CN117482167A - 一种治疗艾滋病相关的肺部感染的中药组合物及其中药制剂 - Google Patents
一种治疗艾滋病相关的肺部感染的中药组合物及其中药制剂 Download PDFInfo
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- CN117482167A CN117482167A CN202311321048.8A CN202311321048A CN117482167A CN 117482167 A CN117482167 A CN 117482167A CN 202311321048 A CN202311321048 A CN 202311321048A CN 117482167 A CN117482167 A CN 117482167A
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Abstract
本发明公开了一种治疗艾滋病相关的肺部感染的中药组合物及其中药制剂,具体涉及中药技术领域。所述中药组合物由如下重量份数的原料组成:生石膏15‑45份、生地10‑30份、地骨皮10‑30份、葛根10‑30份、天花粉10‑30份、秦艽5‑20份、青蒿10‑30份、紫草5‑30份、白茅根10‑30份、地丁5‑30份、知母5‑20份、甘草2‑15份。本发明的一种治疗艾滋病相关的肺部感染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。
Description
技术领域
本发明涉及中药技术领域,具体涉及一种治疗艾滋病相关的肺部感染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(acquiredimmunodeficiency syndrome,AIDS),其病原体为人类免疫缺陷病毒(human immunodeficiencyvirus,HIV),亦称艾滋病病毒。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2170万例正在接受高效联合抗反转录病毒治疗(highlyactive antiretroviraltherapy,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抵抗力偏低,长期服用药物,也会降低机体的免疫力,患者肺部感染后不易恢复,增加了患者的痛苦程度,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的肺部感染的药物,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的肺部感染的中药组合物及其中药制剂,以解决现有治疗艾滋病相关肺部感染的西药毒副作用强,治疗效果不佳等问题。
为了实现上述目的,本发明提供如下技术方案:
根据本发明一方面提供的一种治疗艾滋病相关的肺部感染的中药组合物,所述中药组合物由如下重量份数的原料组成:生石膏15-45份、生地10-30份、地骨皮10-30份、葛根10-30份、天花粉10-30份、秦艽5-20份、青蒿10-30份、紫草5-30份、白茅根10-30份、地丁5-30份、知母5-20份、甘草2-15份。
进一步的,所述中药组合物由如下重量份数的原料组成:生石膏20-40份、生地15-25份、地骨皮15-25份、葛根15-25份、天花粉15-25份、秦艽6-15份、青蒿15-25份、紫草10-20份、白茅根15-25份、地丁10-20份、知母6-15份、甘草2-10份。
进一步的,所述中药组合物由如下重量份数的原料组成:生石膏30份、生地20份、地骨皮20份、葛根20份、天花粉20份、秦艽10份、青蒿20份、紫草15份、白茅根20份、地丁15份、知母10份、甘草5份。
本发明各原料的作用具体如下:
生石膏:又名"寒水石",主治中风寒热,有解肌发汗,除口干舌焦,头痛牙疼等功能。乃祛瘟解热之良药。
生地:别名生地黄,野地黄、山烟根等,为玄参科植物地黄的块根。甘,寒。归心,肝,肾经。清热凉血、养阴生津。
地骨皮:别名枸杞皮,为茄科、枸杞属植物,是枸杞Lycium chinense Mill.的根皮。性甘,寒。可入药,具有退热除蒸之效,凉血除蒸、清肺降火等功效。
葛根:为豆科植物野葛的干燥根,甘、辛,凉。有解肌退热,透疹,生津止渴,升阳止泻之功效。
天花粉:粉味甘,微苦,性微寒,归肺、胃经。天花粉具有清热泻火、生津止渴、消肿排脓的功效。
秦艽:为龙胆科植物秦艽、麻花秦艽、粗茎秦艽或秦艽的干燥根,具有祛风湿、清湿热、止痹痛的功效,临床用于治疗风湿痹痛、筋脉拘挛、骨节酸痛、日晡潮热、小儿疳积发热等症状。
青蒿:学名:Artemisia carvifolia,苦,辛,寒。归肝、胆经、三焦、肾经。清透虚热,凉血除蒸,解暑,截疟。用于暑邪发热,阴虚发热,夜热早凉,骨蒸劳热,疟疾寒热,湿热黄疸。
