CN105902572A - 一种治疗胃食管反流病的药物组合物及其制备方法和应用 - Google Patents
一种治疗胃食管反流病的药物组合物及其制备方法和应用 Download PDFInfo
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Abstract
本发明提供了一种治疗胃食管反流病的药物组合物及其制备方法和应用,所述的药物组合物的组成成分及其含量按重量份计包括:谷氨酸10~30份,精氨酸20~50份,美洲大蠊提取物20~100份。所述的药物组合物可以是任何适合服用的药物剂型,优选液体制剂、片剂、胶囊剂。本发明所述的药物组合物对胃食管反流病的治疗的总有效率能达到92%,相比于西药,疗效显著,复发率低,无毒副作用。
Description
技术领域
本发明属于医药领域,具体涉及一种治疗胃食管反流病的药物组合物及其制备方法和应用。
背景技术
胃食管反流病(gastroesophageal reflux disease,GERD)是由胃内容物反流引起不适症状和(或)并发症的一种疾病,烧心和反流(反食、泛酸)是本病的特征性症状,主要发病机制是食管下括约肌的一过性松弛,从而导致胃内容物反流入食管。其中食管黏膜有组织病理学损伤改变者称为反流性食管炎(RE),具备 GERD 症状而无内镜下黏膜损害者称为非糜烂性胃食管反流病(NERD)。美国的一项全国范围的调查显示 GERD 的患病率为 14%,发病率随年龄的增加而升高,40-60岁为发病的高峰年龄,男女发病无明显差异。北京、上海两地的流行病学调查表明,食管反流症状发生率高达 8.97%,GERD 患病率为 5.77%,RE发病率为1.92%,在亚太地区,约50%-70%的GERD患者表现为NERD。目前随着国民经济的持续发展、人民生活水平的提高,饮食结构由此发生了改变,以及临床医师对GERD诊断水平的提高,GERD的发病率正逐年上升,因而对GERD的治疗已成为消化学界研究的热点。
GERD的治疗以改善症状、消除食管炎、降低反流损害性、增强抗反流防御机制为主要目的,常用西药有抗酸剂、抑酸剂、促胃动力剂等,目前一致认为治疗本病的一线有效药物为抑酸剂——质子泵抑制剂(PPI)。PPI治疗GERD的机理是通过抑制胃酸的分泌,降低胃内容物的酸度,从而改善其反流所导致的食管炎症或症状,但并未达到减少反流的目的,属于非病因性治疗,因此在临床上存在复发率较高,需要长期用药、治疗费用高昂等缺陷。
发明内容
针对上述技术问题,本发明提供了一种能够有效治疗胃食管反流病的药物组合物。
本发明的目的还在于提供所述的药物组合物的制备方法。
所述的药物组合物的组成成分及其含量以重量份计,包括:谷氨酸10~30份,精氨酸20~50份,美洲大蠊提取物20~100份。
进一步,所述的药物组合物的组成成分及其含量以重量份计,包括:谷氨酸15~25份,精氨酸25~35份,美洲大蠊提取物40~60份。
进一步,所述的药物组合物的组成成分及其含量以重量份计,包括:谷氨酸20份,精氨酸30份,美洲大蠊提取物50份。
所述的美洲大蠊提取物是通过常规的技术手段对美洲大蠊进行提取而得到的,例如有机溶剂(如:乙醇、石油醚、丙酮等有机溶剂)提取,水提取,超临界流体萃取技术,闪式提取法,超声波提取法。
本发明所述的药物组合物可以根据制药领域的常规方法制备成任何一种药剂学上所述的剂型,优选剂型为液体制剂、片剂、胶囊剂。
本发明所述的药物组合物在需要时可以加入药学上可接受的辅料。
本发明还提供了所述的药物组合物在制备治疗胃食管反流病药物中的应用。
