CN105362298B - 一种木醋巴布剂及其制备方法 - Google Patents
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Abstract
本发明公开一种木醋巴布剂及其制备方法。本发明巴布剂配方为:高岭土15重量份,水50重量份,聚丙烯酸钠1.5~4重量份,明胶7~8重量份,羧甲基纤维素钠1.5~2.5重量份,柠檬酸0.03~0.09重量份,无水氯化铝0.01~0.07重量份,丙三醇23~48重量份,精制木醋液3~7重量份。本发明所述木醋巴布剂黏性适宜,外观平整有光泽,皮肤追随性好且无残留亦无刺激性,可反复贴用,特别适用于顽固性皮肤病的治疗,且该制备工艺简单、稳定、可行。
Description
技术领域
本发明涉及医药技术领域,更具体的说,是涉及一种木醋巴布剂及其制备方法。
背景技术
皮肤病是严重影响人民健康的常见病、多发病之一,如麻风、疥疮、真菌病、皮肤细菌感染等。皮肤病是皮肤受到内外因素的影响后,其形态、结构和功能均发生变化,产生病理过程,并相应地产生各种临床表现。皮肤病的发病率很高,多比较轻,常不影响健康,但少数较重甚至可以危及生命。
目前市场上应用最广泛的皮肤病外用膏剂主要是皮质激素类软膏,其治疗效果较好,是治疗皮肤病的主流药物,但长期使用皮质激素类药物容易对人体产生副作用,如:加重感染以及水盐代谢紊乱。副作用轻者会给皮肤带来一系列的变化,如使表皮组织变薄、皮肤的弹性减弱、皮纹消失以及皮肤的色素发生异常,还可表现为皮肤局部的多毛、干燥或鱼鳞病样变化,这一系列的变化尤以面部用药者表现较为明显,尤其是女性,因女性面部皮肤较薄,容易发生不良反应;副作用重者可导致皮肤表面菌群失调、病情加重及扩散等。上述不良反应一旦发生,就很难在短期内得到改变,有些反应甚至是不可逆的。
木醋液俗名又叫植物酸,是木材、木屑、秸秆等物质在干馏热解过程中产生的气体产物经冷凝而得到的一种黑褐色液体。木醋液中含醋酸、酚系化合物及醇等成分。这些成分具有清洁皮肤、软化角质、杀菌和消毒作用,可用于皮肤病的治疗,对脚臭、体臭的治疗也有一定的功效,此外它还具有活化皮肤细胞的功能。但目前市面上关于木醋液人体药用保健相关产品还更多的只是停留在直接使用木醋原液自行调配层面,这样会造成使用者无法安全、方便、舒适地使用。
巴布剂是一种外用贴膏剂,它源于日本民间惯用的泥罨剂,迄今已有1000多年的历史。至70年代初,巴布剂在日本制药业开始引起了广泛关注。我国在上世纪八十年代初,由原上海中药三厂将巴布剂引入中药,制成关节镇痛膏巴布剂,是国内最早的中药巴布剂品种。巴布剂普遍受到关注是在上世纪九十年代中期,由于橡皮膏、黑膏药等传统膏药的缺点日益突出,使得巴布剂的整体优越性突显。巴布剂由于具有载药量大、生物利用度高、起效快以及使用简便等优势,将在很多方面展现良好开发价值和市场应用前景。若将木醋液开发应用于木醋巴布剂,在保持木醋液原有功效的同时还能提高产品的使用价值和性能,让患者能舒适、安全、有效、方便地使用该产品。
经实验验证得知:木醋液对细菌(包括金黄色葡萄球菌、枯草芽孢杆菌、溶壁微球菌和变形链球菌等)和真菌(包括黑根霉、黑曲霉和酵母菌等)均有明显的抑菌效果。以精制木醋液为主要药效成分而制备木醋巴布剂未见文献报道。
发明内容
本发明的目的在于提供一种木醋巴布剂,该木醋巴布剂配方为:高岭土15重量份,水50重量份,聚丙烯酸钠1.5~4重量份,明胶7~8重量份,羧甲基纤维素钠1.5~2.5重量份,柠檬酸0.03~0.09重量份,无水氯化铝0.01~0.07重量份,丙三醇23~48重量份,精制木醋液含量3~7重量份。
本发明的另一目的是提供上述木醋巴布剂的制备方法,按照下述步骤进行:
(1)将7~8重量份的明胶用适量的水在52~56℃水浴锅中加热搅拌至充分溶胀,加入1.5~2.5重量份的羧甲基纤维素钠并搅拌至溶胀,并添加少量水,得溶液(A);
(2)将0.01~0.07重量份的无水氯化铝和0.03~0.09重量份的柠檬酸溶在一定量水中,得到溶液(B);
