CN113925927B - 一种中药组合物在制备治疗复发性口腔溃疡药物中的应用 - Google Patents
一种中药组合物在制备治疗复发性口腔溃疡药物中的应用 Download PDFInfo
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Abstract
本发明提供一种中药组合物在制备治疗复发性口腔溃疡药物中的应用,所述药物是由以下原料制成:酸枣、桑椹、灵芝、百合、山楂、茯苓、陈皮、菊花、荷叶,经试验证实,本发明通过药物配伍、标本兼治,运用益气健脾、滋阴养血之法可使复发性口腔溃疡症状得到治疗,可减少复发的效果,且未发现明显毒副作用,有简、便、廉、效的优点,使得越来越多的患者易于接受,具有广阔的应用前景。
Description
技术领域
本发明涉及一种中药组合物的新用途,具体地,涉及一种中药组合物在制备治疗复发性口腔溃疡药物中的应用。
背景技术
复发性口腔溃疡( recurrent oral ulcer,ROU) 中医称之为“口疮”,是最常见的口腔黏膜溃疡类疾病,常发生于舌缘、唇和软腭等部位的黏膜处。该病是口腔黏膜疾病中最常见的溃疡类疾病,患病率高达20%左右,居口腔黏膜病首位。本病具有周期性、复发性、自限性特征,溃疡灼痛明显。虽无全身症状,但影响患者的说话与进食,不同程度地影响患者的身心、工作和生活质量。
复发性口腔溃疡病因复杂,目前病因及致病机制仍不明,无确切的实验室指标可作为诊断依据,缺乏统一的诊断标准,无特异性的药物,虽治疗方法多但疗效不够理想,治疗后复发率高。目前临床西医对该病的治疗尚无特效药物。使用维生素类药物治疗, 临床疗效不很满意; 口腔药膜贴患处, 虽局部止痛效果不错, 但只能治标,不能治本,且有些部位如舌根、软腭等处不易操作. 疗效不理想。
中医学认为: 脾开窍于口,上唇属脾,下唇属肾,舌为心之苗,心开窍于舌,又舌尖属心肺,舌背中央属脾胃,边缘属肝胆,舌根属肾,腮、颊、牙龈属胃肠,肾脉连咽系舌本。由此可见,口疮的发生与各脏腑的关系密切。中医认为心脾积热、阴虚火旺、脾胃湿热是ROU的主要发病机制,外以热毒为主,内以情志内伤,饮食不节,劳累过度,房室劳倦,先天禀赋不足等密切相关。
本发明通过药物配伍、标本兼治,运用益气健脾、滋阴养血之法可使复发性口腔溃疡症状得到治疗,可减少复发的效果,且未发现明显毒副作用,有简、便、廉、效的优点,使得越来越多的患者易于接受,具有广阔的应用前景。
发明内容
本发明涉及一种中药组合物的新用途,具体地,涉及一种中药组合物在制备治疗复发性口腔溃疡药物中的应用。
本发明提供治疗复发性口腔溃疡的中药组合物,该中药组合物是由如下重量份的原料药制成的:酸枣6-36份、桑椹6-36份、灵芝2-12份、百合1-6份、山楂2-12份、茯苓1-6份、陈皮1-6份、菊花2-12份、荷叶1-6份。
优选的中药组合物由如下重量份的原料药制成:酸枣30-36份、桑椹30-36份、灵芝10-12份、百合5-6份、山楂10-12份、茯苓5-6份、陈皮5-6份、菊花10-12份、荷叶5-6份。
优选的中药组合物由如下重量份的原料药制成:酸枣30份、桑椹30份、灵芝10份、百合5份、山楂10份、茯苓5份、陈皮5份、菊花10份、荷叶5份。
优选的中药组合物由如下重量份的原料药制成:酸枣36份、桑椹36份、灵芝10份、百合6份、山楂12份、茯苓6份、陈皮6份、菊花12份、荷叶6份。
本发明所述中药组合物的活性成分由以下步骤制成:
(1)按照原料药重量比例称取中药材,净选;
(2)将上述净选后药材混匀,粗粉,加9倍量水,浸泡1小时,加热煎煮2次,第一次1.5小时,第二次1小时,滤过,合并滤液,减压浓缩至60℃热测时相对密度为1.20-1.25的清膏,加乙醇静置、醇沉、过滤,滤液减压回收乙醇至无醇味,减压浓缩至60℃热测时相对密度1.02-1.06的流浸膏,干燥,即得活性成分。
