CN107495375A - 一种海藻胶为囊材的防治心脑血管疾病软胶囊制剂的制备方法 - Google Patents
一种海藻胶为囊材的防治心脑血管疾病软胶囊制剂的制备方法 Download PDFInfo
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Abstract
本发明所属保健食品研究开发技术领域。本发明涉及一种海藻胶为囊材的防治心脑血管疾病软胶囊制剂的制备方法。药物组成为西洋红参浸膏粉、黑木耳浸膏粉、大豆微米粉、苦杏仁微米粉、黑芝麻微米粉、海带微米粉、大枣微米粉、生姜微米粉,混合均匀,即为囊心物;囊材原辅料组成为琼脂、亚麻胶、海藻酸钠、乙基香兰醛、二氧化钛、丙三醇、山梨醇或木糖醇;将囊材原辅料放入去离子水中,在85‑90℃下进行溶胶;85‑90℃0.5个真空度下脱气10‑12分钟,成为囊材胶液;将囊材胶液制胶片,加入囊心物,通过压制法制备软胶囊制剂。本发明产品囊材具有延伸性、张力强、韧性好的特点;制剂具有防治心脑血管疾病、辅助抗癌、延年益寿的功能。
Description
技术领域:
本发明所属保健食品研究开发技术领域。本发明涉及一种海藻胶为囊材的防治心脑血管疾病软胶囊制剂的制备方法。本发明产品囊材具有延伸性、张力强、韧性好的特点;制剂具有防治心脑血管疾病、辅助抗癌、延年益寿的功能。
背景技术:
软胶囊(Soft Capsule)自1935年问世以来已成为目前临床应用最广泛的药用制剂之一。许多油状,液状甚至膏状原料药均可加工成软胶囊剂。世界各国已上市的各类软胶囊制剂多达数百种,其中包括VE软胶囊、月见草软胶囊、多烯康软胶囊、深海鱼油软胶囊等常用的品种和形形色色的保健品制剂软胶囊(如鱼肝油软胶囊、锯叶棕油软胶囊等等)。软胶囊与硬胶囊一样均使用药用明胶为主要原料。明胶来自动物屠宰后的副产品(主要是猪、牛、羊骨以及猪皮和牛皮)。但90年代以来英国发生了震惊世界的疯牛病事件从而波及到明胶市场。因为欧洲人喜食牛肉,故牛骨与牛皮是欧洲明胶工业的主要原料。由于公众对疯牛病的普遍担心与恐慌,一些环保组织(如绿色和平组织)开始抵制来自牛副产品的明胶。与此同时,信奉伊斯兰教的国家要求进口明胶必须是″清真″的(即不能掺杂有猪皮和猪骨提取的明胶)。但实际上对于明胶生产厂来说,由于从各地收购的动物骨大多混杂堆放在一起,很难彻底分开,故要求生产明胶的原料绝对符合″清真″要求恐怕操作难度较大。在这种情况下,一些伊斯兰国家也抵制明胶软胶囊制剂的进口。这就给传统的软胶囊制剂产业造成很大冲击。寻找非动物来源的明胶替代产品作为软胶囊辅料已成为当务之急。此外由于明胶属于蛋白类物质,吸湿性强,并能把吸收的水分转移给内部药物,使药品吸潮变质,导致质量不合格和有效期短。
琼脂,学名琼胶,英文名(agar),又名洋菜(agar-agar)、琼胶、石花胶,是植物胶的一种,常用海产的麒麟菜、石花菜、江蓠等制成,为无色、无固定形状的固体,溶于热水。在食品工业中应用广泛,亦常用作细菌培养基。
