CN106421189A - 一种治疗口腔溃疡的中药复方贴膜剂及其制备工艺 - Google Patents
一种治疗口腔溃疡的中药复方贴膜剂及其制备工艺 Download PDFInfo
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Abstract
本发明涉及一种治疗口腔溃疡的中药复方贴膜剂及其膜剂的制备工艺,主要由黄芩苷、金银花、齿苋、射干、紫花地丁、丹皮、生地、葛根、天花粉、玄参、青黛等提取物制备而成;为纯天然中草药,依据中医基础理论,按照君臣佐使组方原则,配伍合理,用量得当,安全有效、无配伍禁忌,无耐药性,无毒副作用,各药协同配伍,共奏清热解毒,散瘀消肿,生肌止痛之功,适用于心脾积热、肺胃郁热、肝胆蕴热等实火上炎型的口腔溃疡,有效的解决当前治疗口腔溃疡药品的不足,临床效果显著。
Description
技术领域
本发明涉及一种治疗口腔溃疡的中药复方贴膜剂,同时还提供了该膜剂的制备工艺,属于中药复方制剂技术领域。
背景技术
口腔溃疡是临床上最常见的口腔粘膜病,主要表现为口腔内散在的椭圆形或圆形小糜烂面,周围充血水肿,患者自觉疼痛,影响日常生活。
口腔溃疡与中医“口疮”症状相似,将其病因归于火热(实火或虚火),与心脾两脏关系密切。嗜好烟酒咖啡,过食肥甘厚腻均可导致心脾积热、肺胃郁热,发为口疮,多为实证。故治疗上应以清热解毒,散瘀止痛为主。
目前西医主要采用免疫抑制剂或激素类的药物,这些药物适用于深大、久治不愈的溃疡,但用药后可能会产生较大的副作用及耐药性。中医药治疗口腔溃疡历史悠久,安全低廉,无耐药性,无毒副作用,疗效显著。
传统治疗口腔溃疡的剂型有散剂、甘油剂、软膏剂等,但这些剂型易被唾液稀释,局部黏附性差而影响疗效。而膜剂能粘附于黏膜表面,既可起到保护作用,又可起到定位释放,从而提高疗效,因此膜剂成为口腔溃疡药物剂型改革的新方向。
发明内容:
本发明提供一种治疗口腔溃疡的中药复方贴膜剂,方中以用清热解毒药为主,散瘀止痛、生津止渴药为辅,具有清热解毒,散瘀消肿,生肌止痛之功。全方安全有效、无配伍禁忌,无耐药性,无毒副作用,有效的解决当前治疗口腔溃疡药品的不足,临床效果显著。
本发明进一步提供了一种治疗口腔溃疡中药复方贴膜剂的制备工艺,制备工艺简单,可推广使用。本发明以PVA17-88(聚乙烯醇17-88)作为载药膜材料,PVA17-99作为空白膜材料,以甘油作为增塑剂,在单层膜的基础上外加背衬层,可保护药物免受唾液影响,使药物单向释放,增大药物浓度梯度,并可阻挡药物的不良口感。适用于心脾积热、肺胃郁热、肝胆蕴热等实火上炎型的口腔溃疡。
本发明的目的是要提供一种治疗口腔溃疡的中药复方贴膜剂,其特征在于,是由以下组分按质量分数比制成的:
载药膜:
黄芩苷0.5~5g、金银花提取物0.5~5g、马齿苋提取物0.5~5g、射干提取物0.5~5g、紫花地丁提取物0.5~5g、丹皮提取物0.5~5g、生地提取物0.5~3g、葛根提取物0.5~3g、天花粉提取物0.5~3g、玄参提取物0.5~3g、青黛0.5~3g、冰片0.2~3g、PVA17-88 1~6g、CMC-Na 1~9g、甘油0.15~10mL、水30~200mL;
空白膜:
PVA17-99 1~5g、甘油0~3mL、水10~40mL。
本发明所述的一种治疗口腔溃疡的中药复方贴膜剂,其优选配比为:
载药膜:
黄芩苷提取物2 g,金银花提取物1.5g,马齿苋提取物1.5g,射干提取物1.5g,紫花地丁提取物1.5g,丹皮提取物1.5g,生地提取物1g,葛根提取物1g,天花粉提取物1g,玄参提取物1g,青黛1g,冰片1g,PVA17-88 4g,CMC-Na 2g、甘油2.3mL,水90mL;
