CN105878198A - 含有盐酸小檗碱片的药物组合物及其制备工艺 - Google Patents
含有盐酸小檗碱片的药物组合物及其制备工艺 Download PDFInfo
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- CN105878198A CN105878198A CN201610360743.9A CN201610360743A CN105878198A CN 105878198 A CN105878198 A CN 105878198A CN 201610360743 A CN201610360743 A CN 201610360743A CN 105878198 A CN105878198 A CN 105878198A
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Abstract
本发明涉及含有盐酸小檗碱片的药物组合物,其包括下述原料:盐酸小檗碱片50kg,羧甲淀粉钠3kg,纯化水18kg,按照常规方法制备片剂100万片;本发明的复方盐酸小檗碱药物组合物对肠胃炎标本兼治、对人体无毒无害、无副作用、价格低廉,制作简便,具有广阔的应用前景。
Description
技术领域
本发明属于医药技术领域,具体涉及治疗肠胃炎的中西药制剂,特别是以西药盐酸小檗碱为主中草药成分为辅的治疗肠胃炎的药物组合物。
背景技术
胃肠炎通常因微生物感染引起,也可因化学毒物或药品导致。典型临床表现为腹泻、恶心、呕吐及腹痛。对于健康成人,胃肠炎通常只会引起不适感及生活上的不便,并不会导致严重后果,但是在病重、虚弱、年幼或年老的患者中却可以导致威胁生命的脱水和电解质紊乱。胃肠炎症状的类型和严重程度取决于微生物或毒物的类型和量的大小。胃肠炎最常见的症状是腹泻,其他症状包括:腹痛、恶心、呕吐、发热、食欲减退、体重减轻(可能是脱水的征象)、大量出汗、皮肤湿冷、肌肉痛或关节僵硬、大便失禁等。剧烈的呕吐和腹泻可以很快导致脱水,其表现有虚弱、极度口渴、少尿或尿色加深、皮肤干燥、口干、眼球下陷,婴儿还可表现为啼哭时少泪。严重的呕吐或腹泻可以引起低钠血症、低钾血症、低血压等。
饮用大量含盐少或不含盐的水分来补充液体的病人易出现低钠血症。水和电解质紊乱有潜在的风险,特别是对于病重、虚弱、年幼或年老的患者,严重的病例可以出现休克和肾功能衰竭。感染性胃肠炎可因感染病毒、细菌、寄生虫引起。毒物及药物可引起化学性胃肠炎。病毒感染是胃肠炎最常见的病因,有多种病毒可引起急性胃肠炎,最常见的是轮状病毒,其次是诺沃克病毒、星状病毒和肠腺病毒。若没有及时对急性胃肠炎进行治疗,对病人的身体将造成不良影响。而现有技术中治疗该病症的药物往往采用西药进行治疗,然而西药治疗副作用大,且无法从根本上对急性肠胃炎进行治疗,存在治疗效果不明显,副作用大的技术缺陷。
盐酸小檗碱为常用的治疗肠胃炎的西药药物,其为一种异喹啉生物碱。存在于小檗科等4科10属的许多植物中。小檗碱从*** 中可析出黄色针状晶体。熔点145℃。溶于水,难溶于苯、***和氯仿。小檗碱为一种季铵生物碱,其盐类在水中的溶解度都比较小,例如盐酸盐为1∶500,硫酸盐为1∶30。小檗碱从水或稀乙醇中析出的晶体带有5.5分子结晶水;若从氯仿、丙酮或苯中结晶,也带有相应的结晶溶剂分子。其对溶血性链球菌、金黄色葡萄球菌、***和弗氏、志贺氏痢疾杆菌均有抗菌作用,并有增强白血球吞噬作用。小檗碱的盐酸盐(俗称盐酸黄连素)已广泛用于治疗胃肠炎、细菌性痢疾等。小檗碱可从三颗针、黄连、黄柏等植物中提取。由于黄连生长缓慢,价格较高,黄柏来源也较少,现我国主要应用三颗针作为提取原料。小檗碱是临床上一种常用的广谱抗菌药,主要用于菌痢、胃肠炎、痈肿等细菌性感染。
