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雅祥三七杜仲胶囊

2018-01-09 22页 doc 97KB 59阅读

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雅祥三七杜仲胶囊雅祥三七杜仲胶囊 (一)、产品简介 (二)产品特点及功能主治 (三)适用人群 (四)用法用量 (五)、雅祥三七杜仲研发过程 【产品简介】 雅祥三七杜仲胶囊,由中华高血压康复慈善促进会联合凯普泰(北京)医药科技有限公司及国内外十几位知名医学专家经过多年对高血压患者临床观察,为增加高血压人群对适用保健食品的可选性,采用传统中药原料进行组方,发挥传统中药原料在降血压方面的优势,及中药原料的多靶点、多环节综合作用特点,从多方面、多途径、多角度对高血压进行调理、治疗,在改善高血压症状方面有自身的优势。 雅祥三七杜仲胶囊...
雅祥三七杜仲胶囊
雅祥三七杜仲胶囊 (一)、产品简介 (二)产品特点及功能主治 (三)适用人群 (四)用法用量 (五)、雅祥三七杜仲研发过程 【产品简介】 雅祥三七杜仲胶囊,由中华高血压康复慈善促进会联合凯普泰(北京)医药科技有限公司及国内外十几位知名医学专家经过多年对高血压患者临床观察,为增加高血压人群对适用保健食品的可选性,采用传统中药原料进行组方,发挥传统中药原料在降血压方面的优势,及中药原料的多靶点、多环节综合作用特点,从多方面、多途径、多角度对高血压进行调理、治疗,在改善高血压症状方面有自身的优势。 雅祥三七杜仲胶囊配方是综合传统中医药的保健理论和现代医药学对高血压发病机理的研究,选用具有调节血压、滋阴益肾、镇肝息风、活血化瘀作用的天connection: connecting two pieces of PVC pipe you want after removing the cutting burrs, evenly coated with special PVC glue, inserted in a sleeve, inserted after a specified depth, gently twist the casing in order to distribute the adhesive evenly on the connecting surface of the casing. (3) construction of junction box: junction box should be strictly in accordance with the electric construction drawing accurately installed at the specified location, the error shall not exceed 2 cm, bottom box of the same indoor installation height difference should not be greater than 5 mm, side installation sockets of the same model of height difference is not more than 1 mm. Junction box fixed, lamp box nails nail directly on the template, conduit Circular box and pipe blocking strong cement mortar so as not to enter. 77 (86)-plastic junction box filled with foamed polystyrene Board, and a cross-shaped with two sets of wire fixing junction boxes, guarantees that it will not shift; junction box with cable pipe lock connection. (4) Concealed within the PVC line pipe in concrete floor surface should have a certain margin and 18th wire, PVC wire tube and floor surface reinforcement binding firm, lashing PVC wire casing joints before and after 100MM you must set a fixed point, the rest fixed spacing should not exceed 1.5 m. PVC conduit when laying in the shear walls and columns, should be as close to the outer surface cladding4.1.6.2 bracket and hanger installation requirements: used steel supports and hangers should be straight, no significant distortions. After cutting the length deviation 然植物杜仲、丹参、葛根、生地黄、三七、昆布为主要原料,利用中药天然独特的保健功效,调理、降低血压改善并发症。产品生产工艺科学合理,质量稳定、可控,为消费者提供了一个安全、有效、可靠、的保健食品,对于高血压人群的养生保健将起到重要的作用。 雅祥三七杜仲与其他同类保健食品相比,具有一定的综合优势。针对高血压及高血压引起的冠心病、心绞痛、心肌缺血、脑血栓、脑梗塞及心脑血管疾病症状有显著效果。 雅祥三七杜仲胶囊是国家食品药品监督管理局2010年最新批准的产品,也是中华高血压康复慈善促进会唯一指定针对高血压人群的保健品,更是高血压新老患者首选良方。 【雅祥三七杜仲胶囊——G6凝聚素】 雅祥凝集素,是从三七、杜仲等六味中药原料提取独有的-G6凝集素,不但含有植物凝集素的特性,同时具有恢复人体交感神经系统的调节功能,在稳定高血压及其并发症的改善上有着全新的突破。 突破一:活性动力因子修复血管内皮,持久平稳血压 雅祥G6凝聚素独含的3000道尔顿分子量的细胞活性酶进入血液循环系统,快速还原机体内的活性细胞,修复血管内皮,使血管弹性增强,恢复张力,血压持久平稳。 突破二:独有的植物活性肽 排纳补钾,自然降压。 G6凝聚素中的植物活性肽可以补充钾、镁、钙等离子,同时清理血管内的脂肪盐和血液垃圾,打通人体泄压通道,恢复自然降压机制。 突破三:独含的细胞活性酶清洁血管保护心脑肾。 雅祥G6凝聚素中独有的细胞活性酶,双重作用交感、副交感神经,让交感神经升压信息减弱、副交感神经降压作用增强,直至达到二者平衡,从根本上控制动脉硬化,保障心脑肾血氧供应。 