CN113304217A - 一种用于治疗2型糖尿病性干眼和过敏性睑皮炎的中药熏眼制剂及其制备方法 - Google Patents
一种用于治疗2型糖尿病性干眼和过敏性睑皮炎的中药熏眼制剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种用于治疗2型糖尿病性干眼和过敏性睑皮炎的中药熏眼制剂及其制备方法,具体是将生地、麦冬、沙参、丹皮、蒲公英、荆芥、薄荷、赤芍和防风,加入温水浸泡后反复加水煎煮,收集制得的混悬液反复蒸馏出提取液;提取液调整PH至6.7~7;加入并溶解冰片后,经过滤,封装,灭菌即得中药熏眼制剂。采用本发明技术方案可以有效缓解2型糖尿病性干眼和过敏性睑皮炎导致的眼部不适,避免了频繁应用抗炎药物对角结膜上皮的毒性作用,也避免药物肝脏首过效应,具有较高的安全性。
Description
技术领域
本发明涉及生物医药技术领域,尤其涉及一种用于治疗2型糖尿病性干眼和过敏性睑皮炎的中药熏眼制剂及其制备方法。
背景技术
2型糖尿病性干眼是严重影响视功能的一种干眼症类型,病因复杂,临床症状多样,因体内血糖的异常增高常伴有睑缘疾病如过敏性睑皮炎。目前中医药的治疗主要采用口服及局部治疗治疗为主,中药雾化治疗是局部治疗的主要方法,其可明显减轻患者的临床症状,但现有中药配方主要以滋肾养阴或益气养阴为主,目前尚不能完全缓解患者的临床症状,仍有部分患者存在眼部不适如(眼痒、畏光、烧灼感、黏腻感等)。
公开号为CN202110044456.8的发明专利公开了一种中药熏眼制剂及其制备方法与应用,先将薄荷、荆芥粉末混合后通过蒸馏法提取,再将粉末状防风、蒲公英、金银花、桑叶以及蝉蜕混合后加入水中进行煎煮提取;合并提取液并加入冰片得到中药熏眼制剂。该方案对2型糖尿病引发的干眼症和过敏性睑皮炎的疗效不可知,且提取液的混合制备步骤较复杂。
发明内容
本发明为解决上述问题,提供一种用于治疗2型糖尿病性干眼和过敏性睑皮炎的中药熏眼制剂及其制备方法,对2型糖尿病性干眼和过敏性睑皮炎的疗效好且安全性较高。
为达到上述目的,本发明采用如下技术方案:
用于治疗2型糖尿病性干眼和过敏性睑皮炎的中药熏眼制剂,组分包括生地、麦冬、沙参、丹皮、蒲公英、荆芥、薄荷、赤芍和防风。
上述中药熏眼制剂中,组分各质量份为:生地6~12质量份、麦冬6~12质量份、沙参6~12质量份、丹皮4~10质量份、蒲公英4~10质量份、荆芥4~10质量份、薄荷2~6质量份、赤芍3~9质量份、防风4~10质量份。
上述中药熏眼制剂组分中还包括0~1质量份冰片。
用于治疗2型糖尿病性干眼和过敏性睑皮炎的中药熏眼制剂制备方法包括以下步骤:
(1)将生地60~120g、麦冬60~120g、沙参60~120g、丹皮40~100g、蒲公英40~100g、荆芥40~100g、薄荷20~60g、赤芍30~90g、防风40~100g,加入温水浸泡后反复加水煎煮,收集制得中药饮片初提混悬液;
(2)初提混悬液反复蒸馏至1000ml提取液;
(3)提取液调整PH至6.7~7;
(4)加入并溶解0~10g冰片后,经过滤,封装,灭菌即得中药熏眼制剂。
上述方法中,步骤(4)加入的冰片的质量为5g。
上述方法中,步骤(1)加入60℃温水浸泡2h后反复加水煎煮至少3次,每次煎煮时间1.5h。
上述方法中,步骤(3)加适量氢氧化钠提取液调整PH至6.7~7。
采用本发明的产生的有益效果为:
(1)本发明制备的中药熏眼制剂由经典方剂增液汤(生地、麦冬)加减而成,原方增加丹皮、蒲公英、荆芥、薄荷、赤芍、防风增强祛风清热活血之作用,该方剂具有养阴生津、疏风清热、祛风除湿、清热凉血、活血通络之功,适宜于阴虚火旺、风邪入络之病症,适用于眼部干涩异物感、眼红眼痒、灼热感、干涩刺痛不适等眼病。可以有效缓解2型糖尿病性干眼和过敏性睑皮炎导致的眼部不适。
