CN111375030B - 一种治疗皮肤瘙痒的中药凝胶剂 - Google Patents

一种治疗皮肤瘙痒的中药凝胶剂 Download PDF

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CN111375030B
CN111375030B CN202010312029.9A CN202010312029A CN111375030B CN 111375030 B CN111375030 B CN 111375030B CN 202010312029 A CN202010312029 A CN 202010312029A CN 111375030 B CN111375030 B CN 111375030B
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CN111375030A (zh
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陈平
朱学明
刘尉
杨向东
张文慧
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Mayinglong Pharmaceutical Group Co Ltd
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Abstract

本发明公开了一种治疗皮肤瘙痒的中药凝胶剂，它由中药活性成分、抑菌活性成分和凝胶基质组成，所述中药活性成分是由蛇床子、苦参、黄柏、防风、地骨皮、地肤子、威灵仙、白鲜皮、百部、苍术、马齿苋、艾叶、薄荷共十三味中药材经提取纯化后制得。本发明通过对现有中药的提取方法进行改进，提高了活性成分含量和药物疗效，所制得的凝胶剂具有较高的透皮吸收性能，与现有剂型相比，本发明的中药凝胶剂具有使用方便，无残留，具有更长保质期等优点。

Description

一种治疗皮肤瘙痒的中药凝胶剂
技术领域
本发明属于中药制剂领域，具体涉及一种治疗皮肤瘙痒的中药凝胶剂。
背景技术
CN 104288634A公开了一种治疗***瘙痒的中药，它由蛇床子、苦参、黄柏、防风、地骨皮等十三味中药材制成。该中药具有清热燥湿、杀虫止痒之功效，能用于治疗皮肤瘙痒。该发明通过将中药进行提取纯化并制成洗剂、乳膏剂或凝胶剂，所制得的药物具有很好的抗炎、抑菌、止痒、抗过敏功效，同时为了促进药物的透皮吸收和提高疗效，该发明还将中药材进行了提取挥发油，水提醇沉和超滤处理。但是该中药仍具有以下缺陷：1)乳膏剂含有较多油脂，皮肤使用后会产生残留，而且在恶劣环境下容易发生析乳、分层，药物保质期短，洗剂使用不便而且不容易控制剂量；2)药物活性成分含量低，疗效有待进一步提高；3)超滤会导致大部分药物成分被截留，产物收率很低，生产成本很高。
发明内容
本发明的目的是在现有中药的基础上，提供一种凝胶剂新剂型，该新剂型具有药物活性成分含量高，杂质少，透皮吸收效果好等优点。
上述目的是通过以下技术手段实现的：
一种治疗皮肤瘙痒的中药凝胶剂，它由中药活性成分、抑菌活性成分和凝胶基质组成，所述中药活性成分是由蛇床子、苦参、黄柏、防风、地骨皮、地肤子、威灵仙、白鲜皮、百部、苍术、马齿苋、艾叶、薄荷共十三味中药材经提取纯化后制得，其中，所述提取纯化方法包括以下步骤：
1)称取中药材，先用3-8倍重量70-95％乙醇渗漉，渗漉液回收乙醇至无醇味，备用；
2)将步骤1)渗漉后的药渣加水煎煮1-3次，收集煎煮液，然后与步骤1)的渗漉液合并，浓缩至相对密度为1.1-1.3的清膏；
3)将清膏上大孔树脂柱，先用水洗脱，再用50-70％乙醇洗脱，收集乙醇洗脱液，浓缩，干燥，即为中药活性成分。
优选地，所述大孔树脂是DA201中等极性苯乙烯型树脂。
优选地，所述渗漉是用5倍重量85％乙醇渗漉。
