CN106806822A - 一种治疗不育症的外用中药制剂及其制备方法 - Google Patents
一种治疗不育症的外用中药制剂及其制备方法 Download PDFInfo
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Abstract
本发明提供一种治疗不育症的外用中药制剂,所述外用中药制剂中各种原料的重量份数包括:艾叶10~20份,薄荷叶10~20份,鸡血藤10~20份,紫草10~20份,赤芍10~20份,防风10~20份,白及10~20份,白芷10~20份,当归10~20份,延胡索10~20份,荆芥10~20份,丹参10~20份,威灵仙10~20份,儿茶10~20份。本发明中药制剂安全,配伍合理,具有补中益气、升阳举陷、温通经脉、活血祛淤、散结消、填精益肾、生精助育的功效。
Description
技术领域
本发明涉及含有来源于植物、动物或矿物组份的医用配制品,特别涉及一种治疗不育症的外用中药制剂及其制备方法。
背景技术
世界卫生组织(WHO)的研究资料表明,全世界约有12%~16%的夫妇发生不孕不育。目前,我国育龄夫妇中有8%~10%发生不同程度的不孕不育,受社会发展、工业污染、大气环境等诸多因素的影响,这个比例还在继续升高。不孕不育轻者导致个人痛苦,重者引起家庭破裂,给患者心理、生理甚至经济上带来极大负担。
精索静脉曲张不育症占各类男子不育症病因的首位,在男性不育症患者中发病率高达21%~42%。不育症是一项世界性的医学和社会学问题,亦是21世纪危害人类生殖健康的重要疾病之一。据世界卫生组织估计,全球有6千万-8千万对不育夫妇。国内外对男性不育的研究进展迅速,研究热点主要集中在Y染色体微缺失、遗传基因、精液中各种参数的相互关系、辅助生殖技术等领域。特别是辅助生殖的研究最为热烈,1978年,妇产科专家Patrik St印tone和胚胎学家Robert Edwards联合应用体外受精-胚胎移植(IVF-ET)培育全世界第一例试管婴儿,其后,辅助生殖技术(assistedreproductive technology,ART)迅速发展为治疗不孕不育症的重要方法。ART的定义为人类不经过两性性交而是运用医学技术和方法对配子、合子、胚胎进行人工操作,帮助精子和卵子相互结合,以达到受孕目的的技术;也就是用人工方法辅助自然过程的某一或全部环节来完成生育的方法辅助生殖技术的发展经历了由简单到复杂的过程,目前国内主要开展的辅助生殖技术有:人工授精(AI)、体外受精-胚胎移植(IVF-ET)、胞装内单精子注射(ICSI)、种植前遗传学诊断(PGD)和未成熟卵母细胞体外培养成熟(IVM)技术等。
目前,在男性辅助生殖方面的研究,主要集中在睾丸生精功能上,睾丸是精子发生和雄激素合成的重要器官,由于遗传性或获得性缺陷造成睾丸病变的称为原发性睾丸机能障碍,是不育症重要的因素。由于下丘脑或垂体病变,引起对睾丸的刺激不足,称为继发性辜丸功能障碍。但大多数男性不育症患者,是由于睾丸外因素造成的。如感染,环境因素,精索静脉曲张,性功能障碍等。其中精索静脉曲张在男性不育症的重要性是明显的,有统计表明男性不育患者中21%-41%患有精索静脉曲张。欧洲泌尿外科指南亦有资料明确提出精索静脉曲张与精液质量异常、睾丸体积减小以及间质细胞功能下降有关。
对于精索静脉曲张合并不育症,西药目前没有明显针对性的用药,治疗上多以单纯手术治疗,其后需药物治疗尚未开发。而中医在治疗此类病证的效果上是具有明显优势的。早在清代由著名医家陈士铎编撰的《石室秘录》就已经提出治疗男性不育六法,即“精寒者温其火,气衰者补其气,痰多者消其痰,火盛者补其水,精少者添其精,气郁者舒其气,则男子无子者可以有子,不可徒补其肾也。”其后,各医家总结出治疗男性不育的主要方法有大多温补肾阳,益肾填精;滋补肾阴,益精养血;舒肝理气,补肾益精及清热利湿等。在这些治疗方法中,又以温补肾阳法应用最多。