空白膜:
PVA17-99 3g、甘油1.5mL、水35mL。
本发明所述的一种治疗口腔溃疡的中药复方贴膜剂的制备方法,包括以下步骤:
取黄芩饮片加水煎煮3次,第1次加10倍水煎煮2小时,第2、3次加8倍水各煎煮1小时,合并煎液,滤过,滤液浓缩至适量;浓缩液在80°C时加入2moL/L盐酸溶液,调节pH值至1.0~2.0,保温1小时,静置24小时滤过;沉淀物加8倍量蒸馏水,用40%氢氧化钠溶液调节pH值至7.0~7.5,加等量乙醇搅拌使溶解,滤过;溶液用2moL/L盐酸溶液调节pH值至2.0,60℃保温30分钟,静置12小时滤过;沉淀用水洗pH值至5.0,继续用70% 乙醇洗至pH值7.0,加8倍量蒸馏水,加热至70℃,用40%氢氧化钠溶液调节pH值至7.0~7.5,搅拌使溶解;再用2moL/L盐酸溶液调节pH到6,加乙醇至溶液含醇量约70%,过滤;滤液再用2moL/L盐酸溶液调节pH为2,冷却静置,至完全沉淀,过滤、干燥,即为黄芩苷;
取金银花饮片,加水煎煮2次,每次1.5小时,合并煎液,滤过,浓缩至相对密度为1.20~1.25(70℃到80℃测得)的清膏;冷至40℃,搅拌下缓缓加入乙醇,使醇含量达到75%,静置12小时,滤取上清液,回收乙醇,浓缩液再加乙醇,使含醇含量达到85%,静置12小时,滤取上清液,回收乙醇至无醇味,低温干燥,粉碎;
取葛根,粉碎机粉碎成粗颗粒,加10倍水浸泡30min,微沸回流提取1.5小时,收集滤液;再加8倍水,微沸回流提取1.5小时,滤过,两次滤液合并,加热浓缩至清膏,喷雾干燥;
取生地饮片,加水煎煮3次,第一次加入10倍水,煎煮2小时,第二、三次加入8倍水,每次煎煮1.5小时,合并滤液,加热浓缩至清膏,喷雾干燥;
天花粉、射干,分别用粉碎机粉碎成粗颗粒,分别加入10、8、8倍水煎煮3次,每次煎煮时间为1.5、1、1小时,加热浓缩至清膏,分别喷雾干燥;
将玄参用粉碎机粉成粗颗粒,加入12倍量的60%乙醇回流提取3次,每次1.5小时,合并滤液,回收乙醇至无味,继续蒸干,收集固体;
取马齿苋,加入20倍量70%乙醇回流提取2次,每次1小时,合并滤液,回收乙醇至无味,继续蒸干,收集提取物;
取紫花地丁,加入10倍量的蒸馏水,浸泡30min,加热煎煮1.5小时,再加入8倍水,煎煮1小时,合并滤液,浓缩至清膏,喷雾干燥;
将丹参用粉碎机粉碎成粗颗粒,加入10倍量95%乙醇回流提取3次,每次1.5小时,合并滤液,回收乙醇至无味,继续蒸干,收集固体;
称取PVA17-88 4g,CMC-Na 2g,分别加入70mL、20mL的蒸馏水浸泡12小时充分溶胀,再将PVA17-88、CMC-Na分别置于85℃水浴上加热溶解,混合,保温30min后备用;
取冰片1g研细,与1g青黛混合均匀,再分别加入黄芩苷粉末2g,金银花提取物1.5g,马齿苋提取物1.5g,射干提取物1.5g,紫花地丁提取物1.5g,丹皮提取物1.5g,生地提取物1g,葛根提取物1g,天花粉提取物1g,玄参提取物1g,研磨均匀,然后,边研磨边分别加入PVA17-88胶浆、甘油,超声30min除去气泡;
称取PVA17-99 3g、甘油1.5mL、水35mL于水浴上加温使之溶化成胶浆,趁热用双层纱布过滤,保温30min待用;
于洁净室内将含药胶浆均匀涂布于涂有液状石蜡润滑剂的平板玻璃上,自然避光干燥约24h后,在膜面上涂以空白胶浆,同法干燥,脱膜,切割成适宜大小,在紫外灯下照射30min灭菌,密封于聚乙稀薄膜中。
选项应符合《2015版中国药典》膜剂项下。
【规格】:10片/盒
