WO2018077276A1 - 一种增强免疫力的组合物及其制备方法 - Google Patents

一种增强免疫力的组合物及其制备方法 Download PDF

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WO2018077276A1
WO2018077276A1 PCT/CN2017/108403 CN2017108403W WO2018077276A1 WO 2018077276 A1 WO2018077276 A1 WO 2018077276A1 CN 2017108403 W CN2017108403 W CN 2017108403W WO 2018077276 A1 WO2018077276 A1 WO 2018077276A1
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parts
extract
flower
vitamin
juice
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PCT/CN2017/108403
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English (en)
French (fr)
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黄爱强
钟文
黄爱毅
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广西圣保堂健康产业股份有限公司
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Publication of WO2018077276A1 publication Critical patent/WO2018077276A1/zh

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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

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  • the invention belongs to the field of medicines, health foods and foods, and relates to a composition preparation and a preparation method thereof, in particular to a composition for enhancing immunity and a preparation method thereof.
  • the traditional Chinese medicines of "medicine and food homologous" and some fruits with health effects are in line with people's treatment of diseases and health care needs.
  • the invention adds a suitable "medicine-food homologous" traditional Chinese medicine to the western medicine to prepare an immune-enhancing composition, which is rich in nutrients and an active ingredient for improving human health, and has immunity enhancement.
  • Vitamin C is a commonly used drug or nutritional supplement in the clinic. It is one of the antioxidant vitamins. It is involved in the hydroxylation reaction in the body and is necessary for the formation of bone, tooth, connective tissue and non-epithelial cells. The normal function of bones and blood vessels, increase the resistance to disease, and is one of the essential nutrients for the human body. It is widely used in the prevention and treatment of various diseases. Vitamin C sodium is the sodium salt of vitamin C. The pH of the aqueous solution is close to neutral. It has the same effect as vitamin C, but because it is sodium salt, the performance is more stable. At the same time, there is no longer strong acidity of vitamin C. The drug is taken at the same time, which is better than vitamin C.
  • the tablet is stable in quality and convenient to take, and is the most basic and most commonly used form of preparation.
  • ordinary tablets are often difficult to take, and long-term medication may even cause psychological refusal, and chewable tablets can make up for this deficiency.
  • Chewable tablets are a type of tablets that can be swallowed after being chewed in the oral cavity.
  • the size is generally the same as that of ordinary tablets, and shaped tablets of different shapes can be made as needed.
  • the tablets are easily swallowed after being chewed, and the surface area of the tablets is increased to promote the dissolution and absorption of the drug in the body.
  • making chewable tablets can accelerate their disintegration and improve drug efficacy.
  • Chewable tablets are convenient to take, even in the absence of water, can be used on time, especially for children, the elderly, patients with dysphagia or poor gastrointestinal function, can reduce the burden of drugs on the gastrointestinal tract. Therefore, chewing tablet applications are becoming more widespread.
  • the invention aims at the problem that the existing vitamin C-containing chewable tablet has high acidity after dissolution, is irritating to the oral cavity, throat esophagus and gastric mucosa, and is not suitable for long-term use, and the vitamin C is easily oxidized and failed during storage, and the chewable tablet is easy to absorb moisture and damp.
  • the invention relates to a composition for enhancing immunity and having the effects of clearing away heat and detoxifying, lowering blood pressure, blood sugar, blood fat, anti-cancer, beauty and beauty, and a preparation method thereof, and solving the problem that the quality of vitamin C in clinical application is unstable, and it is difficult to take long-term use, etc. problem.
  • the immune-enhancing composition of the invention has the advantages of safe, non-toxic and side effects, and can be used for a long time to improve the rehabilitation of cancer patients with low immunity, as well as the health and beauty of women, middle-aged and elderly people, anti-aging and low immunity; or as a Nutritional supplements are taken for a long time.
  • An immunopotentiating composition comprising the following components by weight: 50-200 parts of vitamin C sodium, 0.1-1 part of vitamin A, 10-30 parts of zinc gluconate, 10-30 parts of taurine, flower and fruit 10-20 parts of extract and 10-20 parts of spirulina powder.
  • the flower and fruit extract described above is made of the following raw materials by weight: 20-40 parts of golden tea and 30-60 parts of fresh mulberry.
  • the preparation method of the above flower and fruit extract is as follows:
  • the extraction method under the step S2 is preferably heated reflux extraction and ultrasonic extraction.
  • the drying method under the step S4 is preferably oven heating drying and spray drying.
  • the above-mentioned immunopotentiating composition preferably further comprises the following components by weight: 200-400 parts of starch, 5-20 parts of mannitol, 20-60 parts of microcrystalline cellulose, povidone K-30 5 -20 parts, 10-50 parts of sodium carboxymethyl starch, 5-20 parts of sodium lauryl sulfate, 1-5 parts of magnesium stearate, 10-30 parts of sweetener, 0.1-0.5 parts of mint flavor.
  • the above-mentioned immunopotentiating composition preferably comprises the following components by weight: 120 parts of vitamin C sodium, 0.5 part of vitamin A, 20 parts of zinc gluconate, 20 parts of taurine, and flower and fruit extract 15 Serving, 15 parts of spirulina powder, 300 parts of starch, 12 parts of mannitol, 40 parts of microcrystalline cellulose, 13 parts of povidone K-30, 30 parts of sodium carboxymethyl starch, 12 parts of sodium lauryl sulfate, 3 parts of magnesium stearate, 20 parts of sweetener, and 0.3 parts of mint flavor.
