CN1785179A - Compounding chewable vitamin tablets and its prepn. method - Google Patents
Compounding chewable vitamin tablets and its prepn. method Download PDFInfo
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- CN1785179A CN1785179A CN 200410098421 CN200410098421A CN1785179A CN 1785179 A CN1785179 A CN 1785179A CN 200410098421 CN200410098421 CN 200410098421 CN 200410098421 A CN200410098421 A CN 200410098421A CN 1785179 A CN1785179 A CN 1785179A
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Abstract
A compound chewing tablet of vitamins is prepared from VE, VC, absorbent, excipient, adhesive, flowing aid, stabilizer, flavouring and coloring agent. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to a kind of compounding chewable vitamin tablets and preparation technology thereof, more specifically say so vitamin E is become the masticatory pattern tablet with ascorbic preparation of compositions, solve the shortcoming of this other dosage forms of compositions, improve bioavailability simultaneously, belong to the pharmaceutics field.
Background technology
Vitamin is that body is kept homergy and the necessary class low molecular compound of function.It is one of human body six big nutritional factorss, and is extremely important to health.Because human body self can not synthesize, can only absorb from the external world, so daily vitimin supplement preparation with satisfy needed by human body, enhancing body health is accepted by most of people.
In numerous vitamins products, the vitamin EC complexing agent only is the compound preparation of two kinds of vitamin, but fatsoluble vitamin E and water-soluble vitamin c are compounded in the collaborative antioxidation that produces in the same preparation, than taking better effects if separately; And compare the use crowd with the multivitamin complexing agent more extensive, and price is also lower.
The medical expert of Chinese Soclety of Nutrition advise domestic patient take every day a certain amount of vitamin E and vitamin C so that scientifically replenish the vitamin of needed by human body.
In recent years, along with the continuous pursuit of people to health, improve the taking of pharmaceutical preparation and portability etc., demand for the formulation products that also can take easily under the situation of water is more and more higher, especially for the patient of children's or elderly patient and some dysphagias, can chew the masticatory pattern product of taking and be more prone to be accepted.
At present, the vitamin of selling on the market is in the majority with the person of swallowing, trial as this type of preparation of making great efforts the oral compliance of improvement, the vitamin EC granule of present listing, though can be by using mixing in water for oral taking, because the fat-soluble characteristics of vitamin E are not dissolved in water, and density is littler than water, during the water Instant Drinks, vitamin E swims on the water surface, forms one deck oil film, when drinking, the vitamin E of quite a few is all attached to drinking instrument (glass drying oven, plastic ware or stainless steel ware) wall on, cause the loss on the dosage, therefore, only when swallowing, can dosage accurate.So the vitamin EC granule has lost it and taken comfortable characteristics,, cause the inconvenience of taking to a certain extent on the contrary because of dosage is big.
Vitamin E is a kind of fat-soluble vitamin, with other absorption approach as nonpolar lipoid compositions such as tocotrienols, cholesterols identical (Kayden and Traber, 1993 lipoids research magazine, 34:343-358).The bile that relies on liver to produce is emulsified into microgranule and finishes absorption process.But it is on the low side that the product ubiquity of the vitamin EC class of present listing the bioavailability of vitamin E, only has 20～30%.
Research worker has been made the medicine-releasing system (Chinese patent CN 1086131A) that a lot of trials: Hou Huimin etc. have invented a kind of self emulsifying form on the bioavailability that improves vitamin E, realize improving the purpose of the bioavailability of vitamin E, but the production efficiency of this method is lower, complex process, production cost is higher, make that the price of product is higher, for the present stage situation of China, the patient is difficult for accepting.Also the someone considers that vitamin E is made syrup improves bioavailability, and beam people such as molybdenum has forever been delivered the article of " the bioavailability test of vitamin E syrup " on " Chinese Hospitals pharmaceutical journal " 1986 the 6th the tenth second phases of volume.
