CN113750173A - 金莲清热制剂在治疗传染性单核细胞增多症中的应用 - Google Patents
金莲清热制剂在治疗传染性单核细胞增多症中的应用 Download PDFInfo
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Abstract
本发明涉及金莲清热制剂在治疗传染性单核细胞增多症中的应用。所述金莲清热制剂是由金莲花、大青叶、石膏、知母、地黄、玄参、炒苦杏仁制备而成。临床研究表明，金莲清热制剂能够有效治疗传染性单核细胞增多症。
Description
技术领域
本发明涉及药物应用技术领域，尤其是金莲清热制剂在治疗传染性单核细胞增多症中的应用。
背景技术
传染性单核细胞增多症（infectious mononucleosis，IM），俗称“传单”，是由EB病毒（Epstein-Barr virus，E-BV）所致的急性感染性疾病，主要侵犯儿童和青少年，临床表现复杂多样，症状轻重不一，主要表现为不规则发热，无固定热型，咽峡炎、***肿大、皮疹、外周血中淋巴细胞增高及异常淋巴细胞增高超过10%。传染性单核细胞增多症文献显示，该症患者容易引起心肌损害和肝功能异常，少部分容易诱发慢性活动性EB病毒感染、鼻咽癌、恶性淋巴瘤及EBV相关噬血细胞性淋巴组织细胞增生症等，必须予以重视。目前该病没有特别有效的药物治疗，临床上针以此病症主要使用抗病毒药（阿昔洛韦、更昔洛韦等）及抗生素（头孢、阿奇霉素等）治疗， 但此类药副作用大，疗效一般。
金莲清热制剂由金莲花、大青叶、石膏、知母、地黄、玄参、炒苦杏仁制备而成，具有清热解毒，生津利咽，止咳祛痰的功效。现代药理研究证实，金莲花属于广谱抑菌药，其主要成份黄酮苷对革兰氏阳性菌、革兰氏阴性菌及葡萄球菌等都具有较好的抑制作用，大青叶中的大青素B、蓼蓝叶中的吲哚苷体外显示有抗病毒作用，但金莲清热制剂在治疗传染性单核细胞增多症的作用还未见报道。
发明内容
本发明的目的在于提供金莲清热制剂在治疗传染性单核细胞增多症中的应用。
本发明所述金莲清热制剂是由金莲花、大青叶、石膏、知母、地黄、玄参、炒苦杏仁按一定制备工艺制备而成，其制备方法属于现有技术，可以从现有专利公开的文件或国家药品标准中获得。如CN200510098725.X、YBZ11572006-2009Z。
本发明所述金莲清热制剂是由如下重量份比例的原料药制成： 1400-1600份金莲花、1400-1600份大青叶、1100-1200份石膏、700-800份知母、700-800份地黄、700-800份玄参、1100-1200份炒苦杏仁。
具体的，所述金莲清热制剂是由如下重量份比例的原料药制成：1500份金莲花、1500份大青叶、1125份石膏、750份知母、750份地黄、750份玄参、1125份炒苦杏仁。
所述金莲清热制剂的制备方法为：按上述配比称取金莲花、大青叶、石膏、知母、地黄、玄参、炒苦杏仁混合，加水煎煮二次，第一次加7～8倍量水，煎煮2小时；第二次 加5～6倍量水，煎煮1小时，合并煎液，滤过，滤液减压浓缩至相对密度50℃热测为1.05～1.40的清膏，真空干燥，粉碎成细粉，再根据需要加入一种或多种药学上可接受的辅料，制成药学上可接受的剂型。
所述金莲清热制剂的剂型为胶囊剂、颗粒剂、片剂（含泡腾片）、液体制剂、滴丸剂、喷雾剂、直肠给药制剂、注射剂。优选为泡腾片。
本发明所述的金莲清热制剂在使用时根据病人的情况确定用法用量。如已上市的天津中盛海天生产的金莲清热泡腾片，成人一次2片，一日4次，高烧时每4小时服1次，小儿1岁以下每次1片，一日3次，高烧时每日4次；又如宁夏启元生产的金莲清热颗粒，成人一次5克，一日4次，高烧时每4小时服1次，小儿1岁以下每次2.5克，一日3次，高烧时每日4次。
