CN114404387A - 一种乌贝颗粒及其制备方法 - Google Patents
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Abstract
为解决现有治疗胃溃疡和十二指肠溃疡的药存在的西药副作用大、依赖性强；中药药味多、效果不理想的技术问题，本发明提出一种乌贝颗粒及其制备方法。本发明一种乌贝颗粒，由以下质量份的各组分组成：海螵蛸粉50‑55，浙贝母粉8‑10，38％单糖浆25‑35，陈皮油0.05‑0.15，糊精8‑10。上述乌贝颗粒的制备方法，包括以下步骤：海螵蛸粉制备、浙贝母粉制备、湿颗粒制备、干燥、过筛和包衣。本发明有效利用海螵蛸粉和浙贝母粉的协同作用，对胃溃疡和十二指肠溃疡有显著疗效。
Description
技术领域
本发明属于中医药品领域，尤其涉及一种乌贝颗粒及其制备方法。
背景技术
胃痛胃酸是常见的消化道疾病，主要为消化性溃疡，即胃及十二指肠溃疡。主要表现为上腹部疼痛，可为钝痛、灼痛、剧痛或者胀痛。典型者表现为剑突下持续性疼痛，伴反酸、烧心、打嗝、嗳气等不适。常反复发作，以春季和秋季为多发。上腹部疼痛有一定的规律，胃溃疡一般是餐后一个小时以后出现，而十二指肠溃疡为空腹疼和饥饿疼，有些人夜间常疼醒，吃饭以后可以缓解。
胃溃疡最常见部位是胃小弯的最低处，即胃角，其次是胃的幽门区，临床上常称为胃窦部。十二指肠溃疡是最常见的消化性溃疡，十二指肠球部肠壁较薄且黏膜无环形皱襞，是最常发生溃疡的部位，占十二指肠溃疡的95％。球部以下的十二指肠溃疡称为球后溃疡，占约5％。十二指肠溃疡直径通常＜1cm，多见于青壮年男性，近20～30年老年十二指肠溃疡患者发病明显增多。十二指肠溃疡病人，其平均基础酸分泌量和最大酸分泌量，都较正常人高出很多。
目前，治疗胃溃疡和十二指肠溃疡的药各种各样，以西药为主。西药在治疗过程中有较大的副作用及依赖性，需要长期服用。也有用纯中药治疗的，不是药味多就是效果不明显。
发明内容
为解决现有治疗胃溃疡和十二指肠溃疡的药存在的西药副作用大、依赖性强；中药药味多、效果不理想的技术问题，本发明提出一种乌贝颗粒及其制备方法。
本发明一种乌贝颗粒，由以下质量份的各组分组成：
进一步的，本发明一种乌贝颗粒，由以下质量份的各组分组成：
本发明还提供上述乌贝颗粒的制备方法，包括以下步骤：
S1、海螵蛸粉制备：将净药材的海螵蛸置于不锈钢盆内用水刷洗后置浸泡池浸泡12小时，将浸泡洗后的海螵蛸置于70～80℃烘箱干燥，经粉碎，过100目筛，然后在105℃灭菌50分钟，(F0≥6)，干燥1小时；备用；
S2、浙贝母粉制备：将浙贝母拣选，弃除异物和霉变、虫蛀部分，然后用流动饮用水洗净、沥干，置于70～80℃烘箱干燥，经粉碎，过100目筛，然后在105℃灭菌50分钟，(F0≥6)，干燥80分钟；备用；
S3、湿颗粒制备：将海螵蛸粉、浙贝母粉、糊精加入湿法混合制粒机，低速混合3分钟，加入陈皮油后再低速混合3分钟后，加入50～60℃的38％单糖浆，开启切割刀高速混合制粒5分钟；再用14目尼龙筛网经YK-160摇摆式颗粒机制粒，得到湿颗粒；
S4、干燥：将湿颗粒均匀摊至不锈钢烘盘中，送入CTC-IV热风循环烘箱干燥，干燥温度60～80℃，干燥时间5～6小时；
S5、过筛：选取合格颗粒：选取能通过10目筛不能通过60目筛的合格颗粒；
S6、包衣：将步骤S5得到的合格颗粒置于包衣锅中进行包衣，及得到本发明的乌贝颗粒。
进一步的，所述步骤S1中海螵蛸粉碎等级为20级。
进一步的，所述步骤S2中浙贝母粉碎等级为12级。
进一步的，所述步骤S4中干燥后颗粒水分≤4.5％。
进一步的，所述步骤S6中包衣液由已下质量份的各物质组成：
聚丙烯酸树脂Ⅳ 10
聚乙二醇6000 5
95％乙醇 100。