Summary of the invention
The technical problem to be solved in the present invention be overcome the conventional tablet that contains at present in the vitamin EC class preparation and other dosage form swallow inconvenience, drug compliance is poor even tablet generation vitamin E oozes out, the shortcoming of bioavailability difference, and a kind of taking convenience, dosage is accurate, bioavailability is high compounding chewable vitamin tablets are provided.
Another technical problem that the present invention will solve provides the preparation technology who is suitable for suitability for industrialized production of this compounding chewable vitamin tablets.
If can in gastric juice, form the fine particles of high degree of dispersion, can improve the bioavailability of this product.Experimenter of the present invention attempts by vitamin E being dispersed in the absorbent of matrix type or porous hydrophilic, by solid dispersion method pharmaceutically commonly used, vitamin E is dispersed on a kind of porous or the hydrophilic framework material, form a kind of atomic little dispersion, the solid composite of the vitamin E that discovery is made by this method-absorbent high degree of dispersion, chewing when taking, form superfine microgranule, make vitamin E improve intravital the absorbing greatly of people.Find simultaneously, the chewable tablet of making not only solved vitamin E in the preparation of other types common problems as ooze out, oil mark etc., and bioavailability also is greatly improved, simultaneously, the chewable tablet production technology of utilizing the present invention to make is simple, with low cost, the production efficiency height, and mouthfeel is easy to be accepted by the patient.
Because vitamin E is the heavy-gravity liquid of oily, so this product need solidify earlier when tabletting, and in initial test, we have adopted with modes such as adjuvant absorption such as PEG, poloxamer solid dispersion, dextrin starch and have carried out, and have obtained good effect.Adopted liquid medicine absorption adjuvant micropowder silica gel relatively more commonly used afterwards again, found that the ratio of vitamin E and differential silica gel was at 1: 0.5～5 o'clock, relatively good to the vitamin E absorption effect.Find simultaneously, when vitamin E is disperseed, adopt the solwution method sedimentation method and fusion method pharmaceutically commonly used, all obtained good effect.In addition, after having added vitamin C, consider ascorbic characteristics, bigger to the influence of metal ion and acid-base value, therefore, we have added citric acid and sodium citrate as the chelating agent of metal ion and the acid-base buffer agent of adjusting pH in the prescription in prescription.Can also select tartaric acid and salt thereof, edetic acid and salt thereof for use.
In order to make the tablet of making more beautiful, more make the people acceptant, in compound vitamin EC chewable tablet, can also add the food coloring of 0.5～100 weight portion.
Described attached type agent can be selected any two kinds or any two or more mixture in starch, microcrystalline Cellulose, sucrose, glucose, lactose, dextrin, mannitol, sorbitol, xylitol, erithritol, calcium carbonate, the calcium phosphate.
As everyone knows, vitamin C itself has a kind of fragrance of Fructus Citri sinensis, but because its acidity is bigger, feeling of 60% user owing to acid too has influence on comfortableness when using this product, therefore, add a certain amount of sweeting agent in this product and adopt the attached type agent of a certain amount of sweet taste, add a certain amount of essence simultaneously, make that people are easier to accept.Described correctives comprises sweeting agent (can select cyclamate, aspartame, saccharin sodium, glycyrrhizin, sucrose etc. for use) and flavorant (can select Fructus Citri tangerinae essence, orange flavor, apple essence, cream flavour etc. for use) or combination in any wherein.
Advantage of the present invention is: a kind of taking convenience, dosage is accurate, bioavailability is high compounding chewable vitamin tablets are provided.Simultaneously, the chewable tablet of making by the present invention can not occur fatsoluble vitamin preparation common problems as ooze out, oil mark etc.In addition, the chewable tablet production technology of utilizing the present invention to make is simple, with low cost, and the production efficiency height is easy to suitability for industrialized production.
The invention will be further described below in conjunction with the specific embodiment, and do not limit the present invention in any way.All any this areas of doing according to the disclosure of invention be equal to replacement, all belong within protection scope of the present invention.
Description of drawings
Fig. 1 vitamin EC chewable tablets and vitamin EC granule time front of blood concentration figure.
