CN113855734A - 一种治疗泄泻的药物及其制备方法 - Google Patents
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- CN113855734A CN113855734A CN202111158472.6A CN202111158472A CN113855734A CN 113855734 A CN113855734 A CN 113855734A CN 202111158472 A CN202111158472 A CN 202111158472A CN 113855734 A CN113855734 A CN 113855734A
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Abstract
本发明属于医药技术领域，具体涉及一种治疗泄泻的药物及其制备方法。技术方案是由地锦草、地耳草、黄芩、陈皮、山楂、甘草为原料；经过将步骤1.将地锦草、地耳草、黄芩加乙醇回流提取，合并乙醇提取液，滤过，回收乙醇，滤液备用；步骤2.将药渣与其余的山楂、陈皮、甘草三味药材加水，煎煮，滤过，滤液备用；步骤3.合并滤液，滤液减压浓缩至40℃～65℃时相对密度为1.0～1.5的清膏，干燥，制成干膏粉；步骤4.将制成的干膏粉加适量辅料混匀，用常规工艺制成固体制剂。本发明以清热燥湿、理气消食为基本原则，全方寒温搭配得当，祛邪不伤正，可标本兼治，共奏清热燥湿、理气消食之功；经药效学和临床试验证实，具有明显的治疗泄泻之功效。
Description
技术领域
本发明属于医药技术领域，具体涉及一种治疗泄泻的药物及其制备方法。
背景技术
泄泻，是指排便次数明显超过平日习惯的频率，粪质稀薄，水分增加，每日排便量超过200g，或含未消化食物或脓血、粘液。泄泻常伴有排便急迫感、肛门不适、失禁等症状。泄泻分急性和慢性两类。急性泄泻发病急剧，病程在2～3周之内。慢性泄泻指病程在两个月以上或间歇期在2～4周内的复发性泄泻。急性肠胃炎是胃肠粘膜的急性炎症，临床表现主要为恶心、呕吐、腹痛、泄泻、发热等。细菌性痢疾简称菌痢，是由痢疾杆菌引起的以泄泻为主要症状的肠道传染病。痢疾临床表现为腹痛、泄泻、里急后重、排脓血便，伴全身中毒等症状。
泄泻的危害主要有：(1)可使水电解质失调和酸碱平衡紊乱，使机体丢失大量水分及电解质，从而出现脱水、低钠血症、低钾血症、酸中毒等，缺钾时可出现心律失常、乏力甚至肠麻痹等，严重紊乱及酸中毒都会对机体产生严重损害，如不及时抢救，还可能危及生命。(2)可引起营养不良.泄泻，特别是慢性泄泻时可伴随营养成分丢失，摄入的营养物质不能充分吸收，儿童可影响生长发育。(3)可引起维生素缺乏：导致皮肤头发干燥，缺乏光泽，甚至脱落等现象。(4)可引起贫血，出现口唇、指甲淡白无华，皮肤干燥，脱屑、神疲乏力，头晕耳鸣等症状。(5)可使机体的抵抗力下降。
随着现代人们生活节奏的加快、饮食不规律，以及饮食不卫生引起的脾胃失调、消化不良、肠胃炎、泄泻等问题越来越多。目前，市场上治疗泄泻的药物有：(1)口服肠黏膜保护剂：如蒙托石。(2)口服调节肠道菌群的药物,比如双歧杆菌等。(3)口服解除胃肠道痉挛作用的药物，如654-2、得舒特等。(4)存在肠道细菌感染的情况下，使用抗菌药物，如左氧氟沙星、黄连素等。
