CN108355103B - 治疗幽门螺杆菌相关性胃炎与消化性溃疡的中药组合物 - Google Patents
治疗幽门螺杆菌相关性胃炎与消化性溃疡的中药组合物 Download PDFInfo
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Abstract
本发明提供了一种治疗幽门螺杆菌相关性胃炎与消化性溃疡的中药组合物，由以下重量份的原料药组成：党参10、白术10、砂仁10、半夏15、黄芩10、黄连9、公英30；本发明还提供了一种上述中药组合物制备的片剂。本发明的片剂健脾益胃扶正，清热解毒祛邪，具有抑菌，提高免疫功能并改善胃黏膜微环境，增强组织修复能力的作用，总有效率达94%。经动物实验证实，无毒副作用，避免了铋剂及抗生素长期服用导致的菌群失调，胃肠道反应及耐药情况的发生，具有安全可靠的疗效。
Description
技术领域
本发明涉及一种治疗幽门螺杆菌相关性胃炎与消化性溃疡的中药组合物及其制剂，属于中药技术领域。
背景技术
慢性胃炎（CG）及消化性溃疡（PU）是严重危害人类健康的常见病、多发病。幽门螺杆菌（HP）是一种与慢性胃炎及消化性溃疡密切相关的菌种，HP通过损害胃黏膜屏障并释放毒素和炎性介质，导致未及十二指肠的一系列炎症改变。在我国无症状人群中HP感染率为65.42%。而在消化性溃疡及慢性胃炎人群中高达80%-90%。清除HP后可提高CG和PU痊愈率，降低其复发率。
中医认为消化性溃疡及慢性胃炎属“胃痛”范畴，以上腹疼痛为主症的病症，病因病机多为外感寒邪、内伤饮食、情志刺激、久病虚损等因素，导致脏腑功能失调，胃气失和或胃失所养，气机郁滞，气血交阻，不通而痛。结合多年临床经验，我们认为HP阳性胃炎及消化性溃疡以寒热错杂型多见，其发病机制以脾胃虚弱为其关键。目前，治疗HP相关胃炎及消化性溃疡的公认治疗方案是铋剂为中心的药物联合应用，但依从性高，副作用大且易产生细菌耐药。
发明内容
针对目前治疗幽门螺杆菌相关性胃炎与消化性溃疡副作用大、容易近期菌群失调等问题，本发明提供一种中药组合物。
本发明的另一目的是提供一种制造方便、成本低的上述中药组合物的制剂及其制备方法。
为实现上述目的，本发明采用如下技术方案。
一种治疗幽门螺杆菌相关性胃炎与消化性溃疡的中药组合物，由以下重量份的原料药组成：党参10、白术10、砂仁10、半夏15、黄芩10、黄连9、公英30。
一种上述中药组合物制备的片剂，包括以下制备步骤：
（1）半夏粉碎过筛得半夏细粉；
（2）称取党参、白术、砂仁、黄芩、黄连、公英碎断后水煎，同时收集挥发油，过滤后收集滤液；将滤渣再次水煎，过滤后收集滤液，合并两次滤液后静置，再次过滤得水煎液；水煎液浓缩得稠膏；
（3）将步骤（2）中的挥发油以乙醇溶解为挥发油溶液；
（4）将步骤（1）中的细粉加入步骤（2）的稠膏中，混匀后喷洒步骤（3）中的挥发油溶液，制得混合原料；
（5）将混合原料制片得片剂。
所述半夏细粉的细度优选为过5号筛。
所述步骤（1）中水煎为8-10倍量水，煎煮1-2小时。
所述稠膏的相对密度为1.18-1.24（70℃）。
所述挥发油溶液的浓度为90-95%。所述挥发油溶液的溶剂优选为乙醇。
本发明中党参、白术健脾、益胃、培补中土以固其本共为君药；半夏、砂仁燥湿和中、行气止痛，使其补而不滞为臣；黄芩、黄连、公英清热解毒，苦寒降泄，祛邪外出兼顾其标，共为佐药。全方共奏健脾益气、清热解毒、扶正祛邪之功。
本发明具有以下优点：
本发明的片剂健脾益胃扶正，清热解毒祛邪，总有效率达94%，具有抑菌，提高免疫功能并改善胃黏膜微环境，增强组织修复能力的作用。通过改善胃黏膜微环境，提高机体的免疫力，改善HP赖以生存的条件，从而达到促进胃炎及消化性溃疡痊愈，减少复发的作用，具有标本兼治，剂型优廉的特点。经动物实验证实，无毒副作用，避免了铋剂及抗生素长期服用导致的菌群失调，胃肠道反应及耐药情况的发生，具有安全可靠的疗效。
附图说明
图1为实施例1中片剂制备的工艺流程图；
图2为实施例1中C1与对照药剂治疗前后胃粘膜病理切片。
具体实施方式
下面结合实施例和附图对本发明做进一步说明，但本发明不受下述实施例的限制。
实施例1 片剂制备。