(2)本发明发明制备的中药熏眼制剂具有消炎杀菌、免疫调节、抗氧化等作用,可以改善角结膜炎性反应,维持泪膜稳定性,从而快速缓解眼痒、眼干等不适症状。
(3)本发明发明制备的中药熏眼制剂还可以避免频繁点眼对泪液的冲刷和稀释,保证泪膜的稳定性,避免了频繁应用抗炎药物对角结膜上皮的毒性作用,也避免药物肝脏首过效应,具有较高的安全性。
附图说明
图1为本发明中药熏眼制剂制备流程图。
图2为本发明中药熏眼制剂制备流程图实施例
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白,以下结合实施例对本发明进行进一步的详细说明。应当理解,此处所描述的具体实施例仅用于解释本发明,并不用于限定本发明。
实施例1
本发明涉及一种用于治疗2型糖尿病性和过敏性睑皮炎的中药熏眼制剂,所述的中药熏眼制剂为将药物组合按比例配制中药饮片浓缩获得,所述的中药熏眼制剂按质量份数计包括以下组分:生地6~12g、麦冬6~12g、沙参6~12g、丹皮4~10g、蒲公英4~10g、荆芥4~10g、薄荷2~6g、赤芍3~9g、防风4~10g,冰片0~1g。其中生地、麦冬、沙参养阴清肺、益胃生津,生地清热生津、凉血止血,北沙参能养阴清肺、益胃生津,能明目退翳,丹皮、蒲公英、荆芥、防风均可疏风清热,其中丹皮能凉血清热、活血化瘀,荆芥、防风、薄荷祛风清热、辛凉解表,荆芥兼可辛散祛风止痒;冰片芳香开窍,开通玄府,提高其他药物生物利用度。现代药理学研究表明,生地、玄参、麦冬等药物的提取物或有效成分具有扩张血管改善局部微循环、促进泪液分泌达到补液之功效,蒲公英、丹皮还具有抗炎、抗氧化、免疫调节等作用。同时,麦冬有清除自由基、缓解疲劳、镇静作用,防风具有止痒镇痛作用,冰片能除螨抑菌。此外,促进药物的吸收,提高药物的生物利用度。另外,从中药配伍角度我们认为冰片与其他药物配伍在一定程度上具有“相须相使”的关系。
参考图1和图2,用于治疗2型糖尿病性干眼和过敏性睑皮炎的中药熏眼制剂的制备方法,包括以下步骤:
(1)将生地60g、麦冬60g、沙参60g、丹皮40g、蒲公英40g、赤芍30g共同提取,提取时间为30min,用水量约8倍量,合并,过滤;防风40g打粉、过筛制成饮品粉末;荆芥40g、薄荷20g、加入60℃温水浸泡2h后煎煮3次,每次1.5h,收集混悬液,制得中药饮片1000g;
(2)初提混悬液蒸馏至6000ml之后重复蒸馏至1000ml;
(3)用指纹图谱进行获得的提取物含量测定;
(4)加适量氢氧化钠调整至PH6.7;
(5)加入辅料至药物全部溶解,过滤,封装,灭菌即得所述的中药熏眼制剂。
眼部超声雾化熏眼和(或)喷雾中药由原料药按前述固定比例配伍,按标准工艺制备成中药混悬液,消毒灭菌后,分装为5ml~20ml不等的中药熏眼制剂,供眼部超声雾化和(或)喷雾使用。制作工艺为:中药饮片→提纯物(中间体)→配液→粗滤→精滤→灭菌→灌装→封口→灭菌、检漏→灯检→印字包装→成品。
实施例2
同实施例1的区别在于,所述的中药熏眼制剂按质量份数计包括以下组分:生地12g、麦冬12g、沙参12g、丹皮10g、蒲公英10g、荆芥10g、薄荷6g、赤芍9g、防风10g,冰片1g
包括以下步骤:
(1)将生地120g、麦冬120g、沙参120g、丹皮100g、蒲公英100g、荆芥100g、薄荷60g、赤芍90g、防风100g加入60℃温水浸泡2h后煎煮3次,每次1.5h,收集混悬液,制得中药饮片1000g;
(2)初提混悬液蒸馏至6000ml之后重复蒸馏至1000ml;