目前西医手术疗法在改善精索静脉曲张合并不育症患者精子质量及改善精子形态的效果上仍未达到医家的认同。在男性不育的分类中,精索静脉曲张合并不育症所占的比例最高。现阶段,西医对精索静脉曲张不育症的治疗以手术为主。手术并未能够改善精索静脉曲张不育症患者的生育能力。也有报道认为,手术后精子数量及活动力非但没有改善,反而降低。从中医角度看,根据临床表现和病理特征,精索静脉曲张不育可归属偏坠、筋瘤等范畴,病机是中气下陷、气滞血淤、脾肾亏虚引起不育。中医中药治疗精索静脉曲张配伍合理,具有补中益气、升阳举陷、温通经脉、活血祛淤、散结消、填精益肾、生精助育的功效。从药物经济学角度客观评价其成本效果和效益,更突出本中药方剂在治疗精索静脉曲张不育症方面的优势。可见,中医中药具有良好开发前景,值得临床推广应用。
发明内容
本发明所要解决的技术问题在于,对于精索静脉曲张合并不育症,西药目前没有明显针对性的用药,治疗上多以单纯手术治疗,手术并未能够改善精索静脉曲张不育症患者的生育能力。手术后精子数量及活动力非但没有改善,反而降低。从中医角度看,根据临床表现和病理特征,精索静脉曲张不育可归属偏坠、筋瘤等范畴,病机是中气下陷、气滞血淤、脾肾亏虚引起不育。中医中药治疗精索静脉曲张方是补中益气汤、桂枝茯苓丸和金匮肾气丸加减的合方。中药内服制剂和外用制剂的共同不足之处是,药效持续时间较短,针对性比较差,病患服从性差。
为解决这些技术难题,本发明提供了一种治疗不育症的外用中药制剂,由内服药物和外用药物组成,所述内服药物中各种原料的重量份数为:当归10~20份,菟丝子10~20份,补骨脂10~20份,黄芪10~20份,制首乌10~20份,山茱萸10~20份,淫羊藿10~20份,覆盆子10~20份,丹参10~20份,仙茅10~20份,红花10~20份,巴戟天10~20份,王不留行10~20份,鸡血藤10~20份,川芎10~20份,熟地10~20份,桑葚10~20份,莪术10~20份;
外用药物中各种原料的重量份数为:艾叶10~20份,薄荷叶10~20份,鸡血藤10~20份,紫草10~20份,赤芍10~20份,防风10~20份,白及10~20份,白芷10~20份,当归10~20份,延胡索10~20份,荆芥10~20份,丹参10~20份,威灵仙10~20份,儿茶10~20份。
所述治疗不育症的外用中药制剂,其所述内服药物中各种原料的重量份数可以为:当归10~15份,菟丝子10~15份,补骨脂10~15份,黄芪10~15份,制首乌10~15份,山茱萸10~15份,淫羊藿10~15份,覆盆子10~15份,丹参10~15份,仙茅10~20份,红花10~20份,巴戟天10~20份,王不留行10~20份,鸡血藤10~20份,川芎10~20份,熟地10~20份,桑葚10~20份,莪术10~20份;
外用药物中各种原料的重量份数可以为:艾叶10~15份,薄荷叶10~15份,鸡血藤10~15份,紫草10~15份,赤芍10~15份,防风10~15份,白及10~15份,白芷10~20份,当归10~20份,延胡索10~20份,荆芥10~20份,丹参10~20份,威灵仙10~20份,儿茶10~20份。
所述治疗不育症的外用中药制剂,其所述内服药物中各种原料的重量份数还可以为:当归10~20份,菟丝子10~20份,补骨脂10~20份,黄芪10~20份,制首乌10~20份,山茱萸10~20份,淫羊藿10~20份,覆盆子10~20份,丹参10~20份,仙茅10~15份,红花10~15份,巴戟天10~15份,王不留行10~15份,鸡血藤10~15份,川芎10~15份,熟地10~15份,桑葚10~15份,莪术10~15份;
