CN106362119A - 一种含有人参的生发搽剂及其制备方法 - Google Patents
一种含有人参的生发搽剂及其制备方法 Download PDFInfo
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- CN106362119A CN106362119A CN201610947624.3A CN201610947624A CN106362119A CN 106362119 A CN106362119 A CN 106362119A CN 201610947624 A CN201610947624 A CN 201610947624A CN 106362119 A CN106362119 A CN 106362119A
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- hair growth
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Abstract
本发明涉及一种含有人参的生发搽剂及其制备方法,该含有人参的生发搽剂是由下述重量份中药原料配制而成:人参20‑25份、丹参20‑25份、酸枣仁8‑10份、当归12‑18份、红花11‑15份、补骨脂11‑15份、侧柏叶20‑25份、生姜10‑13份、天花粉5‑7份、地肤子3‑5份、蔓荆子3‑5份、薄荷1‑2份、冰片0.5‑1.2份、平平加0.1‑0.2份。该生发搽剂益气补血,活血通络,生发乌发。用于气血两虚,血瘀阻滞所致的脱发或斑秃症;并有乌发作用。同时,本发明的制备方法使原料药材能充分利用,并在使用过程中能使药物充分被皮肤吸收,安全有效无副作用。
Description
技术领域
本发明涉及一种外敷中药,特别涉及一种含有人参的生发搽剂及其制备方法,属药物领域。
背景技术
随着现在社会工作生活压力的增加以及生活习惯的无规律性,脱发患者越来越多,由于造成脱发的因素很多,因此治疗脱发的外用搽剂也多种多样,但都很难做到对因治疗,而导致效果不佳。
经研究发现造成脱发两个主要因素是:一是血虚脱发;一是因情志等因素所致的斑秃。血虚脱发:“发为血之余”是中医基础理论的重要观点,意思是说,头发是人体气血的外露部分,又是脏腑的一面镜子。因为头发乌黑与萎黄或稀疏能即时反映出体内气血的盈亏和脏腑功能的盛衰,所以血虚是脱发的主要病根。但其生机都归根于肾。肾精充沛,毛发就光泽,肾气虚衰,毛发白而脱落。因为“肾主骨髓”,肾精足则血旺盛,血旺盛则毛发得以润养而生生不息;所以《素问·五脏生成篇》讲:“肾之合骨也,其荣发也”,就说明了头发与肾的生理关系,血虚肝肾亏虚脱发。斑秃:本病因突然脱发,或在一夜间,突然局部或大片脱发,皮肤鲜红光亮,故名“油风”,《外科正宗》说:“油风乃血虚不能随气荣养肌肤,故毛发根空脱落或片,皮肤光亮,痒如虫行,此皆多因情绪受到较大刺激,风热乘虚攻注而然”。油风可发生在任何年龄。斑秃发生的病因病机,多由于血虚不能随气濡养皮肤,以致毛孔张开,风邪乘虚袭入,风盛血燥,发失所养而成片脱落,或因情志抑郁,肝气郁结,过分劳累,心气乃伤,气滞血瘀,毛发失养所致;又因肝藏血,发为血之余,肾主骨,其荣在发,肝肾不足,亦能导致脱发。
目前为止,尤其是针对上述两种情况的脱发的药物并不多,现有的化学制剂副作用大,容易过敏,而一些中药制剂,中药利用率低,而且疗效不明显。
发明内容