然而,盐酸小檗碱也偶有恶心、呕吐、皮疹和药热等副作用,且盐酸小檗碱片与含鞣质的中药与该药品合用后,由于鞣质是生物碱沉淀剂,二者结合,生成难溶性鞣酸盐沉淀,盐酸小檗碱片对于溶血性贫血患者及葡萄糖-6-磷酸脱氢酶缺乏患者禁用。
中医理论认为胃肠炎是一种常见的疾病,多因进食不当引起。好发于夏秋季节,患者常常突然发病,有误食不洁食物的病史,初期先感到胃脘痞闷,食欲减退,恶心、呕吐,吐后症状可暂时减轻,呕吐内容物多为食物甚至胆汁。随后病情加重,可出现腹痛腹泻,大便多呈水样,颜色深黄色或淡绿色,少数患者大便带有黏液脓血。中医将急性胃肠炎辩证分为以下几种类型,胃肠湿热型:症见起病急骤,呕吐吞酸,恶心频繁,腹痛阵作。泻下急迫(里急后重),便行不爽,便色黄褐而臭,口渴欲饮,心烦,尿短赤少,苔黄腻,脉濡数或滑数;寒湿阻滞型:患者呕吐清水,恶心频繁,腹泻水样便,腹痛肠鸣并伴有胃寒发热,颈项或全身关节酸痛,苔薄白或白腻,脉濡;食滞胃肠型:症见患者恶心厌食,得食欲甚,吐后发快,腹痛,泻下秽臭,急迫不爽,泻后痛减,苔厚腻,脉滑实。
目前,临床上不断有新的治疗肠胃炎的药物出现,但这些均未能达到真正令人满意的效果。采用中西药结合,标本兼治,最为合理。当前采用中西医结合治疗肠胃炎的药物尚不多见,因此,开发一种高效低毒、标本兼治的中西药复方新药仍是临床的急切需要。
发明内容
本发明的目的是提供一种标本兼治、副作用小、安全方便、价格低廉的含有盐酸小檗碱片的药物组合物及其制备工艺。其目的是为了解决治疗肠胃炎,克服西药毒副作用以及治疗效果不显著的问题,达到标本兼治的目的。
本申请发明人有鉴于现有的治疗肠胃炎的药物存在的缺陷,基于从事中医药多年丰富的临床经验及专业知识,从祖国传统医药学理论出发,经过多年不断的临床研究筛选中,精选出的一些药物并组方,进行了药理学,药效学以及临床应用等研究,首创研制出本发明的具有健胃止痛、温肾散寒的复方制剂。本发明药物组合物对治疗各种症状引起的胃肠炎具有显著的疗效,服用方便,治愈后不复发,安全无毒副作用,所选药材配伍相宜,符合中医药学和现代医药学理论,能够达到标本兼治的目的,值得临床上广泛推广应用。
为实现上述目的,本发明采用的技术方案如下:
含有盐酸小檗碱的药物组合物,其包括下述原料:
盐酸小檗碱25kg,中草药成分25kg,羧甲淀粉钠3kg,纯化水18kg,按照常规方法制备片剂100万片。
所述盐酸小檗碱采用下述方法制备:
1)取三颗针根粗粉,过20目筛后加入3倍重量的浓度0.5%硫酸水溶液使之浸没药面,浸泡5h,用脱脂棉过滤;
2)步骤1)的滤液中加入石灰乳中和多余硫酸,调整pH到7,静置;
3)步骤2)制备的滤液中加入3倍重量的95%(体积比)乙醇搅拌加热至75℃回流20-30min,然后加入等量的乙醇减压浓缩至滤液呈棕红色浆液;
4)向棕红色浆液中加入3%醋酸(体积浓度)加热至140℃;
5)加入浓度为60%的盐酸(体积浓度)至溶液浑浊为止,用冰水冷却至盐酸小檗碱析出,干燥烘干得到精品盐酸小檗碱。
所述中草药成分,由下述原料制备而得:
甘草、山药、地锦草、茯苓、蒲公英、黄柏、车前草、白芷、葛根、大青叶、金银忍冬、附子、防风、延胡索、干姜、肉豆蔻、竹茹、厚朴、金银花、白头翁、枳壳、芡实、陈皮、桔梗、凌霄花、薏苡仁、白术、五倍子。