  • the flower and fruit extract described above is made of the following raw materials by weight: 30 parts of golden tea and 45 parts of fresh mulberry.
  • the sweetener is preferably aspartame, neotame, or mogroside.
  • the preparation method of the above-mentioned immunity enhancing composition comprises the following steps:
  • T1 Preparation of flower and fruit extract: Weigh the following raw materials by weight: 20-40 parts of golden tea, 30-60 parts of fresh mulberry; take the golden tea with good weighing, add 6-10 times of water, soak for 30 minutes , extract 2-3 times, each time 30-40 minutes, filtered, The flower extract is obtained; the fresh mulberry is weighed, washed, the raw juice is extracted, and the juice is filtered to obtain the juice; the flower extract is mixed with the juice, and concentrated under reduced pressure at 80 ° C to obtain a relative density of 1.18 at 60 ° C. 1.22 flow extract, the flow extract is dried, and the drying temperature is controlled to be 65-80 ° C to obtain a flower and fruit extract;
  • T2 Take vitamin C sodium, vitamin A, zinc gluconate, taurine, flower and fruit extract, spirulina powder, starch, mannitol, microcrystalline cellulose, povidone K-30, sodium carboxymethyl starch , sodium lauryl sulfate, sweetener, crushed, passed through a 100 mesh sieve, and used;
  • T4 Take the mixed powder under T3, add 70-80% ethanol solution to make soft material, granulate and granulate, stir for 4 hours, control the water to 2-4%, sift the whole granule to obtain granules;
  • T5. Weigh magnesium stearate and mint flavor according to the formula amount, mix well with the particles under S3, and compress the tablets.
  • the drying temperature in the step T4 is preferably 60-65 ° C, so that the obtained particles have a moderate hardness and are more favorable for tableting; the sieve used in the sieving step described in the step T4 is preferably 14-30. Head.
  • the invention overcomes the problem that the existing vitamin C-containing chewable tablet has high acidity after dissolution, is irritating to the oral cavity, throat esophagus and gastric mucosa, and is not suitable for long-term use, and the vitamin C is easily oxidized and failed during storage, and the chewable tablet is easy to absorb moisture and damp. To make the product more stable and more effective, it is suitable for long-term use by consumers or patients without side effects.
  • the raw materials of the flower and fruit extract of the present invention and the spirulina are all "medicinal and food homologous" varieties, which are safe, non-toxic and side effects.
  • Golden Camellia is a plant with high medicinal value and high health value. It is unique to Guangxi and belongs to non-toxic grade. It contains more than 400 kinds of nutrients. It has been shown that Jinhua Tea regulates human blood lipids, blood sugar, cholesterol and enhances immunity.
  • the force has obvious effects, and has been used in the folk to refresh the mind, clear the liver fire, detoxify the poison, nourish the vital energy; mulberry, sweet, cold, rich in active protein, vitamins, amino acids, carotene, minerals, Various active ingredients such as flavonoids have the functions of enhancing human immunity, nourishing the skin, delaying aging, promoting thirst, promoting digestion, replenishing liver and kidney, nourishing yin and nourishing blood. It is called "folk fruit”; spirulina contains Rich in high-quality protein, beta carotene, vitamins, and a variety of essential trace elements.
  • Spirulina also contains high levels of gamma-linolenic acid, which enhances the immune system, anti-aging, anti-fatigue, blood pressure lowering, blood sugar, and blood lipids.
  • Anti-tumor, etc. because of its strong health care, it is called the best natural green health food; the above three raw materials, through the West with vitamin C
  • the ingredients are reasonably formulated, which have the functions of enhancing immunity, clearing away heat and detoxifying, lowering blood pressure, blood sugar, blood fat, anti-cancer, beauty and beauty, etc., and can also supplement the nutrition required by the human body, relieve fatigue and delay aging, especially for women, middle-aged and elderly people. Rehabilitation of cancer patients with good health, anti-aging and low immunity.
  • the composition for enhancing immunity of the invention has the advantages of simple preparation, good particle flowability, and no sticking of the tablet, and the prepared tablet has a smooth surface, is not easy to absorb moisture, has a sweet taste, is stable in quality, and is convenient for carrying and convenient to eat, especially Suitable for children, old age People and patients who cannot swallow solid preparations have high bioavailability, are safer and more effective, and can be taken as a nutritional supplement for a long time.
  • the word "preferred" and variants refers to embodiments of the invention that are capable of providing a particular benefit in a particular environment. However, other embodiments may be preferred under the same or other circumstances. In addition, the detailed description of one or more preferred embodiments does not indicate that other embodiments are useless and are not intended to exclude other embodiments from the scope of the invention.
  • the wetting agent moisturizes the powder and presents a viscosity to facilitate the preparation of the granules and compression into tablets.
  • the invention compares the dry pressing tablet, the wet granulation and the re-pulling, the dry pressing tablet adopts the ordinary tableting machine has a poor effect and has high requirements on the equipment, so the invention adopts the wet granulation and the tableting.