本发明的目的是:提供一种含有人参的生发搽剂及其制备方法,该生发搽剂益气补血,活血通络,生发乌发。用于气血两虚,血瘀阻滞所致的脱发或斑秃症;并有乌发作用。同时,本发明的制备方法使原料药材能充分利用,并在使用过程中能使药物充分被皮肤吸收,安全有效无副作用。
本发明的技术方案是:一种含有人参的生发搽剂,其特征是:它是由下述重量份中药原料配制而成:人参20-25份、丹参20-25份、酸枣仁8-10份、当归12-18份、红花11-15份、补骨脂11-15份、侧柏叶20-25份、生姜10-13份、天花粉5-7份、地肤子3-5份、蔓荆子3-5份、薄荷1-2份、冰片0.5-1.2份、平平加0.1-0.2份。
所述的一种含有人参的生发搽剂,其特征是:它是由下述重量份中药原料配制而成:人参22份、丹参22份、酸枣仁9份、当归16份、红花13份、补骨脂13份、侧柏叶22份、生姜11份、天花粉6份、地肤子4份、蔓荆子4份、薄荷1.5份、冰片1份、平平加0.15份。
一种含有人参的生发搽剂的制备方法,其特征是:该方法包括如下步骤:
1)、按下述重量份称取原料:
人参20-25份、丹参20-25份、酸枣仁8-10份、当归12-18份、红花11-15份、补骨脂11-15份、侧柏叶20-25份、生姜10-13份、天花粉5-7份、地肤子3-5份、蔓荆子3-5份、薄荷1-2份、冰片0.5-1.2份、平平加0.1-0.2份;
2)取配方量的人参、丹参、酸枣仁、当归、红花、补骨脂、侧柏叶、地肤子、蔓荆子九味药材混合打粗粉;取配方量的生姜切薄片;取配方量的冰片研粉备用;
3)将步骤2)中混合后的粗粉、生姜薄片与配方量的天花粉混合,加6倍量质量百分比浓度为60%的乙醇,浸渍10天,每隔2-4天搅拌一次,取上清液滤过,得滤液备用;
4)将步骤3)的药渣再加4倍量质量百分比浓度为60%的乙醇,浸渍10天,每隔2-4天搅拌一次,取上清液滤过,滤液,并将此次过滤后的药渣进行压榨得药液;备用;
5)将步骤4)的滤液、压榨的药液和步骤3)的滤液合并得混合液,备用;
6)取配方量的冰片研粉,用质量百分比浓度为95%的乙醇少许溶解,
7)步骤6)溶解后的冰片与配方量薄荷和平平加加至步骤5)的混合液中,充分搅拌;
8)在步骤7)所得的混合液中加入占该混合液总量2%的氮酮,搅拌均匀,静置沉淀48小时天,滤过,加质量百分比浓度为60%的乙醇至10000ml,分装,即得。
本发明的优点是:
本发明的生发搽剂的各原料成份经反复筛选并科学配伍所得,该方人参、当归为君药。人参性味甘,微苦,平。归肺、脾、心经。补气;当归性味甘、辛,温。归肝、心、脾经。补血;二药同用,气血双补。臣药为丹参、红花。丹参,祛瘀止痛,活血通经,还有补血之力;红花活血通经,散瘀止痛。两味臣药以活血化瘀,通经络为主,君药当归养血之中也有活血作用。当归与丹参,红花配伍,再加君药人参之益气作用,加强了活血通经络的作用。酸枣仁、补骨脂、侧柏叶、生姜、地肤子、蔓荆子、天花粉、薄荷和冰片为佐使药。酸枣仁能养血安神药;侧柏叶能凉血,生发乌发;补骨脂归肾、脾经,温阳助气;生姜归肺、脾、胃经,外用能使脱发处皮肤充血,毛细血管扩张,增加皮肤血流量,改善微循环,从而促使新发生长;地肤子治阴虚血亏,并且有抑菌作用;蔓荆子疏散风热,清利头目;天花粉味甘、微苦,性微寒,生津润燥、降火消肿,助君臣润补“体亏(肝血虚、肾阴少)”之弊;冰片辛、苦,微寒,外用有消肿止痛,止痒生肌的作用,它与生姜同用,可以加强对皮肤的刺激,加强毛细血管的扩张,增加皮肤的供血量,加快毛发的生长;薄荷促进血液循环;