外用药物中各种原料的重量份数还可以为:艾叶10~20份,薄荷叶10~20份,鸡血藤10~20份,紫草10~20份,赤芍10~20份,防风10~20份,白及10~20份,白芷10~15份,当归10~15份,延胡索10~15份,荆芥10~15份,丹参10~15份,威灵仙10~15份,儿茶10~15份。
为解决上述技术问题,本发明还提供一种治疗不育症的外用中药制剂的制备方法,其所述内服制剂的剂型为胶囊剂,其制备方法包括:
a、取原料药放入乙醇中浸泡,热提取2次,成膏状,为组分1;
b、药渣加水提取2次,浓缩过滤为膏状,为组分2;
c、将上述两种膏状合并,浓缩成粉末装入胶囊。
所述步骤a中,可以取原料药加入5-10倍量的乙醇中浸泡1-2小时,加热提取2次,每次1-2小时,合并提取液,静置后去上清液,然后100-120目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.36的浸膏,静置备用,成为组分1。
所述步骤b中,可以将上述乙醇提取过的原料药的药渣加10倍量水,加热回流提取2次,每次1~2小时,将2次提取液合并静置;将上述两种提取液合并,减压回收乙醇并浓缩至药液浓度为0.6g生药/mL,抽滤后,滤液的相对密度约为20℃时1.08;浓缩至相对密度为1.20,温度至60℃-70℃的浸膏,静置备用,成为组分2。
所述步骤c中,可以将组分1和组分2的浸膏合并,然后放入减压浓缩罐内,减压浓缩至相对密度为1.20,然后取出,放入烘干机烘干成粉末,放入胶囊中,成胶囊剂。
为解决上述技术问题,本发明再提供一种不育症的外用中药制剂的制备方法,其所述内服制剂的剂型为丸剂,制备方法包括:
将所述组份原料药去杂,晾干,粉碎成颗粒,加水浸泡1小时;将浸泡好的原料置多功能提取罐中加水煎煮二次;第一次加总药材10倍量的水,煎煮1.5~2小时,取煎液,滤过;第二次加总量7倍量的水,煎煮1~1.2小时,取两次煎液混合,滤过;将过滤的滤液置入双效真空浓缩器中,浓缩至90℃时相对密度为1.05的浓缩液,置0~5℃低温冷藏24小时;将冷藏液加0.3%的助滤剂硅藻土,过滤,滤液再置入双效真空浓缩器中,浓缩至每1ml含1g生药量,直接干燥成粉末;然后加蜂蜜搓成丸剂。
为解决上述技术问题,本发明也提供一种不育症的外用中药制剂的制备方法,所述外用制剂的剂型为膏剂的制备方法包括以下步骤:
按照所述份数先将白芷、防风、和艾叶水蒸气法蒸馏,得到结晶物,作为组分1备用;取蒸馏后的药渣混合剩余原料加入5-10倍量的60-90%乙醇浸泡1-2小时,加热提取2次,每次1-2小时,去上清液,合并提取液,80-120目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.36的浸膏,加热浓缩,30分钟~45分钟,将浓缩液静置成浸膏状,药糊继续加热浓缩至浸膏状,静置备用,成为组分2;将蒸馏提取的组分1和乙醇提取的组分2混合,加凡士林成膏剂。
所述治疗不育症的外用中药制剂,其所述外用药物剂型可以为:喷雾剂、粉剂、散剂、软膏剂、栓剂、硬膏剂和纱布剂。
对于精索静脉曲张合并不育症,西药目前没有明显针对性的用药,治疗上多以单纯手术治疗。而中医在治疗此类病证的效果上是具有明显优势,本发明内服外用共同作用,能直达病灶,燥湿除脓、温补肾阳,益肾填精,滋补肾阴,益精养血;舒肝理气,补肾益精及清热利湿等。本发明中药组合物安全,配伍合理,具有补中益气、升阳举陷、温通经脉、活血祛淤、散结消、填精益肾、生精助育的功效。其毒副作用小,使用方便,治愈时间短,治愈后不易复发。能创造较好的社会价值及经济利益。
具体实施方式
