CN1589853A - 治疗粘膜性溃疡的复方制剂 - Google Patents
治疗粘膜性溃疡的复方制剂 Download PDFInfo
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Abstract
本发明涉及一种治疗粘膜性溃疡的药物组合物，特别是涉及一种以植物中草药为原料制成的治疗粘膜性溃疡的药物组合物。本发明所述的治疗粘膜性溃疡的复方制剂主要由以下重量百分比的原料药组成：麦冬1－99％、余甘子1－99％。本发明所述的复方制剂主要用于治疗口腔溃疡、复发性口腔溃疡以及口腔溃疡以外的粘膜性溃疡，急、慢性咽炎，咽喉肿痛等症。
Description
技术领域
本发明涉及一种治疗粘膜性溃疡的药物组合物，特别是涉及一种以植物中草药为原料制成的治疗粘膜性溃疡的药物组合物。
背景技术
粘膜性溃疡是一种常见的疾病，其中又以口腔溃疡为其典型代表，其治疗的药剂有中药制剂，也有西药制剂，中国专利申请CN1257732A公开了一种“治疗口腔溃疡及***的中成药——“速效口疮灵”胶囊”，系一种治疗口腔溃疡及***的中成药，其所用的中药原料及重量配比为：人参12-18份，穿山甲3-7份，山药8-12份，黄芪17-23份，金银花17-23份，薄荷17-23份，冬虫夏草8-12份，肉桂17-23份，西红花12-18份。中国专利申请CN1190013A公开了一种“牙痛口腔溃疡软膏”，是由下述重量分的药物组合而成：朱砂8-12份，硼砂8-12份，黄连15-20份，大黄13-15份，黄柏15-20份，甘草15-20份，冰片25-30份，黄蜡30-35份，香油650-700份。
发明内容
本发明的目的旨在于提供一种由天然植物中草药为原料制成的治疗粘膜性溃疡的复方制剂。
本发明所述的治疗粘膜性溃疡的复方制剂主要由以下重量百分比的原料药组成：麦冬1-99％、余甘子1-99％。
在上述组成中麦冬也可为山麦冬，并且还可加入赤芍10-40％，地黄10-40％，甘草5-30％。
本发明所述的余甘子(Phyllanthus emblica)有收敛，保护粘膜作用，抗氧化，对抗亚硝胺致突变和放射所致染色体畸变作用，降脂、降低心肌耗氧和抗血栓作用；麦冬(Ophiopogon japonicus)有中枢镇静，抗疲劳耐缺氧作用，强心、抗心律失常、保护缺血心肌作用，一定的抑菌作用和降血糖作用，免疫增强作用(非特异性，细胞和体液免疫)；地黄(Rehmannia glutinosa)有抗放射保肝作用，降血糖、轻泻、减肥作用，抗炎消肿，抗真菌和干扰素诱生作用；赤芍药(Paeonia lactiflora)有抑制血小板聚集，抗血栓形成和心肌缺血保护作用，协同化疗药抗癌作用，增强网状内皮系功能，抗菌抗炎消肿作用，免疫调节(Ils，Th/Ts)，促诱生IFN，直接抗病毒作用(使水泡性口炎病毒效价下降)，解痉、镇痛、镇静作用等。
本发明所述的复方制剂为合剂、片剂、颗粒剂、胶囊剂、软胶囊剂等口服制剂。
本发明所述的复方制剂主要用于治疗口腔溃疡、复发性口腔溃疡以及口腔溃疡以外的粘膜性溃疡，急、慢性咽炎，咽喉肿痛等症。
本发明所述的制剂，经急性毒性试验和长期毒性试验，证明本品无明显毒性反应，安全性高。
药效学试验：动物、药物及试剂，菌种、培养基、仪器方法等省略。
方法与结果：
一、本制剂对小鼠免疫功能的调节作用
1、对小鼠腹腔巨噬细胞吞噬功能的影响：
结果显示，CY组巨噬细胞吞噬CRBC的吞噬率和吞噬指数明显低于正常对照组(P＜0.01)。与CY组比本制剂高、低剂量、LMS、口溃灵均能明显提高CY免疫抑制下小鼠的吞噬细胞吞噬百分率和吞噬指数(P＜0.01)；口溃灵与本制剂高剂量组比较无显著性差异(P＞0.2)；高低剂量组间有差异(P＜0.01)。结果说明，本制剂对CY抑制下的小鼠吞噬细胞功能具有明显的激活、增强作用且两种剂量间有着量效关系。
2、对绵羊红细胞(SRBC)诱导的小鼠足垫迟发型超敏反应(DTH)的影响：