总之,诸药合用,通过生姜、冰片的刺激皮肤作用,促使君臣药物渗入皮肤,起到补气补血生发的作用;同时添加了平平加,由于平平加具有良好的湿润性能和分散性,便于药物的充分混合。在制备过程中添加了药用辅料氮酮,促进药物经皮肤吸收能力,使药物的疗效能显著提高。
下面结合实施例对本发明做进一步说明,但不作为对本发明的限定。
具体实施方式
实施例1
1、处方:
一种含有人参的生发搽剂是由下述重量中药原料配制而成:人参22份、丹参22份、酸枣仁9份、当归16份、红花13份、补骨脂13份、侧柏叶22份、生姜11份、天花粉6份、地肤子4份、蔓荆子4份、薄荷1.5份、冰片1份、平平加0.15份;
2、提取工艺优选:
1)搽剂是临床治疗常用的外用液体制剂,处方中药味所含有效成分均具有较好的醇、水溶性,故采用一定比例的乙醇水混合溶液为提取溶媒,选用局部外用搽剂,可促进头部血液循环,增加毛发营养和新陈代谢,使脱发部位逐渐生长,白发逐渐转黑之作用,达到生发乌发目的。
2)吸溶剂率的考察
取配方量的人参、丹参、酸枣仁、当归、红花、补骨脂、侧柏叶、地肤子、蔓荆子、生姜和天花粉药材,准确加入10倍量60%乙醇液密闭浸渍提取12h,滤过,量取滤液,按以下公式计算吸水率,见表1。
表1吸溶剂率测定结果
吸溶剂率=(加溶剂量-滤液量)/药材量
从表1可见,药材的吸醇量为自身重量的1.47倍,因此在正交试验中第1次加水量需多加2倍量的浸渍提取液较合适。
3)浸渍提取正交实验
为优化浸渍提取工艺,按本发明生发搽剂处方比例,称取处方中药材共109g,按试验设计,以提取次数(A)、提取时间(B)、提取溶剂用量(C)、乙醇浓度(D)四个因素作为工艺考察指标,按照L9(34)正交试验设计每一个考察因素选取3个水平进行试验,采用HPLC法测定提取液中丹参酮ⅡA的含量,以丹参酮ⅡA含量高低及干浸膏得率进行综合分析,优化提取工艺。试验设计因素水平表见表2。
表2水提取工艺正交试验因素水平表
4)试验方法
按处方比例称取人参、丹参、酸枣仁、当归、红花、补骨脂、侧柏叶、地肤子、蔓荆子、生姜和天花粉药材共9份,随机编成①~⑨号,按L9(34)正交表(见表3)安排进行试验,提取液滤过,测量总体积,备用。
a)干浸膏制备
精密量取上述各提取液50mL,分别置于已恒重的蒸发皿中,水浴蒸干,残渣于105℃干燥3小时,取出,置于干燥器中放置30分钟,称重计算,结果见表3。
b)丹参酮ⅡA的含量测定
参照中国药典2015年版一部丹参项下丹参酮ⅡA含量测定法测定。
色谱条件色谱柱:Welchrom C18(4.6*250mm,5μm),月旭科技(上海)股份有限公司;流动相:乙腈-0.02%的磷酸溶液(72:28);流速:1mL/min;柱温:25℃;检测波长:270nm。
对照品溶液的制备精密称取在五氧化二磷减压干燥器中干燥36小时的丹参酮ⅡA对照品适量,加甲醇制成每1ml含0.060mg的溶液,得对照品母液。再取母液1ml,用甲醇定容至10ml,得每1ml含0.006mg的对照品溶液。
供试品溶液的制备精密吸取本品溶液1mL,用有机系微孔滤膜(0.45μm)滤过,即得。
样品含量测定依据中国药典2015年版四部髙效液相色谱法(通则0512)测定,分别精密吸取对照品溶液及供试品溶液各10μL,注入液相色谱仪,测定,结果见表3。
表3正交试验安排和数据分析表
综合值=(丹参酮ⅡA量/最大丹参酮ⅡA量)*50+(干浸膏得率/最大干浸膏得率)*50
c)方差分析
依据表3正交试验安排和数据分析中的数据,进行方差分析,结果见下表4。