本发明所述中药组合物的制剂剂型为胶囊剂、片剂、丸剂或口服液。
本发明所述的口服液的制备方法是由以下步骤制成:
(1)按照原料药重量比例称取中药材,净选;
(2)将上述净选后药材混匀,粗粉,加9倍量水,浸泡1小时,加热煎煮2次,第一次1.5小时,第二次1小时,滤过,合并滤液,减压浓缩至 60℃热测时相对密度为1.20-1.25的清膏,加乙醇静置、醇沉、过滤,滤液减压回收乙醇至无醇味,减压浓缩至60℃热测时相对密度1.02-1.06的流浸膏,备用;
(3)将步骤(2)所得流浸膏中加入药学上所接收的防腐剂,调解PH值至规定范围,加水调解浓度,搅匀、静置、滤过、灌封、灭菌,即得。
本发明药物组合物方中,酸枣为君药,具有补肝、宁心、敛汗、安神的功效,重在滋阴生津,以全酸枣入药,既广药源,又增效力;桑椹、灵芝、百合为臣药,补气,补血, 补肝肾阴精,滋阴润燥;山楂重在消食健胃,行气散瘀,使营血充足,益气健脾,茯苓、陈皮使气血足而养心神,菊花疏风除热,解疔毒,养肝明目,四者共为佐药;荷叶为使药,清心解暑、散瘀止血、消风祛湿的功效。诸药合用,养肝补肾,调和五脏功能,补中有通,益心血,养心神,以益气健脾、滋阴养血为基础,用于治疗复发性口腔溃疡,清热泻火、滋阴生津而达到生肌敛疮之效。不仅能够固本培元,还能增强患者身体机能。本发明配伍合理,简单易行,为纯中药制剂,不良反应小,可供病人长期使用。通过本研究发现本发明药物可以有效的治疗复发性口腔溃疡,且具有较好的效果,可以提高患者的生活质量,在减轻病人痛苦方面起到了极大的作用,且在减少口腔溃疡的复发上显出较大优势。
为证实本发明药物治疗复发性口腔溃疡的疗效,用按实施例1制得的口服液(以下称本发明药物)以及超出重量份的相同原料药组成的实验例1和替换功效相似的不同原料药组成的实验例2制得的口服液(以下称药物1、2),进行以下临床试验研究:
试验例
1、资料与方法
1.1 一般资料
选取2017年1月至2018年12月在河北以岭医院收治的200例复发性口腔溃疡患者为研究对象,随机将其分为对照组、治疗组、实验组1和实验组2,各50例。
①对照组男23例,女27例;年龄20~65岁,平均年龄(41±1.54)岁,病程0.5-16年,平均病程(7±4.48)年;
②治疗组男24例,女26例;年龄19~65岁,平均年龄(40±0.33)岁;
病程0.7~16年,平均病程(7±9.56)年;
③实验1组男24例,女26例;年龄20~66岁,平均年龄(40±7.74岁;
病程0.7~15年,平均病程(8±0.08)年;
④实验2组男25例,女25例;年龄19~64岁,平均年龄(39±9.95岁;
病程0.6~16年,平均病程(7±5.29)年;
四组患者的一般资料无显著差异(P>0.05)。此次研究得到我院伦理委员会批准,患者及家属对本研究内容均知情同意。
1.2纳入病例标准
参照《口腔黏膜病学》有关复发性口腔溃疡诊断标准:临床特征口腔黏膜溃疡反复发作、不定位、局部表现为红黄凹痛;身体其他部位无溃疡及糜烂。
1.3排除标准
①无法配合中药治疗者;②创伤性溃疡、白塞病等其他溃疡类型; ③重要脏器疾病、造血系统疾病、感染性疾病; ④对本研究使用的药物过敏者、妊娠期及哺乳期妇女。
1.4治疗方法
对照组给予复方氯己定含漱液, 10~20ml/次,早晚刷牙后含漱;治疗组在对照组的基础上给予口服本发明药物,2支/次,2次/日;实验组1在对照组的基础上给予口服药物1,2支/次,2次/日;实验组2在对照组的基础上口服药物2,2支/次,2次/日;,10天为1个疗程,总共3个疗程。
1.5疗效判定标准
参照《复发性阿弗他溃疡疗效评价试行标准》:
①无效:总口腔溃疡数未改变和口腔溃疡复发;
②有效:总间歇时间延长,总溃疡数无改变,或总间歇时间无改变,总溃疡数减少;
③显效:总间歇时间延长,总溃疡数减少;
④痊愈:患者临床症状完全消失,终止复发超过1 年。