中医学说认为,精索静脉曲张属于中医理论中“筋瘤”、“筋庙”等疾病范畴。其病因病机,多为肝肾亏虚、游血凝滞、脉络不和所致,其病位与肝、脾、肾三脏及肝肾二经联系十分密切。古人提出:“筋瘤”多因癖血为患;或因肝肾不足,外感寒湿,气滞血疲,筋脉失儒;或因举重担物,长途践涉,筋脉受伤,肝络疲滞;或因湿热下注,脉络失和;或因脾虚气陷,血运无力。其发病多表现为:血运受阻,蕴而化热,血不养睾,热灼精伤,而致男性不育。也有人认为肝肾亏虚、肝郁气滞是其病因病机,日久多见癖血停滞,络道阻塞,临床表现为脉络迂曲、显露,阴囊坠胀不适,以致睾丸气血运行不足,生化无力,终至不育。并得出精索静脉曲张不育症病位在外肾,气滞血癖是标,肾精亏虚是本。
在一线临床工作中,多数中医学者发现单纯利用中医内治法治疗精索静脉曲张合并不育症,往往不能取得良好疗效,针对此问题,亦有不少临床工作者做出研究观察。我们认为对于轻、中度精索静脉曲张患者,单纯采用中药治疗,就能取得较好效果,然而对于重度精索静脉曲张患者,手术治疗仍然是第一选择。由此,部分医家就提出,治疗精索静脉曲张合并不育症,首先采用手术治疗,而后待其病根得到纠正后,再结合中医理论辩证施治,理论上可以取得较好疗效。对于精索静脉曲张的治疗,目前多流行手术治疗,临床对于其手术适应症多采用以下标准:①症状明显者,如阴囊下坠不适和钝性疼痛,站立或行走时症状明显,卧床休息后症状可以缓解,有时疼痛不适感可放射到下腹部和大腿根部。②伴有男性不育症者,结合临床实验室检查为不育患者,并通过保守治疗未见好转者。③彩超诊断标准为精索内静脉直径>2mm并有血液反流(做或不做valsava试验)。对于精索静脉曲张合并不育患者,在2006年的美国泌尿外科学会(American UrologyAssociation,AUA)制定的《The Practice Committee ofthe American Society forReproductive Medicine))中就已提出,对患有精索静脉曲张且同时有生育要求者,需同时满足以下条件才能手术治疗:1.体检可触知曲张的精索静脉;2.确诊为不育;3.女方的生殖能力无异常或导致其不孕的病因可以治疗;4.男方CASA异常或精子功能异常。目前暂无生育要求而日后需要伴有可触及的精索静脉曲张合并有精液异常者,也需积极治疗。
然而,就精索静脉曲张合并不育症患者,虽然通过手术治疗后,大部分静脉曲张的病因已得到去除,但其受损的睾丸生精功能往往未能在短期内得到恢复。故在此基础上运用中医中药治疗,往往可以得到较优的效果,然而临床医家并未通过大样本的研究,得出一种有效的、公认的治疗方法。
中医在男性不育症的药物治疗,方法甚多,具体以:温补肾阳,益肾填精;滋补肾阴,益精养血;舒肝理气,补肾益精及清热利湿等治法为主。具体到药物上,又以滋补肾阴,温补肾阳的中药应用最多。滋补肾阴的常用药物有:熟地、黄精、山茱萸、制首乌、覆盆子等。温补肾阳法的常用药物有:菟丝子、肉苁蓉、淫羊藿、仙茅、鹿角胶、巴戟天等和补气药黄芪、太子参等,很多药理学者的研究均表明,补肾壮阳类中药具有类性激素的作用,此类中药含锌量最高,它们主要作用于大鼠垂体性腺轴,具有调节内分泌系统作用,能够促进辜丸组织的发育,增加血清的睾酮水平,对性功能有兴奋作用,能促进精液分泌,提高精子数量,同时能够改善睾丸曲细精管及间质细胞的损害。
经多年临床实践,不少病人手术后还会复发,疗效不确切,多次手术也未能治愈。
赤芍,行瘀、止痛、凉血、消肿。主治:治瘀滞经闭、疝瘕积聚、腹痛、胁痛、衄血、血痢、肠风下血、目赤、痈肿、跌扑损伤。赤芍能清血分实热,散瘀血留滞。该品功能与丹皮相近,故常与丹皮相须为用。但丹皮清热凉血的作用较佳,既能清血分实热,又能治阴虚发热;而赤芍只能用于血分实热,以活血散瘀见长。《本经》:主邪气腹痛,除血痹,破坚积,寒热疝瘕,止痛,利小便,益气。
威灵仙其根及茎入药具有风湿、通经络、消骨哽之功效。在现代临床实践中其新的用途不断的被发现,如治疗胆结石,跟骨骨刺、足跟痛、食管癌等。但用药中须注意的是,气血亏虚及孕妇慎服。祛风除湿,通络止痛,消痰水,散癖积。主治痛风顽痹、风湿痹痛,肢体麻木,膝冷痛,筋脉拘挛,屈伸不利,脚气,疟疾,症瘕积聚,破伤风,扁桃体炎,诸骨鲠咽。《开宝本草》:主诸风,宣通五藏,去腹内冷滞,心隔痰水久积,症瘕痃癣气块,膀胱宿脓恶水,腰膝冷疼及疗折伤。
