CN114159463A - 一种滋润型碘甘油乳头浸剂及其制备方法 - Google Patents
一种滋润型碘甘油乳头浸剂及其制备方法 Download PDFInfo
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- CN114159463A CN114159463A CN202111430793.7A CN202111430793A CN114159463A CN 114159463 A CN114159463 A CN 114159463A CN 202111430793 A CN202111430793 A CN 202111430793A CN 114159463 A CN114159463 A CN 114159463A
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- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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Abstract
本发明公开了一种滋润型碘甘油乳头浸剂及其制备方法,属于兽药制剂领域。所述的高润肤碘甘油乳头浸剂是由碘、碘化钾、甘油、润肤成分、水溶性植物油、增稠剂等组分制备得到。该制剂中碘含量稳定、具有优良润肤护肤效果、易除去乳头污渍,维护乳头自然屏障的功效。该制剂中所用原料均为食品级和医药级别,工艺制备对设备没有特殊要求,成本低,有利于规模化工业生产。
Description
技术领域
本发明属于兽药制剂领域,尤其涉及一种滋润型碘甘油乳头浸剂及其制备方法。
背景技术
奶牛乳房炎,又称乳腺炎,是一种由病原微生物突破机体的机械屏障和免疫系统导致的疾病,会显著降低奶牛的产奶量和产奶的质量,是造成奶业经济损失的最主要原因。乳房炎发生原因众多,病原体感染和环境等因素都不可忽视。药浴液是指奶牛在挤奶前和挤奶后,使用药浴液对乳头进行清洁、消毒的过程,是用于预防奶牛乳房炎非常有效的手段。
中国专利CN 110711204A公开了一种碘甘油乳头浸剂及其制备方法,通过加入阿拉伯胶溶液和复配成膜剂聚乙烯醇1788的方法加入到体系中,变为有吸附能力的胶体溶液,达到了在用药时保证药液涂布均匀,能够吸附在皮肤的表面形成一层保护膜,起到了很好的杀菌效果。该方法在乳头上形成的附着膜有一定的厚度,不会在乳头闭合的时候自动脱落,会使乳头皮肤不透气,保湿润肤作用效果大打折扣。
中国专利CN 102552317B公开了一种碘甘油乳头浸剂及其制备方法,通过在组方中加入具有防冻效果的乙醇、氯化钠,解决了在寒冷季节奶牛药浴后乳头冻伤的现象;该专利在组方中加入甘油,具有滋润皮肤,防止乳头粗糙和皲裂的作用。同时,该组方可延缓碘的挥发,延长碘对病原微生物的杀灭时间。但是在长时间的使用过程中,该组方中乙醇的加入会刺激乳头的皮肤,可能导致皮肤出现脱脂和干燥现象,从而影响牛奶产量和乳制品的质量。
因此研究出在快速杀菌的前提下,具有高效保护乳头皮肤健康,提高自然防御能力的碘甘油乳头浸剂,是本领域技术人员亟需解决的技术问题。
发明内容
本发明的目的在于提供一种具有优良护肤效果、易除去乳头污渍,维护乳头自然屏障作用碘甘油乳头浸剂。本发明中采用甘油、润肤成分、水溶性植物油复配以增强护肤效果,有利于乳房的高速清洁,提高泌乳能力。且目前未有专利对其进行报道。
本发明所述的高润肤碘甘油乳头浸剂是由下述组分组成:碘、碘化钾、甘油、润肤成分、水溶性植物油、增稠剂、纯化水。
一种高润肤碘甘油乳头浸剂的制备方法,包括如下步骤:
其中,物料组成和配比为:
所述碘甘油乳头浸剂,其制备是通过下述技术路线实现的:
步骤1:按处方量精准称取碘和碘化钾,先将碘化钾溶于少量水中,待其完全溶解后边搅拌边加入碘,待其完全溶解,形成溶液A;
步骤2:取适量纯化水,加入处方量的润肤成分和水溶性植物油搅拌使其完全溶解,形成溶液B;
步骤3:在溶液A中依次加入处方量的甘油和溶液B,边加边搅拌,使其混合均匀,形成溶液C;