  • 20% maltodextrin, 30% starch slurry, 40% sucrose syrup, 5% hypromellose aqueous solution, and 80% ethanol were used as wetting agents. The results are shown in Table 1.
  • magnesium stearate, sodium lauryl sulfate and mannitol are added, and the fluidity is good, and the tablet is not stick-punched, and the pressed piece has a suitable hardness, and the sheet surface is smooth and beautiful, and is added.
  • the ratio of magnesium stearate, sodium lauryl sulfate and mannitol was also compared in the test of the present invention, and the results showed that: magnesium stearate, twelve
  • the ratio of sodium alkyl sulphate and mannitol is 3:3:1 or 4:4:1, and the mouthfeel is optimal.
  • sweeteners Only chewable tablets with good taste are easily accepted. Therefore, flavor and taste are very important, and this is often achieved by the selection of flavoring agents such as sweeteners and flavors.
  • the following sweeteners are compared: sucrose, lactose, glucose, stevioside, disodium glycyrrhizinate, aspartame, sodium saccharin, sodium cyclamate, mogroside, neotame, alitame, The results showed that the above sweeteners contained aspartame, mogroside, and neotame in the range of “sweetener 10-30 parts” in combination with mint flavor, and the taste was good and the sweetness was good. Moderate, no discomfort, of which aspartame tastes the best. Therefore, the present invention selects aspartame, mogroside, and neotame as sweeteners, and the amount thereof is 10-30 parts.
  • a method for preparing an immunopotentiating composition comprising the steps of:
  • T1 Preparation of flower and fruit extract: Weigh the following raw materials by weight: 20kg of golden tea, 30kg of fresh mulberry; weighed Good golden tea, add 6 times the amount of water, soak for 30 minutes, ultrasonic extraction 3 times, each time for 30 minutes, filter, get the flower extract; take the weighed fresh mulberry, wash, squeeze the original juice, filter The juice is mixed with the juice, and concentrated under reduced pressure at 80 ° C or lower to obtain a flow extract having a relative density of 1.20 at 60 ° C, and the flow extract is spray-dried to control the drying temperature to 70 ° C to obtain a flower fruit. Extract;
  • T2 Take vitamin C sodium, vitamin A, zinc gluconate, taurine, flower and fruit extract, spirulina powder, starch, mannitol, microcrystalline cellulose, povidone K-30, sodium carboxymethyl starch , sodium lauryl sulfate, neotame, crushed, passed through 100 mesh sieve, spare;
  • T2 Weigh the raw materials of T2 according to the following weights: vitamin C sodium 50kg, vitamin A 0.1kg, zinc gluconate 10kg, taurine 10kg, flower and fruit extract 10kg, spirulina powder 10kg, starch 200kg, 5kg of mannitol, 20kg of microcrystalline cellulose, 5kg of povidone K-30, 10kg of sodium carboxymethyl starch, 5kg of sodium lauryl sulfate, and 10kg of neotame are mixed uniformly in an equal amount to obtain a mixed powder;
  • T4 Take the mixed powder under T3, add 70-80% ethanol solution to make soft material while stirring, granulate through 20 mesh sieve, dry at 63 °C for 4 hours, control moisture to 2-4%, pass 20 mesh sieve Granules, obtained granules;
  • T5. Weigh 1kg of magnesium stearate and 0.1kg of mint flavor according to the following parts by weight, and mix well with the particles under T4, and compress it.
  • a method for preparing an immunopotentiating composition comprising the steps of:
  • T1 Preparation of flower and fruit extract: Weigh the following raw materials by weight: 30kg of golden scented tea and 45kg of fresh mulberry; take the weighed golden tea, add 8 times of water, soak for 30 minutes, heat and reflux for 2 times, each After 40 minutes, filter, get the flower extract; take the weighed fresh mulberry, wash, extract the raw juice, filter, get the juice; mix the flower extract with the juice, concentrate under 80 ° C under reduced pressure, get 60 a flow extract having a relative density of 1.18 at ° C, spray-dried the flow extract, and controlling the drying temperature to 80 ° C to obtain a flower and fruit extract;
  • T2 Take vitamin C sodium, vitamin A, zinc gluconate, taurine, flower and fruit extract, spirulina powder, starch, mannitol, microcrystalline cellulose, povidone K-30, sodium carboxymethyl starch , sodium lauryl sulfate, aspartame, crushed, passed through a 100 mesh sieve, and used;
  • T2 Weigh the raw materials of T2 according to the following weights: vitamin C sodium 120kg, vitamin A 0.5kg, zinc gluconate 20kg, taurine 20kg, flower and fruit extract 15kg, spirulina powder 15kg, starch 300kg, 12kg of mannitol, 40kg of microcrystalline cellulose, 13kg of povidone K-30, 30kg of sodium carboxymethyl starch, 12kg of sodium lauryl sulfate, 20kg of aspartame, mixed uniformly in equal increments, and mixed powder ;
  • T4 Take the mixed powder under T3, add 70-80% ethanol solution to make soft material while stirring, and sieve through 30 mesh sieve, 65 °C Drying for 4 hours, controlling the moisture to 2-4%, passing through a 30 mesh sieve to obtain granules;
  • T5. Weigh 3kg of magnesium stearate and 0.3kg of mint flavor according to the following parts by weight, and mix well with the particles under T4, and compress it.
