CN105998405A - 一种用于治疗脂溢性皮炎的松针复方膏剂及制备方法 - Google Patents

一种用于治疗脂溢性皮炎的松针复方膏剂及制备方法 Download PDF

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CN105998405A
CN105998405A CN201610476672.9A CN201610476672A CN105998405A CN 105998405 A CN105998405 A CN 105998405A CN 201610476672 A CN201610476672 A CN 201610476672A CN 105998405 A CN105998405 A CN 105998405A
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folium pini
seborrheic dermatitis
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周俊华
滕红
胡景初
汪柳英
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ANHUI GAOSHAN PHARMACEUTICAL Co Ltd
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Abstract

本发明公开了一种用于治疗脂溢性皮炎的松针复方膏剂及制备方法，包括以下药物原料：松针、生地黄、地肤子、白藓皮、侧柏叶、苦参、蛇床子、透骨草、地丁、荆芥和辅料聚山梨酯‑80、大豆磷脂、单硬脂酸甘油酯、他克莫司组成。制备方法是：先将中药用乙醇浸泡提取，然后再用水蒸气蒸馏制得中药活性挥发油；将中药醇提物和活性挥发油和辅料加入有机溶剂中混合；经乳化分散‑冷却均质浓缩，制得中药浓缩膏剂；本发明以中药为基本原料，应用现代技术开发出新一代外用中药膏剂，是中医药发展的方向。

