CN107375840A - 一种防治银屑病口服液及其制备工艺 - Google Patents
一种防治银屑病口服液及其制备工艺 Download PDFInfo
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- CN107375840A CN107375840A CN201710651370.5A CN201710651370A CN107375840A CN 107375840 A CN107375840 A CN 107375840A CN 201710651370 A CN201710651370 A CN 201710651370A CN 107375840 A CN107375840 A CN 107375840A
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- diacolation
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- oral liquid
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Abstract
本发明一种防治银屑病口服液及其制备工艺,由防治银屑病口服液配方制定、原材料采购、原材料加工、原材料中药材饮片有效成分提取、配制罐装、包装等工序加工完成;防治银屑病口服液配方制定:生地30克、莪术10克等8种,蜂蜜与蒸馏水用量,按5∶5容积计量,防腐剂用量0.1%,75%乙醇溶剂与中药材饮片总量的采购比例为2∶1;原材料中药材饮片有效成分提取,采用本申请人设计、申请的发明专利(申请日2017年7月3日)“中草药成分套装圆筒电动循环自动过滤渗漉提取装置”进行渗漉提取,提取液加辅料混合搅拌均匀,用200毫升容积口服液瓶进行罐装、包装,口服每次20毫升,一日两次。
Description
技术领域
本发明一种防治银屑病口服液及其制备工艺涉及皮肤病防治领域,尤其涉及一种防治银屑病与肿瘤预防口服液制备工艺。
背景技术
银屑病是一种弥漫性、迁延性、顽固性慢性皮肤病,反复发作,号称不死的癌症,病因不清,有遗传、血液(血毒、血热、血瘀、血燥)、内分泌、炎症、病毒、免疫、精神、情绪、环境、细胞增殖异常等多种说法,治疗方法因医生认知不同而成百上千种,造成患者治疗费用有多没少,患者精神压力亦是重如泰山,生活极为不便。目前银屑病治疗药品种类繁多,新药研发夜以继日,中药西药你追我赶,国内国外投资巨大,治疗方法也是技术多样,日新月异,在银屑病治疗方面,中国中医有着悠久的历史,发挥独特的作用,除中药汤剂外,已涌现出一大批银屑病治疗中成药注射剂、片剂、汤剂、冲剂、散剂、胶囊剂、糖浆、各种外涂剂、泡浴剂、熏蒸剂、药酒等,效果不一。银屑病口服液具有银屑病治疗作用、抗肿瘤作用、补血滋阴作用、清热燥湿作用、清热解毒作用、清热泻火、灭菌止痒作用、化瘀消斑作用、增强免疫作用等多种功能。本发明一种防治银屑病口服液,对众多银屑病治疗保健药品与方法而言,也算是天上繁星一点,希望能对有些银屑病患者带来一缕署光。
发明内容
本发明的目的是,制作一种防治银屑病口服液,具有抗肿瘤、补血滋阴、清热燥湿、清热解毒、清热泻火、灭菌止痒、化瘀消斑、增强免疫多种功能,使患者发病部位起到治疗、保健作用,减轻患者精神负担,提高患者生活质量,给市场和患者提供一种新型治疗银屑病口服液制剂。