本发明基本病机为脾胃湿热、蕴结大肠，气血受阻，传导失职，故见腹痛泄泻，泄下急迫或不爽，大便臭秽等。
发明内容
本发明提供一种治疗泄泻的药物。目的是发挥中医配伍用药，以清热燥湿、理气消食为基本原则，全方寒温搭配得当，祛邪不伤正，可标本兼治，共奏清热燥湿、理气消食之功；经药效学和临床试验证实，本发明具有明显的治疗泄泻之功效。
本发明的另一发明目的是提供该药物的制备方法。
基于上述治疗原则，本发明所采用的技术方案是，一种治疗泄泻的药物，由以下重量份数的药味制成：
地锦草10～30份、地耳草15～45份、黄芩5～15份、陈皮5～15份、山楂5～15份、甘草3～9份。
所述治疗泄泻的药物的制备方法，包括以下步骤：按照重量份数计算
步骤1.将地锦草、地耳草、黄芩加6～10倍量乙醇回流提取1～3次，每次1～2小时，合并乙醇提取液，滤过，回收乙醇，滤液备用；
步骤2.将步骤1的药渣与其余的山楂、陈皮、甘草三味药材加6～10倍量水，煎煮1～3次，每次0.5～2小时，滤过，滤液备用；
步骤3.合并步骤1与步骤2的滤液，滤液减压浓缩至40℃～65℃时相对密度为1.0～1.5的清膏，干燥，制成干膏粉；
步骤4.将步骤3制成的干膏粉加适量辅料混匀，用常规工艺制成固体制剂。
所述的辅料为微晶纤维素、淀粉、蔗糖、乳糖、糊精、碳酸钙、硬脂酸镁、明胶、羟甲基纤维素、微粉硅胶、木糖醇、二氧化硅、羟丙基纤维素、羧甲基纤维素钠、甲基纤维素、乙基纤维素、羟丙基甲基纤维素或羧甲基淀粉钠中的一种或任意几种的混合。
上述药物还可以制成药剂学上的任何一种其它的口服制剂，如片剂、颗粒剂、胶囊剂、散剂、丸剂、口服液等。
对本发明各组份的药性及组合进行药理作用分析如下：
中医学认为，泄泻四季皆可见，但以夏秋季为多，为常见、多发疾病，多因饮食不节，湿热内蕴，阻于脾胃、大肠，或寒温不适、外感湿热之邪，侵袭大肠，使其传导失职而致。其基本病机为脾胃湿热、蕴结大肠，气血受阻，传导失职，故见腹痛泄泻，泄下急迫或不爽，大便臭秽等。方中地锦草，性味辛平，归肺经、胃经、大肠经，可清热解毒、利湿退黄、活血止血。地耳草，性凉，味甘、微苦。归肝经、胆经、大肠经，清热利湿，解毒。二者共为君，以清热利湿、解毒泻火。黄芩，苦、寒，入肺、胆、脾、胃、大肠经，擅长清中上焦湿热，为臣，助君药清热燥湿，泻火解毒。陈皮，苦、辛，温。归肺、脾经。理气健脾，燥湿化痰，山楂，酸、甘，微温。归脾胃、肝经。消食化积、行气散瘀。二者共伍为佐，以理气、消食、导滞，调节饮食失节所致的泄泻。甘草为使以调和诸药，全方寒温搭配得当，祛邪不伤正，可标本兼治，共奏清热燥湿、理气消食之功。
现代药理学研究证实：
地锦草，具有清热解毒、活血止血等功效。近年来发现地锦草可治疗皮肤病、瘙痒、痢疾、肠炎等疾病,具有很好的疗效；许慧瑶等在地锦草有效成分的提取及其生物活性的研究中发现，地锦草具有抗菌性能,且对青霉、曲霉的抗菌效果比较显著；α-淀粉酶的抑制活性的实验表明,地锦草提取物对α-淀粉酶的活性有抑制能力,在pH 6.8、浓度为4.8mg/mL、温度为70℃时,其对α-淀粉酶的抑制效果达到最大。热子亚·麦麦吐逊等在新疆地锦草提取物体外抗氧化及抑菌活性研究中发现，地锦草醇、水两种提取物对受试菌株均有明显的抑菌作用,其中醇、水两种提取物对金黄色葡萄球菌和大肠杆菌的最低抑菌浓度一致，MIC为1.56％。醇提物对枯草芽孢杆菌和变形杆菌的最低抑菌浓度一致,MIC为3.125％，而水提物对枯草芽孢杆菌最低抑菌浓度为12.5％,对变形杆菌最低抑菌浓度为25％。