传染性单核细胞增多症目前临床发病症状为：主要发病为儿童和青少年，临床表现复杂多样，症状轻重不一，主要表现发热，咽痛、***肿大、肝/脾肿大、皮疹、外周血中淋巴细胞增高等。
为了进一步探究金莲清热制剂在治疗传染性单核细胞增多症药物中的应用，本发明进行了体外药效学及临床用药研究。结果显示，本发明所述的金莲清热制剂具有较好的治疗传染性单核细胞增多症的作用。具体地说，本发明提供的金莲清热制剂对EB病毒所致的发热、咽痛、***肿大等的疗效确切、安全性好、恢复程度快，值得推广。
具体实施方式：
下面结合具体的实施方式来对本发明的技术方案做进一步的限定，但要求保护的范围不仅局限于所作的描述。
实验一：金莲清热制剂对B95-8内衣壳抗原（VCA）的影响
1、实验材料：B95-8是绒猴EBV转化的淋巴细胞，能释放EBV的连续细胞株，由含10%胎牛血清的RPMI-1640培养。
2、实验方法：
2.1细胞增殖抑制试验：将处于对数生长期的B95-8细胞离心后，培养于96孔板中，培养基含有不同浓度的金莲清热制剂或阿昔洛韦，金莲清热制剂设5个剂量组为：200、40、8、1.6、0.32mg/ml，为金莲清热泡腾片加水泡腾溶解后稀释所得，阿昔洛韦设5个剂量组为：40、8、1.6、0.32、0.064 mg/ml。于37℃继续教育培养48小时，离心弃上清液，加入新鲜不含药物培养基，再加10μlMTT溶液（5mg/ml）, 37℃孵育4小时，加入100μl三联液（取SDS10g,异丁醇5ml，10MHCl0.1ml，加100ml重蒸水溶解），使结晶溶解。以溶剂处理的细胞为对照组，酶标仪测定吸光度（A），测定波长为570nm。细胞的增殖抑制率＝（对照组A值-药物组A值）/对照组A值×100%。
2.2对B95-8内衣壳抗原（VCA）的影响：将金莲清热泡腾片加20ml水泡腾溶解后，采用MTT实验方法选择药物浓度对细胞增殖抑制率低于10%为大剂量，等级稀释分为大、中、小三个剂量，另设正常对照组、模型组、阳性对照组（阿昔洛韦），每组各三个样，除正常对照组外，其余各组均采用丁酸和TAP诱导细胞。药物作用48h后，将B95-8细胞离心，弃上清液，加入1ml TRlzol Reagent,混合样品至重悬。离心吸取上清液，加入0.2ml三氯甲烷，离心后加入0.5ml异丙醇，离心弃上清液，75%乙醇洗涤沉淀，离心弃上清液，短暂干燥RNA沉淀。用焦碳酸二乙酯水15μl溶解沉淀，-80℃保存。
3、实验结果：
3.1细胞增殖抑制试验：不同浓度的金莲清热制剂和阿昔洛韦分别作用于B95-8细胞48h，检测增殖抑制率。结果显示两种药物对B95-8细胞的生长抑制作用随着药物浓度的升高，抑制率也升高。结果见表1、表2：
表1不同浓度金莲清热制剂对B95-8细胞增殖抑制作用结果
| 浓度（mg/ml） | 200 | 40 | 8 | 1.6 | 0.32 |
| 抑制率（%） | 92.5 | 66.3 | 28.4 | 18.4 | 6.2 |
表2不同浓度阿昔洛韦对B95-8细胞增殖抑制作用结果
| 浓度（mg/ml） | 40 | 8 | 1.6 | 0.32 | 0.064 |
| 抑制率（%） | 98.4 | 72.8 | 38.1 | 14.8 | 1.52 |
3.2对B95-8内衣壳抗原（VCA）的影响：采用丁酸和TAP诱导B95-8细胞后，EBV衣壳抗原分泌明显增多，给药组EBV衣壳抗原分泌明显降低，其中金莲清热大、中剂量组均能显著抑制丁酸和TAP诱导B95-8细胞分泌EBV衣壳抗原，小剂量组对其有抑制作用，结果见表3：
