CN108186968B - 温胃舒胶囊 - Google Patents
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Abstract
本发明涉及医药领域,尤其是一种温胃舒胶囊,为了解决现市面有售的温胃舒胶囊疗效一般的问题,提供一种温胃舒胶囊,包括囊剂、囊壳,囊剂:包括主料炙黄芪183g、党参183g、附片(黑顺片)150g、山药183g、白术(清炒)183g、肉桂90g、南山楂(炒)225g、陈皮150g、砂仁60g、肉苁蓉(酒蒸)183g、乌梅225g、补骨脂183g,辅料淀粉、滑石粉、二氧化硅;囊壳为硬胶囊壳,囊剂灌装在囊壳内,辅料淀粉210g、滑石粉2g、二氧化硅1g,囊壳外包附着粉末状胃肠促动药,胃肠促动药主料为多潘立酮,辅料淀粉,在胃肠促动药的外面包裹有软胶囊层,本发明相对于常规温胃舒胶囊效果更佳显著,疗效更好,患者也可以少吃药。
Description
技术领域
本发明涉及医药领域,尤其是一种温胃舒胶囊。
背景技术
根据法定标准依据:《中国药典》2015年版一部P1626页:
【处方】党参183g,炙黄芪183g,山药183g,白术(清炒)183g,乌梅225g,陈皮150g,附片(黑顺片)150g,肉桂90g,肉苁蓉(酒蒸)183g,南山楂(炒)225g,砂仁60g,补骨脂183g。
【制法】以上十二味,砂仁粉碎成细粉;其余党参等十一味加水煎煮二次,第一次1.5小时,第二次1小时,合并煎液,滤过,滤液静置,取上清液浓缩至相对密度为(70℃)的清膏,加入砂仁细粉与适量滑石粉、淀粉及二氧化硅,混匀,制成颗粒,干燥,装入胶囊,制成1000粒,即得。
【性状】本品为硬胶囊,内容物为棕黄色至棕褐色的细粉和颗粒;味微酸、苦。
【功能与主治】温中养胃,行气止痛。用于中焦虚寒所致的胃痛,症见胃脘冷痛、腹胀嗳气、纳差食少、畏寒无力;慢性萎缩性胃炎、浅表性胃炎见上述证候者。
【用法与用量】口服。一次3粒,一日2次。
【注意】胃大出血时禁用;忌食生冷、油腻及不宜消化的食物。
【规格】每粒装0.4g
【贮藏】密封。
现市面有售的温胃舒胶囊大多按上述处方制作,疗效一般。
发明内容
本发明要解决的技术问题是:为了解决现市面有售的温胃舒胶囊疗效一般的问题,提供一种温胃舒胶囊。
本发明解决其技术问题所采用的技术方案是:一种温胃舒胶囊,包括囊剂、囊壳,囊剂:包括主料炙黄芪183g、党参183g、附片(黑顺片)150g、山药183g、白术(清炒)183g、肉桂90g、南山楂(炒)225g、陈皮150g、砂仁60g、肉苁蓉(酒蒸)183g、乌梅225g、补骨脂183g,辅料淀粉、滑石粉、二氧化硅;囊壳为硬胶囊壳,囊剂灌装在囊壳内,辅料淀粉210g、滑石粉2g、二氧化硅1g,囊壳外包附着粉末状胃肠促动药,胃肠促动药主料为多潘立酮,辅料淀粉,在胃肠促动药的外面包裹有软胶囊层。
为达到最佳的疗效,胃肠促动药主料为多潘立酮10g,辅料淀粉90g。
本发明的另一种方案为,胃肠促动药外包裹糖包衣。
制作本发明的温胃舒胶囊包括以下步骤:
A.将温胃舒主料中炙黄芪、党参、附片(黑顺片)、山药、白术(清炒)、肉桂、南山楂(炒)、陈皮、肉苁蓉(酒蒸)、乌梅、补骨脂十一味饮片,加水煎煮两次,蒸汽压力0.10~0.25MPa,第一次加入水的质量为十一味饮片总质量的7倍,煎煮1.5小时,第二次加入水的质量为十一味饮片总质量的5倍,煎煮1小时,然后用120目纱绢过滤,滤液静置,吸取上清液转入外循环蒸发浓缩器中,外循环蒸发浓缩器控制真空度-0.06~-0.08MPa,蒸汽压力0.05~0.15MPa,温度65~72℃,浓缩至相对密度在70℃时为1.10~1.12后将料液转入减压浓缩罐中继续浓缩,浓缩至相对密度在70℃时为1.28~1.30,得浸膏重200g±5g;
B.将温胃舒主料中砂仁粉碎成细粉,转入二维运动混合机混合,混合8分钟后取样,检测合格后将砂仁细粉、淀粉、滑石粉、二氧化硅过筛,所有物料均过60目筛;
C.粉碎过筛后的砂仁细粉、淀粉、滑石粉、二氧化硅以及步骤A中所得浸膏平均分为6份,砂仁细粉每份10g,淀粉每份35g,滑石粉每份0.333g,二氧化硅每份0.167g,投入湿法混合制粒机操作,调节搅拌转速为150rpm,同时调节侧刀转速为1500rpm,搅拌15分钟;加入浸膏时搅拌速度先下调至80rpm、加浸膏结束后再调回至150rpm,侧刀搅拌速度为1500rpm,从加浸膏开始计时搅拌5分钟,得软材,接着将软材转移至摇摆式颗粒机,用12目筛制湿粒,湿粒转移至烘盘内进行干燥,干燥温度为80~85℃,干燥1小时后取出,置于快速整粒机中操作,用16目筛整粒后转移至穿流式烘箱中继续干燥,湿粒干燥时间为3小时,湿粒干燥完成后,转移至方锥混合机中混合8分钟,总混后的干颗粒称量,调整装量0.4g/粒,装填入空心囊壳中制成内胶囊备用;
D.胃肠促动药:多潘立酮10g粉末和辅料淀粉90g搅拌混合后充分研磨,过60目筛备用;
E.使用软胶囊灌装机在空心软胶囊中先加入步骤C中制得的内胶囊,接着在内胶囊与软胶囊层之间的空间内灌装0.1g/粒胃肠促动药,最后完成封装。
制作糖包衣温胃舒胶囊时:所述胃肠促动药包括主料多潘立酮10g粉末和辅料淀粉90g搅拌混合后充分研磨,过60目筛;称0.1g/粒胃肠促动药,在胃肠促动药上喷洒包衣液后均匀的包裹在内胶囊上,经干燥得温胃舒胶囊。
糖包衣的制作方法:称取包衣粉20g,加入270ml浓度为95%乙醇以及55ml纯水,搅拌机搅拌两小时,使包衣粉完全溶解和分散,制得包衣液。
本发明的有益效果是,本发明的温胃舒胶囊,对现有温胃舒胶囊做出改进,首先患者服药后5~10分钟内胃肠促动药开始溶解,让胃加快蠕动或恢复正常的蠕动速度,在患者服药后30~45分钟后按《中国药典》中记载配置的温胃舒胶囊开始溶解,此时患者肠胃蠕动有力,吸收温胃舒中的药物事半功倍,简单的说就是先激活患者胃肠活性,然后在吸收温胃药物,效果更佳显著,疗效更好,患者也可以少吃药。
具体实施方式
本发明的一种温胃舒胶囊,首先按《中国药典》2015年版一部P1626页温胃舒的处方党参183g,炙黄芪183g,山药183g,白术(清炒)183g,乌梅225g,陈皮150g,附片(黑顺片)150g,肉桂90g,肉苁蓉(酒蒸)183g,南山楂(炒)225g,砂仁60g,补骨脂183g,加入辅料淀粉210g、滑石粉2g、二氧化硅1g,混匀,制成颗粒,干燥,装入胶囊,制成1000粒,在内胶囊外先包裹一层胃肠促动药粉,最后用软胶囊包裹温胃舒胶囊和胃肠促动药粉,也可以在胃肠促动药上喷洒包衣液后均匀的包裹在内胶囊上,干燥后得本发明温胃舒胶囊。