The specific embodiment
Embodiment 1, vitamin EC chewable tablets
| Former, adjuvant | Use amount (g) |
| Vitamin E vitamin C pregelatinized starch dextrin sucrose superfine silica gel powder sweet mellow wine aspartame citric acid natrium citricum PVP-K30 xanthein essence dolomol | 50.0 100.0 70.0 150.0 300.0 150.0 100.0 10.0 6.0 24.0 30.0 an amount of 4.4 50.0 |
Make: 1000
Processing step:
1, the vitamin C of recipe quantity was pulverized 100 mesh sieves, sucrose, pregelatinized Starch, mannitol, aspartame, PVP, the dextrin of recipe quantity were pulverized 80 mesh sieves;
2, with micropowder silica gel, the aspartame mix homogeneously of recipe quantity, make soft material with vitamin E with an amount of ethanol solution, 20 mesh sieves are made wet granular, and are dry below 60 ℃, and 20 mesh sieve granulate are standby;
3, with citric acid, sodium citrate lemon yellow with 20% an amount of dissolve with ethanol, standby;
4, with vitamin C, sucrose, pregelatinized Starch, mannitol, PVP, dextrine powder mix homogeneously, make soft material with above-mentioned citric acid, sodium citrate, lemon yellow solution, granulate 60 ℃ of dryings, 20 order nylon mesh granulate with 20 order nylon mesh;
The two kinds of granules that 5, will make and essence, the magnesium stearate mix homogeneously of recipe quantity, tabletting promptly.
Embodiment 2: vitamin EC chewable tablets
| Former, adjuvant | Use amount (g) |
| Vitamin E vitamin C PEG20000 sucrose pregelatinized starch dextrin sweet mellow wine aspartame citric acid natrium citricum PVP-K30 xanthein orange essence | 10.0 20.0 100.0 250.0 300.0 150.0 100.0 10.0 6.0 24.0 30.0 an amount of 4.4 |
Make: 1000
With vitamin C and pregelatinized Starch, dextrin, mannitol, aspartame, sucrose mix homogeneously in mixer granulator; obtain mixture (I); citric acid, sodium citrate, PVP-K30, pigment be dissolved in an amount of 20～75% the alcoholic solution; make soft material with this solution with above-mentioned mixture I; 20 order nylon mesh are made wet granular; heat-wind circulate drying below 60 ℃ to moisture below 1%, with 20 order nylon mesh granulate, obtain mixture (II).The vitamin E of recipe quantity and the Polyethylene Glycol of recipe quantity are placed in the jacketed pan, and Steam Heating to 60～70 ℃ form a clear solution, and sub-cooled to 4 ℃ is ground into the fine powder more than 40 orders under cryogenic conditions rapidly; With essence, the magnesium stearate mix homogeneously of said mixture II and recipe quantity, tabletting on the high speed rotating tablet machine obtains vitamin E and Chewable C.
Embodiment 3: vitamin EC chewable tablets
| Former, adjuvant | Use amount (g) |
| Vitamin E vitamin C PLURONICS F87 sucrose superfine silica gel powder dextrin sweet mellow wine aspartame citric acid natrium citricum PVP-K30 xanthein orange essence | 100.0 400.0 100.0 100.0 80.0 100.0 50.0 10.0 6.0 24.0 30.0 an amount of 4.4 |
Make: 1000
According to the method for embodiment 2, change wherein Polyethylene Glycol into poloxamer, operate with method, can make vitamin EC chewable tablets.
Embodiment 4:
According to the tablet that embodiment 1～3 makes, place under 60 ℃ of conditions and placed 10 days, carry out item indexs such as taste, appearance character, content, HPLC method related substance and check, the results are shown in following table:
| Project | Embodiment 1 | Embodiment 2 | Embodiment 3 | The vitamin EC sheet | |
| Taste | Sweet and sour taste | Sweet and sour taste | Sweet and sour taste | - | |
| Appearance character | Yellow circular piece | Yellow circular piece | Yellow circular piece | White tablets | |
| Content | Vitamin C | 99.4％ | 100.1％ | 99.8％ | 99.6％ |
| Vitamin E | 97.9％ | 99.1％ | 98.6％ | 97.5％ | |
| Related substance | 0.15％ | 0.43％ | 0.12％ | 1.24％ | |
Embodiment 5:
Use the vitamin EC product by 75 volunteers, one group of per 25 people use three kinds of products respectively, adopt the form of questionnaire, contrast.
