CN106110116A - 含山芝麻的中药组合物及其制备方法 - Google Patents
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Abstract
本发明公开了一种含山芝麻的中药组合物，原料由以下重量份的中药组分组成：山芝麻30‑50份、一枝黄花15‑30份、枇杷叶10‑30份、百部10‑20份、芦根10‑20份、山猪菜8‑15份、甘草5‑15份。该中药组合物能明显改善风热感冒患者发热、恶风、咽痛、头胀痛、口渴、鼻塞、咳嗽等症状，具有清热解毒利咽、疏散风热、祛痰止咳之功效。本发明组方严谨，药少力专，对风热感冒具有良好的疗效。
Description
技术领域
本发明属于药品领域，涉及一种含山芝麻的中药组合物及其制备方法。
背景技术
感冒一般指普通感冒，俗称伤风，又称上呼吸道感染，以鼻咽部卡他症状为主要表现，是最常见的呼吸道疾病。感冒由病毒和细菌所引起，但以病毒为多见，约占90％以上，目前，己发现约有12种200余型病毒可引起感冒，因为感冒病毒种类繁多、变异大、特异性免疫不巩固，目前尚没有特效的疫苗和药物，对感冒的治疗仍然处于“对症”治疗阶段，以减轻症状，缩短病程，对症处理，保护体力，注重护理，防止并发症等为主。中医学将感冒分为以下5种类型：风寒感冒、风热感冒、暑湿感冒、暑热感冒、时行感冒。中医认为，风热感冒是感受风热之邪所致的表证，其发病无年龄、性别、职业和地区差异，且全年皆有发病，尤以冬春季节高发，是风热之邪犯表、肺气失和所致，症状表现为发热、恶风、咽痛、头胀痛、口渴、鼻塞、咳嗽、痰黏或黄、鼻塞黄涕、舌尖边红、苔薄白微黄等。本发明特别针对风热感冒患者，研究出一种安全有效的中药组合物，目前，尚未见相关报道。
(1)山芝麻，为梧桐科山芝麻属植物山芝麻HelictercsangustifoliaL.，以干燥根或干燥全株。《广西中药材标准》1990年版记载：【性味与归经】苦；性凉；小毒；归胃经。【功能与主治】清热解毒。主感冒发热；肺热咳嗽；咽喉肿痛；麻疹；痄腮；肠炎；痢疾；痈肿；瘰疮；毒蛇咬伤。山芝麻根含三萜类化合物山芝麻酸甲酯、山芝麻宁酸甲酯及山芝麻宁酯、新型香豆素类化合物-山芝麻内酯、葫芦素、异葫芦素，胡罗卜苷等。现代药理研究表明，山芝麻具有抗病毒、抗乙肝病毒、抗炎镇痛、抗脂质过氧化及护肝作用、抗HBV病毒、抗肝纤维化等多方面的药理作用。
(2)一枝黄花，为菊科植物一枝黄花Solidago decurrens Lour.的干燥全草。《中国药典》2010年版记载：【性味与归经】辛、苦，凉。归肺、肝经。【功能与主治】清热解毒，疏散风热。用于喉痹，乳蛾，咽喉肿痛，疮疖肿毒，风热感冒。一枝黄花化学成分：含有黄酮类芦丁、山柰酚-3-芦丁糖苷、异槲皮苷、山萘酚-葡萄糖苷；皂苷类一枝黄花酚苷；苯甲酸苄酯类2，3，6-三甲氧基苯甲酸-(2-甲氧基苄基)酯、2，6-二甲氧基苯甲酸-(2-甲氧基苄基)酯、2-羟基-6-甲氧基苯甲酸苄酯、2，6-二甲氧基苯甲酸苄酯；当归酸桂皮酯类当归酸-3，5-二甲氧基-4-乙酰氧基桂皮酯、当归酸-3-甲氧基-4-乙酰氧基桂皮酯；炔属化合物(2E-8z)-癸-二烯-4，6-二炔酸甲酯、(2z-8z)-癸-二烯-4，6-二炔酸甲酯；苯丙酸类咖啡酸(Caffeieacid)、绿原酸。现代药理研究发现，一枝黄花具有：抑菌作用、平喘祛痰、降压、胃黏膜保护等作用。
