CN107998256A - 治疗胃炎的缓释片及其制备方法 - Google Patents
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Abstract
本发明公开了治疗胃炎的缓释片及其制备方法，原料由以下重量份的中药组分组成：开口箭20‑50份、两面针10‑30份、九里香10‑20份、橘核6‑15份、甘草6‑15份。该缓释片能明显改善患者上腹部满闷、疼痛、嗳气、口干、嘈杂、泛酸、乏力、消瘦、食少等症状等急慢性胃炎症状，药物释放缓慢持久、生物利用度较高、无不良反应发生。
Description
技术领域
本发明属于药品领域，涉及一种治疗胃炎的缓释片及其制备方法。
背景技术
胃炎中医名为胃痞，胃脘痛，反酸，嘈杂。是由多种不同病因引起的胃黏膜急性和慢性炎症，常伴有上皮损伤、黏膜炎症反应和上皮再生。胃炎是最常见的消化系统疾病之一。按临床发病的缓急和病程长短，一般将胃炎分为急性胃炎和慢性胃炎。急性胃黏膜炎症，临床上急性发病，常表现为上腹部不适、隐痛等症状；慢性胃炎表现为胃黏膜慢性炎症或萎缩性病变，临床上十分常见，约占接受胃镜检查患者的80％～90％，随年龄增长萎缩性病变的发生率逐渐增高。本发明采用活血化瘀、清热解毒、理气止痛的治疗方法，科学组方而成，对胃炎具有普遍针对性。除本发明外尚未见有开口箭、两面针、九里香、橘核、甘草组合物的报道。
(1)开口箭，本品为百合科植物开口箭Tupistra chinensis Bak.的干燥根茎。【性味】苦，辛，寒，有小毒。【功能主治】清热解毒；祛风除湿；散瘀止痛。主白喉；咽喉肿痛；风湿痹痛；跌打损伤；胃痛；痈肿疮毒；毒蛇咬伤；狂犬咬伤。
(2)两面针，本品为芸香科植物两面针Zanthoxylum nitidum(Roxb.)DC.的根及根茎。【性味】辛；苦；微温；小毒。【归经】肝；心经。【功能主治】祛风通络；胜湿止痛；消肿解毒。主风寒湿痹；筋骨疼痛；跌打骨折；疝痛；咽喉肿痛；胃疼；蛔劂腹痛；牙痛；疮痈瘰疬；烫伤。
(3)九里香，本品为芸香科植物九里香Murraya exotica L.和千里香Murrayapaniculata(Linn.)xJack的干燥叶和带叶嫩枝。【性味】辛、微苦，温；有小毒。【功能主治】行气止痛，活血散瘀。用于胃痛，风湿痹痛；外治牙痛，跌扑肿痛，虫蛇咬伤。
(4)橘核，本品为芸香科植物橘Citrus reticulata Blanco及其栽培变种的干燥成熟种子。【性味】苦，平。【归经】归肝、肾经。【功能主治】理气，散结，止痛。用于小肠疝气，睾丸肿痛，乳痈肿痛。
(5)甘草，本品为豆科植物甘草Glycyrrhiz uralensis Fisch.、胀果甘草Glycyrrhiza inflata Bat.或光果甘草Glycyrrhiza gla-bra L.的干燥报及根茎。【性味与归经】甘，平。归心、肺、脾、胃经。【功能与主治】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，缓解药物毒性、烈性。
以上背景技术内容的公开仅用于辅助理解本发明的发明构思及技术方案，其并不必然属于本专利申请的现有技术，在没有明确的证据表明上述内容在本专利申请的申请日已经公开的情况下，上述背景技术不应当用于评价本申请的新颖性和创造性。
发明内容
本发明的目的是提供一种药物释放缓慢持久、生物利用度较高、服药次数减少、方便服用的治疗胃炎的缓释片，以及制备该缓释片的制备方法。
