CN101219143B - 樟柳碱用于制备治疗弱视的药物的用途 - Google Patents
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Abstract
本发明涉及樟柳碱的新的制药用途,属于药物新用途领域,更具体地说,本发明涉及氢溴酸樟柳碱用于制备治疗弱视的药物中的用途,所制得的药物可以是注射剂、滴眼剂,也可以是片剂、胶囊剂、口服液、滴丸等口服制剂。
Description
技术领域
本发明涉及樟柳碱的新的制药用途,属于化合物新的制药用途领域,更具体地说,本发明涉及樟柳碱在制备治疗弱视的药物中的用途。
背景技术
弱视是由于生后早期(视觉发育关键期)斜视、屈光参差或屈光不正、形觉剥夺等异常视觉经验引起的。半个世纪以来,关于弱视的概念,国内外学者普遍采用Bangerter定义,即“眼本身无器质性改变,或者有器质性改变及屈光异常,但与其病变不相适应的视力下降,屈光异常亦不能矫正,远方视力在0.8(0.9)以下者,统称为弱视。”之后,在《耳鼻喉口腔学》、《眼科学》等经典性著作中对Bangerter定义进行了修正:“由于视觉系统发育的关键期(可塑期)进入眼内的视觉刺激不够充分,剥夺了形成清晰物像的机会(形觉剥夺)和(或)两眼视觉输入不同引起清晰物像与模糊物像间发生竞争(双眼相互作用异常)所造成的单眼或双眼视力发育障碍,一般矫正视力不大于0.8。”
弱视的治疗效果与年龄密切相关,也与弱视程度、类型与注视性质密切相关,早期发现和坚持综合治疗是治疗弱视的关键。国际上一般公认为关键期或敏感期是指小儿自出生至6岁,最迟平均为8.5岁,发病率为3~4%,而0~7岁为最佳治疗期,12岁以后的治疗效果极差。目前,弱视的治疗方法以物理疗法为主,其中传统的“遮盖疗法”虽已经历了200多年的延用,但仍然被认为是目前最主要和最有效的治疗方法。
樟柳碱是从茄科植物唐古特山莨菪根中提取的一种生物碱,是胆碱能神经阻滞剂,有缓解平滑肌痉挛、散瞳等抗胆碱作用,能调节和维持血管张力,增强眼部血流量,临床上主要使用的是它的氢溴酸盐。氢溴酸樟柳碱是白色结晶,易溶于水,不溶于氯仿、乙醚,无臭,味苦,具有散瞳、缓解平滑肌痉挛、抑制唾液分泌等抗胆碱作用。多年的临床研究发现,氢溴酸樟柳碱对缺血性眼病有一定的疗效,如在中国专利97120175中即公开了一种复方樟柳碱注射液,以樟柳碱或者山莨菪碱与普鲁卡因、维生素B12、透明质酸酶等联用,克服了单用樟柳碱对眼缺血疗效不佳并且不良反应多的弊端,对缺血性眼病的有效率达到了90%以上。在中国专利申请02100193中,发明人公开了氢溴酸樟柳碱新的用途,即通过把氢溴酸樟柳碱与盐酸普鲁卡因组成复合物,可用于治疗支气管哮喘和过敏性鼻炎。在中国专利申请CN1981762中,发明人公开了复发樟柳碱的另外一种用途,即可用于治疗肺炎、肺纤维化,心脑血管缺血性病变等。
虽然如上所述,樟柳碱已经得到了广泛的临床应用,但是未见有将樟柳碱用于制备治疗弱视的药物的研究报道。
发明内容
本发明的目的是为了解决现有技术中对于弱视的治疗方案的不足,提供一种更为有效、安全的治疗药物。
本发明所提供的弱视治疗药物是樟柳碱或其酸加成盐,如氢溴酸樟柳椷,所用剂型包括注射剂、滴眼剂,也可以是片剂、胶囊、口服液、滴丸等口服制剂。
本发明所提供的弱视治疗药物进一步可含有盐酸普鲁卡因,其中樟柳碱与盐酸普鲁卡因的重量比范围为2∶1~2∶500,优选1∶1~1∶200,通过采用药学领域已知技术,制成注射剂、滴眼剂,也可以是片剂、胶囊、口服液、滴丸等口服制剂。
本发明所提供的弱视治疗药物还可以含有微生素B12等其它辅助成分。
有益效果:
一、氢溴酸樟柳碱盐酸普鲁卡因复方注射液的制备
本试验所使用的复方注射液(CA),每支量2mL,含氢溴酸樟柳碱0.2mg和盐酸普鲁卡因20mg。制备方法如下:
1.按重量比1∶100精确称量氢溴酸樟柳碱和盐酸普鲁卡因,分别加入部分注射用水溶解完全,用盐酸调PH值至3.5~5.5;
2.加余量注射用水;
3.灌封及压盖;
4.流通蒸汽灭菌,100℃30分钟;
5.进行注射剂常规检测。
二、治疗方法:
将患者分为对照组与治疗组各150例。对照组采用配镜、遮盖、屈光为中高度远视者加用后像红光闪烁及精细目力训练治疗;治疗组在采用与对照组相同治疗的同时,联合CA 2ml于患眼颞浅动脉旁皮下注射,1日1次,14天为1疗程,间歇5天后继续第2疗程。治疗组每半月复诊1次,疗程结束后每月随访1次;对照组每月复诊。所有视力检查均由同一护士在同一检查室采用同一视力表进行。疗效评价标准如下:
基本痊愈:矫正视力≥0.9;
进步:视力提高≥2行;
无效:视力提高≤1行。
基本痊愈和进步之和为合计有效率。结果用SPSS软件及x2检验、t检验等统计学方法进行处理分析。
三、治疗结果
弱视按严重程度分为三级:轻度:视力0.8~0.6;中度:视力0.5~0.2;重度:视力≤0.1。治疗组和对照组各不同弱视程度组之间用x2检验。