琼脂是由海藻中提取的多糖体,是目前世界上用途最广泛的海藻胶之一。它在食品工业、医药工业、日用化工、生物工程等许多方面有着广泛的应用,琼脂用于食品中能明显改变食品的品质,提高食品的档次。价格很高。其特点:具有凝固性,稳定性,能与一些物质形成络合物等物理化学性质,可用作增稠剂,凝固剂,悬浮剂,乳化剂,保鲜剂和稳定剂。广泛用于制造粒粒橙及各种饮料,果冻,冰淇淋,糕点,软糖,罐头,肉制品,八宝粥,银耳燕窝,羹类食品,凉拌食品等等.琼脂在化学工业,医学科研,可作培养基,药膏基及其他用途。
用藻类制成的琼脂是半透明、无定形的粉末、薄片或颗粒。加工生产主要分布在山东、辽宁、广东各省均有加工生产。琼脂外形有细条、长条、薄片、小块等几种不同形体,以细条为佳。国外产地为日本、朝鲜、新西兰、美国和俄罗斯。琼脂不溶于冷水,能吸收相当本身体积20倍的水。易溶于沸水,稀释液在42℃(108°F)仍保持液状,但在37℃凝成紧密的胶冻。琼脂为细胞壁的组成成分,含有复杂的碳水化合物、钙与硫酸盐。
琼脂的最有用特性是它的凝点和熔点之间的温度相差很大。它在水中需加热至95℃时才开始熔化,熔化后的溶液温度需降到40℃时才开始凝固,所以它是配制固体培养基的最好凝固剂。用琼脂配制的固体培养基,可用以进行高温培养而不熔化,在凝固之前接种时,也不致将培养物烫死。因此,琼脂是制备各种生物培养基中应用最广泛的一种凝固剂。琼脂的浓度,通常是液体培养基的1~1.5%。
亚麻胶亚麻胶是从油料作物亚麻籽(又名胡麻籽)中提取的一种新型食用胶。它是以多糖类物质和蛋白质为主要成分的天然高分子复合胶。
1亚麻胶的特性
a:外观特征亚麻胶为粉状,呈淡黄色,带有亚麻籽原色。
b:溶解性亚麻胶直接撒于水中,易吸水结团,如与糖、盐、蛋白、淀粉等物料混合后容易分散于水中,且在75℃的水中加热10分钟,可充分溶解,释放胶性。在具体应用中,亚麻胶随肉料的加热过程,即完成溶解过程,显示出各种性能。
c:亚麻胶溶液特性热溶打开后的亚麻胶溶液为淡黄色(允许有少量不溶物),呈现不符合牛顿力学规律的假塑性流体。口尝溶液感觉:清香、滑润、饱满、细腻、爽口。
2亚麻胶在肉类制品中的应用特性
亚麻胶在肉类制品中的添加量与卡拉胶等同。亚麻胶可斩拌、注射、搅拌、滚揉添加,可在低温肠中添加,也适合在高温肠中使用;可单独添加,也可与卡拉胶复配添加。
a:粘性、持水性常温下,1%亚麻胶溶液粘度在300厘泊以上。
它在肠体中的吸水比为1∶20,而且能保持强度,具有弹性。其特点是,肠体能长期存放而不释水,延长肉类产品的货架期、保质期。
b:乳化、保油性亚麻胶对脂肪有很好的乳化效果,是食用胶中乳化性最强的胶种之一。使用亚麻胶可增加肥肉用量,香而不腻。添加亚麻胶的肠体粘性好,不出油、外表清洁干燥。
c:口感、切片性亚麻胶能结合淀粉、蛋白和肉,形成自然的有机凝胶体。这个凝胶体有很好的弹性、切片性,明显减少淀粉感,增加嫩肉感,口感爽滑、不粘口。
d:增香添加亚麻胶的肠体能品出一种清香味,而且减少香精用量。
e:亚麻胶与其它胶的协同作用亚麻胶与卡拉胶的复配,使卡拉胶的凝胶韧性增大,且延长了持水时间,把两者的优势结合起来,做到优势互补。
