CN112263656B - 一种治疗艾滋病相关睡眠障碍的中药组合物及其中药制剂 - Google Patents
一种治疗艾滋病相关睡眠障碍的中药组合物及其中药制剂 Download PDFInfo
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Abstract
本发明公开了一种治疗艾滋病相关睡眠障碍的中药组合物及其中药制剂,涉及医药技术领域,中药组合物由如下重量份数的原料组成:珍珠母5‑20份、炒枣仁5‑20份、合欢皮5‑20份、郁金5‑20份、远志5‑20份、石菖蒲5‑20份、黄连5‑20份、肉桂1‑10份、桂枝5‑20份份、白芍5‑20份、小麦20‑60份、大枣5‑20份、炙甘草5‑20份。本发明的中药组合物由珍珠母、炒枣仁、合欢皮、郁金、远志、石菖蒲、黄连、肉桂、桂枝、白芍、小麦、大枣、炙甘草13种中草药混合而成,通过这13中中药材之间的相互协同作用,使得到的中药组合物对于艾滋病相关睡眠障碍具有很好的治疗效果。
Description
技术领域
本发明涉及医药技术领域,具体涉及一种治疗艾滋病相关睡眠障碍的中药组合物及其中药制剂。
背景技术
艾滋病,即获得性免疫缺陷综合征(acquired immunodeficiency syndrome,AIDS),其病原体为人类免疫缺陷病毒(human immunodeficiency virus,HIV),亦称艾滋病病毒。目前,艾滋病已成为严重威胁我国公众健康的重要公卫生问题。联合国艾滋病规划署(UNAIDS)估计,截至2017年底,全球现存活 HIV/AIDS患者3690万例,当年新发HIV感染者180万例,有2 170万例正在接受高效联合抗反转录病毒治疗(highly activeantiretroviral therapy, HAART,俗称“鸡尾酒疗法”,现在又称抗反转录病毒治疗。通过HAART可在较短的时间内控制病毒,使HIV/AIDs患者存活期由原来的几年提高到了数十年,但HAART并不能完全清除病毒。因此,患者需要终生服用抗病毒药物。
HIV/AIDs感染者由于感染后的精神压力、长期服药的心理负担以及药物治疗的副反应(如目前一线治疗方案中主要的药物依非韦伦会常常引起的头晕、失眠、困倦、注意力不能集中和异梦等神经毒性及精神异常)常常存在睡眠障碍,睡眠障碍成为HIV/AIDs患者主要的临床症状,这严重地影响了患者长期服用的依从性,易产生耐药及治疗失败等不良后果。因此,发挥中西医结合治疗的优势,从中药中开发出疗效明确治疗艾滋病相关睡眠障碍的药物,减轻西药的毒副作用,提高HIV/AIDs患者的生存质量有重要意义。
发明内容
为此,本发明提供一种治疗艾滋病相关睡眠障碍的中药组合物及其中药制剂,以解决现有治疗艾滋病相关睡眠障碍的西药存在毒副作用等问题。
为了实现上述目的,本发明提供如下技术方案:
根据本发明的第一方面,一种治疗艾滋病相关睡眠障碍的中药组合物,所述中药组合物由如下重量份数的原料组成:珍珠母5-20份、炒枣仁5-20份、合欢皮5-20份、郁金5-20份、远志5-20份、石菖蒲5-20份、黄连5-20份、肉桂1-10份、桂枝5-20份、白芍5-20份、小麦20-60份、大枣5-20份、炙甘草5-20份。
