CN105362799A - 一种治疗干眼症的中药制剂及其制备方法 - Google Patents
一种治疗干眼症的中药制剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗干眼症的中药制剂及其制备方法,属于治疗干眼症的药物的技术领域。本发明包括以下重量份的原料制成:夏枯草8-15、牡丹皮6-9、桑叶3-6、芦根6-9、玉竹5-12、威灵仙8-15、忍冬藤6-9、牛膝6-9、穿山甲3-份、女贞子8-15、木贼6-9、白蒺藜6-9、青皮5-12、栀子6-9、金丝草6-9、黑豆6-9、升麻6-9、蝉蜕3-6、瓜蒌8-15、苋菜6-9。本发明科学配伍,通过疏肝润肺、健脾补肾和祛风明目,达到了清热解毒、活血化瘀和益气补血的功效,直达病灶深处,肝将血液营养物质输送至目,肾主津液,肺主宣降水液,水液上承于目,则滋润目珠,疗效明确,无副作用,标本兼治。
Description
技术领域
本发明属于治疗干眼症的药物的技术领域,特别是指一种治疗干眼症的中药制剂及其制备方法。
背景技术
干眼症是最常见的眼科疾病之一,是由于多种原因使眼球表面水质、粘液和脂质分泌后,所造成的泪液质和量失去平衡而发生的一系列症候群,是一种多因素疾病。干眼症是由泪液动力学的异常及眼表面上皮异常所引起。由于眼表面上皮和泪膜之间的紧密相关,相互依赖并作为一个整体发挥作用,而不是孤立存在的。泪液动力学包括四个过程:1、泪液的生成;2、泪液的分布;3、泪液的蒸发;4、泪液的清除。而以上四个过程任何一个环节发生异常就会导致干眼症。
干眼症常见的症状包括眼睛干涩、容易疲倦、眼痒、有异物感、痛灼热感、分泌物黏稠、怕风、畏光、对外界刺激很敏感;有时眼睛太干,泪液分泌不足,反射性刺激泪液分泌,而造成常常流泪;较严重者眼睛会红肿、充血、角质化、角膜上皮破皮而有丝状物黏附,这种损伤日久则可造成角结膜病变,并会影响视力。
目前,西医主要是采用人工泪液、接触镜、泪点封闭、堵塞泪小管及腮腺移植术治疗干眼症,其中,人工泪液最常用,人工泪液是一种模仿人体泪液,能够对正常的眼睛起到保护作用,消除眼部不适,治疗干眼症,缓解由干眼症引发的其他眼病的眼保健品;但是,人工泪液对干眼症并未有治疗作用。中医治疗主要通过口服中药制剂、眼熏、针灸等,烟熏中药存在皮肤顺应性差和有效成分不能快速吸收的问题,同时,口服中药制剂存在疗程长和见效慢的问题,致使这些中医治疗干眼症的疗效尚不明确。
发明内容
本发明提供一种治疗干眼症的中药制剂及其制备方法,解决了现有技术中治疗干眼症的药物吸收慢、副作用大和疗效差的问题。
本发明的一种治疗干眼症的中药制剂,其主要是通过以下技术方案加以实现的:包括以下重量份的原料制成:夏枯草8-15份、牡丹皮6-9份、桑叶3-6份、芦根6-9份、玉竹5-12份、威灵仙8-15份、忍冬藤6-9份、牛膝6-9份、穿山甲3-6份、女贞子8-15份、木贼6-9份、白蒺藜6-9份、青皮5-12份、栀子6-9份、金丝草6-9份、黑豆6-9份、升麻6-9份、蝉蜕3-6份、瓜蒌8-15份、苋菜6-9份。
优选地,包括以下重量份的原料制成:夏枯草12份、牡丹皮8份、桑叶5份、芦根8份、玉竹10份、威灵仙12份、忍冬藤7份、牛膝7份、穿山甲5份、女贞子13份、木贼8份、白蒺藜7份、青皮10份、栀子8份、金丝草7份、黑豆7份、升麻8份、蝉蜕5份、瓜蒌13份、苋菜8份。
具体地,所述中药制剂的剂型为汤剂、丸剂、颗粒剂、片剂或口服液中的一种。