【用法用量】:局部贴用,2-4片/日。
【适应症】:适用于心脾积热、肺胃郁热、肝胆蕴热等实火上炎型的口腔溃疡。
本发明的药理药性如下:
黄芩,具有清热燥湿、泻火解毒、凉血止血、清热安胎,可用于治疗湿热中阻、湿热黄疸、湿热痢疾、肺热咳嗽、风热感冒、便血崩漏、胎动不安等,现代药理研究表明其具有抗菌抗病毒、抗炎、抗过敏之功;金银花,清热解毒、疏散风热、凉血止痢、清解暑热,可用于治疗疮疡初起红肿热痛、疔疮肿毒、热毒脱疽、肺痈、风热感冒、热毒血痢、咽喉肿痛、热疮、痱子、肝炎、口腔溃疡等,现代研究表明具有抗菌、抗病毒、解热抗炎之功;二者共为君药。马齿苋,清热解毒,散血消肿。治热痢脓血,热淋,血淋,带下,痈肿恶疮,丹毒等;射干,清热解毒、祛痰利咽、消瘀散结,用于热毒痰火郁结,咽喉肿痛,痰涎壅盛,咳嗽气喘; 紫花地丁,清热解毒、凉血消肿,主用于疔疮肿毒、痈疽发背、丹毒、毒蛇咬伤等;牡丹皮,清热、活血散瘀,主温热病热入血分、发斑吐衄、阴虚骨蒸潮热、痈肿疮毒、跌扑伤痛、风湿热痹等;玄参,具有清热凉血,泻火解毒,滋阴之功,可用于热病伤阴、舌绛烦渴、津伤便秘、骨蒸劳嗽、目赤、咽痛、瘰疬、白喉、痈肿疮毒;五药合用,具有清热解毒,凉血消肿,散瘀之功,为臣药。
葛根,具有解肌退热、透疹、生津止渴、升阳止泻之功,可用于表证发热、项背强痛,麻疹不透,热病口渴,阴虚消渴,热泻热痢,脾虚泄泻;生地具有清热凉血、益阴生津之功,可用于温热病热入营血,壮热神昏,口干舌绛;天花粉具体功效是清热泻火,生津止渴,排脓消肿。主治:治热病口渴、消渴、黄疸、肺燥咳血、痈肿、痔痿;青黛,清热解毒、凉血消斑、清肝泻火、定惊,治疗温毒发斑、痄腮喉痹、火毒疮疡、暑热惊痫、抽搐、抗菌、抗肿瘤;冰片,开窍醒神、清热止痛、防腐生肌、抗菌,治疗热病神昏、胸痹心痛、目赤肿痛、口舌生疮、咽喉肿痛等。五药合用,具有清热泻火、凉血滋阴、生津止渴、生肌止痛之功,共为佐药。本发明是依据中医基础理论,按照君臣佐使组方原则,配伍合理,用量得当,各药协同配伍,共奏清热解毒,散瘀消肿,生肌止痛之功。
本发明的积极效果在于:
本发明采用纯天然中草药,依据中医基础理论,按照君臣佐使组方原则,配伍合理,用量得当,安全有效、无配伍禁忌,无耐药性,无毒副作用,各药协同配伍,共奏清热解毒,散瘀消肿,生肌止痛之功,适用于心脾积热、肺胃郁热、肝胆蕴热等实火上炎型的口腔溃疡,有效的解决当前治疗口腔溃疡药品的不足,临床效果显著。
此外本发明以PVA17-88(聚乙烯醇17-88)作为载药膜材料,PVA17-99作为空白膜材料,以甘油作为增塑剂,在单层膜的基础上外加背衬层,可保护药物免受唾液影响,使药物单向释放,增大药物浓度梯度,并可阻挡药物的不良口感。贴膜剂制备工艺简单,可推广使用。
具体实施方式:
为使本发明更加容易理解,下面结合具体实施例,进一步阐述本发明。这些实施例只用于说明本发明而不用于限制本发明的范围。
实施例1:
载药膜:黄芩苷提取物2 g,金银花提取物1.5g,马齿苋提取物1.5g,射干提取物1.5g,紫花地丁提取物1.5g,丹皮提取物1.5g,生地提取物1g,葛根提取物1g,天花粉提取物1g,玄参提取物1g,青黛1g,冰片1g,PVA17-88 4g,CMC-Na 2g、甘油2.3mL,水90mL。
空白膜:PVA17-99 3g、甘油1.5mL、水35mL。