具体生产:
内胶囊药剂制备:
一)领料、分料
A.按照批生产指令单领取饮片。
B.台秤的校准:
a.将台秤放置于平整、稳定的平面调水平。
b.用标准砝码进行校准。
c.将处方中除砂仁外其余11种饮片称重。
二)提取
A.将处方中炙黄芪、党参、附片(黑顺片)、山药、白术(清炒)、肉桂、南山楂(炒)、陈皮、肉苁蓉(酒蒸)、乌梅、补骨脂十一味饮片按《多功能提取罐标准操作规程》(SOP-P-2025)进行操作,加水煎煮二次,蒸汽压力0.10~0.25MPa;第一次加入7倍量水,煎煮1.5小时,第二次加入5倍量水,煎煮1小时,合并煎液;用120目纱绢过滤,滤液静置,吸取上清液转入外循环蒸发浓缩器中;加水量分别为十一味饮片总质量的7倍和5倍。
B.按照《外循环蒸发浓缩器标准操作规程》(SOP-P-2026)进行浓缩,控制真空度-0.06~-0.08MPa,蒸汽压力0.05~0.15MPa,温度65~72℃,浓缩至相对密度在70℃时为1.10~1.12后将料液转入减压浓缩罐中继续浓缩,按《减压浓缩罐标准操作规程》(SOP-P-2031)操作继续浓缩,浓缩至相对密度在70℃时为1.28~1.30,得浸膏重200g±5g。
三)粉碎混合
A.将处方中砂仁按《FWS-350风选式中草药微粉碎机标准操作规程》(SOP-P-2036)粉碎成细粉,转入二维运动混合机后按《EYH-300二维运动混合机标准操作规程》(SOP-P-2008)操作,混合8分钟后取样,检测合格后备用。
B.计算砂仁粉碎工序物料平衡率和粉碎工序收率;物料平衡限度范围97%-100%,收率限度范围96%-100%。
四)过筛
A.将砂仁细粉、淀粉、滑石粉、二氧化硅按《ZS-600振动筛标准操作规程》(SOP-P-2074)过筛,所有物料均过60目筛。
B.计算过筛工序物料平衡率和过筛工序收率;物料平衡限度范围97%-100%,收率限度范围96%-100%。
五)称量、分料
A.将粉碎过筛后的砂仁细粉、淀粉以及浸膏平均分为6份,砂仁细粉每份10g,淀粉每份35g,滑石粉每份0.333g,二氧化硅每份0.167g。
六)制粒、干燥、整粒、总混
A.将砂仁细粉10g、淀粉35g、滑石粉0.333g,二氧化硅0.167g投入湿法混合制粒机,按照《GHL-250型湿法混合制粒机标准操作规程》(SOP-P-2076)操作,调节搅拌转速为150rpm,同时调节侧刀转速为1500rpm,搅拌15分钟;加入浸膏时搅拌速度先下调至80rpm,加浸膏结束后再调回至150rpm,侧刀搅拌速度为1500rpm,从加浸膏开始计时搅拌5分钟,制成适宜软材。
B.将软材转移至摇摆式颗粒机,按《YK-160摇摆式颗粒机标准操作规程》(SOP-P-2005)用12目筛制湿粒。
C.将湿颗粒转移至烘盘内,按照《CTG-Z-Ⅱ穿流式烘箱标准操作规程》(SOP-P-2079)进行干燥,干燥温度为80~85℃。
D.颗粒干燥1小时后,取出,置KZL-200快速整粒机中按《KZL-200快速整粒机标准操作规程》(SOP-P-2180)操作,用16目筛整粒后转移至穿流式烘箱中继续干燥,湿颗粒干燥时间为3小时。