优选地,所述中草药成分,由下述重量的原料制备而得:
甘草33份、山药33份、地锦草33份、茯苓32份、蒲公英32份、
黄柏30份、车前草30份、白芷30份、葛根30份、大青叶30份、
金银忍冬28份、附子28份、防风28份、延胡索25份、干姜25份、
肉豆蔻25份、竹茹25份、厚朴25份、金银花20份、白头翁20份、
枳壳20份、芡实20份、陈皮18份、桔梗15份、凌霄花15份、
薏苡仁10份、白术10份、五倍子10份。
所述中草药成分的制备方法如下:
(1)称取上述原料备用
(2)取甘草、山药、芡实用文火炒8分钟,炒至表面焦黄后晾凉晒干,粉碎过90目筛,制备成分A;
(3)取干姜、陈皮、白术粉碎过100目筛,混合均匀,制备成分B;
(4)取地锦草、茯苓、白芷、葛根、附子、防风、竹茹、白头翁、枳壳、桔梗、薏苡仁、五倍子放入容器内,加入5倍量的蒸馏水,浸泡2小时后,煮沸3小时,提取煎煮液;再次加入3倍量蒸馏水,煮沸2小时,提取煎煮液;最后,加入2倍量蒸馏水,加热煮沸1小时,提取煎煮液;合并三次煎煮液,浓缩成密度为1.1g/ml的浸膏,60℃干燥后,粉碎制备成分C;
(5)取剩余原料添加3倍重量85%(体积比)的乙醇,回流提取2次,每次1小时,提取液合并,浓缩至密度为1.1g/ml的浸膏,60℃干燥后,粉碎制备成分D;
(6)均匀混合成分A、B、C、D即得。
服用方法,一次1片,一日3次。
本发明所述的技术方案是在中医治疗肠胃炎的临床经验基础上,结合现代药学成果研制开发的以中西药结合的复方制剂。将中药和西药有效地结合,具有很强的健胃止痛、温肾散寒的功能。本发明采用不同药性的中药材,进行了科学配伍,能达到理想的治疗效果,且安全,毒副作用小,制备简单,能直达病灶,治愈时间短,治愈后不易复发。
本发明药物的组分均采用天然的中药原料,其配制简便,药源广泛,成本低廉,其遵循中医的处方用药原则,诸药合用,相得益彰;并且针对中草药原料的不同采用不同的处理方式,使得药效最大限 度释放出来,经临床应用验证,其疗效显著可靠,药性平和,未出现毒副作用,应用前景广阔。
本发明通过对药物组份、配比的合理选择,将每片剂的盐酸小檗碱成分降低了一半,大大降低了西药盐酸小檗碱的副作用,且取得了理想的治疗效果,既符合国家药典对有关药物剂量的要求,又能保证良好的治疗效果,无明显副作用。
具体实施方式
实施例1
含有盐酸小檗碱的药物组合物,其包括下述原料:
盐酸小檗碱25kg,中草药成分25kg,羧甲淀粉钠3kg,纯化水18kg,按照常规方法制备片剂100万片。
所述盐酸小檗碱采用市售或下述方法制备:
1)取三颗针根粗粉,过20目筛后加入3倍重量的浓度0.5%硫酸水溶液使之浸没药面,浸泡5h,用脱脂棉过滤;
2)步骤1)的滤液中加入石灰乳中和多余硫酸,调整pH到7,静置;
3)步骤2)制备的滤液中加入3倍重量的95%(体积比)乙醇搅拌加热至75℃回流20-30min,然后加入等量的乙醇减压浓缩至滤液呈棕红色浆液;
4)向棕红色浆液中加入3%醋酸(体积浓度)加热至140℃;
5)加入浓度为60%的盐酸(体积浓度)至溶液浑浊为止,用冰水冷却至盐酸小檗碱析出,干燥烘干得到精品盐酸小檗碱。
上述方法将可以一步直接制得精制小檗碱,且制得的小檗碱纯度高,平均收率达到10%,降低原材料的消耗,提高生产效率。
所述中草药成分,由下述重量的原料制备而得:
甘草33份、山药33份、地锦草33份、茯苓32份、蒲公英32份、
