CN104258263A - 一种治疗胃阴不足型慢性萎缩性胃炎的中药制剂 - Google Patents
一种治疗胃阴不足型慢性萎缩性胃炎的中药制剂 Download PDFInfo
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Abstract
本发明涉及一种中药组合物，属于中药技术领域，尤其涉及一种治疗胃阴不足型慢性萎缩性胃炎的中药制剂，该中药制剂由以下重量份的药用原料制成：北沙参17-23份、复生草30-35份、玉竹25-30份、芦根7-9份、风轮菜21-28份、豆蔻13-17份、三七4-6份、紫地榆15-20份、甘草5-7份。该中药制剂有养阴补虚，健脾和胃，缓急止痛之功，对胃阴不足型慢性萎缩性胃炎的治疗见效快，有效率高，总有效率可达90％以上。
Description
技术领域
本发明涉及一种中药组合物，属于中药技术领域，尤其涉及一种治疗胃阴不足型慢性萎缩性胃炎的中药制剂。
背景技术
慢性萎缩性胃炎(chronic atrophic gastritis CAG)是消化系统疾病中的常见病及难治病之一，以上腹胀满、消瘦乏力、纳少暖气等为主要表现。中医将本病归属于“胃脱痛”、“痞满”、“嘈杂”、“吞酸”、“暖气”等范畴。研究表明，重度CAG伴中重度肠上皮化生及重度不典型增生者，与胃癌的发生有密切关系，是胃癌最重要的癌前病变。
本病的发病原因较多，多数学者认为，发病多因饮食不节、情志所伤、劳倦过度、感受外邪或察赋不足等。饮食不节，过食生冷、寒凉药物，则寒客胃中；饮洒过度、嗜食肥甘辛辣之品，则湿热内生；情志不遂，忧思恼怒，致气郁而伤肝，横逆犯胃；或由感受外邪，外感风寒湿热之邪，因失治误治，邪热入里，结于中焦，致脾胃升降失调而发病；劳倦过度或饥饱失常，久病、先天察赋不足等致脾胃虚弱，因此，本病在病因方而与脾虚、气滞、血疲、寒凝、湿热紧密相关，其中以饮食不节和情志所伤较为突出。成因有虚实之分，实即实邪内阻，包括外邪入里，食滞内停，湿浊中阻，气机郁滞，淤血停滞：虚即脾胃虚弱，中虚不运，实邪内阻，多与中虚不运，升降无力有关，反之，中焦运化无力，最易招致实邪的侵扰，两者常互为因果。另外，各种病邪之间亦可互相影响，使实者愈实，虚者愈虚，正虚邪实，虚实夹杂，各因相兼，互相转化。
尽管有着对于病因的认同，但对病机的认识，则各有仁智之见。中医学对慢性萎缩性胃炎的分型种类繁多，提法各异。但大多数医家认为还是以“脾胃虚弱”、“肝胃不和”、“胃阴不足”、“湿热中阻”、“淤血阻滞”证型居多。胃阴不足症见：胃脘灼热疼痛或隐痛，口干舌燥，纳呆食少，大便干结，舌红少津霍有裂纹，苔少，脉细火弦。
现代医学对于CAG的治疗正处于瓶颈状态、未有突破，因而临床上缺乏特效治疗手段。其常规应用的保守药物治疗或多或少存在着疗程长、费用高、易复发和不良反应大等问题。而内镜下的创伤治疗则由于有创性和并发症较多使得其在临床应用中受到较大的局限。与之相比，医学对本病治疗的独特优势也引起了学者们的广泛关注。
发明内容
本发明的目的是提供一种治疗胃阴不足型慢性萎缩性胃炎的中药制剂。发明人认为胃阴不足型慢性萎缩性胃炎因肝经郁热犯胃，久则易损胃阴，阴液亏损则胃少濡润，导致胃脘少舒，口干引饮，舌光剥或舌裂少苔，此当从“阴”论治。治宜养阴补虚，健脾和胃。