进一步地,所述中药组合物由如下重量份数的原料组成:珍珠母8-15份、炒枣仁8-15份、合欢皮8-15份、郁金8-15份、远志8-15份、石菖蒲8-15份、黄连7-15份、肉桂2-5份、桂枝10-15份、白芍10-15份、小麦25-40份、大枣8-15份、炙甘草8-15份。
进一步地,所述中药组合物由如下重量份数的原料组成:珍珠母10份、炒枣仁10份、合欢皮10份、郁金10份、远志10份、石菖蒲10份、黄连8 份、肉桂3份、桂枝12份、白芍12份、小麦30份、大枣10份、炙甘草10 份。
本发明各原料的作用具体如下:
珍珠母,为蚌科动物三角帆蚌Hyriopsis cumingii(Lea)、褶纹冠蚌Cristariaplicata(Leach)或珍珠贝科动物马氏珍珠贝Pteria martensii(Dunker)的贝壳。咸、寒。归肝、心经。具有平肝潜阳,清肝明目,镇惊安神的功效,主治平肝,潜阳,定惊,止血。治头眩,耳鸣,心悸,失眠,癫狂,惊痫,吐血,衄血,妇女血崩。
炒枣仁,是一种经过炮制的中药材,它是把中药酸枣仁放在锅中用文火炒制以后得到的中药成品。酸枣仁,甘,平。入心、脾、肝、胆经,具有养肝,宁心,安神,敛汗之功效,主治虚烦不眠,惊悸怔忡,烦渴,虚汗。
合欢皮,为豆科(Legumin0sae)植物合欢的干燥树皮,性味甘、平,入心、肝经。有解郁、和血、宁心、消痈肿之功。有治心神不安、忧郁、失眠、肺痈、痈肿、瘰疠、筋骨折伤之效。
郁金,为姜科植物温郁金Curcuma rcenyujin Y,H.Chenet C.Ling、姜黄 CurcumalongaL.、广西莪术Curcumakwangsiensis S.G.Lee et C.F.Liang或蓬莪术 Curcuma phaeocaulis Val.的干燥块根。辛、苦,寒,归肝、心、肺经。具有活血止痛,行气解郁,清心凉血,利胆退黄的功效,主治胸胁刺痛,胸痹心痛,经闭痛经,乳房胀痛,热病神昏,癫痫发狂,血热吐衄,黄疸尿赤。
远志,又名葽绕、蕀蒬等。苦、辛、温,归心、肾、肺经。具有安神益智、祛痰、消肿的功能,用于心肾不交引起的失眠多梦、健忘惊悸,神志恍惚,咳痰不爽,疮疡肿毒,乳房肿痛。
石菖蒲,属天南星科、菖蒲属禾草状多年生草本植物,辛,温。入心、肝经。具有化湿开胃,开窍豁痰,醒神益智的功效,用于脘痞不饥,噤口下痢,神昏癫痫,健忘耳聋。理气,活血,散风,去湿。治癫痫,痰厥,热病神昏,健忘,气闭耳聋,心胸烦闷,胃痛,腹痛,风寒湿痹,痈疽肿毒,跌打损伤。
黄连,别名:味连、川连、鸡爪连,为毛茛科、黄连属多年生草本植物,味苦,性寒,归心、脾、胃、肝、胆、大肠经。具有清热燥湿,泻火解毒的功效,主治湿热痞满,呕吐吞酸,泻痢,黄疸,高热神昏,心火亢盛,心烦不寐,心悸不宁,血热吐衄,目赤,牙痛,消渴,痈肿疗疮;外治湿疹,湿疮,耳道流脓。
肉桂,为樟科植物肉桂Cinnamomum cassia Presl的干燥树皮。味辛、甘,性大热,归肾、脾、心、肝经,其具有补火助阳,引火归元,散寒止痛,温通经脉的功效,主治阳痿宫冷,腰膝冷痛,肾虚作喘,虚阳上浮,眩晕目赤,心腹冷痛,虚寒吐泻,寒疝腹痛,痛经经闭。