本发明的一种治疗干眼症的中药制剂的制备方法,其主要是通过以下技术方案加以实现的:包括以下步骤:1)将夏枯草、牡丹皮、芦根、玉竹、威灵仙、忍冬藤、穿山甲、女贞子、青皮、金丝草、瓜蒌放入凉水中浸泡1-2h;2)将步骤1)中的中草药和浸泡液放入砂锅中进行熬制,大火煮沸后,添加牛膝、木贼、白蒺藜、栀子、升麻和苋菜,改用温火煎煮5-10min后,添加桑叶、黑豆和蝉蜕;3)从沸腾开始计,共煎煮30-40min,倒出滤液,添加清水,进行第二次煎煮,先大火后温火煎煮30-40min,共煎煮三次,合并滤液;4)将步骤3)所得滤液浓缩,制成制剂。
本发明的中药制剂中,夏枯草:味苦、性辛、微寒;归肝、胆经;具有清泄肝火、散结消肿、清热解毒、祛痰止咳、凉血止血的功效;主治淋巴结核、甲状腺肿、乳痈、头目眩晕、口眼歪斜、筋骨疼痛、肺结核、血崩、带下、急性传染性黄疸型肝炎及细菌性痢疾等。
本发明的中药制剂中,牡丹皮:味苦、性辛、微寒;归心、肝、肾经;具有清热凉血、活血化淤、退虚热的功效;主治温病热病热入营血之壮热、身发斑疹、舌红绛,阴虚发热,血热妄行之吐血、衄血、尿血,闭经,跌打损伤,疮疡肿毒等病症。
本发明的中药制剂中,桑叶:味苦、性甘、微寒;归肺、肝经;具有清肝养肝、疏散风热、清肺明目的功效;主治风热感冒,风温初起,发热头痛,汗出恶风,咳嗽胸痛;肺燥干咳无痰,咽干口渴,风热及肝阳上扰,目赤肿痛。
本发明的中药制剂中,芦根:味甘、性寒;归肺、胃经;具有清热生津,除烦,止呕,利尿的功效;主治热病烦渴、胃热呕吐、肺热咳嗽、肺痈吐脓、热淋涩痛。
本发明的中药制剂中,玉竹:味甘,性平;归肺、胃经;具有养阴润燥,生津止渴的功效;主治燥咳、劳咳,肺胃阴伤,高血糖,燥热咳嗽,咽干口渴,内热消渴。
本发明的中药制剂中,威灵仙:性辛、味咸、微温;归膀胱经;具有祛风除湿、通络止痛、消痰水、散癖积的功效;主治痛风顽痹、风湿痹痛、肢体麻木、腰膝冷痛、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。
本发明的中药制剂中,忍冬藤:味甘、性寒;归肺、胃经;具有清热解毒,疏风通络的功效;主治温病发热,热毒血痢,痈肿疮疡,风湿热痹,关节红肿热痛。
本发明的中药制剂中,牛膝:味苦、性平、微酸;归肝、肾经;具有活血祛瘀,补肝肾,强筋骨,利水通淋,引血下行的功效;主治月经不调,痛经,闭经,产后瘀阻,跌打伤痛,腰膝酸痛,下肢乏力,小便不利,淋沥涩痛,吐血,衄血,齿痛,口疮,头痛眩晕。
本发明的中药制剂中,穿山甲:味咸、性微寒;归肝、胃经;具有活血散结,通经下乳,消痈溃坚的功效;主治血瘀经闭,症瘕,风湿痹痛,乳汁不下,痈肿,瘰疬。
本发明的中药制剂中,女贞子:性甘,味苦,微凉;归肝、肾经;具有补益肝肾,明目,清虚热的功效;主治头晕目眩,须发早白,视物昏花,阴虚发热。
本发明的中药制剂中,木贼:味苦、性甘、微平;归肺、肝、胆经;具有疏风散热,解肌,退翳的功效;主治目生云翳,迎风流泪,肠风下血,血痢,脱肝,疟疾,喉痛,痈肿。
本发明的中药制剂中,白蒺藜:性辛、味苦、微平;归肝、肺经;具有疏肝解郁、祛风明目、行气活血和祛风止痒的功效;主治肝阳眩晕头痛,肝郁胁痛,风热头痛,目赤肿痛,皮肤瘙痒等症。
本发明的中药制剂中,青皮:味苦、性辛、微温;归肝、胆、脾、肺、心经;具有疏肝破气,消积化滞的功效;主治肝郁气滞之胁肋胀痛,乳房胀痛,乳核,乳痈,疝气疼痛,食积气滞之胃脘胀痛,以及气滞血瘀所至的癥瘕积聚,久疟癖块。
