CN106880656A - 活血止痛胶囊 - Google Patents
活血止痛胶囊 Download PDFInfo
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Abstract
本发明公开了一种活血止痛胶囊,由下述重量份的原料制备而成:当归40‑50份、三七8‑10份、制乳香8‑10份、冰片2‑3份、土鳖虫20‑24份、煅自然铜10‑12份、辅料0.2‑2份、保鲜剂0.001‑0.002份。本发明活血止痛胶囊,疗效好,副作用少,同时添加辅料和保鲜剂,提高了药物的质量稳定性。
Description
技术领域
本发明涉及中药制剂技术领域,具体涉及一种活血止痛胶囊。
背景技术
活血止痛胶囊是原国家中药四类新药,国家中药保护品种,处方:当归400g、乳香(制)80g、三七80g、冰片20g、土鳖虫200g、自然铜(煅)120g,收载于《中华人民共和国卫生部药品标准新药转正标准》第十WS3-084(Z-74)-95(Z)。制法:以上六味,除冰片外,其余五味粉碎成细粉;将冰片研细,与上述粉末配制,过筛,混匀,装胶囊,制成1000粒(0.5g/粒);或者装胶囊,制成2000粒(0.25g/粒)。
然而,目前药典中活血止痛胶囊仅采用简单粉碎技术,故制剂质量较差,往往容易造成重金属超标、微生物含量超标、制剂稳定性较差、生物利用度不高等问题。同时,目前可供患者服用的行气活血通络止痛药物中,多数存在药量过大、疗程太长、服用后易反复、疗效不够稳定的现状,给患者带来严重的经济负担和身心痛苦。
发明内容
针对现有技术中存在的上述不足,本发明所要解决的技术问题是提供一种活血止痛胶囊。
本发明目的是通过如下技术方案实现的:
一种活血止痛胶囊,由下述重量份的原料制备而成:当归40-50份、三七8-10份、制乳香8-10份、冰片2-3份、土鳖虫20-24份、煅自然铜10-12份、辅料0.2-2份、保鲜剂0.001-0.002份。
优选地,所述辅料为聚乙二醇、甘露醇、月桂醇中一种或多种的混合物。
更优选地,所述的辅料由聚乙二醇、甘露醇、月桂醇混合而成,所述聚乙二醇、甘露醇、月桂醇的质量比为(1-3):(1-3):(1-3)。
优选地,所述保鲜剂为山梨酸甲酯、对羟基苯甲酸丁酯、对羟基苯甲酸甲酯纳盐中一种或多种的混合物。
更优选地,所述保鲜剂由山梨酸甲酯、对羟基苯甲酸丁酯、对羟基苯甲酸甲酯纳盐混合而成,所述山梨酸甲酯、对羟基苯甲酸丁酯、对羟基苯甲酸甲酯纳盐中的质量比为(1-3):(1-3):(1-3)。
具体的,在本发明中:
当归,拉丁学名:Angelica sinensis,别名干归、秦哪、西当归、岷当归、金当归。具有补血和血、调经止痛、润燥滑肠、抗癌、抗老防老、免疫的功效。
三七,拉丁学名:Panax Notoginseng,别名山漆、金不换、参三七、田七。归肝经,胃经,心经,肺经,大肠经。可活血化瘀、定痛祛风。功能主治:胃出血、冠心病、心绞痛、高血脂、顽固性头痛。
乳香,拉丁学名:Boswelliacarteri,是一种由橄榄科植物乳香木产出的含有挥发油的香味树脂。用于止痛、化瘀、活血。其性温,可用于治疗耳聋、中风、口噤、妇人血风。取拣净的乳香,置锅内用文火炒至表面稍见熔化,略呈黄色,取出放凉;或炒至表面熔化时,喷洒米醋,继续炒至外层明亮光透,取出放凉,即得制乳香。