本发明的目的是通过以下技术方案实现的，该治疗胃阴不足型慢性萎缩性胃炎的中药制剂由以下重量份的药用原料制成：北沙参17-23份、复生草30-35份、玉竹25-30份、芦根7-9份、风轮菜21-28份、豆蔻13-17份、三七4-6份、紫地榆15-20份、甘草5-7份。
方中：北沙参、复生草滋阴补虚、益胃生津为君药；风轮菜疏风清热，豆蔻化湿行气，温中开胃、行气醒脾为臣药；玉竹、芦根辅佐北沙参风轮菜清热、生津，三七散瘀止血，消肿定痛，紫地榆清热利湿，活血止血，甘草补脾益气、清热解毒、调和诸药，具为佐使药。诸药相配共奏养阴补虚，健脾和胃，缓急止痛之功。
本发明中药所涉及药材的研究现状如下：
北沙参：性微寒，味甘、微苦。养阴清肺，益胃生津。用于肺热燥咳、劳嗽痰血、热病津伤口渴。
复生草：利尿，调经，滋阴补虚。主治水肿，头晕，耳鸣，小儿营养不良，月经不调，胃痛，小儿腹泻。
玉竹：甘，平。入肺、胃经。用于肺阴受伤，肺燥咳嗽，干咳少痰，以及胃热炽盛，津伤口渴，消谷易饥等症。
芦根：甘，寒。归肺、胃经。功能主治：清热生津，除烦，止呕，利尿。用于热病烦渴，胃热呕哕，肺热咳嗽，肺痈吐脓，热淋涩痛。
风轮菜：苦辛，凉。功能主治：疏风清热，解毒消肿。治感冒，中暑，急性胆囊炎，肝炎，肠炎，痢疾，腮腺炎，乳腺炎，疔疮肿毒，过敏性皮炎，急性结膜炎。现代药理研究表明风轮菜水提液对金黄色葡萄球菌、绿脓杆菌和痢疾杆菌有抑制作用。
豆蔻：味辛，性温。归肺、脾、胃经。功能化湿行气，温中止呕，开胃消食。用于湿浊中阻，不思饮食，湿温初起，胸闷不饥，寒湿呕逆，胸腹胀痛，食积不消。
三七：归肝、胃经。功能主治：散瘀止血，消肿定痛。用于咯血，吐血，衄血，便血，崩漏，外伤出血，胸腹剌痛，跌扑肿痛。
紫地榆：清热利湿，活血止血。用于肠炎，痢疾，消化不良，慢性胃炎，月经不调，鼻衄；外用治跌打损伤。
甘草:甘，平。归心、肺、脾、胃经。功能主治:补脾益气，清热解毒，祛痰止咳，缓急止痛，调和诸药。用于脾胃虚弱，倦怠乏力，心悸气短，咳嗽痰多，脘腹、四肢挛急疼痛，痈肿疮毒，缓解中药毒性、烈性。
优选地，上述所述治疗胃阴不足型慢性萎缩性胃炎的中药制剂由以下重量份的药用原料制成：北沙参21份、复生草32份、玉竹27份、芦根8份、风轮菜25份、豆蔻14份、三七5份、紫地榆17份、甘草6份。
一种治疗胃阴不足型慢性萎缩性胃炎的中药制剂的制备方法，包括以下步骤：
(1)将所述北沙参、复生草、玉竹、芦根、风轮菜、豆蔻、紫地榆、甘草按比例混合，加入相对于混合物质量3～8倍的水，煎煮1～2小时，过滤获得第一提取液；过滤获得的药渣再加入相对于所述药渣质量3～6倍的水，煎煮1～2小时，过滤获得第二提取液；将第一提取液和第二提取液合并，减压浓缩，干燥，获得干膏；
(2)将第一步获得的干膏放置在超微粉碎机中粉碎2～4小时，粉碎，过筛，获得100-200目的细粉；
(3)将所述三七按所述重量份干燥，粉碎成100-200目的细粉，与步骤(2)所得的细粉混合均匀，即得。
为了更好地表达本发明的中药制剂，本发明的中药制剂可以加入制备不同剂型时所需的各种常规辅料，例如崩解剂、润滑剂、粘合剂等以常规的中药制剂方法制备成任何一种常用的口服剂型，比如，散剂、丸剂、颗粒剂、口服液、糖浆、片剂、胶囊剂等制剂。