Description

一种用于治疗脂溢性皮炎的松针复方膏剂及制备方法
技术领域
本发明涉及一种药物及制备方法，尤其涉及一种用于治疗脂溢性皮炎的松针复方膏剂及制备方法，属复方中药膏剂的制备技术领域。
背景技术
脂溢性皮炎是一种常见皮肤病，是由于皮脂腺分泌功能亢进所引起的，在皮脂发达部位较易发生，一种慢性炎症，损害为鲜红或黄红色斑片，表面附有油腻性鳞屑或痂皮，常伴有不同程度瘙痒。脂溢性皮炎的病因复杂，多数是由于饮食太过肥甘油腻，食糖、脂肪过多、饮酒、过食辛辣油腻的食物，内分泌功能失调、消化功能失常会造成脂溢性皮炎，皮炎的初发症状是以毛囊口为中心的皮肤炎症，表现为小丘疹，并逐渐扩大，形成边界清楚的潮湿的油脂性鳞屑斑块。西药内服药物治疗脂溢性皮炎一般以抗组胺药物为主，药物可以有效止痒，但药性稳定性不好；西药外用药物一般采用皮质激素类药物，有比较大的副作用。中药治疗脂溢性皮炎和湿疹应该是比较好的方法，因为中药制剂的治疗一般副作用比较小，药性稳定、见效比较快。中医一般以清热解毒，燥湿收敛，祛风止痒，消肿散结的药物综合治疗。
发明内容
本发明的目的在于克服现有技术的不足，提供一种用于治疗脂溢性皮炎的松针复方膏剂及制备方法，以解决现有技术领域中药物副作用大、药效不稳、见效慢等技术问题而提出的。
本发明提供了一种用于治疗脂溢性皮炎的松针复方膏剂及制备方法，包括以下制备步骤：
1)称取松针60-80g、生地黄50-70g、地肤子40-60g、白藓皮40-60g、侧柏叶50-70g、苦参40-60g、蛇床子60-70g、透骨草60-80g和地丁50-70g，混匀粉碎后，加入质量为成分重量5-10倍、浓度为50-70％乙醇溶液在常温下浸泡5-8天，过滤取液，再将提取液旋转蒸发浓缩至含水量为10％-15％，即得复方中药提取物。
2)称取荆芥40-60g，以水蒸气蒸馏法提取1h，对馏出液离心，离心静置后，取上层油液得荆芥挥发油。
3)将复方中药提取物用200-1000ml纯化水和10-50ml聚山梨酯-80的混合液进行溶解，超声分散30分钟，加热至65-75℃保温备用，制得水相A；
4)按质量比为1:1-3:1的比例称取大豆磷脂和单硬脂酸甘油酯混合物10-30克，用200-500ml体积比为4:1的乙醇/二氯甲烷混合液为溶剂对混合物进行溶解，加入中药荆芥挥发油和0.5-1克他克莫司原料药继续搅拌，超声溶解分散15分钟，制得油相B。
5)将油相B注入正在搅拌且水浴保温的水相A中，搅拌速度1500-2000rpm，形成乳白色混悬液E。继续保温搅拌蒸发溶剂后，超声分散30分钟，得含水量为5-10％的浓缩膏剂F。
6)将上述浓缩膏剂F与硫磺或凡士林软膏基质以1:0.5-1：1的比例调和均匀，制成用于治疗脂溢性皮炎松针复方膏剂。
本发明的药物具有清热解毒、消疹止痒、祛风除湿之功效，使用时涂覆治疗脂溢性皮炎，一日两次或三次，并轻柔片刻。七日一疗程，瘙痒基本消失，两个疗程皮肤开始恢复正常，肿胀处消退，皮肤抓破处结痂脱落，三个疗程皮肤肤色转为正常。统计患者35例，有效率达92.8％。本发明以中药为基本原料，应用现代技术开发出新一代外用中药膏剂，具有疗效好、见效快、治愈后不易复发、成本低等优点，是中医药发展的方向。
具体实施方式
实施例1
1)称取松针60g、生地黄50g、地肤子40g、白藓皮40g、侧柏叶50g、苦参40g、蛇床子60g、透骨草60g和地丁50g，混匀粉碎后，加入2000g浓度为50％的乙醇溶液在常温下浸泡8天，过滤取液，再将提取液旋转蒸发浓缩至含水量为10％的浓缩液。
2)称取荆芥40g放入三口烧瓶中，以水蒸气蒸馏法提取1h，对馏出液离心，取上层油液得荆芥挥发油。
3)称取浓缩液后，用200ml纯化水及10ml聚山梨酯-80对浓缩物进行溶解，超声分散30分钟，加热至65℃保温备用，制得水相。
4)按1:1的比例称取大豆磷脂和单硬脂酸甘油酯混合物10克，以200ml比例为4:1(体积比)的乙醇/二氯甲烷混合液为溶剂对混合物进行溶解，加入中药荆芥挥发油和0.5克他克莫司原料药继续搅拌，超声溶解分散15分钟，制得油相。
5)将油相注入正在搅拌且水浴保温的水相中，搅拌速度1500rpm，形成乳白色混悬液。继续保温搅拌蒸发溶剂后，超声分散30分钟，得均质乳匀含水量为5％的浓缩膏剂。
6)松针复方膏剂制备：
将上述浓缩膏剂与硫磺软膏基质以1:0.5的比例调和均匀，制成治疗脂溢性皮炎的松针复方膏剂。
实施例2
1)称取松针80g、生地黄70g、地肤子60g、白藓皮60g、侧柏叶70g、苦参60g、蛇床子70g、透骨草80g、地丁70g，混匀粉碎后，加入5千克浓度为70％的乙醇溶液在常温下浸泡5天，过滤取液，再将提取液旋转蒸发浓缩至含水量为15％的浓缩液。
2)称取荆芥60g放入三口烧瓶中，以水蒸气蒸馏法提取1h，对馏出液离心，取上层油液得荆芥挥发油。
3)取浓缩液，以1000ml纯化水及50ml聚山梨酯-80溶解，超声分散30分钟，加热至75℃保温备用，制得水相。
4)按3:1的比例称取大豆磷脂和单硬脂酸甘油酯混合物30克，以500ml比例为4:1(体积比)的乙醇/二氯甲烷混合液为溶剂对混合物进行溶解，加入中药荆芥挥发油和1g他克莫司原料药继续搅拌，超声溶解分散15分钟，制得油相。
5)将油相注入正在搅拌且水浴保温的水相中，搅拌速度2000rpm，形成乳白色混悬液。继续保温搅拌蒸发有机溶剂后，超声分散30分钟，得均质乳匀含水量为10％的浓缩膏剂。
6)松针复方膏剂制备
将上述浓缩膏剂与凡士林软膏基质以1:1的比例调和均匀，制成治疗脂溢性皮炎的松针复方膏剂。
实施例3
1)称取松针70g、生地黄70g、地肤子60g、白藓皮50g、侧柏叶60g、苦参60g、蛇床子70g、透骨草80g和地丁60g，混合后进行粉碎，以浓度为60％的乙醇溶液对混合物浸泡7天，过滤，收集滤液并对所述滤液蒸发溶剂后，得到复方中药提取物Ⅰ；
2)称取荆芥50g，放入三口烧瓶中，蒸馏，对馏出液离心处理，离心后静置，取上层油液，即得荆芥挥发油Ⅱ；
3)将复方中药提取物Ⅰ用800ml纯化水和40ml聚山梨酯-80的混合液进行溶解，超声分散30分钟，加热至65-75℃保温备用，制得水相A；
4)将质量比为2:1的大豆磷脂和单硬脂酸甘油酯混合后，得到30g的混合物B，用500ml体积比为4:1的乙醇/二氯甲烷混合液对30g混合物B进行溶解，得到溶液C，将步骤2)中所得的薄荷挥发油Ⅱ与所述溶液C以及0.7g他克莫司原料药三者混合搅拌，超声分散后，制得油相D；
5)将油相D注入正在搅拌且水浴保温的所述水相A中，搅拌，形成乳白色混悬液E，保温搅拌蒸发溶剂后，超声分散，得浓缩膏剂F；
6)将所得的浓缩膏剂F与硫磺软膏基质以质量比为1:1的比例调和均匀，即得用于治疗脂溢性皮炎的松针复方膏剂。

