CN1194733C - 一种治疗甲亢的药物及制备方法 - Google Patents
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Abstract
本发明涉及一种中药复方制剂，即治疗甲亢的龙珠平亢药物及制备方法。它由玄参、龙胆、麦冬、鳖甲、夏枯草、珍珠等15味原料制成。其工艺为珍珠粉、鳖甲、牡丹皮制粉；浙贝母粉碎成粗粉经醇提备用；牡蛎煎制，再加入玄参等其余十味，煎制，合并煎液，滤过，滤液浓缩，加入上述浙贝母浸膏，混匀，浓缩成稠膏；加入鳖甲粉、牡丹皮粉、珍珠极细粉，混匀，用水泛丸，烘干，包衣，打光，制成水丸。具有滋阴清火，养心宁神，化痰软坚散结之功能。用于阴虚火旺型甲状腺机能亢进症所致之恶热、食欲亢进、心悸、心烦、多汗、疲乏、手颤。经对甲亢患者临床试验表明，总有效率100%，愈合率97.14%，未见明显不良反应。
Description
技术领域：本发明涉及一种中药复方制剂，即治疗甲亢的龙珠平亢药物及制备方法。
背景技术：在已有技术中，甲状腺机能亢进症(简称″甲亢″)是一组因甲状腺功能异常增高，甲状腺激素分泌过多，以致血液中甲状腺激素超过正常值高限的多发、常见，且较难治愈的内分泌疾病。临床以甲状腺肿大、神经兴奋及基础代谢增高症状群为主要表现。目前，由于对本病症的致病原因尚不清楚，因而尽管抗甲状腺西药(如丙基硫氧嘧淀、他巴唑等)能对其症状有较好的控制作用，却无法达到根治的目的，且在长期服药的过程中，不可避免地会出现诸如粒细胞减少、过敏性病症等不良反应，以致部分患者无法正常完成规范治疗的过程。在专利方面，中国发明专利说明书ZL专利号99123038.8公开了一种名称为“治疗甲状腺肿大甲亢的药物”，其组成黄芪、桔梗、肉桂、三七、当归、天门冬、冰片、穿山甲、琥珀、川贝母、海藻、延胡索、牡蛎、文哈、昆布、姜黄、党参、夏枯草、沙参、柴胡、水蛭、百合、鳖甲、壁虎、白术、黄连由制成，与本发明不同。
发明内容：本发明的目的是针对上述不足而提供一种组方严谨、简单、疗效显著的治疗甲亢的龙珠平亢药物及制备方法。
本发明技术解决方案是：一种治疗甲亢的龙珠平亢药物，它由以下重量的原料物质制成：玄参260-390g、龙胆172-259g、地黄207-310g、麦冬172-259g、白芍260-390g、制鳖甲260-390g、牡蛎519-778g、夏枯草260-390g、郁金172-259g、牡丹皮172-259g、浙贝母207-310g、海藻172-259g、酸枣仁260-390g、珍珠17-26g、太子参260-390g。优选制成水丸，各药用成份还可与药用载体或添加剂混合制成胶囊、片剂、冲剂、口服液、颗粒等制药上常用制剂。
根据中医辩证施治的原则，以滋阴清火，养心宁神，化痰软坚散结为法选药加味而成。本病病因病机主要是先禀赋不足，素体阴血亏虚，加之情志内伤，导致痰气壅结，郁久化火，火盛则伤阴精，以致形成阴虚火旺，本虚标实的症候。故以滋阴清火为主，辅以养心宁神，化痰软坚散结。方中玄参和龙胆，既能滋阴清火，又能散结消瘰，故为君药；生地、麦冬养阴生津，白芍养血敛阴，鳖甲、牡蛎滋阴清热、软坚散结，夏枯草清肝火，散郁结，丹皮清热凉血散瘀，浙贝母、海藻清热化痰，软坚散结消瘿，酸枣仁、珍珠养心定悸安神，太子参补气生津而扶正，同为佐药。诸药合用，共奏滋阴清火，养心宁神，化痰软坚散结之功效。
制备方法：珍珠粉、鳖甲、牡丹皮制粉，浙贝母粉碎成粗粉，加70％乙醇适量，加热回流二次，合并回流液，过滤，滤液回收乙醇并浓缩至相对密度1.05-1.10，备用；取牡蛎先加水煎，再加入玄参等其余十味，加水煎煮二次，合并煎液，滤过，滤液浓缩至相对密度1.05-1.10，加入上述浙贝母浸膏，混匀，再浓缩到密度1.34-1.40稠膏；加入鳖甲粉、牡丹皮粉、珍珠极细粉，混匀，用水泛丸，烘干，包衣，打光，制成水丸。