  • a method for preparing an immunopotentiating composition comprising the steps of:
  • T1 Preparation of flower and fruit extract: Weigh the following raw materials by weight: 40kg of golden tea and 6kg of fresh mulberry; take the weighed golden tea, add 10 times of water, soak for 30 minutes, ultrasonic extraction 3 times, each time 40 minutes, filtered, to get the flower extract; take the weighed fresh mulberry, wash, extract the raw juice, filter, get the juice; mix the flower extract with the juice, concentrate under 80 ° C under reduced pressure, get 60 ° C When the relative density is 1.22, the flow extract is placed in an oven for heating and drying, and the drying temperature is controlled to 65 ° C to obtain a flower and fruit extract;
  • T2 Take vitamin C sodium, vitamin A, zinc gluconate, taurine, flower and fruit extract, spirulina powder, starch, mannitol, microcrystalline cellulose, povidone K-30, sodium carboxymethyl starch , sodium lauryl sulfate, mogroside, crushed, passed through a 100 mesh sieve, and used;
  • T2 Weigh the raw materials of T2 according to the following weights: vitamin C sodium 200kg, vitamin A 1kg, zinc gluconate 30kg, taurine 30kg, flower and fruit extract 20kg, spirulina powder 20kg, starch 400kg, nectar 20 kg of alcohol, 60 kg of microcrystalline cellulose, 20 kg of povidone K-30, 50 kg of sodium carboxymethyl starch, 20 kg of sodium lauryl sulfate, 30 kg of mogroside, and mixed uniformly in an equal amount to obtain a mixed powder;
  • T4 Take the mixed powder under T3, add 70-80% ethanol solution to make soft material while stirring, granulate through 14 mesh sieve, dry at 60 °C for 4 hours, control moisture to 2-4%, pass through 14 mesh sieve Granules, obtained granules;
  • T5. Weigh 5kg of magnesium stearate and 0.5kg of mint flavor according to the following parts by weight, and mix well with the particles under T4, and compress it.
  • the samples of the above Examples 1-3 were respectively packaged with an aluminum-plastic composite film, and the stability was accelerated in the test chamber: temperature: 40 ⁇ 2° C., relative humidity: 75 ⁇ 5%, accelerated test for 3 months, and the results were as follows.
