CN114848694B - 八宝丹在制备用于治疗慢性肾脏病的药物中的用途 - Google Patents
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Abstract
本发明提供了八宝丹在制备用于治疗慢性肾脏病的药物中的用途。
Description
技术领域
本发明属于医药领域，具体而言，涉及八宝丹在制备用于治疗慢性肾脏病的药物中的用途。
背景技术
慢性肾脏病(CKD)又称慢性肾功能不全或慢性肾衰竭，是临床常见疾病，其发病率与死亡率较高，且病情难以根治。CKD3、4期是肾脏保护、延缓病情进展至终末期的关键时期，因此在CKD3、4期开展病情干预十分重要。中医中药传承千年，是我国宝贵的医学文化遗产，其在防治慢性肾脏病方面具有独特优势。
八宝丹(Babao Dan,BBD)源自宫廷秘方，是传统抗炎中成药，至今已有四百余年历史，其主要成分包括牛黄、三七、羚羊角、麝香、蛇胆、珍珠等，具有清热解毒，祛湿退黄，活血止痛等功效，临床上常用于病毒性肝炎、胆囊炎及泌尿系感染。
然而，至今为止，尚无八宝丹对慢性肾脏病，特别是慢性肾脏病3、4期(CKD3、4期)治疗的相关文献报道。
发明内容
本发明人以慢性肾脏病(CKD3、4期)患者为研究对象，分析八宝丹应用下慢性肾脏病3、4期(CKD3、4期)患者炎症相关指标及肾功能的改善情况，从而进一步明确八宝丹能够改善慢性肾脏病患者微炎症状态，延缓慢性肾脏病3、4期(CKD3、4期)病情进展，进而起到保护肾脏的作用。
因此，本发明提供了八宝丹在制备用于治疗慢性肾脏病的药物中的用途。
本发明中，优选地，所述慢性肾脏病为CKD3、4期。
本发明中，优选地，所述八宝丹是厦门中药厂股份有限公司生产的八宝丹胶囊，国药准字Z10940006。
本发明的药物可以为本领域常规的各种剂型，例如固体、半固体或液体的形式，可以为水溶液、非水溶液、混悬液、锭剂、胶囊剂、片剂、颗粒剂、丸剂和散剂等。所述药物的给药途径可以为注射给药或口服给药。所述注射给药可以包括静脉注射、肌肉注射、腹腔注射、皮内注射或皮下注射等途径。
基于质量百分比，所述药物可以包括0.01～99.99％八宝丹或其提取物，以及99.99～0.01％的药学上可接受的辅料。
所述药学上可接受的辅料例如可以选自赋形剂、填充剂、稀释剂、表面活性剂、粘合剂、抗氧剂、防腐剂、矫味剂、甜味剂、风味剂、香精、吸附剂、润滑剂、包衣剂、缓释剂、促进剂、推进剂、着色剂、颜料、染料等。
本发明通过实施例证实，八宝丹用于慢性肾脏病(CKD3、4期)患者临床药物治疗方案中，能够有效改善患者肾功能及微炎症状态，促进病情的缓解与改善。
具体实施方式
以下对本发明的具体实施方式进行详细说明。应当理解的是，此处所描述的具体实施方式仅用于示例性地对本发明进行说明，并不用于限制本发明。
实施例
药物与试剂：八宝丹胶囊(国药准字Z10940006，生产厂家：厦门中药厂股份有限公司)规格0.3g/粒。
研究对象：满足以下条件：
1.慢性肾脏病(CKD3、4期)患者。
2.诊断标准：根据MDRD公式，肾小球滤过率(GFR)在15～59ml/(min·1.73㎡)之间，持续至少3个月且伴有肾脏病理学检查异常或肾损害的实验室指标(如血、尿或影像学)异常。
3.年龄、性别不限。
4.未进行肾脏替代治疗者。
5.无妊娠或计划妊娠及哺乳期妇女。
实施例1
患者梁某，男，56岁，患有慢性肾功能不全(CKD3期)，2020年3月25日检查血肌酐为155μmol/L，尿酸为571μmol/L；给药八宝丹0.6g/次，每日三次(tid)；治疗2周后，2020年4月8日复查血肌酐为119μmol/L，尿酸为484μmol/L；治疗4周后，2020年4月22日复查血肌酐为93μmol/L，尿酸为468μmol/L，说明肾功能明显改善。
实施例2
患者陈某某，男，81岁，患有慢性肾功能不全(CKD3期)，2020年5月22日检查血肌酐为106μmol/L，尿酸为466μmol/L；给药八宝丹0.6g/次，tid；治疗49天后，2020年7月10日复查血肌酐降至76μmol/L，尿酸为367μmol/L，说明肾功能明显改善。
实施例3
患者张某，男，81岁，患有慢性肾功能不全(CKD3期)，2019年11月9日检查血肌酐为122μmol/L；给药八宝丹0.6g/次，tid；治疗1周后，2019年11月16日复查血肌酐为98μmol/L，说明肾功能明显改善。
实施例4
患者吴某某，女，47岁，高血压10余年，肌酐逐渐升高3余年，诊断为：慢性肾脏病4期(CKD4期)，高血压；检查血降钙素原(PCT)为1.71ng/ml；给药八宝丹0.6g/次，tid；治疗1周后，2020年3月9日复查降钙素原(PCT)为0.301ng/ml。
从以上实施例可以证实，八宝丹对慢性肾脏病微炎症状态和难治性血肌酐升高具有良好的治疗作用，属于对症治疗。
总的来说，八宝丹用于慢性肾脏病(CKD3、4期)患者临床药物治疗方案中，能够有效改善患者肾功能及微炎症状态，促进病情的缓解与改善。
Claims (5)
1.八宝丹在制备用于治疗慢性肾脏病的药物中的用途。
2.根据权利要求1所述的用途，其中，所述慢性肾脏病为CKD3、4期。
3.根据权利要求1所述的用途，其中，所述药物为固体、半固体或液体的形式。
4.根据权利要求1所述的用途，其中，所述药物为水溶液、非水溶液、混悬液、锭剂、胶囊剂、片剂、颗粒剂、丸剂或散剂。
5.根据权利要求1所述的用途，其中，所述药物的给药途径为口服给药。
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104288594A (zh) * | 2014-09-11 | 2015-01-21 | 湖北省中医院 | 一种治疗慢性肾脏病气阴两虚证的中药制剂及其制备方法 |
| CN104983763A (zh) * | 2015-07-22 | 2015-10-21 | 厦门中药厂有限公司 | 八宝丹在制备治疗脑梗塞药物中的应用 |
| CN108403740A (zh) * | 2018-04-18 | 2018-08-17 | 厦门中药厂有限公司 | 八宝丹及其制剂在制备治疗血精症的药物中的应用 |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104288594A (zh) * | 2014-09-11 | 2015-01-21 | 湖北省中医院 | 一种治疗慢性肾脏病气阴两虚证的中药制剂及其制备方法 |
| CN104983763A (zh) * | 2015-07-22 | 2015-10-21 | 厦门中药厂有限公司 | 八宝丹在制备治疗脑梗塞药物中的应用 |
| CN108403740A (zh) * | 2018-04-18 | 2018-08-17 | 厦门中药厂有限公司 | 八宝丹及其制剂在制备治疗血精症的药物中的应用 |
Non-Patent Citations (1)
| Title |
|---|
| 八宝丹的临床应用研究进展;柯樱 等;中成药;第39卷(第2期);386-389 * |
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