CN106109523A - A kind of crocin and Carlina acaulis composite chewable tablet and preparation method thereof - Google Patents
A kind of crocin and Carlina acaulis composite chewable tablet and preparation method thereof Download PDFInfo
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Abstract
Description
技术领域technical field
本发明属于药物制剂领域,具体涉及一种藏红花素和朝鲜蓟复合咀嚼片及其制备方法。The invention belongs to the field of pharmaceutical preparations, and in particular relates to a compound chewable tablet of saffron and artichoke and a preparation method thereof.
背景技术Background technique
肝脏是维持人体新陈代谢的重要脏器,对生物合成、生物转化、解毒、分泌、排泄、免疫各方面起着重要作用,情绪、睡眠、饮食甚至药物等,均会影响肝的疏泄功能。随着生活方式改变和营养水平的提高,肝脏疾病已经成为威胁健康的重大疾病之一,其诱因多种多样,而且是长期积累潜伏的过程,一旦肝脏受到损害,很难完全恢复。目前肝脏病一般是在发病后才进行治疗,主要采用药疗、化疗、手术切除、手术移植等手段,这些手段对人体刺激伤害较大,很多时候不能有效的缓解和治疗肝脏病。因此日常的保肝护肝显得尤为重要,亟需一种服用方便,预防保健效果好的药物或保健制品。The liver is an important organ that maintains the metabolism of the human body. It plays an important role in biosynthesis, biotransformation, detoxification, secretion, excretion, and immunity. Emotions, sleep, diet, and even drugs all affect the catharsis function of the liver. With the change of lifestyle and the improvement of nutritional level, liver disease has become one of the major diseases that threaten health. Its causes are various, and it is a long-term accumulation and latent process. Once the liver is damaged, it is difficult to fully recover. At present, liver diseases are generally treated after the onset of the disease, mainly using methods such as drug therapy, chemotherapy, surgical resection, and surgical transplantation. Therefore daily hepatoprotective and hepatoprotective seem particularly important, need badly a kind of easy to take, good medicine or health product of preventive health care effect.
发明内容Contents of the invention
本发明的目的在于克服现有技术的不足之处,提供了一种藏红花素和朝鲜蓟复合咀嚼片及其制备方法,得到的咀嚼片兼具朝鲜蓟与藏红花素的双重保健作用,且口感酸甜、营养丰富、不含蔗糖、风味独特。The purpose of the present invention is to overcome the deficiencies of the prior art, and provide a compound chewable tablet of saffron and artichoke and its preparation method. The chewable tablet obtained has the dual health effects of artichoke and saffron, and has a sour taste. Sweet, nutritious, sucrose-free, and unique in flavor.
本发明解决其技术问题所采用的技术方案之一是:One of the technical solutions adopted by the present invention to solve its technical problems is:
一种藏红花素和朝鲜蓟复合咀嚼片的制备方法,其原料按质量份数计,包括朝鲜蓟冻干粉0.4~3份,藏红花素0.05~0.6份,乳糖18~28份,葡萄糖3~8份,甘露醇1~5份,维生素C 3~8份,硬脂酸镁0.2~0.4份;其制备方法包括:A method for preparing a compound chewable tablet of saffron and artichoke. The raw materials thereof include 0.4 to 3 parts of artichoke freeze-dried powder, 0.05 to 0.6 parts of saffron, 18 to 28 parts of lactose, and 3 to 8 parts of glucose in parts by mass. 1 to 5 parts of mannitol, 3 to 8 parts of vitamin C, and 0.2 to 0.4 parts of magnesium stearate; the preparation method comprises:
1)取粒径为10~30目的朝鲜蓟茎叶粉末,加入8~25倍量(质量体积比)的水,180~320W微波提取50~200s,提取液浓缩至18~27波美度后,用大孔吸附树脂分离纯化:按照3~6BV/h的体积流量上样,2~6BV的45~55%乙醇洗脱,洗脱速度为3~6BV/h,得到的洗脱液浓缩至38~47波美度后,冷冻干燥45~75h,得到朝鲜蓟冻干粉,其中洋蓟酸的含量为4.5~6.0%;1) Take artichoke stem and leaf powder with a particle size of 10-30 mesh, add 8-25 times the amount (mass volume ratio) of water, extract with 180-320W microwave for 50-200s, and concentrate the extract to 18-27 degrees Baume , Separation and purification with macroporous adsorption resin: load the sample according to the volume flow rate of 3-6BV/h, elute with 2-6BV of 45-55% ethanol, and the elution rate is 3-6BV/h, and the obtained eluate is concentrated to After 38-47 degrees Baume, freeze-dry for 45-75 hours to obtain freeze-dried artichoke powder, wherein the content of artichoke acid is 4.5-6.0%;