  • the stability of the 1-3 samples such as the appearance, taste, hardness, friability, and main component content, did not change significantly compared with the results of the sample measurement at 0, and the taste of the taste did not change.
  • the sample quality is relatively stable and can meet the stability requirements of storage, transportation and use.
  • the test results are shown in Table 4.

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Abstract

一种增强免疫力的组合物，该组合物包括以下重量份的组分：维生素C钠 50-200份、维生素A 0.1-1份、葡萄糖酸锌10-30份、牛磺酸10-30份、花果提取物10-20份、螺旋藻粉10-20份。所述花果提取物由以下重量份原料制成：金花茶20-40份、鲜桑葚30-60份。

Description

一种增强免疫力的组合物及其制备方法 技术领域
本发明属于药品、保健食品、食品领域，涉及一种组合物制剂及其制备方法，特别是涉及一种增强免疫力的组合物及其制备方法。
背景技术
现代人由于工作繁忙、平时饮食的不注意等原因，导致很多人的免疫力低下，身体都处于亚健康状态，如不注意将会发展为疾病甚至危及生命。随着生活水平的提高，人们对健康也日益重视，故希望使用的产品也是安全有效的，而“药食同源”类中药以及一些具有保健作用的瓜果符合人们的治疗疾病、保健需求。本发明在西药的基础上加入合适的“药食同源”类中药，制成一种增强免疫力的组合物，此组合物含有丰富的营养物质及改善人体健康的有效成分，具有增强免疫力、清热解毒、降血压、血糖、血脂、抗癌、美容养颜等功效，还可以补充人体所需的营养、缓解疲劳、延缓衰老，特别针对妇女、中老年人的健体美颜、抗衰老以及免疫力低下的癌症患者的康复。
维生素C是临床基本常用药物或营养补充剂，是抗氧化维生素当中的一种，它参与体内羟化反应，为形成骨骼、牙齿、结缔组织及非上皮组织细胞间粘物所必需，可维持牙齿、骨骼、血管的正常功能，增加对疾病的抵抗能力，为人体必需的营养元素之一，广泛应用于多种疾病预防和治疗。维生素C钠是维生素C的钠盐，水溶液pH值接近中性，它的作用与维生素C相同，但由于是钠盐，所以性能更稳定，同时不再有维生素C的强酸性，可以长期与多种药物同时服用，更优于维生素C。
片剂质量稳定、服用方便，是一种最基本、最常用的制剂形式。然而，对于儿童、老人以及吞咽困难的患者，普通片剂往往服用困难，长期服药甚至会使其产生心理上的拒药现象，咀嚼片则可弥补这种不足。咀嚼片是一类可在口腔内嚼碎后咽下的片剂，大小一般与普通片剂相同，可根据需要制成不同形状的异形片。药片经嚼碎后便于吞服，药片表面积增大，可促进药物在体内的溶解、吸收。对于难崩解的药物，制成咀嚼片可加速其崩解，提高药效。咀嚼片服用方便，即使在缺水的条件下也可以按时用药，特别适用于小儿、老人、吞咽困难或胃肠功能较差的患者，可减少药物对胃肠道的负担。因此，咀嚼片剂应用逐渐广泛起来。
发明内容
本发明针对现有含维生素C咀嚼片溶解后酸性大、对口腔、咽喉食道以及胃粘膜刺激较大、不宜长期服用，及存储过程中维生素C容易氧化失效、咀嚼片易吸湿受潮等问题，提供 一种增强免疫力同时具有清热解毒、降血压、血糖、血脂、抗癌、美容养颜等功效的组合物及其制备方法，解决了临床上应用维生素C存在的质量不稳定、不易长期服用的等问题。本发明增强免疫力的组合物，安全、无毒副作用，可长期用于改善免疫力低下以及妇妇、中老年人的健体美颜、抗衰老及免疫力低下的癌症患者的康复；或作为营养补充剂长期服用。
为解决上述技术问题，本发明是通过以下技术方案实现的：
一种增强免疫力的组合物，包括以下重量份的组分：维生素C钠50-200份、维生素A 0.1-1份、葡萄糖酸锌10-30份、牛磺酸10-30份、花果提取物10-20份、螺旋藻粉10-20份。
以上所述花果提取物由以下重量份的原料制成：金花茶20-40份、鲜桑葚30-60份。
以上所述花果提取物的制备方法为：
S1：按以下重量份称取原料：金花茶5-10份、鲜桑葚30-60份；
S2：取称量好的金花茶，加6-10倍量水，浸泡30分钟，提取2-3次，每次30-40分钟，滤过，得花提取液；
S3：取称量好的鲜桑葚，洗净，榨取原汁，滤过，得果汁；
S4：将花提取液与果汁混合，80℃以下减压浓缩，得60℃时相对密度为1.18-1.22的流浸膏，将流浸膏进行干燥，控制干燥温度为65-80℃，得花果提取物。
所述步骤S2项下提取方法优选为加热回流提取、超声提取。
所述步骤S4项下干燥方法优选为烘箱加热干燥、喷雾干燥。