取黄芩饮片加水煎煮3次,第1次加10倍水煎煮2小时,第2、3次加8倍水各煎煮1小时,合并煎液,滤过,滤液浓缩至适量,浓缩液在80°C时加入2moL/L盐酸溶液,调节pH值至1.0~2.0,保温1小时,静置24小时滤过。沉淀物加8倍量蒸馏水,用40%氢氧化钠溶液调节pH值至7.0~7.5,加等量乙醇搅拌使溶解,滤过。溶液用2moL/L盐酸溶液调节pH值至2.0,60℃保温30分钟,静置12小时滤过。沉淀用水洗pH值至5.0,继续用70% 乙醇洗至pH值7.0,加8倍量蒸馏水,加热至70℃,用40%氢氧化钠溶液调节pH值至7.0~7.5,搅拌使溶解。再用2moL/L盐酸溶液调节pH到6,加乙醇至溶液含醇量约70%,过滤。滤液再用2moL/L盐酸溶液调节pH为2,冷却静置,至黄芩苷完全沉淀,过滤、干燥,即为黄芩苷。取金银花饮片,加水煎煮2次,每次1.5小时,合并煎液,滤过,浓缩至相对密度为1.20~1.25(70℃到80℃测得)的清膏。冷至40℃,搅拌下缓缓加入乙醇,使醇含量达到75%,静置12小时,滤取上清液,回收乙醇,浓缩液再加乙醇,使含醇含量达到85%,静置12小时,滤取上清液,回收乙醇至无醇味,低温干燥,粉碎。取葛根,粉碎机粉碎成粗颗粒,加10倍水浸泡30min,微沸回流提取1.5小时,收集滤液;再加8倍水,微沸回流提取1.5小时,滤过,两次滤液合并,加热浓缩至清膏,喷雾干燥。取生地饮片,加水煎煮3次,第一次加入10倍水,煎煮2小时,第二、三次加入8倍水,每次煎煮1.5小时,合并滤液,加热浓缩至清膏,喷雾干燥。天花粉、射干,分别用粉碎机粉碎成粗颗粒,分别加入10、8、8倍水煎煮3次,每次煎煮时间为1.5、1、1小时,加热浓缩至清膏,分别喷雾干燥。将玄参用粉碎机粉成粗颗粒,加入12倍量的60%乙醇回流提取3次,每次1.5小时,合并滤液,回收乙醇至无味,继续蒸干,收集固体。取马齿苋,加入20倍量70%乙醇回流提取2次,每次1小时,合并滤液,回收乙醇至无味,继续蒸干,收集提取物。取紫花地丁,加入10倍量的蒸馏水,浸泡30min,加热煎煮1.5小时,再加入8倍水,煎煮1小时,合并滤液,浓缩至清膏,喷雾干燥。将丹参用粉碎机粉碎成粗颗粒,加入10倍量95%乙醇回流提取3次,每次1.5小时,合并滤液,回收乙醇至无味,继续蒸干,收集固体。
称取PVA17-88 4g,CMC-Na 2g,分别加入70mL、20mL的蒸馏水浸泡12小时充分溶胀,再将PVA17-88、CMC-Na分别置于85℃水浴上加热溶解,混合,保温30min后备用。取冰片1g研细,与1g青黛混合均匀,再分别加入黄芩苷粉末2g,金银花提取物1.5g,马齿苋提取物1.5g,射干提取物1.5g,紫花地丁提取物1.5g,丹皮提取物1.5g,生地提取物1g,葛根提取物1g,天花粉提取物1g,玄参提取物1g,研磨均匀,然后边研磨边分别加入PVA17-88胶浆、甘油,超声30min除去气泡。称取PVA17-99 3g、甘油1.5mL、水35mL于水浴上加温使之溶化成胶浆,趁热用双层纱布过滤,保温30min待用。于洁净室内将含药胶浆均匀涂布于涂有液状石蜡润滑剂的平板玻璃上,自然避光干燥约24h后,在膜面上涂以空白胶浆,同法干燥,脱膜,切割成适宜大小,在紫外灯下照射30min灭菌,密封于聚乙稀薄膜中。
选项应符合《2015版中国药典》膜剂项下。
实施例2:
载药膜:黄芩苷0.5g,金银花提取物0.5g,马齿苋提取物0.5g,射干提取物0.5g,紫花地丁提取物0.5g,丹皮提取物0.5g,生地提取物0.5g,葛根提取物0.5g,天花粉提取物0.5g,玄参提取物0.5g,青黛0.5g,冰片0.2g,PVA17-88 1g,CMC-Na 1g、甘油0.15mL,水30mL。
空白膜:PVA17-99 1g、甘油0mL、水10mL。