优选地，本发明中药制剂按照常规制备工艺制备成胶囊剂。
用法与用量：服用胶囊剂，一次1-2粒，日服三次，四周为一疗程。
本发明与现有技术相比具有以下有益效果：
1.本发明中药制剂有养阴补虚，健脾和胃，缓急止痛之功，对胃阴不足型慢性萎缩性胃炎的治疗见效快，有效率高，总有效率可达90％以上；
2.本发明中药制剂为常规剂型方便服用、携带，可长期保存，避免了长期服用中药汤剂煎药麻烦、单次服用量大、患者服用依从相差的缺点。
具体实施方式
下面结合具体实施例对本发明作更进一步的说明，以便本领域的技术人员更了解本发明，但并不因此限制本发明。
实施例1本发明中药制剂胶囊的制备
处方：北沙参21g、复生草32g、玉竹27g、芦根8g、风轮菜25g、豆蔻14g、三七5g、紫地榆17g、甘草6g。
制备方法：将所述北沙参、复生草、玉竹、芦根、风轮菜、豆蔻、紫地榆、甘草按所属处方比例混合，加入相对于混合物质量3～8倍的水，煎煮1～2小时，过滤获得第一提取液；过滤获得的药渣再加入相对于所述药渣质量3～6倍的水，煎煮1～2小时，过滤获得第二提取液；将第一提取液和第二提取液合并，减压浓缩，干燥，获得干膏。将上述获得的干膏放置在超微粉碎机中粉碎，粉碎，过筛，获得100-200目的细粉。将所述三七按所述重量份干燥，粉碎成100-200目的细粉，与上述步骤所得的细粉混合，加入适量辅料混合均匀，灭菌，装入胶囊壳，即得本发明所述的胶囊剂100粒，每粒0.3g，每粒相当于含有生药1.55g。
实施例2本发明中药制剂胶囊的制备
处方：北沙参17g、复生草30g、玉竹25g、芦根7g、风轮菜21g、豆蔻13g、三七4g、紫地榆15g、甘草5g。
制备方法：参照实施例1进行。
实施例3本发明中药制剂胶囊的制备
处方：北沙参19g、复生草32g、玉竹25g、芦根8g、风轮菜24g、豆蔻14g、三七5g、紫地榆17g、甘草6g。
制备方法：参照实施例1进行。
实施例4本发明中药制剂胶囊的制备
处方：北沙参22g、复生草32g、玉竹30g、芦根7g、风轮菜25g、豆蔻15g、三七5g、紫地榆17g、甘草6g。
制备方法：参照实施例1进行。
实施例5本发明中药制剂胶囊的制备
处方：北沙参23g、复生草35g、玉竹30g、芦根9g、风轮菜23g、豆蔻15g、三七6g、紫地榆17g、甘草6g。
制备方法：参照实施例1进行。
实施例6本发明中药制剂胶囊的制备
处方：北沙参23g、复生草35g、玉竹30g、芦根9g、风轮菜28g、豆蔻17g、三七6g、紫地榆20g、甘草7g。
制备方法：参照实施例1进行。
实施例7本发明中药制剂颗粒的制备
处方：北沙参23g、复生草34g、玉竹28g、芦根8g、风轮菜25g、豆蔻15g、三七5g、紫地榆20g、甘草6g。
制备方法：将所述北沙参、复生草、玉竹、芦根、风轮菜、豆蔻、紫地榆、甘草按所属处方比例混合，加入相对于混合物质量3～8倍的水，煎煮1～2小时，过滤获得第一提取液；过滤获得的药渣再加入相对于所述药渣质量3～6倍的水，煎煮1～2小时，过滤获得第二提取液；将第一提取液和第二提取液合并，减压浓缩，干燥，获得干膏。将上述获得的干膏放置在超微粉碎机中粉碎，粉碎，过筛，获得100-200目的细粉。将所述三七按所述重量份干燥，粉碎成100-200目的细粉，与上述步骤所得的细粉混合，加入适量辅料混合均匀，制粒、整理灭菌，装入袋，即得。