以上所述的增强免疫力的组合物，优选还包括以下重量份的组分：淀粉200-400份、甘露醇5-20份、微晶纤维素20-60份、聚维酮K-30 5-20份、羧甲基淀粉钠10-50份、十二烷基硫酸钠5-20份、硬脂酸镁1-5份、甜味剂10-30份、薄荷香精0.1-0.5份。
以上所述的增强免疫力的组合物，最佳优选包括以下重量份的组分：维生素C钠120份、维生素A 0.5份、葡萄糖酸锌20份、牛磺酸20份、花果提取物15份、螺旋藻粉15份、淀粉300份、甘露醇12份、微晶纤维素40份、聚维酮K-30 13份、羧甲基淀粉钠30份、十二烷基硫酸钠12份、硬脂酸镁3份、甜味剂20份、薄荷香精0.3份。
以上所述花果提取物由以下重量份的原料制成：金花茶30份、鲜桑葚45份。
以上所述增强免疫力的组合物，所述甜味剂优选为阿斯巴甜、纽甜、罗汉果甜苷。
以上所述增强免疫力的组合物的制备方法，包括如下步骤：
T1：花果提取物的制备：按重量份称取以下原料：金花茶20-40份、鲜桑葚30-60份；取称量好的金花茶，加6-10倍量水，浸泡30分钟，提取2-3次，每次30-40分钟，滤过， 得花提取液；取称量好的鲜桑葚，洗净，榨取原汁，滤过，得果汁；将花提取液与果汁混合，80℃以下减压浓缩，得60℃时相对密度为1.18-1.22的流浸膏，将流浸膏进行干燥，控制干燥温度为65-80℃，得花果提取物；
T2：分别取维生素C钠、维生素A、葡萄糖酸锌、牛磺酸、花果提取物、螺旋藻粉、淀粉、甘露醇、微晶纤维素、聚维酮K-30、羧甲基淀粉钠、十二烷基硫酸钠、甜味剂，粉碎，过100目筛，备用；
T3.分别按配方量称取T1项下各原辅料，以等量递增法混合均匀，得混合粉；
T4.取T3项下的混合粉，一边搅拌一边加70-80％乙醇溶液制软材、过筛制粒，干燥4小时，控制水分为2-4％，过筛整粒，得颗粒；
T5.按配方量称取硬脂酸镁、薄荷香精，与S3项下颗粒混合均匀，压片，即得。
所述步骤T4项下干燥的温度优选为60-65℃,这样得到的颗粒硬度适中，更有利于压片；所述步骤T4项下所述的过筛步骤所用的筛网优选为14-30目。
本发明的有益效果是：
1.本发明克服现有含维生素C咀嚼片溶解后酸性大、对口腔、咽喉食道以及胃粘膜刺激较大、不宜长期服用，及存储过程中维生素C容易氧化失效、咀嚼片易吸湿受潮等问题，使产品稳定性更好，疗效更确切，适用于消费者或患者长期服用，无副作用。
2.本发明方中花果提取物的各原料以及螺旋藻均为“药食同源”品种，安全无毒副作用。其中金花茶是一种药用价值、保健价值极高的植物，为广西特有，属无毒级，含有400多种营养物质，经研究表明金花茶对于调节人体血脂、血糖、胆固醇，增强机体免疫力有明显的效果，在民间一直被用于提神醒脑、清肝火、解热毒、养元气；桑葚，味甘，性寒，含有丰富的活性蛋白、维生素、氨基酸、胡萝卜素、矿物质、黄酮等多种活性成分，具有增强人体免疫力、营养肌肤、延缓衰老、生津止渴、促进消化、补肝益肾、滋阴补血等功效，被称为“民间圣果”；螺旋藻，含有丰富的优质蛋白质、β胡萝卜素、维生素、以及多种人体必需的微量元素，螺旋藻中还含很高的γ-亚麻酸，具有增强免疫系统、抗衰老、抗疲劳、降血压、血糖、血脂、抗肿瘤等作用，由于其保健作用极强，被称为最佳天然绿色保健食品；以上三种原料，通过与维生素C钠等西药成分合理配制，具有增强免疫力、清热解毒、降血压、血糖、血脂、抗癌、美容养颜等功效，还可以补充人体所需的营养、缓解疲劳、延缓衰老，特别针对妇女、中老年人的健体美颜、抗衰老以及免疫力低下的癌症患者的康复。
3.本发明增强免疫力的组合物，制剂简便，颗粒流动性好，压片不粘冲，所制得的片剂表面光滑，不易吸湿，口感香甜，质量稳定，利于携带、方便食用，尤其适用于儿童、老年 人和不能吞咽固体制剂的患者，生物利用度高，使用更安全有效，可作为营养补充液长期服用。
具体实施方式
虽然本说明书通过特别指出并清楚要求保护本发明的权利要求书作出结论，但应该相信下列说明将更好地理解本发明。
如本文所用，单词“优选”及变体是指在特定环境下能够提供特定有益效果的本发明的实施方案。然而，其它的实施方案在相同或其它的环境下也可以是优选的。此外，一个或多个优选实施方案的详述并不表示其它实施方案是无用的，并且不旨在从本发明的范畴排除其它的实施方案。
一、制剂条件筛选
1.润湿剂选择
润湿剂能使粉粒润湿，呈现粘性，以利于制备颗粒，压成片剂。本发明对比了干法压片、湿法制粒再压片，干法压片采用普通压片机效果不好，对设备要求高，故本发明采用湿法制粒再压片。试验中对比了20％麦芽糊精、30％淀粉浆、40％蔗糖糖浆、5％羟丙甲纤维素水溶液、80％乙醇做润湿剂，结果见表1。
表1润湿剂考察结果表
Figure PCTCN2017108403-appb-000001
从表1中的试验结果可知:本发明使用80％乙醇制粒情况效果最好，故本发明润湿剂选择乙醇。为进一步优化乙醇浓度，本发明继续优化乙醇浓度，试验结果见表2。
表2乙醇浓度考察结果表
序号 湿润剂 制粒情况 颗粒外观
1 50％乙醇 成团，制粒困难 颗粒紧
2 60％乙醇 成团，制粒困难 颗粒紧
3 70％乙醇 成团，制粒不结块 颗粒松紧合适
4 80％乙醇 成团，制粒不结块 颗粒松紧合适
5 90％乙醇 不成团，制粒困难 颗粒松