地耳草，性凉，味甘、微苦。归肝经、胆经、大肠经，清热利湿，解毒之功效；地耳草含多种化学成分，主要包括间苯三酚衍生物、黄酮类、酮类、吡喃酮类、二肽类及萜类等成分。研究表明，其药理作用主要表现为抗疟活性、抑菌活性及抗病毒活性等作用；从地耳草中分离得到的间苯三酚类化合物对金黄色葡萄球菌具有显著抑制作用。
黄芩，具有清热燥湿，泻火解毒之功效；黄芩化学成分丰富,包括黄酮类、挥发油、酚酸类、苯乙醇、微量元素等。研究表明,黄芩除具有利尿、解热、止咳平喘、保胎等药理活性外,还具有抗菌、保肝、抗肿瘤、抗氧化、心脑血管保护、神经系统保护等多种药理活性。黄芩中的黄芩素及黄芩苷能抑制多种细菌生长,如多种革兰氏阳性及阴性菌。黄芩有较强的抗菌抗病毒作用,并能明显抑制引起病性肌肤真菌。白猛等证实了乐东黄芩化合物抗菌活性良好,尤其是对枯草芽孢杆菌、金黄色葡萄球菌、铜绿假单胞菌、大肠杆菌、副溶血弧菌、溶藻弧菌等。
陈皮，理气健脾、燥湿化痰,在方中既可调节脾胃升降之机,也可疏通肝气、疏泄胆汁,促进脾胃功能。现代药理研究陈皮具有抗氧化、降脂、抗炎、保肝等作用。主要药效成分为黄酮类(陈皮苷、陈皮多甲氧基黄酮、川陈皮素)、挥发油(柠檬烯)、生物碱类(辛弗林)等。现代药理学表明，陈皮挥发油能促进胃液分泌,有助于消化；陈皮水提液对离体唾液淀粉酶活性有明显的促进作用，陈皮的理气健脾作用有实验依据。
山楂，消食健胃，行气散瘀，化浊降脂之功效；山楂的主要成分为总黄酮、有机酸、三萜酸和原花青素等。现代药理研究发现山楂应用于心脑血管系统能够降压、降脂、抗动脉粥样硬化、抗心律失常、抗心肌缺血、抑制脑细胞凋亡,应用于消化系统能够双向调节胃肠道蠕动、促进消化酶的分泌,保护肝脏,应用于内分泌系统能够降低血糖、治疗糖尿病并发症,同时山楂亦具有抗菌、抗肿瘤作用。
甘草，能补脾益气,清热解毒,止咳祛痰、缓急定痛、调和诸药等功效。其药性平和通行十二经脉,有调和诸药、解百毒、补虚、止咳润肺等多种功能，有“阁老”之称。主要有效成分有三萜类化合物(甘草甜素亦甘草酸盐,甘草次酸等),黄酮类化合物(甘草黄碱酮,异甘草黄铜,甘草素等)及甘草多糖类化合物等三大类。现代药理学研究表明，甘草的醇提取物及甘草酸钠在体外对金黄色葡萄球菌,结核杆菌,大肠杆菌,阿米巴原虫均有抑制作用。
为表明本发明对治疗泄泻的效果，提供本发明药物的药效学实验报告如下：
1.试验材料
1.1受试药物
治疗湿热泄泻的药物：北京海德润制药有限公司加工。
用法用量：口服，按干膏粉计算4.3g/60kg/日，相当于生药43g/日。
1.2阳性对照药物的选取
根据《中药新药研究指南(药学、药理学、毒理学)》中阳性药的选取原则，本实验选用下面药物作为阳性对照药。
1.2.1阿司匹林泡腾片阿斯利康制药有限公司，批号：1809115。
【适应症】用于普通感冒或流行性感冒引起的发热，也用于缓解轻至重度疼痛如头痛、关节痛、偏头痛、牙痛、肌肉痛、神经痛、痛经。
【用法用量】每片0.5g，温开水溶解后口服。14岁以上儿童及成人，一次1片。
1.2.2复方地芬诺酯片，江苏平光制药有限公司，批号:1911062。
本品每片含盐酸地芬诺酯2.5mg，硫酸阿托品25ug。
【适应症】本品用于急慢性功能性腹泻及慢性肠炎。