f:亚麻胶的特异功能亚麻胶的抗冷冻和阻止淀粉回生的特异功能是目前所有食用胶中的最强者。总之,亚麻胶属于肉制品中降低成本、提高品质、理想的新型添加剂。
海藻多糖(海藻酸钠)是从褐藻类的海带或马尾藻中提取的一种多糖碳水化合物,是由d-L-甘露糖醛酸(M单元)与β-D-古罗糖醛酸(G单元)依靠1,4-糖苷键连接并由不同比例的GM、MM和GG片段组成的共聚物,是海藻酸衍生物中的一种,所以有时也称褐藻酸钠或海带胶和海藻胶。海藻多糖以其良好的生物降解性和生物相容性,而被广泛应用于化学、生物、医药、食品等领域。
随着人们对植物胶囊的了解,以及国内外公众用药理念的转变,将会使植物来源胶囊的市场需求迅速增长。同时由于植物胶囊不使用任何明胶,广大穆斯林患者可以放心装药服用,产品可以出口到广大伊斯兰国家及犹太教地区,将为国家创收外汇,提高了企业的经济效益。
1西洋参西洋参为五加科植物西洋参Panax quinquefolium L.的干燥根。甘、微苦,凉。归心、肺、肾经。补气养阴,清热生津。用于气虚阴亏,内热,咳喘痰血,虚热烦倦,消渴,口燥咽干。西洋参作为补气保健首选药材,可以促进血清蛋白合成、骨髓蛋白合成、器官蛋白合成等,提高机体免疫力,抑制癌细胞生长,有效抵抗癌症。西洋参有抗疲劳、抗氧化、抗应激、抑制血小板聚集、降低血液凝固性的作用,另外,对糖尿病患者还有调节血糖的作用。西洋参可以有效增强中枢神经,达到静心凝神、消除疲劳、增强记忆力等作用,可适用于失眠、烦躁、记忆力衰退及老年痴呆等症状。西洋参含人参皂苷Ro、Rb1、Rb2、Rc、Rd、Re、Rg1以及假人参皂苷F11(pseudoginsenosideF11),尚含精氨酸、天冬氨酸等18种氨基酸;又含挥发油、树脂等。动物实验表明对大脑有镇静作用,对生命中枢则有中度的兴奋作用。
西洋参中的单体皂苷Rb1,Rg2等都有极强的降血脂作用,故常服西洋参能有效降低血液粘稠度,降低血脂。而西洋参中的多糖成分对于降血糖和治疗肥胖有很大的疗效。
西洋参经选参,刷参,晾晒,蒸制,晾晒,干燥,下须,自然干燥工艺,可以加工为西洋红参。西洋红参含有抗癌活性成分。
2大豆大豆为Glycine max(L.)Merr)的种子,通称黄豆。大豆是豆类中营养价值最高的品种,在百种天然的食品中,它名列榜首,含有大量的不饱和脂肪酸,多种微量元素、维生素及优质蛋白质。大豆经加工可制作出很多种豆制品,是高血压、动脉硬化、心脏病等心血管病人的有益食品。大豆富含蛋白质,且所含氨基酸较全,尤其富含赖氨酸,正好补充了谷类赖氨酸的不足的缺陷,所以应以谷豆混食,使蛋白质互补。大豆味甘、性平,入脾、大肠经,能杀乌头、附子毒;具有健脾宽中,润燥消水、清热解毒、益气的功效;主治疳积泻痢、腹胀羸瘦、妊娠中毒、疮痈肿毒、外伤出血等。黄豆还能抗菌消炎,对咽炎、结膜炎、口腔炎、菌痢、肠炎有效。大豆中所含的铁,不仅量多,且容易被人体吸收,对生长发育的小孩子及缺铁性贫血病人很有益处。大豆中所富含的高密度脂肪,有助于去掉人体同多余的胆固醇,因此,经常食用可预防心脏病、冠状动脉硬化。