以下通过试验例来进一步阐述本发明中药的有益效果，这些试验例包括本发明中药制剂的动物试验和临床观察试验。
试验例1本发明中药制剂对慢性萎缩性胃炎SD大鼠的治疗作用
1.试验动物：SD大鼠，体重200±20g，SPF级，雌雄各半，8周龄，由北京维通利华实验动物技术有限公司提供，实验动物生产许可证号:SCXK(京)2012-0007。
2.试验药物：本发明实施例1制备的中药制剂胶囊。
3.造模与给药：大鼠适应性饲养7天后，剔除不合格动物，随机分为正常对照组(A)，模型组。模型组以20mmol/L去氧胆酸钠溶液(去离子水配制，pH7～7.8)自由饮用，连续30天。同时，灌胃60％乙醇(2ml/只)，10天/次；第31天起30％乙醇及10mmol/L去氧胆酸钠溶液交替饮用，7天/周期，在造模后第40d、80d随机抽取大鼠，进行胃组织病理学检测，检测模型复制程度。慢性萎缩性胃炎大鼠模型复制成功后随机分为5组：模型组(B组)、阳性对照组(C组)、本发明中药制剂高剂量组(D组)、本发明中药制剂中剂量组(E组)、本发明中药制剂低剂量组(F组)。正常对照组(A组)、模型组(B组)ig生理盐水10mL/kg。阳性对照组ig维酶素片液0.5g/kg(相当于临床剂量的10倍)，本发明中药制剂高、中、低剂量组分别ig本发明实施例1制备的胶囊1.55、0.78、0.39g/kg(分别相当于临床剂量20，10，5倍)，连续给药30d。期间，动物自由饮水、常规饲养，试验结束后处死,处死大鼠并进行相关指标分析。
4.评价指标
4.1胃腔黏膜损伤评价：大鼠麻醉后，胃幽门环下0.3cm处结扎，由食道向胃腔注入10ml pH值7.2～7.6的PBS缓冲盐溶液，随即结扎食道并将胃浸泡于冰水中。15min后沿胃大弯剪开暴露胃腔，冲洗干净，记录胃黏膜损伤情况。
4.2胃组织病理学观察：实验周期结束后，处死大鼠，胃组织10％甲醛溶液固定，取胃组织进行常规石蜡包埋，切片，HE染色，显微镜下进行胃组织病理学炎性评分。同时，观察胃黏膜固有层厚度、黏膜肌层厚度及固有腺体萎缩发生率。其中，炎性评分以慢性炎症程度(单核细胞浸润)；炎症活动程度(中性粒细胞浸润)及萎缩性程度(黏膜固有层固有腺体的减少)作为评分指标，每项分为正常(-)、轻度(+)、中度(++)、重度(+++)(对应0、1、2、3分，有其余炎性表现加1分)，最终以幽门部和胃体部两者得分之和为病理学炎性评分结果：正常：0分；轻度:1～4分；中度：5～8分；重度:9分以上。
4.3胃液量pH值及胃蛋白酶活性测定大鼠10％水合氯醛(0.35ml/100g)麻醉后仰位姿势，垫高头部使其高于胃位置，幽门下0.3cm处结扎。5小时后，剪开结扎处10ml离心管收集胃液，4000rpm，15min后，吸取上清液测量体积并转入2.0ml EP管，13000rpm，10min，取上清按试剂盒说明书测定胃蛋白酶活性及用酸度计及精密pH试纸测量pH值。
5.结果：
应用SPSS13.0统计学软件,采用t检验处理分析各组实验数据,P<0.05为差异具有显著性。
大鼠胃部解剖肉眼观察可见，正常对照组(A组)大鼠胃黏膜表面光滑、柔软有光泽，胃体呈橘红色，胃窦为橘黄色；模型组(B组)大鼠胃黏膜表面粗糙或呈颗粒状，红白相间，黏膜下暗红色微小血管暴露，可见少量出血点，表明本实验建模成功。