桂枝,属樟目,樟科中等大乔木,辛、甘,温。归心、肺、膀胱经。其具有发汗解肌,温通经脉,助阳化气,平冲降气的功效,常用于风寒感冒,脘腹冷痛,血寒经闭,关节痹痛,痰饮,水肿,心悸等。
白芍,为毛茛科植物芍药Paeonia tacti lora Pall.的干燥根。味苦、酸,性微寒,归肝、脾经。其具有养血调经,敛阴止汗,柔肝止痛,平抑肝阳之功效,常用于血虚萎黄,月经不调,自汗,盗汗,胁痛,腹痛,四肢挛痛,头痛眩晕。
小麦,是小麦属植物的统称,富含淀粉、蛋白质、脂肪、矿物质、钙、铁、硫胺素、核黄素、烟酸及维生素A等。味甘,性凉。其具有养心安神,除烦的功效,主治心神不宁,失眠,妇女脏躁,烦躁不安,精神抑郁,悲伤欲哭。
大枣,蔷薇目鼠李科枣属植物,富含蛋白质、脂肪、糖类、胡萝卜素、B 族维生素、维生素C、维生素P以及钙、磷、铁和环磷酸腺苷等营养成分。甘,温,归脾、胃经。其具有补中益气,养血安神的功效,主治脾虚食少,乏力便溏,妇人脏躁。
炙甘草,系豆科植物,炙甘草是用蜜烘制的甘草,性温,味甘,归心经、肺经、胃经、脾经。其具有滋阴养血,益气通阳,复脉定悸的功效,主治心阴阳两虚证,后世医家在张仲景临床应用基础之上将其扩展用于治疗虚劳、肺痿、肺燥阴伤等证.现代医家则用于治疗心血管疾病及其他系统性疾病。
根据本发明的第二方面,一种治疗艾滋病相关睡眠障碍的中药制剂,所述中药制剂由上述的中药组合物和药学上可接受的载体或稀释剂组成。
进一步地,所述中药制剂为颗粒剂、片剂、胶囊、丸剂、汤剂、糖浆剂。
进一步地,所述药学上可接受的载体或稀释剂是指药学领域常规的药物载体,选自填充剂、粘合剂、崩解剂、润滑剂、表面活性剂或矫味剂中的一种或几种。
进一步地,所述填充剂选自淀粉、蔗糖、乳糖、甘露醇、山梨醇、木糖醇、微晶纤维素或葡萄糖中的一种或几种。
进一步地,所述粘合剂选自纤维素衍生物、藻酸盐、明胶或聚乙烯吡咯烷酮中的一种或几种。
本发明具有如下优点:
本发明一种治疗艾滋病相关睡眠障碍的中药组合物由珍珠母、炒枣仁、合欢皮、郁金、远志、石菖蒲、黄连、肉桂、桂枝、白芍、小麦、大枣、炙甘草 13种中草药混合而成,通过这13中中药材之间的相互协同作用,使得到的中药组合物对于艾滋病相关睡眠障碍具有很好的治疗效果,通过大量的临床试验可以看出本发明的中药组合物疗效确切。
本发明一种治疗艾滋病相关睡眠障碍的中药制剂使用纯中药制剂,避免了对患者胃的刺激和对肝脏产生的毒副作用,经过大量人群实践证实,安全可靠,无明显不良反应,且制备方法简单,对环境无污染,具有极大的推广应用价值。
具体实施方式
以下由特定的具体实施例说明本发明的实施方式,熟悉此技术的人士可由本说明书所揭露的内容轻易地了解本发明的其他优点及功效,显然,所描述的实施例是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1
一种治疗艾滋病相关睡眠障碍的中药组合物,所述中药组合物由如下重量份数的原料组成:珍珠母5份、炒枣仁5份、合欢皮5份、郁金5份、远志5 份、石菖蒲5份、黄连5份、肉桂1份、桂枝5份、白芍5份、小麦20份、大枣5份、炙甘草5份。
实施例2
一种治疗艾滋病相关睡眠障碍的中药组合物,所述中药组合物由如下重量份数的原料组成:珍珠母20份、炒枣仁20份、合欢皮20份、郁金20份、远志20份、石菖蒲20份、黄连20份、肉桂10份、桂枝20份、白芍20份、小麦60份、大枣20份、炙甘草20份。
