CN106511667A - 通宣理肺丸 - Google Patents

通宣理肺丸 Download PDF

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CN106511667A
CN106511667A CN201610962683.8A CN201610962683A CN106511667A CN 106511667 A CN106511667 A CN 106511667A CN 201610962683 A CN201610962683 A CN 201610962683A CN 106511667 A CN106511667 A CN 106511667A
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刘世超
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Shanghai Chen Song New Mstar Technology Ltd
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Abstract

本发明公开了一种通宣理肺丸,所述通宣理肺丸由下述重量份的原料制备而成:紫苏叶155‑170份、前胡100‑115份、桔梗100‑115份、苦杏仁75‑90份、麻黄100‑115份、甘草75‑90份、陈皮100‑115份、半夏75‑90份、茯苓100‑115份、枳壳100‑115份、黄芩100‑115份、矫味剂0.1‑0.5份、抗氧剂0.5‑2.5份。本发明通宣理肺丸,具有解表散寒、宣肺止嗽的功效,可用于治疗风寒束表、肺气不宣所致的感冒咳嗽等症,配方中添加抗氧剂,保证了药物的质量稳定。

Description

通宣理肺丸
技术领域
本发明涉及中药制剂技术领域,具体涉及一种通宣理肺丸。
背景技术
通宣理肺丸是一个传统的中药制剂,2005年版《中国药典》(一部)收载的品种,主要由紫苏叶、前胡、苦杏仁等11味中药组成,具有解表散寒、宣肺止嗽之功效,用于风寒、肺气不宜所致的感冒咳嗽,症见发热、恶寒、咳嗽、头疼、无汗、鼻塞流涕、肢体酸痛等。
方中紫苏、麻黄性温辛散,可疏风散寒、发汗解表、宣肺平喘,共为君药;前胡、苦杏仁降气化痰平喘,桔梗宣肺化痰利咽,三药相伍,以复肺脏宣发肃降之机,陈皮、半夏燥湿化痰,茯苓健脾渗湿,以绝生痰之源,共为臣药;黄芩清泻肺热,以防外邪内郁而化热,并防麻黄、半夏等温燥太过,枳壳理气,使气行则痰化津复,共为佐药;甘草化痰止咳、调和诸药,为使药。诸药相合,共奏解表散寒、宣肺止咳之功。该药解表散寒、宣肺止嗽,是治疗风寒感冒咳嗽的良药。但现有技术制备的通宣理肺丸稳定性较差,且不易长时间存放。
发明内容
针对现有技术中存在的上述不足,本发明所要解决的技术问题是提供一种通宣理肺丸。
本发明目的是通过如下技术方案实现的:
一种通宣理肺丸,由下述重量份的原料制备而成:紫苏叶155-170份、前胡100-115份、桔梗100-115份、苦杏仁75-90份、麻黄100-115份、甘草75-90份、陈皮100-115份、半夏75-90份、茯苓100-115份、枳壳100-115份、黄芩100-115份、矫味剂0.1-0.5份、抗氧剂0.5-2.5份。
优选地,所述的矫味剂为海藻酸钠、柠檬酸钠、羧甲基纤维素钠中一种或多种的混合物。
更优选地,所述的矫味剂由海藻酸钠、柠檬酸钠、羧甲基纤维素钠混合而成,所述海藻酸钠、柠檬酸钠、羧甲基纤维素钠的质量比为(1-3):(1-3):(1-3)。
优选地,所述的抗氧剂为桑黄酮、甘草查而酮A、罗汉松双黄酮A中一种或多种的混合物。
更优选地,所述的抗氧剂由桑黄酮、甘草查而酮A、罗汉松双黄酮A混合而成,所述桑黄酮、甘草查而酮A、罗汉松双黄酮A的质量比为(1-3):(1-3):(1-3)。
本发明还提供了上述通宣理肺丸的制备方法,包括以下步骤:
(1)紫苏叶、前胡、桔梗、苦杏仁、麻黄、甘草、陈皮、半夏、茯苓、枳壳、黄芩11味中药粉碎,过筛,混合均匀,进行超临界二氧化碳流体萃取,萃取时间108-142分钟,萃取温度31-48℃,萃取压力22-38MPa,二氧化碳的流量为10-20kg/h,采用200目滤布过滤,滤渣备用,滤液减压浓缩至密度为1.15-1.25(50℃)的萃取清膏;
(2)步骤(1)中所得药渣中加入药渣量8-12倍的水,煎煮1.5个小时,趁热采用200目滤布过滤,收集滤液;药渣中再加入药渣重量6-10倍的水煎煮1个小时,采用200目滤布过滤弃渣;合并两次滤液,减压浓缩浓缩至相对密度为1.15-1.25(50℃)的水提清膏;
(3)将萃取清膏、水提清膏、矫味剂、抗氧剂混合均匀,制丸,干燥,即得。
具体的,在本发明中:
紫苏叶,为唇形科植物紫苏Perilla frutescens(L.)Britt的干燥叶。
前胡,为伞形科植物白花前胡Peucedanum praeruptorum Dunn的干燥根。
麻黄,为麻黄科植物草麻黄Ephedra sinica Stapf的干燥草质茎。
半夏,为天南星科植物半夏Pinellia ternata(Thunb.)Breit.的干燥块茎。
枳壳,为芸香科植物酸橙Citrus aurantium L.的干燥未成熟果实。
黄芩,为唇形科植物黄芩Scutellaria baicalensis Georgi的干燥根。
苦杏仁,为蔷薇科植物山杏(苦杏)Prunus armeniaca L.var.ansu Maxim.的干燥成熟种子。
陈皮,为芸香科植物橘Citrus reticulata Blanco的干燥成熟果皮。
甘草,拉丁学名:Glycyrrhiza uralensis Fisch,别名:国老、甜草、乌拉尔甘草、甜根子。豆科、甘草属多年生草本,根与根状茎粗壮,是一种补益中草药。
桔梗,拉丁学名:Platycodon grandiflorus(Jacq.)A.DC,为桔梗科植物桔梗Platycodon grandiflorum(Jacq.)A.DC.的干燥根。
茯苓,拉丁学名:Wolfiporia cocos,又称玉灵、茯灵、万灵桂、茯菟。是拟层孔菌科真菌茯苓的干燥菌核。
海藻酸钠,CAS号:31581-02-9。
柠檬酸钠,CAS号:6132-04-3。
羧甲基纤维素钠,CAS号:9004-32-4。
桑黄酮,CAS号:62949-77-3。
甘草查而酮A,CAS号:58749-22-7。
罗汉松双黄酮A,CAS号:22136-74-9。
本发明通宣理肺丸,具有解表散寒、宣肺止嗽的功效,可用于治疗风寒束表、肺气不宣所致的感冒咳嗽等症,配方中添加抗氧剂,保证了药物的质量稳定。
具体实施方式
实施例1
通宣理肺丸原料:紫苏叶164份、前胡109份、桔梗109份、苦杏仁82份、麻黄109份、甘草82份、陈皮109份、半夏82份、茯苓109份、枳壳109份、黄芩109份、矫味剂0.21份、抗氧剂1.8份。
所述的矫味剂由海藻酸钠、柠檬酸钠、羧甲基纤维素钠按质量比为1:1:1搅拌混合均匀得到。
所述的抗氧剂由桑黄酮、甘草查而酮A、罗汉松双黄酮A按质量比为1:1:1搅拌混合均匀得到。
上述通宣理肺丸的制备方法,包括以下步骤:
(1)紫苏叶、前胡、桔梗、苦杏仁、麻黄、甘草、陈皮、半夏、茯苓、枳壳、黄芩11味中药粉碎为80目,过筛,混合均匀,进行超临界二氧化碳流体萃取,萃取时间124分钟,萃取温度41℃,萃取压力32MPa,二氧化碳的流量为15kg/h,采用200目滤布过滤,滤渣备用,滤液减压浓缩至密度为1.20(50℃)的萃取清膏;
(2)步骤(1)中所得药渣中加入药渣量10倍的水,煎煮1.5个小时,趁热采用200目滤布过滤,收集滤液;药渣中再加入药渣重量8倍的水煎煮1个小时,采用200目滤布过滤弃渣;合并两次滤液,减压浓缩浓缩至相对密度为1.20(50℃)的水提清膏;
(3)将萃取清膏、水提清膏、矫味剂、抗氧剂混合均匀,制丸,干燥。得到实施例1的通宣理肺丸。
实施例2
与实施例1基本相同,区别仅仅在于:所述的矫味剂由柠檬酸钠、羧甲基纤维素钠按质量比为1:1搅拌混合均匀得到。得到实施例2的通宣理肺丸。
实施例3