弱视严重程度与治疗后疗效的关系如下表所示:
弱视程度与疗效
组别 | 总例数 | 基本痊愈 | 进步 | 合计 | |||
例数 | 率(%) | 例数 | 率(%) | 例数 | 率(%) |
治疗组轻度中度重度 | 150626622 | 343040 | 22.7%48.4%6.1%0.0% | 68203810 | 45.3%32.3%57.6%45.5% | 102504210 | 68.0%80.6%63.6%45.5% |
对照组轻度中度重度 | 150557322 | 10730 | 6.7%12.7%4.1%0.0% | 4520223 | 30.0%36.4%30.1%13.6% | 5527253 | 36.7%49.1%34.2%13.6% |
由以上数据以及统计分析结果可知:轻度和中度弱视治疗组和对照组的总体有效率差异有非常显著意义(P<0.005),重度弱视的总体有效率差异有显著意义(P<0.05);另外对治疗组不同程度组间进行两两比较x2检验(检验水准α’=0.05/3=0.0167),轻度弱视治疗有效率高于重度弱视。
盐酸普鲁卡因为局部麻醉药物,它作用于外周神经产生传导阻滞作用,依靠浓度梯度以弥散方式穿透神经细胞膜,在内侧阻断钠离子通道,使神经细胞兴奋阈值升高,丧失兴奋性和传导性,信息传递被阻断,具有良好的局部麻醉作用,因此在本注射液中为辅助成分,同样可以用其它局部麻醉药物(如利多卡因)替代。
氢溴酸樟柳碱对于弱视有明显的治疗效果。
具体实施方式
实施例1:樟柳碱口服液的制备
原材料 用量
氢溴酸樟柳碱 400mg
蔗糖 500mg
纯化水 加至10000mL
------------------------------
分装 得口服液1000支
实施例2:氢溴酸樟柳碱片的制备
原材料 用量
氢溴酸樟柳碱 500mg
盐酸普鲁卡因 500mg
乳糖-水合物 65g
微晶纤维素 30g
硬脂酸酶 500mg
2%HPMC水溶液 适量
------------------------------
制得1000片
实施例3:氢溴酸樟柳碱盐酸普鲁卡因注射液
原材料 用量
氢溴酸樟柳碱 200mg
盐酸普鲁卡因 20g
氯化钠 18g
加注射用水 适量
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制得1000支
以上实施方式中的制剂均可采用药学领域常用的方法制备得到,同理,在本发明主体思想下,本领域技术人员可以很清晰的知道将樟柳碱用于制备得到其它相应的剂型。
Claims (8)
1. 樟柳碱用于制备治疗弱视的药物的用途。
2. 根据权利要求1所述的用途,其特征在于樟柳碱是氢溴酸樟柳碱。
3. 根据权利要求1或2所述的用途,其特征在于药物中还含有盐酸普鲁卡因。
4. 根据权利要求3所述用途,其特征在于樟柳碱与盐酸普鲁卡因的重量比范围为2∶1~2∶500。
5. 根据权利要求3所述用途,其特征在于樟柳碱与盐酸普鲁卡因的重量比范围为1∶1~1∶200。
6. 根据权利要求1~5任意一项权利要求所述的用途,其特征在于把药物制备成为注射剂、滴眼剂或者口服制剂。
7. 权利要求6所述的口服制剂为片剂、胶囊、口服液或滴丸中的一种。
8. 根据权利要求1~5任意一项权利要求所述的用途,其特征在于把药物制备成为注射剂。
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CN117599054B (zh) * | 2024-01-24 | 2024-03-29 | 成都第一制药有限公司 | 一种治疗假性近视的药物组合物及其用途 |
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CN1222392A (zh) * | 1997-11-18 | 1999-07-14 | 宋琛 | 治疗缺血性眼病的复方注射液 |
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CN1222392A (zh) * | 1997-11-18 | 1999-07-14 | 宋琛 | 治疗缺血性眼病的复方注射液 |
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RU2812786C2 (ru) * | 2018-08-21 | 2024-02-02 | Минерва Ньюросайенсиз, Инк. | Применение ролуперидона для лечения негативных симптомов и заболеваний, повышения нейропластичности и содействия нейрозащите |
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