本实施例提供了治疗幽门螺杆菌相关性胃炎与消化性溃疡的中药组合物的片剂的制备方法，其工艺流程如图1所示：
（1）半夏粉碎过5号筛得半夏细粉；
（2）称取党参10kg、白术10kg、砂仁10kg、黄芩10 kg、黄连9 kg、公英30 kg碎断后，加10倍水煎2 h，同时收集挥发油，过滤后收集滤液；将滤渣加8倍再次水煎1 h，过滤后收集滤液，合并两次滤液后静置，再次过滤得水煎液；水煎液浓缩为1.24（70℃）的稠膏；
（3）将步骤（2）中的挥发油以乙醇溶解为95%的挥发油溶液；
（4）将步骤（1）中的细粉15 kg加入步骤（2）的稠膏中，混匀后喷洒步骤（3）中的挥发油溶液，制得混合原料；
（5）将混合原料制为0.25 g的粒，80℃干燥，然后压片，制得0.25 g/片的片剂C1。
实施例2 抑菌试验。
（一）材料和方法
1. 受试药物：按照实施例1制备得到水煎剂，浓缩至药物浓度为1 g/mL，121℃灭菌20 min备用；对照药剂为口服枸橼酸铋钾颗粒（商品名：丽珠得乐，丽珠集团丽珠制药厂生产，批号1206121）；
2. 菌株：幽门螺杆菌，由胃黏膜活检组织块中分离培养，鉴定为幽门螺杆菌，比浊法调整菌液浓度为108 cfu/mL，供抑菌试验用；
3. 培养基：空肠弯曲菌琼脂基础培养基，上海市防疫站生产，按说明配制，临用前加10%卵黄盐水，万古霉素0.5 mg/100 mL，多粘菌素B 0.38 mg/100 mL，制成分离培基；
4. 方法：平皿二倍稀释法，受试药物用双倍浓度分离培养基作1:2稀释，然后对倍稀释，制成含药平皿，加菌液10 μL，37℃微氧环境培养3天，观察有无细菌生长，以无菌生长的最高药物稀释浓度为最低抑菌浓度。
（二）结果
抑菌结果见表1。由表1可知：0.25 g/mL时对全部5株菌株均有抑菌作用，个别较敏感菌株在0.125 g/mL时仍可受到抑制，对照组均正常生长。
表1 中药组合物水煎液对5株幽门螺旋杆菌的抑菌作用
注：“-”为无细菌生长、“++++～+”为细菌生长状况。
实施例3 免疫试验。
3.1 材料和方法
1. 受试药物：实施例1中片剂C1；对照药剂为丽珠得乐（丽珠集团丽珠制药厂生产）；
2. 试验动物：昆明种小鼠，体重20±2 g，雌雄各半，购自山东大学动物中心；
3. 其他试剂：肝素-Hank’s液、蛋白胨水、5%鸡红细胞、Alseve’s液，均由本室制作；
4. 方法：将小鼠随机分成5组，每组10只，雌雄各半，分别为（1）正常对照组（2）阳性对照组（2 g/kg）（3）C1大剂量组（1 g/kg）（4）中剂量组（0.5 g/kg）（5）小剂量组（0.2 g/kg），分别以灌胃法给予生理盐水和药物，每日一次，连续6天。第4次给药后2小时，腹腔注射蛋白胨水1ml，末次给药后2小时，腹腔注射5%鸡红细胞悬液0.5 ml，间隔4小时注入肝素-Hank’s液，立即脱颈椎处死。轻揉腹部，开腹取腹腔液制片，甲醇固定、瑞氏染色，显微镜下计数200个巨噬细胞，分别计算巨噬百分率和巨噬指数。
3.2 结果
片剂C1对小鼠免疫细胞吞噬功能的影响结果见表2。由表2可知，实施例1制备的片剂在低、中、高三个计量水平均可刺激小鼠免疫细胞的吞噬功能。在中剂量时，即能刺激小鼠免疫细胞的吞噬功能达到药剂对照组的水平，与正常对照相比效果极显著；小剂量组也能够有效刺激小鼠免疫细胞的吞噬功能，与正常对照相比，吞噬指数也可达极显著水平，吞噬百分率也可达显著水平。
表2 片剂C1对小鼠免疫细胞吞噬功能的影响
注：*为p<0.05，**为p<0.01，***为p<0.005。
实施例4 药效试验。
4.1 病例选择
中医诊断标准根据《中医病证诊断疗效标准》中“胃脘痛”确定；中医辨证属寒热错杂型；经快速尿素酶、胃窦及胃体黏膜活检确定为幽门螺旋杆菌阳性者。选择病例160人，其中C1治疗组100例，对照药剂组60例。性别分布为C1组男性54例，女性46例，对照组男性31例，女性29例。年龄分布为C1组<20岁3例，21-30 18例，31-40 35例，41-50 37例，>50岁 7例；对照组<20岁2例，21-30 9例，31-40 22例，41-50 23例，>50岁 4例。经统计学检验，C1组与对照组性别、年龄分布无差异。C1组轻度21例，中度68例，重度11例；对照组轻度12例，中度40例，重度8例。经统计学检验，两组间病情无差异。
