CN101450037A - 一种木糖醇静脉注射液及其制备方法 - Google Patents
一种木糖醇静脉注射液及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种木糖醇静脉注射液及其制备方法。该注射液每1000毫升注射液中含有木糖醇25mg～500mg，吐温－80 7～30g，余量为注射用水或等渗溶液。本发明所制备的木糖醇静脉注射液在体内代谢不依赖胰岛素的参与，其甜味及产热量与葡萄糖相仿，可用于糖尿病患者作为糖的代用品。此外，尚有抑制酮体生成的作用，能使血浆脂肪酸生成减少。可以作为糖尿病、手术麻醉时酮中毒的合并用药。
Description
技术领域
本发明属于药物制剂技术领域，涉及一种木糖醇静脉注射液及其制备方法。
背景技术
糖尿病是由于胰岛素不足或胰岛素的细胞代谢作用缺陷所引起的葡萄糖、蛋白质及脂质代谢紊乱的一种综合症。其特征为血循环中葡萄糖浓度异常升高及尿糖。血糖过高时可出现典型的三多一少症状，即：多饮、多尿、多食及体重减轻，且伴有疲乏无力。严重者可发生酮症酸中毒及高渗性昏迷，且易合并多种感染。随着病程的延长，其代谢紊乱可导致眼，肾、神经、血管及心脏等组织器官的慢性并发症。糖尿病在医学界被列为继爱滋病、癌症之后的第三大“杀手”、有“亚癌症”之称。得了糖尿病不可怕，可怕的是由此而引发的并发症，如急性并发症---主要包括酮症酸中毒、高渗透昏迷、乳酸性酸中毒，慢性并发症----主要包括心血管、视网膜、肾脏、神经病变。并发症不仅给病人带来了痛苦，而且严重者可危及患者生命。
木糖醇是糖尿病人的治疗剂、营养剂和最佳甜味剂。木糖醇作为糖类代谢中间体，不需要胰岛素的促进(能促进胰脏分泌胰岛素)，以自己独特的代谢途径，通过葡萄糖醛酸木酮糖和磷酸戊糖支路产生磷酸核糖，进而生成6-磷酸葡萄糖，再合成糖元或进一步氧化代谢获得能量，木糖醇能调整糖代谢异常，在患者缺胰岛素时，木糖醇照常能透过细胞膜，供给细胞营养和能量，起到葡萄糖加胰岛素的功能，服用本品后，病人的“三多”病状减轻，口渴与饥饿基本消失，尿糖减少，长期服用后病症消失，有效地控制了糖尿病并发症的发生。
据统计，约50％以上的糖尿病患者在发生诸如感染、休克、手术等应激情况时，会因输注含葡萄糖的溶液、糖皮质激素等药物，而发生感染恶化、糖尿病酮症酸中毒或非酮症高渗昏迷等意外事故。此外，已知糖尿病患者发生急性并发症，急需补充能量及输液用药，又不宜输注葡萄糖液时，易发生医疗纠纷。因此，寻求非葡萄糖又不依赖胰岛素的供能型载体输注液，具有重要的意义。
发明内容
本发明采用的技术方案如下：
一种木糖醇静脉注射液，其特征在于，该注射液每1000毫升注射液中含有木糖醇25mg～500mg，吐温-807～30g，余量为注射用水或等渗溶液。
本发明所述的木糖醇静脉注射液，其中的等渗溶液为氯化钠、氯化钾、氯化镁、乳酸钠或山梨醇。
本发明所述木糖醇静脉注射液的制备方法，其特征在于：纯度98％以上取木糖醇25mg～500mg，吐温-807～30g，用注射用水或等渗溶液溶解，调节pH5.0～6.2，上述溶液经过滤后加入注射用水或等渗溶液至1000毫升，再经过精滤后灌封，灭菌，制得静脉注射液可用于静脉滴注。
本发明所制备的木糖醇静脉注射液在体内代谢不依赖胰岛素的参与，其甜味及产热量与葡萄糖相仿，可用于糖尿病患者作为糖的代用品。此外，尚有抑制酮体生成的作用，能使血浆脂肪酸生成减少。可以作为糖尿病、手术麻醉时酮中毒的合并用药。具体表现在：
1.对糖尿病人的作用：
不需要胰岛素的参与真霎进入细胞内被利用，对血糖浓度无影响；促进胰岛素分泌，抑制由精氨酸引起的胰高血糖素释放反应；增加靶细胞对胰岛素敏感性；抑制酮体生成作用，避免酮症酸中毒。
2.对高血脂及肥胖病人的作用：
木糖醇能抑制生物组织中脂肪酸的合成，减少血中游离脂肪酸、丙酮酸生成，具有调整脂类代谢和抗酮体，控制体重，防止肥胖等作用。故适用于肥胖病人、高血脂病人及各种限糖病人的能量补充。
3.手术期营养型：
木糖醇在结构上没有醛基和酮基，可使氨基酸合成蛋白质的利用率达到80-90，比葡萄糖、果糖等其它糖醇效果好。患者手术期应用木糖醇能加速伤口愈合，预防切口感染，同时又可提供充足的能量。故适用于手术前后、麻醉过程、危重病人、年老体弱者。
4.肝病的辅助治疗：
木糖醇能促进肝糖原合成，降低转氨酶，是良好的护肝药物。适用于各种肝病，预防脂肪肝发生。