(3)枇杷叶，为蔷薇科植物枇杷Eriobotrya jaPon.ica(Thunb.)I，indl.的干燥叶。《中国药典》2010年版记载：【性味与归经】苦，微寒。归肺、胃经。【功能与主治】清肺止咳，降逆止呕；用于肺热咳嗽，气逆喘急，胃热呕逆，烦热口渴。药物化学研究表明，枇杷中主要含有挥发油、三萜类、倍半萜类、黄酮类、氨基酸、糖类、及其他有机酸类等化学成分。现代药理学研究表明枇杷叶具有抗炎、止咳、有抗肿瘤、抗病毒、降血糖、保肝利胆、清除氧自由基、增强机体免疫功能等作用，临床常用于治疗急慢性呼吸道等疾病。
(4)百部，为百部科植物直立百部Stemona sessilifolia(Miq.)Miq.、蔓生百部Stemona ja Ponica(Bl.)Miq.或对叶百部Stemona tuberosa Lour.的干燥块根。【性味与归经】甘、苦，微温。归肺经。【功能与主治】润肺下气止咳，杀虫灭虱；用于新久咳嗽，肺痨咳嗽，顿咳；外用于头虱，体虱，蛲虫病，阴痒；蜜百部润肺止咳。用于阴虚劳嗽。百部化学成分主要为百部碱类，目前其根部分离得到了六十多个结构各异的百部生物碱。现代药理研究表明，百部对多种致病性细菌、真菌以及多种寄生虫、昆虫有较好的杀灭作用，还具有中枢镇静、镇痛等功效。
(5)芦根，为禾本科植物芦苇Phragmites communis Trin.的新鲜或干燥根茎。《中国药典》2010年版记载：【性味与归经】甘，寒。归肺、胃经。【功能与主治】清热泻火，生津止渴，除烦，止呕，利尿。用于热病烦渴，肺热咳嗽，肺痈吐脓，胃热呕哕，热淋涩痛。
(6)山猪菜，为旋花科植物篱栏网Merremia hederacea(Burm.f.)Hall.f.的全草。【性味与归经】味甘、淡，性凉。【功能与主治】清热、利咽、凉血。主治风热感冒，咽喉肿痛，乳娥，尿血，急性眼结膜。
(7)甘草，为豆科植物甘草Glycyrrhiza uralensis Fisch.、胀果甘草Glycyrrhiza inflata Bat.或光果甘草Glycyrrhiza glabra L.的干燥根及根茎。【性味与归经】甘，平。归心、肺、脾、胃经。【功能与主治】补脾益气，清热解毒，祛痰止咳，缓急止痛，调和诸药。用于脾胃虚弱，倦怠乏力，心悸气短，咳嗽痰多，脘腹、四肢挛急疼痛，痈肿疮毒，缓解药物毒性、烈性。
发明内容
本发明的目的是提供一种含山芝麻的中药组合物及其制备方法，该中药组合物具有清热解毒利咽、疏散风热、祛痰止咳功效，能有效治疗风热感冒。
本发明所采用的技术方案如下：
一种含山芝麻的中药组合物，原料由以下重量份的中药组分组成：山芝麻30-50份、一枝黄花15-30份、枇杷叶10-30份、百部10-20份、芦根10-20份、山猪菜8-15份、甘草5-15份。
以上所述含山芝麻的中药组合物，原料优选由以下重量份的中药组分组成：山芝麻40份、一枝黄花20份、枇杷叶20份、百部15份、芦根15份、山猪菜12份、甘草8份。
以上所述含山芝麻的中药组合物，可制备成药学上可接受的任意剂型，如：散剂、颗粒剂(冲剂)、丸剂、片剂、胶囊、汤剂、合剂(包括口服液)、糖浆剂等。作为优选，所述剂型为口服液。
一种以上所述含山芝麻中药组合物制成口服液的制备方法，包括以下步骤：
1.分别取山芝麻、一枝黄花、枇杷叶、百部、芦根、山猪菜、甘草，净选，干燥；