本发明所述的药物组合物的有益效果具体体现在:本发明所述的药物组合物对胃食管反流病治疗的总有效率可以达到92%,相比于西药的治疗,疗效显著,复发率低,无毒副作用。
具体实施方式
本发明所述的谷氨酸和精氨酸购置于天津天安药业股份有限公司。
实施例
1
利用有机溶剂提取制备美洲大蠊提取物
将干燥的美洲大蠊粗碎100kg,加4倍量70%乙醇,浸泡1小时后,温度70℃,提取2次,第一次8小时;第二次加乙醇3倍量,提取6小时合并二次提取液,过滤,绿叶浓缩至相对密度为1.09~1.16(70℃)的清膏时,加入水,70℃保温搅拌60分钟,静置12小时,弃去上层油脂,下层药液过滤,滤液回收乙醇,减压浓缩至相对密度为1.16~1.22的药液(70℃),干燥,即得美洲大蠊提取物。
实施例
2
利用闪式提取法制备美洲大蠊提取物
取美洲大蠊粗粉100g,美洲大蠊粗粉与水的质量体积比为25:12,在电压80伏的条件下提取3次,每次3分钟,将提取的药液在4000r/分的条件下离心30分钟,滤过,合并滤液,预冻24小时后,在冷冻干燥机中冷冻干燥48小时,即得美洲大蠊提取物。
实施例
3
液体制剂的制备
称取20g谷氨酸,30g精氨酸,50g实施例1制备的美洲大蠊提取物,在适量注射用水中溶解,再加入2g山梨酸钾和50ml甘油,混合均匀后,补充注射用水至1000ml,调节pH值至6.5~7.5,过滤,灌封,115℃灭菌30min,包装,即得。
实施例
4
液体制剂的制备
称取20g谷氨酸,30g精氨酸,50g实施例2制备的美洲大蠊提取物,在适量注射用水中溶解,再加入2g山梨酸钾和50ml甘油,混合均匀后,补充注射用水至1000ml,调节pH值至6.5~7.5,过滤,灌封,115℃灭菌30min,包装,即得。
实施例
5
片剂的制备
称取20g谷氨酸,30g精氨酸,50g实施例1制备的美洲大蠊提取物,加入80g的糊精和12g的羧甲基淀粉钠,聚维酮10g,混匀后制粒,再加入4g的滑石粉,混匀,压片,包装,即得。
实施例
6
胶囊剂的制备
称取20g谷氨酸,30g精氨酸,50g实施例2制备的美洲大蠊提取物,75g的微晶纤维素和16g的羧甲基淀粉钠混匀,制粒,再加入1.6g的硬脂酸镁,混匀,填充入胶囊中,即得。
实施例
7
液体制剂的制备
称取10g谷氨酸,50g精氨酸,100g实施例1制备的美洲大蠊提取物,混合均匀后,加入适量的注射用水进行溶解,再加入苯甲酸1g,62g聚乙二醇400,调节pH值至6.5~7.5,滤过,灌封,115℃灭菌30min,包装,即得。
实施例
8
胶囊剂的制备
称取25g谷氨酸,35g精氨酸,60g实施例2制备的美洲大蠊提取物,混合均匀后,加入54g淀粉、15g羧甲基淀粉钠混匀,制粒,再加入2g的滑石粉,再填充入空胶囊中,即得。
实施例
9
片剂的制备
称取15g谷氨酸,25g精氨酸,100g实施例1制备的美洲大蠊提取物,混合均匀后,加入糊精80g,淀粉18g,混匀后,直接压片,即得。
实施例
10
液体制剂的制备
称取30g谷氨酸,20g精氨酸,40g实施例1制备的美洲大蠊提取物,混合均匀后,加入适量的注射用水进行溶解,再加入0.1g尼泊金酯,以及80ml甘油,调节pH值至6.5~7.5,滤过,灌封,115℃灭菌30min,包装,即得。
实施例
11
胶囊剂的制备
称取10g谷氨酸,50g精氨酸,20g实施例2制备的美洲大蠊提取物,混合均匀后,加入糊精52g,预胶化淀粉10g,聚乙烯吡咯烷酮8g,混合均匀后,制粒,在加入2g微粉硅胶,填充入胶囊壳中,即得。
上述实施例中所述的药物组合物在加入药学上可接受的辅料后,按照常规的技术手段可以制成片剂、液体制剂、胶囊剂,使用时直接按剂量口服即可,这些采用现有的工业化生产过程均能实现。以下将通过实验对本发明所述的药物组合物的疗效进行说明。