突破四:(量子高频谐振技术)在零动力状态下,药效增强100倍。 雅祥G6凝聚素中具有的活性动力因子、植物活性肽及细胞活性酶通过量子“高频谐振”技术在零副作用及零级动力学的状态下,变成了比纳米更小的微粒,活性更高,药效更强,比原来药效提升100倍。 connection: connecting two pieces of PVC pipe you want after removing the cutting burrs, evenly coated with special PVC glue, inserted in a sleeve, inserted after a specified depth, gently twist the casing in order to distribute the adhesive evenly on the connecting surface of the casing. (3) construction of junction box: junction box should be strictly in accordance with the electric construction drawing accurately installed at the specified location, the error shall not exceed 2 cm, bottom box of the same indoor installation height difference should not be greater than 5 mm, side installation sockets of the same model of height difference is not more than 1 mm. Junction box fixed, lamp box nails nail directly on the template, conduit Circular box and pipe blocking strong cement mortar so as not to enter. 77 (86)-plastic junction box filled with foamed polystyrene Board, and a cross-shaped with two sets of wire fixing junction boxes, guarantees that it will not shift; junction box with cable pipe lock connection. (4) Concealed within the PVC line pipe in concrete floor surface should have a certain margin and 18th wire, PVC wire tube and floor surface reinforcement binding firm, lashing PVC wire casing joints before and after 100MM you must set a fixed point, the rest fixed spacing should not exceed 1.5 m. PVC conduit when laying in the shear walls and columns, should be as close to the outer surface cladding4.1.6.2 bracket and hanger installation requirements: used steel supports and hangers should be straight, no significant distortions. After cutting the length deviation 【产品成分】 三七、杜仲、丹参、葛根、生地黄、昆布、硬脂酸镁等名贵的优质药材。三七杜仲含有大量的活性氨基酸和蛋白质,能够补充人体所缺的营养成分促进血液循环,促进新陈代谢,改善人体的血压不平衡及高血压并发症,是一个天然无毒副作用的血压平衡剂,对于高血压人群的养生保健将起到重要的作用。 【雅祥三七杜仲胶囊提纯工艺】 雅祥三七杜仲胶囊产品配方主要是根据祖国医学对高血压的辩证论治、现代医学药理理论出发进行组方。祖国医学治疗“眩晕”症一般用滋阴益肾、镇肝息风、活血化瘀、调节血压来进行论治。 利用现代科技植物酶解技术,小分子提纯技术从六种中药中萃取的“雅祥G6凝集素”能够全方面,多途径、多角度的针对高血压及其并发症进行针对性调理,效果显著。 配方用量及提存方法主要参照《中华人民共和国药典》规定用量及配方原料复方制剂用量文献报道制定,另根据配方中诸原料整体发挥功效的作用,各原料用量相对《中华人共和国药典》规定用量进行了适当的调整,而且保健食品主要起改善、辅助治疗作用,长期食用安全是其主要特点,据此制定本产品原料用量,有效配伍和安全的用量上都符合保健食品配方的要求,且无配伍禁忌。 【雅祥三七杜仲的功能主治】 connection: connecting two pieces of PVC pipe you want after removing the cutting burrs, evenly coated with special PVC glue, inserted in a sleeve, inserted after a specified depth, gently twist the casing in order to distribute the adhesive evenly on the connecting surface of the casing. (3) construction of junction box: junction box should be strictly in accordance with the electric construction drawing accurately installed at the specified location, the error shall not exceed 2 cm, bottom box of the same indoor installation height difference should not be greater than 5 mm, side installation sockets of the same model of height difference is not more than 1 mm. Junction box fixed, lamp box nails nail directly on the template, conduit Circular box and pipe blocking strong cement mortar so as not to enter. 