冰片,拉丁学名:Dryobalanops aromatica Gaertn.f.,味辛、苦,性微寒。有开窍醒神、清热消肿、止痛的功能。可用于闭证神昏、目赤肿痛、喉痹口疮、疮疡肿痛、溃后不敛、眼疾、牙龈肿痛、冠心病、心绞痛等。
土鳖虫,拉丁学名:D.dispar Chanisso et Eysenhard,为鳖蠊科昆虫地鳖的雌虫干燥体。捕捉后,置沸水中烫死,晒干或烘干。具有破血逐瘀,续筋接骨的功效。用于跌打损伤、筋伤骨折、血瘀经闭、产后瘀阻腹痛、瘾瘕痞块。
煅自然铜,拉丁学名:Pyritum,别名石髓铅,为硫化物类铁矿族矿物黄铁矿,含二硫化铁(FeS2)矿石。采挖后除去杂质,洗净、干燥、砸碎;或以火煅、醋淬至表面呈黑褐色、光泽消失、酥松为度、晒干,碾粗末。有散瘀止痛,续筋接骨的功效。
聚乙二醇,CAS号:25322-68-3。
甘露醇,CAS号:87-78-5。
月桂醇,CAS号:112-53-8。
山梨酸甲酯,CAS号:689-89-4。
对羟基苯甲酸丁酯,CAS号:94-26-8。
对羟基苯甲酸甲酯纳盐,CAS号:5026-62-0。
β-环糊精,CAS号:7585-39-9。
本发明活血止痛胶囊,疗效好,副作用少,同时添加辅料和保鲜剂,提高了药物的质量稳定性。
具体实施方式
实施例1
活血止痛胶囊原料(重量份):当归45份、三七9份、制乳香9份、冰片2.5份、土鳖虫22份、煅自然铜10份、辅料0.6份、保鲜剂0.0012份。
活血止痛胶囊的制备方法,包括以下步骤:
(1)将当归、三七、制乳香分别粉碎过80目筛,混合均匀,进行超临界二氧化碳萃取,萃取时间为3小时,萃取温度45℃,萃取压力40MPa,二氧化碳的流量为12kg/h,得萃取药液和药渣,采用300目滤布过滤,得到滤液,滤液减压浓缩至密度为1.20g/mL(45℃)的萃取清膏(Ⅰ);
(2)向步骤(1)所得药渣中加入药渣重量8倍的水,煎煮3个小时,趁热采用300目滤布过滤,得到滤液,滤液减压浓缩至密度为1.20g/mL(45℃)的水提清膏(Ⅱ);
(3)将土鳖虫用其重量5倍的水浸渍3个小时,趁热采用300目滤布过滤,得到滤液,滤液减压浓缩至密度为1.20g/mL(45℃)的清膏(Ⅲ);
(4)将煅自然铜粉碎过100目筛,用布袋包裹,加入煅自然铜重量8倍的水煎煮3个小时,趁热采用300目滤布过滤,得到滤液,滤液减压浓缩至密度为1.20g/mL(45℃)的清膏(Ⅳ);
(5)将冰片用其重量30倍的乙醇溶解,得到冰片溶液,另取冰片重量10倍的β-环糊精,溶解于β-环糊精重量15倍的水中,混合均匀,再将冰片溶液缓缓滴入β-环糊精溶液中,滴完后搅拌1个小时,放置冰箱中5℃下保存48小时,采用200目滤布过滤,蒸馏水洗涤,60℃干燥8小时即得冰片包合物;
(6)将萃取清膏(Ⅰ)、水提清膏(Ⅱ)、清膏(Ⅲ)、清膏(Ⅳ)分别于80℃减压真空干燥2个小时,得干膏,再与辅料0.06份和保鲜剂0.012份混合均匀,粉碎过200目筛,60℃干燥8小时后,加入冰片包合物,混合均匀,装胶囊,即得。
所述辅料由聚乙二醇、甘露醇、月桂醇按质量比为1:1:1混合均匀得到。
所述保鲜剂由山梨酸甲酯、对羟基苯甲酸丁酯、对羟基苯甲酸甲酯纳盐按质量比为1:1:1混合均匀得到。
实施例2
与实施例1基本相同,区别仅仅在于:所述辅料由聚乙二醇、甘露醇按质量比为1:1混合均匀得到。得到实施例2的活血止痛胶囊。
实施例3