(3)可以采用用指纹图谱进行获得的提取物含量测定,以确定有效成分含量;
(4)加适量氢氧化钠调整至PH7;
(5)加入10g冰片及辅料至药物全部溶解,过滤,封装,灭菌即得所述的中药熏眼制剂。
其中步骤5中,加入5g冰片能获得更好的治疗效果。
此外还可参考图2的传统方式,将生地、麦冬、沙参、丹皮、蒲公英、赤芍、薄荷和荆芥和防风三者分开进行处理后再混合。
本发明用于治疗2型糖尿病性干眼和过敏性睑皮炎的中药熏眼制剂还可以作为超声雾化用制剂使用,如用作眼部熏蒸,用量为10~20ml本发明所述的中药熏眼制剂,利用超声雾化产生的雾状微小颗粒熏眼10~20分钟/每次,达到缓解眼痒、眼干等症状目的。
本发明中药熏眼制剂中多种药物具有消炎杀菌、免疫调节、抗氧化等作用。细小药物颗粒持续雾化到眼球表明,可以改善角结膜炎性反应,维持泪膜稳定性,从而快速缓解眼痒、眼干等不适症状;还可以避免频繁点眼对泪液的冲刷和稀释,保证泪膜的稳定性。最后,雾化避免了频繁应用抗炎药物对角结膜上皮的毒性作用,也避免药物肝脏首过效应,具有较高的安全性。
除了上述超声雾化熏眼的诸多优点外,本发明中药熏眼制剂还可以灵活应用于便携式或家用喷雾装置,从而实现随身携带或家用,摆脱患者对医院的依赖,真正做到随时随地可以使用,从而实现既有滴眼液的便利性,又比滴眼液吸收更充分,作用更持久的目的。具有经济、方便、疗效好、副作用小等优点,适宜于推广。
一、本发明中药熏眼制剂治疗2型糖尿病性干眼疗效分析
2018年度在我科就诊并诊断为2型糖尿病性干眼的450名患者为统计对象。患者随机分为热敷+局部人工泪液滴眼液组+无菌注射用水雾化熏眼(以下简称对照组)以及热敷+人工泪液滴眼液+本发明中药熏眼制剂雾化熏眼(喷雾)组(以下简称治疗组)。其中治疗组350例,男性80例,女性270例,年龄(47.26±14.66)岁;对照组150例,男性50例,女性100例,年龄(46.33±13.47)岁。
治疗方法:热敷+局部人工泪液滴眼液治疗方法为先热敷,再局部使用玻璃酸钠滴眼液点眼治疗。雾化熏眼(喷雾)方法为专科超声雾化治疗仪及喷雾装置,将注射用水或本发明中药熏眼制剂导入雾化杯中,持续雾化或喷雾15分钟。每10次为一个疗程,每次治疗结束后1周行下一次治疗,1疗程结束后疗效情况如下表1所示,本发明中药熏眼有效率90.6%,远高对照组,经卡方检验,差异性显著。
表1治疗2型糖尿病性干眼1疗程结束后疗效情况统计表
组别 | N(例数) | 显效 | 有效 | 无效 | 总有效率% |
治疗组 | 300 | 237(79%) | 35(11.6%) | 29(9.6%) | 272(90.6%) |
对照组 | 150 | 92(61.3%) | 23(15.3%) | 35(23.3%) | 115(76.6%) |
x<sup>2</sup> | 28.995 | 29.008 | |||
P | <0.01 | <0.01 |
说明热敷+人工泪液滴眼液联合本发明中药熏眼制剂熏眼更能改善患者干眼症的临床症状。
二、本发明中药熏眼制剂治疗过敏性睑皮炎疗效分析
2018年度在我科就诊并诊断为过敏性睑皮炎并接受中药雾化熏眼的患者96例,其中男性35例,女性61例;年龄35~75岁。患者随机分为普拉洛芬滴眼液组+无菌注射用水雾化熏眼(以下简称对照组)以及普拉洛芬滴眼液+本发明中药熏眼制剂雾化熏蒸组(以下简称治疗组)。其中治疗组共50例,男性22例,女性28例,年龄(48±2.58)岁;对照组46例,男性16例,女性30例,年龄(45.4±2.31)岁。
