CN1223373C - 一种利咽止痛的制剂 - Google Patents
一种利咽止痛的制剂 Download PDFInfo
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Abstract
一种利咽止痛的制剂，配方是(重量份)：肿节风30-40、金银花10-30、薄荷脑0-2份。本药具有疏风清热，解毒消肿，利咽止痛之功效，对治疗风热喉痹和风热型急喉喑有明显疗效。
Description
技术领域
本发明属治疗风热喉痹和风热型急喉喑的中药制剂领域。
背景技术
咽喉炎是一种常见病和多发病，大部分与上呼吸道细菌、病毒感染有关，中医诊断认为这种疾病属于风热喉痹和风热型急喉喑。目前常见药物不少，但有效的治疗药物为数不多，有些还有副作用。西医治疗急性咽喉炎常采用抗菌素，效果比较好，但长期使用副作用多；而中药对急慢性咽喉炎均有较好的疗效。由我国江西江中制药厂生产的复方草珊瑚含片，临床治疗597例总有效率为92.87％，很受患者欢迎。这种药的主要有效成分由肿节风提取。
肿节风：为金粟兰科植物草珊瑚Sarcandra glabra(Thumb.)Nakai的干燥全株。味苦，辛，性平。清热解毒，祛风通络，活血止痛。主治感冒高热，扁桃体炎，肺炎，痢疾，急性肠胃炎，疮疡肿毒，齿周脓肿，跌打损伤，风湿痹痛等症。中国药典1977年版已予收载，总结概括其作用为祛风通络，活血散结，抗菌消炎。经抑菌试验和动物试验，具有广谱抗菌作用，对金黄色葡萄球菌、绿脓杆菌、甲链球菌、卡他球菌、链球菌、流感杆菌、肺炎双球菌等都有中敏到高敏抑制作用，且经实验证明无毒性。
我国中药资源十分丰富，我们有条件在这资源宝库中筛选出一些疗效好、价格低廉的药材与肿节风配伍，以求取得更好的疗效，并同时解决药源较少的问题。
在已知的药材中，金银花(双花)特别值得注意。金银花为忍冬科植物忍冬Lonicerajaponica Thumb.红腺忍冬Lonicera hypoglauca Miq.山银花Lonicera confusa DC.或毛花柱忍冬Lonicera dasystyla Rehd.的干燥花蕾或带初开的花。味甘，性寒，归肺、胃、大肠经。清热解毒，且有轻宣疏散之效，用于外感风热，温热病初起，热毒泻痢，疮、痈、疖肿等。《滇南本草》载：“清热，解诸疮”。《本草备要》曰：“养血止渴”。广州部队《常用中草药手册》载：“清热解毒，治外感发热，咳嗽，肠炎等”。药理研究表示有较强的抗菌作用，在体外对多种细菌(伤寒杆菌、副伤寒杆菌、大杆菌、变形杆菌、绿脓杆菌、葡萄球菌、链球菌、肺炎双球菌等)均有抑制作用。中国药典历年各版均予收载，1990年版一部总结概括其作用为清热解毒，凉散风热。
薄荷脑在药物中一般只作为辅助药物使用，但在某些药物中薄荷脑却有不小作用。薄荷脑是从薄荷油中得到的一种饱和环状醇，而薄荷油是唇形科植物薄荷Menthahaplocalyx Briq地上部分(指新鲜茎叶)的提取物。薄荷脑为无色针状或棱柱状结晶或白色结晶性粉末，有薄荷的特殊香气，味初灼热后清凉；乙醇溶液显中性反应。为芳香、调味、驱风药。用于皮肤或粘膜产生凉感以减轻不适及疼痛。熔点为42-44℃。
发明内容
本发明要解决的技术问题是提供一种以肿节风和金银花为主药的利咽止痛制剂。
