，跹精滑精，小便频数，虚汗不止，妇女崩漏，内热消渴，温肝补肾，除一切风，止月经过多，治老人尿频。
柏子仁：具有养心安神，滋阴止汗，戢阳气，止盗汗，进饮食，退经络热功效，治劳欲过度，心血亏损，精神恍惚，夜多怪梦，怔仲惊悸，健忘遗泄，治血虚有火，月经耗损，渐至不通，赢瘦而生潮热，及室女思虑过度；柏子仁味甘、酸，性平。能滋养心肝，对于轻度失眠具有一定的疗效。在临床上面，采用柏子仁进行失眠治疗，对于轻度或是重度失眠均可取得较为显著理想的疗效。
生龙骨：生品潜阳安神，治阴虚阳亢，烦躁易怒，心悸失眠，头晕目眩，癫狂惊等症；
生牡蛎：具有平肝潜阳，重镇安神，软坚散结，收敛固涩，滋阴养血、补五脏、活血充肌等功效，治阴虚烦热失眠、心神不安。
乳香：具有镇痛功效，能调气活血，定痛，追毒，治气血凝滞、心腹疼痛，痈疮肿毒，跌打损伤，痛经，产后瘀血刺痛。
没药：有活血止痛、消肿生肌等功效，主治胸腹瘀痛、痛经、经闭、症瘕、跌打损伤、痈肿疮疡、肠痈、目赤肿痛。
中医认为心悸主要是由于心虚胆怯、心血不足、心阴亏虚、心阳不振、心脉瘀阻或水饮凌心所致。因此，本发明以龙眼肉、柏子仁、生龙骨、生牡蛎为君药，益气补血，安神定志，养心安神，滋阴止汗，潜阳安神，平肝潜阳，重镇安神，治心悸失眠、怔仲惊悸。以酸枣仁、山萸肉为臣药，宁心安神，养肝，敛汗，补益肝肾，收敛固脱。佐以乳香，使以没药，调气活血，定痛追毒，活血止痛。以达到镇惊定志，养心安神，补血养心，益气安神；滋阴清火，养心安神；温补心阳，安神定悸；活血化瘀，理气通络；振奋心阳，化气行水的效果。本发明所述的药物承中医之精髓、严谨组方，诸药君臣佐使合用，补破结合、相得益彰，符合中医用药规律和辨证施治的原则。
有益效果
本发明中药组合物能够镇惊定志，养心安神，补血养心，益气安神；滋阴清火，养心安神，温补心阳，安神定悸；活血化瘀，理气通络；振奋心阳，化气行水，对治疗心脏神经官能症心悸、失眠，成效显著，且无毒副作用。
临床试验：
1、选择病例
临床上则取心脏神经官能症心悸患者146例，大部分是女性患者，平均年龄36岁。
、诊断标准
心脏神经官能症心悸，临床表现为：主诉心悸、心慌、心前区疼痛、胸闷、气短、呼吸困难、焦虑；伴有头晕、失眠、多梦、健忘、眩晕、耳鸣；经各项检查非器质性病变引起的心悸。
、治疗方案
实施例2所制备胶囊，每天早中晚饭后半小时各4-6粒，每粒0.3g，5天为一个疗程，用药4个疗程后观察统计。
、疗效评价标准
治愈：心慌、胸痛消失，胸闷、气短、呼吸困难、焦虑感消失，睡眠质量良好，睡后有精神；半年内不复发。
有效：心慌、胸痛减轻，胸闷、气短、呼吸困难、焦虑感被动注意，睡眠质量较好；
无效：患者主诉体征无变化或加重；
总有效率=治愈率+有效率。
、数据统计
| 病例数 | 治愈 | 有效 | 无效 | 治愈率 | 总有效率 |
| 146 | 107 | 39 | 0 | 73.29% | 100.00% |
6、结论
依据诊断标准和疗效评价标准，按照治疗方案对146例心脏神经官能症心悸患者进行治疗，治愈107例，治愈率为73.29%，有效39例，无效0例，总有效率达到100%。临床试验显示，本发明药物对对治疗心脏神经官能症心悸有显著疗效。
急毒性试验：较大剂量和较长疗程服用对大鼠的生长无显著毒性，对大鼠的脑、心、肝、肾等切片形态学检查未见明显毒性损伤改变，试验显示，本药物毒性甚小。
镇静作用药效学试验：取体重18.0±1.0g小白鼠10只，对照组5只，治疗组5只，给药前先观察其正常活动情况，两组小白鼠均适应环境后，给予治疗组灌胃本发明药物，用直接观察法记录下两组小白鼠活动情况，治疗组小白鼠活动次数和频率明显小于对照组小白鼠。证明本发明药物具有镇静作用。
具体实施方式
实施例1：一种治疗心悸的药物及其制备方法。它是由以下重量份数配比的原料药制备而成的药剂：龙眼肉13-17g、酸枣仁8-12g、山萸肉8-12g、柏子仁3-7g、生龙骨13-17g、生牡蛎13-17g、乳香2-5g、没药2-5g。所述药剂为胶囊剂、片剂或丸剂。
