CN114848788A - 一种地骨皮散汤剂及其制备方法和应用 - Google Patents
一种地骨皮散汤剂及其制备方法和应用 Download PDFInfo
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Abstract
本发明涉及一种地骨皮散汤剂,由以下重量份的原材料组成:地骨皮35~45份,知母30~35份,半夏25~30份,银柴胡35~40份,人参35~40份,甘草20~35份,赤茯苓35~45份,生姜55~60份,粳米30~35份。还提供了地骨皮散汤剂的制备方法及其应用。本发明具有凉血除蒸、清肺降火、降逆止呕、润肺止咳的功效,对外感风寒和风热引发的小儿发热具有良好的治疗效果。此外,本发明提供了地骨皮散更加详细的药方以及制备方法,缩小了加减化裁的空间,避免了地骨皮散的药效波动过大,提高药效的稳定性,从而有利于批量化生产。
Description
技术领域
本发明属于中药领域,尤其是一种地骨皮散汤剂及其制备方法和应用。
背景技术
地骨皮散源自北宋钱乙所著医书《小儿证直诀》,主治小儿虚热潮作;亦治伤寒壮热及余热,所需药材包括地骨皮(自采佳)、知母、银州柴胡(去芦)、甘草(炙)、半夏(汤洗七次,切,焙)、人参(切去顶,焙)、赤茯苓各等分。用法用量:上为细末。每服二钱,加生姜五片,水一盏,煎至八分,食后温服。
该药方的记载过于简要,使用时加减化裁的范围过大,只有经验十分丰富的医师才能把控,不利于保证药效的稳定。
发明内容
本发明所要解决的技术问题是提供一种地骨皮散汤剂及其制备方法和应用,提供了更加详细的药方,缩小加减化裁的空间,保证疗效,有利于批量化生产。
为解决上述问题,本发明采用的技术方案为:一种地骨皮散汤剂,由以下重量份的原材料组成:
地骨皮35~45份,知母30~35份,半夏25~30份,银柴胡35~40份,人参35~40份,甘草20~35份,赤茯苓35~45份,生姜55~60份,粳米30~35份。
进一步地,由以下重量份的原材料组成:地骨皮40份,知母35份,半夏30份,银柴胡35份,人参40份,甘草30份,赤茯苓40份,生姜60份,粳米30份。
上述一种地骨皮散汤剂的制备方法,包括
S1、称取地骨皮35~45份,知母30~35份,半夏25~30份,银柴胡35~40份,人参35~40份,甘草20~35份,赤茯苓35~45份,粳米30~35份,将各组分分别按照1:1的比例分为干法组和湿法组;
S2、将各组分的干法组混合,并在60至80℃的温度下炒制,使各药材的含水量低于1%,然后进行破碎,得到粒径小于0.1mm的散剂;
S3、称取生姜55~60份,将生姜与各组分的湿法组混合,加水浸泡,再加盖煎煮45~60min;然后过滤,得到药液;
S4、将散剂和药液分别分为多份,各份散剂的重量相等,各份药液的重量相等,服用时,将一份散剂与一份药液混合并搅拌,得到汤剂。
进一步地,步骤S3中,水的重量为被浸泡药材总重量的5至8倍,浸泡时间至少为1h。
进一步地,步骤S4中,每一份散剂的重量为5g。
进一步地,步骤S4中,每一份药液的重量为10g。
将上述地骨皮散汤剂用于小儿退烧药物的制备。
