CN106729258A - 一种二十五味肺病颗粒剂或片剂 - Google Patents
一种二十五味肺病颗粒剂或片剂 Download PDFInfo
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- CN106729258A CN106729258A CN201611254200.5A CN201611254200A CN106729258A CN 106729258 A CN106729258 A CN 106729258A CN 201611254200 A CN201611254200 A CN 201611254200A CN 106729258 A CN106729258 A CN 106729258A
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Abstract
本发明公开了一种二十五味肺病颗粒剂或片剂，它是将由檀香、悬钩木、石灰华、山奈、红花等原料分别进行除杂、洗净、干燥，混合，采用水提法或醇提法制得，所得浓缩液、挥发油与牛黄混合，制成活性组分；在活性组分中加入辅料：填充剂、崩解剂、润滑剂、黏合剂，并以常规的中药制剂方法制备成颗粒剂或片剂。本发明与现有技术二十五味肺病丸相比，具有以下特点：1、溶出迅速，利于药物吸收，增加治疗效果。2、制备方法简单易行，易于产业化。3、部分药材采用提取超微粉碎的制备方法，或采用水煎煮、乙醇回流提取，既能有效保留药材中的有效挥发油成分，也能大大提高生药的成分含量，有助于生物利用度和溶出速率的提高。
Description
技术领域
本发明属于藏药领域，尤其是涉及一种二十五味肺病颗粒剂或片剂。
背景技术
二十五味肺病丸史载于《四部医典》全称“甘露精要八支秘诀窍续”，收载于卫生部药品标准藏药第一册C1-158。二十五味肺病丸处方为：檀香75g，悬钩木150g，石灰华100g，山奈50g，红花70g，葡萄70g，獐牙菜70g，甘草150g，兔耳草70g，沙棘膏70g，巴夏嘎70g、香旱芹50g、榜噶70g、白花龙胆75g、诃子130g、肉果草100g、毛诃子80g、无茎芥50g、余甘子100g、甘肃蚤缀75g、藏木香70g、铁棒锤(根、叶)80g、宽筋藤100g、牛黄3g、力嘎都60g。
制法：以上二十五味，除沙棘膏，牛黄外，其余粉碎成细粉，过筛，加入牛黄细粉，混匀，用沙棘膏加适量水泛丸，干燥，即得。
功能与主治：清热消炎，止咳。用于各种肺病引起的咳嗽，胸胁痛，发烧，呼吸急促，痰带脓血，盗汗。
藏药二十五味肺病丸主要适用于外邪引起的咳痰不止，呼吸急促，肺热，肺结核等。对陈旧性肺结核、慢性肺炎、肺气肿、间质性肺炎等热性肺病的疗效明显。但传统的水丸存在崩解困难、疗效不稳定的缺陷、其粗放型的工艺控制过程容易导致产品质量不稳定、差异性大；部分药物组分溶出、渗透能力差，生物利用度低，不能完全发挥药物疗效，且服用顺应性较差，极大影响了产品的推广。
发明内容
本发明目的在于提供一种用于清热消炎，止咳的二十五味肺病颗粒剂或片剂，它是以传统藏药二十五味肺病丸的处方为基础，通过提取的药材主要成分、改变剂型制备得到。
本发明目的是这样实现的：