大豆中所含的异黄酮能抑制一种刺激肿瘤生长的酶,阻止肿瘤的生长,防治癌症,尤其是乳腺癌、前列腺癌、结肠癌。大豆中所含的植物雌激素,可以调节更年期妇女体内的激素水平,防止骨骼中钙的流失,可以缓解更年期综合征,骨质疏松症。大豆对男性的明显益处是可以帮助克服前列腺疾病。大豆含植物性蛋白质,有“植物肉”的美称。人体如果缺少蛋白质,会出现免疫力下降、容易疲劳的症状。吃黄豆补蛋白,可避免吃肉胆固醇升高的问题。大豆富含大豆卵磷脂,它是大脑的重要组成成分之一。多吃黄豆有助预防老年痴呆症。此外,大豆卵磷脂中甾醇,可增加神经机能和活力。大豆卵磷脂还能促进脂溶性维生素的吸收,强健人体各组织器官。另外,它可以降低胆固醇,改善脂质代谢,预防和治疗冠状动脉硬化。大豆中的蛋白质,可以增加大脑皮层的兴奋和抑制功能,提高学习和工作效率,还有助于缓解沮丧、抑郁的情绪。大豆富含大豆异黄酮,这种植物雌激素能改善皮肤衰老,还能缓解更年期综合征。此外,日本研究人员发现,黄豆中含有的亚油酸可以有效阻止皮肤细胞中黑色素的合成。
3苦杏仁苦杏仁为蔷薇科植物山杏(苦杏)、西伯利亚杏(山杏)、东北杏或杏的干燥成熟种子。北方产的杏仁属于苦杏仁(又名北杏仁),带苦味,多作药用,具有润肺、平喘的功效,味苦,性微温;归肺、大肠经。降气止咳平喘,润肠通便。用于咳嗽气喘,胸满痰多,血虚津枯,肠燥便秘。
(1)润肺苦杏仁能止咳平喘,润肠通便,可治疗肺病、咳嗽等疾病。
(2)降低胆固醇苦杏仁还含有丰富的黄酮类和多酚类成分,这种成分不但能够降低人体内胆固醇的含量,还能显著降低心脏病和很多慢性病的发病危险。
(3)促进皮肤血液循环苦杏仁还有美容功效,能促进皮肤微循环,使皮肤红润光泽。
(4)抗肿瘤苦杏仁抗肿瘤作用主要是由于苦杏仁中含有一种生物活性物质--苦杏仁苷,可以进入血液专杀癌细胞,而对健康细胞没有作用,因此可以改善晚期癌症病人的症状,延长病人生存期。同时,由于含有丰富的胡萝卜素,因此可以抗氧化,防止自由基侵袭细胞,具有预防肿瘤的作用。
4黑芝麻黑芝麻为胡麻科、胡麻属植物脂麻(Sesamum indicum L.)的干燥成熟种子,含有大量的脂肪和蛋白质,还有糖类、维生素A、维生素E、卵磷脂、钙、铁、铬等营养成分。可以做成各种美味的食品。一般人均可食用。黑芝麻含有的多种人体必需氨基酸,在维生素E和维生素B1的作用参与下,能加速人体的代谢功能;黑芝麻含有的铁和维生素E是预防贫血、活化脑细胞、消除血管胆固醇的重要成分;黑芝麻中所含亚油酸可降低血中胆固醇含量。并有防治动脉硬化作用,有延年益寿的作用。中医中药理论认为,黑芝麻具有补肝肾、润五脏、益气力、长肌肉、填脑髓的作用,可用于治疗肝肾精血不足所致的眩晕、须发早白、脱发、腰膝酸软、四肢乏力、步履艰难、五脏虚损、皮燥发枯、肠燥便秘等病症,还具有滋润皮肤,乌发养颜的功效。黑芝麻所含有的卵磷脂是胆汁中的成分之一,如果胆汁中的胆固醇过高及与胆汁中的胆酸、卵磷脂的比例失调,均会沉积而形成胆结石,卵磷脂可以分解、降低胆固醇,所以卵磷脂可以防止胆结石的形成。还有健脑益智、延年益寿的作用。小孩吃了对身体增强免疫力。
