CN116327828A - 一种用于轻中度烧烫伤的紫草牡丹籽油喷膜及其制备方法 - Google Patents
一种用于轻中度烧烫伤的紫草牡丹籽油喷膜及其制备方法 Download PDFInfo
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Abstract
本发明公开一种用于轻中度烧烫伤的紫草牡丹籽油喷膜及其制备方法，属于中药医用制剂领域。该喷膜是由紫草、牡丹籽油、薄荷脑、壳聚糖等各原材料按一定工艺加工而成的。所述紫草牡丹籽油喷膜剂包含如下质量百分比的组分：紫草1‑10％，牡丹籽油1‑10％、薄荷脑0.5‑1.0％、聚乙烯吡咯烷酮2‑7％、壳聚糖盐酸盐0.2‑0.5％、羟丙甲纤维素0.2‑0.5％、乙醇20‑50％、甘油0.5‑10％、水余量。与目前临床所用烧烫伤制剂相比，本发明喷膜在治疗治疗轻中度烧烫伤中，具有成膜快、疗效好、顺应性好等显著优势；再者，本发明能有效避免烧烫伤处理时的二次物理损伤，使用及携带方便、制备工艺简单、原料丰富等明显优势。
Description
技术领域
本发明公开一种用于轻中度烧烫伤的中药喷膜制剂，对烧烫伤具有显著的治疗作用，属于医药技术领域。
背景技术
烧烫伤是常见的皮肤损害。外用药物是烫伤治疗的首选措施，临床用药中西药制剂均有。西药治疗主要机制在控制感染，疗效一般。而植物提取物，诸如沙棘油、紫草油、红花籽油、麻油等植物籽油常被人们所使用，合理的使用能有效控制烫伤后体液渗出、预防感染、促进修复。牡丹籽油等也被研究报道，具备烧烫伤治疗作用。但是，目前临床用药多为涂抹药剂，创伤表面的药物涂抹本身就是物理刺激，会使患者经历二次痛苦，甚者出现二次伤害。
喷膜剂以液体形式储存，应用时雾状喷出后在皮肤表面形成可溶性生物薄膜，集合了多种制剂的优点。患者使用依从性好，更是避免了烧烫伤使用时的二次伤害，增加药物附着时间，防止感染发生。
发明内容
本发明提供了一种紫草牡丹籽油喷膜，对烧烫伤具有显著的治疗作用。
本发明还公开了一种紫草牡丹籽油喷膜的制备方法，克服了常用制剂的不足，并且生产工艺简单、生产原料丰富、治疗作用显著、患者依从性好。
本发明所述的一种紫草牡丹籽油喷膜，其特征在于是由以下药物按重量份数比制成的：
本发明还提供了一种紫草牡丹籽油喷膜剂的制备方法，所述制备方法包括以下步骤：
(1)紫草药材使用牡丹籽油提取或紫草提取物溶解于牡丹籽油中，得溶液A；
(2)将聚乙烯吡咯烷酮加入乙醇溶液中，混匀得到溶液B；
(3)将壳聚糖盐酸盐和羟丙甲纤维素溶解于水中，得到溶液C；
(4)将溶液B加入到步骤(3)所得的溶液C中，搅拌均匀得到溶液D；
(5)将溶液A、薄荷脑、甘油、水加入步骤(4)所得的溶液D中，得所述紫草牡丹籽油喷膜剂。
本发明所用的植物提取物具有广泛的生物活性。紫草是治疗烧烫伤的传统著名药物，为紫草科植物新疆紫草、紫草或内蒙紫草的干燥根，功效有凉血，活血，解毒透疹；牡丹籽油具有抗菌、抗氧化、调节代谢、抗衰老、治疗烫伤等作用，作为菏泽市观赏花卉牡丹的衍生产品，原料丰富，前期动物药理研究证实了在烫伤治疗中的良好作用；薄荷脑从薄荷中提取，局部应用时，有促进血循环及消炎、止痒等作用，可用于消炎、止痒、止痛、减轻浮肿等。成膜材料壳聚糖盐酸盐同时具有抗菌、促进伤口愈合等作用。
本发明安全有效，对烧烫伤具有显著的治疗作用，多种药物协同配伍，止痛抗炎、减少烧烫伤后的渗出、防治感染出现、预防疤痕形成。经反复研究制备成喷膜，使用方便，避免了患者的二次伤害，患者顺应性好。本制剂生产、储存、携带、使用均比较方便，有着良好的市场前景。
具体实施方式
以下结合实施例对本发明作进一步的说明，但本发明不仅限于这些实施例，在未脱离本发明宗旨的前提下，所作的任何改进均落在本发明的保护范围之内。
