CN115645364A - 一种宠物用双黄连口服液 - Google Patents
一种宠物用双黄连口服液 Download PDFInfo
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- CN115645364A CN115645364A CN202211400273.6A CN202211400273A CN115645364A CN 115645364 A CN115645364 A CN 115645364A CN 202211400273 A CN202211400273 A CN 202211400273A CN 115645364 A CN115645364 A CN 115645364A
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Abstract
本发明公开了一种宠物用双黄连口服液,属于宠物用中药口服液技术领域,该中药口服液采用的原辅料由以下主要组分组成:金银花提取物0.1‑0.3%、黄芩提取物0.2‑0.4%、连翘提取物0.6‑1.0%、蜂蜜40‑60%、助溶剂2‑10%、防腐剂0.2‑0.3%、乙醇2‑10%,余量为纯化水。该发明保留了双黄连口服液配方中的金银花、黄芩和连翘及其具有辛凉解表,清热解毒的功效。在此配方基础上添加助溶剂增加难溶性药物的溶解度,有利于提高双黄连口服液的稳定性。
Description
技术领域
本发明属于宠物用中药口服液技术领域,特别涉及一种宠物用双黄连口服液。
背景技术
宠物的风热感冒大多是受外部环境影响,多发于春夏季,一般是外感风热所致,由于外部的因素,如淋雨、室内外温差大,洗澡没有及时吹干毛发等,导致全身或呼吸道局部防御力降低引发的感冒,老幼体弱的宠物因为自身免疫力低下的原因而感冒,感冒是宠物临床常见的一种病症,主要症状表现为体温升高,精神状态不佳,萎靡不振,食欲下降,咳嗽呕吐,咽喉肿痛等。宠物感冒的过程时间从几个星期到一两个月不等,幼小、营养不良、毛发脏乱和抵抗力弱的宠物特别容易感冒。因此,针对宠物感冒的治疗应当以清热解毒,润肺止咳,补中益气,开胃消食为主。
双黄连口服液由金银花、黄芩、连翘三味中药组成。为解表剂,具有疏风解表、清热解毒的功效。用于外感风热所致的感冒,症状见发热、咳嗽、咽喉疼痛。中医认为,这三味中药具有良好的清热解毒、表里双清的作用。现代医学研究也认为,双黄连口服液具有广谱抗病毒、抑菌、提高机体免疫功能的作用,是目前有效的广谱抗病毒药物之一。
综上所述,针对宠物风热感冒的治疗,双黄连口服液是不错的选择,由于双黄连全身组织液归属于中成药制剂,具有清热解毒的功能,虽然中药制剂效果比较温和,但也有肯定的反效果。第一点,此药品成份会含有蔗糖,会造成宠物的血糖降低,关于有糖尿病病史的宠物使用此药品肯定要谨慎。
第二点双黄连口服液是以金银花、黄芩和连翘为主要原料,蔗糖为辅料制备的中成药,这是一种生活中常见的药物组合,但也同时出现了双黄连口服液在生产后,常温放置一段时间会发现pH值下降以及析出的质量问题,因此在双黄连口服液配方中添加助溶剂是当前发展的需要。
发明内容
本发明要解决的技术问题是提供一种宠物用双黄连口服液及其制备方法。该双黄连口服液保留了配方中的金银花、黄芩、连翘。将蔗糖更改为蜂蜜,有止咳也有调味的功效,患有糖尿病病史的宠物也可放心服用。添加助溶剂能增加制剂的稳定性,改善物理性,减轻刺激,改善吸收,增加药理作用,能有效解决产品生产后静置一段时间后出现的pH值下降和析出的问题。
