CN1261116C - 治疗呼吸系统疾病的片剂及其制备工艺 - Google Patents
治疗呼吸系统疾病的片剂及其制备工艺 Download PDFInfo
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Abstract
本发明是一种治疗呼吸系统疾病的片剂及其制备工艺。它含有金银花、连翘、穿心莲和板蓝根。本发明克服了复方双花口服液剂型落后带来的缺点，该药疗效可靠，安全无毒，服用方便，质量稳定，运输、携带方便，生产周期短，生产成本低。
Description
技术领域
本发明涉及一种治疗呼吸系统疾病的中成药及其制备工艺，尤其是涉及一种治疗呼吸系统疾病与复方双花口服液原料药物相同的中药片剂及其制备工艺。
背景技术
呼吸系统疾病是由多种细菌及病毒感染引起的常见病，一年四季均可发作。特别是在北方地区，冬季气候寒冷，气温变化较大，持续时间较长，因此，外感引起的发热、咳嗽、咽痛等症极为常见。复方双花口服液是治疗呼吸系统疾病的常用药物，但是其剂型落后，体积大，运输、携带不方便，服用不便，生产周期长，成本高，质量不稳定，限制了该药的生产和广泛应用。
发明内容
本发明的目的是为克服背景技术的不足，而提供一种治疗呼吸系统疾病与复方双花口服液原料药物相同的片剂及其制备工艺。
本发明是采用以下技术方案实现的。本发明为复方双花口服液的改剂型，它是由下列重量比的原料药物制成的：金银花15-30％、连翘15-30％、穿心莲15-30％、板兰根15-30％。
该药物制备工艺包括以下步骤：
(1)穿心莲、板蓝根、金银花、连翘按《中国药典》2000版药典要求，处理成净饮片；
(2)按投料量投入多功能提取罐中，第一次加药材重量8倍量水，浸泡30min，微沸煎煮1小时；第二次加6倍量水，微沸煎煮1小时，合并煎煮液，过滤，药液减压浓缩至相对密度1.12(60℃热测)，加入2倍量95％乙醇，醇沉24小时，上清液回收乙醇，浓缩至相对密度1.32-1.34(50℃热测)，60℃以下减压干燥成干浸膏，粉碎，备制剂配料用；
(3)将浸膏粉、淀粉、羧甲基淀粉钠，混合均匀，备制粒用；
(4)制粒，干燥，整粒，加入硬脂酸镁，称量、总混，备压片用；
(5)按0.62g/片压成椭圆片，检验合格，备包衣用；
(6)包薄膜衣，检验合格，备铝塑包装用；
(7)铝塑板包装，检验合格，备外包装用；
(8)外包装，检验合格后入库。
上述配方中金银花为忍冬科植物，早在两千多年以前，我们的祖先对其就有一定的认识，公元五世纪，人们开始用其茎叶入药；《神农本草经》将其列为上品并有“久服轻身”、“茎、叶、花、根功能皆同”的记载；《名医别录》记述了它有治疗“署热身肿”的功能；明朝李时珍以花蕾入药，在《本草纲目》中说它能治“一切风湿气及诸肿毒，疥癣、杨梅诸恶疮，散热解毒”，称其既是“治风除胀，解痢逐尸”之良药，又为“消肿散毒、治疮之良剂”，并做出了忍冬、茎叶及花功用皆同，久服轻身长寿的结论。据化验分析，金银花的茎、叶、花中主要成份为绿原酸，绿原酸在临床上具有抗菌消炎的作用。另外，花中含有肌醇，皂甙、挥发油、黄酮等；叶中含有鞣质、忍冬甙、番木鳖甙、紫丁香甙和忍冬黄素等；茎和茎皮含有木犀草黄素、皂甙和纯纤维素等；果实中含有还原糖。现代医学研究证明，金银花对于容血性链球菌、金黄葡萄球菌、伤寒杆菌、痢疾杆菌、大肠及绿脓杆菌、肺炎双球菌、百日咳杆菌、脑膜炎球菌等，都有较强的抑菌力，对治疗流行性感冒和炎症均有一定疗效。金银花性寒，味甘，中医归肺、心、胃经，具有清热、解毒、凉血、通经活络之功效。在临床应用上，金银花主治风热感冒、咽喉肿痛、肺炎、痢疾、痈肿疙疡、丹毒、蜂窝组织炎等症；忍冬藤具有清热解毒、通痰活血等功能，主治关节疼痛、荨麻疹、腮腺炎、细菌性痢疾、湿病发热等症。连翘为木犀科植物，味苦，凉。入心、肝、胆经，清热，解毒，散结，消肿。治温热，丹毒，斑疹，痈疡肿毒，瘰疬，小便淋闭。穿心莲为爵床科植物，味苦，寒。归心、肺、大肠、膀胱经，清热解毒，凉血，消肿。用于感冒发热，咽喉肿痛，口舌生疮，顿咳劳嗽，泄泻痢疾，热淋涩痛，痈肿疮疡，毒蛇咬伤。板兰根为十字花科植物，味苦，寒。归心、胃经，清热解毒，凉血利咽。用于温毒发斑，舌绛此暗，痄腮，喉痹，烂喉丹痧，大头瘟疫，丹毒，痈肿。
本发明的优点是：该药疗效可靠，安全无毒，服用方便，质量稳定，运输、携带方便，生产周期短，生产成本低。
具体实施方式
实施例1
本实施例是由下列重量比的原料药物制成的：
金银花25％ 连翘25％ 穿心莲25％ 板兰根25％。
