CN110755384A - Effervescent granules containing lutein ester - Google Patents
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- CN110755384A CN110755384A CN201911029163.1A CN201911029163A CN110755384A CN 110755384 A CN110755384 A CN 110755384A CN 201911029163 A CN201911029163 A CN 201911029163A CN 110755384 A CN110755384 A CN 110755384A
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- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
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Abstract
The invention provides an effervescent granule containing lutein ester, which takes calcium carbonate as an alkali source, and the weight ratio of lutein ester micro-capsule powder, calcium carbonate and an acid source is 1: 3.3-3.7: 4-4.5; the effervescent granule not only further improves the bioavailability of lutein ester, but also greatly improves the compliance of taking the lutein ester, is beneficial to continuously supplementing lutein for people and protecting eye health.
Description
Technical Field
The invention relates to an effervescent granule containing lutein ester, belonging to the field of preparations.
Background
Blue light is light with relatively high energy at wavelengths between 400nm and 480nm and is able to penetrate the lens and reach the retina. Blue light irradiation of the retina produces free radicals which cause retinal pigment epithelium to die, resulting in a deficiency of nutrients to light sensitive cells causing vision impairment, and these impairments are irreversible. The blue light can also increase the amount of toxins in the macular region in the eye, and seriously threatens the health of the eyeground of people. The damage to the eye by blue light is exacerbated as the length of exposure increases.
In the rapid development of science and technology, blue light is ubiquitous, and lighting equipment, office/study equipment and sunlight all contain a large amount of blue light, such as computer displays, fluorescent lamps, mobile phones, digital products, display screens, LED lamps and the like, and the blue light surrounds the blue light, so that two eyes are exposed to the blue light for a long time and are full of the damage of the blue light. Leading to the remarkable increase of people with myopia, eye fatigue, fundus aging and macular degeneration in recent years. The incidence rate of the asthenopia syndrome is nearly 50%, although the asthenopia syndrome is not a fatal disease, the health threat to human body is not small, and the asthenopia syndrome can be developed from partial discomfort of eyes to general symptoms such as listlessness, vertigo, headache, memory deterioration and the like, so that the psychology and mental health of people are influenced.
The lutein has the functions of filtering blue light and resisting oxidation, is a key nutrient element of eyes, and has certain importance in the global nutrition community. However, lutein is sensitive to factors such as light, high temperature and pH value and has poor stability, and lutein ester is decomposed into free lutein after being absorbed by human body, and has the basic function of supplementing lutein lost from human body with crystalline lutein, so that lutein ester is usually adopted as nutrient for supplement.
The currently available lutein ester products are mainly tablets and capsules, and a lot of problems are exposed in the practical application process, for example, buccal tablets or chewable tablets can stain and yellow teeth and tongues, and cannot be eaten in working and social time; the common tablet and capsule not only have low bioavailability, but also have limited application due to swallow strong foreign body discomfort. However, the water-insoluble property of lutein ester makes it impossible to prepare effervescent, granule, oral liquid and other dosage forms. Although the water solubility of the existing lutein ester microcapsule powder raw material is obviously improved, the inclusion rate of the microcapsule powder raw material reaches a bottleneck, complete inclusion cannot be realized, the lutein ester which is not included can be adhered to the wall of a cup after being dispersed in water, a very obvious yellow mark is left, the lutein ester cannot be washed off by water, and the lutein ester can be cleaned only by using detergents such as washing agent. This phenomenon, on the one hand, leads to loss of nutrients and, more importantly, to the loss of food which is troublesome for many people. Lutein needs to be continuously supplemented for a long time to achieve the purposes of protecting and nourishing eyes, so that the improvement of compliance and bioavailability of lutein ester preparations is very necessary.
Disclosure of Invention
The technical problem to be solved by the invention is to provide a lutein ester preparation with better compliance and higher bioavailability, so that people can conveniently and enjoyably continuously supplement lutein to achieve the aim of protecting eye health.
