CN114504567A - 一种龙血竭液体创口贴及其制备方法 - Google Patents
一种龙血竭液体创口贴及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种龙血竭液体创口贴及其制备方法，属于医疗器械技术领域。该龙血竭液体创口贴按重量百分数计，包括聚乙烯醇缩丁醛‑72 2％～15％，龙血竭提取物0.05％～2％，95％乙醇20％～35％，乙酸乙酯35％～45％，乙酸正丁酯1％～10％，异丙醇15％～30％，樟脑0.1％～3％，生育酚乙酸酯0.01％～1％，其中，创口贴成膜剂的主要组分为聚乙烯醇缩丁醛‑72；快干溶剂中的主要组分为95％乙醇、乙酸乙酯、乙酸正丁酯和异丙醇；抗氧化剂主要成分为生育酚乙酸酯；增塑剂主要成分为樟脑。上述龙血竭液体创口贴具有良好的成膜性、透气性和阻水性，能够有效阻止外界异物和微生物对伤口的入侵和感染，具有保护创面的作用。
Description
技术领域
本发明属于医疗器械技术领域，尤其涉及一种龙血竭液体创口贴及其制备方法。
背景技术
皮肤是人体最大的器官，皮肤损伤在日常生活中极为常见，常采用创口贴进行伤口处理。传统医用敷料创口贴透气差，受伤口位置及大小限制，使用面积与肌肤不贴合，而液体创口贴与传统创口贴敷料相比，液体创口贴在生物分解自溶性、伤口表面不结痂，保护创面促进创愈合，防水防渗防感染快速吸收功能性，活动自由不受限制，以及临床疗效方面更可靠，适合表浅皮肤创伤或伤口整齐干净、出血不多，不需缝合小伤口等使用的优点,主要优势在于液体创口贴易于形成保护薄膜,将创伤面瞬间封闭,阻隔细菌或异物侵入,具有良好的防水特性,同时液体创口贴对皮肤刺激较小、不容易产生过敏反应,适用人群范围广泛。
申请公布号为CN105363066A(申请号为201510856810.1)的中国发明专利申请公开了一种液体创口贴，按照重量份由如下成分组成：PVB(聚乙烯醇缩丁醛)8-12份，PVP(聚乙烯吡咯烷酮)1-3份，乙醇25-30份，乙酸乙酯53-65份，甘油0.5～2.0份。制备方法：称取乙醇和乙酸乙酯混合均匀，称取PVB一定量边搅拌边加入混合液，密闭搅拌直至溶解；加入PVP继续溶解完全，加入甘油混匀即可。该液体创口贴采用聚乙烯醇树脂作为成膜物质，成膜速度快，并且可以隔离防水，但是存在伤口愈合慢的缺点。
申请公布号为CN101920042A(申请号为201010233179.7)的中国发明专利申请公开了一种液体创口贴及制备方法，原料组成：聚乙烯醇缩醛、邻苯二甲酸二丁酯、甲基纤维素、丙三醇、月桂氮卓酮、壳聚糖、95％乙醇、五味藤、龙血竭、乳香、没药、三七。制备方法：(1)将聚乙烯醇缩醛、壳聚糖、乙醇于50℃恒温水浴中边加热边搅拌，待成膜物质完全溶解后，加入月桂氮卓酮、丙三醇、邻苯二甲酸二丁酯及甲基纤维素，混合搅拌制得膜液；搅拌速度为300—400rpm。(2)将粉碎后的五味藤、龙血竭、乳香、没药、三七分别用乙醇在60℃恒温水浴中回流提取数次直至提取液无色，回流后常压过滤并浓缩至无乙醇。(3)边搅拌膜液，边向其中加入五味藤、龙血竭、乳香、没药、三七浓缩液，混合均匀后即得产品，搅拌速度为300—400rpm。该液体创口贴采用聚乙烯醇缩丁醛作为成膜材料，具有很好的透明性、韧性、弹性，膜中加入中药成分，能加快伤口的愈合。但存在提取的中药成分没有经过精制对伤口的愈合效果不好。
发明内容