77 (86)-plastic junction box filled with foamed polystyrene Board, and a cross-shaped with two sets of wire fixing junction boxes, guarantees that it will not shift; junction box with cable pipe lock connection. (4) Concealed within the PVC line pipe in concrete floor surface should have a certain margin and 18th wire, PVC wire tube and floor surface reinforcement binding firm, lashing PVC wire casing joints before and after 100MM you must set a fixed point, the rest fixed spacing should not exceed 1.5 m. PVC conduit when laying in the shear walls and columns, should be as close to the outer surface cladding4.1.6.2 bracket and hanger installation requirements: used steel supports and hangers should be straight, no significant distortions. After cutting the length deviation 【主治功效】:降血压 、冠心病、脑中风、心肌缺血、心绞痛、脑梗塞等脑血管疾病。 三、适用人群 【各种高血压人群】: 1 、长期大量服用各种抗高血压药物,血压仍然不能降至正常值的高血压患者。 2 、长期服药肝脏受损或惧怕药物毒副作用的高血压患者。 3 、无法坚持长期按时按量服药,导致血压不能真正控制忽升忽降的高血压患者。 4 、单纯收缩期或舒张期高血压病患者(高压高或低压高)。 5 、有高血压病家族史及新发高血压病患者。 【高血糖、高血脂人】 四、用法用量: 【产品规格】:0.45g/粒×12粒/板×2板/盒×8盒 【服用周期】三个月为一周期、六个月为一个疗程 【服用方法及服用量】 口服,每日2次,每次3粒 五、高血压病的介绍 【高血压形成原理】: 首先,我们先抛弃任何病理性及并发症因素,我们从物理学角度来看高血压,根据流体力学的原理及压缩动力学原理,我把心脏和血管及毛细血管比喻成密封的压力循环系统,就是说人体是一台机器,心脏和血管就是润滑系统。 1、从最常见的肥胖者高血压说起,大胖脂肪过多,对血管造成一定的挤压,当管道被挤压以后,动力源需要加大动力才可能使原来的循环达到流通,动力源动力加大,管道压力也会随之加大,就形成了高压。 2、内部血液及其他疾病引起的血栓造成的,血液的新陈代谢,排出不够彻底,在管道内部形成污垢,对管道造成一定的堵塞,会使压力升高。 3、老年性管道硬化及疾病性硬化,管道打折硬化的话,会造成高压。 4、疾病性毛细血管堵塞和外伤性毛细血管堵塞,也是其中的因素之一。 connection: connecting two pieces of PVC pipe you want after removing the cutting burrs, evenly coated with special PVC glue, inserted in a sleeve, inserted after a specified depth, gently twist the casing in order to distribute the adhesive evenly on the connecting surface of the casing. (3) construction of junction box: junction box should be strictly in accordance with the electric construction drawing accurately installed at the specified location, the error shall not exceed 2 cm, bottom box of the same indoor installation height difference should not be greater than 5 mm, side installation sockets of the same model of height difference is not more than 1 mm. Junction box fixed, lamp box nails nail directly on the template, conduit Circular box and pipe blocking strong cement mortar so as not to enter. 77 (86)-plastic junction box filled with foamed polystyrene Board, and a cross-shaped with two sets of wire fixing junction boxes, guarantees that it will not shift; junction box with cable pipe lock connection. (4) Concealed within the PVC line pipe in concrete floor surface should have a certain margin and 18th wire, PVC wire tube and floor surface reinforcement binding firm, lashing PVC wire casing joints before and after 100MM you must set a fixed point, the rest fixed spacing should not exceed 1.5 m. PVC conduit when laying in the shear walls and columns, should be as close to the outer surface cladding4.1.6.2 bracket and hanger installation requirements: used steel supports and hangers should be straight, no significant distortions. After cutting the length deviation 5、机体病变性引起的,一部分高血糖患者,是因为消化系统太过亢奋,在肠胃方面有病变,在肠胃机体方面就会形成一定的血液循环堵塞,也会造成高压,这里只举一个例子。 