本发明的有益效果是:本发明中,地骨皮作为君药,具有凉血除蒸、清肺降火的功效。知母可清热泻火,滋阴润燥;半夏燥湿化痰,降逆止呕,消痞散结;银柴胡具有清虚热、除疳热之功能;人参补益心气,安神增智;赤茯苓益心气,健中和脾,润肺,燥湿,治泻痢;生姜降逆和中;甘草补气健脾;共为臣药。甘草和粳米味甘性平,可缓和地骨皮、知母、银柴胡的寒性,调和诸药,为佐药。诸药合用,具有凉血除蒸、清肺降火、降逆止呕、润肺止咳的功效,对外感风寒和风热引发的小儿发热具有良好的治疗效果。
此外,本发明提供了地骨皮散更加详细的药方以及制备方法,缩小了加减化裁的空间,避免了地骨皮散的药效波动过大,提高药效的稳定性,从而有利于批量化生产。
具体实施方式
下面结合实施例对本发明进一步说明。
实施例一
本实施例的地骨皮散汤剂,由以下重量份的原材料组成:
地骨皮35g,知母30g,半夏25g,银柴胡35g,人参35g,甘草20g,赤茯苓35g,生姜55g,粳米30g。
称取地骨皮35g,知母30g,半夏25g,银柴胡35g,人参35g,甘草20g,赤茯苓35g,粳米30g,将所有药材平均分为两份,一份为干法组,另一份为湿法组。
将上述各组分的干法组混合,并在60至80℃的温度下炒制,直到各药材的含水量低于1%,然后进行破碎,得到粒径小于0.1mm的散剂。
称取生姜55g,将生姜与各组分的湿法组混合,加水1500mL,浸泡至少1h,再加盖煎煮45~60min;然后过滤,得到药液。
将散剂分为多份,每份5g,同时将药液分为多份,每份10g,每一份散剂和药液采用棕色的玻璃瓶进行包装,服用时,采用一次性的注射器将药液从玻璃瓶中抽出,然后注入装有散剂的玻璃瓶,摇匀后口服。一天两次。
实施例二
本实施例的地骨皮散汤剂,由以下重量份的原材料组成:
地骨皮40g,知母35g,半夏30g,银柴胡35g,人参40g,甘草30g,赤茯苓40g,生姜60g,粳米30g。
称地骨皮40g,知母35g,半夏30g,银柴胡35g,人参40g,甘草30g,赤茯苓40g,粳米30g,将所有药材平均分为两份,一份为干法组,另一份为湿法组。
将上述各组分的干法组混合,并在60至80℃的温度下炒制,直到各药材的含水量低于1%,然后进行破碎,得到粒径小于0.1mm的散剂。
称取生姜60g,将生姜与各组分的湿法组混合,加水1600mL,浸泡至少1h,再加盖煎煮45~60min;然后过滤,得到药液。
将散剂分为多份,每份5g,同时将药液分为多份,每份10g,每一份散剂和药液采用棕色的玻璃瓶进行包装,服用时,采用一次性的注射器将药液从玻璃瓶中抽出,然后注入装有散剂的玻璃瓶,摇匀后口服。一天两次。
实施例三
本实施例的地骨皮散汤剂,由以下重量份的原材料组成:
地骨皮45g,知母35g,半夏30g,银柴胡40g,人参40g,甘草35g,赤茯苓45g,生姜60g,粳米35g。
称取地骨皮45g,知母35g,半夏30g,银柴胡40g,人参40g,甘草35g,赤茯苓45g,粳米35g,将所有药材平均分为两份,一份为干法组,另一份为湿法组。
将上述各组分的干法组混合,并在60至80℃的温度下炒制,直到各药材的含水量低于1%,然后进行破碎,得到粒径小于0.1mm的散剂。
称取生姜60g,将生姜与各组分的湿法组混合,加水1800mL,浸泡至少1h,再加盖煎煮45~60min;然后过滤,得到药液。
将散剂分为多份,每份5g,同时将药液分为多份,每份10g,每一份散剂和药液采用棕色的玻璃瓶进行包装,服用时,采用一次性的注射器将药液从玻璃瓶中抽出,然后注入装有散剂的玻璃瓶,摇匀后口服。一天两次。
对于3岁以上的儿童,每次服用的量可以酌情增加。
药效机理
