CN1061262C - 治疗结膜炎的中药滴眼液及其制备方法 - Google Patents
治疗结膜炎的中药滴眼液及其制备方法 Download PDFInfo
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Abstract
本发明滴眼液是一种用于治疗目赤翳障、肿痛等结膜炎、角结膜炎、睑缘炎、麦粒肿等眼病的中药制剂，它是由鱼腥草、金银花、熊胆粉、栀子、板蓝根、麻黄、珍珠粉、冰片等八味中药组成。具有清热解毒、消肿止痛等功效。据六年来对8000余病例临床观察总有效率达96.66%。
Description
本发明涉及一种中药制剂，特别是一种用于治疗目赤翳障、肿痛等结膜炎的中药制剂滴眼液及其制备方法。
结膜炎是眼科的常见病、多发病，其发病率占眼科各种疾病的首位，若反复发作、长期不愈，可使结膜组织遭受破坏，形成结膜干燥症，导致终生痛苦。目前，对结膜炎的治疗尚无特效疗法，一般以局部用抗生素和抗病毒眼药为主。但由于本病多半非细菌、病毒直接所致，因而单纯应用抗生素和抗病毒药物往往疗效不佳，而且长期应用此类药物还会造成结膜的菌群失调，使细菌、病毒对抗生素、抗病毒药物产生耐药性，加之药物本身的副作用，对正常组织也有影响和破坏，由于细菌核蛋白与哺乳动物细胞内线粒体的核蛋白相似，所以抗生素和抗病毒眼药如庆大霉素、氯霉素等，在抑制细菌蛋白合成的过程中，也影响了人体细胞线体的蛋白合成。一些抗病毒药物在抑制病毒核酸合成的同时，也影响了人体细胞的通透性，细胞破坏从而也影响了原发病的治疗。
本发明的目的在于提供一种对细菌、病毒有杀伤和抑制作用而对宿主结膜、角膜组织无毒副作用的安全方便有效的中药制剂滴眼液及其制备方法。
本发明提供的中药制剂滴眼液其配方是由中药：鱼腥草、金银花、熊胆粉、栀子、板兰根、麻黄、珍珠粉和冰片制成滴眼剂。它们各组份的重量比是：鱼腥草10-150g、金银花5-80g、熊胆粉0.3-10g、栀子5-80g、板兰根5-80g、麻黄1-50g、珍珠粉0.1-20g、冰片0.05-0.2g，以上八味中药采用水醇法提取制备的中药滴眼液1000ml，浓度2.6～47％。本发明的制备工艺见附图1，以上八味中药除熊胆粉、冰片粉碎成细粉备用外，其余鱼腥草等六味按药典规程加水煎煮3次，每次各40分钟，合并煎液过滤，滤液浓缩至糖浆状，在80-90℃下相对密度为1.20～1.25的稠膏，加95％乙醇，使含醇量达60％，搅匀，静止24小时，滤过，滤液回收乙醇。按上述方法再用乙醇处理2次，使含醇量分别达到70％,80％，回收乙醇至无醇味止；将上述药液加蒸溜水至800ml，冷藏24小时过滤。将上述备用药粉加入滤液中，充分搅拌使其溶解。另取氯化纳8g、山梨酸1.5g，加少量水使其溶解，加入药液中，搅匀，再加1ml吐温-80搅均匀，用NaOH调节PH值为7-8，放置24小时，过滤，自滤器上添加蒸溜水至1000ml，摇匀密封，用100℃流通蒸汽灭菌30分钟，无菌分装即得。
结膜炎属于中医的“赤丝脉”及“天行赤眼”，热毒蕴结于目，灼伤目经，则见目赤、畏光、眼睑溃烂。对其治疗以清热解毒、消肿止痛为主。配方中鱼腥草、金银花以清热解毒为主药，辅以熊胆、栀子、板兰根共助主药以清热解毒，其中金银花、熊胆、栀子又可凉血以祛目赤，佐以麻黄用其温性以防主辅药苦寒太过，珍珠、冰片清热消肿止痛。所以本发明滴眼液对结膜炎具有清热解毒、消肿止痛之功效。
本发明研制成功之后，经哈尔滨市卫生局审核，哈尔滨市药品检验所检测，由黑龙江省中医药大学药厂试制，应用于临床试验。
中药制剂滴眼液，使用时滴入眼睑内1次1-2滴，一日4-6次，急性期每小时1次。
本发明经过6年来对8000余例眼病患者临床观察，证实其具有如下优点和积极效果：
1、见效快、治愈率高、疗效稳定、应用范围广。一般用药后20分钟左右即见效，充血及眼不适感减轻，经观察对比，总有效率96.66％，显效率达75.24％，除对急慢性和疼痛性结膜炎有明显的疗效外，对目赤翳障、肿痛等角结膜炎、睑缘炎、麦粒肿、沙眼等也有较好的疗效，应用本发明治愈的患者，未发现停药后有复发现象。
2、无刺激性、无耐药性和无副作用。滴眼液滴入眼内对角膜、结膜无刺激性、无不适感觉，患者长期反复应用未发现有毒副作用和耐药性。
3、对应用市场上出售的抗生素、抗病毒眼药水具有耐药性的结膜炎患者，应用治疗结膜炎的中药滴眼液后仍然有效。
实施例：
本发明的制备工艺：
取鱼腥草80g、金银花40g、熊胆粉8g、栀子24g、板兰根24g、麻黄10g、珍珠粉8g、冰片0.1g八味中药，按如上工艺流程制成1000ml活疗结膜炎的中药滴眼液。
Claims (2)
1、一种治疗结膜炎的中药滴眼液，其特征在于它是由下列用量的原料制成的：
鱼腥草10～150g 金银花5～80g
熊胆粉0.3～10g 栀 子5～80g
板兰根5～80g 麻 黄1～50g
珍珠粉0.1～20g 冰 片0.05～0.2g
2、根据权利要求1所述的治疗结膜炎的中药滴眼液，其特征在于它的制备方法是：
A、将鱼腥草、金银花、栀子、板兰根、麻黄、珍珠粉水煎3次各40分钟，合并煎液过滤浓缩成在80～90℃下相对密度为1.2～1.25的稠膏，加入95％浓度的乙醇，使含醇量依次达到60％、70％和80％，备静置24小时后回收乙醇至无醇味止；
B、在上述药液A中加入蒸馏水至800ml，冷藏24小时过滤后加入熊胆、冰片细粉，充分溶解后加入氯化钠8g、山梨酸1.5g搅匀再加入1ml土温-80，用NaOH调节PH值为7-8，静止24小时过滤；
C、将上述药液B添加蒸馏水至1000ml，摇匀密封，用100℃流通蒸汽灭菌30分钟后无菌分装。
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