6、心脏方面的先天及后天的缺失。 7、脑血管疾病引起的。 8、血液干涸造成的高压。 【高血压的分类】:从医学上来说,高血压分为原发性和继发性两大类。高血压是常见的心血管疾病,以体循环动脉血压持续性增高为主要表现的临床综合征。继发性高血压是继发于肾、内分泌和神经系统疾病的高血压,多为暂时的,在原发的疾病治疗好了以后,高血压就会慢慢消失。 雅祥三七杜仲胶囊研究机理 【雅祥研发背景】: 目前,国内市场上销售的辅助降血压的保健食品并不多,在维护人们的健康方面起到了一点的保健作用。目前我国已获批准文号的辅助降血压作用的保健产品有雪王山派藏丹胶囊、药植苑牌舒乐片、紫竹牌双清胶囊、长安长清牌颐养茶、蚁力神牌依欣胶囊、巨劲牌雅博宁胶囊、丹泽牌葛藜胶囊等,这类产品虽然有一定的调理血压的功能,但是效果并不理想,对高血压并发症的改善状况更是微乎其微。 多年来,国家政府有关职能部门一直组织大量人力和物力来进行高血压及其并发症的防治,各个科研机构也都在这方面投入了不少精力进行新产品的开发和研究。北京凯普泰生物医药科技有限公司无疑是这其中的佼佼者,从2001年开始北京凯普泰生物医药科技有限公司就在中华高血压康复慈善促进会的大力支持下,成立了十几人的专家小组,开始进行高血压产品的开发和研制,在经过了十年的刻苦钻研和不懈努力下,功夫不负有心人,终于从数千种中药材中,精心挑选出了对高血压及心脑血管作用显著的六种珍贵药材成分,杜仲,三七,生地黄,葛根,昆布,丹参作为基础组方,进行产品研发。 这六种成分在综合了传统中医药的保健理论和现代医药学对高血压发病机理的研究的基础上选取的,都具有滋阴益肾、镇肝息风、活血化瘀、调节血压的作用,配合使用恰好迎合了中药复方多途径,多靶点,多环节综合起效的特点,完全发挥了传统中药原料在治疗高血压方面的优势,可从多方面对高血压进行调理、治疗,在改善高血压及其并发症方面有着无可比拟的优势。 经过精确提纯的“雅祥三七杜仲胶囊”生产工艺科学合理,质量稳定、可控,为消费者提供了一个安全、有效、可靠的功能性保健产品,对于高血压人群的养生保健起到重要的作用。和其他同类保健食品相比,具有极强的综合优势。 connection: connecting two pieces of PVC pipe you want after removing the cutting burrs, evenly coated with special PVC glue, inserted in a sleeve, inserted after a specified depth, gently twist the casing in order to distribute the adhesive evenly on the connecting surface of the casing. (3) construction of junction box: junction box should be strictly in accordance with the electric construction drawing accurately installed at the specified location, the error shall not exceed 2 cm, bottom box of the same indoor installation height difference should not be greater than 5 mm, side installation sockets of the same model of height difference is not more than 1 mm. Junction box fixed, lamp box nails nail directly on the template, conduit Circular box and pipe blocking strong cement mortar so as not to enter. 77 (86)-plastic junction box filled with foamed polystyrene Board, and a cross-shaped with two sets of wire fixing junction boxes, guarantees that it will not shift; junction box with cable pipe lock connection. (4) Concealed within the PVC line pipe in concrete floor surface should have a certain margin and 18th wire, PVC wire tube and floor surface reinforcement binding firm, lashing PVC wire casing joints before and after 100MM you must set a fixed point, the rest fixed spacing should not exceed 1.5 m. PVC conduit when laying in the shear walls and columns, should be as close to the outer surface cladding4.1.6.2 bracket and hanger installation requirements: used steel supports and hangers should be straight, no significant distortions. After cutting the length deviation 【雅祥三七杜仲胶囊配方及配方依据】 雅祥三七杜仲胶囊之所以对高血压及其并发症有着其他保健类降压产品甚至药品都无可比拟的优势,与它六种成分对心脑血管独特的作用与原产地的特殊性是分不开的。 【雅祥三七杜仲中药成分分析】 杜仲: 杜仲,浑身都是宝,是人所共知的名贵中药材,具有神奇的保健治病作用,被人们誉为“植物黄金”。早在2000多年前,我国传统中医就视杜仲为"药之上品"。明代伟大的医药学家李时珍在其所著的"《本草纲目》称:杜仲补肝肾、强筋骨,补中益精气,久服可轻身、耐老。 