CN1927195A - 含有薁磺酸钠的眼用膜剂 - Google Patents
含有薁磺酸钠的眼用膜剂 Download PDFInfo
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Abstract
本发明公开一种含有薁磺酸钠的眼用膜剂，包括有主药薁磺酸钠、成膜剂、增塑剂、灭菌水、脱膜剂，其中：增塑剂为甘油，脱膜剂为液体石蜡，具体含量是在1800cm2～2200cm2的眼用膜剂中含有：薁磺酸钠0.1～0.5g；成膜剂25～40g；增塑剂5～10ml；灭菌水100ml；脱膜剂适量。所述的成膜剂为聚乙烯醇或羟丙纤维素或羟丙甲基纤维素中的一种。本发明的含有薁磺酸钠的眼用膜剂，是由薁磺酸钠为主药，以高分子成膜材料作为药物载体，具有无毒、无刺激、性质稳定、能维持较长的有效浓度，疗效显著，使用方便的特点。
Description
技术领域
本发明涉及一种眼用膜剂。特别是涉及一种使用方便，疗效显著的含有薁磺酸钠的眼用膜剂。
背景技术
结膜炎、角膜炎等眼科疾病，是因眼部感染病菌或机体抵抗力下降所致。患者主诉眼部有结膜充血，脓性分泌物，眼部刺激和睡醒时上下眼睑粘住等现象，这些都是细菌性结膜炎的特征。角膜炎性病变典型的临床表现有疼痛、畏光、流泪、眼睑痉挛等刺激症状及睫状充血，角膜浸润混浊或角膜溃疡等特征。对该类眼病临床一般采用消炎药、抗菌药治疗，其中抗感染是治疗的重要措施之一。
目前，国内外应用临床治疗结膜炎，角膜炎的药物常用的主要为化学药。如：氯霉素、新霉素、氧氟沙星、左氧氟沙星、庆大霉素、红霉素等制成的滴眼液和药膏。除此之外，也有少数的中药应用于临床。这些中药对临床分离出的金色葡萄球菌、绿脓杆菌有一定的抑制作用。如黄苓苷眼膏，临床观察表明，该眼膏对结膜炎、角膜炎均有较好的疗效，缺点是起效慢。治疗时间长。
国外研究报道，薁磺酸钠及其衍生物对眼科常见的结膜炎、角膜炎等疾病的治疗有显著的疗效。目前，含有薁磺酸钠的滴眼液在日本有很大的市场。含有薁磺酸钠的滴眼液，由于不能较长时间停留在结膜囊内，故一天中需多次使用。眼膏虽然可长时间停留在结膜囊内，但因其粘度太大，遮挡视线，因而使用起来会受到限制。
发明内容
本发明所要解决的技术问题是，提供一种使用方便，疗效显著的含有薁磺酸钠的眼用膜剂。
本发明所采用的技术方案是：一种含有薁磺酸钠的眼用膜剂，包括有主药薁磺酸钠、成膜剂、增塑剂、灭菌水、脱膜剂，其中：增塑剂为甘油，脱膜剂为液体石腊，具体含量是在1800cm2～2200cm2的眼用膜剂中含有：薁磺酸钠0.1～0.5g；成膜剂25～40g；增塑剂5～10ml；灭菌水100ml；脱膜剂适量。
所述的成膜剂为聚乙烯醇或羟丙纤维素或羟丙甲基纤维素中的一种。
本发明的含有薁磺酸钠的眼用膜剂，是由薁磺酸钠为主药，以高分子成膜材料作为药物载体，具有无毒、无刺激、性质稳定、能维持较长的有效浓度，疗效显著，使用方便的特点。
具体实施方式
下面结合实施例对本发明的含有薁磺酸钠的眼用膜剂做出详细说明。
本发明的含有薁磺酸钠的眼用膜剂，包括有主药薁磺酸钠、成膜剂、增塑剂、灭菌水、脱膜剂，其中：增塑剂为甘油，脱膜剂为液体石腊，具体含量是在1800cm2～2200cm2的眼用膜剂中含有：薁磺酸钠0.1～0.5g；成膜剂25～40g；增塑剂5～10ml；灭菌水100ml；脱膜剂适量。其中，所述的成膜剂为聚乙烯醇或羟丙纤维素或羟丙甲基纤维素。
增塑剂还可以选用山梨醇；脱膜剂还可以选用甘油。