实施例3
一种治疗艾滋病相关睡眠障碍的中药组合物,所述中药组合物由如下重量份数的原料组成:珍珠母8份、炒枣仁8份、合欢皮8份、郁金8份、远志8 份、石菖蒲8份、黄连7份、肉桂2份、桂枝10份、白芍10份、小麦25份、大枣8份、炙甘草8份。
实施例4
一种治疗艾滋病相关睡眠障碍的中药组合物,所述中药组合物由如下重量份数的原料组成:珍珠母15份、炒枣仁15份、合欢皮15份、郁金15份、远志15份、石菖蒲15份、黄连15份、肉桂5份、桂枝15份、白芍15份、小麦40份、大枣15份、炙甘草15份。
实施例5
一种治疗艾滋病相关睡眠障碍的中药组合物,所述中药组合物由如下重量份数的原料组成:珍珠母10份、炒枣仁10份、合欢皮10份、郁金10份、远志10份、石菖蒲10份、黄连8份、肉桂3份、桂枝12份、白芍12份、小麦 30份、大枣10份、炙甘草10份。
实施例6
一种治疗艾滋病相关睡眠障碍的中药制剂,所述中药制剂由实施例1至5 所述的中药组合物按照常规方法制成汤剂。
实施例7
一种治疗艾滋病相关睡眠障碍的中药制剂,所述中药制剂由实施例1至5 所述的中药组合物和药学上可接受的载体或稀释剂组成;所述药学上可接受的载体或稀释剂是指药学领域常规的药物载体,选自填充剂、粘合剂、崩解剂、润滑剂、表面活性剂或矫味剂中的一种或几种。所述填充剂选自淀粉、蔗糖、乳糖、甘露醇、山梨醇、木糖醇、微晶纤维素或葡萄糖中的一种或几种。所述粘合剂选自纤维素衍生物、藻酸盐、明胶或聚乙烯吡咯烷酮中的一种或几种。其制备方法如下:
取实施例1至5所述的中药组合物,将上述原料粉碎后,添加药学上可接受的载体或稀释剂,按照常规方法,整粒,干燥,制得中药颗粒剂。
实施例8
一种治疗艾滋病相关睡眠障碍的中药制剂,所述中药制剂由实施例1至5 所述的中药组合物和药学上可接受的载体或稀释剂组成;所述药学上可接受的载体或稀释剂是指药学领域常规的药物载体,选自填充剂、粘合剂、崩解剂、润滑剂、表面活性剂或矫味剂中的一种或几种。所述填充剂选自淀粉、蔗糖、乳糖、甘露醇、山梨醇、木糖醇、微晶纤维素或葡萄糖中的一种或几种。所述粘合剂选自纤维素衍生物、藻酸盐、明胶或聚乙烯吡咯烷酮中的一种或几种。其制备方法如下:
取实施例1至5所述的中药组合物,将上述原料粉碎后,添加药学上可接受的载体或稀释剂,按照常规方法,制粒,填充胶囊,制得中药胶囊剂。
实施例9
一种治疗艾滋病相关睡眠障碍的中药制剂,所述中药制剂由实施例1至5 所述的中药组合物和药学上可接受的载体或稀释剂组成;所述药学上可接受的载体或稀释剂是指药学领域常规的药物载体,选自填充剂、粘合剂、崩解剂、润滑剂、表面活性剂或矫味剂中的一种或几种。所述填充剂选自淀粉、蔗糖、乳糖、甘露醇、山梨醇、木糖醇、微晶纤维素或葡萄糖中的一种或几种。所述粘合剂选自纤维素衍生物、藻酸盐、明胶或聚乙烯吡咯烷酮中的一种或几种。其制备方法如下:
取实施例1至5所述的中药组合物,将上述原料粉碎后,添加药学上可接受的载体或稀释剂,按照常规塑制法或泛制法,制得中药丸剂。
实施例10