2)取粒径为10~30目的大花栀子干果粉末,室温下加入8~25倍量的含有0.5~1.5%助溶剂的去离子水,45~55℃下浸提两次,每次提取22~26h;浸提液合并,2500~5500rpm下离心5~45min除去杂质后,在常温、0.08~0.6MPa下用孔径4~6μm的微滤膜过滤,然后在常温、0.04~0.15MPa下用截留分子量8000~15000D的中空纤维超滤膜进一步过滤;滤液上大孔树脂柱吸附达饱和后,依次用去离子水洗脱3~6BV除去杂质,15~35%醇洗脱3~6BV除去极性较大的物质,再用35~95%醇4~6BV洗脱目标物质;将含有目标物质的洗脱液浓缩,喷雾干燥,得到藏红花素,纯度为65~80%;2) Take the dried fruit powder of Gardenia grandiflora with a particle size of 10 to 30 meshes, add 8 to 25 times the amount of deionized water containing 0.5 to 1.5% co-solvent at room temperature, and extract twice at 45 to 55 ° C, each time Extract for 22-26 hours; combine the extracts, centrifuge at 2500-5500rpm for 5-45min to remove impurities, filter with a microfiltration membrane with a pore size of 4-6μm at room temperature and 0.08-0.6MPa, and then filter at room temperature and 0.04-0.15MPa Further filter with a hollow fiber ultrafiltration membrane with a molecular weight cut-off of 8000-15000D; after the filtrate is adsorbed to a saturated macroporous resin column, it is sequentially eluted with deionized water for 3-6BV to remove impurities, and 15-35% alcohol for 3-6BV to remove For substances with higher polarity, the target substance is eluted with 35-95% alcohol 4-6BV; the eluate containing the target substance is concentrated and spray-dried to obtain saffron with a purity of 65-80%;
3)将乳糖、葡萄糖、甘露醇和维生素C粉碎后过110~130目筛备用;取步骤1)得到的朝鲜蓟冻干粉0.4~3份,步骤2)得到的藏红花素0.05~0.6份与上述乳糖18~28份、葡萄糖3~8份、甘露醇1~5份、维生素C 3~8份混合均匀;3) Pulverize lactose, glucose, mannitol and vitamin C and pass through a 110-130 mesh sieve for later use; take 0.4-3 parts of artichoke freeze-dried powder obtained in step 1), 0.05-0.6 parts of crocin obtained in step 2) and the above-mentioned Mix 18-28 parts of lactose, 3-8 parts of glucose, 1-5 parts of mannitol, and 3-8 parts of vitamin C;
4)将步骤3)得到的混合后的物料用含有2~4%的聚乙烯吡咯烷酮的无水乙醇溶液制软材;4) making a soft material from the mixed material obtained in step 3) with an absolute ethanol solution containing 2 to 4% polyvinylpyrrolidone;
5)软材过10~30目筛,铺盘,45~70℃烘干,然后14~18目筛整粒;5) Pass the soft material through a 10-30 mesh sieve, spread it on a tray, dry it at 45-70°C, and then sieve it through a 14-18 mesh sieve;
6)向步骤5)得到的颗粒中加入0.2~0.4份硬脂酸镁,混合均匀,压片,即得所述之藏红花素和朝鲜蓟复合咀嚼片,其中藏红花素和洋蓟酸的含量分别为0.25~1.50%和0.08~0.4%。6) Add 0.2 to 0.4 parts of magnesium stearate to the granules obtained in step 5), mix well, and press into tablets to obtain the compound chewable tablet of crocin and artichoke, wherein the contents of crocin and cynic acid are respectively 0.25-1.50% and 0.08-0.4%.
一实施例中:所述步骤3)中,朝鲜蓟冻干粉为0.4~0.6份,藏红花素为0.05~0.15份,乳糖为19~21份,葡萄糖为4~6份,甘露醇为1~3份,维生素C为3~5份。In one embodiment: in the step 3), 0.4-0.6 parts of artichoke freeze-dried powder, 0.05-0.15 parts of crocin, 19-21 parts of lactose, 4-6 parts of glucose, and 1-6 parts of mannitol 3 parts, vitamin C is 3 to 5 parts.
一实施例中:所述步骤3)中,朝鲜蓟冻干粉为1~3份,藏红花素为0.4~0.6份,乳糖为24~26份,葡萄糖为6~8份,甘露醇为3~5份,维生素C为5~7份。In one embodiment: in the step 3), 1 to 3 parts of artichoke freeze-dried powder, 0.4 to 0.6 parts of crocin, 24 to 26 parts of lactose, 6 to 8 parts of glucose, and 3 to 8 parts of mannitol 5 parts, vitamin C is 5 to 7 parts.
一实施例中:所述步骤3)中,朝鲜蓟冻干粉为1~2份,藏红花素为0.2~0.4份,乳糖为22~24份,葡萄糖为5~7份,甘露醇为2~4份,维生素C为4~6份。In one embodiment: in the step 3), 1-2 parts of artichoke freeze-dried powder, 0.2-0.4 parts of crocin, 22-24 parts of lactose, 5-7 parts of glucose, and 2-2 parts of mannitol 4 parts, vitamin C is 4 to 6 parts.
一实施例中:所述步骤3)中,朝鲜蓟冻干粉为0.5~1.5份,藏红花素为0.1~0.3份,乳糖为22~24份,葡萄糖为6~7份,甘露醇为2~3份,维生素C为4~6份。In one embodiment: in the step 3), 0.5-1.5 parts of artichoke freeze-dried powder, 0.1-0.3 parts of crocin, 22-24 parts of lactose, 6-7 parts of glucose, and 2-2 parts of mannitol 3 parts, vitamin C is 4 to 6 parts.
一实施例中:所述步骤3)中,朝鲜蓟冻干粉为0.5~1.5份,藏红花素为0.1~0.3份,乳糖为21~23份,葡萄糖为5~7份,甘露醇为1~3份,维生素C为4~5份。In one embodiment: in the step 3), the artichoke freeze-dried powder is 0.5-1.5 parts, crocin is 0.1-0.3 parts, lactose is 21-23 parts, glucose is 5-7 parts, and mannitol is 1-23 parts. 3 parts, vitamin C is 4 to 5 parts.
