CN1965892A - 治疗过敏性鼻炎用的液体制剂 - Google Patents
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Abstract
一种治疗过敏性鼻炎用的液体制剂，该液体制剂的成分重量百分比为：紫苏子油1.5～6.8％，丙二醇5～2％，吐温80 0.25～2％，CremophorRH40 5～25％，冰片1～2％，月桂醇0.5～3％，焦亚硫酸钠0.1％，尼泊金乙酯0.2％，蒸馏水加至100％。同现有技术比较，本发明的优点是：制剂制备工艺简单、稳定性好、患者依从性高，治疗过敏性鼻炎起效快、且无任何副作用，来源广泛，药食同源，携带方便，对常年或季节性变应性鼻炎疗效优于现有的同类药物，14天治愈率可达91.2％。
Description
技术领域
本发明涉及一种含有来源于植物材料的医用配制品，特别涉及一种治疗过敏性鼻炎用的液体制剂。
背景技术
过敏性鼻炎是由IgE为介导的鼻黏膜组织的慢性炎症性疾病。在病变过程中，多种炎症性细胞参与以及由其释放的各种介质、细胞因子和位于鼻黏膜组织中的一些炎症活性物质，都对炎症的发生、发展以及鼻部症状的出现起重要的作用。目前治疗过敏性鼻炎的常用药物有抗组织胺药，皮质类固醇类药，色酮类药，减充血剂药和抗白三烯药等。其中抗组织胺药起效快，但对鼻充血效果差；皮质类固醇类药可抑制鼻黏膜的炎症反应，但起效慢，且对有些人群不适用；色酮类药只适合于预防性治疗；减充血剂药可缓解鼻塞症状，但对其它症状无效，长期应用易产生药物性鼻炎；抗白三烯药耐受性好，但目前只有口服制剂。临床上仍在寻求一种起效快、疗效好且无副作用的治疗过敏性鼻炎用的药物。
被中国药典所收载的紫苏子，具有抗炎、抗过敏作用，现代药理证明：紫苏子含有两大类抗过敏、抗炎症物质，即脂肪酸类成分和多元酚类成分，它们均属于过敏介质拮抗剂类。紫苏子油是用唇形科植物紫苏(Perillafrutescens[L]Britt)的干燥成熟果实紫苏子压榨而得的脂肪油，紫苏子油含有较高的α-亚麻酸(可高达70％以上)成分，在体内代谢过程中，通过竞争酶系统，能抑制亚油酸向花生四烯酸转化，从而降低体内花生四烯酸水平，减少前列腺素等过敏介质的产生。通过对T-细胞功能的调节，可抑制Th2细胞因子分泌功能，同时它还具有抑制白三烯、血管活化因子和组胺的作用，具有较强的抗过敏作用，临床上尤其对物理性光辐射与温差的变化、化学物的刺激、虾蟹类无脊椎动物蛋白类食物引发的过敏性荨蔴症、变应性鼻炎、咽炎、哮喘性咳嗽均有良效。对鼻炎自觉症状如喷嚏、流涕和鼻塞有很好的改善作用。
现代医学研究已证实，大多数传染性疾病其病原体是通过黏膜表面(如皮肤、呼吸道黏膜、胃肠道黏膜、生殖道黏膜等)侵入机体的，机体约有80％的感染首先发生在黏膜，可见黏膜免疫的重要性，故有学者提出了“黏膜免疫系统”的概念。现阶段，临床上使用的疫苗均以注射为主要途径。由于常规的注射疫苗只能产生全身性的体液免疫应答，而对病原体入侵部位则无法产生相应的局部免疫应答和长久的免疫记忆力。可以通过粘膜产生免疫的给药途径有：口服给药、鼻粘膜给药、肺部给药、直肠给药和阴道给药等，其中，鼻粘膜免疫被证明为最有效和方便的途径。
鼻腔具有约150cm2丰富的黏膜，黏膜上有系列绒毛和上皮细胞，绒毛使鼻黏膜吸收面积增加，黏膜下大量的毛细血管网，使药物可以很快被吸收。鼻腔给药具有药物吸收迅速、给药后起效时间快、无首过效应、无胃肠道反应、生物利用度高等优点，药物可达到高效、速效、安全、方便的治疗效果。紫苏来源广，价廉，有广泛的药食两用的基础。所以对细胞因子拮抗剂-紫苏制剂的开发具有广阔的前景。
发明内容
本发明的目的是提供一种治疗过敏性鼻炎用的液体制剂，其中有效剂量为紫苏子油，紫苏子油日给药剂量为0.015～0.40g；该液体制剂含有精选的免疫佐剂，增溶剂，黏膜吸收促进剂，稳定剂以及防腐剂，用于治疗过敏性鼻炎具有起效快、疗效好且无任何副作用的优点。
本液体制剂中的免疫佐剂选用尿苷酸、异丙肌苷，在活体内具有明显增强或改善主体免疫反应的能力，它们可以通过改变抗原的物理性状，如增加了抗原的表面积，使抗原易于被巨噬细胞吞噬、促进淋巴细胞之间的接触，增强辅助T细胞的作用、刺激致敏淋巴细胞的分裂和浆细胞产生抗体等作用机理，改变机体免疫应答的能力或改变抗体的产生类型，使得抗原性药物发挥更佳的药理疗效。