治疗方法:普拉洛芬定滴眼液组治疗方法为患者双眼结膜囊点普拉洛芬滴眼液,每天2次,连续治疗1周。雾化方法为应用专科超声雾化治疗仪或喷雾装置,将注射用水或本发明中药熏眼制剂导入雾化杯中,持续雾化或喷雾15分钟,雾化熏眼为每天1次,连续治疗10次。两者患者中伴有过敏性鼻炎或其他过敏性疾病者参照相关疾病诊疗方案继续治疗。两组患者分别在治疗后1周及10天观察患者疗效如下表2所示,两组治疗1周后有效率82%,10天后有效率92%,远高对照组,经卡方检验,差异性显著。
表2治疗过敏性睑皮炎1周及10天后疗效情况统计表
组别 | N(例数) | 1周疗效 | 10天疗效% |
治疗组 | 50 | 41(82%) | 46(92%) |
对照组 | 46 | 28(61%) | 34(74%) |
x<sup>2</sup> | 8.020 | 5.702 | |
P | <0.01 | <0.01 |
说明本发明中药熏眼制剂雾化熏眼治疗能更迅速缓解睑皮炎引起的眼表临床症状。
三、本发明中药熏眼制剂雾化熏眼治疗2型糖尿病性干眼和过敏性睑皮炎2例分析:
病例(一)
张**,女,52岁,陕西省西安市人,以“双眼干涩困乏伴眼睑痒2月余”为主诉于2020年4月15日就诊我院。2个月前患者因用眼过度后出现双眼干涩、异物感、困乏,伴见频繁眨眼,喜揉眼,晨起有少量分泌物,眼睑皮肤潮红,无眼痛,无哭闹,在当地医院前后予“玻璃酸钠滴眼液、可乐必妥、氟米龙”等滴眼液治疗,症状可短暂好转,但停药后即复发,并且症状加重。随在我院干眼专病门诊就诊。发病以来,神志清,精神可,胃纳一般,夜眠可,二便调,无明显体重下降。刻下症:频繁眨眼,喜揉,喜闭眼,双眼睑皮肤红皱。舌红苔薄黄,脉数。既往有2型糖尿病病史约10年,过敏性鼻炎病史约3年。
专科检查:视力:OD:0.8,OS:0.8,眼压:OD:15mmHg,OS:14mmHg,双眼上下睑周围皮肤红肿皱褶,睫毛根部见鳞屑,泪河窄,结膜充血水肿,角膜下方点状荧光着染,前房清深,瞳孔圆,直径约3mm,对光反射灵敏,晶状体透明,眼底:舌红苔薄黄,脉数。
辅助检查:泪液分泌量检测:双眼<2.0mm,泪膜破裂时间:双眼:1.0s。
诊断:双眼2型糖尿病性干眼、过敏性睑皮炎。
治疗经过:告知患者控制血糖/合理用眼,适当室外活动、注意饮食卫生、控制患者揉眼的同时,眼局部在给予热敷、红霉素眼膏涂眼同时配合中药雾化治疗。连续治疗一疗程后患者干涩异物感、眼睑皮肤明显好转。
患者1周后随访,上述症状明显减轻,夜间用眼时仍会出现双眼困乏、眼睑红肿症状,建议患者间断中药雾化熏眼治疗,每2日一次,在治疗2周后,患者干涩困乏及眼睑症状基本消退。
病例(二)
王*,男,47岁,西安市长安区,以“双眼干涩畏光伴眼睑肿胀不适约半年”为主诉于2019年7月03日首诊于我科。半年前无明显诱因下出现双眼干涩、畏光,眼睑红肿,见鳞屑,不喜欢睁眼等不适,症状间断出现,无明显分泌物增多,无溢泪,在当地医院予“聚乙烯醇滴眼液、0.1%氟米龙滴眼液、典必殊眼膏”治疗后症状未见时好时坏,遂至我院就诊。发病以来,神志清,精神可,胃纳一般,夜眠差,二便调,无明显体重下降。刻下症:患者喜闭眼,眼涩,眼睑红肿,舌红苔薄黄。既往史:糖尿病病史8年,目前血糖控制不稳定。
专科检查:眼压:双眼:25mmHg,双眼睑红肿,皮肤粗糙,睫毛根部见鳞屑,外眦部皮肤破溃结痂,双眼泪河窄,睑球结膜充血水肿,角膜大片荧光着染,前房清深,瞳孔圆,直径约3mm,对光反射灵敏,晶状体皮质混浊,眼底:未见明显异常。舌红苔薄黄,脉数。
辅助检查:泪液分泌量检测:右眼:0mm,左眼<1.0mm,泪膜破裂时间:双眼<2.0s。
诊断:双眼2型糖尿病性干眼,双眼睑皮炎。