4.2 治疗方法
C1治疗组（C1组）：口服C1片剂，每次8片，每日3次，餐前半小时服用；
药剂对照组（对照组）：口服枸橼酸铋钾颗粒（商品名：丽珠得乐，丽珠集团丽珠制药厂生产，批号1206121），每次10g，每天3次；呋喃唑酮片（商品名：痢特灵，山西云鹏制药有限公司，批号120801），每次0.2g，每天3次。餐前半小时服用。
两组病例服药4周为一疗程，停药观察1个月，结束后按以下标准统计疗效：
（1）幽门螺旋杆菌判定标准：
显效：胃脘痛及其他症状消失，胃镜及病理检查胃粘膜炎症消失，溃疡愈合或疤痕期，HP检测呈阴性；
有效：胃脘痛缓解，发作次数减少，其他症状减轻，胃镜及病理检查黏膜炎症减轻，溃疡愈合期，HP检测呈弱阳性或感染度减轻；
无效：症状无改善，胃镜及病理检查粘膜无变化，HP检测呈弱阳性或感染度无变化。
（2）中医症状总疗效判定标准：
显效：症状消失或总积分减少2/3；
有效：总积分减少1/3，未达2/3；
无效：总积分减少1/3。
（3）中医单项症状疗效标准：
显效：原有症状消失或症状改善在II级以上；
有效：症状改善I级或未消失；
无效：症状无变化。
（4）消化性溃疡疗效标准：
显效：疗程结束后溃疡愈合疤痕形成；
有效：溃疡面积缩小50%以上；
无效：溃疡面积缩小≤50%或扩大。
4.3 观察指标
治疗前后分别记录临床症状、血及二便常规、肝肾功能、胃粘膜胃镜下及病理结果的改变，尿素酶及组织染色的改变以及不良反应，复发情况。治疗完成后分别于1月、半年、1年随访观察。
4.4 疗效分析
两组治疗病人的总疗效、单项疗效、胃粘膜炎症、消化性溃疡、消化性溃疡复发率结果如表3-7所示。两组治疗病人的胃粘膜尿素酶与幽门螺旋杆菌抑杀率结果如表8-9所示。两组治疗病人的副反应发生率结果如表10所示。经统计学分析，C1组症状疗效显著优于对照组（Ridit分析）；C1组在改善恶心呕吐、乏力、口淡无味和纳呆等症状方面显著（Ridit分析）；C1组在改善胃粘膜炎症、消化性溃疡方面，显著优于对照组（Ridit分析，p<0.05）；两组半年内复发率相近，C1组在1年后复发率极显著低于对照组（t-检验，p<0.01）；两组在HP抑杀率相近，统计学上无显著差异；治疗组观察的100例中，未见任何副反应发生，对照组中有34例出现恶心呕吐、腹泻、头晕、黑便、味觉异常等现象，两组治疗前后，血、粪、尿常规、肝肾功能、心电图未见异常。
表3 症状总疗效
表4 单项症状疗效
表5 胃粘膜炎症疗效
表6 消化性溃疡疗效
表7 消化性溃疡复发率疗效
表8 胃粘膜尿素酶
表9 HP抑杀率
表10 副反应发生率
C1组与对照组治疗前后胃粘膜病理切片如图2所示，其中，a与b为C1组治疗前、后胃粘膜病理切片图片；c与d为对照组治疗前、后胃粘膜病理切片图片。由图2可知，C1治疗组治疗后胃粘膜溃疡愈合，且愈合情况优于对照组。
Claims (6)
1.一种治疗幽门螺杆菌相关性胃炎与消化性溃疡的中药组合物，其特征在于，由以下重量份的原料药制成：党参10、白术10、砂仁10、半夏15、黄芩10、黄连9、公英30。
2.一种如权利要求1所述的中药组合物制备的片剂，其特征在于，包括以下制备步骤：
（1）半夏粉碎过筛得半夏细粉；
（2）称取党参、白术、砂仁、黄芩、黄连、公英碎断后水煎，同时收集挥发油，过滤后收集滤液；将滤渣再次水煎，过滤后收集滤液，合并两次滤液后静置，再次过滤得水煎液；水煎液浓缩得稠膏；
（3）将步骤（2）中的挥发油以乙醇溶解为挥发油溶液；
（4）将步骤（1）中的细粉加入步骤（2）的稠膏中，混匀后喷洒步骤（3）中的挥发油溶液，制得混合原料；
（5）将混合原料制片得片剂。
3.根据权利要求2所述的片剂，其特征在于，所述半夏细粉的细度为过5号筛。
4.根据权利要求2所述的片剂，其特征在于，所述步骤（1）中水煎为8-10倍量水，煎煮1-2小时。
5.根据权利要求2所述的片剂，其特征在于，所述稠膏70℃下的相对密度为1.18-1.24。
6.根据权利要求2所述的片剂，其特征在于，所述挥发油溶液的浓度为90-95%。
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