据《中医精华浅说》所载:小儿发热不一般,表里虚实莫同看。里宜清解表宜汗,辨证论治热自安。小儿发热是儿科常见的证候之一,很多疾病都可以引起小儿发热,临床多见者,不外外感、内伤。外感又分风寒、风热,内伤多因伤食积滞。在儿科临床外感夹食尤为常见。在小儿易感的很多传染病,初期每多发热,须与其他症状结合仔细辨证,切不可以从感冒着眼,以免误病机。俗说:“走马看小儿”,意思是说,小儿稚阴稚阳,抗病力弱,起病骤急,变化神速,易寒易热,易虚易实,表里传变较之成人为快,故业儿科者,辨热不可稍有疏忽。
根据中医理论,对于外感风寒,治则:祛风散寒,宣肺解表;外感风热,治则:疏风解表,清热宣肺;脾胃积热,治则:导滞清热。
依据上述理论,结合传统的地骨皮散配方,本发明采用地骨皮作为君药,《本经》记载:味苦,寒。入肺、肝、肾经。《别录》记载:主风湿,下胸胁气,客热头痛,补内伤大劳嘘吸,坚筋,强阴,利大小肠,耐寒暑。
知母、半夏、银柴胡、人参、甘草、赤茯苓、生姜共为臣药。其中,知母:味苦,性寒,归肺、胃、肾经。《神农本草经》记载:“主消渴热中,除邪气肢体浮肿,下水,补不足,益气。主治热病烦渴,肺热燥咳,骨蒸潮热,内热消渴,肠燥便秘。
半夏:味辛,性温。归脾、胃、肺经。可燥湿化痰,降逆止呕,消痞散结。用于湿痰寒痰,咳喘痰多,痰饮眩悸,风痰眩晕,痰厥头痛,呕吐反胃,胸脘痞闷,梅核气;外治痈肿痰核。
银柴胡:性味微寒,味甘。具有清虚热、除疳热之功能,用于阴虚发热、骨蒸痨热、小儿疳热等症。临床常应用于治疗小儿疳积发热、久病发热、阴虚潮热、感冒高热等疾病。银柴胡不仅具有清热凉血功能,还具抗炎、治疗过敏性疾病、抗癌、扩张血管等作用。
人参:味甘、微苦,性微温;归肺、脾、心经。神农本草经》记载“主补五脏,安精神,定魂魄,止惊悸,除邪气,明目,开心益智。久服,轻身延年”。常用于调整血压、恢复心脏功能、神经衰弱及身体虚弱等症,也有祛痰、健胃、利尿、兴奋等功效。
甘草:味甘,性平。归心、肺、脾、胃经。可靠补脾益气,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,四肢挛急疼痛,痈肿疮毒,缓解药物毒性、烈性。
赤茯苓:甘淡,性平。入心、脾、膀胱经。治疗浮肿、小肠、膀胱湿热、小便短赤。益心气,健中和脾,润肺,燥湿。治泻痢。
生姜:味辛,性微温。归肺、脾、胃经。解表散寒,温中止呕,温肺止咳,解毒。主治风寒感冒,脾胃寒症,胃寒呕吐,肺寒咳嗽,解鱼蟹毒。
甘草和粳米味甘,性平,可缓和地骨皮、知母、银柴胡的寒性,用以调和诸药,为佐药。
可见,本发明利用地骨皮、知母、半夏、赤茯苓、生姜和银柴胡清热润肺,化痰止咳,疏风解表,可有效治疗外感风寒和风热引发的小儿发热,利用银柴胡、人参、甘草等健胃导滞,辅助解热宣肺,诸药合用,具有凉血除蒸、清肺降火、降逆止呕、润肺止咳、健胃消食的功效,对外感风寒、风热以及脾胃积热引发的小儿发热均具有良好的治疗效果。
此外,本发明分别制备散剂(粉末状药材)和药液,是依据《小儿证直诀》中记载的“上为细末。每服二钱,加生姜五片,水一盏,煎至八分,食后温服”这一用法,具体原因不明,经推测,服用散剂可能有利于某些有效成分的吸收,或者避免煎煮过程中某些有效成分被破坏或挥发。一般来说,煎煮后的药液更加有利于吸收,降低肠胃负担,因此将散剂和药液混合服用,可保证药效的同时减轻肠胃负担。
本发明的地骨皮散汤剂除了直接口服之外,还可以用于制备小儿退烧药物,如将汤剂制成颗粒、药片等其他形式。