上世纪50年代初,前苏联科研人员用杜仲皮提取液临床治疗证明:杜仲对医治"人类第一杀手"高血压病,具有效果好、作用时间长的神奇疗效,究其原因,杜仲中富含大量绿原酸、总黄酮等60多种天然活性物质。 三七: 三七又名田七,明代著名的药学家李时珍称其为“金不换”。 主要成分为三七总皂苷(PNS)、三七素、黄酮等,尤以三七总皂苷具有改善心肌缺血、降血脂、降血压、抗血栓、抗纤维化活性、降血糖、抗衰老增强免疫力和保肝利胆作用。是中药材中的一颗明珠,清朝药学著作《本草纲目拾遗》中记载:“人参补气第一,三七补血第一,味同而功亦等,故称人参三七,为中药中之最珍贵者。”扬名中外的中成药“云南白药”和“片仔黄”,即以三七为主要原料制成。 丹参: 丹参始载于《神农本草经》,列为上品,以后历代本草均有收载。丹参为唇形科植,是一种双子叶植物,生于山野阳处。多年生草本,高30,80厘米,表面是红砖色,根部是圆柱形稍弯曲,春、秋二季采挖,除去泥沙,干燥入药。主要生长在我国河南河北等地。 昆布: 昆布为海带科植物海带、或翅藻科植物昆布、裙带菜的叶状体。夏、秋采收,由海中捞出,晒干。富含多糖类成分藻胶酸和昆布素、甘露醇、无机盐、维生素C、蛋白质、脯氨酸等氨基酸。 葛根: 葛根,豆类科植物葛根的块根,无毒,生长在亚热带高山丛林中,人类保健食用历史源远流长,素有“南方人参”之称。中国卫生部1999年正式认定葛根为人类药食同源、药食两用植物。 connection: connecting two pieces of PVC pipe you want after removing the cutting burrs, evenly coated with special PVC glue, inserted in a sleeve, inserted after a specified depth, gently twist the casing in order to distribute the adhesive evenly on the connecting surface of the casing. (3) construction of junction box: junction box should be strictly in accordance with the electric construction drawing accurately installed at the specified location, the error shall not exceed 2 cm, bottom box of the same indoor installation height difference should not be greater than 5 mm, side installation sockets of the same model of height difference is not more than 1 mm. Junction box fixed, lamp box nails nail directly on the template, conduit Circular box and pipe blocking strong cement mortar so as not to enter. 77 (86)-plastic junction box filled with foamed polystyrene Board, and a cross-shaped with two sets of wire fixing junction boxes, guarantees that it will not shift; junction box with cable pipe lock connection. (4) Concealed within the PVC line pipe in concrete floor surface should have a certain margin and 18th wire, PVC wire tube and floor surface reinforcement binding firm, lashing PVC wire casing joints before and after 100MM you must set a fixed point, the rest fixed spacing should not exceed 1.5 m. PVC conduit when laying in the shear walls and columns, should be as close to the outer surface cladding4.1.6.2 bracket and hanger installation requirements: used steel supports and hangers should be straight, no significant distortions. After cutting the length deviation 地黄: 为玄参科植物,秋季采挖,除去芦头、须根及泥沙,鲜用;或将地黄缓缓烘焙至约八成干。前者习称“鲜地黄”,后者习称“生地黄”。 【雅祥三七杜仲胶囊原辅料的来源】 日照,温度,湿度,海拔,药材生长周期长短等等的不同,可以极大的影响药材的药效,可以说中药材的产地是决定药效的关键因素。为了保证雅祥三七杜仲胶囊对高血压极其并发症的治疗效果,保证产品的高纯度,高药效,雅祥三七杜仲胶囊对原材料的产地选择,采集时间,生长年份均有严格要求—— “植物黄金”——张家界野生杜仲: “金不换”——云南文山州野生三七 “中药之宝”——河南安阳野生丹参 “心脑血管卫士”——葛根 “海中仙草”——来自千米深海的野生昆布 “皇帝草”——野生地黄 【剂型选择、产品形态、工艺路线设计及工艺筛选研究】 1、产品形态与剂型选择 本产品使用原料为固体粉末,故选择胶囊剂型。其依据如下:固体剂型更易被患者接,物理、化学稳定:可掩盖原料的不适气味,外形光洁、美观;辅料用量少,生产工艺不复杂,可节约成本;与片剂、丸剂相比,胶囊制备时不加粘合剂和压力,食用后在胃肠道中崩解快,功效成分释放与吸收快,生物利用率高;能提高原料中各种成分的稳定性,光敏或热敏性成分可起到保护作用,使不受湿气、氧气及光线的影响;携带、运输、贮藏及服用均较为方便。 另外,经预试验雅祥胶囊中的活性成分G6凝集素在口腔中易被唾液分解,易吸入气管内,不宜足量的到达人体病变部位,这些成分装入胶囊,既保护了活性成分的药性不被破坏,也保护了消化器官和呼吸道。去掉胶囊壳就会造成活性成分流失、药物浪费、药效降低。另外,凝集素的活性成分需要在肠内溶解吸收,胶囊保护凝集素的活性成分中药物不被胃酸破坏;而胶囊进入人体内显效的速度又比片剂快,所以雅祥采用胶囊制剂。雅祥制成硬胶囊工艺科学、稳定性好,硬胶囊各指标都合格。 