取黄芩饮片加水煎煮3次,第1次加10倍水煎煮2小时,第2、3次加8倍水各煎煮1小时,合并煎液,滤过,滤液浓缩至适量,浓缩液在80°C时加入2moL/L盐酸溶液,调节pH值至1.0~2.0,保温1小时,静置24小时滤过。沉淀物加8倍量蒸馏水,用40%氢氧化钠溶液调节pH值至7.0~7.5,加等量乙醇搅拌使溶解,滤过。溶液用2moL/L盐酸溶液调节pH值至2.0,60℃保温30分钟,静置12小时滤过。沉淀用水洗pH值至5.0,继续用70% 乙醇洗至pH值7.0,加8倍量蒸馏水,加热至70℃,用40%氢氧化钠溶液调节pH值至7.0~7.5,搅拌使溶解。再用2moL/L盐酸溶液调节pH到6,加乙醇至溶液含醇量约70%,过滤。滤液再用2moL/L盐酸溶液调节pH为2,冷却静置,至黄芩苷完全沉淀,过滤、干燥,即为黄芩苷。取金银花饮片,加水煎煮2次,每次1.5小时,合并煎液,滤过,浓缩至相对密度为1.20~1.25(70℃到80℃测得)的清膏。冷至40℃,搅拌下缓缓加入乙醇,使醇含量达到75%,静置12小时,滤取上清液,回收乙醇,浓缩液再加乙醇,使含醇含量达到85%,静置12小时,滤取上清液,回收乙醇至无醇味,低温干燥,粉碎。取葛根,粉碎机粉碎成粗颗粒,加10倍水浸泡30min,微沸回流提取1.5小时,收集滤液;再加8倍水,微沸回流提取1.5小时,滤过,两次滤液合并,加热浓缩至清膏,喷雾干燥。取生地饮片,加水煎煮3次,第一次加入10倍水,煎煮2小时,第二、三次加入8倍水,每次煎煮1.5小时,合并滤液,加热浓缩至清膏,喷雾干燥。天花粉、射干,分别用粉碎机粉碎成粗颗粒,分别加入10、8、8倍水煎煮3次,每次煎煮时间为1.5、1、1小时,加热浓缩至清膏,分别喷雾干燥。将玄参用粉碎机粉成粗颗粒,加入12倍量的60%乙醇回流提取3次,每次1.5小时,合并滤液,回收乙醇至无味,继续蒸干,收集固体。取马齿苋,加入20倍量70%乙醇回流提取2次,每次1小时,合并滤液,回收乙醇至无味,继续蒸干,收集提取物。取紫花地丁,加入10倍量的蒸馏水,浸泡30min,加热煎煮1.5小时,再加入8倍水,煎煮1小时,合并滤液,浓缩至清膏,喷雾干燥。将丹参用粉碎机粉碎成粗颗粒,加入10倍量95%乙醇回流提取3次,每次1.5小时,合并滤液,回收乙醇至无味,继续蒸干,收集固体。
称取PVA17-88 1g,CMC-Na 1g,分别加入20mL、10mL的蒸馏水浸泡12小时充分溶胀,再将PVA17-88、CMC-Na分别置于85℃水浴上加热溶解,混合,保温30min后备用。取冰片0.2g研细,与0.5g青黛混合均匀,再分别加入黄芩苷粉末0.5g,金银花提取物0.5g,马齿苋提取物0.5g,射干提取物0.5g,紫花地丁提取物0.5g,丹皮提取物0.5g,生地提取物0.5~g,葛根提取物0.5g,天花粉提取物0.5g,玄参提取物0.5g,研磨均匀,然后边研磨边分别加入PVA17-88胶浆、甘油,超声30min除去气泡。称取PVA17-99 1g、水10mL于水浴上加温使之溶化成胶浆,趁热用双层纱布过滤,保温30min待用。于洁净室内将含药胶浆均匀涂布于涂有液状石蜡润滑剂的平板玻璃上,自然避光干燥约24h后,在膜面上涂以空白胶浆,同法干燥,脱膜,切割成适宜大小,在紫外灯下照射30min灭菌,密封于聚乙稀薄膜中。
选项应符合《2015版中国药典》膜剂项下。
实施例3:
载药膜:黄芩苷5g,金银花提取物5g,马齿苋提取物5g,射干提取物5g,紫花地丁提取物5g,丹皮提取物5g,生地提取物3g,葛根提取物3g,天花粉提取物3g,玄参提取物3g,青黛3g,冰片3g,PVA17-88 6g,CMC-Na 9g、甘油10mL,水200mL。
空白膜:PVA17-99 5g、甘油3mL、水40mL。