为了实现上述目的,本发明采用的技术方案是:一种防治银屑病口服液制备工艺,由口服液配方制定、原材料采购、原材料加工、原材料有效成分提取、口服液配制与灌装、与灌装口服液灭菌标签粘贴多道工序加工完成;防治银屑病口服液配方制定:生地30克、莪术10克、丹皮10克、赤芍10克、苦参10克、白鲜皮20克、蝉蜕5克、防风5克。蜂蜜与蒸馏水用量,按5∶5容积计量,防腐剂用量0.1%,75%乙醇溶剂与中药材饮片的比例2∶1;原材料采购:先确定防治银屑病口服液本批次总生产瓶数、每瓶容量、生产总容量、每瓶服用天数、服用总天数,再按配方计算出8种中药材饮片每天需用量,分品种进行采购,采购的各种中药材饮片必须符合每种中药材饮片的质量指标和规格标准,无霉变、无病虫害、无杂质、无污染;75%溶剂乙醇采购与中药材饮片总量采购比例为2∶1;原材料加工:除蜂蜜、防腐剂、蒸馏水外,对每种中药材饮片进行精选和晾晒,充分混合均匀后,先用10毫米粒径粉碎机粉碎,再用5毫米粒径粉碎机粉碎备用;原材料中药材饮片有效成分提取,采取醇提水沉法进行,采用本申请人设计、申请的发明专利(申请日2017年7月3日)“中草药成分套装圆筒电动循环自动过滤渗漉提取装置”进行渗漉提取;该装置由渗漉提取装置支架、套装圆筒渗漉装置、电泵循环渗漉装置、渗漉溶液自动过滤装置、自动控温热水循环加热装置、渗漉溶剂蒸发分离装置、渗漉溶剂冷凝回收装置七部分组成;该渗漉提取装置操作工艺流程为:①关闭渗漉溶液控制阀-→打开加料密封盖-→计量原料装入内筒-→分层装入虚实均匀-→加入渗漉溶剂淋入圆槽-→圆槽中缓慢加入渗漉溶剂-→溶剂均匀淋入原料-→压住圆槽不要浮起-→溶剂加至不再淋入距圆槽底5厘米止-→将密封盖中部圆孔旋转至淋入圆槽内边-→开启渗漉溶液循环泵-→调节渗漉溶液循环阀不使渗漉溶液溢出止-→关闭渗漉溶液循环泵-→关闭加料密封盖穿入螺丝拧紧-→静置渗漉36小时-→开启渗漉溶液循环泵循环渗漉36小时-→关闭渗漉溶液循环泵-→打开渗漉溶液控制阀-→渗漉溶液经内筒筒底过滤网自动过滤-→经渗漉溶液控制阀-→渗漉溶液流入蒸发筒上部过滤网自然过滤-→过滤液流入渗漉溶液蒸发筒下部-→打开加料密封盖-→开启渗漉溶液循环泵-→确定内筒筒底过滤网是否过滤结束-→②结束过滤关闭渗漉溶液控制阀-→加入新渗漉溶剂-→进行二次循环渗漉提取(操作流程与第-次相同)-→二次循环渗漉提取完成后-→打开渗漉溶液控制阀-→二次渗漉溶液经内筒筒底过滤网自动过滤-→流入渗漉溶液蒸发筒上部过滤网自然过滤-→二次渗漉溶液流入渗漉溶液蒸发筒下部-→与第一次渗漉溶液混合-→③取出内筒倒出药渣清洗-→内筒重新放入外筒-→关闭渗漉溶液控制阀-→计量原料装入内筒-→进入下次渗漉提取程序-→二次渗漉溶液蒸发筒内部过滤网过滤结束-→④接通水源-→给热水箱、热水槽、冷凝器加水-→开启电磁灶给热水箱加热-→开启热水循环泵-→热水箱与热水槽热水开始循环-→给渗漉溶液蒸发筒加热-→⑤开启自动控温仪-→调节控温仪高温至90℃、低温至80℃-→热水槽水温升至90℃电磁灶自动关闭-→热水槽水温降至80℃电磁灶自动开启-→蒸发筒渗漉溶液溶剂蒸发-→溶剂蒸发汽体经汽体输送管-→⑥汽体送入冷凝器溶剂汽体汇集室-→溶剂汽体进入冷凝器螺旋形冷凝管冷凝为液体-→液体进入冷凝器冷凝溶剂收集室-→流入冷凝溶剂回收筒-→放入冷凝溶剂存储筒-→循环使用或存储-→⑦开启渗漉溶液蒸发筒下部阀门-→粗提取药放入存储筒-→预备水沉搅拌器-→水沉搅拌器加入占提取药60%的蒸馏水-→缓慢加入提取药快速搅拌-→搅拌均匀装入沉淀筒-→放入0--5℃冷柜或冷库低温沉淀-→沉淀完成倒出上清液-→得防治银屑病成品提取药。