白芷性味归经:辛,温。归肺、胃经。祛风散寒,通窍止痛,消肿排脓,燥湿止带。《日华子本草》:治目赤胬肉,及补胎漏滑落,破宿血,补新血,乳痈、发背、瘰疬、肠风、痔瘘,排脓,疮痍、疥癣,止痛生肌,去面皯疵瘢。
延胡索主治心腹腰膝诸痛;月经不调;症瘕;崩中;产后血晕;恶露不尽;跌打损伤。有镇痛、镇静、催眠作用。活血;散瘀;理气;止痛。主心腹腰膝诸痛;月经不调;症瘕;崩中;产后血晕;恶露不尽;跌打损伤。用于胸胁、脘腹疼痛,经闭痛经,产后瘀阻,跌扑肿痛。镇痛作用:延胡索粉有镇痛作用,其止痛效价约为阿片的1/100;延胡索总碱、延胡索甲素、乙素、丑素、癸素均有镇痛作用,以乙素较强.各种剂型以醇制浸膏及粉剂作用强。《开宝本草》:主破血,产后诸病,因血所为者。妇人月经不调,腹中结块,崩中淋露,产后血运,暴血冲上,因损下血,或酒摩及煮服。
荆芥味平,性温,无毒,清香气浓。荆芥为发汗,解热药,是中华常用草药之一。能镇痰、怯风、凉血。治流行感冒,头疼寒热发汗,呕吐。祛风;解表;透疹;止血。主感冒发热;头痛;目痒;咳嗽;咽喉肿痛;麻疹;痈肿;疮疥;衄血;吐血;便血;崩漏;产后血晕。用于感冒,头痛,麻疹,风疹,疮疡初起。《纲目》:散风热,清头目,利咽喉,消疮肿。治项强,目中黑花,及生疮,阴颓,吐血,衄血,下血,血痢,崩中,痔漏。
紫草性寒,味甘、咸。归心、肝经。功能主治凉血,活血,解毒透疹。用于血热毒盛、斑疹紫黑、麻疹不透、疮疡、湿疹、水火烫伤。清热凉血,用于麻疹,热病癍疹,湿疹,尿血,血淋,血痢,疮疡,丹毒,烧伤,热结便秘。
艾叶辛、苦,温;有小毒。归肝、脾、肾经。散寒止痛,温经止血。用于少腹冷痛,经寒不调,宫冷不孕,吐血,衄血,崩漏经多,妊娠下血;外治皮肤瘙痒,脱皮。醋艾炭温经止血。用于虚寒性出血。《唐本草》:主下血,衄血,脓血痢,水煮及丸散任用。
防风性味:味辛;甘;性微温。归膀胱经;肺经;脾经;肝经。祛风解表、胜湿止痛、解痉、止痒。主治:外感风寒;头痛身痛;风湿痹痛;骨节酸痛;腹痛泄泻;肠风下血;破伤风;风疹瘙痒;疮疡初起。体外抑菌试验:采用平板法进行体外抑菌实验,结果防风对金黄色葡萄球菌、乙型溶血性链球菌、肺炎双球菌及二种霉菌(产黄青霉、杂色曲霉)等有抑菌作用,而对流感杆菌、伤寒杆菌、福氏及志贺氏痢疾杆菌无抑菌作用。《本经》:主大风头眩痛,恶风,风邪,目盲无所见,风行周身,骨节疼痹,烦满。
儿茶,苦、涩,微寒。归肺经,别名儿茶膏、孩儿茶、黑儿茶,为豆科合欢属植物儿茶树,用于清热、生津、止血,主治肺热咳嗽,咯血,腹泻,小儿消化不良;外用治疮疡久不收回,皮肤湿疹,口疮,扁桃体炎。儿茶煎剂对金黄色葡萄球菌、白喉杆菌、变形杆菌、福氏痢疾杆菌及伤寒杆菌均有抑制作用;对于常见治病性皮肤真菌亦有抑制作用。其叶的提取物对金黄色葡萄球菌、大肠杆菌均有抑制作用。《本草正》:降火生津,清痰涎咳嗽,治口疮喉痹,烦热,止消渴,吐血,衄血,便血,尿血,湿热痢血,及妇人崩淋,经血不止,小儿疳热,口疮,热疮,湿烂诸疮,敛肌长肉,亦杀诸虫。
白及苦、甘、涩,微寒。归肺、肝、胃经。补肺,止血,消肿,生肌,敛疮。治肺伤咳血,衄血,金疮出血,痈疽肿毒,溃疡疼痛,汤火灼伤,手足皲裂。《本经》:"主痈肿恶疮败疽,伤阴死肌,胃中邪气,贼风痱缓不收。"《日华子本草》:"止惊邪、血邪,痢疾,赤眼,症结,发背,瘰疬,肠风,痔瘿,刀箭疮扑损,温热疟疾,血痢,汤火疮,生肌止痛,风痹。"