从表2中的试验结果可知:本发明使用70％-80％乙醇制粒情况效果较好，浓度低太紧，浓度高太松，均影响制粒，故本发明润湿剂选择70％-80％乙醇。
2.润滑剂的选择
压片时为增加颗粒的流动性，使填充良好、片剂密度分布均匀，需加入一定的润滑剂，以解决压片时出现颗粒流动性差、易粘冲等现象。本发明试验中对比了硬脂酸镁、微粉硅胶、滑石粉、十二烷基硫酸钠、甘露醇做润滑剂时的压片情况，结果见表3。
表3润滑剂试用结果表
Figure PCTCN2017108403-appb-000002
从表3中的试验结果可知:加入硬脂酸镁、十二烷基硫酸钠、甘露醇，流动性均较好，且压片不粘冲，压出来的片硬度合适，片面光滑美观，加入微粉硅胶，流动性好，压片时不粘冲，但压出来的片硬度低，加入滑石粉，流动性不好，压片时粘冲，压出来的片硬度大。故本发明选用硬脂酸镁、十二烷基硫酸钠、甘露醇作为润滑剂。为了调节咀嚼片的口感以及基于对生产成本的考虑，本发明试验中还对比了硬脂酸镁、十二烷基硫酸钠、甘露醇三者的比例，结果表明：硬脂酸镁、十二烷基硫酸钠、甘露醇三者的比例为3:3:1或者4:4:1其口感达到最佳。
4.矫味剂的选择
只有具有良好口感的咀嚼片才易被人们接受，因此，风味、口感非常重要，而此往往通过甜味剂、香精等矫味剂的选择来实现。本发明试验中对比如下甜味剂：蔗糖、乳糖、葡萄糖、甜菊糖、甘草酸二钠、阿斯巴甜、糖精钠、环己基氨基磺酸钠、罗汉果甜苷、纽甜、阿力甜，结果表明：上述甜味剂中阿斯巴甜、罗汉果甜苷、纽甜，在组分中比例为“甜味剂10-30份”的范围内与薄荷香精配合使用，口感风味好，甜度适中，没有不适感，其中阿斯巴甜口感最佳。故本发明选用阿斯巴甜、罗汉果甜苷、纽甜为甜味剂，并规定其加入量为10-30份。
二、缓解视疲劳的组合物的制备方法
实施例1
增强免疫力的组合物的制备方法，包括如下步骤：
T1：花果提取物的制备：按重量份称取以下原料：金花茶20kg、鲜桑葚30kg；取称量 好的金花茶，加6倍量水，浸泡30分钟，超声提取3次，每次30分钟，滤过，得花提取液；取称量好的鲜桑葚，洗净，榨取原汁，滤过，得果汁；将花提取液与果汁混合，80℃以下减压浓缩，得60℃时相对密度为1.20的流浸膏，将流浸膏进行喷雾干燥，控制干燥温度为70℃，得花果提取物；
T2：分别取维生素C钠、维生素A、葡萄糖酸锌、牛磺酸、花果提取物、螺旋藻粉、淀粉、甘露醇、微晶纤维素、聚维酮K-30、羧甲基淀粉钠、十二烷基硫酸钠、纽甜，粉碎，过100目筛，备用；
T3.分别按以下重量份称取T2项下各原辅料：维生素C钠50kg、维生素A 0.1kg、葡萄糖酸锌10kg、牛磺酸10kg、花果提取物10kg、螺旋藻粉10kg、淀粉200kg、甘露醇5kg、微晶纤维素20kg、聚维酮K-30 5kg、羧甲基淀粉钠10kg、十二烷基硫酸钠5kg、纽甜10kg，以等量递增法混合均匀，得混合粉；
T4.取T3项下的混合粉，一边搅拌一边加70-80％乙醇溶液制软材、过20目筛制粒，63℃干燥4小时，控制水分为2-4％，过20目筛整粒，得颗粒；
T5.按以下重量份称取硬脂酸镁1kg、薄荷香精0.1kg，与T4项下颗粒混合均匀，压片，即得。
实施例2
增强免疫力的组合物的制备方法，包括如下步骤：
T1：花果提取物的制备：按重量份称取以下原料：金花茶30kg、鲜桑葚45kg；取称量好的金花茶，加8倍量水，浸泡30分钟，加热回流提取2次，每次40分钟，滤过，得花提取液；取称量好的鲜桑葚，洗净，榨取原汁，滤过，得果汁；将花提取液与果汁混合，80℃以下减压浓缩，得60℃时相对密度为1.18的流浸膏，将流浸膏进行喷雾干燥，控制干燥温度为80℃，得花果提取物；
T2：分别取维生素C钠、维生素A、葡萄糖酸锌、牛磺酸、花果提取物、螺旋藻粉、淀粉、甘露醇、微晶纤维素、聚维酮K-30、羧甲基淀粉钠、十二烷基硫酸钠、阿斯巴甜，粉碎，过100目筛，备用；
T3.分别按以下重量份称取T2项下各原辅料：维生素C钠120kg、维生素A 0.5kg、葡萄糖酸锌20kg、牛磺酸20kg、花果提取物15kg、螺旋藻粉15kg、淀粉300kg、甘露醇12kg、微晶纤维素40kg、聚维酮K-30 13kg、羧甲基淀粉钠30kg、十二烷基硫酸钠12kg、阿斯巴甜20kg，以等量递增法混合均匀，得混合粉；
T4.取T3项下的混合粉，一边搅拌一边加70-80％乙醇溶液制软材、过30目筛制粒，65℃ 干燥4小时，控制水分为2-4％，过30目筛整粒，得颗粒；
T5.按以下重量份称取硬脂酸镁3kg、薄荷香精0.3kg，与T4项下颗粒混合均匀，压片，即得。
实施例3
增强免疫力的组合物的制备方法，包括如下步骤：
T1：花果提取物的制备：按重量份称取以下原料：金花茶40kg、鲜桑葚6kg；取称量好的金花茶，加10倍量水，浸泡30分钟，超声提取3次，每次40分钟，滤过，得花提取液；取称量好的鲜桑葚，洗净，榨取原汁，滤过，得果汁；将花提取液与果汁混合，80℃以下减压浓缩，得60℃时相对密度为1.22的流浸膏，将流浸膏放进烘箱进行加热干燥，控制干燥温度为65℃，得花果提取物；