The invention provides an effervescent granule containing lutein ester, wherein the lutein ester is lutein ester microcapsule powder, the alkali source of the effervescent granule is calcium carbonate, and the weight ratio of the lutein ester microcapsule powder, the calcium carbonate and the acid source is 1: 3.3-3.7: 4-4.5. The lutein ester microcapsule powder is prepared by coating lutein ester into a powdery substance by a high-quality wall material by utilizing a microcapsule technology, so that the water solubility of the lutein ester microcapsule powder is improved. The lutein ester microcapsule powder used in the present invention is of 5% specification, i.e. approximately 5 g of lutein ester is contained in one hundred g of lutein ester microcapsule powder. When the lutein ester microcapsule powder with other specifications is selected, the dosage relationship of the lutein ester microcapsule powder, the lutein ester microcapsule powder and the lutein ester microcapsule powder can be adjusted under the guidance of the technical scheme of the invention to achieve the purpose of the invention.
Most of the lutein ester is dissolved in water by other means, and the wall hanging phenomenon caused by a small amount of insoluble lutein ester can be solved by the technical scheme of the invention.
The effervescent granule is put into water in vitro, reacts and disintegrates rapidly, and is dissolved into liquid state, the process generally only needs 1-3 minutes, the liquid is distributed in a large area in the gastrointestinal tract after oral administration, and the blood can be absorbed in about 10-30 minutes. While the common tablet or capsule is slowly disintegrated in the stomach and intestine, generally 15-60 minutes is needed, the effective components can be absorbed into the blood after dissolution, and 2-3 hours, even one or two days is needed for achieving the effective blood concentration. Therefore, the bioavailability of the effervescent granules is obviously higher than that of common tablet capsules.
The effervescence technology relies on the reaction of an acid source and an alkali source in water to release a large amount of carbon dioxide, which is like boiling. Commonly used acid sources are: citric acid, malic acid, tartaric acid, fumaric acid, boric acid, and the like; common sources of base are: sodium bicarbonate, sodium carbonate and mixtures thereof, potassium bicarbonate, and the like. The selection and the proportion of the acid source and the alkali source have obvious influence on the stability and the effect of the effervescent granules.
In order to solve the problems of low dyeing, foreign body sensation (compliance) and bioavailability of the existing lutein ester preparation product, the inventor tries to prepare the lutein ester preparation into effervescent granules, and tests are carried out on different combinations of lutein ester microcapsule powder, common alkali sources and acid sources of various manufacturers. However, the raw materials of all manufacturers have different wall hanging problems except the different degrees of effervescence and taste, and the wall hanging is relatively light when the effervescence is severe because the wall hanging is influenced by the intensity of effervescence. The lutein ester is a natural fat-soluble pigment, a small amount of non-included lutein ester can be adhered to the wall of a water cup, the annular imprint of the water surface height after brewing is the most serious, the deeper the imprint is, the deeper the color is, the lutein ester cannot be washed clean by water, and people feel sticky and uncomfortable.
When a test sample and a calcium supplement effervescent granule are brewed simultaneously for drinking, the inventor unexpectedly finds that the wall hanging phenomenon is relieved, and the alkali source of the calcium supplement effervescent granule is calcium carbonate. The alkali source is replaced by calcium carbonate which is less used (the nature of calcium carbonate causes it to react slower with common acid sources than sodium bicarbonate and sodium carbonate). A large number of comparison experiments show that the wall-hanging phenomenon of the lutein ester can be obviously improved when the weight ratio of the lutein ester microcapsule powder, the calcium carbonate and the acid source is within the range of 1: 3.3-3.7: 4-4.5. Among acid sources, the bubbling effect of fumaric acid is poor, and the wall built-up alleviating effect is relatively weak; the tartaric acid effervescence effect is good, but precipitates with calcium element easily; citric acid and/or malic acid are preferred as the acid source. Particularly, when the mixture of citric acid and malic acid mixed according to the proportion of 1: 0.8-1.2 is used as an acid source, the effervescent effect is optimal. In a preferred embodiment, the weight ratio of lutein ester microcapsule powder, calcium carbonate and acid source is 1: 3.5: 4.2.