一种二十五味肺病颗粒剂，特征是：活性组分由以下具体方法提取：称取檀香75重量份、悬钩木150重量份、石灰华100重量份、山奈50重量份、红花70重量份、葡萄70重量份、獐牙菜70重量份、甘草150重量份、兔耳草70重量份、沙棘膏70重量份、巴夏嘎70重量份、香旱芹50重量份、榜噶70重量份、白花龙胆75重量份、诃子130重量份、肉果草100重量份、毛诃子80重量份、无茎芥50重量份、余甘子100重量份、甘肃蚤缀75重量份、藏木香70重量份、铁棒锤(根、叶)80重量份、宽筋藤100重量份、力嘎都60重量份，分别进行除杂、洗净、干燥，混合，采用水提法或醇提法(曹春林主编的《中药制剂学》第73-74页，上海科技出版社1986年11月出版)制得，所得浓缩液、挥发油与牛黄3重量份混合，制成活性组分；在活性组分中加入辅料：填充剂、崩解剂、黏合剂，并以常规的中药制剂方法(曹春林主编的《中药制剂学》第73-74页，上海科技出版社1986年11月出版)制备成颗粒剂。
或，一种二十五味肺病片剂，特征是：活性组分由以下具体方法提取：称取檀香75重量份、悬钩木150重量份、石灰华100重量份、山奈50重量份、红花70重量份、葡萄70重量份、獐牙菜70重量份、甘草150重量份、兔耳草70重量份、沙棘膏70重量份、巴夏嘎70重量份、香旱芹50重量份、榜噶70重量份、白花龙胆75重量份、诃子130重量份、肉果草100重量份、毛诃子80重量份、无茎芥50重量份、余甘子100重量份、甘肃蚤缀75重量份、藏木香70重量份、铁棒锤(根、叶)80重量份、宽筋藤100重量份、力嘎都60重量份，分别进行除杂、洗净、干燥，混合，采用水提法或醇提法(曹春林主编的《中药制剂学》第73-74页，上海科技出版社1986年11月出版)制得，所得浓缩液、挥发油与牛黄3重量份混合，制成活性组分；在活性组分中加入辅料：填充剂、崩解剂、黏合剂，并以常规的中药制剂方法(曹春林主编的《中药制剂学》第73-74页，上海科技出版社1986年11月出版)制备成片剂颗粒剂。
所述辅料还包括润滑剂。
本发明的二十五味肺病颗粒剂或片剂的辅料及用量为：填充剂：淀粉0-3600重量份、糊精0-900重量份、微晶纤维素0-500重量份中的至少一种；崩解剂：羧甲基淀粉钠0-3600重量份、交联羧甲基纤维素钠0-3600份中的至少一种；黏合剂：聚乙烯吡咯烷酮0-900重量份，75％乙醇中的至少一种；润滑剂：硬脂酸镁0-5重量份。
本发明的二十五味肺病颗粒剂或片剂的制备方法，具体步骤如下：
(1)、将檀香、悬钩木、石灰华、山奈、红花、葡萄、獐牙菜、甘草、兔耳草、沙棘膏、巴夏嘎、香旱芹、榜噶、白花龙胆、诃子、肉果草、毛诃子、无茎芥、余甘子、甘肃蚤缀、藏木香、铁棒锤、宽筋藤、力嘎都除杂、洗净，干燥，混合得到混合原料药；
(2)、牛黄研磨成细粉；
(3)、称取步骤(1)中的混合原料药总量的10％-100％，用5-20重量倍的水煎煮1-4次，每次煎煮0.5-5小时，分别收集、合并提取液和挥发油，滤过，在55-95℃温度下，将提取液浓缩成相对密度为1.0-1.5的浓缩液，将挥发油加入到浓缩液中，得浓缩液a；
或，称取步骤(1)中的混合原料药总量的10％-100％，用5-20重量倍的30-90％乙醇回流提取1-4次，每次提取0.5-24小时，收集提取液，滤过，在55-85℃温度下，将提取液浓缩成相对密度为1.0-1.5的浓缩液a；
(4)、将剩余的混合原料药混合药物粉碎成粒径为0.1-150μm的药粉，再与上述浓缩液a、牛黄细粉和辅料混合均匀，制成二十五味肺病颗粒剂。
或，将剩余的混合原料药混合药物粉碎成粒径为0.1-150μm的药粉，再与上述浓缩液a、牛黄细粉和辅料混合均匀，压片，制成二十五味肺病片剂。
本发明二十五味肺病颗粒剂或片剂与现有技术二十五味肺病丸相比，具有以下特点：
1、溶出迅速，利于药物吸收，增加治疗效果。
2、制备方法简单易行，易于产业化。
3、部分药材采用提取超微粉碎的制备方法，或采用水煎煮、乙醇回流提取，既能有效保留药材中的有效挥发油成分，也能大大提高生药的成分含量，有助于生物利用度和溶出速率的提高。