E.颗粒干燥完成后,转移至方锥混合机中,按《JFH1.5M3方锥混合机标准操作规程》(SOP-P-2081)混合8分钟。
F.总混后的干颗粒称量。
G.计算工序物料平衡率和工序收率;物料平衡限度范围95%-100%,收率限度范围94%-100%。
七)胶囊填充
A.领取计量盘、填充杆等部件,进行清洁消毒并干燥,干燥后安装。
B.按《NJP-2500C胶囊填充机标准操作规程》(SOP-P-2042)操作,调整装量0.4g/粒,将干颗粒装入空心胶囊中,制得内胶囊。
C.入罐备用。
胃肠促动药配置:
领料、分料、称重执行规程与内胶囊药剂制备相同,下文就不再详细说明;首先领取多潘立酮粉剂和辅料淀粉,研磨后过60目筛称得多潘立酮粉剂10g,淀粉90g,两者混合倒入搅拌机中低速搅拌2分钟高速搅拌1分钟如此循环10次后,取出备用。
本发明的软胶囊温胃舒制备方法:
市购符合医用标准的软胶囊壳,用软胶囊灌装机灌装,首先装入已经制备好的内胶囊,在内胶囊与软胶囊层之间加入0.1g胃肠促动药,最后封装,制得软胶囊温胃舒胶囊。
上述制成的软胶囊温胃舒胶囊针对是老胃病患者效果佳,软胶囊在患者服下10分钟左右溶解掉,内部的胃肠促动药为细小的粉末状,其次胃肠促动药调配完后没有进行干燥,含水量相对于经干燥工艺的胃肠促动药高,当进入胃液后迅速溶解吸收,作用于胃肠使胃肠蠕动增强,服药后45分钟左右硬胶囊壳崩解内部药物开始溶解,此时距离胃肠促动药生效30分钟左右,胃肠活性已经相当高,此时吸收内胶囊中的成分,事半功倍效果更佳。
本发明的糖包衣温胃舒制备方法:
市购符合医用标准的包衣粉,称取包衣粉20g,加入270ml浓度为95%乙醇以及55ml纯水,搅拌机搅拌两小时,使包衣粉完全溶解和分散,制得包衣液待用,包衣液根据厂商不同调配可能存在差异;取制备好的内胶囊,在内胶囊的硬胶囊壳外包裹0.1g的胃肠促动药,在胃肠促动药上均匀喷涂包衣液,喷涂后的药丸经过干燥处理后得本发明的糖包衣温胃舒胶囊;药丸的具体干燥时间根据包衣粉的不同以及喷涂量的不同也有所不同;在内胶囊的硬胶囊壳外包裹胃肠促动药的方法可以根据企业实际情况而有所改动,如可以选用专门植粉剂的设备执行,也可以先在硬胶囊壳外少量喷洒包衣液帮助包裹胃肠促动药。
上述制成的糖包衣温胃舒胶囊适用于胃肠功能差或是新胃病患者,0.1g/粒的胃肠促动药在被喷洒包衣液后大部分混合在了包衣液中,干燥后也就和包衣层混合在了一起,患者服下本胶囊,5分钟左右包衣层溶解,溶解时包裹在包衣层中的胃肠促动药也跟着一起释放,包衣层溶解完胃肠促动药也溶解完,相比上述软胶囊温胃舒中的胃肠促动药溶解过程更长释放更慢,其次胃肠促动药喷涂包衣层后进行干燥处理,吸收起来也比上述软胶囊温胃舒来的缓慢,患者胃肠负担更小;服药后30分钟左右硬胶囊壳崩解内部药物开始溶解,此时距离胃肠促动药生效25分钟左右,胃肠活性相对之前有所提高,此时吸收内胶囊中的成分,效果显著。
总的来说本发明的温胃舒首先帮助患者恢复或提高胃肠蠕动,提高后续对内胶囊中药剂的吸收;上述数值为制得1000粒本发明温胃舒的配方,制得1000粒为理想状态,即生产过程中没有破损没有不合品的出现,此配方可以按比例扩大或缩小生产规模。