本发明的含有薁磺酸钠的眼用膜剂的主药为薁磺酸钠，其化学名称为1.4-二甲基-7-异丙基-3-薁磺酸钠，化学通式为：C15H17NaO3S·H2O，结构式为：
成膜剂要求具有无毒、无刺激、性质稳定、不降低主药的药效、成膜薄、软、韧性好的特性。所以本发明选用聚乙烯醇或羟丙纤维素或羟丙甲基纤维素作为成膜剂。
其中，聚乙烯醇(PVA05-88)是白色或淡黄色粉末或颗粒状，4％水溶液PH约为6.0，在温水中能很快溶解。无毒、无刺激、不易被微生物污染；
羟丙纤维素是白色粉末，无臭、无味、无毒、溶于水及醇，不溶于醚、苯，化学性质稳定，不与酸性及碱性药物发生作用，加热时塑性强，成膜性能好；
羟丙甲基纤维素(HPMC)是白色粉末，在60℃以下的水中膨胀溶解，超过60℃水中不溶。能溶于乙醇-二氯甲烷混合液和乙醇-氯仿混合液。与主药无反应，成膜性好。高温下不粘着。
本发明的含有薁磺酸钠的眼用膜剂的制备方法是：按处方取成膜剂、甘油，加适量注射用水浸泡3～24小时，使成膜剂完全浸泡膨胀后，在水浴上加热至80℃溶解，制成成膜材料浆液待用。另按处方量称取薁磺酸钠加注射灭菌水用水浴加热使之溶解，加入已溶解成膜材料浆液中搅均，置80℃±5的水浴保温30分钟，然后将其倾入预先涂有少量液体石蜡的玻璃板上，手工制膜2000cm2，经70～80℃的鼓风干燥1小时后，立即脱膜，取出在紫外灯下灭菌30分钟，切成0.5×1cm2小块，无菌包装。
以上方法适用于小批量生产，大量生产用涂膜机涂膜、干燥、灭菌、切割、包装，以机械化流水线作业。
本发明的含有薁磺酸钠的眼用膜剂，在睡前使用药效最好。用灭菌小镊子或75％酒精消毒的手指，取1片置于眼下结膜穹窿部位，眼用膜剂在结膜囊内溶解成胶状物，能维持较长的有效浓度，提高了疗效。每日只需一小片即可。
下面给出具体的实施例。
实施例1：
处方：薁磺酸钠0.1g；聚乙烯醇30g；甘油5ml；灭菌水100ml；脱膜剂用液体石蜡2g，制膜2000cm2，切成0.5×1cm2兰色小块，无菌包装。
操作方法：称取聚乙烯醇30g、甘油5ml，加入50ml灭菌水中浸泡24小时，使聚乙烯醇完全浸润膨胀后，在水浴上加热至80℃溶解，制成成膜材料浆液。另取薁磺酸钠0.1g加入灭菌水50ml在水浴上加热使之溶解后，加入到已溶解成膜材料的浆液中搅匀，置80℃±5水浴保温30分钟，然后将其倾入预先涂有2g液体石蜡的玻璃板上，手工制膜2000cm2，经70～80℃的鼓风干燥1小时后，立即脱膜，取出在紫外灯下灭菌30分钟，切成0.5×1cm2兰色小块，无菌包装。
实施例2：
处方：薁磺酸钠0.4g；羟丙纤维素35g；甘油6ml；灭菌水100ml；脱膜剂用甘油2g，制膜2000cm2，切成0.5×1cm2小块，无菌包装。
操作方法：称取羟丙纤维素35g，甘油6ml，加入50ml灭菌水中浸泡4小时，使聚乙烯醇完全浸润膨胀后，在水浴上加热至80℃溶解，制成成膜材料浆液。另取薁磺酸钠0.4g加入灭菌水50ml在水浴上加热使之溶解后，加入到已溶解成膜材料的浆液中搅匀，置80℃±5水浴保温30分钟，然后将其倾入预先涂有2g甘油的玻璃板上，手工制膜2000cm2，经70～80℃的鼓风干燥1小时后，立即脱膜，取出在紫外灯下灭菌30分钟，切成0.5×1cm2小片，无菌包装。
实施例3：
处方：薁磺酸钠0.25g；羟丙甲基纤维素40g；甘油8ml；灭菌水100ml；脱膜剂用液体石蜡2g，制膜2000cm2，切成0.5×1cm2小块，无菌包装。
