CN108524648A - 一种克立硼罗复合保健缓释膜及其制备方法 - Google Patents
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- 229910052796 boron Inorganic materials 0.000 title claims abstract description 43
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Abstract
本发明公开了一种克立硼罗复合保健缓释膜及其制备方法，由以下原料配比而成：克立硼罗9‑18mg，土荆皮提取物0.2‑1.2mg，黄柏提取物0.2‑1.2mg，变性淀粉1‑2.5mg，卡波普0.6‑1.0mg，甘油4‑10mg。本发明解决药物使用的频率过高以及提供更长的皮肤滞留时间和减少给药次数，抗性淀粉具有良好的成胶性，但结构较为松散，加入卡波普和甘油能够加强结构强度，使得物料容易成膜，提高成品率。
Description
技术领域
本发明涉及一种克立硼罗复合保健缓释膜及其制备方法，属于生物医学材料领域。
背景技术
克立硼罗(Crisaborole)是一种磷酸二酯酶4(PDE4)抑制剂，这种抑制导致细胞内环磷酸腺苷(cAMP)水平增高，用于治疗真菌感染，更具体的说用于治疗甲癣和/或皮肤真菌感染。该药物于2016年12月获得美国食品药品监督管理局(FDA)批准上市，由Anacor制药公司研发并负责在美国上市销售，商品名为Crisaborole的化学名称为5-(4-氰基苯氧基)-1,3-二氢-1-羟基-2,1-苯并氧杂硼杂环戊二烯，英文名称为4-((1-hydroxy-1,3-dihydrobenzo[c][1,2]oxaborol-5-yl)oxy)benzonitrile，化学结构式如式(Ⅰ)所示：
药物缓释的特点是通过对药物医疗剂量的有效控制，达到降低药物毒副作用，减少人体抗药性，提高药物的稳定性和有效利用率的目的。由于选用的高分子材料不同，药物分子的控制释放机制也不相同，因此高分子药物缓释材料的研究具有十分重要的意义。目前，克立硼罗制剂大部分为膏药剂，没有涉及缓释方面，需要定点给药，且较易被擦拭，不能长时间保留。
发明内容
鉴于上述不足，本发明提供的克立硼罗复合保健缓释膜及其制备方法，解决药物使用的频率过高以及提供更长的皮肤滞留时间和减少给药次数。本发明是通过以下技术方案来实现的：
一种克立硼罗复合保健缓释膜，由以下原料配比而成：克立硼罗9-18mg，土荆皮提取物0.2-1.2mg，黄柏提取物0.2-1.2mg，变性淀粉1-2.5mg，卡波普0.6-1.0mg，甘油4-10mg。
优选由以下原料配比而成：克立硼罗12-16mg，土荆皮提取物0.4-1.0mg，黄柏提取物0.4-1.0mg，变性淀粉1.5-2.0mg，卡波普0.7-0.9mg，甘油5-8mg。
更优选由以下原料配比而成：克立硼罗14mg，土荆皮提取物0.7mg，黄柏提取物0.7mg，变性淀粉1.7mg，卡波普0.8mg，甘油7mg。
本发明还提供一种克立硼罗复合保健缓释膜的制备方法，具体步骤如下：
A、按照上述重量称取各原料，将变性淀粉溶于去离子水中形成混悬液，备用；
B、将卡波普和甘油加入到上述混悬液中，混合均匀；
C、将克立硼罗、土荆皮提取物和黄柏提取物加入到适量去离子水中，搅拌均匀；
D、将B和C得到的产物进行混合搅拌，得均匀粘稠物；