表4方差分析表
F0.1(2.2)=9.00F0.05(2.2)=19.00F0.01(2.2)=99
由表3中R值显示,因素作用主次为D>A>B>C,由表4方差分析得出因素D有显著性差异,A、B、C均差异较小;最佳提取为A3B3C1D3即加70%的乙醇4倍量,浸渍10天,共3次。因丹参中还含有极性较大有效成分丹酚酸B,易溶于水,为较多的保留此成分,兼顾极性小的丹参酮ⅡA量,故选适中的60%醇浓度(D2)较合适。如果第一次加4倍量溶剂,发现是无法完全将药材淹没(通过吸溶剂率试验为1.47倍),因此第一次加溶剂选C2(6倍量),第二次加4倍量较合适。如果浸渍时间为3次,每次10天,那么一批生产周期为一个月,时间太长,而浸渍时间3次与2次极差很小,为了节省人工、水电成本,浸渍2次较好,因此最终优选浸渍提取工艺为A2B2C1D3即用60%的乙醇浸渍2次,第一次加6倍量,第二次4倍量,每次浸渍提取10天。
d)验证试验:按处方比例量称取药材,按优选的工艺条件进行了验证试验,结果见表5。
表5验证试验结果
从表5验证结果来看,按处方比例进行折算,丹参酮ⅡA量及干浸膏得率均接近于正交表中最高的一次试验,且重现性好,说明选择的工艺相对稳定合理。
3、该含有人参的生发搽剂的制备方法:
1)、按上述配方量称取原料;
2)取配方量的人参、丹参、酸枣仁、当归、红花、补骨脂、侧柏叶、地肤子、蔓荆子九味药材混合打粗粉;取配方量的生姜切薄片;取配方量的冰片研粉备用;
3)将步骤2)中混合后的粗粉、生姜薄片与配方量的天花粉混合,加6倍量质量百分比浓度为60%的乙醇,浸渍10天,每隔2-4天搅拌一次,取上清液滤过,得滤液备用;
4)将步骤3)的药渣再加4倍量质量百分比浓度为60%的乙醇,浸渍10天,每隔2-4天搅拌一次,取上清液滤过,滤液,并将此次过滤后的药渣进行压榨得药液;备用;
5)将步骤4)的滤液、压榨的药液和步骤3)的滤液合并得混合液,备用;
6)取配方量的冰片研粉,用质量百分比浓度为95%的乙醇少许溶解,
7)步骤6)溶解后的冰片与配方量的薄荷和配方量的平平加加至步骤5)的混合液中,充分搅拌;
8)在步骤7)所得的混合液中加入占该混合液总量2%的氮酮,搅拌均匀,静置沉淀48小时天,滤过,加质量百分比浓度为60%的乙醇至10000ml,分装,即得。
实施例2
一种含有人参的生发搽剂是由下述重量份中药原料配制而成:人参20份、丹参20份、酸枣仁8份、当归12份、红花11份、补骨脂11份、侧柏叶20份、生姜10份、天花粉5份、地肤子3份、蔓荆子3份、薄荷1份、冰片0.5份、平平加0.1份;
1)、按上述配方量称取原料;
2)取配方量的人参、丹参、酸枣仁、当归、红花、补骨脂、侧柏叶、地肤子、蔓荆子九味药材混合打粗粉;取配方量的生姜切薄片;取配方量的冰片研粉备用;
3)将步骤2)中混合后的粗粉、生姜薄片与配方量的天花粉混合,加6倍量质量百分比浓度为60%的乙醇,浸渍10天,每隔2-4天搅拌一次,取上清液滤过,得滤液备用;
4)将步骤3)的药渣再加4倍量质量百分比浓度为60%的乙醇,浸渍10天,每隔2-4天搅拌一次,取上清液滤过,滤液,并将此次过滤后的药渣进行压榨得药液;备用;
5)将步骤4)的滤液、压榨的药液和步骤3)的滤液合并得混合液,备用;
6)取配方量的冰片研粉,用质量百分比浓度为95%的乙醇少许溶解,
7)步骤6)溶解后的冰片与配方量的薄荷和配方量的平平加加至步骤5)的混合液中,充分搅拌;