与实施例1基本相同,区别仅仅在于:所述的矫味剂由海藻酸钠、羧甲基纤维素钠按质量比为1:1搅拌混合均匀得到。得到实施例3的通宣理肺丸。
实施例4
与实施例1基本相同,区别仅仅在于:所述的矫味剂由海藻酸钠、柠檬酸钠按质量比为1:1搅拌混合均匀得到。得到实施例4的通宣理肺丸。
实施例5
与实施例1基本相同,区别仅仅在于:所述的抗氧剂由甘草查而酮A、罗汉松双黄酮A按质量比为1:1搅拌混合均匀得到。得到实施例5的通宣理肺丸。
实施例6
与实施例1基本相同,区别仅仅在于:所述的抗氧剂由桑黄酮、罗汉松双黄酮A按质量比为1:1搅拌混合均匀得到。得到实施例6的通宣理肺丸。
实施例7
与实施例1基本相同,区别仅仅在于:所述的抗氧剂由桑黄酮、甘草查而酮A按质量比为1:1搅拌混合均匀得到。得到实施例7的通宣理肺丸。
测试例1
将实施例1-7制备的通宣理肺丸,置于25℃,相对湿度85%环境下保藏半年,然后进行大肠杆菌(ATYCC 25922)菌落总数测试,参照GBT 4789.2-2008食品卫生微生物学检验菌落总数测定。具体测试结果见表1。
表1:菌落总数测试表cfu/g
比较实施例1与实施例2-4,实施例1(海藻酸钠、柠檬酸钠、羧甲基纤维素钠复配)防腐性能明显优于实施例2-4(海藻酸钠、柠檬酸钠、羧甲基纤维素钠中任意二者复配);比较实施例1与实施例5-7,实施例1(桑黄酮、甘草查而酮A、罗汉松双黄酮A复配)防腐性能明显优于实施例5-7(桑黄酮、甘草查而酮A、罗汉松双黄酮A中任意二者复配)。
测试例2
对实施例1-7制备的通宣理肺丸进行稳定性测试。
本发明通宣理肺丸中包含的柠檬烯是紫苏叶的指标性成分。将实施例1-7制备的通宣理肺丸分别用铝塑复合膜袋密封包装,将它们置于38℃温度下放置3个月,测定各试样中3月时的柠檬烯相对于该试样0月时的残余含量。测试方法参照文献熊运海等《化学计量学法对紫苏叶与紫苏子挥发油共有组分分析》。具体结果见表2。
表2:稳定性测试结果表 单位:%
柠檬烯残余含量
实施例1 99.5
实施例2 95.3
实施例3 95.8
实施例4 96.1
实施例5 94.8
实施例6 95.2
实施例7 95.1
比较实施例1与实施例2-4,实施例1(海藻酸钠、柠檬酸钠、羧甲基纤维素钠复配)稳定性能明显优于实施例2-4(海藻酸钠、柠檬酸钠、羧甲基纤维素钠中任意二者复配);比较实施例1与实施例5-7,实施例1(桑黄酮、甘草查而酮A、罗汉松双黄酮A复配)稳定性能明显优于实施例5-7(桑黄酮、甘草查而酮A、罗汉松双黄酮A中任意二者复配)。

Claims (1)

1.一种通宣理肺丸,其特征在于,由下述重量份的原料制备而成:紫苏叶155-170份、前胡100-115份、桔梗100-115份、苦杏仁75-90份、麻黄100-115份、甘草75-90份、陈皮100-115份、半夏75-90份、茯苓100-115份、枳壳100-115份、黄芩100-115份、矫味剂0.1-0.5份、抗氧剂0.5-2.5份。
所述的矫味剂由海藻酸钠、柠檬酸钠、羧甲基纤维素钠混合而成,所述海藻酸钠、柠檬酸钠、羧甲基纤维素钠的质量比为(1-3):(1-3):(1-3)。
所述的抗氧剂由桑黄酮、甘草查而酮A、罗汉松双黄酮A混合而成,所述桑黄酮、甘草查而酮A、罗汉松双黄酮A的质量比为(1-3):(1-3):(1-3)。
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Publication number Priority date Publication date Assignee Title
CN114224960A (zh) * 2021-12-31 2022-03-25 哈尔滨瀚钧现代制药有限公司 一种通宣理肺颗粒及制备工艺

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114224960A (zh) * 2021-12-31 2022-03-25 哈尔滨瀚钧现代制药有限公司 一种通宣理肺颗粒及制备工艺

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