增溶剂选用丙二醇、吐温、聚氧乙烯氢化蓖麻油Cremophor RH40的混合物；黏膜吸收促进剂选用冰片、月桂醇的混合物；稳定剂选用焦亚硫酸钠，防腐剂选用尼泊金乙酯。药物用法：滴鼻，或者鼻腔喷雾。
一种治疗过敏性鼻炎用的液体制剂，其特征在于该液体制剂的成分重量百分比为：
紫苏子油 1.5～6.8％
丙二醇 5～20％
吐温80 0.25～2％
Cremophor RH40 5～25％
冰片 1～2％
月桂醇 0.5～3％
焦亚硫酸钠 0.1％
尼泊金乙酯 0.2％
蒸馏水 加至100％
一种治疗过敏性鼻炎用的液体制剂，其特征在于该液体制剂的成分重量百分比为：
紫苏子油 2～4％
丙二醇 8～10％
吐温80 1～1.5％
Cremophor RH40 10～15％
冰片 1～2％
月桂醇 1～2％
焦亚硫酸钠 0.1％
尼泊金乙酯 0.2％
蒸馏水 加至100％
其制备方法如下：按成分配比，称取吐温80、CremophorRH40、尼泊金乙酯，及总量60％的水，加热至60℃溶解成水溶液后，自然冷却；按成分配比，称取紫苏子油、冰片、月桂醇溶于丙二醇中，缓慢加入到上述水溶液中，边加边搅拌，成为澄清透明液体，然后加入焦亚硫酸钠，再加水至足量，混匀、分装、灭菌，获得所需的液体制剂。
用法及疗效：每天用药3-4次，滴鼻，每次1-2滴。7天缓解，14天治愈率可达91.2％。
同现有技术比较，本发明的突出优点是：制剂制备工艺简单、稳定性好、患者依从性高，治疗过敏性鼻炎起效快、且无任何副作用，来源广泛，药食同源，携带方便，对常年或季节性变应性鼻炎疗效优于现有的同类药物，14天治愈率可达91.2％。
具体实施方式
实施例1：
一种治疗过敏性鼻炎用的液体制剂，制备该液体制剂100g时：称取吐温80 2g，Cremophor RH40 5g，尼泊金乙酯0.2g，放入60g的蒸馏水中，加热至60℃后自然冷却成水溶液；将紫苏子油1.5g，冰片1g，月桂醇3g，溶于20g的丙二醇后，缓慢加入到上述的水溶液中，边加边搅拌，得到澄清透明液体，加入焦亚硫酸钠0.1g，加蒸馏水至足量，混匀、分装、灭菌，获得治疗过敏性鼻炎用的液体制剂100g。
实施例2：
一种治疗过敏性鼻炎用的液体制剂，制备该液体制剂100g时：称取吐温800.25g，Cremophor RH40 25g，尼泊金乙酯0.2g，放入60g的蒸馏水中，加热至60℃后自然冷却成水溶液；将紫苏子油6.8g，冰片2g，月桂醇0.5g，溶于5g的丙二醇后，缓慢加入到上述的水溶液中，边加边搅拌，得到澄清透明液体，加入焦亚硫酸钠0.1g，加蒸馏水至足量，混匀、分装、灭菌，获得治疗过敏性鼻炎用的液体制剂100g。
实施例3：
一种治疗过敏性鼻炎用的液体制剂，制备该液体制剂100g时：称取吐温80 1g，Cremophor RH40 15g，尼泊金乙酯0.2g，放入60g的蒸馏水中，
加热至60℃后自然冷却成水溶液；将紫苏子油4g，冰片1.5g，月桂醇1.5g，溶于12.5g的丙二醇后，缓慢加入到上述的水溶液中，边加边搅拌，得到澄清透明液体，加入焦亚硫酸钠0.1g，加蒸馏水至足量，混匀、分装、灭菌，获得治疗过敏性鼻炎用的液体制剂100g。
Claims (2)
1.一种治疗过敏性鼻炎用的液体制剂，其特征在于该液体制剂的成分重量百分比为：
紫苏子油 1.5～6.8％
丙二醇 5～2％
吐温80 0.25～2％
Cremophor RH40 5～25％
冰片 1～2％
月桂醇 0.5～3％
焦亚硫酸钠 0.1％
尼泊金乙酯 0.2％
蒸馏水 加至100％
2.根据权利要求1所述的液体制剂，其特征在于该液体制剂的成分重量百分比为：
紫苏子油 2～4％
丙二醇 8～10％
吐温80 1～1.5％
Cremophor RH40 10～15％
冰片 1～2％
月桂醇 1～2％
焦亚硫酸钠 0.1％
尼泊金乙酯 0.2％
蒸馏水 加至100％
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN108743523A (zh) * | 2018-06-11 | 2018-11-06 | 滕川 | 一种黄芪多糖制剂及其制备方法和应用 |
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