本发明以如下技术方案解决上述技术问题：
本利咽止痛制剂的配方是(重量份)：
肿节风30-40 金银花10-30 薄荷脑0-2份
制备工艺：
1.含片：
肿节风、金银花加水煎煮1次以上，合并煎液，浓缩至规定密度后，加辅料制成颗粒，干燥。薄荷脑粉碎成细粉加入颗粒中，或用乙醇溶解，喷入颗粒中，密闭过夜、压片。
2.喷雾剂或气雾剂：
肿节风、金银花加水煎煮1次以上，合并煎液，滤过，浓缩，薄荷脑用乙醇溶解，加入上述滤液中，用蒸馏水调整总量，静置，滤过，灭菌制成喷雾剂或气雾剂。
临床试验情况如下：
一、所纳入之观察对象均为18-65岁，中医辨证属于风热喉痹之急性咽炎患者，或中医辨证属于风热型急喉喑之急性喉炎患者，分治疗组、对照组，两组性别、年龄分布均无显著性差异。
二、诊断标准：
(一)中医：
1、风热喉痹：咽痛、干燥灼热、口微渴、发热、微恶寒、咽部轻度充血水肿，舌边尖红、苔薄白、脉浮数。
2、急喉喑(风热型)：喉内不适，干痒而咳，音低而粗，声出不利，或喉内有灼热感，可并见发热，恶寒、头痛、肢体怠倦、骨节疼痛等症，舌边微红，苔白或兼黄，脉浮数。
(二)西医：
1、急性咽炎：
(1)常有受凉、疲劳、烟酒过度、各种物理和化学的刺激等诱因；
(2)起病较急、咽部干躁、灼热、疼痛或吞咽痛，发热、畏寒、食欲不振，四肢酸痛；
(3)检查：咽部粘膜充血，颜色鲜红，咽后壁淋巴滤泡和咽侧索红肿，局部或有黄、白色分泌物附着、悬雍垂、软腭水肿；咽拭子培养可有致病菌或阴性。
2、急性喉炎：
(1)常见于感冒后，与急性鼻炎、咽炎等并发。可因用声过度喉部创伤，吸入高热蒸汽及化学气体等引起，烟酒过度可诱发。
(2)主要症状为声嘶，喉鸣，喉部干痒，疼痛和干咳。重者发热，畏寒，疲倦、食欲不振。
(3)镜检查：粘膜弥漫性充血、肿胀，有时有声带闭合不全，表面附有粘稠分泌物。
以上具备部分或全部症状，并有1项或2项以上检查所见阳性体征，即可诊断。
三、观察方法：
共观察180例，随机分为2组。其中治疗组120例，使用本发明的含片，对照组60例，使用江西江中制药厂生产的复方草珊瑚含片。用法和用量均为：每半小时含服1次，每次1片，每日10次，连用7天。试验前常规对患者作详细体格检查，测外周血白细胞，试验后第3、5、7天各随诊1次，询问用药情况，记录病情及副作用，疗程结束后复查外周血白细胞，治疗效果用记分法评定，疗效判断直接由观察者作出。观察期间不用其他药物。
四、疗效评定标准：
1、临床痊愈：用药3天以内症状减轻，5天以内临床症状及体征消失。
2、显效：用药5天以内症状减轻，大部分体征消失。
3、有效：用药5天以内症状减轻，部分体征消失。
4、无效：用药1周以内不能使临床症状及体征消失。
五、副作用：在观察期间是否发现明显不良反应及毒副作用。
六、结果：
治疗组120例，治疗风热喉痹及风热型急喉喑的有效率分别为91.7％和90％。对照组60例，总有效率分别为83.3％和80％，两组疗效比较无显著差异，提示本发明的含片治疗风热喉痹及风热型急喉喑疗效与复方草珊瑚含片一致。
本品安全可靠，无明显不良反应及毒副作用。