动物试验
选取健康的wistar大鼠30只,雄性和雌性各一半左右,SPF级,体重150至200g,由凯学生物科技(上海)有限公司提供,将30只大鼠随机分为空白组、对照组、实验一组、实验二组和实验三组,每组6只。
主要仪器:电子体温计。
主要试剂:干酵母,购买于安琪酵母股份有限公司;生理盐水,自制。
试剂制备:将干酵母进行研磨,称取15g研磨后的干酵母,加入150mL生理盐水,搅拌得到混悬液。
试验过程如下:
对空白组、对照组、实验一组、实验二组和实验三组的大鼠的直肠进行刺激,每天3次(早中晚各一次),持续一周。
注射混悬液前30分钟内测定空白组、对照组、实验一组、实验二组和实验三组的大鼠的体温3次,取平均值作为基础体温值,基础体温值计算结果如下表所示:
空白组℃ | 对照组℃ | 实验一组℃ | 实验二组℃ | 实验三组℃ | |
第一只 | 37.4 | 37.6 | 37.3 | 37.2 | 37.4 |
第二只 | 37.7 | 37.4 | 37.6 | 38.1 | 37.5 |
第三只 | 37.4 | 38.0 | 37.5 | 37.6 | 37.1 |
第四只 | 38.0 | 37.5 | 37.4 | 37.7 | 37.7 |
第五只 | 37.5 | 37.1 | 36.9 | 37.4 | 37.6 |
第六只 | 37.2 | 37.7 | 37.2 | 37.3 | 37.9 |
所有大鼠的体温均处于正常范围(36.6至38.3℃)。
向对照组、实验一组、实验二组和实验三组的大鼠注射混悬液,注射剂量为5mL/kg,向空白组的大鼠注射生理盐水,然后每隔一小时测量大鼠体温一次,共测量十次,第十次的测量结果为:
可见,空白组的大鼠体温处于正常范围,而对照组、实验一组、实验二组和实验三组的大鼠体温均超过正常范围,出现了发热症状。
取实施例一制得的散剂5g,药液10mL,将散剂与药液混合后加蒸馏水100mL进行稀释,取稀释后的汤剂1mL对实验一组进行饲喂;
取实施例二制得的散剂5g,药液10mL,将散剂与药液混合后加蒸馏水100mL进行稀释,取稀释后的汤剂1mL对实验二组进行饲喂;
取实施例三制得的散剂5g,药液10mL,将散剂与药液混合后加蒸馏水100mL进行稀释,取稀释后的汤剂1mL对实验三组进行饲喂;
空白组和对照组饲喂生理盐水1mL。
饲喂后,每隔一小时测量空白组、对照组、实验一组、实验二组和实验三组的大鼠体温,第三次测量结果如下表所示:
空白组℃ | 对照组℃ | 实验一组℃ | 实验二组℃ | 实验三组℃ | |
第一只 | 37.2 | 38.4 | 38.4 | 38.3 | 38.4 |
第二只 | 37.9 | 38.7 | 38.7 | 37.9 | 38.1 |
第三只 | 37.7 | 38.5 | 38.8 | 38.3 | 38.3 |
第四只 | 37.5 | 38.9 | 38.0 | 38.7 | 37.8 |
第五只 | 37.3 | 38.6 | 38.1 | 38.0 | 38.3 |
第六只 | 37.8 | 38.7 | 38.2 | 38.4 | 38.2 |
通过比较空白组、对照组、实验一组、实验二组和实验三组的每只大鼠的体温变化,可知,空白组的大鼠体温始终处于正产范围,对照组的体温先前处于正常范围,注射干酵母后体温均超过正常范围,出现了发热症状,饲喂本发明的地骨皮散3小时后,实验一组、实验二组和实验三组的大鼠体温均有所降低,而对照组的大部分大鼠体温继续升高,发热情况加重。