Claims (5)

1.一种用于治疗脂溢性皮炎的松针复方膏剂的制备方法，其特征在于，包括以下制备步骤：
1)称取松针、生地黄、地肤子、白藓皮、侧柏叶、苦参、蛇床子、透骨草和地丁，混合后进行粉碎，以浓度为50-70％的乙醇溶液对混合物浸泡5-8天，过滤，收集滤液并对所述滤液蒸发溶剂后，得到复方中药提取物Ⅰ；
2)称取荆芥放入三口烧瓶中，蒸馏，对馏出液离心处理，离心后静置，取上层油液，即得荆芥挥发油Ⅱ；
3)将复方中药提取物Ⅰ用纯化水和聚山梨酯-80的混合液进行溶解，超声分散30分钟，加热至65-75℃保温备用，制得水相A；
4)将质量比为1:1-3:1的大豆磷脂和单硬脂酸甘油酯混合后，得到混合物B，用体积比为4:1的乙醇/二氯甲烷混合液对所述混合物B进行溶解，得到溶液C，将步骤2)中所得的薄荷挥发油Ⅱ与所述溶液C以及他克莫司原料药三者混合搅拌，超声分散后，制得油相D；
5)将油相D注入正在搅拌且水浴保温的所述水相A中，搅拌，形成乳白色混悬液E，保温搅拌蒸发有机溶剂后，超声分散，得浓缩膏剂F；
6)将所得的浓缩膏剂F与硫磺软膏基质以质量比为1:0.5-1:1的比例调和均匀，即得用于治疗脂溢性皮炎的松针复方膏剂。
2.如权利要求1所述的一种用于治疗脂溢性皮炎的松针复方膏剂的制备方法，其特征在于，所述松针、生地黄、地肤子、白藓皮、侧柏叶、苦参、蛇床子、透骨草、地丁、荆芥和他克莫司的重量为：
松针60-80g
生地黄50-70g
地肤子40-60g
白藓皮40-60g
侧柏叶50-70g
苦参40-60g
蛇床子60-70g
透骨草60-80g
地丁50-70g
荆芥40-60g
他克莫司0.5-1g。
3.如权利要求1所述的一种用于治疗脂溢性皮炎的松针复方膏剂的制备方法，其特征在于，所述松针、生地黄、地肤子、白藓皮、侧柏叶、苦参、蛇床子、透骨草、地丁、荆芥和他克莫司的重量为：
松针60g
生地黄50g
地肤子40g
白藓皮40g
侧柏叶50g
苦参40g
蛇床子60g
透骨草60g
地丁50g
荆芥40g
他克莫司0.5g。
4.如权利要求2所述的一种用于治疗脂溢性皮炎的松针复方膏剂的制备方法，其特征在于，步骤2)中所述蒸馏用到的方法是水蒸气蒸馏法，步骤3)中所述纯化水的用量200-1000ml，所述聚山梨酯-80的用量为10-50ml，步骤4)中所述混合物B的重量为10-30g。
5.一种用于治疗脂溢性皮炎的松针复方膏剂，其特征在于，所述用于治疗脂溢性皮炎的松针复方膏剂是通过权利要求1-4所述的一种用于治疗脂溢性皮炎的松针复方膏剂的制备方法中任一方法制备的。
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