经实践证明：本发明的产品对风热喉痹及风热型急喉喑有较好的治疗作用，治疗后患者咽痛、咽干、发热、喉内不适，声音嘶哑等症状明显改善，提示本制剂含片具有疏风清热，解毒消肿、利咽止痛之功效，用于急慢性咽喉炎及咽喉干灼、疼痛、声音嘶哑等，且安全可靠，无明显不良反应和毒副作用。
具体实施方式
本利咽止痛制剂的配方是：(重量份)
肿节风30-40 金银花10-30 薄荷脑0-2
制备工艺是：
1.含片：
肿节风、金银花加5倍量以上的水煎煮1次以上，每次20分钟以上，合并煎液，浓缩至规定密度后，加辅料制成颗粒，干燥。薄荷脑粉碎成细粉加入颗粒中，或用乙醇溶解，喷入颗粒中，密闭过夜、压片。
2.喷雾剂或气雾剂：
肿节风、金银花加5倍量以上的水煎煮1次以上，每次20分钟以上，合并煎液，滤过，浓缩至相对密度1.1(80℃)，薄荷脑用乙醇溶解，加入上述滤液中，用蒸馏水调整总量，静置，滤过，灭菌制成喷雾剂或气雾剂。
实施例1：
配方 肿节风160g 金银花120g 薄荷脑4g
制备工艺：取肿节风，金银花切碎，分别加水煎煮二次，每次加水10倍量，第一次煎煮2h，第二次煎煮1h，合并煎液，滤过，滤液浓缩至相对密度为1.18(85℃)的清膏，加蔗糖15倍量制成颗粒，干燥；薄荷脑乙醇溶解，喷入颗粒中，混匀，密闭过夜，加入适量辅料，压制成1000片，即得含片。
实施例2：
配方 肿节风75g 金银花31g 薄荷脑2g
制备工艺：取肿节风，金银花切碎，分别加水煎煮三次，每次加水6倍量，第一次煎煮1.5h，第二、三次各煎煮1h，合并煎液，滤过，滤液浓缩至相对密度为1.18(85℃)的清膏，加可溶性淀粉15倍量制成颗粒，干燥，薄荷脑粉碎成细粉，加入颗粒中，混匀，再加入可溶性淀粉适量，压制成1000片，即得含片。
实施例3：
配方 肿节风60g 金银花20g
制备工艺：取肿节风，金银花切碎，分别加水煎煮二次，每次加水8倍量，每次煎煮1.5h，合并煎液，滤过，滤液浓缩至相对密度为1.18(85℃)的清膏，加蔗糖15倍量制成颗粒，干燥，薄荷脑用乙醇溶解，喷入颗粒中，混匀，密闭过夜，再加入蔗糖适量，压制成1000片，即得含片。
实施例4：
配方 肿节风75克 金银花31克 薄荷脑2克
制备工艺：
以上三味，取肿节风、金银花切碎，分别加水煎煮二次，每次加水8倍量，每次煎煮1.5h，合并煎液，滤过，滤液浓缩至相对密度1.1(80℃)，薄荷脑用5毫升乙醇溶解，加入上述滤液中，用蒸馏水调整总量至1000毫升，静置，滤过，灭菌制成喷雾剂。
Claims (3)
1、一种利咽止痛的制剂，以肿节风为主药，其特征是其原料成分的重量份为：肿节风30-40 金银花10-20 薄荷脑0-2份。
2、一种利咽止痛的制剂的制备工艺，其特征是：
原料成分的重量份为：肿节风30-40 金银花10-20 薄荷脑0-2份；
制备工艺是将肿节风、金银花加水煎煮1次以上，适当浓缩，加辅料制成颗粒，干燥；薄荷脑粉碎成细粉加入颗粒中，或用乙醇溶解，喷入颗粒中，密闭过夜、压片。
3、一种利咽止痛的制剂的制备工艺，其特征是
原料成分的重量份为：肿节风30-40 金银花10-20 薄荷脑0-2份；
制备工艺是将肿节风、金银花加水煎煮1次以上，滤过，浓缩；薄荷脑用乙醇溶解，加入上述液中，用蒸馏水调整总量，静置，滤过，灭菌制成喷雾剂或气雾剂。
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