按照下述重量份数配比称取原料药：
龙眼肉13-17g、酸枣仁8-12g、山萸肉8-12g、柏子仁3-7g、生龙骨13-17g、生牡蛎13-17g、乳香2-5g、没药2-5g。
所述胶囊剂、片剂、丸剂的制备方法步骤如下：
（1）取方中龙眼肉、酸枣仁、山萸肉、柏子仁、生龙骨、生牡蛎、乳香、没药粉碎筛析；
（2）将步骤（1）中筛制的混合物加水煎煮2-3次，合并煎液、过滤，将虑液浓缩成70-80度时，胶囊、丸剂相对密度为1.0-1.6的稠膏，片剂相对密度为1.0-1.4的稠膏；
（3）制作胶囊、丸剂时：
将稠膏分离纯化、干燥，制成干颗粒；将干颗粒混合均匀，填充胶囊内即制成胶囊；将干颗粒喷加炼蜜、混合均匀，制成小丸即制成丸剂；
制作片剂时：
将2-4份淀粉与步骤（2）中的稠膏混合均匀，制成颗粒、干燥，制成干颗粒，将干颗粒压制成片剂，包糖衣，即制成片剂。
步骤（2）中所述的混合物，加水煎煮的优选次数为2次，第一次为60-80分钟，第二次为40-60分钟。
实施例2：一种治疗心悸的药物及其制备方法。它是由以下重量份数配比的原料药制备而成的药剂：龙眼肉15g、酸枣仁10g、山萸肉10g、柏子仁5g、生龙骨15g、生牡蛎15g、乳香3g、没药3g。所述药剂为胶囊剂、片剂或丸剂。
按照下述重量份数配比称取原料药：
龙眼肉15g、酸枣仁10g、山萸肉10g、柏子仁5g、生龙骨15g、生牡蛎15g、乳香3g、没药3g。
所述胶囊剂、片剂、丸剂的制备方法步骤如下：
（1）取方中龙眼肉、酸枣仁、山萸肉、柏子仁、生龙骨、生牡蛎、乳香、没药粉碎筛析；
（2）将步骤（1）中筛制的混合物加水煎煮2-3次，合并煎液、过滤，将虑液浓缩成70-80度时，胶囊、丸剂相对密度为1.0-1.6的稠膏，片剂相对密度为1.0-1.4的稠膏；
（3）制作胶囊、丸剂时：
将稠膏分离纯化、干燥，制成干颗粒；将干颗粒混合均匀，填充胶囊内即制成胶囊；将干颗粒喷加炼蜜、混合均匀，制成小丸即制成丸剂；
制作片剂时：
将2-4份淀粉与步骤（2）中的稠膏混合均匀，制成颗粒、干燥，制成干颗粒，将干颗粒压制成片剂，包糖衣，即制成片剂。
步骤（2）中所述的混合物，加水煎煮的优选次数为2次，第一次为60-80分钟，第二次为40-60分钟。
实施例3：本发明药物还可以为汤剂、口服液、颗粒剂等。
Claims (5)
1.一种治疗心悸的药物，其特征在于它是由以下重量份数配比的原料药制备而成的药剂：龙眼肉13-17g、酸枣仁8-12g、山萸肉8-12g、柏子仁3-7g、生龙骨13-17g、生牡蛎13-17g、乳香2-5g、没药2-5g。
2.根据权利要求1所述的治疗心悸的药物，其特征在于它是由以下重量份数配比的原料药制备而成的药剂：龙眼肉15g、酸枣仁10g、山萸肉10g、柏子仁5g、生龙骨15g、生牡蛎15g、乳香3g、没药3g。
3.根据权利要求1或2所述的治疗心悸的药物，其特征在于：所述药剂为汤剂、胶囊剂、片剂或丸剂。
4.根据权利要求3所述的治疗心悸的药物，其特征在于：所述胶囊剂、片剂、丸剂的制备方法步骤如下：
（1）取方中龙眼肉、酸枣仁、山萸肉、柏子仁、生龙骨、生牡蛎、乳香、没药粉碎筛析；
（2）将步骤（1）中筛制的混合物加水煎煮2-3次，合并煎液、过滤，将虑液浓缩成70-80度时，胶囊、丸剂相对密度为1.0-1.6的稠膏，片剂相对密度为1.0-1.4的稠膏；
（3）制作胶囊、丸剂时：
将稠膏分离纯化、干燥，制成干颗粒；将干颗粒混合均匀，填充胶囊内即制成胶囊；将干颗粒喷加炼蜜、混合均匀，制成小丸即制成丸剂；
制作片剂时：
将2-4份淀粉与步骤（2）中的稠膏混合均匀，制成颗粒、干燥，制成干颗粒，将干颗粒压制成片剂，包糖衣，即制成片剂。
5.根据权利要求4所述的治疗心悸的药物的制备方法，其特征在于步骤（2）中所述的混合物，加水煎煮的次数为2次，第一次为60-80分钟，第二次为40-60分钟。
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