CY组足垫肿胀厚度显著低于NS组(P＜0.01)。本制剂、口溃灵、LMS各组足垫肿胀厚度显著高于CY组(P＜0.01)。同时显示口溃灵提高DHT的作用比本制剂较明显(P＜0.01)。
3、对小鼠血清溶血素形成的影响：
本制剂、口溃灵、LMS均能增强CY抑制的OD值(P＜0.01)。口溃灵与本制剂(高、低剂量)OD值无显著性差异(P＞0.1)。说明本制剂对CY抑制的体液免疫呈剂量相关性增强促进作用，明显提高脾脏的抗体形成能力。
4、对小鼠脾细胞con A和LPS增殖反应的影响：
与正常组比较，CY明显抑制了T细胞增殖反应(P＜0.01)，给药各组均能促进CY抑制的T淋巴细胞转化，使转化率明显增高(P＜0.01)说明本制剂对小鼠细胞免疫功能有促进作用，同时可见口溃灵与低剂量本制剂OD值无显著性差异(P＜0.01)。
本制剂高、低组和口溃灵均能提高CY抑制的LPS增殖反应为(P＜0.001)，同时显示口溃灵和本制剂高、低组间作用无显著性差异(P＞0.05)。
二、本制剂对细菌的抑制作用
药品的配制：菌种的制备及试验方法省略。
结果表明本制剂对备菌的MIC分别为：金黄色葡萄球菌112.5mg/ml；白色念珠菌56.25mg/ml。
三、本制剂对二甲苯致小鼠耳廓肿胀的影响
药液的配制、试验方法省略。
结果表明：对照组小鼠右耳明显肿胀厚度增加，两耳片重差较大，而给药组两耳片重差明显低于对照组。表明本制剂高、中剂量组及阿司匹林组均有较好的抑制肿胀的作用，抗炎作用明显，并有一定的量效关系。
结论和讨论
一、实验结果表明，本制剂具有明显对抗CY所致小鼠免疫功能低下的作用。表现为：
1、明显提高CY免疫抑制小鼠的腹腔巨噬细胞吞噬功能。
2、对CY所致的血清溶血素形成抑制和迟发型超敏反应(DTH)抑制有明显的促进恢复作用。
3、可显著促进CY免疫抑制小鼠conA，LPS诱导的脾脏淋细胞的增殖反应。
以上免疫指标综合结果提示了本制剂在免疫功能被抑制时可发挥其调节作用，表现为免疫抑制非特异性免疫细胞吞噬功能提高，促进抗体生成、B和T淋巴细胞增殖。
二、本制剂对口腔常见菌具有一定的抑菌作用。
三、本制剂具有明显的抗炎消肿作用。
综上所述，本制剂对免疫抑制的提高和多方面调节作用以及抗炎消肿和一定的抗菌作用为其应用于复发性口腔溃疡和炎症提供了药效学实验依据。
临床试验：
凡符合阴虚口疮中医诊断和辩证标准及西医RAU诊断标准者，均可纳入试验病例。经345例患者参加本试验，结果为临床治愈(即服药4天，口腔溃疡全部愈合，疼痛消失，其他伴随症状亦消失)122例，显效(即服药4天，口腔溃疡愈合达三分之二以上，疼痛大减，仍伴随症状大减)141例，进步(即服药4天，口腔溃疡愈合不足三分之二，疼痛减轻)56例，无效(即服药4天，口腔溃疡及疼痛等无变化或加重)26例，有效率92.5％，显效率76.2％，无效率7.5％。
具体实施方式
实施例1：
取麦冬400克、余甘子400克，分别加水10000ml、8000ml、6000ml，煎煮，合并三次煎煮液，真空减压浓缩，加防腐剂及其他辅料适量，加热灭菌，制成合剂1000ml。
实施例2：
取麦冬500克、余甘子800克，赤芍300克，加水煎煮两次，每次加水12倍，煎煮1.5小时，过滤，滤液浓缩至比重1.10-1.15，加乙醇至醇浓度为50-60％放置过夜，过滤，滤液减压蒸除乙醇后，蒸干，加入辅料，制粒，压片，制成0.35g/片剂1000片。
实施例3：
取余甘子300克、麦冬600克、赤芍300克、地黄600克。
加水煎煮二次，每次加水12倍，滤过，滤液通过JD-(WLD)、D101、DiaionHP-20或D201大孔吸附树脂，吸附物以10-90％乙醇洗脱，洗脱液减压浓缩，真空或喷雾干燥，制粒，制成片剂或胶囊剂1000片(颗)。
实施例4：
取余甘子600克、麦冬300克、赤芍300克、地黄400克、甘草100克。
加10-90％乙醇回流或渗漉提取，浓缩提取液，浸膏制成合剂、片剂、颗粒剂、胶囊剂、软胶囊剂等口服制剂。
实施例5：
取余甘子100克、麦冬500克、赤芍500克、地黄500克。