取黄芩饮片加水煎煮3次,第1次加10倍水煎煮2小时,第2、3次加8倍水各煎煮1小时,合并煎液,滤过,滤液浓缩至适量,浓缩液在80°C时加入2moL/L盐酸溶液,调节pH值至1.0~2.0,保温1小时,静置24小时滤过。沉淀物加8倍量蒸馏水,用40%氢氧化钠溶液调节pH值至7.0~7.5,加等量乙醇搅拌使溶解,滤过。溶液用2moL/L盐酸溶液调节pH值至2.0,60℃保温30分钟,静置12小时滤过。沉淀用水洗pH值至5.0,继续用70% 乙醇洗至pH值7.0,加8倍量蒸馏水,加热至70℃,用40%氢氧化钠溶液调节pH值至7.0~7.5,搅拌使溶解。再用2moL/L盐酸溶液调节pH到6,加乙醇至溶液含醇量约70%,过滤。滤液再用2moL/L盐酸溶液调节pH为2,冷却静置,至黄芩苷完全沉淀,过滤、干燥,即为黄芩苷。取金银花饮片,加水煎煮2次,每次1.5小时,合并煎液,滤过,浓缩至相对密度为1.20~1.25(70℃到80℃测得)的清膏。冷至40℃,搅拌下缓缓加入乙醇,使醇含量达到75%,静置12小时,滤取上清液,回收乙醇,浓缩液再加乙醇,使含醇含量达到85%,静置12小时,滤取上清液,回收乙醇至无醇味,低温干燥,粉碎。取葛根,粉碎机粉碎成粗颗粒,加10倍水浸泡30min,微沸回流提取1.5小时,收集滤液;再加8倍水,微沸回流提取1.5小时,滤过,两次滤液合并,加热浓缩至清膏,喷雾干燥。取生地饮片,加水煎煮3次,第一次加入10倍水,煎煮2小时,第二、三次加入8倍水,每次煎煮1.5小时,合并滤液,加热浓缩至清膏,喷雾干燥。天花粉、射干,分别用粉碎机粉碎成粗颗粒,分别加入10、8、8倍水煎煮3次,每次煎煮时间为1.5、1、1小时,加热浓缩至清膏,分别喷雾干燥。将玄参用粉碎机粉成粗颗粒,加入12倍量的60%乙醇回流提取3次,每次1.5小时,合并滤液,回收乙醇至无味,继续蒸干,收集固体。取马齿苋,加入20倍量70%乙醇回流提取2次,每次1小时,合并滤液,回收乙醇至无味,继续蒸干,收集提取物。取紫花地丁,加入10倍量的蒸馏水,浸泡30min,加热煎煮1.5小时,再加入8倍水,煎煮1小时,合并滤液,浓缩至清膏,喷雾干燥。将丹参用粉碎机粉碎成粗颗粒,加入10倍量95%乙醇回流提取3次,每次1.5小时,合并滤液,回收乙醇至无味,继续蒸干,收集固体。
称取PVA17-88 6g,CMC-Na 9g,分别加入100mL的蒸馏水浸泡12小时充分溶胀,再将PVA17-88、CMC-Na分别置于85℃水浴上加热溶解,混合,保温30min后备用。取冰片3g研细,与3g青黛混合均匀,再分别加入黄芩苷粉末5g,金银花提取物5g,马齿苋提取物5g,射干提取物5g,紫花地丁提取物5g,丹皮提取物5g,生地提取物3g,葛根提取物3g,天花粉提取物3g,玄参提取物3g研磨均匀,然后边研磨边分别加入PVA17-88胶浆、甘油,超声30min除去气泡。称取PVA17-99 5g、甘油3mL、水40mL于水浴上加温使之溶化成胶浆,趁热用双层纱布过滤,保温30min待用。于洁净室内将含药胶浆均匀涂布于涂有液状石蜡润滑剂的平板玻璃上,自然避光干燥约24h后,在膜面上涂以空白胶浆,同法干燥,脱膜,切割成适宜大小,在紫外灯下照射30min灭菌,密封于聚乙稀薄膜中。
选项应符合《2015版中国药典》膜剂项下。
实验例:
使用本发明治疗口腔溃疡患者50例,其中女性28例,男性22例,涉及年龄段为18~65岁,通过中医辨证确诊为心脾积热、肺胃郁热、肝胆蕴热等实火上炎型的口腔溃疡。根据溃疡个数,取用相应数量的膜剂贴敷,每日2~4次,用药3天为一个疗程,根据病情可连续使用1~2个疗程,观察治疗效果。
典型实验例1:
李某,女,22岁,有口腔溃疡反复发作病史,近期再次发作,位于口腔颊粘膜可见1个溃疡面,直径2mm,呈椭圆形,周界清晰,周围有充血、红肿,溃疡中央凹陷,灼痛,同时伴有口鼻干燥,口渴欲饮,尿赤便干,舌尖红,脉细数。连续使用实施例1制备的贴膜1个疗程后,溃疡面基本愈合,周围红肿消失,灼痛感消失,口不干,二便正常。
典型实验例2:
张某,女,28岁,分别于口腔颊黏膜、唇粘膜处出现溃疡,溃疡面直径分别为5mm、3mm,周围有充血、红肿、渗出,疼痛难忍,同时伴有头痛,心烦失眠,易怒,口苦咽干,尿赤便干,舌红苔黄,脉滑数。连续使用实施例1制备的贴膜1个疗程后,溃疡面显著缩小,周围红肿渗出减轻,疼痛减轻,继续使用2天后,溃疡面基本愈合。
典型实验例3:
蔡某,男,37岁,有反复发作口腔溃疡史,近期因嗜食辛辣食物诱发,与口唇粘膜处有一直径3mm溃疡,周围充血、红肿,边缘整齐,基部不硬,溃疡面覆盖淡黄色假膜,进食疼痛,同时伴有咽喉肿痛,牙龈充血红肿,口干口渴,烦躁易怒,尿黄便干,舌红苔黄,脉数。连续使用实施例1制备的贴膜1个疗程后,溃疡面显著缩小,疼痛减轻,周围红肿减轻,咽喉肿痛及牙龈红肿也有所减轻,继续使用1天后,溃疡面基本愈合。
典型实验例4:
胡某,男,64岁,口腔溃疡反复发作病史,近期再次复发,于颊粘膜处可见一直径约5mm的溃疡面,病程5天,周围红肿,充血,疼痛,影响进食,同时伴有眩晕耳鸣,口干口渴,大便粘滞,舌红有裂纹,脉滑数。连续使用实施例1制备的贴膜1个疗程后,溃疡范围有所减小,周围红肿减轻,此后又继续使用1个疗程,溃疡面基本愈合,疼痛感消失。
典型实验例5:
杨某,女,18岁,近期学习压力较大,突然出现口腔粘膜疼痛,并可见一直径约2mm的溃疡,周围红肿,口干,舌尖红,脉细数。连续使用实施例1制备的贴膜2天,溃疡范围并未继续扩展,反而出现周围红肿消失,溃疡面愈合,疼痛感消失。
典型实验例6:
赵某,男,45岁,有反复发作口腔溃疡病史,且每次发作需10天以上才能自愈,嗜好烟酒。今日于大量饮酒后,口唇粘膜出现2处溃疡,直径约4mm,周围红肿,边缘整齐,疼痛难忍,影响饮食,同时伴有口臭,大便粘滞不爽,舌红苔黄腻,脉滑数。连续使用实施例1制备的贴膜1个疗程后,溃疡面显著缩小,疼痛减轻,继续使用2天后,溃疡基本愈合。
经6例典型患者临床验证,该治疗口腔溃疡中药复方口腔溃疡贴膜剂,具有清热解毒,散瘀消肿,生肌止痛之功,适用于心脾积热、肺胃郁热、肝胆蕴热等实火上炎型的口腔溃疡,可减轻溃疡面充血、渗出,促进溃疡面愈合。此外,本发明制备的膜剂,工艺简单,质量稳定,使用方便,可使药物长时间在口腔停留,最大程度的发挥药效,可以推广使用。
Claims (3)
1.一种治疗口腔溃疡的中药复方贴膜剂,其特征在于,是由以下组分按质量分数比制成的:
载药膜:
黄芩苷0.5~5g、金银花提取物0.5~5g、马齿苋提取物0.5~5g、射干提取物0.5~5g、紫花地丁提取物0.5~5g、丹皮提取物0.5~5g、生地提取物0.5~3g、葛根提取物0.5~3g、天花粉提取物0.5~3g、玄参提取物0.5~3g、青黛0.5~3g、冰片0.2~3g、PVA17-88 1~6g、CMC-Na 1~9g、甘油0.15~10mL、水30~200mL;
空白膜:
PVA17-99 1~5g、甘油0~3mL、水10~40mL。
2.如权利要求1所述的一种治疗口腔溃疡的中药复方贴膜剂,其优选配比为:
载药膜:
黄芩苷提取物2 g,金银花提取物1.5g,马齿苋提取物1.5g,射干提取物1.5g,紫花地丁提取物1.5g,丹皮提取物1.5g,生地提取物1g,葛根提取物1g,天花粉提取物1g,玄参提取物1g,青黛1g,冰片1g,PVA17-88 4g,CMC-Na 2g、甘油2.3mL,水90mL;