治疗经过:患者干眼症、睑皮炎诊断明确,结合患者糖尿病病史,患者眼部症状明显,眼部继续予玻璃酸钠滴眼液、普拉洛芬滴眼液、重组人表皮生长因子衍生物滴眼液治疗,因眼压增高,暂停典必殊眼膏,同时予热敷、红霉素眼膏并联合中药雾化熏眼治疗,告知患者积极控制血糖水平。患者中药雾化治疗1疗程后眼症减轻,查体见双眼睑皮肤红肿减轻,鳞屑减少,结膜充血好转,角膜透明,予停局部普拉洛芬滴眼液、重组人表皮生长因子衍生物滴眼液治疗,继续中药雾化、红霉素眼膏治疗,方法为隔日一次,再治疗1疗程后干涩畏光、眼睑症状明显好转,改玻璃酸钠滴眼液、红霉素眼膏为隔日使用,4次/天。2周后复诊双眼干涩、畏光、眼红、眼痒等症状消退,查体眼睑、结膜无明显充血,角膜透明,玻璃酸钠滴眼液、红霉素眼膏继续使用巩固疗效。
病例分析:本组两例患者伴糖尿病病史且出现干涩异物感、眼睑炎症等不适症状,我们虽然使用热敷及玻璃酸钠滴眼液减轻症状,但效果不明显且停药后症状反复,同时局部激素治疗眼压明显增高,说明常规局部滴眼液治疗临床疗效差,容易导致症状反复、眼压增高等。现代医学并没有安全可靠的方法来缓解眼干等症状。中药雾化能帮助患者缓解症状,且安全可靠、症状缓解持久,体现了临床治疗的优势。
针对2型糖尿病性干眼和过敏性睑皮炎配制了本发明中药熏眼制剂雾化熏眼方,全方以滋阴、祛风、除湿、止痒为主,成功的解决了此类患者“无药可医”的棘手情况。更为重要的是,避免激素导致眼压升高的风险,中药雾化熏眼联合人工泪液药物应用,可以迅速缓解眼干等不适,且症状持续。而且对配合欠佳患者,中药雾化仍然会有大部分药液能进入眼内,达到治疗作用,相比单纯滴眼药水的效果自然更好,而更容易配合,疗效也更为理想。
以上内容是结合具体实施例对本发明所作的进一步详细说明,不能认定本发明的具体实施只限于此。对于本发明所属技术领域的普通技术人员来说,在不脱离本发明构思的前提下做出若干等同替代或明显变型,且性能或用途相同,都应当视为属于本发明由所提交的权利要求书确定的专利保护范围。
Claims (7)
1.一种用于治疗2型糖尿病性干眼和过敏性睑皮炎的中药熏眼制剂,其特征在于包括组分:生地、麦冬、沙参、丹皮、蒲公英、荆芥、薄荷、赤芍和防风。
2.根据权利要求1所述的用于治疗2型糖尿病性干眼和过敏性睑皮炎的中药熏眼制剂,其特征在于所述组分各质量份为:生地6~12质量份、麦冬6~12质量份、沙参6~12质量份、丹皮4~10质量份、蒲公英4~10质量份、荆芥4~10质量份、薄荷2~6质量份、赤芍3~9质量份、防风4~10质量份。
3.根据权利要求2所述的用于治疗2型糖尿病性干眼和过敏性睑皮炎的中药熏眼制剂,其特征在于所述组分还包括0~1质量份冰片。
4.一种用于治疗2型糖尿病性干眼和过敏性睑皮炎的中药熏眼制剂制备方法,其特征在于包括以下步骤:
(1)将生地60~120g、麦冬60~120g、沙参60~120g、丹皮40~100g、蒲公英40~100g、荆芥40~100g、薄荷20~60g、赤芍30~90g、防风40~100g,加入温水浸泡后反复加水煎煮,收集制得中药饮片初提混悬液;
(2)初提混悬液反复蒸馏至1000ml提取液;
(3)提取液调整PH至6.7~7;
(4)加入并溶解0~10g冰片后,经过滤,封装,灭菌即得中药熏眼制剂。
5.根据权利要求4所述的方法,其特征在于,所述的步骤(4)加入的冰片的质量为5g。
6.根据权利要求4所述的方法,其特征在于,所述的步骤(1)加入60℃温水浸泡2h后反复加水煎煮至少3次,每次煎煮时间1.5h。
7.根据权利要求4所述的方法,其特征在于,所述的步骤(3)加适量氢氧化钠提取液调整PH至6.7~7。
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