CN113730499B - 一种中药组合物在制备治疗斑秃药物中的应用 - Google Patents
一种中药组合物在制备治疗斑秃药物中的应用 Download PDFInfo
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Abstract
本发明提供一种中药组合物在制备治疗斑秃药物中的应用,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,可使斑秃症状得到治疗,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斑秃药物中的应用。
背景技术
斑秃是一种非瘢痕性脱发,常发生于身体有毛发的部位,斑秃的病因目前尚不明确,可能与自身免疫因素、遗传因素、内分泌失调、精神心理因素等相关。斑秃可发生于任何年龄,男女发病率无明显差异,斑秃的皮损表现为圆形或卵圆形非瘢痕性脱发,严重者头发可出现全部脱落。脱发对患者的心理、工作和社会活动均产生严重影响。
斑秃的治疗目前比较困难,主要是局部和全身使用皮质类固醇、外用毛囊刺激剂如米诺地尔和皮质类固醇制剂等,这些方法虽有一定疗效,但有不同程度的副作用。目前少数重型病例治疗需要长期使用副作用较大的激素和免疫抑制剂,否则病情反复、迁延,皮质类固醇和T细胞抑制剂如环孢素A治疗斑秃有效, 但依赖性强, 减量和停药后易复发。故此,斑秃的治疗难点在于部分斑秃患者病情的复发性、进展性和儿童斑秃。
中医认为,脱发与人体五脏中的肝、肾、脾及气血有关. 发乃血之荣,没有充盈的血液,头发则无以滋养; 肝藏血,主疏泄,肝失疏泄则气机不畅,血不能随气濡养皮肤,毛孔舒张则发落;肾主骨,其荣在发;脾主运化,将水谷精微上输心肺而化为气血等重要生命物质。补血要注意气为血帅,血为气母,除了抓住补血不放外,还要紧密配合补气,补血能为头发提供物质基础,补气则为头发的生发提供动力,只有既补精血,又补气分才能相得益彰。
本发明通过药物配伍、标本兼治,可使斑秃症状得到治疗,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斑秃药物中的应用。
本发明提供治疗斑秃的中药组合物,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、生津的功效,重在养心阴,安心神,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,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,引诸脏之清气上荣于脑,使髓海得充,神气得养。诸药合用,养肝补肾,调和五脏功能,补中有通,益心血,养心神,补精血,补气分,气血流畅,诸症自除。用于治疗斑秃,以养肝补肾为基础,进一步补气养血、活血化察、理气通络,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斑秃,且具有较好的效果,可以提高患者的生活质量。
为证实本发明药物治疗斑秃的疗效,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100例斑秃患者为研究对象,随机将其分为对照组、治疗组、实验组1和实验组2,各25例。
①对照组男13例,女12例;年龄15~70岁,平均年龄(35±8.54)岁,
病程7~120d,平均病程(55±5.22)d;
②治疗组男12例,女13例;年龄15~71岁,平均年龄(36±0.27)岁;
病程10~121d,平均病程(53±8.99)d;
③实验1组男12例,女13例;年龄17~70岁,平均年龄(35±5.74岁;
病程10~125d,平均病程(54±3.19)d;
④实验2组男13例,女12例;年龄14~69岁,平均年龄(34±9.14岁;
病程8~118d,平均病程(54±6.53)d;。
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
参考1997年卫生部《中药新药临床研究指导原则》:中药新药治疗秃发症的临床研究指导原则。斑秃的诊断标准: ①突然或短期内头发片状脱落; ②脱发区皮色正常, 无明显的炎症反应;③脱发区皮肤未见萎缩及瘢痕。
1.3排除标准
①无法配合中药治疗者;②入选前4 周内接受过系统激素药物治疗者; ③入选前2 周内曾受过局部激素药物治疗者; ④假性斑秃与瘢痕性脱发;患有神经、精神疾病或严重内分泌疾病者;⑤其他系统性疾病和感染性疾病患者。
1.4治疗方法
四组均用生姜汁外搽局部皮损处, 3 次/d,对照组口服胱氨酸片100mg , 3次/日,维生素B6 片20mg , 3次/日;治疗组给予口服本发明药物,2支/次,3次/日;实验组1给予口服药物1,2支/次,3次/日;实验组2口服药物2,2支/次,3次/日;15天为一个疗程,总共4个疗程。
1.5疗效判定标准
(1)痊愈:脱发区新发全部生长;
显效:脱发区新发生长70% 以上;
有效:脱发区新发生长20% ~70 %;
无效:仍有头发脱落, 或脱发区无毛发长出或新发生长<20 %。
临床治疗总有效率=[(痊愈例数+显效例数+有效例数)/总例数]×100%。
(2)对痊愈患者进行为期1年的随访, 在随访期间患者又发现有新的秃发皮损为复发, 根据随访结果统计复发率。
1.6统计学方法
采用两样本比较秩和检验和两个样本率比较χ2检验进行统计学分析。
2结果
2.1治疗结果
治疗组患者治疗效果总有效率为92%, 显著高于对照组的60%,实验组1的总有效率达到68%以及实验组2的总有效率达到76%,差异具有统计学意义(P<0.05),见表1。
2.2四组患者复发效果比较
对照组有2例失访,治疗组有1例失访,实验组1有1例失访,实验组2有1例失访。治疗组患者复发率为12.5%, 显著低于对照组的62.5%,实验组1的复发率为41.7%以及实验组2的复发率为50%,差异具有统计学意义(P<0.05)。见表2。
2.3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。
3结论
本研究在四组患者用生姜汁外搽局部皮损处的基础上,加入本发明药物治疗后,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,总复发率显著低于对照组、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斑秃疗效显著。
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 (5)
1.一种中药组合物在制备治疗斑秃药物中的应用,其特征在于该中药组合物是由如下重量份的原料药制成: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。
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。
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。
4.根据权利要求1-3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。
5.根据权利要求1-3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。
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