优选地，所述加水煎煮的次数是2次，每次煎煮的时间是2小时。
优选地，所述乙醇洗脱的浓度为55％。
优选地，所述凝胶基质由以下成分组成，各成分的重量配比为：
Figure BDA0002458216790000021
进一步优选地，所述凝胶中各成分的重量配比为：
Figure BDA0002458216790000022
优选地，所述中药材的重量份数是：蛇床子5-20份，苦参5-20份，黄柏5-20份，防风5-20份，地骨皮5-20份，地肤子5-20份，威灵仙5-20份，白鲜皮5-20份，百部5-20份，苍术5-20份，马齿苋5-20份，艾叶3-15份，薄荷3-15份。
优选地，所述抑菌活性成分选自醋酸氯已定、苯扎溴铵、苄索氯铵、2，4，4`-三氯-3`-羟基二苯醚、4-氯-3,5-二甲基苯酚、聚六亚甲基双胍中的一种或多种。
本发明中所涉及的乙醇浓度均为体积浓度，如20％乙醇指的是每100ml乙醇水溶液中含有乙醇20ml。
本发明的有益效果是：
1)本发明首先针对中药的提取方法进行改进，一是用高浓度乙醇渗漉代替原有的水蒸气蒸馏工艺，高浓度乙醇具有较低的极性，能用于提取中药的亲脂性成分，而水蒸气蒸馏只能提取挥发性亲脂性成分而且产量很少，该方法具有很大的局限性，另外由于渗漉法不需要加热，低温条件下提取的成分化学性质更加稳定；二是用大孔树脂吸附纯化法代替了原有的醇沉和超滤工艺，试验结果证明，通过大孔树脂纯化能更好地提高活性成分含量和减少杂质，而且具有较高的提取物收率。
2)本发明制备的凝胶剂具有较高的透皮吸收速率，药物活性成分能很快透过皮肤角质层被人体吸收，从而迅速起效。
3)与洗剂相比，凝胶剂具有使用舒适方便而且容易控制剂量等优点。与乳膏剂相比，凝胶剂不含油脂性成分，使用后皮肤无残留，而且凝胶剂不会发生破乳、分层等现象，性质稳定，比乳膏剂具有更长的保质期。
具体实施方式
下面通过具体实施例对本发明进行详细说明。
实施例1
蛇床子12g，苦参12g，黄柏12g，防风12g，地骨皮8g，地肤子8g，威灵仙8g，白鲜皮8g，百部8g，苍术8g，马齿苋8g，艾叶5g，薄荷5g
制法：1)称取六倍处方量的中药材，先用5倍重量85％乙醇渗漉，渗漉液回收乙醇至无醇味，备用；
2)将步骤1)渗漉后的药渣加水煎煮2次，每次2小时，收集煎煮液，然后与步骤1)的渗漉液合并，浓缩至相对密度为1.15的清膏；
3)将清膏平均分成六份，其中五份分别上D101型、DA201型、AB-8型、ADS-7型、HPD-100型五种大孔吸附树脂柱，上样量为0.5g清膏/ml柱体积，先用水洗脱3倍柱体积，再用55％乙醇洗脱6倍柱体积，收集乙醇洗脱液，浓缩，干燥至恒重；将另一份清膏直接浓缩，干燥至恒重。
参照《中国药典》2015年版，采用HPLC法分别检测六份干膏样品中的蛇床子素、盐酸小檗碱、苦参碱的含量，具体检测条件如下：
蛇床子素HPLC色谱条件：以十八烷基硅烷键合硅胶为填充剂；以乙腈-水(60：40)为流动相；检测波长为322nm。
盐酸小檗碱HPLC色谱条件：以十八烷基硅烷键合硅胶为填充剂；以乙腈-0.1磷酸溶液(50：50)为流动相，检测波长265nm。
苦参碱HPLC色谱条件：以氨基键合硅胶为填充剂；以乙腈-无水乙醇-3％磷酸溶液(80：10：10)为流动相；检测波长为220nm。
检测结果见下表1。
表1不同大孔树脂对中药提取物中活性成分含量的影响
干膏量(g) 蛇床子素(％) 盐酸小檗碱(％) 苦参碱(％)
D101 9.2 0.66 2.29 0.81
DA201 11.3 0.85 2.12 0.96
AB-8 13.5 0.61 1.61 0.85
ADS-7 8.7 0.93 1.87 0.74
HPD-100 10.4 0.79 1.64 1.16
未纯化 27.4 0.45 1.09 0.63