E、将D得到的粘稠物倾倒在玻璃板上，均匀铺平，进行烘箱干燥，冷却，切割，揭膜即得克立硼罗复合保健缓释膜。
其中，所述土荆皮提取物的制备方法为，按土荆皮：水＝1:10，在容器中将土荆皮与水混合，加热至90℃提取2-3h后，过滤收集滤液I和残渣I，再将残渣I：水＝1:8进行提取2-3h，过滤收集滤液II，合并滤液I和滤液II，真空浓缩得浸膏，再进行冷冻干燥得土荆皮提取物。
其中，所述黄柏提取物的制备方法为，按黄柏：乙醇＝1:10，在容器中将黄柏与乙醇混合，加热至60℃进行循环提取2-3h后，过滤收集滤液I和残渣I，再将残渣I：乙醇＝1:8进行提取2-3h，过滤收集滤液II，合并滤液I和滤液II，真空浓缩得浸膏，再进行冷冻干燥得黄柏提取物。
优选的，E步骤中，烘箱温度为60-80℃。
在本发明中，土荆皮和黄柏具有抗菌抗炎、治疗甲癣的功效，其中，黄柏还具有清热燥湿的功效，能够与克立硼罗产生协同效应，加强产品的治疗效果。
在本发明中，抗性淀粉具有良好的成胶性，但结构较为松散，加入卡波普和甘油能够加强结构强度，使得物料容易成膜，提高成品率。
在本发明中，先将抗性淀粉制备成混悬液，再添加卡波普和甘油，按照该顺序进行混合，能够充分发挥各辅料的作用，提高成膜质量，最后加入活性成分的水溶液，料液分散均匀，缓释效果好。
附图说明
图1实施例3、对比例1和对比例2的药物缓释情况。
具体实施方式
下面结合实施例对本发明作进一步描述。以下实施例仅用于更加清楚地说明本发明的技术方案，而不能以此来限制本发明的保护范围。
实施例1
A、称取以下原料：克立硼罗9mg，土荆皮提取物0.2mg，黄柏提取物0.2mg，变性淀粉1mg，卡波普0.6mg，甘油4mg，将变性淀粉溶于去离子水中形成混悬液，备用；
B、将卡波普和甘油加入到上述混悬液中，混合均匀；
C、将克立硼罗、土荆皮提取物和黄柏提取物加入到适量去离子水中，搅拌均匀；
D、将B和C得到的产物进行混合搅拌，得均匀粘稠物；
E、将D得到的粘稠物倾倒在玻璃板上，均匀铺平，进行烘箱干燥，温度60℃，冷却，切割，揭膜即得克立硼罗复合保健缓释膜。
实施例2
A、称取以下原料：克立硼罗18mg，土荆皮提取物1.2mg，黄柏提取物1.2mg，变性淀粉2.5mg，卡波普1.0mg，甘油10mg，将变性淀粉溶于去离子水中形成混悬液，备用；
B、将卡波普和甘油加入到上述混悬液中，混合均匀；
C、将克立硼罗、土荆皮提取物和黄柏提取物加入到适量去离子水中，搅拌均匀；
D、将B和C得到的产物进行混合搅拌，得均匀粘稠物；
E、将D得到的粘稠物倾倒在玻璃板上，均匀铺平，进行烘箱干燥，温度70℃，冷却，切割，揭膜即得克立硼罗复合保健缓释膜。
实施例3
A、克立硼罗14mg，土荆皮提取物0.7mg，黄柏提取物0.7mg，变性淀粉1.7mg，卡波普0.8mg，甘油7mg，将变性淀粉溶于去离子水中形成混悬液，备用；
B、将卡波普和甘油加入到上述混悬液中，混合均匀；
C、将克立硼罗、土荆皮提取物和黄柏提取物加入到适量去离子水中，搅拌均匀；
D、将B和C得到的产物进行混合搅拌，得均匀粘稠物；
E、将D得到的粘稠物倾倒在玻璃板上，均匀铺平，进行烘箱干燥，温度80℃，冷却，切割，揭膜即得克立硼罗复合保健缓释膜。
对比例1
A、克立硼罗14mg，土荆皮提取物0.7mg，黄柏提取物0.7mg，变性淀粉1.7mg，甘油7.8mg，将变性淀粉溶于去离子水中形成混悬液，备用；
B、将卡波普和甘油加入到上述混悬液中，混合均匀；