(3)23~48重量份的丙三醇置于烧杯中在52~56℃水浴条件下加热,将1.5~4重量份的聚丙烯酸钠加入丙三醇中搅拌至分散均匀,添加15重量份的高岭土搅拌至分散均匀后加入适量水,搅拌至充分溶胀,得溶液(C);
(4)将溶液(A)加入溶液(C)中,搅拌均匀后,加入溶液(B),52~56℃水浴条件下继续加热搅拌至均匀,得到溶液(D);
(5)向溶液(D)中加入3~7重量份的精制木醋液,52~56℃水浴条件下继续加热搅拌至均匀;成型后涂布,涂布操作时要用玻璃棒趁热均匀涂布在无纺布(7×10cm自制)上,厚度为0.5mm,涂布完毕后,室温放置24小时后盖上聚乙烯保护膜;
上述各步骤添加水的总量为50重量份。
所述精制木醋液的制备方法为:第一步:酶解,取木醋液原液,加入木瓜蛋白酶,进行酶解反应,反应温度54~62℃,反应时间15~45min,pH值6.4~7.2,酶的添加量400~600U/mL;
第二步:蒸馏,将酶解完的木醋液进行蒸馏,先在70±2℃、0.01±0.005MPa条件下进行一次蒸馏,收集90%馏分;将馏分进行二次蒸馏,温度为50±2 ℃,压强为0.01±0.005MPa,收集50%馏分,得到无色木醋液;
第三步:吸附,将二次蒸馏的馏分使用粉末活性炭进行吸附,粉末活性炭的加入量为其体积的5%,室温下吸附1小时。
所述无纺布的尺寸为7×10cm。
本发明的有益效果为:
(1)本发明能针对性治疗皮肤病变伴有的红、肿、热、痛症状,从根本上治疗皮肤病;
(2)本发明采用聚丙烯酸钠作为基质的凝胶骨架剂,自主解决了聚丙烯酸钠的充分溶胀问题,改善和提高木醋巴布剂的质量。
(3)本发明木醋巴布剂对皮肤渗透性好、透气佳、黏性适宜、外观平整有光泽、无残留、无刺激过敏性、皮肤追随性好,可反复贴用,用3天以上对皮肤无刺激,特别适用于顽固性皮肤病的治疗;
(4)本发明的主要有效成分为精制木醋液,对人体基本无副作用、药味小,精制木醋液的工艺相对简单、稳定、可行,适合于工业化大生产。
具体实施方式
下面结合具体实施例对本发明做进一步说明。
实施例1:
本实施例木醋巴布剂由以下原料制得:高岭土15g,水50g,聚丙烯酸钠2.0g,明胶7.0g,羧甲基纤维素钠1.5g,柠檬酸0.09g,无水氯化铝0.07g,丙三醇38g,精制木醋液4g。
制备方法按照如下步骤进行:
(1)7.0g 明胶用15g水在54℃水浴锅中加热搅拌至充分溶胀,加入1.5g 羧甲基纤维素钠并搅拌至溶胀,并添加2g水,得溶液(A);
(2)将0.07g 无水氯化铝和0.09g 柠檬酸溶于3g水中,得到溶液(B);
(3)38g丙三醇置于烧杯中在54℃水浴条件下加热,将2.0g聚丙烯酸钠加入丙三醇中搅拌至分散均匀,添加15g高岭土搅拌至分散均匀后加入30g水,搅拌至充分溶胀,得溶液(C);
(4)将溶液(A)加入溶液(C)中,搅拌均匀后,加入溶液(B),54℃水浴条件下继续加热搅拌至均匀,得到溶液(D);
(5)向溶液(D)中加入4g精制木醋液,54℃水浴条件下继续加热搅拌至均匀;成型后涂布,涂布操作时要用玻璃棒趁热均匀涂布在无纺布(7×10 cm自制)上,厚度约为0.5mm,涂布完毕后,室温放置24小时后盖上聚乙烯保护膜。
实施例2:
本实施例木醋巴布剂由以下原料制得:高岭土15g,水50g,聚丙烯酸钠2.5g,明胶7.0g,羧甲基纤维素钠1.5g,柠檬酸0.06g,无水氯化铝0.05g,丙三醇33g,精制木醋液6g。
制备方法按照如下步骤进行:
(1)7.0g 明胶用15g水在56℃水浴锅中加热搅拌至充分溶胀,加入1.5g 羧甲基纤维素钠并搅拌至溶胀,并添加2g水,得溶液(A);
(2)将0.05g 无水氯化铝和0.06g 柠檬酸溶于3g水中,得到溶液(B);
(3)33g 丙三醇置于烧杯中在56℃水浴条件下加热,将2.5g聚丙烯酸钠加入丙三醇中搅拌至分散均匀,添加15g高岭土搅拌至分散均匀后加入30g水,搅拌至充分溶胀,得溶液(C);
(4)将溶液(A)加入溶液(C)中,搅拌均匀后,加入溶液(B),56℃水浴条件下继续加热搅拌至均匀,得到溶液(D);