正常对照组(A组)胃黏膜腺管排列整齐，大小形状一致，呈单柱状，壁细胞、主细胞界限清楚，固有层内胃腺体排列紧密整齐，未见或少见炎性细胞，黏膜下层无水肿；模型组(B组)胃黏膜充血、水肿、腺管排列紊乱或疏密不均，黏膜固有层变薄，黏膜肌层紊乱、增厚，黏膜下层水肿明显，固有层内有淋巴细胞浸润，有少量嗜酸性粒细胞和中性粒细胞。经治疗后C、D、E、F各组大鼠，胃黏膜固有层炎性细胞数目不同程度地减少，固有胃腺数目增多，腺管排列稍整齐平整。
表1 CAG大鼠胃组织病理学评分
注：与A组相比，*P＜0.05，**P＜0.01；与B组相比，#P＜0.05，##P＜0.01,与C组相比，$P＜0.05，$$P＜0.01。
由表1可知，与A组比较，B组大鼠的组织病理学炎性评分显著升高，差异有统计学意义(P＜0.01)；与B组比较，C、D、E、F各组大鼠的组织病理学炎性评分显著降低差异有统计学意义(P＜0.01)；与C组相比，D、E、F各组大鼠的组织病理学炎性评分显著降低差异有统计学意义(分别P＜0.05，P＜0.01)，表明本发明的药物制剂的治疗作用优于阳性对照药组。
表2 CAG大鼠胃黏膜固有层腺体萎缩情况
注：与A组相比，*P＜0.05，**P＜0.01；与B组相比，#P＜0.05，##P＜0.01。
表2大鼠胃黏膜萎缩统计结果表明，B组大鼠胃黏膜固有层腺体萎缩率达到75％，与A组比较差异显著，经治疗后C、D、E、F各组大鼠，胃黏膜固有层腺体萎缩率不同程度地减少，表明各组均有不同程度的治疗作用。
胃肠激素分泌功能分析实验结果表明，与A组比较，B组胃蛋白酶活性下降、胃液pH值降低，胃液分泌量减少；治疗后，胃蛋白酶活性与B组比较显著升高，差异有统计学意义，见表3。
表3 CAG大鼠胃分泌功能分析
注：与A组相比，*P＜0.05，**P＜0.01；与B组相比，#P＜0.05，##P＜0.01。
总之，通过实验胃组织病理学等级评分、扫描电镜结果和胃肠激素分泌指标，采用阳性药物维酶素作为阳性对照药，以判断模型对本发明中药制剂的敏感性。结果表明本发明中药制剂对萎缩性胃炎模型组大鼠实验指标有显著的改善，表明本模型复制的成功且对本发明中药制剂的治疗作用实验室指标表现敏感。
实施例2临床观察试验
1.一般资料：选择2012年2月至2013年2月在我处就诊的痞满胃阴不足证患者100例(男55例/女45例)，年龄18～66岁，按随机数字表法分成对照组和观察组。对照组50例(男27例/女23例)年龄(48.5±6.1)岁。观察组50例(男26例/女24例)，年龄(47.6±5.5)岁。两组痞满胃阴不足证患者年龄、性别比等一般资料差异无统计学意义(P＞0.05)，具有可比性。
2.纳入标准：符合2006年全国第二届慢性胃炎共识会议制定的慢性萎缩性胃炎诊断标准及中医证候诊断标准参照《中药新药临床研究指导原则》有关证属胃阴不足型；近1月内未服用与本病相关治疗药物；知情同意，志愿受试。
3.排除标准：合并消化性溃疡、胃黏膜有重度异型增生或病理诊断疑有恶变者；合并心、脑、肝、肾和造血系统严重原发性疾病、精神病患者；妊娠或哺乳期妇女；未按规定用药治疗、或中断治疗无法判定疗效、或资料不全等影响疗效或安全性判断者。