C、将克立硼罗、土荆皮提取物和黄柏提取物加入到适量去离子水中，搅拌均匀；
D、将B和C得到的产物进行混合搅拌，得均匀粘稠物；
E、将D得到的粘稠物倾倒在玻璃板上，均匀铺平，进行烘箱干燥，温度80℃，冷却，切割，揭膜即得克立硼罗复合保健缓释膜。
对比例2
A、克立硼罗14mg，土荆皮提取物0.7mg，黄柏提取物0.7mg，变性淀粉1.7mg，卡波普0.4mg，甘油7mg，将变性淀粉溶于去离子水中形成混悬液，备用；
B、将卡波普和甘油加入到上述混悬液中，混合均匀；
C、将克立硼罗、土荆皮提取物和黄柏提取物加入到适量去离子水中，搅拌均匀；
D、将B和C得到的产物进行混合搅拌，得均匀粘稠物；
E、将D得到的粘稠物倾倒在玻璃板上，均匀铺平，进行烘箱干燥，温度80℃，冷却，切割，揭膜即得克立硼罗复合保健缓释膜。
以上所述仅是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明技术原理的前提下，还可以做出若干改进和变形，这些改进和变形也应视为本发明的保护范围。
Claims (7)
1.一种克立硼罗复合保健缓释膜，其特征在于，由以下原料配比而成：克立硼罗9-18mg，土荆皮提取物0.2-1.2mg，黄柏提取物0.2-1.2mg，变性淀粉1-2.5mg，卡波普0.6-1.0mg，甘油4-10mg。
2.根据权利要求1所述的一种克立硼罗复合保健缓释膜，其特征在于，由以下原料配比而成：克立硼罗12-16mg，土荆皮提取物0.4-1.0mg，黄柏提取物0.4-1.0mg，变性淀粉1.5-2.0mg，卡波普0.7-0.9mg，甘油5-8mg。
3.根据权利要求1所述的一种克立硼罗复合保健缓释膜，其特征在于，由以下原料配比而成：克立硼罗14mg，土荆皮提取物0.7mg，黄柏提取物0.7mg，变性淀粉1.7mg，卡波普0.8mg，甘油7mg。
4.根据权利要求1-3所述的一种克立硼罗复合保健缓释膜的制备方法，其特征在于，具体步骤如下：
A、按照上述重量称取各原料，将变性淀粉溶于去离子水中形成混悬液，备用；
B、将卡波普和甘油加入到上述混悬液中，混合均匀；
C、将克立硼罗、土荆皮提取物和黄柏提取物加入到适量去离子水中，搅拌均匀；
D、将B和C得到的产物进行混合搅拌，得均匀粘稠物；
E、将D得到的粘稠物倾倒在玻璃板上，均匀铺平，进行烘箱干燥，冷却，切割，揭膜即得克立硼罗复合保健缓释膜。
5.根据权利要求4所述的一种克立硼罗复合保健缓释膜的制备方法，其特征在于，土荆皮提取物的制备方法为，按土荆皮：水＝1:10，在容器中将土荆皮与水混合，加热至90℃提取2-3h后，过滤收集滤液I和残渣I，再将残渣I：水＝1:8进行提取2-3h，过滤收集滤液II，合并滤液I和滤液II，真空浓缩得浸膏，再进行冷冻干燥得土荆皮提取物。
6.根据权利要求4所述的一种克立硼罗复合保健缓释膜的制备方法，其特征在于，黄柏提取物的制备方法为，按黄柏：乙醇＝1:10，在容器中将黄柏与乙醇混合，加热至60℃进行循环提取2-3h后，过滤收集滤液I和残渣I，再将残渣I：乙醇＝1:8进行提取2-3h，过滤收集滤液II，合并滤液I和滤液II，真空浓缩得浸膏，再进行冷冻干燥得黄柏提取物。
7.如权利要求4所述的一种克立硼罗复合保健缓释膜的制备方法，其特征在于，E步骤中，烘箱温度为60-80℃。
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