(5)向溶液(D)中加入6g精制木醋液,56℃水浴条件下继续加热搅拌至均匀;成型后涂布,涂布操作时要用玻璃棒趁热均匀涂布在无纺布(7×10 cm自制)上,厚度约为0.5mm,涂布完毕后,室温放置24小时后盖上聚乙烯保护膜。
实施例3:
本实施例木醋巴布剂由以下原料制得:高岭土15g,水50g,聚丙烯酸钠3.0g,明胶7.0g,羧甲基纤维素钠1.5g,柠檬酸0.06g,无水氯化铝0.05g,丙三醇35g,精制木醋液5g。
制备方法按照如下步骤进行:
(1)7.0g 明胶用15g水在52℃水浴锅中加热搅拌至充分溶胀,加入1.5g 羧甲基纤维素钠并搅拌至溶胀,并添加2g水,得溶液(A);
(2)将0.05g 无水氯化铝和0.06g 柠檬酸溶于3g水中,得到溶液(B);
(3)35g 丙三醇置于烧杯中在52℃水浴条件下加热,将3.0g聚丙烯酸钠加入丙三醇中搅拌至分散均匀,添加15g高岭土搅拌至分散均匀后加入30g水,搅拌至充分溶胀,得溶液(C);
(4)将溶液(A)加入溶液(C)中,搅拌均匀后,加入溶液(B),52℃水浴条件下继续加热搅拌至均匀,得到溶液(D);
(5)向溶液(D)中加入5g精制木醋液,52℃水浴条件下继续加热搅拌至均匀;成型后涂布,涂布操作时要用玻璃棒趁热均匀涂布在无纺布(7×10 cm自制)上,厚度约为0.5mm,涂布完毕后,室温放置24小时后盖上聚乙烯保护膜。
按中国药典2010年版一部规定,采用斜面滚球测定方法对本实施例制备的木醋巴布剂进行初粘力测定;同时,对巴布剂的外观、皮肤追随性、基质残留和反复揭贴性等进行综合感官评价。所制备的木醋巴布剂黏性适宜,外观平整有光泽,皮肤追随性好且无残留亦无刺激性。且该工艺简单、稳定、可行。
需要注意的是,以上列举的仅是本发明的若干个具体实施例。显然,本发明不限于以上实施例,还可以有许多变形。本领域的普通技术人员能从本发明公开的内容直接导出或联想到的所有变形,均应认为是本发明的保护范围。
Claims (3)
1.一种木醋巴布剂,其特征是,所述木醋巴布剂配方为:高岭土15重量份,水50重量份,聚丙烯酸钠1.5~4重量份,明胶7~8重量份,羧甲基纤维素钠1.5~2.5重量份,柠檬酸0.03~0.09重量份,无水氯化铝0.01~0.07重量份,丙三醇23~48重量份,精制木醋液含量3~7重量份。
2.根据权利要求1所述木醋巴布剂,其特征是,所述精制木醋液的制备方法为:第一步:酶解,取木醋液原液,加入木瓜蛋白酶,进行酶解反应,反应温度54~62℃,反应时间15~45min,pH值6.4~7.2,酶的添加量400~600U/mL;
第二步:蒸馏,将酶解完的木醋液进行蒸馏,先在70±2℃、0.01±0.005MPa条件下进行一次蒸馏,收集90%馏分;将馏分进行二次蒸馏,温度为50±2 ℃,压强为0.01±0.005MPa,收集50%馏分,得到无色木醋液;
第三步:吸附,将二次蒸馏的馏分使用粉末活性炭进行吸附,粉末活性炭的加入量为其体积的5%,室温下吸附1小时。
3.一种如权利要求1所述的木醋巴布剂的制备方法,其特征是,按照下述步骤进行:
将7~8重量份的明胶用适量的水在52~56℃水浴锅中加热搅拌至充分溶胀,加入1.5~2.5重量份的羧甲基纤维素钠并搅拌至溶胀,并添加少量水,得溶液(A);
将0.01~0.07重量份的无水氯化铝和0.03~0.09重量份的柠檬酸溶在一定量水中,得到溶液(B);
23~48重量份的丙三醇置于烧杯中在52~56℃水浴条件下加热,将1.5~4重量份的聚丙烯酸钠加入丙三醇中搅拌至分散均匀,添加15重量份的高岭土搅拌至分散均匀后加入适量水,搅拌至充分溶胀,得溶液(C);
将溶液(A)加入溶液(C)中,搅拌均匀后,加入溶液(B),52~56℃水浴条件下继续加热搅拌至均匀,得到溶液(D);
向溶液(D)中加入3~7重量份的精制木醋液,52~56℃水浴条件下继续加热搅拌至均匀;成型后涂布,涂布操作时要用玻璃棒趁热均匀涂布在自制的7×10cm无纺布上,厚度为0.5mm,涂布完毕后,室温放置24小时后盖上聚乙烯保护膜;
上述各步骤添加水的总量为50重量份。
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