CN104208250B - 一种治疗艾滋病的药物组合物 - Google Patents
一种治疗艾滋病的药物组合物 Download PDFInfo
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Abstract
本发明公开了一种治疗艾滋病的药物组合物。所述的药物组合物以下述重量份的原料制成：人参12-24份、柴胡12-24份、苦参12-24份、蒲公英12-24份、大青叶12-24份、洗手果12-24份、青黛12-24份、轻粉12-24份、麝香12-24份、雄黄9-21份、狼毒9-21份、蕲蛇9-21份、喜树9-21份、雷公藤9-21份、徐长卿9-21份、蟑螂9-21份、冬凌草9-21份为活性成分，克服现有治疗艾滋病药物的不足，提供一种治疗艾滋病效果较好的药物组合物。
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的药物组合物。
背景技术
艾滋病，即获得性免疫缺陷综合征(AcquiredImmunodeficiencySyndrome,AIDS)，是由人类免疫缺陷病毒(HumanImmundeficiencyVirus,HIV)感染引起的慢性传染病。在人类免疫缺陷病毒直接或间接作用下，T细胞免疫缺陷，同时其他免疫细胞均不同程度受损，促使各种严重的机会性感染和肿瘤发生，导致死亡。具体的，HIV通过攻击人体免疫系统，破坏免疫平衡，从而使人体感染其它疾病，导致各种复合感染而死亡。HIV病毒感染宿主细胞后，大量繁殖、破坏CD4+T淋巴细胞，使机体抵抗力下降，导致各种复合感染发生而死亡。常见的感染如：丙肝、肺结核、真菌感染、带状疱疹、卡氏肺孢子虫肺炎、脑炎以及恶性肿瘤的发生等。
艾滋病不仅已成为严重威胁人民健康的公共卫生问题，且已影响到经济发展和社会稳定。在治疗艾滋病的药物的毒副作用方面，瑞士的一组HIV研究中显示，接受抗逆转录病毒治疗((ART)的病人中，有45％的病人出现临床不良事件，27％的病人出现实验室不良事件。药物相关的事件可能出现在早期(治疗的前几周或几个月)，出现在早期的主要副作用包括消化道症状，难以忍受的恶心、呕吐、腹泻、腹痛以及特定药物如AZT的骨髓抑制，EFV的头痛、头晕、恶梦，甚至精神障碍；非核苷类药物引起的皮疹以及肝功能异常；ABC引起的发热、全身不适以及呼吸困难；IDV引起的肾结石；ATV引起的间接胆红素升高等。药物相关的事件也可能出现在晚期(6个月之后或者更长)。晚期的副作用主要包括代谢的并发症和形态的改变，长期服用核苷类药物所引起的线粒体毒性，如严重的乳酸酸中毒、肌病、心肌病、胰腺炎、末梢神经炎；蛋白酶抑制剂所引起的代谢异常，脂肪代谢障碍，出现四肢、臀部以及面部等周围皮下脂肪萎缩而中央躯干脂肪堆积，与脂肪萎缩相关的代谢特性包括：高甘油三酯血症、高胆固醇血症、胰岛素抵抗、乳酸血症，骨密度减低以及由于高脂血症和胰岛素抵抗而增加心血管疾病的危险。
现代医学防治艾滋病采用的是抗病毒、提高机体免疫、控制和治疗各种机会性感染症，但药物作用单一，往往需要多药并用，药价昂贵，毒副作用大。中国艾滋病治疗用药主要依靠进口，年人均药品费用至少需人民币3万-5万元。同时，国家在艾滋病控制方面的投入也急剧增加。
发明内容
本发明要解决的技术问题是克服现有治疗艾滋病药物的不足，提供一种治疗艾滋病效果较好的药物组合物。
本发明药物组合物中各组分的用量是发明人经过大量实践总结得出的，由下述重量份的原料制成：
优选地，它是由下列原料按重量份计制成：
更优选地，它是由下列原料按重量份计制成：
本发明所述药物组合物的剂型可以是胶囊、丸剂、片剂、汤剂等医学上可接受的剂型，它们的制备方法、辅料用量按现有常规工艺进行。
本发明还包括上述药物组合物在制备治疗艾滋病的药物中的应用。
本发明所述药物组合物组方中：
雄黄--具有散和排肿解毒、抗癌肿作用；
人参--具有大补元气、利水固脱作用；
柴胡--具有疏肝清热、升阳作用；
苦参--具有凉血化湿、消肿解毒作用；
蒲公英--具有清热解毒、利湿通淋作用；
大青叶--具有凉血、清热解毒作用；