Table 5: to the product comparison of the like product of sale in the market together that obtains according to embodiment 1-3
| Product | Vitamin EC chewable tablets | The vitamin EC sheet | The vitamin EC granule |
| Take mode | Chew clothes | Swallow | Mixing in water for oral taking |
| Accept wish (5 grades) * | 5 | 3 | 4 |
| Comfortableness (5 grades) * | 5 | 2 | 3 |
*: 1, unacceptable, 2, accept reluctantly, 3, can accept, 4, be ready to accept, 5, like accepting.
By above test as can be known, for the user, vitamin EC chewable tablets obviously is being better than existing vitamin EC preparation aspect acceptance level and the comfort.
Embodiment 6:
By embodiment 1 prepared sample is carried out the test of bioavailability with the vitamin EC granule that goes on the market to the vitamin E in the formulation products, the results are shown in Table 6.
Table 6: vitamin EC granule bioavailability result of the test:
| Time | Blood drug level | |||||||
| 1 | 2 | 3 | 4 | 5 | 6 | On average | S | |
| 0 0.5 0.75 1 1.5 2 3 4 6 8 10 24 | 1.60 90.67 241.33 382.67 654.00 740.67 582.00 426.67 210.00 118.00 114.67 105.33 | 108.00 224.00 338.00 504.00 568.00 651.33 678.00 684.00 401.33 312.67 268.67 204.67 | 0.00 26.00 67.33 178.00 220.00 343.33 398.67 362.67 334.67 279.33 166.67 146.67 | 87.33 123.33 210.67 261.33 651.33 616.67 536.00 464.00 404.67 254.00 199.33 186.67 | 50.00 103.33 202.67 349.33 429.33 438.67 432.00 354.67 306.67 293.33 284.67 269.33 | 62.00 113.33 129.33 306.67 450.00 536.67 533.33 523.33 390.00 268.00 212.00 184.67 | 51.49 113.44 198.22 330.33 495.44 554.56 526.67 469.22 341.22 254.22 207.67 182.89 | 7.35 10.69 15.54 18.53 27.59 24.29 16.91 20.46 12.58 11.62 10.56 9.22 |
Table 7: vitamin EC chewable tablets bioavailability result of the test:
| Time | Blood drug level | |||||||
| 1 | 2 | 3 | 4 | 5 | 6 | On average | S | |
| 0 0.5 0.75 1 1.5 2 3 4 6 8 | 62.5 129.17 253.33 436.67 536.67 548.33 540.00 443.33 383.33 366.67 | 77.5 141.67 161.67 383.33 562.50 670.83 666.67 654.17 487.50 335.00 | 135 280.00 422.50 630.00 710.00 814.17 847.50 855.00 501.67 390.83 | 0 32.50 84.17 222.50 275.00 429.17 498.33 453.33 418.33 349.17 | 109.17 154.17 263.33 326.67 814.17 770.83 670.00 580.00 505.83 317.50 | 2 113.33 301.67 478.33 817.50 925.83 727.50 533.33 262.50 147.50 | 64.36 141.81 247.78 412.92 619.31 693.19 658.33 586.53 426.53 317.78 | 9.19 13.37 19.42 23.16 34.49 30.37 21.13 25.58 15.72 14.53 |
| 10 24 | 355.83 336.67 | 265.00 230.83 | 335.83 255.83 | 208.33 183.33 | 249.17 233.33 | 143.33 131.67 | 259.58 228.61 | 13.20 11.52 |
Table 8: the pharmacokinetic parameters of vitamin EC preparation:
| Parameter | Granule | Chewable tablet |
| AUC(0-inf)(ng*hr/mL) | 6255 | 7819 |
| Coefficient of variation | 72％ | 61％ |
| Cmax(ng/mL) | 554 | 693 |
| Coefficient of variation | 44％ | 40％ |
| Tmax(min) | 29.8 | 28.3 |
| T(hr) | 0.86 | 1.08 |
Fig. 1: vitamin EC chewable tablets and vitamin EC granule time front of blood concentration figure:
Find that by above test the vitamin EC chewable tablets human bioavailability is apparently higher than the vitamin EC granule.