The wall-hanging phenomenon of the lutein ester is relieved by specifically generating microscopic changes in the effervescent reaction process by taking calcium carbonate as an alkali source, but the experimental result shows that the more sufficient the calcium carbonate reacts with an acid source, the poorer the wall-hanging relieving effect is, and the calcium carbonate possibly plays a certain adsorption role. Therefore, when the weight ratio of the lutein ester microcapsule powder, the calcium carbonate and the acid source is in the range of 1: 3.3-3.7: 4-4.5, although the wall hanging phenomenon is basically solved, a small amount of calcium carbonate is precipitated at the bottom of a cup when the solution after the effervescence reaction is kept still for about 1 hour, and although a small amount of water can be added for shaking up and drinking, the situation is ambiguous for consumers who do not know the situation.
In order to solve the defect, the effervescent granules containing lutein ester also contain β -carotene microcapsule powder, wherein the β -carotene microcapsule powder is 1% in specification, has good water solubility, can promote eye health, has certain thickening and toning effects, can enable a small amount of unreacted calcium carbonate to be in a suspension state, gives consideration to taste and a solution state after effervescence, the dosage ratio of the lutein ester microcapsule powder to the β -carotene microcapsule powder is preferably 1: 1.5-2.5, in another preferred embodiment is 1: 2, and when β -carotene microcapsule powder with other specifications is selected, the optimal dosage can be obtained only by limited tests under the guidance of the technical scheme of the invention.
In continuous attempts of the preparation method of the effervescent granules, the inventor finds that the preparation process also has influence on the wall-hanging phenomenon, and finally the wall-hanging problem of the lutein ester is thoroughly solved, and the specific method comprises the following steps: the lutein ester microcapsule powder is firstly mixed with calcium carbonate and then mixed with an acid source.
The preparation method of the effervescent granules further comprises the following steps:
(1) uniformly mixing lutein ester microcapsule powder and calcium carbonate to obtain a mixture 1;
(2) mixing citric acid and malic acid, and mixing with β -carotene microcapsule powder to obtain mixture 2;
(3) mixing mixture 1 and mixture 2 uniformly.
In order to further adjust the taste and facilitate the production and the split charging, the effervescent granules also comprise a filling agent and a flavoring agent. The filler and the flavoring agent are water-soluble common adjuvants, such as lactose, mannitol, maltodextrin, starch and other fillers, and sweetening agent, aromatic and other flavoring agents, and are known in the art and are not described again. At the moment, the effervescent granules are prepared by the following method:
(1) uniformly mixing a flavoring agent, lutein ester microcapsule powder and calcium carbonate according to an equivalent incremental method to obtain a mixture 1;
(2) mixing citric acid and malic acid, and mixing with β -carotene microcapsule powder to obtain mixture 2;
(3) mixing mixture 1 and mixture 2, and mixing with filler.
The effervescent granules containing lutein ester are very simple in preparation method, links such as granulating, drying, tabletting or encapsulating are not needed, damage to effective components in the production process is reduced, the production efficiency is improved, and the production cost is reduced.
The effervescent granule containing lutein ester can also contain other components which are beneficial to eye health, such as water-soluble substances like vitamin A, vitamin E, vitamin C, zinc gluconate and the like, or substances which are soluble after treatment.
Compared with the existing similar products, the effervescent granules containing lutein ester not only further improve the bioavailability of active ingredients, but also more importantly, because the product is convenient to take and good in taste, the nutrient supplement can be completed in the process of enjoying delicacy for people, and the long-term continuous eating of people is facilitated, and the most important factor for generating effect is the insisting supplement. Meanwhile, a new process thought is provided for the effervescent granules, the production process is simplified, and the use of production equipment and workshops is reduced, so that the production cost is reduced, and the production efficiency is improved.