本实施例的制备工艺包括以下步骤：
(1)穿心莲、板蓝根、金银花、连翘按《中国药典》2000版药典要求，处理成净饮片；
(2)按投料量投入多功能提取罐中，第一次加药材重量8倍量水，浸泡30min，微沸煎煮1小时；第二次加6倍量水，微沸煎煮1小时，合并煎煮液，过滤，药液减压浓缩至相对密度1.12(60℃热测)，加入2倍量95％乙醇，醇沉24小时，上清液回收乙醇，浓缩至相对密度1.32-1.34(50℃热测)，60℃以下减压干燥成干浸膏，粉碎，备制剂配料用；
(3)将浸膏粉、淀粉、羧甲基淀粉钠，混合均匀，备制粒用；
(4)制粒，干燥，整粒，加入硬脂酸镁，称量、总混，备压片用；
(5)按0.62g/片压成椭圆片，检验合格，备包衣用；
(6)包薄膜衣，检验合格，备铝塑包装用；
(7)铝塑板包装，检验合格，备外包装用；
(8)外包装，检验合格后入库。
实施例2
本实施例是由下列重量比的原料药物制成的：
金银花30％ 连翘30％ 穿心莲20％ 板兰根20％。
其制备工艺同实施例1。
实施例3
本实施例是由下列重量比的原料药物制成的：
金银花20％ 连翘20％ 穿心莲30％ 板兰根30％。
其制备工艺同实施例1。
临床实验：本实验中共观察病例523例，其中治疗组390例，对照组133例，门诊病例408例，住院病例115例，男性274例，女性249例。治疗组用本发明药物，口服，成人一次2-4片，一日3-4次，治疗七天为一疗程；对照组用强力银翘片，口服，一次2-4片，一日3-4次，治疗七天为一疗程。组间可比性分析结果表明，治疗组与对照组间均无显著意义，组间可比性好，两组间均未发现不良反应。总体疗效分析结果表明，治疗组总有效率为95.64％，对照组总有效率为91.73％。
本发明克服了复方双花口服液剂型落后带来的缺点，疗效可靠，安全无毒，服用方便，质量稳定，运输、携带方便，生产周期短，生产成本低。
Claims (2)
1、一种治疗呼吸系统疾病的片剂，为复方双花口服液的改剂型，其特征在于它是由下列重量比的原料药物制成的：金银花15-30％、连翘15-30％、穿心莲15-30％、板兰根15-30％；该片剂采用下述方法制得：先将穿心莲、板蓝根、金银花、连翘处理成净饮片，按投料量投入多功能提取罐中，第一次加药材重量8倍量水，浸泡30min，微沸煎煮1小时；第二次加6倍量水，微沸煎煮1小时，合并煎煮液，过滤，药液减压浓缩至相对密度1.12，60℃热测，加入2倍量95％乙醇，醇沉24小时，上清液回收乙醇，浓缩至相对密度1.32-1.34，50℃热测，60℃以下减压干燥成干浸膏，干浸膏粉碎后加淀粉、羧甲基淀粉钠混合均匀，制粒，干燥，最后加入硬脂酸镁总混，按0.62g/片压成椭圆片，检验合格后包装入库。
2、制备权利要求1所述的治疗呼吸系统疾病的片剂的制备工艺，其特征在于它包括以下步骤：
(1)穿心莲、板蓝根、金银花、连翘按《中国药典》2000版药典要求，处理成净饮片；
(2)按投料量投入多功能提取罐中，第一次加药材重量8倍量水，浸泡30min，微沸煎煮1小时；第二次加6倍量水，微沸煎煮1小时，合并煎煮液，过滤，药液减压浓缩至相对密度1.12，60℃热测，加入2倍量95％乙醇，醇沉24小时，上清液回收乙醇，浓缩至相对密度1.32-1.34，50℃热测，60℃以下减压干燥成干浸膏，粉碎，备制剂配料用；
(3)将浸膏粉、淀粉、羧甲基淀粉钠，混合均匀，备制粒用；
(4)制粒，干燥，整粒，加入硬脂酸镁，称量、总混，备压片用；
(5)按0.62g/片压成椭圆片，检验合格，备包衣用；
(6)包薄膜衣，检验合格，备铝塑包装用；
(7)铝塑板包装，检验合格，备外包装用；
(8)外包装，检验合格后入库。
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| CN106420940A (zh) * | 2016-09-26 | 2017-02-22 | 陕西康惠制药股份有限公司 | 复方双花泡腾片及制备方法和质量控制方法 |
| CN115054627B (zh) * | 2022-07-11 | 2023-05-26 | 陕西康惠制药股份有限公司 | 一种复方双花中药组合物的制备方法 |
| CN114984083B (zh) * | 2022-07-11 | 2023-06-06 | 陕西康惠制药股份有限公司 | 一种治疗上呼吸道感染的中药组合物及其制备方法 |
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