本发明人通过中医理论的指导，与现代中药先进制剂技术相结合，通过合理配制，制成一种治疗胃炎的缓释片，具有清热解毒，活血化瘀，理气止痛之功效，能有效治疗急、慢性胃炎，达到提高生活质量的目的。
本发明所采用的技术方案如下：
治疗胃炎的缓释片，其特征在于，原料由以下重量份的中药组分组成：开口箭20-50份、两面针10-30份、九里香10-20份、橘核6-15份、甘草6-15份；其制备方法为：将称量好的开口箭、两面针、九里香、橘核、甘草，加6-10倍量水煎煮提取，滤过，合并滤液，浓缩，制粒，干燥，粉碎，加入缓释辅料，压片，制成缓释片。
所述缓释辅料优选为羟丙基甲基纤维素5-10份、聚乙烯吡咯烷酮0.8-1.2份、微晶纤维素3-8份、硬脂酸镁0.5-0.8份。
所述原料优选由以下重量份的中药组分组成：开口箭35份、两面针20份、九里香15份、橘核12份、甘草9份。
所述缓释辅料优选为羟丙基甲基纤维素8份、聚乙烯吡咯烷酮1份、微晶纤维素5份、硬脂酸镁0.6份。
以上所述治疗胃炎的缓释片的制备方法，包括以下步骤：
S1：按重量份分别称取组分：开口箭20-50份、两面针10-30份、九里香10-20份、橘核6-15份、甘草6-15份；
S2：将称量好的开口箭、两面针、九里香、橘核、甘草，加6-10倍量水煎煮提取1-3次，每次1-3小时，滤过，合并滤液，浓缩，制粒，干燥，粉碎，即得干膏粉；
S3：将上述干膏粉加入缓释辅料，压片，制成缓释片。
以上所述治疗胃炎的缓释片的制备方法，所述原料优选由以下重量份的中药组分组成：开口箭35份、两面针20份、九里香15份、橘核12份、甘草9份。
所述步骤S2优选提取2次，每次2小时。
所述缓释辅料优选为羟丙基甲基纤维素5-10份、聚乙烯吡咯烷酮0.8-1.2份、微晶纤维素3-8份、硬脂酸镁0.5-0.8份。
所述缓释辅料为羟丙基甲基纤维素8份、聚乙烯吡咯烷酮1份、微晶纤维素5份、硬脂酸镁0.6份。
以上所述治疗胃炎的缓释片，所述缓释片在治疗急、慢性胃炎方面的应用。
本发明治疗胃炎的缓释片是在中医药传统理论的基础上，结合民间用药经验，运用现代科学理论配制而成。方中开口箭，具有清热解毒，散瘀止痛之功，为方中君药；两面针、九里香具有散瘀、通络、理气之功，同为臣药；橘核具有理气、散结、止痛之功，为佐药；甘草具有补脾益气、清热解毒、祛痰止咳、缓急止痛、调和诸药的功效，为使药；诸药合用共奏清热解毒，散瘀止痛，理气之功。本发明治疗胃炎的缓释片，在24小时内缓缓释放，药物释放平稳、半衰期长，大大有利于提高药物的生物利用度，减少不良反应，对急、慢性胃炎具有良好的疗效。
具体实施方式
下面结合具体实施例对本发明作进一步描述，但不限制本发明的保护范围和应用范围：
一、治疗胃炎的缓释片的制备
实施例1
治疗胃炎的缓释片的制备方法，包括以下步骤：
S1：按重量份分别称取组分：开口箭20kg、两面针10kg、九里香10kg、橘核6kg、甘草6kg；
S2：将称量好的开口箭、两面针、九里香、橘核、甘草，加10倍量水煎煮提取1次，煎煮3小时，滤过，合并滤液，浓缩，制粒，干燥，粉碎，即得干膏粉；
S3：将上述干膏粉加入羟丙基甲基纤维素5kg、聚乙烯吡咯烷酮0.8kg、微晶纤维素3kg、硬脂酸镁0.5kg，混匀，压片，即得。
实施例2
治疗胃炎的缓释片的制备方法，包括以下步骤：
S1：按重量份分别称取组分：开口箭50kg、两面针30kg、九里香20kg、橘核15kg、甘草15kg；
S2：将称量好的开口箭、两面针、九里香、橘核、甘草，加6倍量水煎煮提取3次，每次煎煮1小时，滤过，合并滤液，浓缩，制粒，干燥，粉碎，即得干膏粉；