【用法用量】口服。成人：每次l-2片，每日2-3次，首剂加倍，饭后服。至腹泻控制时，应即减少剂量。
1.3实验材料
冰醋酸分析纯，天津市巴斯夫化工有限公司，批号：20180812。
番泻叶，购于安国药材市场；水煎剂1g生药/ml；
1.4试验动物
健康清洁级昆明种小鼠160只，雌雄各半，体重18～22g。购自北京华阜康生物科技股份有限公司，许可证编号SCXK(京)2009-0004。
所用动物均喂养于清洁恒温环境中，喂养环境平均温度为25±0.5℃，平均湿度为37％。15-20次/小时全新风。光照：12小时明12小时暗。饲料由北京华阜康生物科技股份有限公司提供的消毒饲料，自由饮水进食。
2.剂量设计原则
2.1阳性对照药剂量设计
阿司匹林泡腾片人临床使用量每片0.5g，每日服用3片，即为0.025g/kg/d。
复方地芬诺酯片人临床使用量每日6片，每片含盐酸地芬诺酯2.5mg，即为0.25mg/kg/d。
2.2治疗湿热泄泻的药物剂量设计
治疗湿热泄泻的药物人临床使用量，每日服用(干膏)剂量为0.072g/kg/d。小鼠剂量0.54、1.08、2.16g/kg，与临床拟用量的关系分别是7.5、15、30倍
2.3试验指标设计
空白组、模型组、对照组、给药组小鼠耳廓肿胀度的变化可以直接反应供试药的抗炎作用。
模型组、对照组、给药组醋酸制痛小鼠扭体次数的不同可以反应出供试药的镇痛作用。
模型组、对照组、给药组小鼠的泄泻次数可以反应出供试药的止泻作用。
3.试验方法、步骤
3.1治疗湿热泄泻的药物对小鼠耳肿胀模型的抗炎作用
3.1.1实验动物分组、模型制备及给药
选取健康昆明种小鼠60只，雌雄各半，体重18～22g。随机分为空白对照组(NS)、模型组(ET)、阿司匹林组(Aspirin)、治疗湿热泄泻的药物小、中、大剂量组(CGTR)，各组动物称重，编号；预先灌胃给药2天，空白对照组给予同体积蒸馏水；阿司匹林组0.3g/kg，和治疗湿热泄泻的药物组0.54、1.08、2.16g/kg按照给药体积2ml/100g给予相应浓度的药物；第2天给药后1小时，除空白组外，取30μl二甲苯涂于各组小鼠右耳双面，30min后脱颈椎处死，沿耳廓底部剪下左、右两耳，用8mm打孔器在两耳相同部位取下耳片，置电子分析天枰称重，计算肿胀度(％)。
3.1.2计算肿胀度和耳肿胀抑制率
肿胀度(Δm)＝右耳片重量-左耳片重量
耳肿胀抑制率＝(给药组肿胀度Δm-模型组肿胀度Δm)/模型组肿胀度Δm
3.1.3实验结果
由表1可知，小鼠耳肿胀实验以肿胀度Δm为参数，与空白组比较，模型组Δm值显著上升(P＜0.01)，说明二甲苯致炎小鼠造模成功；与模型组比较，治疗湿热泄泻的药物各组Δm均明显降低(P<0.05或P<0.01)；由此可见，治疗湿热泄泻的药物有较好的抗炎效果。
表1治疗湿热泄泻的药物对二甲苯所致小鼠耳肿胀的影响(
n＝10)
模型组和空白组比较P＜0.01有显著性差异x±sa，P＜0.05有差异x±sb，模型组和其余组比较P＜0.01有显著性差异x±sc，P＜0.05有差异x±sd
3.2治疗湿热泄泻的药物对醋酸扭体小鼠的镇痛作用
3.2.1实验动物分组、模型制备及给药