本发明的中药制剂中,栀子:味苦、性寒、无毒;归心、肝、肺、胃经;具有泻火除烦,清热利湿,凉血解毒的功效;主治热病心烦,肝火目赤,头痛,湿热黄疸,淋证,血痢尿血,口舌生疮,疮疡肿毒,扭伤肿痛。
本发明的中药制剂中,金丝草:味甘、性淡、微凉;归脾、肾、膀胱经;具有清热,解暑,利尿的功效;主治感冒高热,中暑,尿路感染,肾炎水肿,黄疸型肝炎,糖尿病,小儿久热不退。
本发明的中药制剂中,黑豆:味甘、性平、微寒;归脾、肾经;具有补肾益阴,健脾利湿、除热解毒的功效;主治肾虚阴亏,消渴多饮,小便频数,肝肾阴虚,头晕目眩,视物昏暗。
本发明的中药制剂中,升麻:性辛、味甘、微寒;归肺、脾、胃、大肠经;具有发表透疹,清热解毒,升举阳气的功效;主治风热头痛,齿痛,口疮,咽喉肿痛,麻疹不透,阳毒发斑;脱肛,子宫脱垂。
本发明的中药制剂中,蝉蜕:味咸、性甘、微寒;归肺、肝经;具有散风热,宣肺,定痉的功效;主治外感风热,咳嗽音哑,麻疹透发不畅,风疹瘙痒,小儿惊痫,目赤,翳障,疔疮肿毒,破伤风。
本发明的中药制剂中,瓜蒌:甘苦,性寒;归肺、胃、大肠经;具有润肺,化痰,散结,润肠的功效;主治痰热咳嗽,胸痹,结胸,肺痿咳血,消渴,黄疸,便秘,痈肿初起;肺热咳嗽,痰浊黄稠,胸痹心痛,乳痈、肺痈、肠痈肿痛。
本发明的中药制剂中,苋菜:性凉、味微甘;归肺、大肠经;具有清热利湿,凉血止血,止痢的功效;主治赤白痢疾,二便不通,目赤咽痛,鼻衄等病症;其子具有清肝明目的功效,用于角膜云翳,目赤肿痛;其根具有凉血解毒和止痢的功效,用于细菌性痢疾,肠炎,红崩白带,痔疮。
本发明中药的用法与用量:本发明的中药制剂,按活性组分原料药总重量计,每日服用8-10g,每日3次,1周为1个疗程,1-3个疗程可以治愈。
中医认为,干眼症主要与肺、肝和肾三脏有关;中医多从“燥”论治,“燥”为六淫之一。《素闻·玄机原病式》曰:“诸涩枯涸,干劲皲揭,皆属于燥”;叶天士认为“燥为干涩不通之疾”,为内伤所致者多因于肝肾,肝开窍于目,“五脏化液”,肝为之泪,故泪液濡润肝窍—目。当肝阴充足,肝气条达时,泪液分泌正常。而对干眼症的论治还必须抓住肾虚这一点,因在生理上说肝肾不但同属阴经,同在下焦,而且是同源互济的,即“肝肾同源”,肾虚可致肝亦虚。眼的营养主要靠肝血的供应,神光的产生则主要依赖肾精的上乘,如肝肾阴虚,则五脏六腑之精气皆不能上注于目,目失濡养,则易发生“干涩症”。故临床上肝肾阴虚,肝之泪液不足,常致眼干涩,泪液少是发生本病的原因。
本发明的有益效果是:本发明的各味中草药原料科学合理配伍,药效相辅相成,相得益彰,通过疏肝破气、养阴润肺、健脾利湿、益补肝肾和祛风明目,达到了清热解毒、活血化瘀和益气补血的功效,通过口服进入人体,直达病灶深处,有效成分吸收快;同时,还能够增强患者的机体免疫功能,提高患者的机体抵抗力。根据“肝开窍于目”和“肝受血则能视”的原则,利用肝将血液营养物质输送至目,肾主津液,肺主宣降水液,水液上承于目,则滋润目珠,通过滋阴生津,提高了泪液的分泌量,增加了泪河高度,延长了泪膜破裂时间,改善了眼角膜上皮的缺损症状,有效防止了继发感染,对干眼症进行根本性治疗,达到了标本兼治的目的。本发明中药制剂中各味中草药原料均为天然药材,价廉易得,安全性好;其疗效明确,疗程短,治愈率高,无副作用,使用方便,不复发,大大减轻了患者的经济和精神负担。
具体实施方式
下面将结合具体实施例对本发明的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