S3：将上述干膏粉加入羟丙基甲基纤维素10kg、聚乙烯吡咯烷酮1.2kg、微晶纤维素8kg、硬脂酸镁0.8kg，混匀，压片，即得。
实施例3
治疗胃炎的缓释片的制备方法，包括以下步骤：
S1：按重量份分别称取组分：开口箭35kg、两面针20kg、九里香15kg、橘核12kg、甘草9kg；
S2：将称量好的开口箭、两面针、九里香、橘核、甘草，加8倍量水煎煮提取2次，每次煎煮2小时，滤过，合并滤液，浓缩，制粒，干燥，粉碎，即得干膏粉；
S3：将上述干膏粉加入羟丙基甲基纤维素8kg、聚乙烯吡咯烷酮1kg、微晶纤维素5kg、硬脂酸镁0.6kg，混匀，压片，即得。
二、临床应用
1.病例选择标准
所有病例均符合2003年中华医学会消化内镜学分会制订《慢性胃炎的内镜分型分级标准及治疗的试行意见》的诊断标准。
(1)临床主要症状：长期反复发生的上腹部满闷、疼痛、嗳气、口干、嘈杂、泛酸。查体可有上腹部的轻度压痛，无肌紧张及反跳痛。
(2)胃镜提示有浅表性胃炎或糜烂性胃炎或反流性胃炎。
(3)纳入标准：
a.年龄在18-65岁之间。
b.用药前1-2周内经胃镜、病理检查证实者。
c.能配合治疗，按时复诊的患者。
(4)排除标准
a.年龄在18岁以下或65岁以上者。
b.合并消化性溃疡，消化系肿瘤，病理诊断疑似恶变者。
c.合并进行性硬皮病、心、脑血管、肝肾和造血系统等严重原发性疾病、腹
部手术，精神病患者。
d.妊娠或准备妊娠妇女，哺乳期妇女。
e.过敏体质或对多种药物过敏者。
f.未按规定用药或中断治疗，无法判定疗效或资料不全等影响疗效或安全性判断者。
2.治疗方案
(1)治疗组：将上述制备好的实施例3样品，用于临床试验。口服，一次4片，一日3次。疗程：用药10天。
(2)对照组：四方胃片(市售)。口服，一次3片，一日3次。疗程：用药10天。
3.疗效评定标准
疗效指数＝(治疗前积分一治疗后积分)/治疗前积分×100％
(1)痊愈：临床主要症状消失或基本消失，疗效指数≥95％；胃镜检查溃疡及周围炎症全部消失，为瘢痕。
(2)改善：临床主要症状有好转，疗效指数≥30％；胃镜检查溃疡面缩小50％以上。
(3)无效：临床主要症状无改善，疗效指数＜30％；胃镜检查溃疡面缩小不及50％。
4.试验结果：用于治疗和观察55例门诊病人。将上述制备好的实施例3样品和四方胃片，分别用于病人：治疗组：31例(男16例，女15例，平均年龄36岁)，对照组23例(男13例，女10例，平均年龄38岁)，结果详见表1。
表1临床试验效果表
结果表明：采用本发明实施例3治疗，治愈率为77％，有效率达96％，总体效果与对照组相当，没有不良反应发生，使用安全、有效，能明显改善患者上腹部满闷、疼痛、嗳气、口干、嘈杂、泛酸、乏力、消瘦、食少等症状，愈后良好。以下为几个典型病例：
病例1：向××，女，35岁，上腹部饱胀、隐痛、嗳气吞酸。胃镜检查胃粘膜充血。服用本发明实施例3，每次4片，每日3次，连服5日，隐痛症状消除，连服10日，胃炎症状消失，痊愈。1年后回访，无复发。
病例2：黄××，男，30岁，饭前饭后胃隐痛，已有半年，医院胃镜检查结果：浅表性胃炎。服用本发明实施例1，每次4片，每日3次，连服10日，胃炎症状消失，痊愈。1年后回访，无复发。
病例3：李××，男，38岁，有长期酗酒史，空腹易胃痛，时有恶心感。胃镜检查，胃粘膜充血，溃疡。服用本发明实施例2，每次4片，每日3次，连服10日，以上症状消除，胃镜检查，未见胃部充血与糜烂，痊愈。1年后回访，无复发。