本发明解决其技术问题所采用的技术方案之二是:Two of the technical solutions adopted by the present invention to solve the technical problems are:
一种根据上述制备方法所制备的藏红花素和朝鲜蓟复合咀嚼片。A saffron and artichoke compound chewable tablet prepared according to the above preparation method.
本技术方案与背景技术相比,它具有如下优点:Compared with the background technology, this technical solution has the following advantages:
藏红花素具有保肝利胆作用,能改善微循环,促进胆汁的分泌和排泄,降低异常增高的球蛋白和总胆红素,降低胆固醇和增加脂肪代谢,且对有毒物质引起的早期急性肝损害有化学预防作用。朝鲜蓟能够增强肝脏机能,并具有低脂、美容、养颜的效果,朝鲜蓟的茎叶中含有的洋蓟酸具有保护肝脏,促进利尿排毒,防止动脉硬化、保护心血管。藏红花素和朝鲜蓟二者联合应用,协同增效,能更好地发挥保护肝脏、促进新陈代谢、降低胆固醇的保健效果。本发明将二者制成咀嚼片的制剂形式,服用方便,可吞服、咀嚼含吮或用水分散后服用;药片经嚼碎后表面积增大,可促进药物在体内的溶解和吸收,提高藏红花素和朝鲜蓟的生物利用度,即使在缺水状态下也可以保证按时服用,尤其适合老人、小孩、中风患者、吞服困难及胃肠功能差的患者,可以减少药物对胃肠道的负担;且本品不含蔗糖,富含维生素C,口感良好,老少皆宜,是不可多得的养生保健的佳品。Crocetin has the function of protecting the liver and promoting gallbladder, can improve microcirculation, promote the secretion and excretion of bile, reduce abnormally high globulin and total bilirubin, reduce cholesterol and increase fat metabolism, and can prevent early acute liver damage caused by toxic substances. Has chemopreventive effect. Artichoke can enhance the function of the liver, and has the effects of low fat, beauty and beauty. The artichoke acid contained in the stems and leaves of the artichoke can protect the liver, promote diuresis and detoxification, prevent arteriosclerosis, and protect the cardiovascular system. The combined application of saffron and artichoke can synergize, and can better exert the health effects of protecting the liver, promoting metabolism, and lowering cholesterol. The present invention makes the two preparations into chewable tablets, which is convenient to take, can be swallowed, chewed, sucked, or dispersed with water; the surface area of the tablets increases after being chewed, which can promote the dissolution and absorption of drugs in the body, and improve the quality of saffron. The bioavailability of vitamins and artichokes can be taken on time even in the state of water shortage, especially suitable for the elderly, children, stroke patients, patients with difficulty in swallowing and poor gastrointestinal function, and can reduce the burden of drugs on the gastrointestinal tract ; And this product does not contain sucrose, is rich in vitamin C, has a good taste, and is suitable for all ages. It is a rare good product for health care.
具体实施方式detailed description
下面通过实施例具体说明本发明的内容:Below by embodiment the content of the present invention is specified:
实施例1Example 1
一种藏红花素和朝鲜蓟复合咀嚼片,其原料按质量份数计,包括朝鲜蓟冻干粉0.5份,藏红花素0.1份,乳糖20份,葡萄糖5份,甘露醇2份,维生素C 4份,硬脂酸镁0.3份,其制备方法包括:A composite chewable tablet of saffron and artichoke, whose raw materials are calculated in parts by mass, including 0.5 parts of artichoke freeze-dried powder, 0.1 part of saffron, 20 parts of lactose, 5 parts of glucose, 2 parts of mannitol, and 4 parts of vitamin C , 0.3 part of magnesium stearate, its preparation method comprises:
1)清洗朝鲜蓟茎叶,去除吸附在其表面的泥沙和霉菌,洗净后烘干,粉碎至粒径为20目,加入10倍量的水,250W微波提取60s,提取液吸入外循环减压浓缩器浓缩至20~25波美度后,用D101型号大孔吸附树脂分离纯化:按照4BV/h的体积流量上样,3BV的50%乙醇洗脱,洗脱速度为4BV/h,得到的洗脱液再次吸入外循环减压浓缩器浓缩至40~45波美度后,冷冻干燥48h,得到朝鲜蓟冻干粉,其中有效成分洋蓟酸的含量为5.2%;1) Wash the artichoke stems and leaves, remove the silt and mold adsorbed on the surface, dry them after washing, crush to a particle size of 20 mesh, add 10 times the amount of water, extract with 250W microwave for 60s, and inhale the extract into the external circulation After concentrating in a vacuum concentrator to 20-25 degrees Baume, use D101 macroporous adsorption resin for separation and purification: load the sample according to the volume flow rate of 4BV/h, elute with 3BV of 50% ethanol, and the elution rate is 4BV/h. The obtained eluate was inhaled into the external circulation decompression concentrator again and concentrated to 40-45 degrees Baume, and then freeze-dried for 48 hours to obtain freeze-dried artichoke powder, wherein the content of the active ingredient artichoke acid was 5.2%;
