CN105998406A - 一种治疗脂溢性皮炎复方中药膏剂及其制备方法 - Google Patents
一种治疗脂溢性皮炎复方中药膏剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗脂溢性皮炎复方中药膏剂及其制备方法,包括以下药物原料:生地黄、地肤子、白藓皮、紫草、川黄连、苦参、茯苓、蛇床子、侧柏叶、透骨草、荆芥、蒲公英和地丁以及辅料聚山梨酯‑80、大豆磷脂/单硬脂酸甘油酯混合物。本发明的制备方法中包括将中药混合物用乙醇溶液提取、水蒸气蒸馏、溶解和高压均质等步骤,最后制得中药浓缩膏剂;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
技术领域
本发明涉及一种治疗脂溢性皮炎复方中药膏剂的制备方法,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
本发明提供了一种治疗脂溢性皮炎复方中药膏剂的制备方法,复方中药膏剂由以下成分;生地黄、地肤子、白藓皮、紫草、川黄连、苦参、茯苓、蛇床子、侧柏叶、透骨草、荆芥、蒲公英、地丁和他克莫司组成,制备方法是:
1、提取液液的制备
1)称取生地黄40~50g、地肤子30~50g、白藓皮30~50g、紫草40~60g、川黄连50~60g、苦参40~60g、茯苓30~50g、蛇床子60~70g、侧柏叶50~70g、透骨草60~80g、蒲公英30~50g、地丁30~50g,混匀粉碎后,加入成分重量5~10倍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%的浓缩液。
2)称取荆芥40~60g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。
2、复方中药浓缩膏剂的制备:
1)取浓缩液,以200~1000ml纯化水及10~50ml聚山梨酯-80溶解,超声分散30分钟,加热至65~75℃保温备用,制得水相。
2)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,以200~500ml比例为4:1(体积比)的乙醇/二氯甲烷混合物为溶剂溶解,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。
3)将油相注入正在搅拌且水浴保温的水相中,搅拌速度1500~2000rpm,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5%~10%的浓缩膏剂。
3、复方中药膏剂的制备
将上述浓缩膏剂与硫磺(或凡士林)软膏基质以质量比为1:0.5~1:1的比例调和均匀,制成治疗脂溢性皮炎复方中药膏剂。
本发明的药物具有清热解毒、消疹止痒、祛风除湿之功效,涂覆治疗脂溢性皮炎。具有疗效好、见效快、治愈后不易复发、成本低等优点。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。
具体实施方式
实施例1
1)称取生地黄40g、地肤子30g、白藓皮30g、紫草40g、川黄连50g、苦参40g、茯苓30g、蛇床子60g、侧柏叶50g、透骨草60g、蒲公英30g、地丁30g,混匀粉碎后,加入成分重量6倍50%乙醇溶媒在常温浸泡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,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600ml纯化水及10ml聚山梨酯-80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/二氯甲烷混合物为溶剂溶解,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。继续保温搅拌蒸发有机溶剂后,超声分散30分钟,得均质乳匀含水量为5%的浓缩膏剂。
6)复方中药膏剂的制备
将上述浓缩膏剂与硫磺软膏基质以质量比为1:0.5的比例调和均匀,制成治疗脂溢性皮炎复方中药膏剂,
实施例2
1)称取生地黄50g、地肤子50g、白藓皮350g、紫草60g、川黄连60g、苦参60g、茯苓50g、蛇床子70g、侧柏叶70g、透骨草80g、蒲公英50g、地丁50g,混匀粉碎后,加入成分重量8倍70%乙醇溶媒在常温浸泡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,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800ml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/二氯甲烷混合物为溶剂溶解,加入中药荆芥挥发油和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。