结果表明，经大孔树脂纯化后，提取物中的三种活性成分的含量均大幅增加，杂质明显减少，这有利于提高中药的疗效。同时将以上结果综合比较，发现DA201型大孔树脂不仅出膏率较高，而且三种活性成分的含量均处于较高水平，综合纯化效果最好。
实施例2
蛇床子12g，苦参12g，黄柏12g，防风12g，地骨皮8g，地肤子8g，威灵仙8g，白鲜皮8g，百部8g，苍术8g，马齿苋8g，艾叶5g，薄荷5g
制法一：1)称取处方量的中药材，先用3倍重量95％乙醇渗漉，渗漉液回收乙醇至无醇味，备用；
2)将步骤1)渗漉后的药渣加水煎煮3次，每次1小时，收集煎煮液，然后与步骤1)的渗漉液合并，浓缩至相对密度为1.15的清膏；
3)将清膏上DA201型大孔吸附树脂柱，上样量为0.5g清膏/ml柱体积，先用水洗脱3倍柱体积，再用50％乙醇洗脱6倍柱体积，收集乙醇洗脱液，浓缩，干燥至恒重。
制法二：1)称取处方量的中药材，先用8倍重量70％乙醇渗漉，渗漉液回收乙醇至无醇味，备用；
2)将步骤1)渗漉后的药渣加水煎煮1次，时间3小时，收集煎煮液，然后与步骤1)的渗漉液合并，浓缩至相对密度为1.15的清膏；
3)将清膏上DA201型大孔吸附树脂柱，上样量为0.5g清膏/ml柱体积，先用水洗脱3倍柱体积，再用70％乙醇洗脱6倍柱体积，收集乙醇洗脱液，浓缩，干燥至恒重。
制法三：1)称取处方量的中药材，加水煎煮2次，每次2小时，过滤，合并滤液并浓缩至相对密度为1.15的清膏；
2)向步骤1)的清膏中加入乙醇，使乙醇的重量含量达60％，搅拌均匀后静置24小时，取上清液，回收乙醇并浓缩干燥至恒重。
制法四：1)称取处方量的中药材，加水煎煮2次，每次2小时，过滤，合并滤液并浓缩至相对密度为1.15的清膏；
2)向步骤1)的清膏中加入乙醇，使乙醇的重量含量达60％，搅拌均匀后静置24小时，取上清液；
3)将步骤2)的上清液用40KD的中空纤维超滤膜过滤，收集滤液并减压浓缩，干燥至恒重。
表2不同提取纯化方法对中药提取物中活性成分含量的影响
干膏量(g) 蛇床子素(％) 盐酸小檗碱(％) 苦参碱(％)
制法一 11.5 0.78 1.92 1.07
制法二 10.7 0.95 2.03 0.86
制法三 20.8 0.55 1.18 0.66
制法四 8.2 0.67 1.68 0.81
可以看到，制法三采用的水提醇沉工艺，虽然干膏量比大孔吸附树脂增加，但活性成分含量均明显低于大孔树脂纯化工艺；制法四采用了超滤工艺，虽然活性成分含量有所增加，但药物成分大多被超滤膜截留，导致产物收率极低。
实施例3
凝胶剂的制备，处方如下：
表3凝胶剂配方表
Figure BDA0002458216790000051
Figure BDA0002458216790000061
制法：1)将卡波姆、羟丙基甲基纤维素加入到20％乙醇，配置成凝胶溶液；
2)将实施例1中经DA201大孔树脂纯化后制得的中药活性成分、醋酸氯已定加入到凝胶溶液中，搅拌混匀；
3)加入丙二醇、薄荷醇，搅拌混匀；
4)最后加入三乙醇胺，均质后灌装，灭菌。
体外透皮吸收试验：
参考CN 104288634A方法，采用Franz装置，将50％乙醇生理盐水加人接受池。取离体大鼠皮，将真皮层一侧面向接受池，确保无起泡存在，剪去多余皮肤，取制好的凝胶1g涂于离体鼠皮角质层一侧，用塑料薄膜密封，水浴恒温至(37±1)℃，电磁恒速搅拌(300rpm)，分别于2，4，6，8，12h取样，每次取2m1，再立即补充2mL接受液。样品用0.45μm微孔滤膜过滤，取续滤液20mL进样，测定蛇床子素、盐酸小檗碱、苦参碱的含量，并计算出各时间点累计透过量(Q)，以Q-t作线性回归，直线的斜率即为透皮速率，结果见表4。
表4凝胶剂中三种活性成分的透皮速率
透皮速率(μg·cm<sup>-2</sup>·h<sup>-1</sup>)
蛇床子素 156.17
盐酸小檗碱 104.59
苦参碱 51.32
结果表明，本发明制备的凝胶剂具有较高的透皮吸收速率。

