CN108030862A - 一种口腔用中药膜剂及其制备方法 - Google Patents

一种口腔用中药膜剂及其制备方法 Download PDF

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CN108030862A
CN108030862A CN201711204577.4A CN201711204577A CN108030862A CN 108030862 A CN108030862 A CN 108030862A CN 201711204577 A CN201711204577 A CN 201711204577A CN 108030862 A CN108030862 A CN 108030862A
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张建华
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Qingdao Hengxin Pfizer Industrial Technology Co Ltd
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Abstract

本发明属于中药制备技术领域,具体公开一种口腔用中药膜剂及其制备方法。主要包括以下原料,按重量份数计:5~70份的原料药、30~100份的辅料,所述膜剂制作为面积为1cm2的正方形片状膜。本发明提供的口腔用中药膜剂既可附在粘膜表面,对粘膜起保护作用,又可使药物定位释放,使疗效提高。

Description

一种口腔用中药膜剂及其制备方法
发明领域
本发明属于中药制备技术领域,具体地说是涉及一种口腔用中药膜剂及其制备方法。
背景技术
膜剂是指药物或药材提取物溶解或混悬于适宜合成或天然成膜材料中经加工制成的薄膜状的内服、外用制剂。根据不同膜材和药物性能,以及临床用药要求,可以制成速效药膜或定量缓释药膜各种膜剂。
口腔溃疡是口腔粘膜疾病中的常见病,其发病机理常与病毒感染性疾病或与机体免疫功能失调有关。因病因复杂,临床上以对症治疗,局部用药为主的治疗方法。临床单用口服药疗效欠佳,过去常用的剂型有散剂、甘油剂、软膏剂等,虽然对治疗口腔溃疡具有一定的疗效,但也存在着使用不方便,药物易被唾液稀释,局部粘附性差等缺点,使治疗效果受到影响。
发明内容
为解决上述技术问题,本发明提供一种口腔用中药膜剂及其制备方法。本发明制备的口腔用中药膜剂既可附在粘膜表面,对粘膜起保护作用,又可使药物定位释放,使疗效提高。
为达到上述目的,本发明所采取的技术方案为:
一种口腔用中药膜剂,主要包括以下原料,按重量份数计:5~70份的原料药、30~100份的辅料,所述膜剂制作为面积为1cm2正方形片状膜。
优选地,在本发明的较佳实施例中,所述原料药按重量份数计,包括白及2~10份、地榆1~7份、人工牛黄0.15~0.35份、儿茶1.5~5份、黄连2~10份、冰片0.5~3份、荔枝草0.5~5份、白芷1~7份、连翘2~8份、松花粉0.5~1.5份、地黄2~8份、白蜡树叶0.5~2份。
优选地,在本发明的较佳实施例中,按重量份数计,所述辅料包括聚乙烯醇15~40份、羧甲基纤维素钠7~25份、甘油7~25份、吐温-802~8份。
另外,本发明提供了一种口腔用中药膜剂及其制备方法,包括以下步骤:
(1)膜材制备:
a.按配比称取所述聚乙烯醇和所述羧甲基纤维素钠,取所述聚乙烯醇加蒸馏水,水浴加热至75~85℃,搅拌使之溶解,得胶浆1;
b.取所述羧甲基纤维素钠加6~12倍蒸馏水研匀,得胶浆2;
c.称取所述白及研磨成粗粉,加入8~12倍蒸馏水浸泡2~4天,经常搅拌使充分浸透;过滤,得白及胶浆;
d.将所述胶浆1、所述胶浆2和所述白及胶浆混合,迅速搅拌均匀,过20目筛,然后置50~60℃水浴上保温,备用;
(2)配制药膜胶浆:称取除所述白及的所有原料药分别粉碎后过100~120目筛,加所述甘油混匀,再缓缓加入所述吐温-80,混合均匀至细腻状,倒入步骤(1)制得的膜浆中搅匀;
(3)制膜与干燥:将所述药膜胶浆搅拌混合均匀,静置,待混合液无气泡,铺板,涂一层液状石蜡,将药膜胶浆倒在上面,均匀拉膜成0.3~0.5mm厚薄膜,再于60~80℃通风干燥后,切割成面积为1cm2正方形片状膜,即得。
优选地,在本发明的较佳实施例中,步骤1-a中,所述聚乙烯醇与加入蒸馏水重量比为1:1。
写明口腔溃疡的治则和治法,并详细描述中药组合物的君臣佐使关系。
本发明的有益效果:
本发明制备的口腔用中药膜剂既可附在粘膜表面,对粘膜起保护作用,又可使药物定位释放,使疗效提高。用法主要为贴于口腔溃疡处或可用脓肿处,起消炎、愈合溃疡创面的作用。口腔的粘膜薄,面积大,较皮肤更易为药物穿透,粘膜下有大量毛细血管汇总至颈内静脉,不经过肝脏而直达心脏;口腔粘膜给药可避免肝脏的首过作用,提高药物利用度,并可随时终止用药。膜剂薄而软,较适合口腔内粘贴,并以溶解快、奏效迅速为其特点。白及天然植物的根茎内含大量粘液汁,与荔枝草、白芷、连翘、白蜡树叶等原料配合使用,具有止血、消炎、收敛之功效,作为防治口腔溃疡等病的膜剂的成膜材料较为理想。