本发明的目的之一在于提供一种龙血竭液体创口贴，该创口贴按重量百分数计，包括聚乙烯醇缩丁醛-72 2％～15％，龙血竭提取物0.05％～2％，95％乙醇20％～35％，乙酸乙酯35％～45％，乙酸正丁酯1％～10％，异丙醇15％～30％，樟脑0.1％～3％，生育酚乙酸酯0.01％～1％，其中，创口贴成膜剂的主要组分为聚乙烯醇缩丁醛-72；快干溶剂中的主要组分为95％乙醇、乙酸乙酯、乙酸正丁酯和异丙醇；抗氧化剂主要成分为生育酚乙酸酯；增塑剂主要成分为樟脑。
优选地，所述创口贴按重量百分数计，包括5％的聚乙烯醇缩丁醛-72、0.2％的龙血竭提取物、30％的95％乙醇、40％的乙酸乙酯、1％的乙酸正丁酯、23％的异丙醇、0.7％的樟脑、0.1％的生育酚乙酸酯。
优选地，所述创口贴按重量百分数计，包括10％的聚乙烯醇缩丁醛-72、0.1％的龙血竭提取物、25％的95％乙醇、35％的乙酸乙酯、4％的乙酸正丁酯、25％的异丙醇、0.5％的樟脑、0.4％的生育酚乙酸酯。
优选地，所述创口贴按重量百分数计，包括13％的聚乙烯醇缩丁醛-72、0.1％的龙血竭提取物、30％的95％乙醇、35％的乙酸乙酯、2％的乙酸正丁酯、19.5％的异丙醇、0.3％的樟脑、0.1％的生育酚乙酸酯。
优选地，所述龙血竭提取物是经百合科剑叶龙血树属(Dracaenacochinchinensis)植物，龙血树含脂木材以乙酸乙酯为溶剂，超声波辅助提取获得。
更优选地，所述龙血竭提取物的制备过程为：龙血树含脂木材粉碎过24目筛，按龙血竭木材重量，加入8～15倍体积量乙酸乙酯，浸泡4h,在35～55℃温度下，采用频率为40-50kHz超声波提取，提取1h,过滤，渣中加入6～10倍体积量乙酸乙酯，在35～55℃温度下，采用频率为40-50kHz超声波提取，提取2次,每次提取时间为30min，过滤，合并3次提取的滤液，用SCP-1120澄清板过滤，滤液浓缩时浓缩器压力为0.06-0.1MPa，浓缩温度40℃～50℃，滤液浓缩至ρ＝1.15-1.28g/cm3，浓缩液在-40℃条件下真空冷冻干燥30-48h，粉碎成细粉，即得到龙血竭提取物。
本发明的目的之二在于提供一种上述龙血竭液体创口贴的制备方法，该制备方法包括以下步骤：
(1)在配制容器中加入95％乙醇、乙酸正丁酯、异丙醇，缓慢加入聚乙烯醇缩丁醛-72，搅拌25-40min；
(2)在配置好的(1)中依次加入樟脑、生育酚乙酸酯，搅拌10-20min，并搅拌均匀；
(3)在另一配制容器中加入乙酸乙酯再加入龙血竭提取物搅拌溶解；
(4)将配置好的(3)加入到配制好的(2)中，搅拌均匀后，并将混合液置于高压均质机，均质5-10min，过滤，灌装制得龙血竭液体创口贴。
优选地，所述步骤(1)中搅拌时间为30min。
更优选地，所述步骤(2)中搅拌时间为15min。
更优选地，所述步骤(4)中均质时间为5min。
龙血竭为百合科剑叶龙血树含脂木材经高浓度乙醇提取而得，具有活血化瘀、止血、促进伤口愈合等作用，并且龙血竭中黄酮类、多酚类物质具有杀菌和抗氧化作用。经过多年临床用药表明龙血竭疗效确切、安全性极好。本发明中龙血竭提取物为经乙酸乙酯低温提取、澄清板过滤除杂、低温冷冻干燥而得，能最大限度保留龙血竭中活性成分；经过伤口愈合试验表明，加入龙血竭提取物后，促进伤口愈合；大鼠皮肤刺激性试验，龙血竭液体创口贴涂抹后96小时内均未发现红斑和焦痂形成、以及水肿情况，结果表明本发明中的龙血竭液体创口贴对皮肤刺激性较小，安全性高。