防治银屑病口服液成品药配制:粗成品药按容积计量后,从口服液总容量200升中减去,剩余容积量,按5∶5的比例计算出蜂蜜与蒸馏水加入容量,防腐剂按0.1%用量计算;备以300-400升不锈钢圆筒容器,将计量好的总提取药、蜂蜜、蒸馏水、防腐剂加入不锈钢圆筒容器,进行混合搅拌,搅拌时先低速搅拌,不断调节至高速搅拌,直至充分搅拌均匀。防治银屑病口服液灌装灭菌包装:将搅拌均匀的口服液成品加入灌装装置,用200毫升容量瓶进行口服液装瓶加盖,得防治银屑病口服液成品;将瓶装口服液成品经高温灭菌,粘贴标签,装盒装箱,入库保存销售。防治银屑病口服液服用:口服每次20毫升,1日两次。
据《中华本草》记载:生地为玄参科植物地黄的块根。含有多种甙类,其中主含环烯酰萜及其甙类,已分离得到:益母草甙即是筋骨草醇,桃叶珊瑚甙,梓醇,地黄甙,美利妥双甙,地黄素,洋丁香酚甙,异洋丁香酚甙,美利妥单甙,地黄氯化臭蚁醛甙,都桷子甙,筋骨草甙,6-O-E-阿魏酰筋骨草醇,焦地黄素,焦地黄内酯,6,8-二羟基草苁蓉内酯,梓醇甙元,梓醇甙元-α-L-呋喃阿拉伯糖甙即焦地黄甙A,格拉多甙,米欧波罗甙元等。又含葡萄糖胺,磷酸。又含葡萄糖胺,磷酸以及锰、铁、铜、镁、铝、硼、锶、锌等十余种无机元素[11]。苯甲酸,辛酸,苯乙酸,壬酸,癸酸,桂皮酸,3-甲氧基-4-羟基苯甲酸,月桂酸,肉豆蔻酸,十五碳酸,棕榈油酸,榈酸,十七碳酸,亚油酸,硬脂酸,十九碳酸,花生酸,二十一碳酸,花生酸,二十一碳酸,山嵛酸,其中亚油酸的含量最高,大于40%,其次为棕榈酸27%[12]。另含琥珀酸,β-谷甾醇,胡萝卜甙,5-羟甲基糠醛等成分以及腺甙,微量元素[18]等;莪术为姜科植物莪术、广西莪术和温郁金的根茎。含有莪术根茎含挥发油,油中主成分为莪术呋喃烯酮占44.93%,龙脑占4.28%,大牻牛儿酮占6.16%,还含蒎烯,樟烯,柠檬烯,1,8-按叶素,松油烯,异龙脑,丁香烯,姜黄烯,丁香烯环氧化物,姜黄酮,芳姜黄酮,莪术二酮以及莪术烯醇,异莪术烯醇等。另含二呋喃莪术烯酮,莪术二醇。又含抗氧化剂活性的姜黄素类化合物。广西莪术根茎含挥发油,油中主成分为龙脑占11.33%,莪术呋喃酮占9.92%,大牻牛儿酮占7.0%,莪术醇占4.15%,还含蒎烯,樟烯,柠檬烯,1,8-桉叶素,松油烯,异龙脑,松油醇,丁香烯,丁香油酚,姜黄烯,姜黄酮,芳姜黄酮,莪术二酮以及芳樟醇,β-及δ榄香烯,葎草烯,钓樟薁,异莪术烯醇等。又含桂莪术内酯谷甾醇,胡萝卜甙,棕榈酸,以及锌、铁、钛、镍、钡、锶、铅、镉、铜、铬、铝等微量元素。丹皮为芍药科植物牡丹的根皮。含有芍药甙,氧化芍药甙,苯甲酰芍药甙(,牡丹酚,牡丹酚甙,牡丹酚原甙,牡丹酚新甙,苯甲酰基氧化芍药甙,2,3-二羟基-4-甲氧基苯乙酮,3-羟基-4-甲氧基苯乙酮,1,2,3,4,6-五没食子酰基葡萄糖没食子酸等。赤芍为芍药科植物芍药、川芍药、草芍药、毛叶草芍药、美丽芍药、窄叶芍药和块根芍药的根。