2.按重量份比称取：山芝麻30-50份、一枝黄花15-30份、枇杷叶10-30份、百部10-20份、芦根10-20份、山猪菜8-15份、甘草5-15份；
3.将称量好的中药加6-10倍量水煎煮2-3次，每次1-3小时，滤过，合并滤液；
4.将所得滤液浓缩至60℃时相对密度为1.10～1.15的清膏，加入乙醇至含醇量达60％，搅匀，静置24～48小时，取上清液滤过，得滤液；
5.将滤液浓缩至适量，加入防腐剂、矫味剂，煮沸使溶解，加水，搅匀，滤过，灭菌、灌装，即得。
所述防腐剂可为苯甲酸、苯甲酸钠、对羟基苯甲酸甲酯、对羟基苯甲酸乙酯、山梨酸、山梨酸钾等中的一种或两种以上的组合，优选为苯甲酸钠。所述矫味剂为蔗糖、单糖浆、山梨醇、甘露醇、甜菊苷、天冬甜精等中的一种或两种以上的组合优选为甜菊苷。
以上所述含山芝麻中药组合物制成口服液的制备方法，所述步骤2优选按重量份比称取：山芝麻40份、一枝黄花20份、枇杷叶20份、百部15份、芦根15份、山猪菜12份、甘草8份。
本发明是在中医药传统理论的基础上，结合民间用药经验，运用现代科学理论配制而成，诸药合用共奏清热解毒利咽、疏散风热、祛痰止咳之功，能明显改善患者发热、恶风、咽痛、头胀痛、口渴、鼻塞、咳嗽等症状。本发明组方严谨，药少力专，对风热感冒具有良好的疗效。本发明口服液应用先进工艺制备，所得口服液透明澄清，没有沉淀现象，还有宜人的芳香气味、口感好。
具体实施方式
下面结合具体实施例对本发明作进一步描述，但不限制本发明的保护范围和应用范围：
一、含山芝麻中药组合物制成口服液的制备方法
1.试验设计：
本试验用3个实施例分别制备成口服液，具体参数详见表1。
表1实施例制备参数表
2.操作步骤：
(1)分别取山芝麻、一枝黄花、枇杷叶、百部、芦根、山猪菜、甘草，净选，干燥；
(2)按表1重量份称取：山芝麻、一枝黄花、枇杷叶、百部、芦根、山猪菜、甘草；
(3)将称量好的中药加6-10倍量水煎煮2-3次，每次1-3小时，滤过，合并滤液；
(4)将所得滤液浓缩至60℃时相对密度为1.10～1.15的清膏，加入乙醇至含醇量达60％，搅匀，静置24～48小时，取上清液滤过，得滤液；
(5)将滤液浓缩至没有醇味，加入表1所列防腐剂、矫味剂，煮沸使溶解，加适量水，搅匀，滤过，灭菌、灌装，即得。
二、临床应用
1.病例选择标准
所有病例均符合2002年《中药新药临床研究指导原则》的诊断标准。
(1)临床主要症状为：发热、恶风、咽痛咽红、口渴欲饮，鼻塞、流黄涕，咳嗽，舌边尖红，苔白、微黄或黄腻，脉浮数。
(2)体温在38℃以上，病程在48小时之内。
(3)年龄10-70岁。
2.排出标准：
(1)辨证不明确或有过多兼挟症者。
(2)妊娠或乳期妇女。
(3)合并有心血管、肝、肾和造血系统等严重原发性疾病及精神病患者。
(4)未按规定服用药物者。
3.治疗方案
(1)实施例组：将上述制备好的实施例2样品，用于临床试验。口服，一次20ml，一日3次。疗程：用药3天。
(2)对照组：银翘解毒口服液(市售)。口服，一次10ml，一日3次。疗程：用药3天。
3.疗效评定标准
根据病例选择标准，参照《中医病症诊断治疗标准》及《中药新药临床研究指导原则)}，将疗效分为痊愈、有效、无效。
(1)痊愈：治疗3天以内体温恢复正常，感冒的症状基本消失。
(2)有效：治疗3天以内体温较以前降低，感冒的主要症状部分消失。
(3)无效：治疗3天以内体温未降或升高，感冒的主要症状无改善。