与现有技术相比，本发明具有如下有益效果：
(1)本发明所制备的龙血竭液体创口贴涂抹在皮肤患处上能快速形成一层柔软的膜且膜层平整，不受患处位置与大小的限制，使用方便，与皮肤贴合度好，具有良好的成膜性、透气性和阻水性，能够有效阻止外界异物和微生物对伤口的入侵和感染，具有保护创面的作用。
(2)本发明所制备的龙血竭液体创口贴经过大鼠动物试验表明96h内均未发现红斑和焦痂形成、以及水肿情况，说明龙血竭液体创口贴对皮肤刺激性较小，安全性较好；在伤口愈合实验中，使用龙血竭液体创口贴2天时治疗组比对照组伤口愈合要快1倍，损伤面积较小。
附图说明
图1为试验例1中伤口面积减少率结果图。
图2为试验例1中HE及Masson染色结果图。
图3为试验例2中小鼠区域划分示意图。
具体实施方式
以下实施例中所用95％乙醇为药用酒精。
实施例1
本实施例提供的龙血竭液体创口贴中各组分的质量百分数如下：
5％的聚乙烯醇缩丁醛-72(CAS:63148-65-2)、0.2％的龙血竭提取物、30％的95％乙醇、40％的乙酸乙酯、1％的乙酸正丁酯、23％的异丙醇、0.7％的樟脑、0.1％的生育酚乙酸酯。
上述龙血竭液体创口贴的制备方法如下：
(1)百合科剑叶龙血树属(Dracaena cochinchinensis)植物，龙血树含脂木材粉碎过24目筛，按龙血竭木材重量，加入10倍体积量乙酸乙酯，浸泡4h,在50℃温度下，采用频率为40kHz超声波提取，提取1h,过滤，渣中加入6倍体积量乙酸乙酯，在50℃温度下，采用频率为40Hz超声波提取，提取2次,每次提取时间为30min，过滤，合并3次提取的滤液，用SCP-1120澄清板过滤，滤液浓缩时浓缩器压力为0.06MPa，浓缩温度40℃，滤液浓缩至ρ＝1.15g/cm3，浓缩液在-40℃条件下真空冷冻干燥45h，粉碎成细粉，即得到龙血竭提取物。
(2)在配制容器中加入30％的95％乙醇、1％的乙酸正丁酯、23％的异丙醇，缓慢加入5％的聚乙烯醇缩丁醛-72，搅拌30min。
(3)在配置好的(2)中依次加入0.7％的樟脑、0.1％的生育酚乙酸酯，搅拌15min。
(4)在另一配制容器中加入40％的乙酸乙酯，再加入0.2％的龙血竭提取物搅拌溶解。
(5)将配置好的(4)加入到配制好的(3)中，搅拌均匀后，并将混合液置于高压均质机，于30℃下，均质5min至整个体系无颗粒状固体成分，灌装制得本发明龙血竭液体创口贴。
试验例1
本试验例对实施例1制备的龙血竭液体创口贴进行伤口愈合试验，步骤如下：
取ICR小鼠10只，将小鼠背部的毛发去掉，用打孔器在小鼠背脊两侧各制造直径为8mm的皮肤全切除创伤；每只小鼠以左侧创伤为模型组，即创伤不做任何处理，右侧创伤使用实施例1的龙血竭液体创口贴进行处理，药物涂抹后每天测量1次伤口面积，并计算伤口面积减少率，具体结果参见图1。进行病理切片观察，选取伤口中心、伤口边界处及正常皮肤组织切片，进行HE及Masson染色，显微镜下观察伤口愈合情况及胶原增生情况，结果参见图2，进行综合评价。实验结果表明治疗组比对照组伤口愈合要快，损伤面积较小。HE染色结果显示，创口皮肤有大量炎性细胞浸润，并伴有局部组织纤维化和血管增生，治疗组有基本相近的形态变化。Masson染色，胶原含量在损伤区都比较少，给药组略微含量偏高。
试验例2
本试验例对实施例1制备的龙血竭液体创口贴进行皮肤刺激性试验，步骤如下：