以上内容是结合具体的/优选的实施方式对本发明所作的进一步详细说明，不能认定本发明的具体实施只局限于这些说明。对于本发明所属技术领域的普通技术人员来说，在不脱离本发明构思的前提下，其还可以对这些已描述的实施例做出若干替代或变型，而这些替代或变型方式都应当视为属于本发明的保护范围。
Claims (10)
1.治疗胃炎的缓释片，其特征在于，原料由以下重量份的中药组分组成：开口箭20-50份、两面针10-30份、九里香10-20份、橘核6-15份、甘草6-15份；其制备方法为：将称量好的开口箭、两面针、九里香、橘核、甘草，加6-10倍量水煎煮提取，滤过，合并滤液，浓缩，制粒，干燥，粉碎，加入缓释辅料，压片，制成缓释片。
2.根据权利要求1所述的治疗胃炎的缓释片，其特征在于，所述缓释辅料为羟丙基甲基纤维素5-10份、聚乙烯吡咯烷酮0.8-1.2份、微晶纤维素3-8份、硬脂酸镁0.5-0.8份。
3.根据权利要求1所述的治疗胃炎的缓释片，其特征在于，原料由以下重量份的中药组分组成：开口箭35份、两面针20份、九里香15份、橘核12份、甘草9份。
4.根据权利要求1所述的治疗胃炎的缓释片，其特征在于，所述缓释辅料为羟丙基甲基纤维素8份、聚乙烯吡咯烷酮1份、微晶纤维素5份、硬脂酸镁0.6份。
5.一种如权利要求1所述治疗胃炎的缓释片的制备方法，其特征在于，包括以下步骤：
S1：按重量份分别称取组分：开口箭20-50份、两面针10-30份、九里香10-20份、橘核6-15份、甘草6-15份；
S2：将称量好的开口箭、两面针、九里香、橘核、甘草，加6-10倍量水煎煮提取1-3次，每次1-3小时，滤过，合并滤液，浓缩，制粒，干燥，粉碎，即得干膏粉；
S3：将上述干膏粉加入缓释辅料，压片，制成缓释片。
6.根据权利要求5所述治疗胃炎的缓释片的制备方法，其特征在于，所述原料由以下重量份的中药组分组成：开口箭35份、两面针20份、九里香15份、橘核12份、甘草9份。
7.根据权利要求5所述治疗胃炎的缓释片的制备方法，其特征在于，所述步骤S2提取2次，每次2小时。
8.根据权利要求5所述治疗胃炎的缓释片的制备方法，其特征在于，所述缓释辅料为羟丙基甲基纤维素5-10份、聚乙烯吡咯烷酮0.8-1.2份、微晶纤维素3-8份、硬脂酸镁0.5-0.8份。
9.根据权利要求5所述治疗胃炎的缓释片的制备方法，其特征在于，所述缓释辅料为羟丙基甲基纤维素8份、聚乙烯吡咯烷酮1份、微晶纤维素5份、硬脂酸镁0.6份。
10.如权利要求1所述治疗胃炎的缓释片，其特征在于，所述缓释片在治疗急、慢性胃炎方面的应用。
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| CN113367247A (zh) * | 2021-01-05 | 2021-09-10 | 安徽科技学院 | 一种预防肉鸡肌胃腺胃炎的饲料添加剂 |
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| CN113367247A (zh) * | 2021-01-05 | 2021-09-10 | 安徽科技学院 | 一种预防肉鸡肌胃腺胃炎的饲料添加剂 |
| CN113367247B (zh) * | 2021-01-05 | 2023-11-14 | 安徽科技学院 | 一种预防肉鸡肌胃腺胃炎的饲料添加剂 |
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