5.肺部感染：
木糖醇能作为辅助治疗药预防患者肺部感染。通过使患者呼吸道表面黏液层中PH值下降，提高预防肺部感染的能力。
6.年老体弱及消耗性疾病：
木糖醇作为年老体弱患者和恶性肿瘤、萎缩性胃炎、肺结核等消耗性疾病的营养性输液。木糖醇可使氨基酸合成蛋白质的利用率高达80-90，有利于病情恢复。
下面结合临床实验进一步说明本发明的积极效果：
实验目的：探讨采用含有木糖醇静脉注射液的肺炎治疗药物及随访情况。
方法：159例患有糖尿病肺炎支原体肺炎，分别给予含有木糖醇静脉注射液的红霉素静脉滴注(静脉组)和阿奇霉素口服(口服组)治疗，比较疗效并随访。结果静脉组2周内痊愈63例(724％)，口服组2周内痊愈37例(51.4％)，两组差异有显著性，P<0.05.1。年后随访的157例患有糖尿病的患儿有44例(28.0％)出现反复呼吸道感染，静脉组占25例(28.7％)，口服组占19例(27.1％)，两组差异无显著性.病程≥4周的40例患儿中17例(42.5％)有反复呼吸道感染，而病程<4周的117例中仅27例(23.1％)有反复呼吸道感染，两组差异有显著性，P<0.05。
结论患有糖尿病的肺炎支原体肺炎静脉滴注木糖醇-红霉素的近期疗效优于阿奇霉素口服。部分患儿肺炎支原体肺炎痊愈后1年随访出现反复呼吸道感染，与初始治疗前的病程长短有关。
具体实施方式
下面结合实施例对本发明做进一步的描述。
实施例1
在1000毫升注射液中加入木糖醇25mg，吐温-807g，加入少量活性炭加热搅拌，压滤，滤液经微孔滤膜过滤，滤液补足注射用水，混匀，灌封，灭菌配成注射液。
实施例2
在每1000毫升注射液中加入木糖醇500mg，吐温-8030g，余量为氯化钠等渗溶液。加入少量活性炭加热搅拌，压滤，滤液经微孔滤膜过滤，滤液补足注射用水，混匀，灌封，灭菌配成注射液。
实施例3
在每1000毫升注射液中加入木糖醇150mg，吐温-8010g，余量为等渗氯化钾溶液。加入少量活性炭加热搅拌，压滤，滤液经微孔滤膜过滤，滤液补足注射用水，混匀，灌封，灭菌配成注射液。
实施例4
在每1000毫升注射液中加入木糖醇200mg，吐温-8015g，余量为等氯化镁渗溶液。加入少量活性炭加热搅拌，压滤，滤液经微孔滤膜过滤，滤液补足注射用水，混匀，灌封，灭菌配成注射液。
实施例5
在每1000毫升注射液中加入木糖醇280mg，吐温-8025g，余量为注射用水。加入少量活性炭加热搅拌，压滤，滤液经微孔滤膜过滤，滤液补足注射用水，混匀，灌封，灭菌配成注射液。
实施例6
在每1000毫升注射液中加入木糖醇300mg，吐温-8018g，余量为乳酸钠等渗溶液。加入少量活性炭加热搅拌，压滤，滤液经微孔滤膜过滤，滤液补足注射用水，混匀，灌封，灭菌配成注射液。
实施例7
在每1000毫升注射液中加入木糖醇400mg，吐温-8028g，余量为注射用水。加入少量活性炭加热搅拌，压滤，滤液经微孔滤膜过滤，滤液补足注射用水，混匀，灌封，灭菌配成注射液。
以上尽管本发明结合它的专门的实施例已做了详细的描述，但是很明显对本技术领域的熟练人来说仍能做出各种各样的变化和改进，这些都不会偏离本发明权利要求的精神实质和保护范围。
Claims (3)
1、一种木糖醇静脉注射液，其特征在于，该注射液每1000毫升注射液中含有木糖醇25mg～500mg，吐温-807～30g，余量为注射用水或等渗溶液。
2、如权利要求1所述的木糖醇静脉注射液，其特征在于，所述的等渗溶液为氯化钠、氯化钾、氯化镁、乳酸钠或山梨醇。
3、权利要求1所述木糖醇静脉注射液的制备方法，其特征在于：纯度98％以上取木糖醇25mg～500mg，吐温-807～30g，用注射用水或等渗溶液溶解，调节pH5.0～6.2，上述溶液经过滤后加入注射用水或等渗溶液至1000毫升，再经过精滤后灌封，灭菌，制得静脉注射液可用于静脉滴注。
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| US9707190B2 (en) | 2010-06-30 | 2017-07-18 | David Segal | Injectable pharmaceutical compositions for the treatment of joints |
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