步骤4:取适量纯化水,加入处方量的增稠剂,搅拌使其完全溶解,形成溶液D;
步骤5:在搅拌状态下,将溶液D缓慢加入到溶液C,使其混合均匀;
步骤6:上述溶液用纯化水定容至处方量,搅拌均匀,即得。
优选的物料组成和配比为:
优选地,润肤成分包含山梨醇。
进一步优选地,润肤成分中包括山梨醇、氨基酸、乳酸钠、芦荟、透明质酸钠、聚谷氨酸钠、水溶性羊毛脂中的一种或多种。
山梨醇、透明质酸、聚谷氨酸钠、芦荟是常用的保湿剂。氨基酸、乳酸钠、透明质酸钠、水溶性羊毛脂具有保湿滋润作用。
氨基酸,氨基酸能为皮肤提供免疫功能,调节水分、酸碱、平衡油脂,对敏感性皮肤具有增强抵抗力,增强皮肤的抗过敏能力。
乳酸钠易于配伍形成水化膜而防止皮肤水分挥发,使皮肤优质轻松湿润状态,被用作滋润剂。
透明质酸钠,具有保湿性,有助于皮肤的润滑和成膜,并可以对皮肤损伤的修复与预防
所述水溶性植物油为水溶性杏仁油、水溶性椰子油、水溶性巴巴苏油酯、水溶性棉花籽油酯、水溶性霍霍巴油酯、水溶性鳄梨油酯的一种或多种。
所述增稠剂为阿拉伯树胶、黄原胶、海藻酸钠、羧甲基纤维素钠、羟丙甲纤维素、果胶、瓜尔豆胶中的一种或多种。
本发明特点如下:
(1)提供一种制备高护肤碘甘油乳头浸剂的新方法,与常规制备碘甘油乳头浸剂的方法不同。本发明使用高保湿成分作为润肤成分,使用后在乳头形成一层水和因子膜,这层保护面膜对奶牛乳头起着关键的保护,可以防止细菌的侵入,防止乳头皮肤干裂,并长时间维持附着状态,达到杀菌的作用。同时,这层膜具有易擦除、透气性高的特点,不影响奶牛的再次泌乳,保证原奶质量。
(2)本发明制备的高润肤碘甘油乳头浸剂,采用甘油与润肤成分复配,对乳头皮肤双重防护进一步增强润肤效果,能帮助修复破损皮肤,改善乳头皮肤状态,提高自然屏障能力。更加有利于奶牛产生泌乳反射,帮助释放牛乳。药浴液能附在奶牛乳头上,不是因为它有粘度,而是因为药浴液里有很多亲肤成分,本发明中采用多种亲肤成分复配,解决了乳头干裂等问题。
(3)本发明制备的高润肤碘甘油乳头浸剂,使用水溶性植物油可以在挤奶前后使用药浴液对乳头进行清洁时,表面污垢(牛粪、灰尘)更易清除污垢,使乳头更加清洁。同时所使用的水溶性植物油具有经典的营养和调理功能,该性质保证了碘甘油乳头浸剂在具有瞬时杀菌的同时,又对乳头起着高润肤作用。
(4)本发明制备的高稳定性碘甘油乳头浸剂,组方中增稠剂的添加可以提高溶液的粘度,使体系中分子的运动速度降低,减少分子间有效的碰撞,因此降低了碘分解和升华的损失,有效保证了碘甘油乳头浸剂中有效成分的含量。
(5)本发明所述高润肤碘甘油乳头浸剂,杀菌高效光谱、作用持久,提高了药浴液有效成分的含量稳定性,也提高对乳头的保护,增强了乳头的自然保护屏障功能。此外,所用原料均为食品级和医药级别,工艺制备对设备没有特殊要求,成本低,有利于规模化工业生产。
具体实施方案
下面将结合实例对本发明的实施方案进行详细描述,但本发明的实施不限于此。
实施例1
一种高润肤碘甘油乳头浸剂及其制备方法:
制备方法:
步骤1:按处方量精准称取碘和碘化钾,先将碘化钾溶于20g纯化水中,待其完全溶解后边搅拌边加入碘,待其完全溶解,形成溶液A;
步骤2:取200g纯化水,加入处方量的润肤成分山梨醇和透明质酸钠,水溶性椰子油,搅拌使其完全溶解,形成溶液B;
步骤3:在溶液A中依次加入处方量的甘油和溶液B,边加边搅拌,使其混合均匀,形成溶液C;
步骤4:取50g纯化水,加入处方量的海藻酸钠,搅拌使其完全溶解,形成溶液D;
步骤5:在搅拌状态下,将溶液D缓慢加入到溶液C,使其混合均匀;
步骤6:上述溶液用纯化水定容至1000g,搅拌均匀,即得。
实施例2
一种高润肤碘甘油乳头浸剂及其制备方法:
制备方法:
步骤1:按处方量精准称取碘和碘化钾,先将碘化钾溶于40g纯化水中,待其完全溶解后边搅拌边加入碘,待其完全溶解,形成溶液A;
步骤2:取200g纯化水,加入处方量的润肤成分山梨醇、乳酸钠,水溶性巴巴苏油酯,搅拌使其完全溶解,形成溶液B;