紫草:学名:Lithospermum erythrorhizon Sieb.et Zucc.紫草科紫草属多年生草本植物,苦,寒。清热解毒,凉血活血,愈合溃疡的功效。
白茅根:为禾本科植物白茅的根茎。凉血,止血,清热,利尿。治热病烦渴,吐血,衄血,肺热喘急,胃热哕逆,淋病,小便不利,水肿,黄疸。
地丁:地丁草,性寒,味苦,小毒;入心、脾经,清热解毒。治温病高热烦躁,流感,传染性肝炎,肾炎,瘰疬,腮腺炎,疔疮及其它化脓性感染。
知母:性味:苦,寒。入肺、胃、肾经。功能主治:滋阴降火,润燥滑肠。治烦热消渴,骨蒸劳热,肺热咳嗽,大便燥结,小便不利。
甘草:豆科、甘草属多年生草本。甘草的根及根茎性味甘平,归心肺脾胃经。清热解毒、镇咳祛痰、补脾益气。
根据本发明另一方面提供的一种治疗艾滋病相关的肺部感染的中药制剂,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。
进一步的,所述中药制剂为颗粒剂、片剂、胶囊、丸剂、汤剂、糖浆剂。
进一步的,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。
进一步的,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。
进一步的,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肺部感染的中药组合物由生石膏、生地、地骨皮、葛根、天花粉、秦艽、青蒿、紫草、白茅根、地丁、知母、甘草12种中草药混合而成,通过这12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的肺部感染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。
本发明的一种治疗艾滋病相关的肺部感染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的肺部感染的中药组合物,其特征在于,所述中药组合物由如下重量份数的原料组成:生石膏30份、生地20份、地骨皮20份、葛根20份、天花粉20份、秦艽10份、青蒿20份、紫草15份、白茅根20份、地丁15份、知母10份、甘草5份。
实施例2
一种治疗艾滋病相关的肺部感染的中药组合物,其特征在于,所述中药组合物由如下重量份数的原料组成:生石膏15份、生地10份、地骨皮10份、葛根10份、天花粉10份、秦艽5份、青蒿10份、紫草5份、白茅根10份、地丁5份、知母5份、甘草2份。
实施例3
一种治疗艾滋病相关的肺部感染的中药组合物,其特征在于,所述中药组合物由如下重量份数的原料组成:生石膏45份、生地30份、地骨皮30份、葛根30份、天花粉30份、秦艽20份、青蒿30份、紫草30份、白茅根30份、地丁30份、知母20份、甘草15份。
实施例4
一种治疗艾滋病相关的肺部感染的中药组合物,其特征在于,所述中药组合物由如下重量份数的原料组成:生石膏4份、生地25份、地骨皮25份、葛根25份、天花粉25份、秦艽15份、青蒿25份、紫草20份、白茅根25份、地丁20份、知母15份、甘草10份。
实施例5
一种治疗艾滋病相关的肺部感染的中药组合物,其特征在于,所述中药组合物由如下重量份数的原料组成:生石膏20份、生地15份、地骨皮15份、葛根15份、天花粉15份、秦艽8份、青蒿15份、紫草10份、白茅根15份、地丁12份、知母8份、甘草3份。
实施例6
一种治疗艾滋病相关的肺部感染的中药制剂,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的肺部感染的中药制剂,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的肺部感染的中药制剂,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的肺部感染的中药制剂,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的肺部感染的中药制剂,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的肺部感染的中药制剂,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。
实验例
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的肺部感染疗效确切。
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70名存在艾滋病相关的肺部感染的患者,男性患者58名,女性患者12名;其中,20岁—29岁有18例,30岁—39岁有41例,40岁以上的11例。
2、治疗方法