5黑木耳黑木耳属担子菌纲,木耳目的食用真菌。主要生长在中国和日本。中国大部分是东北木耳和秦岭木耳。木耳蛋白质的含量是牛奶的六倍,钙、磷、铁纤维素含量也不少,此外,还有甘露聚糖、葡萄糖、木糖等醣类,及卵磷脂、麦角甾醇和维生素C等,木耳具有预防动脉粥样硬化的功效。蛋白质丰富,而且富含多种维生素和矿物质,特别是铁元素含量极高,每100克干木耳含铁达185毫克,是肉类的100倍。黑木耳是缺铁性贫血患者的极佳食品。黑木耳还有润肠解毒功能。黑木耳中的腺嘌呤核苷有显著的抑制血栓形成的作用,因此,还是中老年人的优良保健食品。黑木耳对胆结石、肾结石、膀胱结石、粪石等内源性异物也有比较显著的化解功能。黑木耳还含有多种矿物质,能对各种结石产生强烈的化学反应,剥脱、分化、侵蚀结石,使结石缩小,排出。黑木耳为补品,药力平缓,故只宜用于轻症、缓症或亚健康者的日常保健。
减轻动脉硬化木耳煎剂30g/kg,连续灌服20d,木耳多糖28mg/kg,连服8d,均可明显降低高脂血症大鼠血清三酰甘油(甘油三酯)和血清总胆固醇(TC)含量,提高血清高密度脂蛋白胆固醇(HDL-C)与总胆固醇比值,且有降胆固醇作用。木耳多糖180mg/kg灌服可防止高胆固醇引起的小鼠高胆固醇血症的形成。每日在喂胆固醇同时,加喂黑木耳2.5g/只,共90d,有降低兔血浆胆固醇、过氧化脂质(LPO)、血栓素A2(TXA2)的含量,提高前列环素/血栓素A2(PGI2/TXA2)比值,减轻动脉粥样硬化的作用。
延缓衰老作用每日给家兔黑木耳2.5g/只,共90d,可降低动脉粥样硬化家兔氧自由基,肝、心、脑组织脂褐质,血浆过氧化脂质,血浆胆固醇含量及减轻动脉粥样硬化病变的作用。提示黑木耳可能通过降血浆胆固醇,减少脂质过氧化产物脂褐质的形成,以维护细胞的正常代谢,显示有延缓衰老作用。运用化学发光分析法,研究了2.5%黑木耳水提取物50μl,800μl,1000μl对H2O2或由酶体系及非酶体系产生的超氧化物自由基(O-2)有清除作用,清除能力与用量之间呈量效关系,提示黑木耳水提取物中含有抗氧化作用的成分。黑木耳多糖100mg/kg,腹腔注射,连续7d,可使小鼠在水中平均游泳时间延长50.40%,有增强小鼠抗疲劳的能力;还能明显降低小鼠心肌组织脂褐质含量;能明显增加小鼠脑和肝组织中超氧化物歧化酶(SOD)的比活力;对小鼠离体脑中单胺氧化酶B(MAO-B)活性有明显抑制作用,抑制强度随浓度增加而加强,并能增加果蝇飞翔能力。黑木耳多糖能明显延长果蝇平均寿命,为对照组的1.26倍,口服黑木耳多糖40d后,果蝇脂褐质含量有所降低。