取SD大鼠10只，使用消毒后的手术剪除去大鼠背部的被毛，将其背部两侧划分为左右相互对称的6个区域(参见图3)，将样品均匀的涂布于受试区域。A为阳性组：20％十二烷基硫酸钠，B为龙血竭液体创口贴，C为阴性组：PBS溶液。并分别于涂布样品0h、1h、24h、48h、72h和96h后拍照，并监测皮肤情况，皮肤反应及评分标准如表1所示：
表1
| 红斑和焦痂形成 | 刺激计分 |
| 无红斑 | 0 |
| 极轻微红斑(勉强可见) | 1 |
| 清晰红斑 | 2 |
| 中度红斑 | 3 |
| 重度红斑(紫红色) | 4 |
实验结果表明阳性药组24h大鼠皮肤可见清晰红斑情况，龙血竭液体创口贴涂抹后96h内均未发现红斑和焦痂形成、以及水肿情况，具体评分结果参见表2。说明龙血竭液体创口贴对皮肤刺激性较小，安全性较好。
表2
实施例2
本实施例提供的龙血竭液体创口贴中各组分的质量百分数如下：
10％的聚乙烯醇缩丁醛-72(CAS:63148-65-2)、0.1％的龙血竭提取物、25％的95％乙醇、35％的乙酸乙酯、4％的乙酸正丁酯、25％的异丙醇、0.5％的樟脑、0.4％的生育酚乙酸酯。
本实施例龙血竭液体创口贴的制备方法如下：
(1)百合科剑叶龙血树属(Dracaena cochinchinensis)植物，龙血树含脂木材粉碎过24目筛，按龙血竭木材重量，加入15倍体积量乙酸乙酯，浸泡4h,在35℃温度下，采用频率为50kHz超声波提取，提取1h,过滤，渣中加入8倍体积量乙酸乙酯，在40℃温度下，采用频率为50Hz超声波提取，提取2次,每次提取时间为30min，过滤，合并3次提取的滤液，用SCP-1120澄清板过滤，滤液浓缩时浓缩器压力为0.1MPa，浓缩温度50℃，滤液浓缩至ρ＝1.2g/cm3，浓缩液在-40℃条件下真空冷冻干燥30h，粉碎成细粉，即得到龙血竭提取物。
(2)在配制容器中加入25％的95％乙醇、4％的乙酸正丁酯、25％的异丙醇，缓慢加入10％的聚乙烯醇缩丁醛-72，搅拌25min。
(3)在配置好的(2)中依次加入0.5％的樟脑、0.4％的生育酚乙酸酯，搅拌20min。
(4)在另一配制容器中加入35％的乙酸乙酯，再加入0.1％的龙血竭提取物搅拌溶解。
(5)将配置好的(4)加入到配制好的(3)中，搅拌均匀后，并将混合液置于高压均质机，于25℃下，均质10min至整个体系无颗粒状固体成分，灌装制得本发明龙血竭液体创口贴。
实施例3
本实施例提供的龙血竭液体创口贴中各组分的质量百分数如下：
13％的聚乙烯醇缩丁醛-72(CAS:63148-65-2)、0.1％的龙血竭提取物、30％的95％乙醇、35％的乙酸乙酯、2％的乙酸正丁酯、19.5％的异丙醇、0.3％的樟脑、0.1％的生育酚乙酸酯。本实施例龙血竭液体创口贴的制备方法如下：
(1)百合科剑叶龙血树属(Dracaena cochinchinensis)植物，龙血树含脂木材粉碎过24目筛，按龙血竭木材重量，加入8倍体积量乙酸乙酯，浸泡4h,在55℃温度下，采用频率为50kHz超声波提取，提取1h,过滤，渣中加入10倍体积量乙酸乙酯，在35℃温度下，采用频率为40Hz超声波提取，提取2次,每次提取时间为30min，过滤，合并3次提取的滤液，用SCP-1120澄清板过滤，滤液浓缩时浓缩器压力为0.1MPa，浓缩温度45℃，滤液浓缩至ρ＝1.28g/cm3，浓缩液在-40℃条件下真空冷冻干燥48h，粉碎成细粉，即得到龙血竭提取物。