按不同比例组成的复方，采用实施例1、2、3、4方法提取、精制后的浸膏，制成合剂、片剂、颗粒剂、胶囊剂、软胶囊剂等口服制剂。
Claims (4)
1、一种治疗粘膜性溃疡的复方制剂，其特征在于主要由以下重量百分比的原料药组成：麦冬1-99％、余甘子1-99％。
2、按照权利要求1所述的复方制剂，其特征在于含有赤芍10-40％。
3、按照权利要求1所述的复方制剂，其特征在于含有地黄10-40％。
4、按照权利要求1所述的复方制剂，其特征在于含有甘草5-30％。
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103432380A (zh) * | 2013-09-05 | 2013-12-11 | 滇虹药业集团股份有限公司 | 中药制剂生产方法及其生产的粘膜性溃疡药物和测定方法 |
| CN104740483A (zh) * | 2015-04-24 | 2015-07-01 | 高元琴 | 一种用于治疗复发性口腔溃疡的中药 |
| CN107106477A (zh) * | 2014-12-23 | 2017-08-29 | 高露洁-棕榄公司 | 口腔护理组合物和使用方法 |
| CN107281383A (zh) * | 2017-07-07 | 2017-10-24 | 云南蓝钻生物科技股份有限公司 | 一种复方咽炎制剂及其制备方法 |
| CN107372999A (zh) * | 2017-08-29 | 2017-11-24 | 成都中医药大学 | 一种麦冬润喉糖配方的组成及工艺 |
| CN111184809A (zh) * | 2020-03-26 | 2020-05-22 | 穆棱市晟宇生物科技有限公司 | 一种清咽润喉的食品、保健品或药品组合物及其制备方法 |
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2003
- 2003-08-28 CN CNB031541933A patent/CN100506260C/zh not_active Expired - Lifetime
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103432380A (zh) * | 2013-09-05 | 2013-12-11 | 滇虹药业集团股份有限公司 | 中药制剂生产方法及其生产的粘膜性溃疡药物和测定方法 |
| CN103432380B (zh) * | 2013-09-05 | 2016-01-20 | 滇虹药业集团股份有限公司 | 中药制剂生产方法及其生产的粘膜性溃疡药物和测定方法 |
| CN107106477A (zh) * | 2014-12-23 | 2017-08-29 | 高露洁-棕榄公司 | 口腔护理组合物和使用方法 |
| CN104740483A (zh) * | 2015-04-24 | 2015-07-01 | 高元琴 | 一种用于治疗复发性口腔溃疡的中药 |
| CN107281383A (zh) * | 2017-07-07 | 2017-10-24 | 云南蓝钻生物科技股份有限公司 | 一种复方咽炎制剂及其制备方法 |
| CN107372999A (zh) * | 2017-08-29 | 2017-11-24 | 成都中医药大学 | 一种麦冬润喉糖配方的组成及工艺 |
| CN111184809A (zh) * | 2020-03-26 | 2020-05-22 | 穆棱市晟宇生物科技有限公司 | 一种清咽润喉的食品、保健品或药品组合物及其制备方法 |
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| CN100506260C (zh) | 2009-07-01 |
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