2)取清洗去杂的大花栀子干果,粉碎至粒径为20目,室温下加入10倍量的含有1%助溶剂吐温80的去离子水,50℃下浸提两次,每次24h;浸提液合并,4000rpm下离心30min除去杂质后,在常温、0.1~0.5MPa下用孔径5μm的PP棉微滤膜过滤,然后在常温、0.05~0.1MPa下用截留分子量10000D的中空纤维超滤膜进一步过滤;滤液用AB-8大孔树脂吸附饱和后,依次用去离子水洗脱5BV以除去杂质,20~30%乙醇洗脱5BV以除去极性较大的物质,再用40~90%乙醇洗脱5BV以洗脱目标物质;将含有目标物质的洗脱液浓缩,喷雾干燥,得到藏红花素,纯度为78%;2) Take the dried fruit of Gardenia grandiflora that has been cleaned and removed, crush it to a particle size of 20 mesh, add 10 times the amount of deionized water containing 1% co-solvent Tween 80 at room temperature, and extract twice at 50 ° C. 24 hours; the extracts were combined, centrifuged at 4000rpm for 30min to remove impurities, then filtered with PP cotton microfiltration membrane with a pore size of 5μm at room temperature and 0.1-0.5MPa, and then filtered with a hollow membrane with a molecular weight cut-off of 10000D at room temperature and 0.05-0.1MPa Fibrous ultrafiltration membrane is further filtered; after the filtrate is saturated with AB-8 macroporous resin, 5BV is eluted with deionized water successively to remove impurities, 5BV is eluted with 20-30% ethanol to remove more polar substances, and then used 40-90% ethanol elutes 5BV to elute the target substance; the eluate containing the target substance is concentrated and spray-dried to obtain saffron with a purity of 78%;
3)将乳糖、葡萄糖、甘露醇和维生素C用粉碎机粉碎后,过120目筛备用;取步骤1)得到的朝鲜蓟冻干粉0.5份,步骤2)得到的藏红花素0.01份与上述乳糖20份、葡萄糖5份、甘露醇2份、维生素C 4份投入混合机中混合均匀;3) After pulverizing lactose, glucose, mannitol and vitamin C with a pulverizer, pass through a 120-mesh sieve for later use; take 0.5 part of artichoke freeze-dried powder obtained in step 1), 0.01 part of saffron obtained in step 2) and 20 parts of the above-mentioned lactose 5 parts of glucose, 2 parts of mannitol, and 4 parts of vitamin C are put into the mixer and mixed evenly;
4)将步骤3)得到的混合后的物料用含有3%的聚乙烯吡咯烷酮的无水乙醇溶液混合均匀,制成软材,以手捏即可成团且轻压即散为合格软材标准;4) Mix the mixed material obtained in step 3) evenly with an anhydrous ethanol solution containing 3% polyvinylpyrrolidone to make a soft material, which can be formed into a ball by hand kneading and disperse when lightly pressed to be a qualified soft material standard ;
5)软材过20目筛后,在搪瓷盘上均匀铺开,送入烘箱50~65℃烘干,干燥的颗粒过16目筛整粒;5) After the soft material passes through a 20-mesh sieve, spread it evenly on the enamel plate, send it to an oven for drying at 50-65°C, and pass the dried granules through a 16-mesh sieve for granulation;
6)向步骤5)整粒,得到颗粒中加入0.3份硬脂酸镁,混合均匀,投入旋转压片机中压片,即得所述之藏红花素和朝鲜蓟复合咀嚼片,其中藏红花素和洋蓟酸的含量分别为0.26%和0.086%。6) To step 5) granulate, add 0.3 parts of magnesium stearate to the obtained granules, mix evenly, and put it into a rotary tablet press for tableting, to obtain the crocin and artichoke compound chewable tablets, wherein crocin and artichoke The content of thistle acid is 0.26% and 0.086%, respectively.
实施例2Example 2
一种藏红花素和朝鲜蓟复合咀嚼片,其原料按质量份数计,包括朝鲜蓟冻干粉2份,藏红花素0.5份,乳糖25份,葡萄糖7份,甘露醇4份,维生素C 6份,硬脂酸镁0.3份,其制备方法包括:A compound chewable tablet of saffron and artichoke, its raw materials are calculated in parts by mass, including 2 parts of freeze-dried artichoke powder, 0.5 parts of saffron, 25 parts of lactose, 7 parts of glucose, 4 parts of mannitol, and 6 parts of vitamin C , 0.3 part of magnesium stearate, its preparation method comprises:
1)清洗朝鲜蓟茎叶,去除吸附在其表面的泥沙和霉菌,洗净后烘干,粉碎至粒径为20目,加入15倍量的水,300W微波提取120s,提取液吸入外循环减压浓缩器浓缩至20~25波美度后,用AB-8型号大孔吸附树脂分离纯化:按照4BV/h的体积流量上样,4BV的50%乙醇洗脱,洗脱速度为4BV/h,,得到的洗脱液再次吸入外循环减压浓缩器浓缩至40~45波美度后,冷冻干燥48h,得到朝鲜蓟冻干粉,其中有效成分洋蓟酸的含量为5.1%;1) Wash the artichoke stems and leaves, remove the silt and mold adsorbed on the surface, dry them after washing, crush to a particle size of 20 mesh, add 15 times the amount of water, extract with 300W microwave for 120s, and inhale the extract into the external circulation After concentrating in a vacuum concentrator to 20-25 degrees Baume, use AB-8 type macroporous adsorption resin for separation and purification: according to the volume flow rate of 4BV/h, the sample is loaded, 4BV of 50% ethanol is eluted, and the elution rate is 4BV/h h, the obtained eluate was sucked into the external circulation decompression concentrator again and concentrated to 40-45 degrees Baume, and then freeze-dried for 48 hours to obtain freeze-dried artichoke powder, wherein the content of the active ingredient artichoke acid was 5.1%;
2)取清洗去杂的大花栀子干果,粉碎至粒径为20目,室温下加入14倍量的含有1%助溶剂吐温80的去离子水,50℃下浸提两次,每次24h;浸提液合并,4000rpm下离心40min除去杂质后,在常温、0.1~0.5MPa下用孔径5μm的PP棉微滤膜过滤,然后在常温、0.05~0.1MPa下用截留分子量10000D的中空纤维超滤膜进一步过滤;滤液用AB-8型号大孔树脂吸附饱和后,依次用去离子水洗脱4BV以除去杂质,20~30%乙醇洗脱5BV以除去极性较大的物质,再用40~90%乙醇洗脱5BV以洗脱目标物质;将含有目标物质的洗脱液浓缩,喷雾干燥,得到藏红花素,纯度为70%;2) Take the dried fruit of Gardenia grandiflora that has been cleaned and removed, crush it to a particle size of 20 mesh, add 14 times the amount of deionized water containing 1% co-solvent Tween 80 at room temperature, and extract twice at 50 ° C. 24 hours; the extracts were combined, centrifuged at 4000rpm for 40min to remove impurities, then filtered with a PP cotton microfiltration membrane with a pore size of 5μm at room temperature and 0.1-0.5MPa, and then filtered with a hollow membrane with a molecular weight cut-off of 10000D at room temperature and 0.05-0.1MPa. Fibrous ultrafiltration membrane is further filtered; after the filtrate is saturated with AB-8 macroporous resin, 4BV is sequentially eluted with deionized water to remove impurities, and 5BV is eluted with 20-30% ethanol to remove polar substances. Eluting 5BV with 40-90% ethanol to elute the target substance; concentrating the eluate containing the target substance and spray drying to obtain saffron with a purity of 70%;
3)将乳糖、葡萄糖、甘露醇和维生素C用粉碎机粉碎后,过120目筛备用;取步骤1)得到的朝鲜蓟冻干粉2份,步骤2)得到的藏红花素0.5份与上述乳糖25份、葡萄糖7份、甘露醇4份、维生素C 6份投入混合机中混合均匀;3) After pulverizing lactose, glucose, mannitol and vitamin C with a pulverizer, pass through a 120-mesh sieve for later use; take 2 parts of artichoke freeze-dried powder obtained in step 1), 0.5 part of saffron obtained in step 2) and 25 parts of the above-mentioned lactose 7 parts of glucose, 4 parts of mannitol, and 6 parts of vitamin C are put into the mixer and mixed evenly;
4)将步骤3)得到的混合后的物料用含有3%的聚乙烯吡咯烷酮的无水乙醇溶液混合均匀,制成软材,以手捏即可成团且轻压即散为合格软材标准;4) Mix the mixed material obtained in step 3) evenly with an anhydrous ethanol solution containing 3% polyvinylpyrrolidone to make a soft material, which can be formed into a ball by hand kneading and disperse when lightly pressed to be a qualified soft material standard ;
5)软材过20目筛后,在搪瓷盘上均匀铺开,送入烘箱50~65℃烘干,干燥的颗粒过16目筛整粒;5) After the soft material passes through a 20-mesh sieve, spread it evenly on the enamel plate, send it to an oven for drying at 50-65°C, and pass the dried granules through a 16-mesh sieve for granulation;
6)向步骤5)整粒,得到颗粒中加入0.3份硬脂酸镁,混合均匀,投入旋转压片机中压片,即得所述之藏红花素和朝鲜蓟复合咀嚼片,其中藏红花素和洋蓟酸的含量分别为1.20%和0.34%。6) To step 5) granulate, add 0.3 parts of magnesium stearate to the obtained granules, mix evenly, and put it into a rotary tablet press for tableting, to obtain the crocin and artichoke compound chewable tablets, wherein crocin and artichoke The content of thistle acid is 1.20% and 0.34%, respectively.
实施例3Example 3
一种藏红花素和朝鲜蓟复合咀嚼片,其原料按质量份数计,包括朝鲜蓟冻干粉1.5份,藏红花素0.3份,乳糖23份,葡萄糖6份,甘露醇3份,维生素C 5份,硬脂酸镁0.3份,其制备方法包括:A saffron and artichoke compound chewable tablet, the raw materials of which are calculated in parts by mass, include 1.5 parts of artichoke freeze-dried powder, 0.3 parts of saffron, 23 parts of lactose, 6 parts of glucose, 3 parts of mannitol, and 5 parts of vitamin C , 0.3 part of magnesium stearate, its preparation method comprises:
1)清洗朝鲜蓟茎叶,去除吸附在其表面的泥沙和霉菌,洗净后烘干,粉碎至粒径为20目,加入20倍量的水,200W微波提取180s,提取液吸入外循环减压浓缩器,5BV的50%乙醇洗脱,洗脱速度为4BV/h,,得到的洗脱液再次吸入外循环减压浓缩器浓缩至40~45波美度后,冷冻干燥72h,得到朝鲜蓟冻干粉,其中有效成分洋蓟酸的含量为5.6%;1) Wash the artichoke stems and leaves, remove the silt and mold adsorbed on the surface, dry them after washing, crush to a particle size of 20 mesh, add 20 times the amount of water, extract with 200W microwave for 180s, and suck the extract into the external circulation Decompression concentrator, 5BV of 50% ethanol for elution, the elution rate is 4BV/h, the eluate obtained is sucked into the external circulation decompression concentrator again and concentrated to 40-45 degrees Baume, then freeze-dried for 72h to obtain Freeze-dried artichoke powder, wherein the content of active ingredient cynic acid is 5.6%;
2)取清洗去杂的大花栀子干果,粉碎至粒径为20目,室温下加入15倍量的含有1%助溶剂吐温40的去离子水,50℃下浸提两次,每次6h;浸提液合并,3000rpm下离心20min除去杂质后,在常温、0.1~0.5MPa下用孔径5μm的PP棉微滤膜过滤,然后在常温、0.05~0.1MPa下用截留分子量10000D的中空纤维超滤膜进一步过滤;滤液用D101型号大孔树脂吸附饱和后,依次用去离子水洗脱5BV以除去杂质,20~30%乙醇洗脱5BV以除去极性较大的物质,再用40~90%乙醇洗脱5BV以洗脱目标物质;将含有目标物质的洗脱液浓缩,喷雾干燥,得到藏红花素,纯度为75%;2) Take the dried fruit of Gardenia grandiflora that has been cleaned and removed, crush it to a particle size of 20 mesh, add 15 times the amount of deionized water containing 1% co-solvent Tween 40 at room temperature, and extract twice at 50° C. 6 hours; the extracts were combined, centrifuged at 3000rpm for 20min to remove impurities, then filtered with PP cotton microfiltration membrane with a pore size of 5μm at room temperature and 0.1-0.5MPa, and then filtered with a hollow membrane with a molecular weight cut-off of 10000D at room temperature and 0.05-0.1MPa. Fibrous ultrafiltration membrane was further filtered; after the filtrate was saturated with D101 macroporous resin, 5BV was eluted with deionized water to remove impurities, 5BV was eluted with 20-30% ethanol to remove more polar substances, and then 40 ~90% ethanol elutes 5BV to elute the target substance; concentrate the eluate containing the target substance, and spray dry to obtain saffron with a purity of 75%;
3)将乳糖、葡萄糖、甘露醇和维生素C用粉碎机粉碎后,过120目筛备用;取步骤1)得到的朝鲜蓟冻干粉1.5份,步骤2)得到的藏红花素0.3份与上述乳糖23份、葡萄糖6份、甘露醇3份、维生素C 5份投入混合机中混合均匀;3) After pulverizing lactose, glucose, mannitol and vitamin C with a pulverizer, pass through a 120-mesh sieve for later use; take 1.5 parts of artichoke freeze-dried powder obtained in step 1), 0.3 parts of saffron obtained in step 2) and 23 parts of the above-mentioned lactose 6 parts of glucose, 3 parts of mannitol, and 5 parts of vitamin C are put into the mixer and mixed evenly;
4)将步骤3)得到的混合后的物料用含有3%的聚乙烯吡咯烷酮的无水乙醇溶液混合均匀,制成软材,以手捏即可成团且轻压即散为合格软材标准;4) Mix the mixed material obtained in step 3) evenly with an anhydrous ethanol solution containing 3% polyvinylpyrrolidone to make a soft material, which can be formed into a ball by hand kneading and disperse when lightly pressed to be a qualified soft material standard ;
5)软材过20目筛后,在搪瓷盘上均匀铺开,送入烘箱50~65℃烘干,干燥的颗粒过16目筛整粒;5) After the soft material passes through a 20-mesh sieve, spread it evenly on the enamel plate, send it to an oven for drying at 50-65°C, and pass the dried granules through a 16-mesh sieve for granulation;
6)向步骤5)整粒,得到颗粒中加入0.3份硬脂酸镁,混合均匀,投入旋转压片机中压片,即得所述之藏红花素和朝鲜蓟复合咀嚼片,其中藏红花素和洋蓟酸的含量分别为0.79%和0.27%。6) To step 5) granulate, add 0.3 parts of magnesium stearate to the obtained granules, mix evenly, and put it into a rotary tablet press for tableting, to obtain the crocin and artichoke compound chewable tablets, wherein crocin and artichoke The content of thistle acid is 0.79% and 0.27%, respectively.