选取健康昆明种小鼠50只，雌雄各半，体重18～22g。随机分为模型组(ET)、、阿司匹林组(Aspirin)、治疗湿热泄泻的药物小、中、大剂量组(CGTR)，各组动物称重，编号；预先灌胃给药3天，模型组给予同体积蒸馏水；阿司匹林组0.3g/kg(浓度1.5％)、和治疗湿热泄泻的药物组0.54、1.08、2.16g/kg，按照给药体积2ml/100g给予相应浓度的药物；第3天给药后1个小时，各组小鼠用1ml注射器腹腔注射0.6％的冰醋酸0.2ml；观察并记录20min内小鼠扭体次数并计算扭体抑制率。
3.2.2扭体抑制率的计算
扭体抑制率＝1-(各组平均扭体次数/模型组平均扭体次数)
3.2.3实验结果
由表2可知，小鼠镇痛实验以扭体次数为参数，与模型组比较，治疗表寒里热证感冒的药物各组扭体次数明显下降(P<0.05或P<0.01)；表明治疗湿热泄泻的药物有较好的镇痛效果。
表2治疗湿热泄泻的药物对醋酸所致小鼠扭体反应的影响(
n＝10)
模型组和其余组比较P＜0.01有显著性差异x±sa，0.01＜p＜0.05有差异x±sb
3.3治疗湿热泄泻的药物对小鼠的止泻作用
3.3.1实验动物分组、模型制备及给药
选取健康昆明种小鼠50只，雌雄各半，体重18～22g。随机分为模型组(ET)、、地芬诺酯组、治疗湿热泄泻的药物小、中、大剂量组(CGTR)，各组动物称重，编号；预先灌胃给药3天，模型组给予同体积蒸馏水；地芬诺酯组0.3mg/kg、和治疗湿热泄泻的药物组0.54、1.08、2.16g/kg，按照给药体积2ml/100g给予相应浓度的药物；第3天给药前禁食12h，末次给药30min后每只小鼠灌胃100％番泻叶水煎剂(生药1g/ml)0.4ml/只，然后将小鼠放在铺有白纸的鼠笼内，每只单独放一鼠笼，每隔2h换垫纸，分别统计0-2h，2-4h，4-6h三个时间段内泄泻次数及6h泄泻累计次数。
3.3.2实验结果
由表3可知，与模型组比较，治疗湿热泄泻的药物能明显减少番泻叶引起的小鼠泄泻次数(P<0.05或P<0.01)；表明治疗湿热泄泻的药物有较好的止泻作用。
表3治疗湿热泄泻的药物止泻作用(
n＝10)
4.试验结论
4.1通过二甲苯所致小鼠耳肿胀模型验证，治疗湿热泄泻的药物有较好抗炎作用。
4.2通过醋酸所致小鼠扭体实验证明，治疗湿热泄泻的药物有很好的镇痛效果。
4.3通过减少番泻叶引起小鼠泄泻次数证实，治疗湿热泄泻的药物具有止泻作用。
临床研究资料
1.一般资料：观察病例90例均为门诊病例，随机分2组，治疗组60例，其中男性34例，女性26例，年龄12-65岁，平均42岁。对照组30例，其中男性16例，女性14例，平均40岁。两组均为脾胃湿热型泄泻，其性别、年龄、病程等一般资料经统计学处理无统计学差异。
1.1中医诊断标准：
参考国家中医药管理局2017年发布的泄泻病中医诊疗方案及《中医内科学》(张伯礼主编，人民卫生出版社2012年出版)。
诊断要点：
泄泻：以腹痛、大便粪质清稀为主要依据。或大便次数增多，粪质清稀，甚则如水样；或泻下完谷不化。常先有腹胀腹痛，旋即泄泻。暴泻起病急，泻下急迫而量多，多由外感寒热、暑湿或饮食不当所致；久泻起病缓，泻下势缓而量少，有反复发作史，多由外邪、饮食、情志、劳倦等因素诱发或加重。
脾胃湿热证：腹痛泄泻；泄下急迫或不爽；大便臭秽；胸闷不舒，渴不欲饮；口干口苦，甚或口臭；舌红，苔黄腻；脉滑。
1.2西医诊断标准
参考《感染性腹泻病》①起病急，一年四季均可发生，以春夏季发病率高；②大便次数增多，每日3次以上，常见黄色或赤色的稀便或水样便，有腥臭味或混有少量黏液；③可伴有发热、腹痛、恶心呕吐；④大便常规检查可见白细胞或脓细胞及红细胞。