治疗疗程:4周为一个疗程。
服药方法:将实施例1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肺部感染标准:
参照《成人呼吸系统感染性疾病病原学诊断专家意见》,诊断主要依据发热、呼吸困难等症状体征、病原学和血清学等实验室检查以及影像学检查。组织活检标本是诊断金标准。
4、疗效评定标准:证候疗效判定标准参照《中药新药临床研究指导原则(试行)》(中国医药科技出版社,2002)制定。
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:疗效指数=[(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28例,有效29例,无效13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的肺部感染的有效率达81.4%,疗效确切。
典型案例
病例1:张某某,男,45岁,同性恋者。2018年3月无明显诱因出现胸闷、咳嗽咳痰、气短,为阵发性咳嗽,痰白而粘,不易咳出,伴有乏力、头晕,于当地医院就诊确诊为感染性肺炎。随后来北京地坛医院就诊,诊断HIV阳性。HIV抗体检测为阳性,HIV病载3.5×105copies/ml,全血CD4+T淋巴细胞计数95μL-1,给予抗HIV治疗方案3TC/TDF/EFV。给予实施例1的中药组合物制成的中药汤剂联合磺胺等治疗肺部感染,1周后症状明显好转,2周胸闷咳嗽症状消失,乏力症状明显改善,随后继续服用中药汤剂治疗,期间无复发且无不良反应。继续服用原方案抗HIV治疗。
病例2:崔某某,男,38岁,河北保定人。2019年11月无明显诱因出现喘憋、胸闷等症状。随后于北京地坛医院就诊,CT提示双肺磨玻璃影改变。此外,检测HIV抗体阳性,HIV病载3.0×106copies/ml,全血CD4+T淋巴细胞计数76μL-1,诊断为艾滋病、肺孢子菌肺炎,给予实施例1的中药组合物制成的中药汤剂联合磺胺等抗感染治疗1周,肺部症状好转。给予抗HIV治疗方案3TC/TDF/EFV。继续服用至4周,患者肺部症状消失,期间无复发及不良反应。继续服用原方案抗HIV治疗。
病例3:王某某,男,39岁,北京海淀人,同性恋者。2019年5月无明显诱因出现发热、乏力、干咳、胸闷,呼吸困难。随后来北京地坛医院就诊,胸部CT显示双肺弥漫性磨玻璃影,其间可见支气管血管束。HIV抗体检测为阳性,HIV病载5.6×105copies/ml,全血CD4+T淋巴细胞计数55μL-1,诊断为肺孢子菌肺炎、艾滋病。给予实施例2的中药组合物制成的中药汤剂联合磺胺等抗感染治疗2周,肺部症状明显好转。同时启动抗HIV治疗,治疗方案3TC/TDF/EFV。4周后,肺部症状消失,无不良反应,期间病情稳定未复发。复查CD4+T细胞计数上升至180μL-1。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 (8)
1.一种治疗艾滋病相关的肺部感染的中药组合物,其特征在于,所述中药组合物由如下重量份数的原料组成:生石膏15-45份、生地10-30份、地骨皮10-30份、葛根10-30份、天花粉10-30份、秦艽5-20份、青蒿10-30份、紫草5-30份、白茅根10-30份、地丁5-30份、知母5-20份、甘草2-15份。
2.如权利要求1所述的一种治疗艾滋病相关的肺部感染的中药组合物,其特征在于,所述中药组合物由如下重量份数的原料组成:生石膏20-40份、生地15-25份、地骨皮15-25份、葛根15-25份、天花粉15-25份、秦艽6-15份、青蒿15-25份、紫草10-20份、白茅根15-25份、地丁10-20份、知母6-15份、甘草2-10份。
3.如权利要求2所述的一种治疗艾滋病相关的肺部感染的中药组合物,其特征在于,所述中药组合物由如下重量份数的原料组成:生石膏30份、生地20份、地骨皮20份、葛根20份、天花粉20份、秦艽10份、青蒿20份、紫草15份、白茅根20份、地丁15份、知母10份、甘草5份。
4.一种治疗艾滋病相关的肺部感染的中药制剂,其特征在于,所述中药制剂由权利要求1-3任一项所述的中药组合物和药学上可接受的载体或稀释剂组成。
5.如权利要求4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。
6.如权利要求4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。
7.如权利要求6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。
8.如权利要求6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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