一种治疗干眼症的中药制剂,包括以下重量份的原料制成:夏枯草8-15份、牡丹皮6-9份、桑叶3-6份、芦根6-9份、玉竹5-12份、威灵仙8-15份、忍冬藤6-9份、牛膝6-9份、穿山甲3-6份、女贞子8-15份、木贼6-9份、白蒺藜6-9份、青皮5-12份、栀子6-9份、金丝草6-9份、黑豆6-9份、升麻6-9份、蝉蜕3-6份、瓜蒌8-15份、苋菜6-9份。
进一步地,本发明的中药制剂,包括以下重量份的原料制成:夏枯草12份、牡丹皮8份、桑叶5份、芦根8份、玉竹10份、威灵仙12份、忍冬藤7份、牛膝7份、穿山甲5份、女贞子13份、木贼8份、白蒺藜7份、青皮10份、栀子8份、金丝草7份、黑豆7份、升麻8份、蝉蜕5份、瓜蒌13份、苋菜8份。
更进一步地,本发明的中药制剂中,所述中药制剂的剂型为汤剂、丸剂、颗粒剂、片剂或口服液中的一种。
本发明的一种治疗干眼症的中药制剂的制备方法:包括以下步骤:1)将夏枯草、牡丹皮、芦根、玉竹、威灵仙、忍冬藤、穿山甲、女贞子、青皮、金丝草、瓜蒌放入凉水中浸泡1-2h;2)将步骤1)中的中草药和浸泡液放入砂锅中进行熬制,大火煮沸后,添加牛膝、木贼、白蒺藜、栀子、升麻和苋菜,改用温火煎煮5-10min后,添加桑叶、黑豆和蝉蜕;3)从沸腾开始计,共煎煮30-40min,倒出滤液,添加清水,进行第二次煎煮,先大火后温火煎煮30-40min,共煎煮三次,合并滤液;4)将步骤3)所得滤液浓缩,制成制剂。
实施例一
本发明的治疗干眼症的中药制剂,包括以下重量份的原料制成:夏枯草8份、牡丹皮6份、桑叶3份、芦根6份、玉竹5份、威灵仙8份、忍冬藤6份、牛膝6份、穿山甲3份、女贞子8份、木贼6份、白蒺藜6份、青皮5份、栀子6份、金丝草6份、黑豆6份、升麻6份、蝉蜕3份、瓜蒌8份、苋菜6份。
将夏枯草、牡丹皮、芦根、玉竹、威灵仙、忍冬藤、穿山甲、女贞子、青皮、金丝草、瓜蒌放入适量的凉水中浸泡1-2h;然后,将上述中草药和浸泡液放入砂锅中进行熬制,大火煮沸后,添加牛膝、木贼、白蒺藜、栀子、升麻和苋菜,改用温火煎煮5-10min后,添加桑叶、黑豆和蝉蜕;从沸腾开始计,共煎煮30-40min,倒出滤液,添加适量清水,进行第二次煎煮,先大火后温火煎煮30-40min,共煎煮三次,合并滤液;将上述滤液浓缩至体积为200-300mL,制成汤剂,分3次服用,饭前温服。
当然,也可以对浓缩后的滤液继续进行杀菌,装瓶,制成口服液。
实施例二
本发明的治疗干眼症的中药制剂,包括以下重量份的原料制成:夏枯草12份、牡丹皮8份、桑叶5份、芦根8份、玉竹10份、威灵仙12份、忍冬藤7份、牛膝7份、穿山甲5份、女贞子13份、木贼8份、白蒺藜7份、青皮10份、栀子8份、金丝草7份、黑豆7份、升麻8份、蝉蜕5份、瓜蒌13份、苋菜8份。
按照实施例一的方法进行熬制,将合并后的滤液浓缩,干燥,添加蜂蜜,制成丸剂,每丸重1-2g,每次1-2丸,每日3次,饭前服用。
实施例三
本发明的治疗干眼症的中药制剂,包括以下重量份的原料制成:夏枯草15份、牡丹皮9份、桑叶6份、芦根9份、玉竹12份、威灵仙15份、忍冬藤9份、牛膝9份、穿山甲6份、女贞子15份、木贼9份、白蒺藜9份、青皮12份、栀子9份、金丝草9份、黑豆9份、升麻9份、蝉蜕6份、瓜蒌15份、苋菜9份。
按照实施例一的方法进行熬制,将合并后的滤液浓缩,干燥,制成颗粒剂或片剂,每日3次,每次2-4g,饭前温服。
下面结合具体试验例进一步阐述本发明,其中,包括本发明的中药制剂的动物毒性试验、药效学试验和临床观察试验。