Claims (11)
1. compound vitamin EC chewable tablet is a principal agent with vitamin E and vitamin C, it is characterized in that its component and consumption are as follows: weight portion:
Vitamin E 10～100
Vitamin C 20～400
Absorbent 1～20
Excipient 200～2000
Binding agent 2～100
Fluidizer 2～80
Stabilizing agent 3～100
Correctives 5～300
Coloring agent 0.5～100
2. compound vitamin EC chewable tablet according to claim 1 is characterized in that described absorbent is one or more of liquid phase micronization silica gel, gas phase micronization silica gel, polyoxyethylene, poly yamanashi esters, polyoxyethylene ether apoplexy due to endogenous wind.
3. compound vitamin EC chewable tablet according to claim 1 is characterized in that described excipient is any two kinds or any two or more mixture in starch, microcrystalline Cellulose, sucrose, glucose, lactose, dextrin, mannitol, sorbitol, xylitol, erithritol, calcium carbonate, the calcium phosphate.
4. compound vitamin EC chewable tablet according to claim 1 is characterized in that described binding agent is one or more in polyvinylpyrrolidone, hydroxypropyl emthylcellulose, hydroxyethyl-cellulose, methylcellulose, carboxymethyl starch sodium, starch slurry, the dextrin.
5. compound vitamin EC chewable tablet according to claim 1 is characterized in that described fluidizer is the Polyethylene Glycol of micropowder silica gel, magnesium stearate, Pulvis Talci, micronizing, in the sodium stearyl fumarate one or more.
6. compound vitamin EC chewable tablet according to claim 1, it is characterized in that organic acid or their alkali metal or the alkali salt of described stabilizing agent for metal ion is had complexing, can be in citric acid and salt thereof, tartaric acid and salt thereof, edetic acid and the salt thereof one or more.
7. compound vitamin EC chewable tablet according to claim 1 is characterized in that described correctives is one or more in acceptable sweeting agent, the spice in one or more pharmaceuticals industries or the food industry.
8. compound vitamin EC chewable tablet according to claim 1, it is characterized in that described coloring agent is natural or the acceptable pigment in pharmaceuticals industry and in the food industry of synthetic, can be in sunset yellow, carmine, light green, Radix Raphani pigment, the curcumin one or more.
9. compound vitamin EC sheet according to claim 1 is characterized in that its component and consumption are as follows: weight portion:
Vitamin E 50.0
Vitamin C 100.0
Pregelatinized Starch 150.0
Dextrin 150.0
Sucrose 320.0
Micropowder silica gel 50.0
Mannitol 100.0
Aspartame 10.0
Citric acid 6.0
Sodium citrate 24.0
PVP 30.0
Xanthein is an amount of
Essence 4.4
Magnesium stearate 5
Make 1000
10. the preparation technology of compound vitamin EC chewable tablet according to claim 11 may further comprise the steps:
A, the vitamin C of recipe quantity was pulverized 100 mesh sieves, sucrose, pregelatinized Starch, mannitol, aspartame, PVP, the dextrin of recipe quantity were pulverized 80 mesh sieves;
B, vitamin E is dissolved in an amount of dehydrated alcohol, acetone or the ethyl acetate, stirs with micronization silica gel, drying obtains mixture I.With the aspartame of mixture I and recipe quantity, the pregelatinized Starch of 2/3 amount and the dextrin mix homogeneously of 2/3 amount, make soft material with the ethanol solution of 2/3 PVP that measures, 20 mesh sieves are made wet granular, and 60 degrees centigrade of dryings obtain granule II, and are standby;
The dextrine powder mix homogeneously of c, pregelatinized Starch, mannitol, 1/3 amount with vitamin C, sucrose, 1/3 amount, 20% ethanol with citric acid, sodium citrate, lemon yellow, 1/3 PVP that measures is made soft material, granulate 60 ℃ of dryings, 20 order nylon mesh granulate with 20 order nylon mesh; Obtain granule III;
D, the essence with above-mentioned granule II and granule III and recipe quantity, magnesium stearate mix homogeneously, tabletting are promptly packed, promptly.