实施例1
本实施所述的一种紫草牡丹籽油喷膜，由以下药物按重量百分比比制成的：
本实施例所述紫草牡丹籽油喷膜，采用以下步骤制备而成：
(1)紫草药材使用牡丹籽油加热提取，得溶液A；
(2)将聚乙烯吡咯烷酮加入乙醇溶液中，混匀得到溶液B；
(3)将壳聚糖盐酸盐和羟丙甲纤维素溶解于水中，得到溶液C；
(4)将溶液B加入到步骤(3)所得的溶液C中，搅拌均匀得到溶液D；
(5)将溶液A、薄荷脑、甘油、水加入步骤(4)所得的溶液D中，得所述紫草牡丹籽油喷膜剂。
实施例2
本实施所述的一种紫草牡丹籽油喷膜，由以下药物按重量百分比制成的：
本实施例所述紫草牡丹籽油喷膜，采用以下步骤制备而成：
(1)紫草提取物使用牡丹籽油加热溶解，得溶液A；
(2)将聚乙烯吡咯烷酮加入乙醇溶液中，混匀得到溶液B；
(3)将壳聚糖盐酸盐和羟丙甲纤维素溶解于水中，得到溶液C；
(4)将溶液B加入到步骤(3)所得的溶液C中，搅拌均匀得到溶液D；
(5)将溶液A、薄荷脑、甘油、水加入步骤(4)所得的溶液D中，得所述紫草牡丹籽油喷膜剂。
实施例3
1实验方法
1.1烧伤模型及给药
大鼠适应性饲养后,背部毛剔除，参考文献使用浸润无水乙醇的直径2cm圆形纱布置于脱毛部位燃烧20s，造成局部皮肤Ⅱ度烧伤模型；动物随机分为5组，造模4小时后对烧伤面进行给药，一天一次，连续给药21天，所有大鼠单笼饲养，所用治疗药物为实施例1制备的喷膜。
1.2大鼠烧伤模型分组
实验共分为5组。
1.3检测指标
伤口面积：治疗前，治疗3天、7天、10天、14天、17天和21天，将每只大鼠创面在相同条件下拍数码照片，用塑料透明纸描记创面，用Photoshop软件，计算大鼠烧伤面积。
1.4统计学处理
实验数据以均数±标准差(±s)表示，使用SPSS19.0软件采用ANOVA检验比较差异的显著性。P<0.05为差异具有统计学意义。
2.实验结果
模型对照组动物创面存在自愈现象。紫草牡丹籽油喷膜药物治疗组创面愈合明显优于模型组对照组，剂量与效果且呈现正相关。
实施例4
实验方法：选取2022年7月-12月间诊治的Ⅱ度烧烫伤患者50例，将其随机分为治疗组和对照组，每组25例，对照组患者予磺胺嘧啶银软膏患处处理，治疗组患者给予实施例2制备的喷膜患处给药，1日3次，治疗15天，观察对比两组患者的临床疗效。
实验结果：治疗组患者Ⅱ度烧烫伤的愈显率95.6％显著高于对照组74.3％；两组患者在治疗过程中均无不良反应症状发生。紫草牡丹籽油喷膜剂剂可有效治疗Ⅱ度烧烫伤患者，在缓解患者创面渗液、肿胀和疼痛等方面具有显著疗效，无不良反应症状发生。
Claims (4)
1.一种用于轻中度烧烫伤的紫草牡丹籽油喷膜，其特征在于，所述烫伤喷膜剂包含如下质量百分比的组分：
水余量。
2.根据权利要求1所述的紫草牡丹籽油喷膜剂，其特征在于，所述紫草使用牡丹籽油冷浸、加热提取制备，以及紫草水、乙醇溶剂提取物的牡丹籽油溶液。
3.根据权利要求1所述的紫草牡丹籽油喷膜剂，其特征在于，所述聚乙烯吡咯烷酮为聚乙烯吡咯烷酮K15、K25、K30、K90中的至少一种。
4.根据权利要求1～3所述紫草牡丹籽油喷膜剂的制备方法，其特征在于，所述制备方法包括以下步骤：
(1)紫草药材使用牡丹籽油提取或紫草提取物溶解于牡丹籽油中，得溶液A；
(2)将聚乙烯吡咯烷酮加入乙醇溶液中，混匀得到溶液B；
(3)将壳聚糖盐酸盐和羟丙甲纤维素溶解于水中，得到溶液C；
(4)将溶液B加入到步骤(3)所得的溶液C中，搅拌均匀得到溶液D；
(5)将溶液A、薄荷脑、甘油、水加入步骤(4)所得的溶液D中，得所述紫草牡丹籽油喷膜剂。
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