2、工艺路线设计的依据 connection: connecting two pieces of PVC pipe you want after removing the cutting burrs, evenly coated with special PVC glue, inserted in a sleeve, inserted after a specified depth, gently twist the casing in order to distribute the adhesive evenly on the connecting surface of the casing. (3) construction of junction box: junction box should be strictly in accordance with the electric construction drawing accurately installed at the specified location, the error shall not exceed 2 cm, bottom box of the same indoor installation height difference should not be greater than 5 mm, side installation sockets of the same model of height difference is not more than 1 mm. Junction box fixed, lamp box nails nail directly on the template, conduit Circular box and pipe blocking strong cement mortar so as not to enter. 77 (86)-plastic junction box filled with foamed polystyrene Board, and a cross-shaped with two sets of wire fixing junction boxes, guarantees that it will not shift; junction box with cable pipe lock connection. (4) Concealed within the PVC line pipe in concrete floor surface should have a certain margin and 18th wire, PVC wire tube and floor surface reinforcement binding firm, lashing PVC wire casing joints before and after 100MM you must set a fixed point, the rest fixed spacing should not exceed 1.5 m. PVC conduit when laying in the shear walls and columns, should be as close to the outer surface cladding4.1.6.2 bracket and hanger installation requirements: used steel supports and hangers should be straight, no significant distortions. After cutting the length deviation 据文献报道,杜仲中有多种活件成分都具有降压作用,临床和药理研究显示杜仲煎具有确切的降压作用;丹参中起降血压作用的主要是水溶性成分丹参素,又称丹参酸甲。丹参素能改善微循环、扩张血管,而且有很多降压产品对杜仲、丹参、生地黄的利用上也是采用水煎煮提取使用等;生地黄含苷类、梓醇、氨基酸以及环烯醚萜类化合物成分,研究发现地黄水提取物降血压作用明显强于乙醇、乙醚提取物:葛根中降血压的主要成分是其异黄酮类成分;三七起降血压作用的主要是三七总皂苷成分; 昆布中降血压成分可能主要是昆布氨酸,昆布氨酸是一种活性生物成分,可溶于热水,因此杜仲、丹参、葛根、生地黄、三七、昆布如果采用传统的水煎煮提取方式,可以保证普通药效的留存,但效果一般,根据上述各原料主要成分的化学性,发挥辅助降血压的主要功效成分的特性,并参考文献,本着既要确保功效成分的提取完全,又要节约能源、降低成本的原则,利用目前国际最先进的酶解技术可以有效的分离出杜仲、丹参、葛根、生地黄、三七、昆布中对高血压和心脑血管有益的成分,并保证其活性和纯度,再将酶解出的有益成分,利用小分子打碎技术进行融合而成的“植物凝集素”,可以使有益成分以极小分子存在,不仅便于人体吸收,切药效强大,将集合而成的“植物凝集素”粉末,填充胶囊,包装即可。 3、酶解提取工艺技术条件的研究 影响酶解工艺的主要因素有酶解纯度、提取时间以及提取次数等,以L9(34)正交试验表进行试验,确定最佳的提取工艺。以提取物于浸膏粉中总皂苷(以人参皂苷Re计)含量和出膏率为考查指标,试验取1/10的配方量原料进行试验。具体因素水平见下表。 F(0.1)=9, F(0.05)=19, F(0.01)=99 在酶解提取工艺中,出膏率高并不一定代表浸膏的有效成分含量高、提取效果好。因此,在酶解工艺考察试验中,以干浸膏中的有效成分含量为考察指标更有意义。通过直规分析,从极差R值大小显示,其影响因素作用主次关系分别为C>B>A,且AI>A3>A2、33>B2>BI、C2>C3>CI。从方差分析结果看,因素B、C为显著性因素。比较实际生产时间、本等具体因素,确定酶解的最佳工艺组合为AIB3C2。即杜仲、丹参、葛根、生地黄、三七、昆布用8倍量酶解2次为佳。 4、辅料、辅料用量制定 本品拟采用粉末直接填充胶囊,这样可以减少制粒、干燥、整粒等工序。根据原料浸膏提取物得率,另外考虑到辅料尽量少用的原则等因素,加入适当的润滑剂进行混昆合,再填充胶囊。试验方法:取配方量(1 000粒)杜仲、丹参、葛根、生地黄、三七、昆布干浸膏粉,加入硬脂酸镁混匀,逐渐加大硬脂酸镁用量,:考察混合粉的休止角,最终终确定硬脂酸镁的用量3g (0.67%)。硬脂酸镁是常用的辅料,食用安全,也是片剂、胶囊剂常用的润滑剂,加适量的硬脂酸镁,可有效改善填充时颗粒或粉末的流动性,减少装量差异。 