11. the preparation technology of chewable tablet according to claim 12 is characterized in that: can also adopt the fluid bed marumerization to granulate.
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101156862B (en) * | 2007-09-29 | 2010-06-23 | 北京世纪博康医药科技有限公司 | A lecithin vitamine E mastication piece and method for making same |
| CN101843613A (en) * | 2010-05-06 | 2010-09-29 | 北京四环科宝制药有限公司 | Vitamin EC chewable tablets with high stability and preparation method thereof |
| CN102552247A (en) * | 2012-03-07 | 2012-07-11 | 常州市第四制药厂有限公司 | Composition of vitamin C and preparation method thereof |
| CN104126806A (en) * | 2014-07-21 | 2014-11-05 | 福建省力菲克药业有限公司 | Vitamin B12 sublingual tablet and preparation method thereof |
| CN105361160A (en) * | 2015-11-30 | 2016-03-02 | 广州市富诺生物科技有限公司 | Iron, zinc and calcium chewable tablets and production method thereof |
| CN106511287A (en) * | 2016-10-28 | 2017-03-22 | 芜湖市诺康生物科技有限公司 | Vitamin C chewable tablets and preparation method thereof |
| CN107348216A (en) * | 2017-07-31 | 2017-11-17 | 安徽省金安禽业有限公司 | A kind of preparation method of food stuff for chicken laying vitamin and minerals premix |
| CN110833531A (en) * | 2019-12-19 | 2020-02-25 | 健康元药业集团股份有限公司 | Vitamin E preparation and preparation method thereof |
| CN112056546A (en) * | 2019-10-17 | 2020-12-11 | 浙江新维士生物科技有限公司 | Vaccinium myrtillus lutein health food tablet with eye fatigue relieving effect and preparation method thereof |
-
2004
- 2004-12-10 CN CN 200410098421 patent/CN1785179A/en active Pending
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101156862B (en) * | 2007-09-29 | 2010-06-23 | 北京世纪博康医药科技有限公司 | A lecithin vitamine E mastication piece and method for making same |
| CN101843613A (en) * | 2010-05-06 | 2010-09-29 | 北京四环科宝制药有限公司 | Vitamin EC chewable tablets with high stability and preparation method thereof |
| CN101843613B (en) * | 2010-05-06 | 2012-01-11 | 北京四环科宝制药有限公司 | Vitamin EC chewable tablets with high stability and preparation method thereof |
| CN102552247A (en) * | 2012-03-07 | 2012-07-11 | 常州市第四制药厂有限公司 | Composition of vitamin C and preparation method thereof |
| CN104126806A (en) * | 2014-07-21 | 2014-11-05 | 福建省力菲克药业有限公司 | Vitamin B12 sublingual tablet and preparation method thereof |
| CN105361160A (en) * | 2015-11-30 | 2016-03-02 | 广州市富诺生物科技有限公司 | Iron, zinc and calcium chewable tablets and production method thereof |
| CN106511287A (en) * | 2016-10-28 | 2017-03-22 | 芜湖市诺康生物科技有限公司 | Vitamin C chewable tablets and preparation method thereof |
| CN107348216A (en) * | 2017-07-31 | 2017-11-17 | 安徽省金安禽业有限公司 | A kind of preparation method of food stuff for chicken laying vitamin and minerals premix |
| CN112056546A (en) * | 2019-10-17 | 2020-12-11 | 浙江新维士生物科技有限公司 | Vaccinium myrtillus lutein health food tablet with eye fatigue relieving effect and preparation method thereof |
| CN110833531A (en) * | 2019-12-19 | 2020-02-25 | 健康元药业集团股份有限公司 | Vitamin E preparation and preparation method thereof |
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