结论:本发明的地骨皮散具有良好的清热退烧效果。
临床用药
辛某,18个月,发热,恶寒,无汗,流清涕,舌苔薄白,指纹鲜红,脉浮紧。经浙江大学医学院附属第一医院中医科诊断为外感风寒,服用本发明地骨皮散汤剂早晚各一次,每次10mL,三天后症状得到缓解。
张某,3岁,发热重,恶风,微汗,鼻塞,咽喉红肿,口干而渴,舌苔薄黄,脉浮数。经杭州市中医院诊断为外感风热,服用本发明地骨皮散汤剂早晚各一次,每次10mL,四天后痊愈。
尹某,3岁半,发热,手足心热,盗汗,口干,大便干,小便黄,舌质红,无舌苔。经杭州市中医院诊断为阴虚发热,服用本发明地骨皮散汤剂早晚各一次,每次10mL,三天后症状得到缓解。
齐某,3岁,发热腹胀,恶心呕吐,便秘,舌苔黄腻,脉弦滑数,经杭州市中医院诊断为脾胃积热,服用本发明地骨皮散汤剂早晚各一次,每次10mL,两天后症状得到缓解。
刘某,3岁,发热,头痛,无食欲,喷嚏,流黄鼻涕,指纹红紫,大便少、干,经浙江大学医学院附属第一医院中医科诊断为外感风热兼伤食积滞,服用本发明地骨皮散汤剂早晚各一次,每次10mL,四天后症状得到缓解,七天后痊愈。
以上所述仅为本发明的优选实施例而已,并不用于限制本发明,对于本领域的技术人员来说,本发明可以有各种更改和变化。凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (7)
1.一种地骨皮散汤剂,其特征在于,由以下重量份的原材料组成:
地骨皮35~45份,知母30~35份,半夏25~30份,银柴胡35~40份,人参35~40份,甘草20~35份,赤茯苓35~45份,生姜55~60份,粳米30~35份。
2.如权利要求1所述的一种地骨皮散汤剂,其特征在于,由以下重量份的原材料组成:地骨皮40份,知母35份,半夏30份,银柴胡35份,人参40份,甘草30份,赤茯苓40份,生姜60份,粳米30份。
3.如权利要求1或2所述一种地骨皮散汤剂的制备方法,其特征在于,包括
S1、称取地骨皮35~45份,知母30~35份,半夏25~30份,银柴胡35~40份,人参35~40份,甘草20~35份,赤茯苓35~45份,粳米30~35份,将各组分分别按照1:1的比例分为干法组和湿法组;
S2、将各组分的干法组混合,并在60至80℃的温度下炒制,使各药材的含水量低于1%,然后进行破碎,得到粒径小于0.1mm的散剂;
S3、称取生姜55~60份,将生姜与各组分的湿法组混合,加水浸泡,再加盖煎煮45~60min;然后过滤,得到药液;
S4、将散剂和药液分别分为多份,各份散剂的重量相等,各份药液的重量相等,服用时,将一份散剂与一份药液混合并搅拌,得到汤剂。
4.如权利要求3所述的地骨皮散汤剂的制备方法,其特征在于,步骤S3中,水的重量为被浸泡药材总重量的5至8倍,浸泡时间至少为1h。
5.如权利要求3所述的地骨皮散汤剂的制备方法,其特征在于,步骤S4中,每一份散剂的重量为5g。
6.如权利要求3所述的地骨皮散汤剂的制备方法,其特征在于,步骤S4中,每一份药液的重量为10g。
7.将权利要求1或2所述的一种地骨皮散汤剂用于小儿退烧药物的制备。
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