The inventors further verified the technical effects of the present invention through experiments.
Restated again: the following tests are only exemplary experiments in many experiments in the process of developing the invention, and do not cover and exhaust all the experiments performed by the inventor for the invention, and the purpose is to use those data to illustrate the influence of different acid sources and alkali sources on the wall hanging condition of lutein ester effervescent granules and the beneficial effect of the product of the invention on the relief of asthenopia.
Test one: wall hanging effect comparison of different formulas
The experimental method comprises the following steps: the raw materials are weighed according to the proportion in the table 1 and are directly and uniformly mixed to prepare the formula 1-7. Weighing samples (single dose) of each part respectively, placing the samples in white porcelain cups, adding 50ml of warm water respectively, stirring, standing for 10 minutes, pouring out liquid, observing the color (color 1 for short) of the original water surface of the cup wall, then adding 20ml of warm water respectively, shaking, pouring out, observing the color (color 2 for short) of the cup wall again, and comparing the difference among the parts.
TABLE 1 Experimental formulation (mg)
The experiment result shows that the wall-hanging phenomenon is obvious in different combinations of the sodium bicarbonate and the sodium carbonate with the citric acid, the malic acid and the tartaric acid, and the wall-hanging phenomenon is relieved to different degrees when the calcium carbonate is used as an alkali source. And the proportion of the calcium carbonate and the acid source, the variety and the dosage of the acid source also influence the effect of relieving the wall hanging, the wall hanging phenomenon basically disappears when the proportion is 7, and the wall hanging is thoroughly improved by process optimization.
And (2) test II: clinical observation of asthenopia relieving effect
1. Test method
70 patients (all non-physical workers, aged 18-60 years; excluding patients with other diseases and pregnant or pregnant and lactating women) diagnosed as asthenopia in Beijing Hospital were selected and randomly divided into 2 groups of 35 patients each.
Test group 1, example 7 was given 1 time a day, 2 bags each time, and was taken with warm water;
test 2 groups, the commercially available blueberry lutein ester tabletted candies were administered 1 time a day, 4 tablets each time, and swallowed.
The taking period is 2 months, and the scoring conditions of the visual fatigue clinical symptoms before and after taking are compared.
2. The tested people group in the group and fall off
TABLE 2 basic conditions of the test person
As can be seen from Table 2, the test subjects had a balanced comparability between 2 groups with respect to age and gender, and 7 subjects were dropped during the test, wherein 1 subject dropped due to missed visits and 6 subjects dropped (unwilling to continue) due to active abandonment in the test 2.
3. Grading standard and pre-test grading condition
At present, there is no clear international diagnostic standard, and the test standard is formulated with reference to "clinical practice guidelines (ophthalmology book) written by the chinese medical society in 2007, which is specifically shown in table 3.
TABLE 3 Scoring standards
TABLE 4 comparison of clinical symptom scores of the two groups before the trial
As can be seen from Table 4, the difference between the clinical symptom scores of the two groups before the test is not statistically significant (P is more than 0.05), and the conditions of the western medicine before the treatment of the three groups of patients are equivalent and have balanced comparability.
4. Test results
After two groups of test persons took the corresponding lutein ester product for 2 months, clinical symptom scoring was performed again, and the results are shown in table 5.
TABLE 5 comparison of clinical symptom scores of the two groups after the test
The results in Table 5 show that the clinical symptoms of the visual fatigue of the two groups of the tested people are improved compared with the values before the lutein ester product is taken, and the effect of relieving the visual fatigue of the group 1 is obviously better than that of the group 2. After the test, the comparison of the clinical symptom scores of the two groups is less than 0.05, and the statistical significance is achieved.