具体实施方式
下面结合具体实施例对本发明所述技术方案作进一步的说明。
以下实施例中白及、地榆、人工牛黄、儿茶、黄连、冰片、荔枝草、白芷、连翘、松花粉、地黄、白蜡树叶来自于安国市桓荣中药材有限公司;
甘油和吐温-80来自于济南华赢化工有限公司;
聚乙烯醇和羧甲基纤维素钠来自于深圳市伯顺化工有限公司。
实施例1:
本发明的实施例1提供了一种口腔用中药膜剂,按重量份数计,主要包括5份原料药和30份辅料。
原料药按重量份数计,包括白及2份、地榆1份、人工牛黄0.15份、儿茶1.5份、黄连2份、冰片0.5份、荔枝草0.5份、白芷1份、连翘2份、松花粉0.5份、地黄2份、白蜡树叶0.5份。
辅料包括聚乙烯醇、羧甲基纤维素钠、甘油、吐温-80。
另外,本实施例还提供了一种口腔用中药膜剂及其制备方法,包括以下步骤:
(1)膜材制备:
a.称取15份聚乙烯醇,加入重量比为1:1的蒸馏水,水浴加热至75℃,搅拌使之溶解,得胶浆1;
b.取7份羧甲基纤维素钠加6倍蒸馏水研匀,得胶浆2;
c.称取2份白及研磨成粗粉,加入8倍蒸馏水浸泡2-4天,经常搅拌使充分浸透;过滤,得白及胶浆;
d.将胶浆1、胶浆2和白及胶浆混合,迅速搅拌均匀,过20目筛,然后置50℃水浴上保温,备用;
(2)配制药膜胶浆:称取除白及的所有原料药分别粉碎后过100目筛,加7份甘油混匀,再缓缓加入2份吐温-80,混合均匀至细腻状,倒入步骤(1)制得的膜浆中搅匀;
(3)制膜与干燥:将药膜胶浆搅拌混合均匀,静置,待混合液无气泡,铺板,涂一层液状石蜡,将药膜胶浆倒在上面,均匀拉膜成0.3mm厚薄膜,再于60℃通风干燥后,切割成面积为1cm2正方形片状膜,即得。
实施例2:
本发明的实施例2提供了一种口腔用中药膜剂,主要包括以下原料,按重量份数计:70份的原料药、100份的辅料。
原料药按重量份数计,包括白及10份、地榆7份、人工牛黄0.35份、儿茶5份、黄连10份、冰片3份、荔枝草5份、白芷7份、连翘8份、松花粉1.5份、地黄8份、白蜡树叶2份。
辅料包括聚乙烯醇、羧甲基纤维素钠、甘油、吐温-80。
另外,本实施例提供了一种口腔用中药膜剂及其制备方法,包括以下步骤:
(1)膜材制备:
a.称取40份聚乙烯醇,加入重量比为1:1的蒸馏水,水浴加热至85℃,搅拌使之溶解,得胶浆1;
b.取25份羧甲基纤维素钠加12倍蒸馏水研匀,得胶浆2;
c.称取10份白及研磨成粗粉,加入12倍蒸馏水浸泡4天,经常搅拌使充分浸透;过滤,得白及胶浆;
d.将胶浆1、胶浆2和白及胶浆混合,迅速搅拌均匀,过20目筛,然后置60℃水浴上保温,备用;
(2)配制药膜胶浆:称取除白及的所有原料药分别粉碎后过120目筛,加25份甘油混匀,再缓缓加入8份吐温-80,混合均匀至细腻状,倒入步骤(1)制得的膜浆中搅匀;
(3)制膜与干燥:将药膜胶浆搅拌混合均匀,静置,待混合液无气泡,铺板,涂一层液状石蜡,将药膜胶浆倒在上面,均匀拉膜成0.5mm厚薄膜,再于80℃通风干燥后,切割成面积为1cm2正方形片状膜,即得。
实施例3:
本发明的实施例3提供了一种口腔用中药膜剂,主要包括以下原料,按重量份数计:37份的原料药、65份的辅料。
原料药按重量份数计,包括白及6份、地榆4份、人工牛黄0.25份、儿茶3.2份、黄连6份、冰片1.7份、荔枝草2.7份、白芷4份、连翘5份、松花粉1份、地黄5份、白蜡树叶1.25份。
辅料包括聚乙烯醇、羧甲基纤维素钠、甘油、吐温-80。
另外,本实施例提供了一种口腔用中药膜剂及其制备方法,包括以下步骤:
(1)膜材制备:
a.称取27份聚乙烯醇,加入重量比为1:1的蒸馏水,水浴加热至80℃,搅拌使之溶解,得胶浆1;
b.取16份羧甲基纤维素钠加9倍蒸馏水研匀,得胶浆2;
c.称取6份白及研磨成粗粉,加入10倍蒸馏水浸泡3天,经常搅拌使充分浸透;过滤,得白及胶浆;
d.将胶浆1、胶浆2和白及胶浆混合,迅速搅拌均匀,过20目筛,然后置55℃水浴上保温,备用;
(2)配制药膜胶浆:称取除白及的所有原料药分别粉碎后过110目筛,加16份甘油混匀,再缓缓加入5份吐温-80,混合均匀至细腻状,倒入步骤(1)制得的膜浆中搅匀;
(3)制膜与干燥:将药膜胶浆搅拌混合均匀,静置,待混合液无气泡,铺板,涂一层液状石蜡,将药膜胶浆倒在上面,均匀拉膜成0.4mm厚薄膜,再于70℃通风干燥后,切割成面积为1cm2正方形片状膜,即得。
该膜剂治疗口腔溃疡效果考察:将60名患有口腔溃疡志愿者平均分为四组,一组使用冰硼散作为对照组,实施例1、2、3制备的膜剂分别贴附于志愿者口腔颊膜上,20分钟不脱落,口感好,无异物感,自觉无刺激性。
表1:疗效结果
组别 起效时间时间,min 口感 治愈率
冰硼散 5 刺激性气味 83%
实施例1 1.5 好,无异物感 96%
实施例2 2 好,无异物感 98%
实施例3 1 好,无异物感 99%
本发明制备的口腔用中药膜剂既可附在粘膜表面,对粘膜起保护作用,见效快,治愈率高。
以上所述仅为本发明的优选实施例而已,并不用于限制本发明,对于本领域的技术人员来说,本发明可以有各种更改和变化。凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。