空白膜:
PVA17-99 3g、甘油1.5mL、水35mL。
3.如权利要求1或2所述的一种治疗口腔溃疡的中药复方贴膜剂的制备方法,包括以下步骤:
取黄芩饮片加水煎煮3次,第1次加10倍水煎煮2小时,第2、3次加8倍水各煎煮1小时,合并煎液,滤过,滤液浓缩至适量;浓缩液在80°C时加入2moL/L盐酸溶液,调节pH值至1.0~2.0,保温1小时,静置24小时滤过;沉淀物加8倍量蒸馏水,用40%氢氧化钠溶液调节pH值至7.0~7.5,加等量乙醇搅拌使溶解,滤过;溶液用2moL/L盐酸溶液调节pH值至2.0,60℃保温30分钟,静置12小时滤过;沉淀用水洗pH值至5.0,继续用70% 乙醇洗至pH值7.0,加8倍量蒸馏水,加热至70℃,用40%氢氧化钠溶液调节pH值至7.0~7.5,搅拌使溶解;再用2moL/L盐酸溶液调节pH到6,加乙醇至溶液含醇量约70%,过滤;滤液再用2moL/L盐酸溶液调节pH为2,冷却静置,至完全沉淀,过滤、干燥,即为黄芩苷;
取金银花饮片,加水煎煮2次,每次1.5小时,合并煎液,滤过,浓缩至相对密度为1.20~1.25(70℃到80℃测得)的清膏;冷至40℃,搅拌下缓缓加入乙醇,使醇含量达到75%,静置12小时,滤取上清液,回收乙醇,浓缩液再加乙醇,使含醇含量达到85%,静置12小时,滤取上清液,回收乙醇至无醇味,低温干燥,粉碎;
取葛根,粉碎机粉碎成粗颗粒,加10倍水浸泡30min,微沸回流提取1.5小时,收集滤液;再加8倍水,微沸回流提取1.5小时,滤过,两次滤液合并,加热浓缩至清膏,喷雾干燥;
取生地饮片,加水煎煮3次,第一次加入10倍水,煎煮2小时,第二、三次加入8倍水,每次煎煮1.5小时,合并滤液,加热浓缩至清膏,喷雾干燥;
天花粉、射干,分别用粉碎机粉碎成粗颗粒,分别加入10、8、8倍水煎煮3次,每次煎煮时间为1.5、1、1小时,加热浓缩至清膏,分别喷雾干燥;
将玄参用粉碎机粉成粗颗粒,加入12倍量的60%乙醇回流提取3次,每次1.5小时,合并滤液,回收乙醇至无味,继续蒸干,收集固体;
取马齿苋,加入20倍量70%乙醇回流提取2次,每次1小时,合并滤液,回收乙醇至无味,继续蒸干,收集提取物;
取紫花地丁,加入10倍量的蒸馏水,浸泡30min,加热煎煮1.5小时,再加入8倍水,煎煮1小时,合并滤液,浓缩至清膏,喷雾干燥;
将丹参用粉碎机粉碎成粗颗粒,加入10倍量95%乙醇回流提取3次,每次1.5小时,合并滤液,回收乙醇至无味,继续蒸干,收集固体;
称取PVA17-88 4g,CMC-Na 2g,分别加入70mL、20mL的蒸馏水浸泡12小时充分溶胀,再将PVA17-88、CMC-Na分别置于85℃水浴上加热溶解,混合,保温30min后备用;
取冰片1g研细,与1g青黛混合均匀,再分别加入黄芩苷粉末2g,金银花提取物1.5g,马齿苋提取物1.5g,射干提取物1.5g,紫花地丁提取物1.5g,丹皮提取物1.5g,生地提取物1g,葛根提取物1g,天花粉提取物1g,玄参提取物1g,研磨均匀,然后,边研磨边分别加入PVA17-88胶浆、甘油,超声30min除去气泡;
称取PVA17-99 3g、甘油1.5mL、水35mL于水浴上加温使之溶化成胶浆,趁热用双层纱布过滤,保温30min待用;
于洁净室内将含药胶浆均匀涂布于涂有液状石蜡润滑剂的平板玻璃上,自然避光干燥约24h后,在膜面上涂以空白胶浆,同法干燥,脱膜,切割成适宜大小,在紫外灯下照射30min灭菌,密封于聚乙稀薄膜中。
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