The effervescent granule containing lutein ester of the present invention has excellent eye protecting effect compared with common tablet, and may be related to the following factors, that is, the eye nutrients in the product of the present invention, including lutein ester and β -carotene, calcium and calcium, are favorable to eye health, and have the functions of eliminating eye muscle tension and strengthening sclera toughness.
Detailed Description
Example 1
Effervescent granule containing lutein ester
Formula (1000 bags): lutein ester microcapsule powder 100g calcium carbonate 330g citric acid 220g malic acid 180g
The process comprises the following steps: uniformly mixing lutein ester microcapsule powder and calcium carbonate; mixing citric acid and malic acid; mixing the two parts, and packaging.
Example 2
Effervescent granule containing lutein ester
Formula (1000 bags): lutein ester microcapsule powder 100g calcium carbonate 370g citric acid 200g malic acid 200g
The process comprises the following steps: the same as in example 1.
Example 3
Effervescent granule containing lutein ester
Formula (1000 bags): lutein ester microcapsule powder 100g calcium carbonate 350g citric acid 250g malic acid 200g
The process comprises the following steps: same as example 1
Example 4
Effervescent granule containing lutein ester
Formula (1000 bags) comprises lutein ester microcapsule powder 100g β -carotene microcapsule powder 150g calcium carbonate 330g citric acid 430g
The process comprises the following steps:
1. uniformly mixing lutein ester microcapsule powder and calcium carbonate to obtain a mixture 1;
2. mixing citric acid and β -carotene microcapsule powder to obtain mixture 2;
3. mixing mixture 1 and mixture 2, and packaging.
Example 5
Effervescent granule containing lutein ester
Formula (1000 bags) comprises lutein ester microcapsule powder 100g calcium carbonate 350g malic acid 420g β -carotene microcapsule powder 200g sucralose 10g mannitol 420g
The process comprises the following steps:
1. uniformly mixing sucralose and lutein ester microcapsule powder by an equivalent incremental method, and then uniformly mixing the sucralose and lutein ester microcapsule powder with calcium carbonate to obtain a mixture 1;
2. uniformly mixing malic acid and β -carotene microcapsule powder to obtain mixture 2;
3. mixing mixture 1 and mixture 2, mixing with mannitol, and packaging.
Example 6
Effervescent granule containing lutein ester
Formula (1000 bags) comprises lutein ester microcapsule powder 100g calcium carbonate 340g citric acid 200g malic acid 240g β -carotene microcapsule powder 250g aspartame 12g maltodextrin 860g
The process comprises the following steps:
1. uniformly mixing aspartame and lutein ester microcapsule powder by an equivalent incremental method, and uniformly mixing with calcium carbonate to obtain a mixture 1;
2. mixing citric acid and malic acid, and mixing with β -carotene microcapsule powder to obtain mixture 2;
3. mixing mixture 1 and mixture 2, mixing with maltodextrin, and packaging.
Example 7
Effervescent granule containing lutein ester
Formula (1000 bags) comprises lutein ester microcapsule powder 100g calcium carbonate 360g citric acid 200g malic acid 250g β -carotene microcapsule powder 180g sucralose 9g orange essence 20g lactose 381g
The process comprises the following steps:
1. mixing sucralose and sweet orange essence uniformly, then mixing the sucralose and lutein ester microcapsule uniformly, and finally mixing the lutein ester microcapsule and calcium carbonate uniformly to obtain mixture 1;
2. mixing citric acid and malic acid, and mixing with β -carotene microcapsule powder to obtain mixture 2;
3. mixing mixture 1 and mixture 2, mixing with lactose, and packaging.