黄柏30份、车前草30份、白芷30份、葛根30份、大青叶30份、
金银忍冬28份、附子28份、防风28份、延胡索25份、干姜25份、
肉豆蔻25份、竹茹25份、厚朴25份、金银花20份、白头翁20份、
枳壳20份、芡实20份、陈皮18份、桔梗15份、凌霄花15份、
薏苡仁10份、白术10份、五倍子10份。
所述中草药成分的制备方法如下:
(1)称取上述原料备用
(2)取甘草、山药、芡实用文火炒8分钟,炒至表面焦黄后晾凉晒干,粉碎过90目筛,制备成分A;
(3)取干姜、陈皮、白术粉碎过100目筛,混合均匀,制备成分B;
(4)取地锦草、茯苓、白芷、葛根、附子、防风、竹茹、白头翁、枳壳、桔梗、薏苡仁、五倍子放入容器内,加入5倍量的蒸馏水,浸泡2小时后,煮沸3小时,提取煎煮液;再次加入3倍量蒸馏水,煮沸2小时,提取煎煮液;最后,加入2倍量蒸馏水,加热煮沸1小时,提取煎煮液;合并三次煎煮液,浓缩成密度为1.1g/ml的浸膏,60℃干燥后,粉碎制备成分C;
(5)取剩余原料添加3倍重量85%(体积比)的乙醇,回流提取2次,每次1小时,提取液合并,浓缩至密度为1.1g/ml的浸膏,60℃干燥后,粉碎制备成分D;
(6)均匀混合成分A、B、C、D即得。
服用方法,一次1片,一日3次。
实施例2
急性毒性研究
健康大鼠和小鼠分别单次经口灌胃给予本发明的药物组合物,灌胃剂量为临床拟用量的100倍。给药后小鼠出现轻微活动减少,1小时左右恢复正常,给药后连续观察7天,无一动物死亡,其全身状况、饮食、摄水、小便和体重增长均正常,未出现明显的急性毒性反应,也未引起动物死亡。小鼠未出现明显的急性毒性反应,大鼠出现拉稀便,活动减少等反应,急性毒性靶器官为肝脏和脾脏。提示该药急性毒性低,临床用药安全。
实施例3
临床实验
病例选择:
选择确诊的胃肠炎患者103例临床观察,病人随机分成治疗组和对照组两组,治疗组52例,对照组51例,治疗组和对照组两组病例的病程、症状轻重程度基本一致,无显著差异,具有可比性。
药物选择:
治疗组服用本发明药物组合物,口服,每日3次,每次1片;
对照组服用市售盐酸小檗碱片,口服,每日3次,每次1片。
饭后温开水送服;3天为1个疗程,病情严重者遵医嘱酌增用量。
疗效判定:
(1)治愈:腹痛、恶心、呕吐、发热、食欲减退、体重减轻、大量出汗、皮肤湿冷、肌肉痛或关节僵硬症状全部消失,身体恢复正常。
(2)显效:腹痛、恶心、呕吐、发热、食欲减退、体重减轻、大量出汗、皮肤湿冷、肌肉痛或关节僵硬症状明显减轻,身体有所好转。
(3)有效:腹痛、恶心、呕吐、发热、食欲减退、体重减轻、大量出汗、皮肤湿冷、肌肉痛或关节僵硬症状有所减轻,身体明显好转。
(4)无效:通过治疗后上述症状无减轻或加重。
具体治疗结果表1所示:P<0.05
表1
组别 | 例次 | 治愈 | 显效 | 有效 | 无效 | 总有效率(%) |
治疗组 | 52 | 29 | 12 | 7 | 4 | 94 |
对照组 | 51 | 16 | 9 | 17 | 9 | 82.5 |
由上表可见:治疗组总有效率明显优于对照组,有显著性差异。
实施例4
典型实施例
张某,女,29岁,患者近来常常上腹及上腹偏右下阵痛,饮食差,伴有恶心,厌油,有时出现呕吐,腹泻症状,经胃镜查确诊为胃肠炎,给予本发明实施例1制备的药物组合物进行治疗,服用1个疗程后,食纳变佳,厌油减轻,阵痛、腹泻次数减少,服用2个疗程后,阵痛、腹泻全部消失,治愈。