以上述依据本发明的理想实施例为启示,通过上述的说明内容,相关工作人员完全可以在不偏离本项发明技术思想的范围内,进行多样的变更以及修改。本项发明的技术性范围并不局限于说明书上的内容,必须要根据权利要求范围来确定其技术性范围。
Claims (1)
1.一种温胃舒胶囊,其特征在于:包括囊剂、囊壳,囊剂:包括主料炙黄芪183g 、党参183g、黑顺片150g 、山药183g、清炒白术183g、肉桂90g、炒南山楂225g 、陈皮150g、砂仁60g、酒蒸肉苁蓉183g 、乌梅225g、补骨脂183g,辅料淀粉210g、滑石粉2g、二氧化硅1g;囊壳为硬胶囊壳,囊剂灌装在囊壳内制成内胶囊,囊壳外包附着粉末状胃肠促动药,在胃肠促动药上喷洒包衣液后均匀的包裹在内胶囊上;胃肠促动药主料为多潘立酮10g,辅料淀粉90g;
所述温胃舒胶囊由如下制备方法制得:
A.将温胃舒主料中炙黄芪、党参、黑顺片、山药、清炒白术、肉桂、炒南山楂、陈皮、酒蒸肉苁蓉、乌梅、补骨脂十一味饮片, 加水煎煮两次,蒸汽压力0.10~0.25MPa,第一次加入水的质量为十一味饮片总质量的7倍,煎煮1.5小时,第二次加入水的质量为十一味饮片总质量的5倍,煎煮1小时,用120目纱绢过滤,滤液静置后吸取上清液转入外循环蒸发浓缩器中,外循环蒸发浓缩器控制真空度-0.06~-0.08MPa、蒸汽压力0.05~0.15MPa、温度65~72℃,浓缩至相对密度在70℃时为1.10~1.12后将料液转入减压浓缩罐中继续浓缩,浓缩至相对密度在70℃时为1.28~1.30,得浸膏重200g±5g;
B.将温胃舒主料中砂仁粉碎成细粉,转入二维运动混合机混合,混合8分钟后取样,检测合格后将砂仁细粉、淀粉、滑石粉、二氧化硅过筛,所有物料均过60目筛;
C.粉碎过筛后的砂仁细粉、淀粉、滑石粉、二氧化硅以及步骤A中所得浸膏平均分为6份,砂仁细粉每份10g,淀粉每份35g,滑石粉每份0.333g,二氧化硅每份0.167g,投入湿法混合制粒机操作,调节搅拌转速为150rpm,同时调节侧刀转速为1500rpm,搅拌15分钟;加入浸膏时搅拌速度先下调至80rpm、加浸膏结束后再调回至150rpm,侧刀搅拌速度为1500rpm,从加浸膏开始计时搅拌5分钟,得软材,接着将软材转移至摇摆式颗粒机,用12目筛制湿粒,湿粒转移至烘盘内进行干燥,干燥温度为80~85℃,干燥1小时后取出,置于快速整粒机中操作,用16目筛整粒后转移至穿流式烘箱中继续干燥,湿粒干燥时间为3小时,湿粒干燥完成后,转移至方锥混合机中混合8分钟,总混后的干颗粒称量,调整装量0.4g/粒,装填入空心囊壳中制成内胶囊备用;
D.胃肠促动药:多潘立酮10g粉末和辅料淀粉90g搅拌混合后充分研磨,过60目筛;称0.1g/粒胃肠促动药,在胃肠促动药上喷洒包衣液后均匀的包裹在内胶囊上,经干燥得温胃舒胶囊;
所述包衣液的制备方法为:称取包衣粉20g,加入270ml浓度为95%乙醇以及55ml纯水,搅拌机搅拌两小时,使包衣粉完全溶解和分散,制得包衣液。
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