动物毒性试验
急性毒性试验:取成年大鼠20只,雌雄兼用,体重180-220g,分为两组,每组10只;将本发明的中药制剂分别按照临床日用量的240倍和350倍给两组成年大鼠灌胃给药,观察两周,每天观察给药反应;多次试验均结果表明,两组成年大鼠均健存,其活动、饮食、毛发、排泄物未发现异常,未见毒性反应;对成年大鼠口腔和破损皮肤进行刺激性试验,未见有刺激性反应和其它不良反应。这说明本发明的中药制剂对成年大鼠急性用药毒性小,应用安全。
长期毒性实验:另取成年大鼠20只,雌雄兼用,体重180-220g,分为两组,每组10只;将本发明的中药制剂按照临床日用量的50倍给成年大鼠灌胃给药,连续用药16周,每天2次,每天观察给药反应;两组成年大鼠分别于用药16周和停药4周后,剖检,进行组织学检查,肉眼仔细观察主要内部脏器的情况;试验结果表明:本发明的中药制剂对两组试验成年大鼠的毛发、行为、大小便、体重、脏器重量、血象、肝肾功能、血糖、血脂等指标均无明显影响,脏器肉眼没有发现异样变化;组织学检查结果表明,用药16周和停药4周后,成年大鼠各脏器均无明显改变。这说明本发明中药制剂对成年大鼠长期用药后毒性小,停药后也没有异样反应,应用安全。
动物药效学试验
1、本发明的中药制剂对去势致干眼症大鼠的作用
取成年大鼠60只,雌雄兼用,体重180-220g,随机分为6组,分别为假手术组、模型组、实施例一至实施例三的三种中药制剂组成的实验组和某市售治疗干眼症的中草药汤剂对照组。除假手术组外,其余各组大鼠分别以10%水合氯醛按350mg/Kg腹腔注射麻醉,俯卧固定,无菌条件下切除双侧睾丸及附睾,缝合切口;假手术处理:只将阴囊切开,不切除双侧睾丸及附睾;同时,记录各组大鼠泪液量。术后第8天开始给药组灌药,每日1次,用量均为临床用药的5倍,连续3个月,假手术组及模型组给予等量纯净水,分别于给药后1个月、2个月及实验结束时测泪液量,实验测试结果如表1所示。
表1本发明的中药制剂对去势致干眼症大鼠泪液分泌的影响
备注:与模型组相比,*——P<0.05,**——P<0.01。
由表1可以看出,与模型组相比,本发明实施例一至实施例三的三种中药制剂和市售的某治疗干眼症的中草药汤剂(即表1中的对照组)均可以增加去势干眼症大鼠泪液的分泌;与市售的某治疗干眼症的中草药汤剂相比,本发明的实施例一至实施例三的三种中药制剂在增加去势干眼症大鼠泪液的分泌方面更具有优势,其用药后的泪液分泌量呈极显著性的增加,即P<0.01。
2、本发明的中药制剂对甲亢阴虚小鼠的作用
取昆明小鼠60只,雌雄兼用,体重18-22g,随机分为6组,分别为假手术组、模型组、实施例一至实施例三的三种中药制剂组成的实验组和某市售治疗干眼症的中草药汤剂对照组。除假手术组外,其余各组均每日上午灌胃甲状腺素片0.32g/Kg,容量为0.1mL/10Kg体重,连续14天,同时给药组小鼠每日下午灌胃给与相应药物,用量均为临床用药的5倍,假手术组和模型组给予等量纯净水。末次给药后30min,腹腔注射酚红(500mg/Kg体重,5%酚红生理盐水0.1mL/10g体重),半小时后,将小鼠用乙醚轻麻,摘眼球取血,检测血清SOD活力和MDA含量;处死动物,剥去气管周围组织剪下自甲状软骨至气管分支处的一段气管,放进盛有2mL生理盐水的试管中,再加1mol/LNaOH溶液0.1mL,用722型分光光度计(波长546nm)测OD值(用OD值表示酚红排泌量的多少);剖取小鼠胸腺和睾丸称重,计算胸腺指数和睾丸指数;试验测试结果如表2所示。