附图说明
图1为各对照品混合溶液、丸剂供试品色谱图，图中：1.没食子酸；2.羟基红花黄色素A；3.土木香内酯；4.齐墩果酸；A.阴性对照组；B.对照品混合溶液；C.丸剂供试样品。
具体实施方式
为了更好地理解本发明，下面结合实施例进一步阐明本发明的内容，但本发明的内容不仅仅局限于下面的实施例。
实施例1：二十五味肺病颗粒剂
称取檀香75g，悬钩木150g，石灰华100g，山奈50g，红花70g，葡萄70g，獐牙菜70g，甘草150g，兔耳草70g，沙棘膏70g，巴夏嘎70g、香旱芹50g、榜噶70g、白花龙胆75g、诃子130g、肉果草100g、毛诃子80g、无茎芥50g、余甘子100g、甘肃蚤缀75g、藏木香70g、铁棒锤(根、叶)80g、宽筋藤100g、牛黄3g、力嘎都60g，先将牛黄粉碎成细粉，其余药材用药物总重量10倍的水，煎煮3次，每次煎煮2小时，分别收集、合并提取液和挥发油，滤过并在95℃温度下浓缩提取液成相对密度为1.05-1.15的浓缩液，将挥发油加入到浓缩液中，再加入牛黄细粉，搅拌均匀，得浓缩液a。取浓缩液a 100g，加入淀粉100g、糊精25g、羧甲基淀粉钠100g，混匀，用75％乙醇制软材，过14目筛制粒，60℃烘干，依次过1号筛及4号筛，收集通过1号筛而不能通过4号筛的颗粒，称重，分装，即得二十五味肺病颗粒剂。
实施例2：二十五味肺病片剂
称取檀香75g、悬钩木150g、石灰华100g、山奈50g、红花70g、葡萄70g、獐牙菜70g、甘草150g、兔耳草70g、沙棘膏70g、巴夏嘎70g、香旱芹50g、榜噶70g、白花龙胆75g、诃子130g、肉果草100g、毛诃子80g、无茎芥50g、余甘子100g、甘肃蚤缀75g、藏木香70g、铁棒锤(根、叶)80g、宽筋藤100g、牛黄3g、力嘎都60g，先将牛黄粉碎成细粉，取其余药材总量的60％，用药物总重量15倍的水煎煮2次，每次煎煮3小时，分别收集、合并提取液和挥发油，滤过并在85℃温度下浓缩提取液成相对密度为1.05-1.15的浓缩液，将挥发油加入到浓缩液得到浓缩液a，同时将剩余混合药材粉碎至40-60μm，与上述浓缩液、牛黄细粉、淀粉90g、糊精75g混匀，用3％聚乙烯吡咯烷酮湿法制粒，60℃以下干燥，加入3％重量计的交联羧甲基纤维素钠和0.2％重量计的硬脂酸镁混合均匀，压片机压片，即得二十五味肺病片剂。
以下通过试验例来进一步阐述本发明的有益效果。
1.HPLC分析方法的建立
建立可同时分析5种药材4种主要成分的HPLC分析方法。
色谱条件：sunFire C18色谱柱(250mm×4.6mm，5μm)；流速1.0mL/min；检测波长210nm；柱温25℃；进样量20μL；流动相：甲醇-0.1％磷酸，梯度洗脱，按表1色谱条件进样。对照品、供试品色谱图见图1，经精密度、准确度、稳定性实验证明，该分析方法符合方法学要求。
表1梯度洗脱方案
2.二十五味肺病颗粒剂对二甲苯诱导小鼠耳廓肿胀的影响
2.1灌胃混悬液的配置
称取二十五味肺病丸2.1456g(B，1.2g/kg)、二十五味肺病颗粒剂2.1456g(C，1.2g/kg)分别配置成100ml溶液。
2.2试验方法
对3组小鼠进行称重并标记，按小鼠体重进行给药量的计算，模型组灌胃给予生理盐水(A)，其余各组灌胃给予相应组药物混悬液，2次/d，连续7d。末次给药后，在小鼠右耳正反两面用微量移液枪各滴加15μl二甲苯致炎，40min后脱颈椎处死小鼠，沿耳廓基线剪下双耳，用直径8mm打孔器将左右两耳廓相同部位等面积取下两圆耳片，立即称定重量(g)，计算肿胀率(％)，结果如下表2所示。