芍药甙,氧化芍药甙,苯甲酰芍药甙,白芍甙,芍药甙无酮,没食子酰芍药甙,β-蒎-10-烯基-β-巢菜甙,芍药新甙,芍药内酯,β-谷甾醇,胡萝卜甙。还从根的鞣质中分得1,2,3,6-四没食子酰基葡萄糖,6-五没食子酰基葡萄糖及相应的六没食子酰基葡萄糖和七没食子酰基葡萄糖等。又含右旋儿茶精及挥发油。挥发油主要含苯甲酸,牡丹酚及其他醇类和酚类成分共33个。川赤芍根含芍药甙,四川产品还含微量的苯甲酰芍药甙。草芍药根含芍药甙,北京地区产品还含氧化芍药甙和牡丹酚原甙。还含苯甲酸,挥发油,脂肪油,树脂,鞣质,糖,淀粉,粘液质,蛋白质等。美丽芍药根含芍药甙,氧化芍药甙,苯甲酰芍药甙,牡丹酚原甙。窄叶芍药根含芍药甙,苯甲酰芍药甙,氧化芍药甙,牡丹酚原甙,苯甲酸,水杨酸,没食子酸,β-香树脂醇,β-谷甾醇。还含挥发油及环烯醚萜类物质。块根芍药根含芍药甙、氧化芍药甙。苦参为豆科植物苦参的根。含有苦参碱,氧化苦参碱,N-氧化槐根碱、槐定碱,右旋别苦参碱,右旋异苦参碱,右旋槐花醇,槐花醇N-氧化物,左旋槐根碱,左旋槐胺碱,右旋-N-甲基金雀花碱,左旋臭豆碱,赝靛叶碱。根中还含多种黄酮类化合物:苦参新醇,苦参查耳酮,苦参查耳酮醇,苦参醇,新苦参醇,降苦参醇,异苦参酮,刺芒柄花素,苦参酮,降苦参酮,甲基苦参新醇C,1-山槐素,三叶豆紫檀甙及三叶豆紫檀甙丙二酸酯,苦参素,异脱水淫羊藿素,降脱水淫羊藿素,黄腐醇,异黄腐酸,木犀草素-7-葡萄糖甙。此外,根中还含有三萜皂甙:苦参皂甙,大豆皂甙以及醌类化合物:苦参醌。白鲜皮为芸香科植物白鲜和狭叶白鲜的根皮。含有补骨脂素,花椒毒素,东莨菪素,槲皮素,异槲皮素,根含白鲜碱,γ-崖椒碱,前茵芋碱,茵芋碱,白鲜明碱,胡芦巴碱,胆碱,O-乙基-降-白鲜碱,O-乙基-降-γ-崖椒碱,O-乙基-降-茵芋碱,异斑点沸林草碱,吴茱萸苦素,白鲜醇,娠烯酸酮,秦皮酮,黄柏酮,柠檬苦素,β-谷甾醇,莱油甾醇,皂甙等。狭叶白鲜根皮中含有秦皮酮,黄柏酮,柠檬苦素,柠檬苦素地奥酚及白鲜二醇。主治风热湿毒所致的风疹;湿疹;疥癣;湿热痹;蝉蜕为蝉科昆虫黑蚱羽化后的蜕壳。含有甲壳质,蝶啶类色素;异黄质喋呤,赤蝶呤,蛋白质,氨基酸,有机酸,酚类化合物。氨基酸的相对含量以丙氨酸,脯氨酸和天冬氨酸等最高;丝氨酸,苏氨酸,谷氨酸,β丙氨酸,酪氨酸和γ-氨基丁酸次之;异亮氨酸苯丙氨酸,亮氨酸较低;缬氨酸,鸟氨酸,蛋氨酸等量最低。并含可溶性钙。防风为伞形科植物防风的根。含有色酮类成分:防风色酮醇,4′-O-葡萄糖基-5-O-甲基齿阿密醇,3′-O-当归酰基亥酚,亥茅酚,3′-O-乙酰基亥茅酚,亥茅酚甙,5-O-甲基具阿米醇,升麻素,升麻素甙;香豆精类成分:香柑内酯,补骨脂素,欧前胡内酯,珊瑚菜素,德尔妥因,花椒毒素,川白芷内酯,东莨菪素,印度榅桲素;聚乙炔类成发:人参炔醇又称镰叶芹醇,镰叶芹二醇,防风酸性多糖;挥发油含数10种成分,能鉴定的共20种,含量较高的有辛醛,β-甜没药烯,壬醛,7-辛烯-4-醇,己醛,侧析烯和β-桉叶醇。还含β-谷甾醇,β-谷醇-β-D-葡萄糖甙,甘露醇,香草酸等。