表2本发明的中药制剂对甲亢阴虚小鼠的影响
备注:与模型组相比,*——P<0.05,**——P<0.01。
由表2可以看出,与模型组相比,本发明实施例一至实施例三的三种中药制剂和市售的某治疗干眼症的中草药汤剂(即表2中的对照组)均可以显著促进气管酚红的排泌;与市售的某治疗干眼症的中草药汤剂相比,本发明的实施例一至实施例三的三种中药制剂在促进气管酚红排泌方面更具有优势。同时,与模型组相比,本发明实施例一至实施例三的三种中药制剂和市售的某治疗干眼症的中草药汤剂均可以显著提高甲亢阴虚小鼠血清SOD活力和降低MDA含量;与市售的某治疗干眼症的中草药汤剂相比,本发明的实施例一至实施例三的三种中药制剂在提高甲亢阴虚小鼠血清SOD活力和降低MDA含量方面更具有优势。其次,与模型组相比,本发明实施例一至实施例三的三种中药制剂和市售的某治疗干眼症的中草药汤剂均可以显著增加甲亢阴虚小鼠的胸腺指数和睾丸指数;与市售的某治疗干眼症的中草药汤剂相比,本发明的实施例一至实施例三的三种中药制剂在增加甲亢阴虚小鼠的胸腺指数和睾丸指数方面更具有优势,其用药后的胸腺指数和睾丸指数极显著性的增加,即P<0.01。
综上所述,与某市售的治疗干眼症的中草药汤剂相比,本发明的中药制剂可以明显地提高泪液的分泌量,具有更好的滋阴生津作用。
临床观察试验
患者资料
随机选取25-75岁的干眼症患者200例,其中,男100例,女100例,平均年龄为47.25岁;按照男女比例、年龄比例和病程比例均衡的方法分为两组,分别为一个对照组和一个治疗组,每组各100例,两组患者之间没有统计学上的差异性,两组患者都均符合干眼症的诊断标准;这两组患者在接受本次治疗之前,均曾用西药或中药等治疗方法,但是,效果不显著,易复发,不能除根。
诊断标准
参照国家中医药管理局1994年发布的《中医药诊断疗效标准》,以临床症状、泪液分泌量、泪膜破裂时间、角膜荧光素染色为观察指标。
诊断方法
使用传统的三项检查方法:使用SchirmerI法测量泪液基础生成量,在无表面麻醉情况下,将Schirmer试纸一端折放于下睑中外1/3穹窿部,沿睑缘下垂,5min后取下滤纸,测量泪液浸湿试纸的长度;如<5mm/5min为强阳性(++),<10mm/5min为阳性(+)。BUT泪膜破碎时间反应泪膜的稳定性,用玻璃棒蘸荧光素钠点于患者下眼睑,嘱患者闭眼,在裂隙灯下观察患者从睁开眼到角膜表面出现第一个黑斑之间的时间,此间隔即BUT<10s为阳性(+)。角膜荧光素染色:反应角膜上皮缺损情况,无染色为0分,每个象限分轻、中、重3级;因此,共0-12分,一般认为<1分为正常。
治疗方案
对照组:患者口服某市售的治疗干眼症的中草药汤剂,每日3次,每次100mL,饭前服用,15天为1个疗程,连续使用3个疗程;
治疗组:患者口服本发明的中药制剂,每日3次,按活性组分原料药总重量计,每日服用8-10g,1周为1个疗程,连续服用3个疗程。
每日随访一次,用药前和用药后分别做评价,治疗完毕之后,继续随访1年,治疗前、复诊及随访时填写病例报告表。
所有受试者在试验期间均不得合并使用任何其它治疗干眼症的药物和可能影响临床疗效和不良反应评价的药品。
治疗效果
治愈:自觉症状消失,SchirmerI试验多次测定大于10mm/5min,泪膜破裂时间BUT大于10s,角膜荧光素着色消失;
好转:自觉症状减轻,SchirmerI试验多次测定5-10mm/5min,泪膜破裂时间BUT为5-10s,角膜荧光素着色减少;