T2：分别取维生素C钠、维生素A、葡萄糖酸锌、牛磺酸、花果提取物、螺旋藻粉、淀粉、甘露醇、微晶纤维素、聚维酮K-30、羧甲基淀粉钠、十二烷基硫酸钠、罗汉果甜苷，粉碎，过100目筛，备用；
T3.分别按以下重量份称取T2项下各原辅料：维生素C钠200kg、维生素A 1kg、葡萄糖酸锌30kg、牛磺酸30kg、花果提取物20kg、螺旋藻粉20kg、淀粉400kg、甘露醇20kg、微晶纤维素60kg、聚维酮K-30 20kg、羧甲基淀粉钠50kg、十二烷基硫酸钠20kg、罗汉果甜苷30kg，以等量递增法混合均匀，得混合粉；
T4.取T3项下的混合粉，一边搅拌一边加70-80％乙醇溶液制软材、过14目筛制粒，60℃干燥4小时，控制水分为2-4％，过14目筛整粒，得颗粒；
T5.按以下重量份称取硬脂酸镁5kg、薄荷香精0.5kg，与T4项下颗粒混合均匀，压片，即得。
三、稳定性试验
将上述实施例1-3样品分别用铝塑复合膜包装好，置稳定性加速试验箱内试验:温度：40±2℃，相对湿度：75±5％，加速试验3个月，结果实施例1-3样品的外观性状、口感、硬度、脆碎度、主要成分含量等稳定性重点考察指标与0时样品测定结果比较，均无明显变化，口感风味也没有变化，说明本发明实施例1-3样品质量较为稳定，可满足贮存、运输、使用的稳定性要求。试验结果见表4。
表4增强免疫力的组合物稳定性试验结果表
Figure PCTCN2017108403-appb-000003
Figure PCTCN2017108403-appb-000004

Claims (12)

  1. 一种增强免疫力的组合物，其特征在于，包括以下重量份的组分：维生素C钠50-200份、维生素A 0.1-1份、葡萄糖酸锌10-30份、牛磺酸10-30份、花果提取物10-20份、螺旋藻粉10-20份；
    所述花果提取物由以下重量份的原料制成：金花茶20-40份、鲜桑葚30-60份。
  2. 如权利要求1所述的增强免疫力的组合物，其特征在于，所述花果提取物的制备方法为：
    S1：按以下重量份称取原料：金花茶20-40份、鲜桑葚30-60份；
    S2：取称量好的金花茶，加6-10倍量水，浸泡30分钟，提取2-3次，每次30-40分钟，滤过，得花提取液；
    S3：取称量好的鲜桑葚，洗净，榨取原汁，滤过，得果汁；
    S4：将花提取液与果汁混合，80℃以下减压浓缩，得60℃时相对密度为1.18-1.22的流浸膏，将流浸膏进行干燥，控制干燥温度为65-80℃，得花果提取物。
  3. 如权利要求2所述的增强免疫力的组合物，其特征在于，步骤S2项下提取方法为加热回流提取、超声提取。
  4. 如权利要求2所述的增强免疫力的组合物，其特征在于，步骤S4项下干燥方法为烘箱加热干燥、喷雾干燥。
  5. 如权利要求2－4中任一所述的增强免疫力的组合物，其特征在于，加辅料制成保健食品、食品上允许的制剂。
  6. 如权利要求5所述的增强免疫力的组合物，其特征在于，所述制剂为颗粒剂、丸剂、片剂、胶囊、口服液、糖浆剂、饮料或茶饮。
  7. 如权利要求6所述的增强免疫力的组合物，其特征在于，所述片剂为咀嚼片。
  8. 一种如权利要求7所述的增强免疫力的组合物制成咀嚼片，其特征在于，还包括以下重量份的组分：淀粉200-400份、甘露醇5-20份、微晶纤维素20-60份、聚维酮K-30 5-20份、羧甲基淀粉钠10-50份、十二烷基硫酸钠5-20份、硬脂酸镁1-5份、甜味剂10-30份、薄荷香精0.1-0.5份。
  9. 一种如权利要求8所述的增强免疫力的组合物制成咀嚼片的制备方法，其特征在于，包括以下步骤：
    T1：花果提取物的制备：按重量份称取以下原料：金花茶20-40份、鲜桑葚30-60份；取称量好的金花茶，加6-10倍量水，浸泡30分钟，提取2-3次，每次30-40分钟，滤过，得花提取液；取称量好的鲜桑葚，洗净，榨取原汁，滤过，得果汁；将花提取液与果汁混合，80℃以下减压浓缩，得60℃时相对密度为1.18-1.22的流浸膏，将流浸膏进行干燥，控制干燥温度为65-80℃，得花果提取物；
    T2：分别取维生素C钠、维生素A、葡萄糖酸锌、牛磺酸、花果提取物、螺旋藻粉、淀粉、甘露醇、微晶纤维素、聚维酮K-30、羧甲基淀粉钠、十二烷基硫酸钠、甜味剂，粉碎，过100目筛，备用；
    T3.分别按配方量称取T1项下各原辅料，以等量递增法混合均匀，得混合粉；
    T4.取T3项下的混合粉，一边搅拌一边加70-80％乙醇溶液制软材、过筛制粒，干燥4小时，控制水分为2-4％，过筛整粒，得颗粒；
    T5.按配方量称取硬脂酸镁、薄荷香精，与S3项下颗粒混合均匀，压片，即得。
  10. 如权利要求9所述的增强免疫力的组合物制成咀嚼片的制备方法，其特征在于，步骤T4项下干燥的温度为60-65℃。
  11. 如权利要求9所述的增强免疫力的组合物制成咀嚼片的制备方法，其特征在于，步骤T4项下所述的过筛步骤所用的筛网为14-30目。
  12. 如权利要求8-9中任一所述的增强免疫力的组合物制成的咀嚼片，其特征在于，所述甜味剂为阿斯巴甜、纽甜、罗汉果甜苷。
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