与实施例1基本相同,区别仅仅在于:所述辅料由甘露醇、月桂醇按质量比为1:1混合均匀得到。得到实施例3的活血止痛胶囊。
实施例4
与实施例1基本相同,区别仅仅在于:所述辅料由聚乙二醇、月桂醇按质量比为1:1混合均匀得到。得到实施例4的活血止痛胶囊。
实施例5
与实施例1基本相同,区别仅仅在于:所述保鲜剂由山梨酸甲酯、对羟基苯甲酸丁酯按质量比为1:1混合均匀得到。得到实施例5的活血止痛胶囊。
实施例6
与实施例1基本相同,区别仅仅在于:所述保鲜剂由对羟基苯甲酸丁酯、对羟基苯甲酸甲酯纳盐按质量比为1:1混合均匀得到。得到实施例6的活血止痛胶囊。
实施例7
与实施例1基本相同,区别仅仅在于:所述步骤(1)的夹带剂由山梨酸甲酯、对羟基苯甲酸甲酯纳盐按质量比为1:1混合均匀得到。得到实施例7的活血止痛胶囊。
测试例1
对实施例1-7制备的活血止痛胶囊的稳定性进行测试。
本发明活血止痛胶囊中含有阿魏酸,阿魏酸为当归的有效成分,具有活血化瘀等作用,故将其主要成分阿魏酸定为活血止痛胶囊含量测定的指标成分之一。分别取实施例1-7制得的活血止痛胶囊用铝塑复合膜袋密封包装,将它们置于38℃下放置3个月,测定各试样中3月时的阿魏酸相对于该试样0月时的残余含量。测试方法参照张娴等《HPLC法测定活血止痛胶囊中阿魏酸的含量》,具体结果见表1。
表1:稳定性测试结果表 单位:%
比较实施例1与实施例2-4,实施例1(聚乙二醇、甘露醇、月桂醇复配)稳定性明显优于实施例2-4(聚乙二醇、甘露醇、月桂醇任意二者复配)。比较实施例1与实施例5-7,实施例1(山梨酸甲酯、对羟基苯甲酸丁酯、对羟基苯甲酸甲酯纳盐复配)稳定性明显优于实施例5-7(山梨酸甲酯、对羟基苯甲酸丁酯、对羟基苯甲酸甲酯纳盐任意二者复配)。
测试例2
将实施例1-7制备的活血止痛胶囊,置于25℃,相对湿度85%环境下保藏半年,然后进行大肠杆菌(ATYCC 25922)菌落总数测试,参照《GBT 4789.2-2008食品卫生微生物学检验菌落总数测定》。具体测试结果见表2。
表2:菌落总数测试表
大肠杆菌菌落总数,cfu/g | |
实施例1 | 213 |
实施例2 | 726 |
实施例3 | 439 |
实施例4 | 620 |
实施例5 | 507 |
实施例6 | 611 |
实施例7 | 553 |
比较实施例1与实施例2-4,实施例1(聚乙二醇、甘露醇、月桂醇复配)防腐性能明显优于实施例2-4(聚乙二醇、甘露醇、月桂醇任意二者复配)。比较实施例1与实施例5-7,实施例1(山梨酸甲酯、对羟基苯甲酸丁酯、对羟基苯甲酸甲酯纳盐复配)防腐性能明显优于实施例5-7(山梨酸甲酯、对羟基苯甲酸丁酯、对羟基苯甲酸甲酯纳盐任意二者复配)。
Claims (1)
1.一种活血止痛胶囊,其特征在于,由下述重量份的原料制备而成:当归40-50份、三七8-10份、制乳香8-10份、冰片2-3份、土鳖虫20-24份、煅自然铜10-12份、辅料0.2-2份、保鲜剂0.001-0.002份;
所述的辅料由聚乙二醇、甘露醇、月桂醇混合而成,所述聚乙二醇、甘露醇、月桂醇的质量比为(1-3):(1-3):(1-3);
所述保鲜剂由山梨酸甲酯、对羟基苯甲酸丁酯、对羟基苯甲酸甲酯纳盐混合而成,所述山梨酸甲酯、对羟基苯甲酸丁酯、对羟基苯甲酸甲酯纳盐中的质量比为(1-3):(1-3):(1-3)。
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