进一步的，所述步骤S6中包衣锅转速2～5转/分钟；热风温度60～90℃；喷雾速度180～320ml/分钟。
进一步的，所述步骤S6中包衣液的加入量为：1kg乌贝颗粒，包衣液为130ml。
本发明有效利用海螵蛸粉和浙贝母粉的协同作用，对胃溃疡和十二指肠溃疡有显著疗效。
浙贝母是百合科多年生草本植物浙贝母的地下鳞茎。因主产于浙江而得名，故简称浙贝。因其原产于浙江象山，故又称为象贝母，简称象贝。因其外形较川贝大，故又称为大贝母，简称大贝。在江苏、安徽、湖南等地也有出产。浙贝味苦而性寒，入心肺经，功能解毒，临床常与元参、牡蛎、蒲公英、天花粉、连翘、薏苡仁、鱼腥草、鲜芦根、夏枯草、海藻、昆布、莪术等配伍用于痰热郁肺的咳嗽及痈毒肿痛、瘰疬未溃等病症的治疗；与乌贼骨、煅瓦楞子、白及、黄连、吴茱萸、竹茹、清半夏等药配伍可治胃痛、反酸、烧心。现代药理研究证实，浙贝母含有浙贝母碱等多种生物碱，浙贝母碱能缓解支气管平滑肌痉挛、减少支气管黏膜分泌、扩大瞳孔、降低血压、兴奋子宫等多种药理作用。
海螵蛸为乌贼科动物无针乌贼Sepiella maindroni deRoehebrune或金乌贼Sepia esculenta Hoyle的干燥内壳。分布于浙江、福建、山东等地。具有收敛止血，涩精止带，制酸止痛，收湿敛疮之功效。常用于吐血衄血，崩漏便血，遗精滑精，赤白带下，胃痛吞酸；外治损伤出血，湿疹湿疮，溃疡不敛。
陈皮是芸香科植物橘以及其栽培变种的成熟干燥果皮，主要分布在广东、广西、湖南、四川、重庆、江西、福建等地，具有理气健脾、燥湿化痰等多种生理功效。陈皮主要含有挥发油类和黄酮类成分，而多甲氧黄酮是甲氧基数等于或大于4的黄酮类物质，是芸香科柑橘属植物的主要化学成分之一。陈皮是我国的传统中药材之一,有着悠久的食用及药用历史,兼具药食两用特色。陈皮挥发油具有行气、祛痰、平喘等作用,其主要成分是柠檬烯,具有理气、消炎、抗菌、镇咳、止痛、溶解胆固醇结石等作用。陈皮中主要含有挥发油、黄酮苷、多甲氧基黄酮和少量生物碱等成分。通过GC-MS对陈皮挥发油进行研究,发现油中主要成分为D-柠檬烯,α-蒎烯、β-蒎烯、β-月桂烯、4-间-散花烃、γ-松油烯等。
本发明所述制备乌贝颗粒的方法，其操作简单，可以大规模生产。本发明所述的乌贝颗粒外观为类白色或微黄色颗粒，味微苦，易于携带；具有制酸止痛，收敛止血的功效，能够用于治疗胃溃疡和十二指肠溃疡。其对胃溃疡、十二指肠溃疡的治疗效果显著。
具体实施方式
所举实施例是为了更好地对本发明的内容进行说明，但并不是本发明的内容仅限于所举实施例。熟悉本领域的技术人员根据上述发明内容对实施方案进行非本质的改进和调整，仍属于本发明的保护范围。生产前检查和生产后清场按《生产前检查和确认标准管理规程》、《预处理车间提取岗位标准操作规程》、《清场标准管理规程》执行。
实施例1
本发明一种乌贝颗粒，由以下质量份的各组分组成：
实施例2
本发明一种乌贝颗粒，由以下质量份的各组分组成：
实施例3
本发明一种乌贝颗粒，由以下质量份的各组分组成：
实施例1-3的制备方法，包括以下步骤：
S1、海螵蛸粉制备：将净药材的海螵蛸置于不锈钢盆内用水刷洗后置浸泡池浸泡12小时，将浸泡洗后的海螵蛸置于70～80℃烘箱干燥，经粉碎为20级，过100目筛，然后在105℃灭菌50分钟，(F0≥6)，干燥1小时；备用；
S2、浙贝母粉制备：将浙贝母拣选，弃除异物和霉变、虫蛀部分，然后用流动饮用水洗净、沥干，置于70～80℃烘箱干燥，经粉碎为12级，过100目筛，然后在105℃灭菌50分钟，(F0≥6)，干燥80分钟；备用；
S3、湿颗粒制备：将海螵蛸粉、浙贝母粉、糊精加入湿法混合制粒机，低速混合3分钟，加入陈皮油后再低速混合3分钟后，加入50～60℃的38％单糖浆，开启切割刀高速混合制粒5分钟；再用14目尼龙筛网经YK-160摇摆式颗粒机制粒，得到水分≤4.5％的湿颗粒；