功能主治：滋阴清火，养心宁神，化痰软坚散结。用于阴虚火旺型甲状腺机能亢进症所致之恶热、食欲亢进、心悸、心烦、多汗、疲乏、手颤。本品合并抗甲状腺药应用时，可降低抗甲状腺药物的用量，降低白细胞下降及皮疹等不良反应发生率。
用法与用量：以水丸为例，口服，一次4g，一日三次。
本发明的优点是：1、疗效确切，使用方便，安全无毒副作用。2、工艺稳定，经济可行。3、急性毒性与长期毒性试验结果表明，本发明用药安全。4、本药经广州中医药大学第二附属医院对60例甲亢患者临床试验表明，总有效率100％，愈合率97.14％，临床试验中未见明显不良反应。
下面将结合实施例对本发明作进一步详细描述：
具体实施方式：
实施例1：龙珠平亢丸：玄参325g、龙胆216.3g、地黄258.8g、麦冬216.3g、白芍325g、制鳖甲325g、牡蛎648.8g、夏枯草325g、郁金216.3g、牡丹皮216.3g、浙贝母258.8g、海藻216.3g、酸枣仁325g、珍珠21.95g、太子参325g，制成1000丸。
实施例2：龙珠平亢丸：玄参380g、龙胆190g、地黄240g、麦冬180g、白芍380g、制鳖甲280g、牡蛎648.8g、夏枯草380g、郁金200g、牡丹皮200g、浙贝母240g、海藻200g、酸枣仁325g、珍珠19g、太子参350g，制成1000丸。
实施例3：制备工艺：1原料：见实施例1。2、珍珠粉碎成极细粉，备用；鳖甲粉碎成粗粉，备用；牡丹皮粉碎成细粉，备用。浙贝母粉碎成粗粉，加70％乙醇适量，加热回流二次，每次2小时，合并回流液，过滤，滤液真空回收乙醇并浓缩至相对密度1.05-1.10(70-80℃)，备用。取牡蛎先加水煎1小时，再加入玄参等其余十味。加水煎煮二次，第一次2小时，第二次1.5小时，合并煎液，滤过，滤液真空浓缩至相对密度1.05-1.10(70-80℃)，加入上述浙贝母浸膏，混匀，再真空浓缩到密度1.34-1.40(70-80℃)稠膏，加入鳖甲粗粉，混匀，干燥，然后再加入牡丹皮粗粉，粉碎成细粉，过筛，加入珍珠极细粉，混匀，干燥，然后再加入牡丹皮粗粉，粉碎成细粉，过筛，加入珍珠极细粉，混匀，用水泛丸，于80℃烘干，红氧化铁包衣，打光，制成1000g水丸。
Claims (5)
1、一种治疗甲亢的药物，其特征在于它由以下重量的原料物质制成：玄参260-390g、龙胆172-259g、地黄207-310g、麦冬172-259g、白芍260-390g、制鳖甲260-390g、牡蛎519-778g、夏枯草260-390g、郁金172-259g、牡丹皮172-259g、浙贝母207-310g、海藻172-259g、酸枣仁260-390g、珍珠17-26g、太子参260-390g。
2、按照权利要求1所述的治疗甲亢的药物，其特征在于其剂型为水丸。
3、按照权利要求2所述的治疗甲亢的药物，其特征在于由以下重量的原料物质制成：玄参325g、龙胆216.3g、地黄258.8g、麦冬216.3g、白芍325g、制鳖甲325g、牡蛎648.8g、夏枯草325g、郁金216.3g、牡丹皮216.3g、浙贝母258.8g、海藻216.3g、酸枣仁325g、珍珠21.95g、太子参325g。
4、按照权利要求1所述的治疗甲亢的药物，其特征在于其剂型为胶囊剂、片剂、冲剂、口服液或颗粒剂。
5、一种如权利要求2所述的治疗甲亢的药物的制备方法，其特征在于制法如下：珍珠粉、鳖甲、牡丹皮制粉，浙贝母粉碎成粗粉，加70％乙醇适量，加热回流二次，合并回流液，过滤，滤液回收乙醇并浓缩至相对密度1.05-1.10，备用；取牡蛎先加水煎，再加入其余十味，加水煎煮二次，合并煎液，滤过，滤液浓缩至相对密度1.05-1.10，加入上述浙贝母浸膏，混匀，再浓缩到密度1.34-1.40稠膏；加入鳖甲粉、牡丹皮粉、珍珠极细粉，混匀，用水泛丸，烘干，包衣，打光，制成水丸。
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