6海带海带,海藻类植物之一,是一种在低温海水中生长的大型海生褐藻植物,因其生长在海水,柔韧似带而得名。海带是一种营养价值很高的蔬菜,同时具有一定的药用价值。每百克干海带中含:粗蛋白8.2克,脂肪0.1克,糖57克,粗纤维9.8克,无机盐12.9克,钙2.25克,铁0.15克,以及胡萝卜素0.57毫克,硫胺素(维生素B1)0.69毫克,核黄素(维生素B2)0.36毫克,尼克酸16毫克,能发出262千卡热量。与菠菜、油菜相比,除维生素C外,其粗蛋白、糖、钙、铁的含量均高出几倍、几十倍。海带是一种含碘量很高的海藻,一般含碘3~5‰,多可达7~10‰。从中提制得的碘和褐藻酸,广泛应用于医药、食品和化工。碘是人体必须的元素之一,缺碘会患甲状腺肿大,多食海带能防治此病,还能预防动脉硬化,降低胆固醇与脂的积聚。食海带过多会诱发碘甲亢。碘剂虽能抑制甲状腺素的释放,但不能抑制甲状腺素的合成,故长期使用碘剂,于甲亢不利。海带中褐藻酸钠盐有预防白血病和骨痛病的作用;对动脉出血亦有止血作用,口服可减少放射性元素锶-90在肠道内的吸收。褐藻酸钠具有降压作用。海带淀粉具有降低血脂的作用。近年来还发现海带的一种提取物具有抗癌作用。海带甘露醇对治疗急性肾功能衰退、脑水肿、乙性脑炎、急性青光眼都有效。脾胃虚寒者少食用。
7大枣又名红枣、干枣、枣子,起源于中国,在中国已有八千多年的种植历史,自古以来就被列为“五果”(栗、桃、李、杏、枣)之一。大枣富含蛋白质、脂肪、糖类、胡萝卜素、B族维生素、维生素C、维生素P以及钙、磷、铁和环磷酸腺苷等营养成分。其中维生素C的含量在果品中名列前茅,有维生素王之美称。据国外的一项临床研究显示:连续吃大枣的病人,健康恢复比单纯吃维生素药剂快3倍以上。红枣所含有的环磷酸腺苷是人体细胞能量代谢的必需成分,能够增强肌力、消除疲劳、扩张血管、增加心肌收缩力、改善心肌营养,对防治心血管系统疾病有良好的作用;中医中药理论认为,红枣对慢性肝炎、肝硬化、贫血、过敏性紫癜等病症有较好疗效;红枣含有三萜类化合物及环磷酸腺苷,有较强的抗癌、抗过敏作用。
8生姜生姜生姜是姜科多年生草本植物姜(Zingiber officinale Roscoe)的新鲜根茎。生姜性温,具有温补脾胃、散寒解表、增加食欲,延缓衰老、止呕、止咳等功效。其特有的“姜辣素”能刺激胃肠黏膜,使胃肠道充血,消化能力增强,能有效地治疗吃寒凉食物过多而引起的腹胀、腹痛、腹泻、呕吐等。吃过生姜后,人会有身体发热的感觉,这是因为它能使血管扩张,血液循环加快,促使身上的毛孔张开,这样不但能把多余的热带走,同时还把体内的病菌、寒气一同带出。当身体吃了寒凉之物,受了雨淋或在空调房间里呆久后,吃生姜就能及时消除因肌体寒重造成的各种不适。生姜中含有多种活性成分,其中姜辣素有很强的抗自由基的作用,它比抗衰老的维生素E的功效还强。因此,常食生姜可及时清除人体内致衰老因子的自由基,还能去除因自由基作用而产生的老年斑。生姜中含有的水杨酸,能降血脂、降血压、防止血液凝固、抑制血栓形成。
发明内容:
1.一种海藻胶为囊材的防治心脑血管疾病软胶囊制剂的制备方法,其特征在于包括以下步骤:
(1)囊心物原料组成及重量为西洋红参6-9g、黑木耳3-6g、大豆3-6g、苦杏仁1-3g、黑芝麻1-3g、海带1-3g、大枣1-3g、生姜0.5-1.0g;
(2)将(1)中西洋红参、黑木耳进行水提取3-4次,每次加水量为西洋红参、黑木耳重量的6-8倍,时间为每次3-4h,60-80℃,得到水提取液,合并,60-80℃减压浓缩为西洋红参和黑木耳浸膏;