本发明内服蜜丸剂的制作过程为:将当归1000g,菟丝子1000g,补骨脂1000g,黄芪1000g,制首乌1000g,山茱萸1000g,淫羊藿1000g,覆盆子1000g,丹参1000g,仙茅1000g,红花1000g,巴戟天1000g,王不留行1000g,鸡血藤1000g,川芎1000g,熟地1000g,桑葚1000g,莪术1000g,取原料加入5-10倍量的乙醇中浸泡1-2小时,加热提取2次,每次1-2小时,去上清液,合并提取液,100-120目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.36的浸膏,加热浓缩至膏状,静置备用,成为组分1;将乙醇提取过的药渣放入10倍量水中,加热回流提取2次,每次提取时间为1~2小时,100-120目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.36的浸膏,加热浓缩至膏状,静置备用,成为组分2;将合并后组分1和组分2的膏状放入减压浓缩罐内,减压浓缩至相对密度为1.20,温度至60℃-70℃的浸膏;放入烘箱,烘干后冷却,与蜂蜜混在一起搓成细条,腊封包装。
本发明胶囊剂的制作过程为:将当归1100g,菟丝子1200g,补骨脂1200g,黄芪1100g,制首乌1200g,山茱萸1200g,淫羊藿1100g,覆盆子1200g,丹参1200g,仙茅1200g,红花1200g,巴戟天1100g,王不留行1100g,鸡血藤1200g,川芎1200g,熟地1200g,桑葚1200g,莪术1200g,加入10倍量乙醇中加热提取2次,每次1~2小时,将2次提取液合并静置;将上述乙醇提取过的组份原料药材的药渣加10倍量水加热回流提取2次,每次1~2小时,将2次提取液合并静置。将上述两种提取液合并,减压回收乙醇并浓缩至药液浓度为0.6g生药/mL,抽滤后,滤液的相对密度约为20℃时1.08;减压至0.03-0.08MPa,温度保持在60-80℃,浓缩至相对密度为1.20,温度至60℃-70℃的浸膏,放入烘箱干燥得到组份药粉,装入胶囊制为胶囊剂。可以每12粒为一版。
本发明颗粒剂的制作过程为:取将当归1200g,菟丝子1200g,补骨脂1200g,黄芪1100g,制首乌1300g,山茱萸1200g,淫羊藿1100g,覆盆子1200g,丹参1200g,仙茅1200g,红花1200g,巴戟天1100g,王不留行1100g,鸡血藤1200g,川芎1200g,熟地1200g,桑葚1200g,莪术1300g,取原料加入5-10倍量的乙醇中浸泡1-2小时,加热提取2次,每次1-2小时,去上清液,合并提取液,100-120目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.36的浸膏,加热浓缩至膏状,静置备用,成为组分1;上述乙醇提取过的组份原料药材的药渣加10倍量水加热回流提取2次,每次1~2小时,将2次提取液合并静置;将上述两种提取液合并,减压回收乙醇并浓缩至药液浓度为0.6g生药/mL,抽滤后,滤液的相对密度约为20℃时1.08;减压至0.03-0.08MPa,温度保持在60-80℃,浓缩至相对密度为1.20,温度至60℃-70℃的浸膏,成为组分2;将合并后组分1和组分2的膏状放入减压浓缩罐内,减压浓缩至相对密度为1.20,温度至60℃-70℃的膏状;掺入糊精,放入制粒机中,制成颗粒剂。
本发明外用膏剂的制备方法:
按照所述份数将白芷1000g、防风1000g、和艾叶1000g蒸馏成结晶,备用;取蒸馏后的药渣混合剩余原料鸡血藤1000g,紫草1000g,赤芍1000g,白及1000g,当归1000g,延胡索1000g,荆芥1000g,丹参1000g,威灵仙1000g,儿茶1000g,加入5-10倍量的60-90%乙醇浸泡1-2小时,加热提取2次,每次1-2小时,去上清液,合并提取液,80-120目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.36的浸膏,加热浓缩,30分钟~45分钟,将浓缩液静置成浸膏状,药糊继续加热浓缩至浸膏状,静置备用,成为组分2;将蒸馏提取的组分1和乙醇提取的组分2混合,成膏剂,加适量凡士林成膏剂。