4.试验结果：用于治疗和观察78例门诊病人。将上述制备好的实施例2样品和银翘解毒口服液，分别用于病人：治疗组：48例(男25例，女23例，平均年龄37.5岁)，对照组30例(男13例，女17例，平均年龄41.8岁)，结果详见表2。
表2临床试验效果表
结果表明：采用本发明实施例2治疗，治愈率为67％，有效率达96％，总体效果与对照组相当，没有不良反应发生，使用安全、有效，能明显改善患者能明显改善患者发热、恶风、咽痛、头胀痛、口渴、鼻塞、咳嗽等症状，具有清热解毒利咽、疏散风热、祛痰止咳之功效，愈后良好。以下为几个典型病例：
病例1：覃××，男，18岁，体温38.6℃，病程在48小时之内。主要症状为发热、微恶风、咽痛、口渴、鼻塞，尿少、黄，喜冷饮。服用本发明实施例2，每次2支(10ml/支)，每日3次。服1日，体温下降到37.3℃，咽痛缓解，服3日，体温37.0℃，发热、恶风、咽痛、口渴、鼻塞症状消除，小便正常，痊愈。
病例2：尚××，男，28岁，体温39.2℃，病程在24小时之内。主要症状为打喷嚏、恶风、头胀痛、有汗、咽喉红肿疼痛、咳嗽、痰黄。服用本发明实施例2，每次2支(10ml/支)，每日3次，连服3日，上述感冒症状消失，痊愈。
病例3：冯××，女，35岁，体温38.1℃，病程在48小时之内。主要症状为咽喉肿痛、咳嗽、痰黄粘稠，舌尖边红、苔薄白微黄。服用本发明实施例2，每次2支(10ml/支)，每日3次，连服3日，以上感冒症状消除，痊愈。
Claims (7)
1.一种含山芝麻的中药组合物，其特征在于，原料由以下重量份的中药组分组成：山芝麻30-50份、一枝黄花15-30份、枇杷叶10-30份、百部10-20份、芦根10-20份、山猪菜8-15份、甘草5-15份。
2.根据权利要求1所述含山芝麻的中药组合物，其特征在于，原料由以下重量份的中药组分组成：山芝麻40份、一枝黄花20份、枇杷叶20份、百部15份、芦根15份、山猪菜12份、甘草8份。
3.根据权利要求1或2所述含山芝麻的中药组合物，其特征在于,所述组合物制备成药学上可接受的任意剂型。
4.根据权利要求3所述含山芝麻的中药组合物，其特征在于，所述剂型为口服液。
5.一种如权利要求4所述含山芝麻中药组合物制成口服液的制备方法，其特征在于，包括以下步骤：
(1)分别取山芝麻、一枝黄花、枇杷叶、百部、芦根、山猪菜、甘草，净选，干燥；
(2)按重量份比称取：山芝麻30-50份、一枝黄花15-30份、枇杷叶10-30份、百部10-20份、芦根10-20份、山猪菜8-15份、甘草5-15份；
(3)将称量好的中药加6-10倍量水煎煮2-3次，每次1-3小时，滤过，合并滤液；
(4)将所得滤液浓缩至60℃时相对密度为1.10～1.15的清膏，加入乙醇至含醇量达60％，搅匀，静置24～48小时，取上清液滤过，得滤液；
(5)将滤液浓缩至适量，加入防腐剂、矫味剂，煮沸使溶解，加水，搅匀，滤过，灭菌、灌装，即得。
6.根据权利要求5所述含山芝麻中药组合物制成口服液的制备方法，其特征在于，所述防腐剂为苯甲酸钠，所述矫味剂为甜菊苷。
7.根据权利要求5所述含山芝麻中药组合物制成口服液的制备方法，其特征在于，所述步骤(2)按重量份比称取：山芝麻40份、一枝黄花20份、枇杷叶20份、百部15份、芦根15份、山猪菜12份、甘草8份。
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