(3)将(2)中西洋红参和黑木耳浸膏,加入葡萄糖120-180g、乳酸菌3-9g,在39-43℃发酵72-96h,得到乳酸菌发酵西洋红参和黑木耳浸膏,60-80℃减压浓缩、干燥,混匀;
(4)将(1)中的大豆、苦杏仁、黑芝麻、海带、大枣和生姜冷冻真空干燥,再通过胶体磨或振动磨或气流磨将其粉碎为微米级粉末,混匀;
(5)将(3)中乳酸菌发酵西洋红参和黑木耳浸膏粉和(4)中大豆、苦杏仁、黑芝麻、海带、大枣和生姜微米级粉末混合均匀,即为囊心物;
(6)囊材原辅料组成及重量为琼脂1.0-3.0kg、亚麻胶0.3-1.0kg、海藻酸钠0.2-0.4kg、乙基香兰醛0.01-0.02kg,二氧化钛0.02-0.03kg,丙三醇0.1-0.2kg、山梨醇或木糖醇0.1-0.2kg;
(7)将(6)中囊材原辅料放入7.0-8.5kg的去离子水中,在85-90℃下保持30-35分钟进行溶胶;85-90℃0.5个真空度下脱气10-12分钟,成为囊材胶液;
(8)将(7)中囊材胶液制胶片,加入(5)中囊心物,通过压制法制备软胶囊制剂。
本发明的目的在于提供一种海藻胶为囊材的防治心脑血管疾病软胶囊制剂的制备方法,囊材具有延伸性、张力强、韧性好的特点;制剂具有防治心脑血管疾病、辅助抗癌、延年益寿的功能。
具体实施方案:
本发明所述的一种海藻胶为囊材的防治心脑血管疾病软胶囊制剂的制备方法包括以下实施例,下面的实施例可进一步说明本发明,但不以任何方式限制本发明。
实施例1:
1.一种海藻胶为囊材的防治心脑血管疾病软胶囊制剂的制备方法,其特征在于包括以下步骤:
(1)囊心物原料组成及重量为西洋红参6g、黑木耳3g、大豆3g、苦杏仁1g、黑芝麻1g、海带1g、大枣1-3个、生姜0.5g;
(2)将(1)中西洋红参、黑木耳进行水提取3次,每次加水量为西洋红参、黑木耳重量的6倍,时间为每次3h,60℃,得到水提取液,合并,60℃减压浓缩为西洋红参和黑木耳浸膏;
(3)将(2)中西洋红参和黑木耳浸膏,加入葡萄糖120g、乳酸菌3g,在39℃发酵96h,得到乳酸菌发酵西洋红参和黑木耳浸膏,60℃减压浓缩、干燥,混匀;
(4)将(1)中的大豆、苦杏仁、黑芝麻、海带、大枣和生姜冷冻真空干燥,再通过胶体磨或振动磨或气流磨将其粉碎为微米级粉末,混匀;
(5)将(3)中乳酸菌发酵西洋红参和黑木耳浸膏粉和(4)中大豆、苦杏仁、黑芝麻、海带、大枣和生姜微米级粉末混合均匀,即为囊心物;
(6)囊材原辅料组成及重量为琼脂1.0kg、亚麻胶0.3kg、海藻酸钠0.2kg、乙基香兰醛0.01kg,二氧化钛0.02kg,丙三醇0.1kg、山梨醇或木糖醇0.1kg;
(7)将(6)中囊材原辅料放入7.0kg的去离子水中,在85℃下保持35分钟进行溶胶;85℃0.5个真空度下脱气12分钟,成为囊材胶液;
(8)将(7)中囊材胶液制胶片,加入(5)中囊心物,通过压制法制备软胶囊制剂。
实施例2:
1.一种海藻胶为囊材的防治心脑血管疾病软胶囊制剂的制备方法,其特征在于包括以下步骤:
(1)囊心物原料组成及重量为西洋红参9g、黑木耳6g、大豆6g、苦杏仁3g、黑芝麻3g、海带3g、大枣1-3g、生姜1.0g;
(2)将(1)中西洋红参、黑木耳进行水提取4次,每次加水量为西洋红参、黑木耳重量的8倍,时间为每次4h,80℃,得到水提取液,合并,80℃减压浓缩为西洋红参和黑木耳浸膏;
(3)将(2)中西洋红参和黑木耳浸膏,加入葡萄糖180g、乳酸菌9g,在43℃发酵72h,得到乳酸菌发酵西洋红参和黑木耳浸膏,80℃减压浓缩、干燥,混匀;
(4)将(1)中的大豆、苦杏仁、黑芝麻、海带、大枣和生姜冷冻真空干燥,再通过胶体磨或振动磨或气流磨将其粉碎为微米级粉末,混匀;
(5)将(3)中乳酸菌发酵西洋红参和黑木耳浸膏粉和(4)中大豆、苦杏仁、黑芝麻、海带、大枣和生姜微米级粉末混合均匀,即为囊心物;
(6)囊材原辅料组成及重量为琼脂3.0kg、亚麻胶1.0kg、海藻酸钠0.4kg、乙基香兰醛0.02kg,二氧化钛0.03kg,丙三醇0.2kg、山梨醇或木糖醇0.2kg;
(7)将(6)中囊材原辅料放入8.5kg的去离子水中,在90℃下保持35分钟进行溶胶;90℃0.5个真空度下脱气10分钟,成为囊材胶液;
(8)将(7)中囊材胶液制胶片,加入(5)中囊心物,通过压制法制备软胶囊制剂。
Claims (1)
1.一种海藻胶为囊材的防治心脑血管疾病软胶囊制剂的制备方法,其特征在于包括以下步骤:
(1)囊心物原料组成及重量为西洋红参6-9g、黑木耳3-6g、大豆3-6g、苦杏仁1-3g、黑芝麻1-3g、海带1-3g、大枣1-3g、生姜0.5-1.0g;
(2)将(1)中西洋红参、黑木耳进行水提取3-4次,每次加水量为西洋红参、黑木耳重量的6-8倍,时间为每次3-4h,60-80℃,得到水提取液,合并,60-80℃减压浓缩为西洋红参和黑木耳浸膏;
(3)将(2)中西洋红参和黑木耳浸膏,加入葡萄糖120-180g、乳酸菌3-9g,在39-43℃发酵72-96h,得到乳酸菌发酵西洋红参和黑木耳浸膏,60-80℃减压浓缩、干燥,混匀;
(4)将(1)中的大豆、苦杏仁、黑芝麻、海带、大枣和生姜冷冻真空干燥,再通过胶体磨或振动磨或气流磨将其粉碎为微米级粉末,混匀;
(5)将(3)中乳酸菌发酵西洋红参和黑木耳浸膏粉和(4)中大豆、苦杏仁、黑芝麻、海带、大枣和生姜微米级粉末混合均匀,即为囊心物;
(6)囊材原辅料组成及重量为琼脂1.0-3.0kg、亚麻胶0.3-1.0kg、海藻酸钠0.2-0.4kg、乙基香兰醛0.01-0.02kg,二氧化钛0.02-0.03kg,丙三醇0.1-0.2kg、山梨醇或木糖醇0.1-0.2kg;
(7)将(6)中囊材原辅料放入7.0-8.5kg的去离子水中,在85-90℃下保持30-35分钟进行溶胶;85-90℃0.5个真空度下脱气10-12分钟,成为囊材胶液;
(8)将(7)中囊材胶液制胶片,加入(5)中囊心物,通过压制法制备软胶囊制剂。
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