临床治疗总有效率=[(痊愈例数+显效例数+有效例数)/总例数]×100%。
1.6统计学方法
采用SPSS20.0 统计软件对数据进行统计学分析。计数采用χ2 检验;使用方差分析对计量资料多组间均数进行比较;P < 0.05 为差异具有显著性。
治疗结果
治疗组患者治疗效果总有效率为90%, 显著高于对照组的76%,实验组1的78%以及实验组2的80%;治疗组患者治疗效果痊愈率为44%, 显著高于对照组的16%,实验组1的总有效率20%以及实验组2的14%,差异均具有统计学意义(P<0.05),见表1。
表1 四组患者治疗效果比较(n,%)
组别 | 例数 | 痊愈 | 显效 | 有效 | 无效 | 总有效率 |
对照组 | 50 | 8 | 14 | 16 | 12 | 76 |
治疗组 | 50 | 22 | 13 | 10 | 5 | 90* |
实验组1 | 50 | 10 | 17 | 12 | 11 | 78 |
实验组2 | 50 | 7 | 12 | 21 | 10 | 80 |
注:与对照组、实验组1、实验组2比较,*P<0.05
2.2不良反应
对照组、治疗组、实验组1和实验组2均未见不良反应。
结论
本研究在四组患者用复方氯己定含漱液的基础上,加入本发明药物以及药物1、2治疗后,治疗组的治疗效果的总有效率显著高于对照组、实验组1以及实验组2,治愈率显著高于对照组、实验组1以及实验组2,充分证明特定范围的重量份配比、特定药味组方的本发明药物用于治疗复发性口腔溃疡疗效显著。
具体实施方式
实施例1:
原料药配方为:酸枣300g 桑椹300g 灵芝100g 百合50g山楂100g 茯苓50g 陈皮50g 菊花100g 荷叶50g;
制备方法:
(1)按照处方量称取中药材,净选;
(2)将上述净选后药材混匀,粗粉,加9倍量水,浸泡1小时,加热煎 煮2次,第一次1.5小时,第二次1小时,滤过,合并滤液,减压浓缩至60 ℃热测时相对密度为1.20-1.25的清膏,加乙醇调节浓度至含醇量为70%,4℃以下静置24小时,过滤,滤液减压回收乙醇至无醇味,减压浓缩至60℃热测 时相对密度1.02-1.06的流浸膏,备用;
(3)将步骤(2)所得流浸膏中加入苯甲酸钠0.1g,调解PH值至3.5, 加水至100ml,搅匀、静置、滤过、灌封、灭菌,即得。
实施例2:
原料药配方为:酸枣360g 桑椹360g 灵芝100g 百合60g山楂120g 茯苓60g 陈皮60g 菊花120g 荷叶60g;
制备方法:
(1)按照处方量称取中药材,净选;
(2)将上述净选后药材混匀,粗粉,加9倍量水,浸泡1小时,加热煎 煮2次,第一次1.5小时,第二次1小时,滤过,合并滤液,减压浓缩至60 ℃热测时相对密度为1.20-1.25的清膏,加95%乙醇调节浓度至75%,4℃以 下静置24小时,过滤,滤液减压回收乙醇至无醇味,减压浓缩至60℃热测 时相对密度1.02-1.06的流浸膏,备用;
(3)将步骤(2)所得流浸膏干燥、粉碎、制粒,按常规方法压成100片片剂。
实施例3:
原料药配方为:酸枣60g 桑椹360g 灵芝20g 百合60g山楂20g 茯苓60g 陈皮10g菊花120g 荷叶10g;
制备方法:
(1)按照处方量称取中药材,净选;
(2)将上述净选后药材混匀,粗粉,加9倍量水,浸泡1小时,加热煎 煮2次,第一次1.5小时,第二次1小时,滤过,合并滤液,减压浓缩至60 ℃热测时相对密度为1.20-1.25的清膏,加95%乙醇调节浓度至75%,4℃以 下静置24小时,过滤,滤液减压回收乙醇至无醇味,减压浓缩至60℃热测 时相对密度1.02-1.06的流浸膏,备用;
(3)将步骤(2)所得流浸膏中加入苯甲酸钠0.1%,调解PH值至规定范围, 加水至100ml,搅匀、静置、滤过、灌封、灭菌,即得。
实验例1:
原料药配方为:酸枣390g 桑椹50g 灵芝10g 百合200g
山楂200g 茯苓170g 陈皮10g 菊花150g 荷叶100g;
制备方法:
((1)按照处方量称取中药材,净选;
(2)将上述净选后药材混匀,粗粉,加9倍量水,浸泡1小时,加热煎 煮2次,第一次1.5小时,第二次1小时,滤过,合并滤液,减压浓缩至60 ℃热测时相对密度为1.20-1.25的清膏,加乙醇调节浓度至含醇量为70%,4℃以下静置24小时,过滤,滤液减压回收乙醇至无醇味,减压浓缩至60℃热测 时相对密度1.02-1.06的流浸膏,备用;
(3)将步骤(2)所得流浸膏中加入苯甲酸钠0.1g,调解PH值至3.5, 加水至100ml,搅匀、静置、滤过、灌封、灭菌,即得。
实验例2:
原料药配方为:红枣300g 桑椹300g 人参100g 百合50g
麦芽100g 茯苓50g 陈皮50g 菊花100g 荷叶50g;
制备方法:
(1)按照处方量称取中药材,净选;
(2)将上述净选后药材混匀,粗粉,加9倍量水,浸泡1小时,加热煎 煮2次,第一次1.5小时,第二次1小时,滤过,合并滤液,减压浓缩至60 ℃热测时相对密度为1.20-1.25的清膏,加乙醇调节浓度至含醇量为70%,4℃以下静置24小时,过滤,滤液减压回收乙醇至无醇味,减压浓缩至60℃热测 时相对密度1.02-1.06的流浸膏,备用;
(3)将步骤(2)所得流浸膏中加入苯甲酸钠0.1g,调解PH值至3.5, 加水至100ml,搅匀、静置、滤过、灌封、灭菌,即得。
Claims (7)
1.一种中药组合物在制备治疗复发性口腔溃疡药物中的应用,其特征在于该中药组合物是由如下重量份的原料药制成的:酸枣6-36份、桑椹6-36份、灵芝2-12份、百合1-6份、山楂2-12份、茯苓1-6份、陈皮1-6份、菊花2-12份、荷叶1-6份。
2.根据权利要求1所述的应用,其特征在于所述中药组合物由如下重量份的原料药制成:酸枣30-36份、桑椹30-36份、灵芝10-12份、百合5-6份、山楂10-12份、茯苓5-6份、陈皮5-6份、菊花10-12份、荷叶5-6份。
3.根据权利要求1所述的应用,其特征在于所述中药组合物由如下重量份的原料药制成:酸枣30份、桑椹30份、灵芝10份、百合5份、山楂10份、茯苓5份、陈皮5份、菊花10份、荷叶5份。
4.根据权利要求1所述的应用,其特征在于所述中药组合物由如下重量份的原料药制成:酸枣36份、桑椹36份、灵芝10份、百合6份、山楂12份、茯苓6份、陈皮6份、菊花12份、荷叶6份。
5.根据权利要求1-4中任一项所述的应用,其特征在于所述中药组合物的活性成分由以下步骤制成:
(1)按照原料药重量比例称取中药材,净选;
(2)将上述净选后药材混匀,粗粉,加9倍量水,浸泡1小时,加热煎煮2次,第一次1.5小时,第二次1小时,滤过,合并滤液,减压浓缩至60℃热测时相对密度为1.20-1.25的清膏,加乙醇静置、醇沉、过滤,滤液减压回收乙醇至无醇味,减压浓缩至60℃热测时相对密度1.02-1.06的流浸膏,干燥,即得活性成分。
6.根据权利要求1-4任一所述的应用,其特征在于所述中药组合物的制剂剂型为胶囊剂、片剂、丸剂或口服液。
7.根据权利要求6所述的应用,其特征在于所述的口服液的制备方法是由以下步骤制成:
(1)按照原料药重量比例称取中药材,净选;
(2)将上述净选后药材混匀,粗粉,加9倍量水,浸泡1小时,加热煎煮2次,第一次1.5小时,第二次1小时,滤过,合并滤液,减压浓缩至 60℃热测时相对密度为1.20-1.25的清膏,加乙醇静置、醇沉、过滤,滤液减压回收乙醇至无醇味,备用;
(3)将步骤(2)所得浸膏中加入药学上所接收的防腐剂,调解PH值 至规定范围,加水调解浓度,搅匀、静置、滤过、灌封、灭菌,即得。
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