为解决上述问题,本发明采用的技术方案为:一种宠物用双黄连口服液及其制备方法。由以下原料药和辅料组成:金银花提取物0.1-0.3%、黄芩提取物0.2-0.4%、连翘提取物0.6-1.0%、蜂蜜40-60%、助溶剂2-10%、防腐剂0.2-0.3%、乙醇2-10%,余量为纯化水。
最佳配比: 金银花提取物0.12-0.25%、黄芩提取物0.2-0.3%、连翘提取物0.7-0.8%、蜂蜜50-58%、助溶剂4-8%、防腐剂0.25-0.28%、乙醇3-7%,余量为纯化水。
其中助溶剂为甲酰胺、乙酰胺、碳酰胺的一种或几种。
其中防腐剂为尼泊金甲酯、尼泊金乙酯、尼泊金丙酯的一种或多种。
制备方法:制备成口服液的形式使用,具体为:制备成每1ml相当于原生药1.5g。
优选制备方法步骤如下:
步骤1,用处方量的乙醇,依次加入处方量金银花提取物、黄芩提取物、连翘提取物搅拌溶解。
步骤2,加入处方量防腐剂,搅拌溶解。
步骤3,加入处方量蜂蜜,搅拌30min。
步骤4,加入处方量助溶剂,搅拌溶解。
步骤5,加入纯化水搅拌溶解定容。
本发明所选原料药理作用分析如下:
(1)金银花提取物:金银花提取物是一种提取物,提取自天然植物金银花,主要成份为绿原酸,颜色是棕色粉末。其作用功效主要体现在消炎、抗菌两方面。药理作用:(1)抗菌及增强免疫功能的作用:试验表明金银花对伤寒杆菌、副伤寒杆菌、大肠杆菌、变形杆菌、绿脓杆菌、百日咳杆菌、霍乱弧菌、葡萄球菌、链球菌、肺炎双球菌、脑膜炎球菌等均有抑制作用。(2)抑制耐药菌蛋白质合成:金银花提取物对金黄色葡萄球菌耐药植株的呼吸有显著刺激作用,多用于耐药菌株导致的内外科炎症,如治疗肺结核并发呼吸道感染、肺炎、急性细菌性痢疾、腹泻。也有用于降低咽喉部带菌率。
(2)黄芩提取物: 本品为黄芩经提取干燥制得的淡黄色的粉末;气微,味苦。功效作用:清热燥湿,泻火解毒,止血,安胎。用于湿热、暑热胸闷呕恶,湿热痞满,泻痢,黄疸,肺热咳嗽,高热烦渴,血热吐衄,痈肿疮毒,胎动不安。药理作用:⑴抗炎抗变态反应 黄芩甙、黄芩甙对豚鼠离体气管过敏性收缩及整体动物过敏性气喘,均有缓解作用,并与麻黄碱表现协同。甙元的磷酸盐较硫酸钠盐作用强,黄芩甙元能抑制离体气管及回肠之Schul-tz-Dale反应,对豚鼠被动性皮肤过敏反应、组织胺皮肤反应亦表现抑制,在抗变态反应方面,甙元较甙作用强。黄芩此种抗变态反应,是由于伤害了肥大细胞的酶激活系统,抑制了过敏性介体的释放,因而不产生过敏反应,此外它对平滑肌本身,也有直接的松弛作用。黄芩甙元及黄芩甙均能抑制过敏性之浮肿及炎症,二者并能降低小鼠耳毛细血管的通透性情,后者尚能防止低气压引起小白鼠肺出血。⑵抗微生物作用 黄芩有较广的抗菌谱,在试管内对痢疾杆菌、白喉杆菌、绿脓杆菌、葡萄球菌、链球菌、肺炎双球菌以及脑膜炎球菌等均有抑制作用,煎剂作喉头喷雾,对脑膜炎带菌者亦有效,即使对青霉素已产生抗药性的金黄色葡萄球菌,对黄芩仍属敏感。试管内对入型结核病有抑制作用,报告不一至,煎剂对小白鼠实验性结核病有效,但对豚鼠则无效。试管内对流感病毒PR8株有抑制作用,鼠感染病毒后,能使之减轻肺部损伤和延长存活日期。对多种皮肤致病性真菌体外亦有抑制力,并能杀死钩端螺旋体。
(3)连翘提取物:本品为连翘提取炼制的棕褐色粉末;气香,味苦。功效作用:主要有抗菌、抗病毒、抗炎、抗辐射损伤、解热等作用,还具有镇吐,抗肝损伤治疗肝炎,强心、利尿等作用。药理作用:连翘含三萜皂甙,果皮含甾醇、酚性成分(连翘酚)、生物碱、皂甙、齐墩果酸、香豆精类,还有丰富的维生素及少量挥发油。连翘有广谱抗菌作用,对金黄色葡萄球菌、贺氏痢疾杆菌有很强的抑制作用,对伤寒杆菌、霍乱弧菌、大肠杆菌、绿脓杆菌、百日咳杆菌、结核杆菌、肺炎双球菌、溶血性链球菌均有抑制作用,对流感病毒也有抑制作用,并有抗真菌作用。醇提取物对钩端螺旋体有杀灭作用。连翘酚为抗菌的有效成分。此品所含齐墩果酸有强心、利尿及降血压作用;维生素C可降低血管通透性及脆性,防止渗血。煎剂有镇吐作用,能对抗洋地黄和阿朴吗啡引起的呕吐,镇吐作用可能是由于连翘能抑制延脑催吐化学感受区之故。齐墩果酸是连翘抗肝损伤的有效成分,两者均能降低实验性肝损伤动物的血清谷丙转氨酶。