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)复方中药膏剂的制备
将上述浓缩膏剂与硫磺(或凡士林)软膏基质以1:1的比例调和均匀,制成治疗脂溢性皮炎复方中药膏剂。
实施例3
1)称取生地黄40g、地肤子40g、白藓皮40g、紫草50g、川黄连50g、苦参50g、茯苓30g、蛇床子60g、侧柏叶60g、透骨草70g、蒲公英40g、地丁40g,混合后进行粉碎,以浓度为60%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,即得中药活性物荆芥挥发油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,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物30g混合后,得到混合物B,用500ml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)中所得的荆芥挥发油Ⅱ和他克莫司原料药1g与所述溶液C三者混合,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,即得脂质纳米粒混悬液粗品F;
6)将所述脂质纳米粒混悬液粗品F注入高压均质机中进行高压均质,设定的压力为2000Bar,浓缩后,得复方中药固体脂质纳米粒G;
7)将步骤6)中所述复方中药固体脂质纳米粒G与硫磺软膏基质以质量比1:1的比例调和均匀,即得治疗脂溢性皮炎复方中药膏剂,然后用铝包装袋进行存储包装。
Claims (5)
1.一种治疗脂溢性皮炎复方中药膏剂的制备方法,其特征在于,包括以下制备步骤:
1)称取生地黄、地肤子、白藓皮、紫草、川黄连、苦参、茯苓、蛇床子、侧柏叶、透骨草、蒲公英和地丁,混合后进行粉碎,以浓度为50~70%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,即得中药活性物荆芥挥发油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,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)中所得的荆芥挥发油Ⅱ与所述溶液C以及他克莫司原料药三者混合,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,即得脂质纳米粒混悬液粗品F;
6)将所述脂质纳米粒混悬液粗品F注入高压均质机中进行高压均质,浓缩后,得复方中药固体脂质纳米粒G;
7)将步骤6)中所述复方中药固体脂质纳米粒G与硫磺软膏基质以1:0.5~1:1的比例调和均匀,即得治疗脂溢性皮炎复方中药膏剂,并进行包装存储。
2.如权利要求1所述的一种治疗脂溢性皮炎复方中药膏剂的制备方法,其特征在于,所述生地黄、地肤子、白藓皮、紫草、川黄连、苦参、茯苓、蛇床子、侧柏叶、透骨草、蒲公英、地丁、聚山梨酯-80、大豆磷脂/单硬脂酸甘油酯混合物、荆芥和他克莫司的组份含量是:
生地黄 40~50g
地肤子 30~50g
白藓皮 30~50g
紫草 40~60g
川黄连 50~60g
苦参 40~60g
茯苓 30~50g
蛇床子 60~70g
侧柏叶 50~70g
透骨草 60~80g
蒲公英 30~50g
地丁 30~50g
聚山梨酯-80 10~50ml
大豆磷脂/单硬脂酸甘油酯混合物 10~30g
荆芥 40~60g
他克莫司 0.5~1g。
3.如权利要求1所述的一种治疗脂溢性皮炎复方中药膏剂的制备方法,其特征在于,所述生地黄、地肤子、白藓皮、紫草、川黄连、苦参、茯苓、蛇床子、侧柏叶、透骨草、蒲公英、地丁、聚山梨酯-80、大豆磷脂/单硬脂酸甘油酯混合物、荆芥和他克莫司的组份含量是:
生地黄 40g
地肤子 30g
白藓皮 30g
紫草 40g
川黄连 50g
苦参 40g
茯苓 30g
蛇床子 60g
侧柏叶 50g
透骨草 60g
蒲公英 30g
地丁 30g
聚山梨酯-80 10ml
大豆磷脂/单硬脂酸甘油酯混合物 10g
荆芥 40g
他克莫司 0.5g。
4.如权利要求2所述的一种治疗脂溢性皮炎复方中药膏剂的制备方法,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4)中所述乙醇/二氯甲烷混合液的体积为200~500ml。
5.一种治疗脂溢性皮炎复方中药膏剂,其特征在于,所述治疗脂溢性皮炎复方中药膏剂是通过权利要求1~4所述的一种治疗脂溢性皮炎复方中药膏剂的制备方法中任一方法制备的。
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