Example 8
Effervescent granule containing lutein ester
Formula (1000 bags) comprises lutein ester microcapsule powder 100g calcium carbonate 350g citric acid 210g malic acid 210g β -carotene microcapsule powder 200g sucralose 10g orange essence 30g maltodextrin 890g
The process comprises the following steps:
1. mixing sucralose and sweet orange essence uniformly, then mixing the sucralose and lutein ester microcapsule uniformly, and finally mixing the lutein ester microcapsule and calcium carbonate uniformly to obtain mixture 1;
2. mixing citric acid and malic acid, and mixing with β -carotene microcapsule powder to obtain mixture 2;
3. mixing mixture 1 and mixture 2, mixing with maltodextrin, and packaging.
Example 9
Effervescent granule containing lutein ester
Formula (1000 bags) comprises lutein ester microcapsule powder 100g calcium carbonate 350g tartaric acid 450g β -carotene microcapsule powder 220g aspartame 10g pineapple essence 20g maltodextrin 350g
The process comprises the following steps:
1. uniformly mixing aspartame and pineapple essence, uniformly mixing with lutein ester microcapsule, and uniformly mixing with calcium carbonate to obtain mixture 1;
2. uniformly mixing tartaric acid and β -carotene microcapsule powder to obtain mixture 2;
3. mixing mixture 1 and mixture 2, mixing with maltodextrin, and packaging.
The above are only some examples of the present invention, which are further intended to illustrate the present invention and not to limit the scope of the present invention. Modifications and variations of the above-described embodiments may be made by anyone without departing from the scope and spirit of the invention, and are intended to be covered by the appended claims.
Claims (10)
1. An effervescent granule containing lutein ester, wherein the lutein ester is lutein ester microcapsule powder, and is characterized in that an alkali source of the effervescent granule is calcium carbonate, and the weight ratio of the lutein ester microcapsule powder, the calcium carbonate and an acid source is 1: 3.3-3.7: 4-4.5.
2. The effervescent granule of claim 1, wherein the acid source is citric acid and/or malic acid.
3. The effervescent granule as claimed in claim 1, wherein the acid source is a mixture of citric acid and malic acid, and the mixing ratio is 1: 0.8-1.2.
4. An effervescent granule as claimed in claim 3, wherein the weight ratio of lutein ester microcapsule powder, calcium carbonate and acid source is 1: 3.5: 4.2.
5. An effervescent granule as claimed in any one of claims 1 to 4, further comprising β -carotene microcapsule powder.
6. The effervescent granule as claimed in claim 5, wherein the dosage ratio of the lutein ester microcapsule powder to the β -carotene microcapsule powder is 1: 1.5-2.5.
7. The effervescent granule of claim 1, further comprising a bulking agent and a flavoring agent.
8. The effervescent granule as claimed in claim 1, which is prepared by a process comprising: and uniformly mixing the lutein ester microcapsule powder with calcium carbonate, and uniformly mixing with an acid source to obtain the lutein ester microcapsule.
9. The effervescent granule as claimed in claim 8, which is produced by the following method:
(1) uniformly mixing lutein ester microcapsule powder and calcium carbonate to obtain a mixture 1;
(2) mixing citric acid and malic acid, and mixing with β -carotene microcapsule powder to obtain mixture 2;
(3) mixing mixture 1 and mixture 2 uniformly.
10. The effervescent granule as claimed in claim 8, which is produced by the following method:
(1) uniformly mixing a flavoring agent, lutein ester microcapsule powder and calcium carbonate according to an equivalent incremental method to obtain a mixture 1;
(2) mixing citric acid and malic acid, and mixing with β -carotene microcapsule powder to obtain mixture 2;
(3) mixing mixture 1 and mixture 2, and mixing with filler.
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| CN105077504A (en) * | 2015-09-22 | 2015-11-25 | 哈尔滨宝德生物技术股份有限公司 | Vitamin C effervescent tablet containing xangold and preparing method of vitamin C effervescent tablet |
| CN110179038A (en) * | 2019-07-04 | 2019-08-30 | 江苏汉典生物科技股份有限公司 | A kind of formula and processing technology of lutein ester effervescent tablet |
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