本发明的有益效果是:上述8种中药材组方,生地具有滋阴清热;凉血补血、治疗肿瘤、肝炎、高血压、高血糖、骨质增生、关节炎、皮肤病、增强免疫等作用;莪术具有抗肿瘤作用、升高白细胞的作用、.抗菌作用、活血化瘀作用、保肝肾作用、抑制血小板聚集和抗血栓作用、抑制血小板聚集和抗血栓形成作用、抗炎作用等;丹皮具有清热凉血、活血化瘀,抗肿瘤、抗凝血、抗动脉硬化、降血压、降血脂、抗菌、抗炎、增强免疫等作用;赤芍具有抗肿瘤作用、抗血栓形成作用、抗血小板聚集作用、降血脂和抗动脉硬化作用、降血压作用、保肝作用、镇静和镇痛作用等;苦参具有抗肿瘤作用、升白细胞作用、扩张血管和对急性心肌缺血的保护作用;降压作用、平喘祛痰作用、安定作用、抗过敏作用、调节免疫作用、溃疡作用、抗炎作用、抗菌作用;治清热燥湿;祛风杀虫。主湿热泻痢;肠风便血;黄疸;小便不利;水肿;白鲜皮具有抗癌作用、抗心律失常、抗炎、清热燥湿;祛风止痒;解毒;蝉蜕具有抗肿瘤、调节免疫、抗过敏、镇静、宣散风热;透疹利咽;退翳明目;祛风止痉。治风热感冒;咽喉肿痛;咳嗽音哑;单板机疹不透;风疹瘙痒;防风具有祛风解表;胜湿止痛;解痉;止痒。治外感风寒;头痛身痛;风湿痹痛;骨节酸痛;腹痛泄泻;肠风下血;破伤风;风疹瘙痒;疮疡初起等。上述8种中药材饮片,具有抗肿瘤作用、补血滋阴作用、清热燥湿作用、清热解毒作用、清热泻火、灭菌止痒作用、化瘀消斑作用、增强免疫作用等多种功能。功效互补,作用广泛,按疗程常饮,再加上必要的体育锻炼,调节心理素质,一定能使银屑病患者起到治疗、保健作用,减轻患者精神负担,提高患者生活质量。
具体实施方式
具体实施例:
1、制定防治银屑病口服液配方为:生地30克、莪术10克、丹皮10克、赤芍10克、苦参10克、白鲜皮20克、蝉蜕5克、防风5克;蜂蜜与蒸馏水用量,按5∶5容积计量,防腐剂用量0.1%。
2、确定本批次防治银屑病口服液生产量为1000瓶,每瓶装200毫升,共需制备口服液总量为200升。
3、按本批次防治银屑病口服液生产量计算所需中药材饮片总量为500千克,按配方比例计算出8种中药材饮片采购量分别为;生地150千克、莪术50千克、丹皮50千克、赤芍50千克、苦参50千克、白鲜皮100千克、蝉蜕25千克、防风25千克,总量为500千克。蜂蜜与蒸馏水的比例为5∶5,等中药材有效成分提取完成后计量采购;防腐剂用量为0.1%,75%乙醇溶剂采购为中药材饮片总量的2倍,循环使用。
4、中药材饮片加工:对每种中药材饮片进行精选和晾晒,充分混合均匀后,先用6毫米粒径粉碎机粉碎,再用3毫米粒径粉碎机粉碎备用。
5、中药材饮片有效成分提取:采取醇提水沉法进行,采用本申请人设计、申请的发明专利(申请日2017年7月3日)“中草药成分套装圆筒电动循环自动过滤渗漉提取装置”进行渗漉提取;该装置由渗漉提取装置支架、套装圆筒渗漉装置、电泵循环渗漉装置、渗漉溶液自动过滤装置、自动控温热水循环加热装置、渗漉溶剂蒸发分离装置、渗漉溶剂冷凝回收装置七部分组成;该渗漉提取装置操作工艺流程为:①关闭渗漉溶液控制阀-→打开加料密封盖-→计量原料装入内筒-→分层装入虚实均匀-→加入渗漉溶剂淋入圆槽-→圆槽中缓慢加入渗漉溶剂-→溶剂均匀淋入原料-→压住圆槽不要浮起-→溶剂加至不再淋入距圆槽底5厘米止-→将密封盖中部圆孔旋转至淋入圆槽内边-→开启渗漉溶液循环泵-→调节渗漉溶液循环阀不使渗漉溶液溢出止-→关闭渗漉溶液循环泵-→关闭加料密封盖穿入螺丝拧紧-→静置渗漉36小时-→开启渗漉溶液循环泵循环渗漉36小时-→关闭渗漉溶液循环泵-→打开渗漉溶液控制阀-→渗漉溶液经内筒筒底过滤网自