S4、干燥：将湿颗粒均匀摊至不锈钢烘盘中，送入CTC-IV热风循环烘箱干燥，干燥温度60～80℃，干燥时间5～6小时；
S5、过筛，选取合格颗粒：选取能通过10目筛不能通过60目筛的合格颗粒；
S6、包衣：将步骤S5得到的合格颗粒置于包衣锅中进行包衣，及得到本发明的乌贝颗粒。
其中，包衣液由已下质量份的各物质组成：
聚丙烯酸树脂Ⅳ 10
聚乙二醇6000 5
95％乙醇 100。
包衣锅转速2～5转/分钟；热风温度60～90℃；喷雾速度180～320ml/分钟。
包衣液的加入量为：1kg乌贝颗粒，包衣液为130ml。
药效测试：
选取150名胃溃疡和十二指肠溃疡患者，随机分为5组，每组30人，1、2、3组患者分别服用实施例1-3制备的乌贝颗粒，一次4克，一日三次；第4组服用市售西药，第5组服用市售中药，均按使用说明计量服用，将患者服药后状态记录如下：
痊愈：临床症状消失，停药三个月未见复发；
有效：症状减轻，但未完全好转；
无效：症状无明显改变。
从上述检测结果可知，本发明乌贝颗粒对治疗胃溃疡和十二指肠溃疡有显著疗效。
以上所述仅为本发明的优选实施例而已，并不用于限制本发明，对于本领域的技术人员来说，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
Claims (9)
1.一种乌贝颗粒，由以下质量份的各组分组成：
2.根据权利要求1所述的乌贝颗粒，其特征在于：所述乌贝颗粒由以下质量份的各组分组成：
3.根据权利要求1或2所述的乌贝颗粒的制备方法，包括以下步骤：
S1、海螵蛸粉制备：将净药材的海螵蛸置于不锈钢盆内用水刷洗后置浸泡池浸泡12小时，将浸泡洗后的海螵蛸置于70～80℃烘箱干燥，经粉碎，过100目筛，然后在105℃灭菌50分钟，(F0≥6)，干燥1小时；备用；
S2、浙贝母粉制备：将浙贝母拣选，弃除异物和霉变、虫蛀部分，然后用流动饮用水洗净、沥干，置于70～80℃烘箱干燥，经粉碎，过100目筛，然后在105℃灭菌50分钟，(F0≥6)，干燥80分钟；备用；
S3、湿颗粒制备：将海螵蛸粉、浙贝母粉、糊精加入湿法混合制粒机，低速混合3分钟，加入陈皮油后再低速混合3分钟后，加入50～60℃的38％单糖浆，开启切割刀高速混合制粒5分钟；再用14目尼龙筛网经YK-160摇摆式颗粒机制粒，得到湿颗粒；
S4、干燥：将湿颗粒均匀摊至不锈钢烘盘中，送入CTC-IV热风循环烘箱干燥，干燥温度60～80℃，干燥时间5～6小时；
S5、过筛：选取合格颗粒：选取能通过10目筛不能通过60目筛的合格颗粒；
S6、包衣：将步骤S5得到的合格颗粒置于包衣锅中进行包衣，及得到本发明的乌贝颗粒。
4.根据权利要求3所述的乌贝颗粒的制备方法，其特征在于：所述步骤S1中海螵蛸粉碎等级为20级。
5.根据权利要求3所述的乌贝颗粒的制备方法，其特征在于，所述步骤S2中浙贝母粉碎等级为12级。
6.根据权利要求3所述的乌贝颗粒的制备方法，其特征在于，所述步骤S4中干燥后颗粒水分≤4.5％。
7.根据权利要求3-6中任一项所述的乌贝颗粒的制备方法，其特征在于，所述步骤S6中包衣液由已下质量份的各物质组成：
聚丙烯酸树脂Ⅳ 10
聚乙二醇6000 5
95％乙醇 100。
8.根据权利要求7所述的乌贝颗粒的制备方法，其特征在于，所述步骤S6中包衣锅转速2～5转/分钟；热风温度60～90℃；喷雾速度180～320ml/分钟。
9.根据权利要求7所述的乌贝颗粒的制备方法，其特征在于，所述步骤S6中包衣液的加入量为：1kg乌贝颗粒，包衣液为130ml。
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