Claims (5)

1.一种口腔用中药膜剂,其特征在于,主要包括以下原料,按重量份数计:5~70份的原料药、30~100份的辅料,所述膜剂制作为面积为1cm2正方形片状膜。
2.根据权利要求1所述的口腔用中药膜剂,其特征在于:所述原料药按重量份数计,包括白及2~10份、地榆1~7份、人工牛黄0.15~0.35份、儿茶1.5~5份、黄连2~10份、冰片0.5~3份、荔枝草0.5~5份、白芷1~7份、连翘2~8份、松花粉0.5~1.5份、地黄2~8份、白蜡树叶0.5~2份。
3.根据权利要求1所述的口腔用中药膜剂,其特征在于:按重量份数计,所述辅料包括聚乙烯醇15~40份、羧甲基纤维素钠7~25份、甘油7~25份、吐温-802~8份。
4.一种如权利要求1~3所述的口腔用中药膜剂及其制备方法,其特征在于,包括以下步骤:
(1)膜材制备:
a.按配比称取所述聚乙烯醇和所述羧甲基纤维素钠,取所述聚乙烯醇加蒸馏水,水浴加热至75~85℃,搅拌使之溶解,得胶浆1;
b.取所述羧甲基纤维素钠加6~12倍蒸馏水研匀,得胶浆2;
c.称取所述白及研磨成粗粉,加入8~12倍蒸馏水浸泡2~4天,经常搅拌使充分浸透;过滤,得白及胶浆;
d.将所述胶浆1、所述胶浆2和所述白及胶浆混合,迅速搅拌均匀,过20目筛,然后置50~60℃水浴上保温,备用;
(2)配制药膜胶浆:称取除所述白及的所有原料药分别粉碎后过100~120目筛,加所述甘油混匀,再缓缓加入所述吐温-80,混合均匀至细腻状,倒入步骤(1)制得的膜浆中搅匀;
(3)制膜与干燥:将所述药膜胶浆搅拌混合均匀,静置,待混合液无气泡,铺板,涂一层液状石蜡,将药膜胶浆倒在上面,均匀拉膜成0.3~0.5mm厚薄膜,再于60~80℃通风干燥后,切割成面积为1cm2正方形片状膜,即得。
5.根据权利要求4所述的口腔用中药膜剂制备方法,其特征在于:步骤1-a中,所述聚乙烯醇与加入蒸馏水重量比为1:1。
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Cited By (1)

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Publication number Priority date Publication date Assignee Title
CN109453141A (zh) * 2018-11-23 2019-03-12 无锡济民可信山禾药业股份有限公司 一种治疗慢性咽炎膜剂的制备方法

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109453141A (zh) * 2018-11-23 2019-03-12 无锡济民可信山禾药业股份有限公司 一种治疗慢性咽炎膜剂的制备方法
CN109453141B (zh) * 2018-11-23 2022-03-08 无锡济煜山禾药业股份有限公司 一种治疗慢性咽炎膜剂的制备方法

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