(4)蜂蜜:本品为蜜蜂科昆虫中华蜜蜂所酿的蜜。味甘,性平。归肺、脾、大肠经。具有补中润燥、解毒止痛的功效。其药理作用广泛,能够促进组织再生、治疗创面、润肺止咳、抗菌、抗氧化、促进消化、润肠通便、增强机体免疫力等。
(5)乙醇:药理作用:(1)可以用于食用,如酒。因为它能作为良好的有机溶剂,所以中医用它来送服中药,以溶解中药中大部分有机成份。(2)乙醇可以行药势,古人谓“酒为诸药之长”,乙醇可以便药力外达于表而上至于颠,使理气行血药物的作用得到较好的发挥,也能使滋补药物补而不滞;(3)乙醇有助于药物有效成分的溶解,中药的多种成分都易于溶解酒精之中;(4)防腐作用
助溶剂是液体制剂中的常用辅料,随着科技的发展,助溶剂的品种不断增加,助溶难溶性药物在水中当加入第三种物质时能增加其溶解度,这种加入的第三种物质称为助溶剂。其机理为难溶性药物与助溶剂形成可溶性络合、有机分子复合物、缔合物以及通过复分解反应而生成可溶性盐类等四种类型。助溶剂增加难溶性药物的溶解度有利于制剂的制备和应用,除此之外助溶剂还能减少原有药物的一些缺点提高制剂的质量并可开发新制剂:如助溶剂能增加制剂的稳定性,改善物理性,矫臭矫味,减轻刺激,改善吸收,增加药理作用。选择助溶剂时应在较低浓度下能使难溶性药物增加较大的溶解度;不影响主药的效果;使用时无刺激性和毒性;贮存和灭菌 时其稳定性不变;价廉易得。
本发明中金银花,黄芩,连翘作为双黄连口服液中的主要原料,既做到了能够治疗由风热感冒引起的体温升高、轻症肺炎、咳嗽、咽喉肿痛等问题,又能在生病后做到振奋精神、恢复食欲、增强机体免疫力的功能。本发明中的蜂蜜替换了双黄连口服液配方中的蔗糖,使双黄连口服液的味道更满足宠物的味蕾,也不会对患有糖尿病的宠物造成负担。助溶剂在本发明中,能够帮助配方中的主药原料快速溶解,不会出现析出的质量问题。
具体实施方式
下面通过对本发明方案进行详细说明
实施例1
一种防治宠物用双黄连口服液析出及其制备方法,各组分以重量百分比计:
金银花提取物 0.12%
黄芩提取物 0.2%
连翘提取物 0.7%
蜂蜜 50%
乙醇 3%
尼泊金甲酯 0.25%
甲酰胺 4%
纯化水 余量
其制备方法包括以下步骤:
1)用处方量的乙醇,依次加入处方量金银花提取物、黄芩提取物、连翘提取物搅拌溶解。
2)加入处方量尼泊金甲酯,搅拌溶解。
3)加入处方量蜂蜜,搅拌30min。
4)加入处方量甲酰胺,搅拌溶解。
5)加入纯化水搅拌定容。
实施例2
一种防治宠物用双黄连口服液析出及其制备方法,各组分以重量百分比计:
金银花提取物 0.16%
黄芩提取物 0.25%
连翘提取物 0.75%
蜂蜜 55%
乙醇 5%
尼泊金乙酯 0.26%
乙酰胺 6%
纯化水 余量
其制备方法包括以下步骤:
1)用处方量的乙醇,依次加入处方量金银花提取物、黄芩提取物、连翘提取物搅拌溶解。
2)加入处方量尼泊金乙酯,搅拌溶解。
3)加入处方量蜂蜜,搅拌30min。
4)加入处方量乙酰胺,搅拌溶解。
5)加入纯化水搅拌定容。
实施例3
一种防治宠物用双黄连口服液析出及其制备方法,各组分以重量百分比计:
金银花提取物 0.25%
黄芩提取物 0.3%
连翘提取物 0.8%
蜂蜜 58%
乙醇 7%
尼泊金丙酯 0.28%
碳酰胺 8%
纯化水 余量
其制备方法包括以下步骤:
1)用处方量的乙醇,依次加入处方量金银花提取物、黄芩提取物、连翘提取物搅拌溶解。