马某,男,50岁,患急性胃肠炎,伴有恶心、呕吐、腹痛、腹泻、发热等症状,服用本发明实施例1制备的药物组合物,2天后,呕吐、腹泻停止, 1个疗程后,症状消失,痊愈。
本发明采用的上述各中西药互作配伍,能发挥其协同治病作用,所用中药原料各成分之间具有药效相互交织相互促进和协调效能,经临床验证,对肠胃炎有很好的治疗效果,本申请人多年的医疗实践中,治愈的病例数目众多,均取得良好的效果,而且成本低廉,减轻患者的负担。
Claims (7)
1.含有盐酸小檗碱片的药物组合物,其包括下述原料:
盐酸小檗碱50kg,羧甲淀粉钠3kg,纯化水18kg,按照常规方法制备片剂100万片。
2.含有盐酸小檗碱片的药物组合物,其包括下述原料:
盐酸小檗碱25kg,中草药成分25kg,羧甲淀粉钠3kg,纯化水18kg,按照常规方法制备片剂100万片。
3.根据权利要求2所述的药物组合物,其特征在于,所述中草药成分由下述原料制备而得:
甘草、山药、地锦草、茯苓、蒲公英、黄柏、车前草、白芷、葛根、大青叶、金银忍冬、附子、防风、延胡索、干姜、肉豆蔻、竹茹、厚朴、金银花、白头翁、枳壳、芡实、陈皮、桔梗、凌霄花、薏苡仁、白术、五倍子。
4.根据权利要求2-3所述的药物组合物,其特征在于,所述中草药成分由下述重量的原料药制备而得:
甘草33份、山药33份、地锦草33份、茯苓32份、蒲公英32份、
黄柏30份、车前草30份、白芷30份、葛根30份、大青叶30份、
金银忍冬28份、附子28份、防风28份、延胡索25份、干姜25份、
肉豆蔻25份、竹茹25份、厚朴25份、金银花20份、白头翁20份、
枳壳20份、芡实20份、陈皮18份、桔梗15份、凌霄花15份、
薏苡仁10份、白术10份、五倍子10份。
5.根据权利要求2-4所述的药物组合物,其特征在于,所述中草药成分的制备方法如下:
1)称取上述原料备用;
2)取甘草、山药、芡实,混合,用文火炒8分钟,粉碎过90目筛,制备成分A;
3)取干姜、陈皮、白术,混合,粉碎过100目筛,混合均匀,制备成分B;
4)取地锦草、茯苓、白芷、葛根、附子、防风、竹茹、白头翁、枳壳、桔梗、薏苡仁、五倍子,混合,放入容器内,加入5倍重量的蒸馏水,浸泡2小时后,煮沸3小时,提取煎煮液;再次加入3倍重量的蒸馏水,煮沸2小时,提取煎煮液;最后,加入2倍重量的蒸馏水,加热煮沸1小时,提取煎煮液;合并三次煎煮液,浓缩成密度为1.1g/ml的浸膏,60℃干燥后,粉碎制备成分C;
5)取剩余原料药,混合,添加3倍重量85%(体积比)的乙醇,回流提取2次,每次1小时,提取液合并,浓缩至密度为1.1g/ml的浸膏,60℃干燥后,粉碎制备成分D;
6)均匀混合成分A、B、C、D即得。
6.根据权利要求1-4所述的药物组合物,其特征在于,所述盐酸小檗碱采用下述方法制备:
1)取三颗针根粗粉,过20目筛后加入3倍重量的浓度0.5%硫酸水溶液使之浸没药面,浸泡5h,用脱脂棉过滤;
2)步骤1)的滤液中加入石灰乳中和多余硫酸,调整pH到7,静置;
3)步骤2)制备的滤液中加入3倍重量的95%(体积比)乙醇搅拌加热至75℃回流20-30min,然后加入等量的乙醇减压浓缩至滤液呈棕红色浆液;
4)向棕红色浆液中加入3%醋酸(体积浓度)加热至140℃;
5)加入浓度为60%的盐酸(体积浓度)至溶液浑浊为止,用冰水冷却至盐酸小檗碱析出,干燥烘干即得。
7.权利要求1-5所述药物组合物的应用。
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