无效:自觉症状无改善,SchirmerI多次测定小于5mm/5min,泪膜破裂时间BUT小于5s,角膜荧光素染色无变化。
临床观察结果
表3临床治疗前后各项指标对比结果
备注:与对照组相比,*——P<0.05,**——P<0.01。
表4临床治疗结果对比结果
临床实验观察结果如表3和表4所示,由表3和表4可以看出,与对照组相比,本发明的中药制剂可以显著减轻和缓解干眼症患者的诸多症状,治疗后患者的症状积分呈显著性下降,大大延长了其泪膜的破碎时间,而且,其泪河高度也得到了明显提高,提高了泪液的分泌量,减少了角膜上皮的缺损;即本发明的中药制剂对治疗干眼症具有很好的疗效,优势非常明显,治愈率显著升高,达88%,全部有效,总有效率为100%;药性平和,无苦涩异味,温和易服,大大减轻了患者的痛苦;有效成分吸收快,见效快,疗效明确,疗程短,无毒副作用,标本兼治。
典型病例
病例1:赵某,男,38岁,外企工作人员,因眼部不适来医院诊治,经检查,其双眼有干眼症阳性病史和自觉症状,两眼的泪液分泌试验均为3mm/5min,两眼的泪膜破裂时间均为4s,角膜荧光素染色后可见角膜上皮散在点状着色,确诊为干眼症;经过询问,患病时间为半年,表现为眼睛干涩,容易疲倦,有时发痒,有异物感和灼热感,对外界刺激很敏感;曾经外敷过市售的治疗干眼症的滴眼液,该滴眼液滴加困难,对眼睛周围的皮肤有刺激作用,没有除根,症状易反复。近期开始服用本发明的中药制剂,每天3次,饭前服用,并坚持每天早晨采用牛奶清洗眼睛;1个疗程后观察,患者眼睛不适等症状全部消失,角膜染色阴性,两眼的泪液分泌试验均为14mm/5min,两眼的泪膜破裂时间均为15s,达到了临床治愈的治疗效果;随访1年内未复发。
病例2:田某,男,55岁,计算机开发人员,因眼部不适来医院诊治,经检查,其双眼有干眼症阳性病史和自觉症状,泪液分泌试验为2mm/5min(右)和3mm/5min(左),泪膜破裂时间为3s(右)和3.5s(左),角膜荧光素染色后可见角膜上皮散在点状着色,伴有口干鼻燥,皮肤干燥的症状,确诊为干眼症;经过询问,患病时间为3年,眼睛一直干涩,易疲倦,有时发痒,有异物感和灼热感,分泌物粘稠,怕风,畏光,对外界刺激很敏感;曾经服用治疗干眼症的中药并配合治疗干眼症的西药滴眼液一起使用,该中药疗程长,见效慢,不能除根,停止服用该药以后容易复发;该西药只能暂时缓解患者的表面症状,不能除根,还具有副作用,大大影响了患者的心情。服用本发明的中药制剂,每日3次,饭前服用,1个疗程后观察,眼睛不适等症状得到缓解,口干鼻燥和皮肤干燥症状减轻;继续服用1个疗程后,上述症状全部消失,查泪液分泌试验检查泪液13mm/5min(右)、14mm/5min(左),泪膜破裂时间为16s(右)和18s(左),角膜染色呈阴性,机体免疫力得到提高,达到了临床治愈的治疗效果;随访1年内未复发。
病例3:何某,女,73岁,退休干部,因眼部不适来医院诊治,经检查,其双眼有干眼症阳性病史和自觉症状,泪液分泌试验为2mm/5min(右)和1mm/5min(左),泪膜破裂时间为2s(右)和1s(左),角膜荧光素染色后可见角膜上皮散在点状着色,确诊为干眼症;经过询问,患病时间为十年,眼睛持续干涩,局部红肿和充血,易疲倦,有时发痒,有异物感和灼热感,眼皮紧绷沉重,分泌物粘稠,怕风,畏光,对外界刺激很敏感;开始的时候,曾经外敷过某市售的治疗干眼症的滴眼液,该滴眼液只能暂时缓解表面症状,不能除根,还具有副作用;后来,还服用治疗干眼症的中草药汤剂,该中草药疗程长,见效慢,不能除根,停止服用该药以后容易复发。