步骤3:在溶液A中依次加入处方量的甘油和溶液B,边加边搅拌,使其混合均匀,形成溶液C;
步骤4:取50g纯化水,加入处方量的阿拉伯树胶,搅拌使其完全溶解,形成溶液D;
步骤5:在搅拌状态下,将溶液D缓慢加入到溶液C,使其混合均匀;
步骤6:上述溶液用纯化水定容至1000g,搅拌均匀,即得本发明的碘甘油乳头浸剂。
实施例3
一种高润肤碘甘油乳头浸剂及其制备方法:
制备方法:
步骤1:按处方量精准称取碘和碘化钾,先将碘化钾溶于80g纯化水中,待其完全溶解后边搅拌边加入碘,待其完全溶解,形成溶液A;
步骤2:取200g纯化水,加入处方量的润肤成分山梨醇、水溶性羊毛脂,水溶性霍霍巴油酯,搅拌使其完全溶解,形成溶液B;
步骤3:在溶液A中依次加入处方量的甘油和溶液B,边加边搅拌,使其混合均匀,形成溶液C;
步骤4:取30g纯化水,加入处方量的阿拉伯树胶,搅拌使其完全溶解,形成溶液D;
步骤5:在搅拌状态下,将溶液D缓慢加入到溶液C,使其混合均匀;
步骤6:上述溶液用纯化水定容至1000g,搅拌均匀,即得。
实施例4专利CN 110711204A方法制备乳头浸剂(对比例1)
步骤1:称取碘和碘化钾,先将碘化钾溶于水中,待完全溶解后边搅拌边加入碘,准确称取聚乙烯吡咯烷酮加入到上述溶液中,搅拌至完全溶解,得溶液A;
步骤2:然后准确称取阿拉伯胶、聚乙烯醇1788加入到水中,升温至60℃,搅拌至完全溶解,此为溶液B;
步骤3:搅拌条件下将溶液A和溶液B混合,搅拌至均匀;在上述混合均匀的溶液中,加入处方量的甘油,搅拌至均匀;
步骤4:然后用纯化水定容即得对比例1。
实施例5专利CN 102552317B方法制备乳头浸剂(对比例2)
步骤1:按处方量准确称取碘和碘化钾,先将碘化钾溶于适量水中,待完全溶解后边搅拌边加入碘,使其完全溶解,为溶液A;
步骤2:取少量纯化水,加入处方量的氯化钠,搅拌使溶解,为溶液B;
步骤3:搅拌状态下,将溶液A、溶液B混合,搅拌均匀;
步骤4:向混合溶液中加入处方量的乙醇,搅拌使混合均匀后,加入处方量的甘油,搅拌使混合均匀;
步骤5:上述溶液用纯化水定容至处方量,搅拌均匀,即得对比例2。
实施例6碘甘油乳头浸剂中碘含量的检测试验
对本发明实施例1-3与对比例1(专利CN 110711204A)、对比例2(专利CN102552317B) 所制的碘甘油乳头浸剂进行碘含量测定:
碘精密量取本品20ml,置具塞锥形瓶中,加水100ml与醋酸1滴,用硫代硫酸钠滴定液(0.1mol/L)滴定至溶液无色。每1ml硫代硫酸钠滴定液(0.1mol/L)相当于12.69mg的I(碘)。
对上述实施例产品进行室温-10d;50℃-10d;60℃-10d和室温-30d存放后有效碘含量检测结果如表。
放置条件 | 0时 | 50℃-10d | 60℃-10d | 室温-10d | 室温-15d | 室温-30d |
实施例1 | 1.02% | 0.96% | 0.93% | 1.02% | 1.02% | 1.01% |
实施例2 | 1.51% | 1.42% | 1.38% | 1.51% | 1.50% | 1.49% |
实施例3 | 2.03% | 1.91% | 1.88% | 2.03% | 2.03% | 2.01% |
对比例1 | 2.01% | 1.41% | 1.21% | 1.92% | 1.84% | 1.80% |
对比例2 | 2.11% | 1.38% | 1.24% | 1.96% | 1.85% | 1.73% |
试验结果表明,室温-30d有效碘几乎没有变化,加速试验50℃-10d有效碘下降仅为 5.8-6.0%,60℃-10d有效碘下降仅为7.4-8.8%,且均在含量合格范围内(标示量的90-110%)。而对比例1、对比例2室温30d有效碘下降10%和18.1%,加速试验50℃-10d有效碘下降29.9%和34.6%,60℃-10d有效碘下降39.8%和41.2%。从表中可以看出,本发明与对比例1、对比例2相比,有效碘含量下降量低,含量较稳定。同时本发明实施例产品在上述不同条件下存放均无沉淀、无分层现象。可见本发明具较好的稳定性。