8)在步骤7)所得的混合液中加入占该混合液总量2%的氮酮,搅拌均匀,静置沉淀48小时天,滤过,加质量百分比浓度为60%的乙醇至10000ml,分装,即得。
实施例3
一种含有人参的生发搽剂是由下述重量份中药原料配制而成:人参25份、丹参25份、酸枣仁10份、当归18份、红花15份、补骨脂15份、侧柏叶25份、生姜13份、天花粉7份、地肤子5份、蔓荆子5份、薄荷2份、冰片1.2份、平平加0.2份;
该实施例的制备方法同实施例2。
临床试验
观察本发明含有人参的生发搽剂(外用)治疗脱发属于气血两虚,血瘀阻滞证的疗效性和安全性。
1、研究对象:18~60岁脱发患者。
2、诊断标准(参考《中药新药临床研究指导原则》2002版,全国高等学校教材《皮肤性病学》第7版)
2.1西医诊断标准
2.1.1斑秃
斑秃为突然发生的非炎症性、非瘢痕性的片状脱发,一般无自觉症状,突然或短期内头发片状脱落,单发或多发,头发全部秃落(全秃),全身毛发均脱落则称普秃。脱发区皮色正常,无明显炎症反应。脱发区皮肤无萎缩及瘢痕。
2.1.2脂溢性脱发
油脂分泌旺盛,头发油腻,或头皮皮屑明显头发干燥,伴有瘙痒。头发弥漫性缓慢秃落,头发稀疏。
2.2中医诊断标准:气血两虚、血瘀阻滞证
主症:神疲乏力,头晕头痛,头发焦黄或发白。
次症:面色淡白或萎黄,懒言,心悸,失眠,健忘。
舌脉:舌红或有瘀斑,脉沉细。
2.3中医证候量化标准见表6
表6中医证候症状积分量化标准
3、纳入标准
(1)符合脱发西医诊断标准。
(2)符合中医证候(气血两虚、血瘀阻滞)诊断标准。
(3)受试年龄18-60岁。
4、排除标准
(1)妊娠期妇女,过敏体质或对本药过敏者。
(2)合并有心血管、脑血管、肝、肾和造血***等严重原发性疾病,精神病患者。
(3)先天性秃发:因遗传因素完全或部分无发或见毛发发育不良且稀少者。
(4)后天性秃发:内分泌功能障碍,严重急性传染病,慢性疾病等以及因药物、外伤等引起的。
(5)瘢痕性秃发:如感染性皮肤病如黄癣、秃发性毛囊炎等。
(6)依从性差者。
5、治疗方法
5.1试验用药:本发明实施例1-3配制中的任意一种。这里采用实施例1制备的搽剂;
5.2用药方法:根据无发面积大小,一次1~3ml搽于患处,稍加按摩。一日2~3次;每次用量最高不得超过3ml药液。
5.3疗程:1月。
6、观察指标
6.1安全性观测
生命体征:如血压、呼吸、心率、脉搏等。
血、尿常规化验。
心电图、肝功能(详见疗效评定指标)、肾功能(详见疗效评定指标)。
不良事件,随时详细记录。
6.2疗效性观测
(1)相关的症状体征舌、脉。
(2)毛发脱落及新发生长状况
(3)相关检查:拔毛试验。
7、疗效评定标准
7.1临床疗效判定标准
治愈:毛发停止脱落,新发全部长出,其分布密度、粗细、色泽与健发区相同,皮脂腺分泌恢复正常。
显效:毛发停止脱落,有70%以上新发长出,其分布密度、粗细、色泽接近健发区,皮脂腺分泌明显减少。
有效:毛发停止脱落,有30%新发或茸毛长出。
无效:毛发继续脱落,无新发或茸毛长出或新发长出不足30%。
7.2中医证候疗效评定
临床痊愈:中医临床症状、体征消失或基本消失,证候积分减少≥95%。
显效:中医临床症状、体征明显改善,证候积分减少70%,<95%。
有效:中医临床症状、体征均有好转,证候积分减少30%,<70%。
无效:中医临床症状、体征均无明显改善,甚或加重,证候积分减少不足30%。
注:计算公式(尼莫地平法)为:[(治疗前积分-治疗后积分)÷治疗前积分]×100%。
8、疗效及安全性
8.1、病例分布分析