1.3纳入标准
符合中医辩证标准和西医诊断者；年龄12-65岁，并愿意配合临床观察者。
1.4排除标准
不符合中医辩证标准和西医诊断者；
年龄小于12或大于65岁者；
合并有心、肝、肾和造血系统、精神神经系统等严重疾病者、肿瘤；
有严重脱水、酸中毒、休克患者或发热超过39℃者；
细菌性痢疾、肠结核、炎症性肠病者；
病情危重、生命体征不稳定者；
妊娠或哺乳期妇女；
不愿配合临床观察者；
2.治疗方法
2.1治疗组，本品颗粒剂，每次1袋，每日3次，冲服，疗程3日。观察期间禁止使用任何抗生素、抗病毒药物及其他药效相似的中成药。
2.2对照组，葛根芩连颗粒，每次1袋，每日3次，冲服，疗程3日。观察期间禁止使用任何抗生素、抗病毒药物及其他药效相似的中成药。
3.观察指标
3.1安全性指标
一般体检项目、血常规、尿常规、便常规、心电图、肝功能(ALT、AST、GGT、ALP、TBIL)、肾功能(BUN、Cr)及不良事件的观察。
3.2疗效指标：疾病疗效
3.3疗效评定标准，参照《中药新药临床研究指导原则》、《中医病证诊断疗效标准》制订。
痊愈：泄泻症状消失，大便成形，每日1～2次；腹痛及其他症状消失。
显效：大便次数每日2～3次，近似成形，或便溏而每日仅1次，腹痛及其他症状改善程度在2级以上(+++～+)。
有效：大便次数和性状、腹痛及其他症状均有好转。
无效：症状无改善或有加重。
4.治疗结果
表1两组疗效对比例(％)
患者用药3天后，治疗组愈显57例，有效1例，无效2例，总有效率为96.67％。对照组愈显20例，有效3例，无效7例，总有效率为76.67％。
与对照组比较，p<0.01。
用药期间未发生不良事件，治疗前后检测血常规、尿常规、便常规、心电图、肝功能(ALT、AST、GGT、ALP、TBIL)、肾功能(BUN、Cr)等未见异常。
试验证明本品可有效治疗泄泻。
具体实施方式
实施例1
本实施例所述一种治疗泄泻的药物，由以下重量份数的药味制成：
地锦草10份、地耳草15份、黄芩5份、陈皮5份、山楂5份、甘草3份
具体制备方法，包括以下步骤：按照重量份数计算
包括以下步骤：按照重量份数计算
步骤1.将地锦草、地耳草、黄芩加6倍量乙醇回流提取1次，每次1小时，合并乙醇提取液，滤过，回收乙醇，滤液备用；
步骤2.将步骤1的药渣与其余的山楂、陈皮、甘草三味药材加6倍量水，煎煮1次，每次0.5小时，滤过，滤液备用；
步骤3.合并步骤1与步骤2的滤液，滤液减压浓缩至40℃时相对密度为1.0的清膏，干燥，制成干膏粉；
步骤4.将步骤3制成的干膏粉加适量辅料混匀，用常规工艺制成固体制剂。
实施例2
本实施例所述一种治疗泄泻的药物，由以下重量份数的药味制成：
地锦草20份、地耳草25份、黄芩10份、陈皮10份、山楂10份、甘草6份
具体制备方法，包括以下步骤：按照重量份数计算
包括以下步骤：按照重量份数计算
步骤1.将地锦草、地耳草、黄芩加8倍量乙醇回流提取2次，每次1.5小时，合并乙醇提取液，滤过，回收乙醇，滤液备用；
步骤2.将步骤1的药渣与其余的山楂、陈皮、甘草三味药材加8倍量水，煎煮2次，每次1小时，滤过，滤液备用；
步骤3.合并步骤1与步骤2的滤液，滤液减压浓缩至55℃时相对密度为1.3的清膏，干燥，制成干膏粉；
步骤4.将步骤3制成的干膏粉加适量辅料混匀，用常规工艺制成固体制剂。