也可以用上述方法得到的药膏浸泡纱布,制成纱布剂,每晚或空闲包住病患处,慢慢按摩半个小时-1个小时。
本发明外用喷雾剂的制备方法:
按照所述份数将白芷1200g、防风1100g、和艾叶1200g用水蒸汽蒸馏成结晶,备用;取蒸馏后的药渣混合剩余原料鸡血藤1200g,紫草1300g,赤芍1300g,白及1300g,当归1300g,延胡索1200g,荆芥1100g,丹参1100g,威灵仙1100g,儿茶1100g,加入5-10倍量的乙醇中浸泡1-2小时,加热提取2次,每次1-2小时,去上清液,合并提取液,100-120目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.36的浸膏,加热浓缩至膏状,静置备用,成为组分1;上述乙醇提取过的组份原料药材的药渣加10倍量水加热回流提取2次,每次1~2小时,将2次提取液合并静置;将上述两种提取液合并,减压回收乙醇并浓缩至药液浓度为0.6g生药/mL,抽滤后,滤液的相对密度约为20℃时1.08;减压至0.03-0.08MPa,温度保持在60-80℃,浓缩至相对密度为1.20,温度至60℃-70℃的浸膏,成为组分2;将合并后组分1和组分2的膏状放入减压浓缩罐内,减压浓缩至相对密度为1.20,温度至60℃-70℃的膏状;掺入蒸馏出的结晶,加入溶剂,装入医用喷雾器中。
Claims (5)
1.一种治疗不育症的外用中药制剂,其特征在于,所述外用中药制剂中各种原料的重量份数包括:艾叶10~20份,薄荷叶10~20份,鸡血藤10~20份,紫草10~20份,赤芍10~20份,防风10~20份,白及10~20份,白芷10~20份,当归10~20份,延胡索10~20份,荆芥10~20份,丹参10~20份,威灵仙10~20份,儿茶10~20份。
2.根据权利要求1所述治疗不育症的外用中药制剂,其特征在于,外用中药制剂中各种原料的重量份数包括:艾叶10~15份,薄荷叶10~15份,鸡血藤10~15份,紫草10~15份,赤芍10~15份,防风10~15份,白及10~15份,白芷10~20份,当归10~20份,延胡索10~20份,荆芥10~20份,丹参10~20份,威灵仙10~20份,儿茶10~20份。
3.根据权利要求1所述治疗不育症的外用中药制剂,其特征在于,外用药物中各种原料的重量份数包括:艾叶10~20份,薄荷叶10~20份,鸡血藤10~20份,紫草10~20份,赤芍10~20份,防风10~20份,白及10~20份,白芷10~15份,当归10~15份,延胡索10~15份,荆芥10~15份,丹参10~15份,威灵仙10~15份,儿茶10~15份。
4.一种如权利要求1~3中任一项所述治疗不育症的外用中药制剂的制备方法,其特征在于,所述外用制剂的剂型为膏剂的制备方法包括以下步骤:
按照所述份数先将白芷、防风、和艾叶水蒸气法蒸馏,得到结晶物,作为组分1备用;取蒸馏后的药渣混合剩余原料加入5-10倍量的60-90%乙醇浸泡1-2小时,加热提取2次,每次1-2小时,去上清液,合并提取液,80-120目滤过,再经截流分子量为5000-10000的超滤柱超滤,超滤液减压浓缩相对密度为80℃时1.36的浸膏,加热浓缩,30分钟~45分钟,将浓缩液静置成浸膏状,药糊继续加热浓缩至浸膏状,静置备用,成为组分2;将蒸馏提取的组分1和乙醇提取的组分2混合,加凡士林成膏剂。
5.根据权利要求1~3任一项所述治疗不育症的外用中药制剂,其特征在于:所述外用药物剂型为:喷雾剂、粉剂、散剂、软膏剂、栓剂、硬膏剂和纱布剂。
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