实施例7碘甘油乳头浸剂的杀菌效果试验
以金黄色葡萄球菌、大肠杆菌和无乳链球菌作为目标菌株,对本发明实施例1-3进行不同稀释倍数下的杀菌实验(杀菌时间均为30s),结果如下表:
结果表明,对于金黄色葡萄球菌、大肠杆菌和无乳链球菌三种菌株,本发明技术方案在1:1、1:2、1:3和1:4稀释倍数下,均可达到快速杀菌的效果,用于奶牛乳头消毒,更易达到有效杀菌的目的。
实施例8碘甘油乳头浸剂的保湿性能测试实验
对本发明实施例1-3、对比例1(专利CN 110711204A)、对比例2(专利CN102552317B) 进行皮肤水分含量测试,以手背部划分为大小相同的3块区域,清洗干净,将样品均匀涂抹在此区域上,于不同时间段读出皮肤的水分值。记录结果如下表:
注:表中0为涂抹前的皮肤水分含量值。
从上述表中可以看,在使用本发明药浴液3.5-4h后皮肤水分有一定程度的提升,涂抹 300min(5h)湿度值未有明显降低现象;使用对比例1和对比例2产品涂抹药浴液后,皮肤水分未有提升现象,且在涂抹5h中湿度值较本发明值偏低,具有明显降低趋势,因此说明本发明所述技术方案制备的碘甘油乳头浸剂拥有良好的润肤作用,且可以长时间维持保湿状态。
实施例9碘甘油乳头浸剂的临床效果试验
本试验选择本市北辰区某牛场随机选取120头分娩45天内、体型无显著差异的健康奶牛。试验选用恒常放置6个月的样品“实施例1-3、对比例1(专利CN 110711204A)、对比例2 (专利CN 102552317B)”,分别在挤奶前和挤奶后使用药浴液进行杀菌,试验期间记录奶牛乳头情况,结果如下表:
试验表明,本发明实施例1牛奶中体细胞数由45万个/ml下降至16万/ml,实施例2牛奶中体细胞数由48万个/ml下降至18万个,实施例3牛奶中体细胞数由50万个/ml下降至20万个,下降60-64%左右。而对比例1与对比例2使用恒常6个月样品,在连续使用60天后,体细胞数下降19.6%和11.5%,下降量相较本发明程度较低。说明本发明在长期放置过程中仍具有良好的杀菌和助修复功能。此外,实验结束后使用本发明的碘甘油乳头浸剂隐形乳房炎发病率显著降低约3个百分点,在实验过程中乳头皮肤无肿胀、发红现象,未见明显异常。而对比例1与对比例2的隐形乳房炎发病率降低不到1%,乳头皮肤有不同程度的肿胀与发红现象。以上结果进一步表明本发明在良好稳定性前提下,对提高奶牛乳头自然屏障功能具有良好效果。
本发明未尽事宜为公知技术。
Claims (7)
3.根据权利要求1所述的一种滋润型碘甘油乳头浸剂,其特征在于,所述的润肤成分包含山梨醇。
4.根据权利要求1所述的一种滋润型碘甘油乳头浸剂,其特征在于,所述的润肤成分包括山梨醇、氨基酸、乳酸钠、芦荟、透明质酸钠、聚谷氨酸钠、水溶性羊毛脂中的一种或多种。
5.根据权利要求1所述的一种滋润型碘甘油乳头浸剂,其特征在于,所述水溶性植物油为水溶性杏仁油、水溶性椰子油、水溶性巴巴苏油酯、水溶性棉花籽油酯、水溶性霍霍巴油酯、水溶性鳄梨油酯的一种或多种。
6.根据权利要求1所述的一种滋润型碘甘油乳头浸剂,其特征在于,所述增稠剂为阿拉伯树胶、黄原胶、海藻酸钠、羧甲基纤维素钠、羟丙甲纤维素、果胶、瓜尔豆胶中的一种或多种。
7.根据权利要求1至6中任一项所述的一种滋润型碘甘油乳头浸剂的制备方法,其特征在于,包括以下步骤:
步骤1:按处方量精准称取碘和碘化钾,先将碘化钾溶于少量水中,待其完全溶解后边搅拌边加入碘,待其完全溶解,形成溶液A;
步骤2:取适量纯化水,加入处方量的润肤成分和水溶性植物油搅拌使其完全溶解,形成溶液B;
步骤3:在溶液A中依次加入处方量的甘油和溶液B,边加边搅拌,使其混合均匀,形成溶液C;
步骤4:取适量纯化水,加入处方量的增稠剂,搅拌使其完全溶解,形成溶液D;
步骤5:在搅拌状态下,将溶液D缓慢加入到溶液C,使其混合均匀,得混合溶液;
步骤6:上述溶液按处方量补足纯化水,搅拌均匀,即得。
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