(2)在配制容器中加入30％的95％乙醇、2％的乙酸正丁酯、19.5％的异丙醇，缓慢加入13％的聚乙烯醇缩丁醛-72，搅拌40min。
(3)在配置好的(2)中依次加入0.3％的樟脑、0.1％的生育酚乙酸酯，搅拌10min。
(4)在另一配制容器中加入35％的乙酸乙酯，再加入0.1％的龙血竭提取物搅拌溶解。
(5)将配置好的(4)加入到配制好的(3)中，搅拌均匀后，并将混合液置于高压均质机，于30℃下，均质8min至整个体系无颗粒状固体成分，灌装制得本发明龙血竭液体创口贴。
以上所述的实施例仅是对本发明的优选方式进行描述，并非对本发明的范围进行限定，在不脱离本发明设计精神的前提下，本领域普通技术人员对本发明的技术方案做出的各种变形和改进，均应落入本发明权利要求书确定的保护范围内。
Claims (10)
1.一种龙血竭液体创口贴，其特征在于，所述创口贴按重量百分数计，包括聚乙烯醇缩丁醛-72 2％～15％，龙血竭提取物0.05％～2％，95％乙醇20％～35％，乙酸乙酯35％～45％，乙酸正丁酯1％～10％，异丙醇15％～30％，樟脑0.1％～3％，生育酚乙酸酯0.01％～1％。
2.根据权利要求1所述的龙血竭液体创口贴，其特征在于，所述创口贴按重量百分数计，包括5％的聚乙烯醇缩丁醛-72、0.2％的龙血竭提取物、30％的95％乙醇、40％的乙酸乙酯、1％的乙酸正丁酯、23％的异丙醇、0.7％的樟脑、0.1％的生育酚乙酸酯。
3.根据权利要求1所述的龙血竭液体创口贴，其特征在于，所述创口贴按重量百分数计，包括10％的聚乙烯醇缩丁醛-72、0.1％的龙血竭提取物、25％的95％乙醇、35％的乙酸乙酯、4％的乙酸正丁酯、25％的异丙醇、0.5％的樟脑、0.4％的生育酚乙酸酯。
4.根据权利要求1所述的龙血竭液体创口贴，其特征在于，所述创口贴按重量百分数计，包括13％的聚乙烯醇缩丁醛-72、0.1％的龙血竭提取物、30％的95％乙醇、35％的乙酸乙酯、2％的乙酸正丁酯、19.5％的异丙醇、0.3％的樟脑、0.1％的生育酚乙酸酯。
5.根据权利要求1-4中任一项所述的龙血竭液体创口贴，其特征在于，所述龙血竭提取物是经百合科剑叶龙血树属(Dracaena cochinchinensis)植物，龙血树含脂木材以乙酸乙酯为溶剂，超声波辅助提取获得。
6.一种龙血竭液体创口贴的制备方法，其特征在于，所述制备方法包括以下步骤：
(1)在配制容器中加入95％乙醇、乙酸正丁酯、异丙醇，缓慢加入聚乙烯醇缩丁醛-72，搅拌25-40min；
(2)在配置好的(1)中依次加入樟脑、生育酚乙酸酯，搅拌10-20min，并搅拌均匀；
(3)在另一配制容器中加入乙酸乙酯再加入龙血竭提取物搅拌溶解；
(4)将配置好的(3)加入到配制好的(2)中，混合液置于高压均质机中，均质5-10min，过滤，灌装制得龙血竭液体创口贴。
7.根据权利要求6所述的龙血竭液体创口贴的制备方法，其特征在于，所述步骤(1)中搅拌时间为30min。
8.根据权利要求6所述的龙血竭液体创口贴的制备方法，其特征在于，所述步骤(2)中搅拌时间为15min。
9.根据权利要求6所述的龙血竭液体创口贴的制备方法，其特征在于，所述步骤(4)中均质时间为5min。
10.权利要求6-9中任一项所述的制备方法在龙血竭液体创口贴制备中的应用。
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