4.治疗方法：治疗组：给予本发明实施例1制备的胶囊，一日三次，每次1-2粒，一个月为一个疗程。
对照组：维酶素片(四川大冢制药有限公司，国药准字H51023596)，口服，4～6片/次，一日三次。
两组患者在治疗期间注意休息，调畅情志，饮食以清淡易消化食物为主，忌食辛辣、刺激及生冷、油腻食物。
5.疗效评定标准：参照《中药新药临床研究指导原则》制定。
痊愈:治疗4周后，痞满胃阴不足证患者的临床症状、体征消失，胃镜复查黏膜慢性炎症明显好转，病理检查证实腺体萎缩、肠上皮化生和异型增生复常或消失。
显效:治疗4周后，痞满胃阴不足证患者的临床主要症状、体征消失，胃镜复查黏膜慢性炎症好转，病理检查证实腺体萎缩范围缩小1/2以上。
有效:治疗4周后，痞满胃阴不足证患者的临床主要症状、体征明显减轻，胃镜示炎症减轻，病理检查证实慢性炎症减轻1度，腺体萎缩、肠腺上皮化生和异型增生减轻。
无效:治疗4周后，痞满胃阴不足证患者达不到有效标准，甚至恶化。
6.治疗结果
表4.两组分别治疗4周后临床疗效比较例
研究结果表明：本发明中药制剂在临床疗效上优于现有药物，具有显著的进步。
以上所述，仅是本发明的较佳实施例而已，并非是对本发明作其它形式的限制，任何熟悉本专业的技术人员可能利用上述揭示的技术内容加以变更或改型为等同变化的等效实施例。但是凡是未脱离本发明技术方案内容，依据本发明的技术实质对以上实施例所作的任何简单修改、等同变化与改型，仍属于本发明技术方案的保护范围。
Claims (6)
1.一种治疗胃阴不足型慢性萎缩性胃炎的中药制剂，其特征在于由以下重量份的药用原料制成：北沙参17-23份、复生草30-35份、玉竹25-30份、芦根7-9份、风轮菜21-28份、豆蔻13-17份、三七4-6份、紫地榆15-20份、甘草5-7份。
2.如权利要求1所述的治疗胃阴不足型慢性萎缩性胃炎的中药制剂，其特征在于由以下重量份的药用原料制成：北沙参21份、复生草32份、玉竹27份、芦根8份、风轮菜25份、豆蔻14份、三七5份、紫地榆17份、甘草6份。
3.如权利要求1或2所述的治疗胃阴不足型慢性萎缩性胃炎的中药制剂，其特征在于其制备方法，包括以下步骤：
(1)将所述北沙参、复生草、玉竹、芦根、风轮菜、豆蔻、紫地榆、甘草按比例混合，加入相对于混合物质量3～8倍的水，煎煮1～2小时，过滤获得第一提取液；过滤获得的药渣再加入相对于所述药渣质量3～6倍的水，煎煮1～2小时，过滤获得第二提取液；将第一提取液和第二提取液合并，减压浓缩，干燥，获得干膏；
(2)将第一步获得的干膏放置在超微粉碎机中粉碎2～4小时，粉碎，过筛，获得100-200目的细粉；
(3)将所述三七按所述重量份干燥，粉碎成100-200目的细粉，与步骤(2)所得的细粉混合均匀，即得。
4.如权利要求1-3任一所述的治疗胃阴不足型慢性萎缩性胃炎的中药制剂，其特征在于该中药制剂为口服剂型。
5.如权利要求4所述的治疗胃阴不足型慢性萎缩性胃炎的中药制剂，其特征在于该口服剂型为散剂、丸剂、颗粒剂、口服液、糖浆、片剂、胶囊剂。
6.如权利要求5所述的治疗胃阴不足型慢性萎缩性胃炎的中药制剂，其特征在于该口服剂型优选为胶囊剂。
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