2015年7月~2016年6月我院收治脱发患者共102例,均系本院门诊患者,其中。男60例,女42例,年龄18~60岁,平均39岁;病程最长3年,最短5天。受试者入组性别分布见表7;受试者入组年龄、身高、体重血压、心率、呼吸情况见表8。
表7患者入组性别分布情况
表8入组时年龄、身高、体重、血压、心率、呼吸比较
8.2、安全性分析
临床应用过程中,服药期间有2例患者(1.96%)出现涂搽处皮肤瘙痒,考虑可能与方中某些成分敏感性较强有关,未停用药物,2日后缓解。
8.3、疗效分析
8.3.1中医证候疗效
临床痊愈27例(26.47%),显效29例(28.43%),有效36例(31.58%)总有效率90.20%;见表9。治疗前后总积分及主、次症积分比较见表10
表9中医证候疗效
表10治疗前后总积分及主、次症积分比较
8.3.2临床疗效
临床痊愈217例(20.59%),显效26例(25.49%),有效42例(41.18%),无效13例(12.75%);总有效率87.25%。见表11。
表11临床疗效
结论:通过统计分析,本发明的处方对脱发有很好的疗效,且有一定的乌发作用。不良反应较轻,无需停药而自行缓解,故该制剂用于治疗脱发及白发安全有效。
Claims (3)
1.一种含有人参的生发搽剂,其特征是:它是由下述重量份中药原料配制而成:人参20-25份、丹参20-25份、酸枣仁8-10份、当归12-18份、红花11-15份、补骨脂11-15份、侧柏叶20-25份、生姜10-13份、天花粉5-7份、地肤子3-5份、蔓荆子3-5份、薄荷1-2份、冰片0.5-1.2份、平平加0.1-0.2份。
2.根据权利要求1所述的一种含有人参的生发搽剂,其特征是:它是由下述重量份中药原料配制而成:人参22份、丹参22份、酸枣仁9份、当归16份、红花13份、补骨脂13份、侧柏叶22份、生姜11份、天花粉6份、地肤子4份、蔓荆子4份、薄荷1.5份、冰片1份、平平加0.15份。
3.一种如权利要求1所述的含有人参的生发搽剂的制备方法,其特征是:该方法包括如下步骤:
1)按下述重量份称取原料:
人参20-25份、丹参20-25份、酸枣仁8-10份、当归12-18份、红花11-15份、补骨脂11-15份、侧柏叶20-25份、生姜10-13份、天花粉5-7份、地肤子3-5份、蔓荆子3-5份、薄荷1-2份、冰片0.5-1.2份、平平加0.1-0.2份;
2)取配方量的人参、丹参、酸枣仁、当归、红花、补骨脂、侧柏叶、地肤子、蔓荆子九味药材混合打粗粉;取配方量的生姜切薄片;取配方量的冰片研粉备用;
3)将步骤2)中混合后的粗粉、生姜薄片与配方量的天花粉混合,加6倍量质量百分比浓度为60%的乙醇,浸渍10天,每隔2-4天搅拌一次,取上清液滤过,得滤液备用;
4)将步骤3)的药渣再加4倍量质量百分比浓度为60%的乙醇,浸渍10天,每隔2-4天搅拌一次,取上清液滤过,滤液,并将此次过滤后的药渣进行压榨得药液;备用;
5)将步骤4)的滤液、压榨的药液和步骤3)的滤液合并得混合液,备用;
6)取配方量的冰片研粉,用质量百分比浓度为95%的乙醇少许溶解,
7)步骤6)溶解后的冰片与配方量薄荷和平平加加至步骤5)的混合液中,充分搅拌;
8)在步骤7)所得的混合液中加入占该混合液总量2%的氮酮,搅拌均匀,静置沉淀48小时天,滤过,加质量百分比浓度为60%的乙醇至10000ml,分装,即得。
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