Claims (7)

1.一种治疗皮肤瘙痒的中药凝胶剂，它由中药活性成分、抑菌活性成分和凝胶基质组成，所述中药活性成分是由以下重量份数的共十三味中药材经提取纯化后制得，蛇床子5-20份，苦参5-20份，黄柏5-20份，防风5-20份，地骨皮5-20份，地肤子5-20份，威灵仙5-20份，白鲜皮5-20份，百部5-20份，苍术5-20份，马齿苋5-20份，艾叶3-15份，薄荷3-15份，
其特征在于，所述提取纯化方法包括以下步骤：
1）称取中药材，先用3-8倍重量70-95％乙醇渗漉，渗漉液回收乙醇至无醇味，备用；
2）将步骤1）渗漉后的药渣加水煎煮1-3次，收集煎煮液，然后与步骤1）的渗漉液合并，浓缩至相对密度为1.1-1.3的清膏；
3）将清膏上DA201中等极性苯乙烯型大孔树脂柱，先用水洗脱，再用50-70％乙醇洗脱，收集乙醇洗脱液，浓缩，干燥，即为中药活性成分。
2.如权利要求1所述治疗皮肤瘙痒的中药凝胶剂，其特征在于：所述渗漉是用5倍药材重量85％乙醇渗漉。
3.如权利要求1所述治疗皮肤瘙痒的中药凝胶剂，其特征在于：所述加水煎煮的次数是2次，每次煎煮的时间是2小时。
4.如权利要求1所述治疗皮肤瘙痒的中药凝胶剂，其特征在于：所述乙醇洗脱的浓度为55％。
5.如权利要求1-4任何一项所述治疗皮肤瘙痒的中药凝胶剂，其特征在于，所述凝胶剂由以下成分组成，各成分的重量配比为：
中药活性成分2-5％
抑菌活性成分0.1-0.3％
卡波姆0.5-3％
羟丙基甲基纤维素0.1-1％
丙二醇3-8％
薄荷醇0.5-3％
三乙醇胺0.5-2％
20％乙醇余量。
6.如权利要求5所述治疗皮肤瘙痒的中药凝胶剂，其特征在于，各成分的重量配比为：
中药活性成分5％
抑菌活性成分0.2％
卡波姆1.5％
羟丙基甲基纤维素0.5％
丙二醇5％
薄荷醇1％
三乙醇胺1.5％
20％乙醇余量。
7.如权利要求1所述治疗皮肤瘙痒的中药凝胶剂，其特征在于，所述抑菌活性成分选自醋酸氯已定、苯扎溴铵、苄索氯铵、2，4，4`—三氯—3`—羟基二苯醚、4-氯-3,5-二甲基苯酚、聚六亚甲基双胍中的一种或多种。
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