5、装量规格制定 connection: connecting two pieces of PVC pipe you want after removing the cutting burrs, evenly coated with special PVC glue, inserted in a sleeve, inserted after a specified depth, gently twist the casing in order to distribute the adhesive evenly on the connecting surface of the casing. (3) construction of junction box: junction box should be strictly in accordance with the electric construction drawing accurately installed at the specified location, the error shall not exceed 2 cm, bottom box of the same indoor installation height difference should not be greater than 5 mm, side installation sockets of the same model of height difference is not more than 1 mm. Junction box fixed, lamp box nails nail directly on the template, conduit Circular box and pipe blocking strong cement mortar so as not to enter. 77 (86)-plastic junction box filled with foamed polystyrene Board, and a cross-shaped with two sets of wire fixing junction boxes, guarantees that it will not shift; junction box with cable pipe lock connection. (4) Concealed within the PVC line pipe in concrete floor surface should have a certain margin and 18th wire, PVC wire tube and floor surface reinforcement binding firm, lashing PVC wire casing joints before and after 100MM you must set a fixed point, the rest fixed spacing should not exceed 1.5 m. PVC conduit when laying in the shear walls and columns, should be as close to the outer surface cladding4.1.6.2 bracket and hanger installation requirements: used steel supports and hangers should be straight, no significant distortions. After cutting the length deviation 根据预试验中原料提取后干浸膏得率,拟加入适量的辅料及配方日食用量制定本品填充装量规格为0.45g,粒,每日食用2次,每次食用3粒。 【产品研发临床试食试验】: 因为所需时间长,耗费人力多,操作复杂等特点,一直只有OTC,国药准字,处方类药品才允许在三甲医院进行临床试验,目的是为了准确验证药品的疗效性,稳定性,安全性,被获准进行大规模临床试验的药品,必须经过极其严格的审核。保健食品因为对疾病治疗功能有限,一直被排除在临床检验之外。 由凯普泰(北京)医药科技有限公司与中华慈善促进会联合研制的高血压治疗新品【雅祥三七杜仲胶囊】因为对高血压及其并发症特殊的改善作用,经国家食品药品监督管理局特批在天津第三人民医院,广西壮族自治区等多家三甲级医院进行临床试验,这是国内首次开展的保健类产品人体试食试验。 在对有效的17560例符合要求的高血压受试者,经过9个月临床试食观察后,得出的结果令人振奋。在原服用降压药物种类和剂量不变的情况下,试食者按照要求服用。 鉴于【雅祥三七杜仲胶囊】的绝对安全性及对高血压各种症状的明显改善效果,2010年,经国家食品药品监督管理局正式批准为功能性高血压治疗产品,获准入市,具体批准文号为【20100594】。 【产品检验】 CNAS L1789 (广西壮族自治区卫生监测检验中心) 检 验 报 告 样 品 名 称:雅祥三七杜仲胶囊 样品受理编号:食 健20080086 样 品 批 号:20071015、20071018、20071020 受 检 单 位:凯普泰(北京)医药科技有限公司 样 品 性 状:胶囊 生 产 单 位:北京市恒通制药有限公司 样 品 数 量:0.45g/粒×12粒/板×2板/盒 送 检 单 位:凯普泰(北京)医药科技有限公司 ×90盒/批×3批,3kg 收 样 日 期:2008年6月3日 检 验 日 期:2008年7月3日 connection: connecting two pieces of PVC pipe you want after removing the cutting burrs, evenly coated with special PVC glue, inserted in a sleeve, inserted after a specified depth, gently twist the casing in order to distribute the adhesive evenly on the connecting surface of the casing. (3) construction of junction box: junction box should be strictly in accordance with the electric construction drawing accurately installed at the specified location, the error shall not exceed 2 cm, bottom box of the same indoor installation height difference should not be greater than 5 mm, side installation sockets of the same model of height difference is not more than 1 mm. Junction box fixed, lamp box nails nail directly on the template, conduit Circular box and pipe blocking strong cement mortar so as not to enter. 