表2:各实验动物组肿胀率(％)
3.二十五味肺病颗粒剂及片剂对小鼠止咳的影响
取小鼠50只，雌雄兼用，随机分为5组，磷酸可待因及等量生理盐水为阳性对照(A)和模型组(B)，取二十五味肺病丸2.1456g(C，1.2g/kg)、二十五味肺病颗粒剂2.1456g(D，1.2g/kg)、二十五味肺病片剂2.1511g(E，1.2g/kg)分别配置成100ml溶液，按小鼠体重进行给药量的计算给药，连续灌胃3天，末次给药后1h后进行引咳实验，将小鼠置于倒置的500ml玻璃杯中，连续将氨水(28％氢氧化铵)均匀喷入，喷雾5s，观察记录小鼠的咳嗽潜伏期和2min内的咳嗽次数，结果见表3。
表3各实验动物组止咳结果
Claims (6)
1.一种二十五味肺病颗粒剂，其特征在于：活性组分由以下具体方法提取：称取檀香75重量份、悬钩木150重量份、石灰华100重量份、山奈50重量份、红花70重量份、葡萄70重量份、獐牙菜70重量份、甘草150重量份、兔耳草70重量份、沙棘膏70重量份、巴夏嘎70重量份、香旱芹50重量份、榜噶70重量份、白花龙胆75重量份、诃子130重量份、肉果草100重量份、毛诃子80重量份、无茎芥50重量份、余甘子100重量份、甘肃蚤缀75重量份、藏木香70重量份、铁棒锤（根、叶）80重量份、宽筋藤100重量份、力嘎都60重量份，分别进行除杂、洗净、干燥，混合，采用水提法或醇提法制得，所得浓缩液、挥发油与牛黄3重量份混合，制成活性组分；在活性组分中加入辅料：填充剂、崩解剂、黏合剂，并以常规的中药制剂方法制备成颗粒剂。
2.根据权利要求2所述的二十五味肺病颗粒剂，其特征在于：辅料及用量为：
填充剂：淀粉0-3600重量份、糊精0-900重量份、微晶纤维素0-500重量份中的至少一种；崩解剂：使用羧甲基淀粉钠0-3600重量份、交联羧甲基纤维素钠0-3600份中的至少一种；使用聚乙烯吡咯烷酮0-900重量份，75%乙醇中的至少一种。
3.根据权利要求1所述的二十五味肺病颗粒剂，其特征在于：所述辅料还包括润滑剂，润滑剂：硬脂酸镁0-5重量份。
4.一种二十五味肺病片剂，其特征在于：活性组分由以下具体方法提取：称取檀香75重量份、悬钩木150重量份、石灰华100重量份、山奈50重量份、红花70重量份、葡萄70重量份、獐牙菜70重量份、甘草150重量份、兔耳草70重量份、沙棘膏70重量份、巴夏嘎70重量份、香旱芹50重量份、榜噶70重量份、白花龙胆75重量份、诃子130重量份、肉果草100重量份、毛诃子80重量份、无茎芥50重量份、余甘子100重量份、甘肃蚤缀75重量份、藏木香70重量份、铁棒锤（根、叶）80重量份、宽筋藤100重量份、力嘎都60重量份，分别进行除杂、洗净、干燥，混合，采用水提法或醇提法制得，所得浓缩液、挥发油与牛黄3重量份混合，制成活性组分；在活性组分中加入辅料：填充剂、崩解剂、润滑剂、黏合剂，并以常规的中药制剂方法制备成片剂颗粒剂。
5.根据权利要求4所述的二十五味肺病片剂，其特征在于：辅料及用量为：
填充剂：淀粉0-3600重量份、糊精0-900重量份、微晶纤维素0-500重量份中的至少一种；崩解剂：羧甲基淀粉钠0-3600重量份、交联羧甲基纤维素钠0-3600份中的至少一种；聚乙烯吡咯烷酮0-900重量份，75%乙醇中的至少一种。
6.根据权利要求4所述的二十五味肺病颗粒剂，其特征在于：所述辅料还包括润滑剂，润滑剂：硬脂酸镁0-5重量份。
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