一种治疗艾滋病相关睡眠障碍的中药制剂,所述中药制剂由实施例1至5 所述的中药组合物和药学上可接受的载体或稀释剂组成;所述药学上可接受的载体或稀释剂是指药学领域常规的药物载体,选自填充剂、粘合剂、崩解剂、润滑剂、表面活性剂或矫味剂中的一种或几种。所述填充剂选自淀粉、蔗糖、乳糖、甘露醇、山梨醇、木糖醇、微晶纤维素或葡萄糖中的一种或几种。所述粘合剂选自纤维素衍生物、藻酸盐、明胶或聚乙烯吡咯烷酮中的一种或几种。其制备方法如下:
取实施例1至5所述的中药组合物,将上述原料粉碎后,添加药学上可接受的载体或稀释剂,按照常规方法,压制成片,包薄膜衣,制得中药片剂。
实施例11
一种治疗艾滋病相关睡眠障碍的中药制剂,所述中药制剂由实施例1至5 所述的中药组合物和药学上可接受的载体或稀释剂组成;所述药学上可接受的载体或稀释剂是指药学领域常规的药物载体,选自填充剂、粘合剂、崩解剂、润滑剂、表面活性剂或矫味剂中的一种或几种。所述填充剂选自淀粉、蔗糖、乳糖、甘露醇、山梨醇、木糖醇、微晶纤维素或葡萄糖中的一种或几种。所述粘合剂选自纤维素衍生物、藻酸盐、明胶或聚乙烯吡咯烷酮中的一种或几种。其制备方法如下:
取实施例1至5所述的中药组合物,将上述原料粉碎后,添加药学上可接受的载体或稀释剂如蔗糖等,按照常规方法,制得中药糖浆剂。
经过临床实验证实,本发明提供的中药组合物用于治疗艾滋病相关睡眠障碍疗效确切。
1、一般资料
在医院长期接受抗逆转录病毒治疗的患者中挑选了120名存在艾滋病相关睡眠障碍的患者,男性患者116名,女性患者4名;其中,20岁—29岁有55例, 30岁—39岁有38例,40岁以上的27例。
2、治疗方法
治疗疗程:8周为一个疗程。
服药方法:将实施例5的中药组合物制成中药汤剂口服,每日两次,早晚各一次,饭前半小时服用,每次200~300毫升。服药期间,忌食油腻、猪肉以及绿豆等性寒食物。
3、诊断标准
同时满足以下两个标准:
3.1艾滋病诊断标准:参照《艾滋病和艾滋病病毒感染诊断标准》 (WS293-2008)、《艾滋病诊疗指南(2011版)》,有流行病学史,结合抗HIV 阳性,经Western Blot确证试验证实;或仅实验室检查抗HIV阳性即可诊断。
3.2睡眠障碍标准:一.有效睡眠时间不足。入睡困难,熟睡维持困难,易醒和早醒。二.睡眠质量下降,以浅睡眠为主,或由于频繁觉醒而导致睡眠结构断裂,降低了睡眠质量。三.白天缺觉。疲劳和全身不适注意力不集中,记忆力减退,学习工作和社交能力下降,情绪波动或易激惹,兴趣,精力减退,工作中错误倾向增加,紧张,头痛头晕。
4、疗效评定标准
显效:症状、体征明显改善,证候积分减少≥70%;
有效:症状、体征均有好转,证候积分减少≥30%;
无效:症状、体征均无明显改善,甚或加重,证候积分减少不足30%。计算公式(尼莫地平法)为:[治疗前积分—治疗后积分)÷治疗前积分]×100%。
5、治疗结果
接受治疗的患者中,显效53例,有效39例,无效28例。从治疗结果来看,说明本发明提供的中药组合物用于改善艾滋病相关睡眠障碍的有效率达 76.7%,疗效确切。
典型案例