实施例4Example 4
一种藏红花素和朝鲜蓟复合咀嚼片,其原料按质量份数计,包括朝鲜蓟冻干粉1份,藏红花素0.2份,乳糖23份,葡萄糖6.5份,甘露醇2.5份,维生素C 5份,硬脂酸镁0.3份,其制备方法包括:A saffron and artichoke compound chewable tablet, its raw materials are calculated in parts by mass, including 1 part of artichoke freeze-dried powder, 0.2 parts of saffron, 23 parts of lactose, 6.5 parts of glucose, 2.5 parts of mannitol, and 5 parts of vitamin C , 0.3 part of magnesium stearate, its preparation method comprises:
1)清洗朝鲜蓟茎叶,去除吸附在其表面的泥沙和霉菌,洗净后烘干,粉碎至粒径为20目,加入15倍量的水,300W微波提取60s,提取液吸入外循环减压浓缩器浓缩至20~25波美度后,用AB-8型号大孔吸附树脂分离纯化:按照4BV/h的体积流量上样,3BV的50%乙醇洗脱,洗脱速度为4BV/h,,得到的洗脱液再次吸入外循环减压浓缩器浓缩至40~45波美度后,冷冻干燥48h,得到朝鲜蓟冻干粉,其中有效成分洋蓟酸的含量为4.9%;1) Wash the artichoke stems and leaves, remove the silt and mold adsorbed on the surface, dry them after washing, crush to a particle size of 20 mesh, add 15 times the amount of water, extract with 300W microwave for 60s, and inhale the extract into the external circulation After concentrating in a vacuum concentrator to 20-25 degrees Baume, use AB-8 type macroporous adsorption resin for separation and purification: according to the volume flow rate of 4BV/h, the sample is loaded, 3BV of 50% ethanol is eluted, and the elution rate is 4BV/h h, the obtained eluate was inhaled into the external circulation decompression concentrator again to concentrate to 40-45 degrees Baume, and then freeze-dried for 48 hours to obtain freeze-dried artichoke powder, wherein the content of the active ingredient artichoke acid was 4.9%;
2)取清洗去杂的大花栀子干果,粉碎至粒径为20目,室温下加入15倍量的含有1%助溶剂吐温80的去离子水,50℃下浸提两次,每次6h;浸提液合并,5000rpm下离心10min除去杂质后,在常温、0.1~0.5MPa下用孔径5μm的PP棉微滤膜过滤,然后在常温、0.05~0.1MPa下用截留分子量10000D的中空纤维超滤膜进一步过滤;滤液用D101型号大孔树脂吸附饱和后,依次用去离子水洗脱4BV以除去杂质,20~30%乙醇洗脱4BV以除去极性较大的物质,再用40~90%乙醇洗脱5BV以洗脱目标物质;将含有目标物质的洗脱液浓缩,喷雾干燥,得到藏红花素,纯度为73%;2) Take the dried fruit of Gardenia grandiflora that has been cleaned and removed, crush it to a particle size of 20 mesh, add 15 times the amount of deionized water containing 1% co-solvent Tween 80 at room temperature, and extract twice at 50 ° C. 6h; the extracts were combined, centrifuged at 5000rpm for 10min to remove impurities, then filtered with a PP cotton microfiltration membrane with a pore size of 5μm at room temperature and 0.1-0.5MPa, and then filtered with a hollow membrane with a molecular weight cut-off of 10000D at room temperature and 0.05-0.1MPa. Fibrous ultrafiltration membrane was further filtered; after the filtrate was saturated with D101 macroporous resin, 4BV was eluted with deionized water to remove impurities, 4BV was eluted with 20-30% ethanol to remove more polar substances, and then 40 ~90% ethanol elutes 5BV to elute the target substance; the eluate containing the target substance is concentrated and spray-dried to obtain saffron with a purity of 73%;
3)将乳糖、葡萄糖、甘露醇和维生素C用粉碎机粉碎后,过120目筛备用;取步骤1)得到的朝鲜蓟冻干粉1份,步骤2)得到的藏红花素0.2份与上述乳糖23份、葡萄糖6.5份、甘露醇2.5份、维生素C 5份投入混合机中混合均匀;3) After pulverizing lactose, glucose, mannitol and vitamin C with a pulverizer, pass through a 120-mesh sieve for later use; take 1 part of artichoke freeze-dried powder obtained in step 1), 0.2 part of saffron obtained in step 2) and 23 parts of the above-mentioned lactose 6.5 parts of glucose, 2.5 parts of mannitol, and 5 parts of vitamin C are put into the mixer and mixed evenly;
4)将步骤3)得到的混合后的物料用含有3%的聚乙烯吡咯烷酮的无水乙醇溶液混合均匀,制成软材,以手捏即可成团且轻压即散为合格软材标准;4) Mix the mixed material obtained in step 3) evenly with an anhydrous ethanol solution containing 3% polyvinylpyrrolidone to make a soft material, which can be formed into a ball by hand kneading and disperse when lightly pressed to be a qualified soft material standard ;
5)软材过20目筛后,在搪瓷盘上均匀铺开,送入烘箱50~65℃烘干,干燥的颗粒过16目筛整粒;5) After the soft material passes through a 20-mesh sieve, spread it evenly on the enamel plate, send it to an oven for drying at 50-65°C, and pass the dried granules through a 16-mesh sieve for granulation;
6)向步骤5)整粒,得到颗粒中加入0.3份硬脂酸镁,混合均匀,投入旋转压片机中压片,即得所述之藏红花素和朝鲜蓟复合咀嚼片,其中藏红花素和洋蓟酸的含量分别为0.54%和0.17%。6) To step 5) granulate, add 0.3 parts of magnesium stearate to the obtained granules, mix evenly, and put it into a rotary tablet press for tableting, to obtain the crocin and artichoke compound chewable tablets, wherein crocin and artichoke The content of thistle acid is 0.54% and 0.17%, respectively.