动过滤-→经渗漉溶液控制阀-→渗漉溶液流入蒸发筒上部过滤网自然过滤-→过滤液流入渗漉溶液蒸发筒下部-→打开加料密封盖-→开启渗漉溶液循环泵-→确定内筒筒底过滤网是否过滤结束-→②结束过滤关闭渗漉溶液控制阀-→加入新渗漉溶剂-→进行二次循环渗漉提取(操作流程与第-次相同)-→二次循环渗漉提取完成后-→打开渗漉溶液控制阀-→二次渗漉溶液经内筒筒底过滤网自动过滤-→流入渗漉溶液蒸发筒上部过滤网自然过滤-→二次渗漉溶液流入渗漉溶液蒸发筒下部-→与第-次渗漉溶液混合-→③取出内筒倒出药渣清洗-→内筒重新放入外筒-→关闭渗漉溶液控制阀-→计量原料装入内筒-→进入下次渗漉提取程序-→二次渗漉溶液蒸发筒内部过滤网过滤结束-→④接通水源-→给热水箱、热水槽、冷凝器加水-→开启电磁灶给热水箱加热-→开启热水循环泵-→热水箱与热水槽热水开始循环-→给渗漉溶液蒸发筒加热-→⑤开启自动控温仪-→调节控温仪高温至90℃、低温至80℃-→热水槽水温升至90℃电磁灶自动关闭-→热水槽水温降至80℃电磁灶自动开启-→蒸发筒渗漉溶液溶剂蒸发-→溶剂蒸发汽体经汽体输送管-→⑥汽体送入冷凝器溶剂汽体汇集室-→溶剂汽体进入冷凝器螺旋形冷凝管冷凝为液体-→液体进入冷凝器冷凝溶剂收集室-→流入冷凝溶剂回收筒-→放入冷凝溶剂存储筒-→循环使用或存储-→⑦开启渗漉溶液蒸发筒下部阀门-→粗提取药放入存储筒-→预备水沉搅拌器-→水沉搅拌器加入占提取药60%的蒸馏水-→缓慢加入提取药快速搅拌-→搅拌均匀装入沉淀筒-→放入0--5℃冷柜或冷库低温沉淀-→沉淀完成倒出上清液-→得防治银屑病成品提取药。
6、防治银屑病口服液成品药配制:粗成品药按容积计量后,从口服液总容量200升中减去,剩余容积量,按5∶5的比例计算出蜂蜜与蒸馏水加入容量,防腐剂按0.1%用量计算;备以300-400升不锈钢圆筒容器,将计量好的总提取药、蜂蜜、蒸馏水、防腐剂加入不锈钢圆筒容器,进行混合搅拌,搅拌时先低速搅拌,不断调节至高速搅拌,直至充分搅拌均匀。
7、防治银屑病口服液灌装灭菌包装:将搅拌均匀的口服液成品加入灌装装置,用200毫升容量瓶进行防治银屑病口服液装瓶加盖;得防治银屑病口服液成品;将瓶装防治银屑病口服液成品经高温灭菌,粘贴标签,装盒装箱,入库保存销售。
8、防治银屑病口服液服用:口服每次20毫升,1日两次。
Claims (7)
1.一种防治银屑病口服液配方制定,其特征是:生地30克、莪术10克、丹皮10克、赤芍10克、苦参10克、白鲜皮20克、蝉蜕5克、防风5克。蜂蜜与蒸馏水用量,按5∶5容积计量,防腐剂用量0.1%,75%乙醇溶剂与中药材饮片的比例2∶1。
2.原材料采购,其特征是:先确定防治银屑病口服液本批次总生产瓶数、每瓶容量、生产总容量、每瓶服用天数、服用总天数,再按配方计算出8种中药材饮片每天需用量,分品种进行采购,采购的各种中药材饮片必须符合每种中药材饮片的质量指标和规格标准,无霉变、无病虫害、无杂质、无污染;75%溶剂乙醇采购与中药材饮片总量采购比例为2∶1。
3.原材料加工,其特征是:除蜂蜜、防腐剂、蒸馏水外,对每种中药材饮片进行精选和晾晒,充分混合均匀后,先用10毫米粒径粉碎机粉碎,再用5毫米粒径粉碎机粉碎备用。