77 (86)-plastic junction box filled with foamed polystyrene Board, and a cross-shaped with two sets of wire fixing junction boxes, guarantees that it will not shift; junction box with cable pipe lock connection. (4) Concealed within the PVC line pipe in concrete floor surface should have a certain margin and 18th wire, PVC wire tube and floor surface reinforcement binding firm, lashing PVC wire casing joints before and after 100MM you must set a fixed point, the rest fixed spacing should not exceed 1.5 m. PVC conduit when laying in the shear walls and columns, should be as close to the outer surface cladding4.1.6.2 bracket and hanger installation requirements: used steel supports and hangers should be straight, no significant distortions. After cutting the length deviation 检验完成日期:2008年9月10号 检 测 项 目:毒理学安全性试验(包括小鼠急性经口毒性试验、Ames试验、小 鼠骨髓细胞微核试验、小鼠精子畸形试验、大鼠30天喂试验) 检 验 依 据:卫生部《保健食品检验与评价技术》(2003年版) 检验结论: 1(急性经口毒性试验:以最大给药量(剂量为30000 mg/kg BW)的样品给予小鼠灌胃后,》未见动物有中毒症状,无动物死亡,试验结束解剖动物,大体观察未见异常,急性经口毒性属无毒级。 2. 遗传毒性试验:三项遗传毒性试验(Ames、小鼠骨髓细胞微核试验、小鼠精子畸形试验)结果均为阴性。 3. 30天喂养试验:以4500、3375、2250 mg/kg BW(分别相当于人体推荐 用量100、75、50倍)3个剂量的样品连续给大鼠灌胃30天,实验期间动物的生长发育良好,各剂量组的动物体重、增重量、进食量、食物利用率、血常规指标、血生化指标、脏器重量及脏器,体重比值与对照组比较,均无显著性差异(P>0.05);大体解剖观察和组织病理学检查未见与样品有关的异常改变。提示未见该样品30天喂养对大鼠有毒性作用。 connection: connecting two pieces of PVC pipe you want after removing the cutting burrs, evenly coated with special PVC glue, inserted in a sleeve, inserted after a specified depth, gently twist the casing in order to distribute the adhesive evenly on the connecting surface of the casing. (3) construction of junction box: junction box should be strictly in accordance with the electric construction drawing accurately installed at the specified location, the error shall not exceed 2 cm, bottom box of the same indoor installation height difference should not be greater than 5 mm, side installation sockets of the same model of height difference is not more than 1 mm. Junction box fixed, lamp box nails nail directly on the template, conduit Circular box and pipe blocking strong cement mortar so as not to enter. 77 (86)-plastic junction box filled with foamed polystyrene Board, and a cross-shaped with two sets of wire fixing junction boxes, guarantees that it will not shift; junction box with cable pipe lock connection. (4) Concealed within the PVC line pipe in concrete floor surface should have a certain margin and 18th wire, PVC wire tube and floor surface reinforcement binding firm, lashing PVC wire casing joints before and after 100MM you must set a fixed point, the rest fixed spacing should not exceed 1.5 m. PVC conduit when laying in the shear walls and columns, should be as close to the outer surface cladding4.1.6.2 bracket and hanger installation requirements: used steel supports and hangers should be straight, no significant distortions. After cutting the length deviation
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