洗手查--具有凉血、清血化毒作用；
青黛--具有凉血、祛血毒作用；
轻粉--具有去腐生肌、抗癌作用；
麝香--具有开窍、排脓、抗癌作用；
狼毒--具有活血止痛、排脓抗癌作用；
蕲蛇--具有散结排脓、去疮、抗癌作用；
喜树--具有凉血行气、破积、抗癌作用；
徐长卿--具有凉血止痛、抗癌作用；
雷公藤--具有强体、免疫功能提高、解毒作用；
冬凌草--具有清热解毒、止血止痛、抗癌肿作用；
蟑螂--具有破瘀定惊、泻火攻毒、抗癌肿、蛋白质对淋巴细胞白血病有边缘活性作用。
本发明药物组合物纯中药组合，具有良好的治疗艾滋病毒作用，抗艾滋病毒功能十分明显，固体清毒、抗癌作用，快速阻断艾滋病毒破坏各器官，保护造血功能系统。以清解血毒、扶正养血清毒之效。
具体实施方式
下面以具体实施例对本发明作进一步说明，但本发明并不局限于这些实施例。
实施例1
称取以上各原料，洗净烘干，混合粉碎过80目筛，加炼蜜为丸，得丸剂。
实施例2
按配比量称取以上各原料，加水煎煮两次，第一次加7倍量水，煎煮1.5小时，第二次加8倍量水，煎煮1.5小时，合并煎液，过滤，滤液浓缩至相对密度为1.30(70℃时测)的浸膏，加入适量的蔗糖粉，按常规工艺制成颗粒剂。
实施例3
称取以上各原料，加水煎煮两次，第一次加8倍量水，煎煮2小时，第二次加6倍量水，煎煮1.5小时，合并煎液，过滤，得汤剂。
实施例4
按配比量称取以上各原料，加水煎煮两次，第一次加7倍量水，煎煮1.5小时，第二次加8倍量水，煎煮1.5小时，合并煎液，过滤，滤液浓缩至相对密度为1.30(70℃时测)的浸膏，加入常规用量的硬脂酸镁辅料，按常规工艺制成片剂，规格0.5g/片。
实施例5
按配比量称取以上各原料，加水煎煮两次，第一次加7倍量水，煎煮1.5小时，第二次加8倍量水，煎煮1.5小时，合并煎液，过滤，滤液浓缩至相对密度为1.30(70℃时测)的浸膏，加入常规用量的糊精辅料，按常规工艺，制成胶囊，0.5g/粒。
实验例：本发明实施例5治疗艾滋病临床疗效观察：
本发明所述的中药组合物临床试验统计如下:
1、病例及方法
2008-2014年，在广西某省级医院针对艾滋病患者及性能进行治疗，患者68例，男性36例，女性32例，平均年龄38岁。所有病例自愿接受临床研究，从未接受过抗病毒药物治疗。
诊断标准：所有病例均符合HIV/AIDS诊断标准。
治疗方法：本发明实施例5，胶囊，每日3次，每次2粒，口服；30d为1个疗程，停药1-3d后，可进行下一疗程，连用2个疗程。
2、疗效判定
临床疗效评定标准：根据国家中医药管理局制定的《中医药治疗艾滋病试点项目临床技术方案》，疗效评价标准如下:
有效：临床症状体征改善明显，总积分下降≥1/3；CD4升高≥30％或50ul；病毒载量降低＞0.51og/ml。
稳定：临床症状体征有所改善，总积分下降＜1/3；CD4升高＜30％或50ul；病毒载量上升或下降＜0.51og/ml。
无效：临床症状体征无改善或加重，总积分不下降或增加；CD4下降≥30％或50u1；病毒载量水平持续上升，拷贝数上升＞0.51og/ml。
3、疗效总结
| 例数 | 有效 | 稳定 | 无效 | 有效率 |
| 治疗前后体征变化 | 51 | 14 | 3 | 95.6％ |
| 治疗前后CD4变化 | 50 | 16 | 2 | 97.0％ |
| 治疗前后病毒载量变化 | 44 | 13 | 11 | 83.8％ |
临床观察结果表明：服用本发明实施例5胶囊治疗的68例艾滋病患者，明显改善症状、提高CD4、抑制病毒复制等有明显的疗效。
Claims (4)
1.一种治疗艾滋病的药物组合物，其特征在于：该药物组合物是由下述重量份的原料制成：
2.根据权利要求1所述的治疗艾滋病的药物组合物，其特征在于：该药物组合物是由下述重量份的原料制成：
3.根据权利要求1所述的治疗艾滋病的药物组合物，其特征在于：该药物组合物是由下述重量份的原料制成：
4.权利要求1-3中任一项所述的药物组合物在制备治疗艾滋病的药物中的应用。
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