2)加入处方量尼泊金丙酯,搅拌溶解。
3)加入处方量蜂蜜,搅拌30min。
4)加入处方量碳酰胺,搅拌溶解。
5)加入纯化水搅拌定容。
对比例1-3
在实施例1-3的配方基础上,不添加助溶剂,作为对比例1-3,制备步骤不变。
1.双黄连口服液由金银花、黄芩、连翘3味中药组成,本品应为棕红色的澄清液体,pH值应为5.0-7.0,质量控制分别以黄芩苷、连翘苷、绿原酸为主要检测指标。
1.1取实施例1-3和对比例1-3制备的制剂作为试验药物。
双黄连口服液质量标准判定
1.1.1合格
颜色为棕红色澄清液体
pH值5.0-7.0
黄芩苷不得少于10.0mg
绿原酸不得少于0.60mg
连翘苷不得少于0.30mg
1.1.2不合格
颜色不符合棕红色澄清液体
pH值低于5.0或高于7.0
黄芩苷少于10.0mg
绿原酸少于0.60mg
连翘苷少于0.30mg
2.试验结果与分析
对双黄连口服液的外观性状、pH值及含量试验结果见表1
表1 实施例1-3和对比例1-3组制剂的质量标准
由表一中结果可以看出,实施例1-3和对比例1-3在外观性状上都是棕红色澄清液体,检测最终全部溶解时的pH值也符合5.0-7.0的要求,质量控制的3个检测指标也都符合规定。
表2 实施例1-3和对比例1-3组常温制剂稳定性的考察
由表2结果中可以看出实施例1-3的pH值、析出及含量检测均符合规定,反观对比例1-3的pH值有明显的下降,也有析出的现象及含量检测的3个指标也都有含量降低的表现,实施例1-3和对比例1-3虽然pH值和含量检测均合格,但是析出也导致了pH值和含量的明显降低。
根据上述表1和表3的结果得知,双黄连口服液生产之后立即检测到的pH值和含量指标均符合规定,通过加速试验考察制剂稳定性可以看出,三种助溶剂对黄芩苷、绿原酸、连翘苷的含量没有明显干扰作用,所以pH值和含量都很稳定,也没有出现析出的情况,可以作为双黄连口服液的助溶剂。6个月的加速试验中,对比例1-3的pH值和含量因为析出的原因,都呈明显降低的趋势,而实施例1-3的pH值和含量因为没有出现析出,所以pH值和含量都呈稳定发展。证明了添加助溶剂能够增加难溶性药物的溶解度有利于制剂的制备,也能在不影响主药的效果下增加制剂的稳定性。
Claims (6)
1.一种宠物用双黄连口服液,其特征是,由以下重量份的原辅料药组成:金银花提取物0.1-0.3%、黄芩提取物0.2-0.4%、连翘提取物0.6-1.0%、蜂蜜40-60%、助溶剂2-10%、防腐剂0.2-0.3%、乙醇2-10%,余量为纯化水。
2.如权利要求1所述的一种宠物用双黄连口服液,其特征是,由以下重量份的原辅料药组成:金银花提取物0.12-0.25%、黄芩提取物0.2-0.3%、连翘提取物0.7-0.8%、蜂蜜50-58%、4-8%、防腐剂0.25-0.28%、乙醇3-7%,余量为纯化水。
3.权利要求1或2所述的一种宠物用双黄连口服液,其特征是,原料均为提取物。
4.如权利要求3所述的一种宠物用双黄连口服液,其特征是,所述防腐剂为尼泊金甲酯、尼泊金乙酯、尼泊金丙酯的一种或多种。
5.如权利要求4所述的一种宠物用双黄连口服液,其特征是,所述助溶剂为甲酰胺、乙酰胺、碳酰胺的一种或几种。
6.如权利要求5所述的一种宠物用双黄连口服液,其特征是,包括以下步骤:(1)用处方量的乙醇,依次加入处方量金银花提取物、黄芩提取物、连翘提取物搅拌溶解;(2)加入处方量防腐剂,搅拌溶解;(3)加入处方量蜂蜜,搅拌30min;(4)加入处方量助溶剂,搅拌溶解;(5)加入纯化水搅拌溶解并定容。
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