实验例
1
对比本发明按照实施例3、实施例5、实施例6所述的方法制备的制剂对胃食管反流病的有效性和安全性进行效果评价。
1.患者资料
选择胃食管反流病患者200例,其中男107例,女93例,年龄在18~70岁,200例胃食管反流病患者均符合胃食管反流病的诊断标准,患者伴有不同程度的烧心、反流等症状,无颗粒增生型食管炎、食管癌,治疗前3周不曾使用PPI、H2RA、铋剂、碱性制酸剂、NSAID(非甾体抗炎药),无肝病、心脏病、肾脏病、恶性肿瘤等疾患。200例患者均以胃镜检测,且均排除了食管、胃、十二指肠肿瘤及手术的情况。
2.方法
2.1分组
将200例患者随机分为5组,每组40人,各组在年龄、性别、内镜检查分级等方面均无显著性差异。每组的具体用药方法如下:
对照A组:口服奥美拉唑(阿斯利康制药有限公司)20mg,一天1次;
对照B组:口服多潘立酮(西安杨森制药有限公司)20mg,一天3次;
观察A组:口服实施例3制备的液体制剂10ml,一天3次;
观察B组:口服实施例5制备的片剂20mg,一天3次;
观察C组:口服实施例6制备的胶囊剂20mg,一天3次。
2.2观察指标
观察用药8周后各组烧心、反流等症状,按轻重程度进行疗效判定。按洛杉矶分级法,根据内镜下所见食管黏膜损伤程度进行内镜下观察:显效: 烧心、反流等症状完全消失,内镜检查食管黏膜正常;有效: 烧心、反流等症状显著改善,内镜检查反流性食管炎程度减轻至I级以上;无效: 烧心、反流等症状无改善,内镜检查反流性食管炎无变化。
2.3统计学处理
应用SPSS 13. 0统计软件处理数据。等级资料比较采用秩和检验;计量资料比较采用成组设计的t检验。P < 0. 05为差异有统计学意义。
2.4结果
在治疗过程中,患者无不良反应出现;在回访观察的结果中,3个观察组中的患者没有出现复发病例,2个对照组中共有21人复发。具体见表1:
3个观察组的总有效率与2个对照组相比具有统计学意义,p<0.05,3个观察组的总有效率进行相互比较,无统计学差异,p>0.05,由此结果可知,将本发明所述的药物组合物用于液体制剂、片剂、胶囊剂的制备,不会影响所述药物组合物对胃食管反流病的治疗效果。
综上,本发明所述的药物组合物对于胃食管反流病的治疗效果明显强于使用奥美拉唑和多潘立酮,相比于西药的治疗,本发明所述的药物组合物无毒副作用,治疗效果总有效率能达到92%,且复发率低。
Claims (7)
1.一种治疗胃食管反流病的药物组合物,其特征在于,所述的药物组合物的组成成分及其含量以重量份计,包括:谷氨酸10~30份,精氨酸20~50份,美洲大蠊提取物20~100份。
2.根据权利要求1所述的药物组合物,其特征在于,所述的药物组合物的组成成分及其含量以重量份计,包括:谷氨酸15~25份,精氨酸25~35份,美洲大蠊提取物40~60份。
3.根据权利要求1或2所述的药物组合物,其特征在于,所述的药物组合物的组成成分及其含量以重量份计,包括:谷氨酸20份,精氨酸30份,美洲大蠊提取物50份。
4.根据权利要求1~3任意一项所述的药物组合物,其特征在于,所述的药物组合物可以根据制药领域的常规方法制备成任何一种药剂学上所述的剂型。
5.根据权利要求4所述的药物组合物,其特征在于,所述的剂型可以是液体制剂、片剂、胶囊剂。
6.根据权利要求1~5任意一项所述的药物组合物,其特征在于,所述的药物组合物在需要时可以加入药学上可接受的辅料。
7.一种如权利要求1~3任意一项所述的药物组合物在制备治疗胃食管反流病的药物中的应用。
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