病例1:韩某某,男,27岁,江苏镇江人;2013年10月做痔疮手术前,例行检查时发现HIV抗体阳性;进一步检查全血CD4+T淋巴细胞240μL-1,HIV载量4.5×104copies/ml,患者明确诊断HIV感染。2014年1月患者开始进行抗HIV 治疗,方案为3TC/TDF/EFV;服药后出现多梦、易醒、乏力等表现,服用舒乐安定等不能缓解。抗HIV治疗6个月后,检查全血CD4+T淋巴细胞448μL-1, HIV载量不能检出。2014年10月开始服用实施例5的中药组合物制成的中药汤剂,服用8周后,睡眠恢复正常,乏力减轻;随访1年未再出现失眠。继续服用原方案抗HIV治疗。
病例2:刘某某,男,32岁,河北张家口人;2015年10月无明显诱因出现胸闷、喘憋;就诊当地医院胸部CT提示双肺磨玻璃影改变,随转北京地坛医院诊治。检测HIV抗体阳性,全血CD4+T淋巴细胞27μL-1,HIV载量6.5× 106copies/ml,明确诊断为艾滋病、肺孢子菌肺炎;经磺胺等抗感染治疗后肺部症状好转。患者于2015年12月开始抗艾滋病病毒治疗,治疗方案为 3TC/TDF/EFV,服药后出头晕、噩梦、乏力、注意力不集中等症状。2016年1 月开始服用实施例5的中药组合物制成的中药汤剂来治疗失眠,服用8周后,噩梦减轻、头晕缓解;继续治疗16周后,头晕、噩梦症状消失。继续服用原方案抗HIV治疗,CD4+T淋巴细胞恢复正常,HIV载量不能检出。
病例3:任某某,男,21岁,北京海淀人。2017年7月自行检测HIV快筛阳性,随就诊北京地坛医院,HIV抗体检测阳性,全血CD4+T淋巴细胞528μL-1,HIV载量3.5×103copies/ml,明确诊断为HIV感染。给予绥美凯抗HIV治疗,全血CD4+T淋巴细胞恢复正常,HIV载量检测不出。2018年2月就诊时,入睡困难,容易惊醒,急躁易怒。给予实施例5的中药组合物制成的中药汤剂治疗8周后,睡眠明显改善,情绪变好,巩固治疗8周后随访未再出现失眠症状。继续服用原方案抗HIV治疗。
虽然,上文中已经用一般性说明及具体实施例对本发明作了详尽的描述,但在本发明基础上,可以对之作一些修改或改进,这对本领域技术人员而言是显而易见的。因此,在不偏离本发明精神的基础上所做的这些修改或改进,均属于本发明要求保护的范围。
Claims (6)
1.一种治疗艾滋病相关睡眠障碍的中药组合物,其特征在于,所述中药组合物由如下重量份数的原料组成:珍珠母10份、炒枣仁10份、合欢皮10份、郁金10份、远志10份、石菖蒲10份、黄连8份、肉桂3份、桂枝12份、白芍12份、小麦30份、大枣10份、炙甘草10份。
2.一种治疗艾滋病相关睡眠障碍的中药制剂,其特征在于,所述中药制剂由权利要求1所述的中药组合物和药学上可接受的载体或稀释剂组成。
3.如权利要求2所述的中药制剂,其特征在于,所述中药制剂为颗粒剂、片剂、胶囊、丸剂、汤剂、糖浆剂。
4.如权利要求2所述的中药制剂,其特征在于,所述药学上可接受的载体或稀释剂是指药学领域常规的药物载体,选自填充剂、粘合剂、崩解剂、润滑剂、表面活性剂或矫味剂中的一种或几种。
5.如权利要求4所述的中药制剂,其特征在于,所述填充剂选自淀粉、蔗糖、乳糖、甘露醇、山梨醇、木糖醇、微晶纤维素或葡萄糖中的一种或几种。
6.如权利要求4所述的中药制剂,其特征在于,所述粘合剂选自纤维素衍生物、藻酸盐、明胶或聚乙烯吡咯烷酮中的一种或几种。
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