实施例5Example 5
一种藏红花素和朝鲜蓟复合咀嚼片,其原料按质量份数计,包括朝鲜蓟冻干粉1份,藏红花素0.2份,乳糖22份,葡萄糖6份,甘露醇2份,维生素C 4.5份,硬脂酸镁0.3份,其制备方法包括:A compound chewable tablet of saffron and artichoke, its raw materials are calculated in parts by mass, including 1 part of freeze-dried artichoke powder, 0.2 parts of saffron, 22 parts of lactose, 6 parts of glucose, 2 parts of mannitol, and 4.5 parts of vitamin C , 0.3 part of magnesium stearate, its preparation method comprises:
1)清洗朝鲜蓟茎叶,去除吸附在其表面的泥沙和霉菌,洗净后烘干,粉碎至粒径为20目,加入10倍量的水,300W微波提取120s,提取液吸入外循环减压浓缩器浓缩至20~25波美度后,用D101型号大孔吸附树脂分离纯化:按照5BV/h的体积流量上样,5BV的50%乙醇洗脱,洗脱速度为5BV/h,,得到的洗脱液再次吸入外循环减压浓缩器浓缩至40~45波美度后,冷冻干燥72h,得到朝鲜蓟冻干粉,其中有效成分洋蓟酸的含量为5.0%;1) Wash the artichoke stems and leaves, remove the silt and mold adsorbed on the surface, dry them after washing, crush to a particle size of 20 mesh, add 10 times the amount of water, extract with 300W microwave for 120s, and inhale the extract into the external circulation After concentrating in a vacuum concentrator to 20-25 degrees Baume, use D101 macroporous adsorption resin for separation and purification: load the sample at a volume flow rate of 5BV/h, and elute with 50% ethanol at a rate of 5BV/h. , the obtained eluate was sucked into the external circulation decompression concentrator again and concentrated to 40-45 degrees Baume, and then freeze-dried for 72 hours to obtain freeze-dried artichoke powder, wherein the content of the active ingredient artichoke acid was 5.0%;
2)取清洗去杂的大花栀子干果,粉碎至粒径为20目,室温下加入20倍量的含有1%助溶剂吐温80的去离子水,50℃下浸提两次,每次6h;浸提液合并,3000rpm下离心30min除去杂质后,在常温、0.1~0.5MPa下用孔径5μm的PP棉微滤膜过滤,然后在常温、0.05~0.1MPa下用截留分子量10000D的中空纤维超滤膜进一步过滤;滤液用AB-8型号大孔树脂吸附饱和后,依次用去离子水洗脱4BV以除去杂质,20~30%乙醇洗脱5BV以除去极性较大的物质,再用40~90%乙醇洗脱5BV以洗脱目标物质;将含有目标物质的洗脱液浓缩,喷雾干燥,得到藏红花素,纯度为67%;2) Take the dried fruit of Gardenia grandiflora that has been cleaned and removed, crush it to a particle size of 20 mesh, add 20 times the amount of deionized water containing 1% co-solvent Tween 80 at room temperature, and extract twice at 50 ° C. 6h; the extracts were combined, centrifuged at 3000rpm for 30min to remove impurities, then filtered with a PP cotton microfiltration membrane with a pore size of 5μm at room temperature and 0.1-0.5MPa, and then filtered with a hollow membrane with a molecular weight cut-off of 10000D at room temperature and 0.05-0.1MPa. Fibrous ultrafiltration membrane is further filtered; after the filtrate is saturated with AB-8 macroporous resin, 4BV is sequentially eluted with deionized water to remove impurities, and 5BV is eluted with 20-30% ethanol to remove polar substances. Eluting 5BV with 40-90% ethanol to elute the target substance; concentrating the eluate containing the target substance and spray drying to obtain saffron with a purity of 67%;
3)将乳糖、葡萄糖、甘露醇和维生素C用粉碎机粉碎后,过120目筛备用;取步骤1)得到的朝鲜蓟冻干粉1份,步骤2)得到的藏红花素0.2份与上述乳糖22份、葡萄糖6份、甘露醇2份、维生素C 4.5份投入混合机中混合均匀;3) After pulverizing lactose, glucose, mannitol and vitamin C with a pulverizer, pass through a 120-mesh sieve for later use; take 1 part of artichoke freeze-dried powder obtained in step 1), 0.2 part of crocin obtained in step 2) and 22 parts of the above-mentioned lactose 6 parts of glucose, 2 parts of mannitol, and 4.5 parts of vitamin C are put into the mixer and mixed evenly;
4)将步骤3)得到的混合后的物料用含有3%的聚乙烯吡咯烷酮的无水乙醇溶液混合均匀,制成软材,以手捏即可成团且轻压即散为合格软材标准;4) Mix the mixed material obtained in step 3) evenly with an anhydrous ethanol solution containing 3% polyvinylpyrrolidone to make a soft material, which can be formed into a ball by hand kneading and disperse when lightly pressed to be a qualified soft material standard ;
5)软材过20目筛后,在搪瓷盘上均匀铺开,送入烘箱50~65℃烘干,干燥的颗粒过16目筛整粒;5) After the soft material passes through a 20-mesh sieve, spread it evenly on the enamel plate, send it to an oven for drying at 50-65°C, and pass the dried granules through a 16-mesh sieve for granulation;
6)向步骤5)整粒,得到颗粒中加入0.3份硬脂酸镁,混合均匀,投入旋转压片机中压片,即得所述之藏红花素和朝鲜蓟复合咀嚼片,其中藏红花素和洋蓟酸的含量分别为0.47%和0.16%。6) To step 5) granulate, add 0.3 parts of magnesium stearate to the obtained granules, mix evenly, and put it into a rotary tablet press for tableting, to obtain the crocin and artichoke compound chewable tablets, wherein crocin and artichoke The content of thistle acid is 0.47% and 0.16%, respectively.
对实施例15中得到的藏红花素和朝鲜蓟复合咀嚼片的外观、口感、硬度、水分、脆碎度等指标进行了测试,结果如下表所示。The appearance, mouthfeel, hardness, moisture, friability and other indicators of the saffron and artichoke compound chewable tablets obtained in Example 15 were tested, and the results are shown in the table below.
以上所述,仅为本发明较佳实施例而已,故不能依此限定本发明实施的范围,即依本发明专利范围及说明书内容所作的等效变化与修饰,皆应仍属本发明涵盖的范围内。The above is only a preferred embodiment of the present invention, so the scope of the present invention cannot be limited accordingly, that is, the equivalent changes and modifications made according to the patent scope of the present invention and the content of the specification should still be covered by the present invention within range.
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