表3金莲清热泡腾片对B95-8细胞内衣壳抗原（VCA）的影响
| 组别 | 剂量（mg/ml） | 病毒载量（cp/ml） | 抑制率（%） |
| 正常对照组 | ―― | 175.32±24.62 | ―― |
| 模型对照组 | ―― | 2187.54±65.27 | ―― |
| 阳性对照组 | 0.32 | 215.31±32.33 | 90.16 |
| 金莲清热大剂量组 | 1.6 | 217.64±48.52 | 90.05 |
| 金莲清热中剂量组 | 0.8 | 219.61±35.24 | 89.96 |
| 金莲清热小剂量组 | 0.4 | 905.47±48.21 | 58.61 |
实验二：临床经典病例：
1、李XX，女，5岁，发热3天、头痛、咽痛，EB病毒衣壳抗原IgM、IgG抗体阳性；诊断为EB病毒感染，入院后给予抗病毒等静脉点滴药物治疗后体温仍反复，于入院第九天改为口服金莲清热泡腾片治疗2天（每次1.5片，每日4次），体温下降至正常且平稳，一周后临床症状基本消失且恢复正常。
2、赵XX，男，6岁，发热6天， 3天前出现发热，体温37.6℃，伴随咽痛，家中口服抗病毒药物，效果不佳，后经检查确诊为传染性单核细胞增多症，给予头孢西丁钠、更昔洛韦及干扰素治疗后体温反复，口服金莲清热泡腾片2天后（每次2片，每日4次），体温恢复正常，4天后头痛及呼吸道症状消失，一周后所有临床症状消失并恢复正常。
实验三：金莲清热泡腾片的制备
称取金莲花1500g、大青叶1500g、石膏1125g、知母750g、地黄750g、玄参750g、炒苦杏仁1125g混合，加水煎煮二次，第一次加7～8倍量水，煎煮2小时；第二次 加5～6倍量水，煎煮1小时，合并煎液，滤过，滤液减压浓缩至相对密度50℃热测为1.25的清膏，真空干燥，粉碎成细粉，加入酒石酸1200g、阿司帕坦40g及甘露醇适量，混匀、制粒、干燥，压制成1000片，即得。
在此有必要指出的是，以上实施方式仅限于对本发明的技术方案做进一步的阐述和理解，不能理解为对本发明的技术方案做进一步的限定，本领域技术人员作出的非突出实质性特征和显著进步的发明创造，仍然属于本发明的保护范畴。
Claims (6)
1.金莲清热制剂在制备治疗传染性单核细胞增多症药物中的应用。
2.如权利要求1所述的应用，其特征在于，所述金莲清热制剂由如下重量份比例的原料药制成： 1400-1600份金莲花、1400-1600份大青叶、1100-1200份石膏、700-800份知母、700-800份地黄、700-800份玄参、1100-1200份炒苦杏仁。
3.如权利要求1所述的应用，其特征在于，所述金莲清热制剂由如下重量份比例的原料药制成：1500份金莲花、1500份大青叶、1125份石膏、750份知母、750份地黄、750份玄参、1125份炒苦杏仁。
4.如权利要求1-3任一项所述的应用，其特征在于，所述金莲清热制剂的制备方法为：按配比称取金莲花、大青叶、石膏、知母、地黄、玄参、炒苦杏仁混合，加水煎煮二次，第一次加7～8倍量水，煎煮2小时；第二次 加5～6倍量水，煎煮1小时，合并煎液，滤过，滤液减压浓缩至相对密度50℃热测为1.05～1.40的清膏，真空干燥，粉碎成细粉，再根据需要加入一种或多种药学上可接受的辅料，制成药学上可接受的剂型。
5.如权利要求4所述的应用，所述金莲清热制剂的剂型为胶囊剂、颗粒剂、片剂、泡腾片、液体制剂、滴丸剂、喷雾剂、直肠给药制剂、注射剂。
6.如权利要求5所述的应用，其特征在于，所述金莲清热制剂的剂型为泡腾片。
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