操作方法：称取羟丙甲基纤维素40g，加入50ml灭菌水中浸泡3小时，使聚乙烯醇完全浸润膨胀后，在水浴上加热至55℃溶解，制成成膜材料浆液。另取薁磺酸钠0.25g加入灭菌水50ml在水浴上加热到60℃使之溶解后，加入到已溶解成膜材料的羟丙甲基纤维素浆液中搅匀，置60℃水浴保温30分钟，然后将其倾入预先涂有2g石蜡的玻璃板上，手工制膜2000cm2，经70～80℃的鼓风干燥1小时后，立即脱膜，取出在紫外灯下灭菌30分钟，切成0.5×1 cm2小片，无菌包装。
临床疗效实验：
选用病例经门诊断为结膜炎、角膜炎的患者共76例，144只眼。病例入选标准为：年龄18周岁以上，65周岁以下，一周内未用抗生素，临床诊断为细菌性结膜炎、角膜炎，微生物学检查有致病菌。
疗效观察：分成实验组和对照组。对照组采用第三代喹诺酮类眼科药氧氟沙星眼药水。1986年日本首先将氧氟沙星滴眼液用于治疗眼部感染。1987年我国引进该药应用于临床。对细菌性结膜炎、角膜炎有效率93～100％。因此，我们选用氧氟沙星为对照组使用，观察我们发明的含有薁磺酸钠的眼用膜剂是否能达到氧氟沙星滴眼液同等的治疗疗效。
用76名患者144只眼分成用含有薁磺酸钠的眼用膜剂的治疗实验组和用氧氟沙星滴眼液的对照组，临床对比见下表：
| 疗效 | 试验组 | 对照组 | ||
| 眼数 | ％ | 眼数 | ％ | |
| 痊愈 | 53 | 72.6 | 52 | 73.24 |
| 显效 | 11 | 15.06 | 12 | 16.90 |
| 进步 | 6 | 8.22 | 4 | 5.63 |
| 无效 | 3 | 4.11 | 3 | 4.23 |
| 有效率 | 95.89 | 95.77 | ||
实验组有效率95.89％，对照组95.77％。检验组间无显著差异(P＞0.05)。因此认为含有薁磺酸钠的眼用膜剂对结膜炎和角膜炎的治疗疗效是显著的，用药也方便。滴眼液每日用药6次，而眼膜剂每日只在睡前用一次，不影响白天的工作。
Claims (2)
1.一种含有薁磺酸钠的眼用膜剂，其特征在于，包括有主药薁磺酸钠、成膜剂、增塑剂、灭菌水、脱膜剂，其中：增塑剂为甘油，脱膜剂为液体石腊，具体含量是在1800cm2～2200cm2的眼用膜剂中含有：薁磺酸钠0.1～0.5g；成膜剂25～40g；增塑剂5～10ml；灭菌水100ml；脱膜剂适量。
2.根据权利要求1所述的含有薁磺酸钠的眼用膜剂，其特征在于，所述的成膜剂为聚乙烯醇或羟丙纤维素或羟丙甲基纤维素中的一种。
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| CN102018703B (zh) * | 2009-09-11 | 2012-07-25 | 天津市顶硕科贸有限公司 | 含有薁磺酸钠的妇科专用冲洗剂 |
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| CN101999997A (zh) * | 2010-11-27 | 2011-04-06 | 天津市顶硕科贸有限公司 | 含有薁磺酸钠的脱敏面膜 |
| CN101999997B (zh) * | 2010-11-27 | 2012-08-22 | 天津市顶硕科贸有限公司 | 含有薁磺酸钠的脱敏面膜 |
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