4.原材料中药材饮片有效成分提取,采取醇提水沉法进行,采用本申请人设计、申请的发明专利(申请日2017年7月3日)“中草药成分套装圆筒电动循环自动过滤渗漉提取装置”进行渗漉提取;该装置由渗漉提取装置支架、套装圆筒渗漉装置、电泵循环渗漉装置、渗漉溶液自动过滤装置、自动控温热水循环加热装置、渗漉溶剂蒸发分离装置、渗漉溶剂冷凝回收装置七部分组成;该渗漉提取装置操作工艺流程为:①关闭渗漉溶液控制阀-→打开加料密封盖-→计量原料装入内筒-→分层装入虚实均匀-→加入渗漉溶剂淋入圆槽-→圆槽中缓慢加入渗漉溶剂-→溶剂均匀淋入原料-→压住圆槽不要浮起-→溶剂加至不再淋入距圆槽底5厘米止-→将密封盖中部圆孔旋转至淋入圆槽内边-→开启渗漉溶液循环泵-→调节渗漉溶液循环阀不使渗漉溶液溢出止-→关闭渗漉溶液循环泵-→关闭加料密封盖穿入螺丝拧紧-→静置渗漉36小时-→开启渗漉溶液循环泵循环渗漉36小时-→关闭渗漉溶液循环泵-→打开渗漉溶液控制阀-→渗漉溶液经内筒筒底过滤网自动过滤-→经渗漉溶液控制阀-→渗漉溶液流入蒸发筒上部过滤网自然过滤-→过滤液流入渗漉溶液蒸发筒下部-→打开加料密封盖-→开启渗漉溶液循环泵-→确定内筒筒底过滤网是否过滤结束-→②结束过滤关闭渗漉溶液控制阀-→加入新渗漉溶剂-→进行二次循环渗漉提取(操作流程与第一次相同)-→二次循环渗漉提取完成后-→打开渗漉溶液控制阀-→二次渗漉溶液经内筒筒底过滤网自动过滤-→流入渗漉溶液蒸发筒上部过滤网自然过滤-→二次渗漉溶液流入渗漉溶液蒸发筒下部-→与第一次渗漉溶液混合-→③取出内筒倒出药渣清洗-→内筒重新放入外筒-→关闭渗漉溶液控制阀-→计量原料装入内筒-→进入下次渗漉提取程序-→二次渗漉溶液蒸发筒内部过滤网过滤结束-→④接通水源-→给热水箱、热水槽、冷凝器加水-→开启电磁灶给热水箱加热-→开启热水循环泵-→热水箱与热水槽热水开始循环-→给渗漉溶液蒸发筒加热-→⑤开启自动控温仪-→调节控温仪高温至90℃、低温至80℃-→热水槽水温升至90℃电磁灶自动关闭-→热水槽水温降至80℃电磁灶自动开启-→蒸发筒渗漉溶液溶剂蒸发-→溶剂蒸发汽体经汽体输送管-→⑥汽体送入冷凝器溶剂汽体汇集室-→溶剂汽体进入冷凝器螺旋形冷凝管冷凝为液体-→液体进入冷凝器冷凝溶剂收集室-→流入冷凝溶剂回收筒-→放入冷凝溶剂存储筒-→循环使用或存储-→⑦开启渗漉溶液蒸发筒下部阀门-→粗提取药放入存储筒-→预备水沉搅拌器-→水沉搅拌器加入占提取药60%的蒸馏水-→缓慢加入提取药快速搅拌-→搅拌均匀装入沉淀筒-→放入0--5℃冷柜或冷库低温沉淀-→沉淀完成倒出上清液-→得防治银屑病总提取药。
5.防治银屑病口服液成品药配制,其特征是:总提取药按容积计量后,从口服液总容量200升中减去,剩余容积量,按5∶5的比例计算出蜂蜜与蒸馏水加入容量,防腐剂按0.1%用量计算;备以300-400升不锈钢圆筒容器,将计量好的总提取药、蜂蜜、蒸馏水、防腐剂加入不锈钢圆筒容器,进行混合搅拌,搅拌时先低速搅拌,不断调节至高速搅拌,直至充分搅拌均匀。
6.防治银屑病口服液灌装灭菌包装,其特征是:将搅拌均匀的口服液成品加入灌装装置,用200毫升容量瓶进行口服液装瓶加盖,得防治银屑病口服液成品;将瓶装口服液成品经高温灭菌,粘贴标签,装盒装箱,入库保存销售。
7.防治银屑病口服液服用,其特征是:口服每次20毫升,1日两次。
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