近期服用本发明的中制剂,每天3次,饭前服用,并坚持每天晚上采用牛奶清洗眼睛;1个疗程后观察,眼部不适得到缓解,眼睛干涩、发痒、异物感和灼热感减轻;继续服用1个疗程后,分泌物粘稠、怕风和畏光、红肿和充血症状逐渐得到改善;继续服用1个疗程后,上述症状全部消失,查泪液分泌试验检查泪液为13mm/5min(右)和12mm/5min(左),泪膜破裂时间为18s(右)和17s(左),角膜染色呈阴性,机体免疫力有所提高,身体素质较服药前有明显的改善,达到了临床治愈的治疗效果;随访1年内未复发。
因此,本发明的中药制剂的有益效果是:本发明的各味中草药原料科学合理配伍,药效相辅相成,相得益彰,通过疏肝破气、养阴润肺、健脾利湿、益补肝肾和祛风明目,达到了清热解毒、活血化瘀和益气补血的功效,通过口服进入人体,直达病灶深处,有效成分吸收快;同时,还能够增强患者的机体免疫功能,提高患者的机体抵抗力。根据“肝开窍于目”和“肝受血则能视”的原则,利用肝将血液营养物质输送至目,肾主津液,肺主宣降水液,水液上承于目,则滋润目珠,通过滋阴生津,提高了泪液的分泌量,增加了泪河高度,延长了泪膜破裂时间,改善了眼角膜上皮的缺损症状,有效防止了继发感染,对干眼症进行根本性治疗,达到了标本兼治的目的。本发明中药制剂中各味中草药原料均为天然药材,价廉易得,安全性好;其疗效明确,疗程短,治愈率高,无副作用,使用方便,不复发,大大减轻了患者的经济和精神负担。
以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,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 (4)
1.一种治疗干眼症的中药制剂,其特征在于,包括以下重量份的原料制成:
夏枯草8-15份、牡丹皮6-9份、桑叶3-6份、芦根6-9份、玉竹5-12份、威灵仙8-15份、忍冬藤6-9份、牛膝6-9份、穿山甲3-6份、女贞子8-15份、木贼6-9份、白蒺藜6-9份、青皮5-12份、栀子6-9份、金丝草6-9份、黑豆6-9份、升麻6-9份、蝉蜕3-6份、瓜蒌8-15份、苋菜6-9份。
2.根据权利要求1所述的治疗干眼症的中药制剂,其特征在于,包括以下重量份的原料制成:
夏枯草12份、牡丹皮8份、桑叶5份、芦根8份、玉竹10份、威灵仙12份、忍冬藤7份、牛膝7份、穿山甲5份、女贞子13份、木贼8份、白蒺藜7份、青皮10份、栀子8份、金丝草7份、黑豆7份、升麻8份、蝉蜕5份、瓜蒌13份、苋菜8份。
3.根据权利要求1或2所述的治疗干眼症的中药制剂,其特征在于:
所述中药制剂的剂型为汤剂、丸剂、颗粒剂、片剂或口服液中的一种。
4.一种根据权利要求3所述的治疗干眼症的中药制剂的制备方法,其特征在于,包括以下步骤:
1)将夏枯草、牡丹皮、芦根、玉竹、威灵仙、忍冬藤、穿山甲、女贞子、青皮、金丝草、瓜蒌放入凉水中浸泡1-2h;
2)将步骤1)中的中草药和浸泡液放入砂锅中进行熬制,大火煮沸后,添加牛膝、木贼、白蒺藜、栀子、升麻和苋菜,改用温火煎煮5-10min后,添加桑叶、黑豆和蝉蜕;
3)从沸腾开始计,共煎煮30-40min,倒出滤液,添加清水,进行第二次煎煮,先大火后温火煎煮30-40min,共煎煮三次,合并滤液;
4)将步骤3)所得滤液浓缩,制成制剂。
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