实施例3
本实施例所述一种治疗泄泻药物，由以下重量份数的药味制成：
地锦草30份、地耳草45份、黄芩15份、陈皮15份、山楂15份、甘草9份
具体制备方法，包括以下步骤：按照重量份数计算
步骤1.将地锦草、地耳草、黄芩加10倍量乙醇回流提取3次，每次2小时，合并乙醇提取液，滤过，回收乙醇，滤液备用；
步骤2.将步骤1的药渣与其余的山楂、陈皮、甘草三味药材加10倍量水，煎煮3次，每次2小时，滤过，滤液备用；
步骤3.合并步骤1与步骤2的滤液，滤液减压浓缩至65℃时相对密度为1.5的清膏，干燥，制成干膏粉；
步骤4.将步骤3制成的干膏粉加适量辅料混匀，用常规工艺制成固体制剂。
上述所有实施例中所使用的辅料可以选用微晶纤维素、淀粉、蔗糖、乳糖、糊精、碳酸钙、硬脂酸镁、明胶、羟甲基纤维素、微粉硅胶、木糖醇、二氧化硅、羟丙基纤维素、羧甲基纤维素钠、甲基纤维素、乙基纤维素、羟丙基甲基纤维素或羧甲基淀粉钠中的一种或任意几种的混合。
本发明除了制备固体制剂外，还可以用常规工艺制成制成药剂学上的任何一种其它的口服制剂，如片剂、颗粒剂、胶囊剂、散剂、丸剂、口服液等。
Claims (3)
1.一种治疗泄泻的药物，其特征是，由以下重量份数的药味制成：
地锦草10～30份、地耳草15～45份、黄芩5～15份、陈皮5～15份、山楂5～15份、甘草3～9份。
2.一种制备权利要求1所述治疗泄泻的药物的方法，其特征是：包括以下步骤：按照重量份数计算
步骤1.将地锦草、地耳草、黄芩加6～10倍量乙醇回流提取1～3次，每次1～2小时，合并乙醇提取液，滤过，回收乙醇，滤液备用；
步骤2.将步骤1的药渣与其余的山楂、陈皮、甘草三味药材加6～10倍量水，煎煮1～3次，每次0.5～2小时，滤过，滤液备用；
步骤3.合并步骤1与步骤2的滤液，滤液减压浓缩至40℃～65℃时相对密度为1.0～1.5的清膏，干燥，制成干膏粉；
步骤4.将步骤3制成的干膏粉加适量辅料混匀，用常规工艺制成固体制剂。
3.根据权利要求2所述治疗泄泻的药物的制备方法，其特征是：所述的辅料为微晶纤维素、淀粉、蔗糖、乳糖、糊精、碳酸钙、硬脂酸镁、明胶、羟甲基纤维素、微粉硅胶、木糖醇、二氧化硅、羟丙基纤维素、羧甲基纤维素钠、甲基纤维素、乙基纤维素、羟丙基甲基纤维素或羧甲基淀粉钠中的一种或任意几种的混合。
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| CN103816265A (zh) * | 2014-02-14 | 2014-05-28 | 刘维忠 | 一种用于治疗泄泻的药物及其制备方法 |
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| CN103816265A (zh) * | 2014-02-14 | 2014-05-28 | 刘维忠 | 一种用于治疗泄泻的药物及其制备方法 |
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| CN110870894A (zh) * | 2018-08-31 | 2020-03-10 | 张立山 | 一种治疗腹泻的中药组合物 |
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