CN103948672B - Coated tablet and production method thereof - Google Patents
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- CN103948672B CN103948672B CN201410186259.XA CN201410186259A CN103948672B CN 103948672 B CN103948672 B CN 103948672B CN 201410186259 A CN201410186259 A CN 201410186259A CN 103948672 B CN103948672 B CN 103948672B
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- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 34
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims abstract description 32
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Abstract
The invention discloses a coated tablet and a production method thereof, wherein the coated tablet is prepared from soybean extract, vitamin C, white granulated sugar, corn starch, maltodextrin, magnesium stearate, lecithin, cocoa shell pigment, lemon yellow, titanium dioxide, polyvinyl alcohol, talcum powder and polyethylene glycol 4000. When the tablet is subjected to an accelerated test for 3 months, all indexes are not obviously changed. Wherein the content of main functional components such as soybean isoflavone, daidzin, daidzein, genistin, genistein and vitamin C is within 10%, and the content of other physical and chemical indexes and microorganism indexes is within 10%, and the coated tablet produced by the process has good stability.
Description
Technical Field
The invention relates to a coated tablet and a production method thereof, in particular to a coated tablet with functions of supplementing vitamin C and removing chloasma and a production method thereof.
Background
At present, similar products in the market are mostly not coated, brown and yellow spots are easy to appear after tablets are moistened, vitamin C is oxidized and yellowed, soybean isoflavone serving as an effective component is partially lost, the formula is unreasonable, the product stability is poor, the content of the effective component is low, the dosage is large, and the taking effect is not ideal.
Disclosure of Invention
In view of the above, the present invention provides a coated tablet and a method for producing the same, which can improve the stability and storage stability of the coated tablet.
In view of the above objects, the present invention provides a coated tablet made of soybean extract, vitamin C, white granulated sugar, corn starch, maltodextrin, magnesium stearate, lecithin, cocoa shell pigment, lemon yellow, titanium dioxide, polyvinyl alcohol, talc and polyethylene glycol 4000.
Optionally, the coated tablet is prepared from the following raw materials in parts by weight:
100-150 parts of a soybean extract,
50-90 parts of vitamin C,
74-100 parts of white granulated sugar,
90-124 parts of corn starch,
80-120 parts of maltodextrin, namely 80-120 parts of maltodextrin,
1-3 parts of magnesium stearate,
0.1 to 0.5 portion of lecithin,
0.1-0.4 part of cocoa shell pigment,
0.006 to 0.014 parts of lemon yellow,
1.24 to 4.24 parts of titanium dioxide,
2.36 to 5.36 parts of polyvinyl alcohol,
1.25 to 2.25 parts of talc, and
40000.89-1.29 parts of polyethylene glycol.
Preferably, the coated tablet is prepared from the following raw materials in parts by weight:
110-140 parts of a soybean extract,
60-80 parts of vitamin C,
80-95 parts of white granulated sugar,
92-120 parts of corn starch,
88-110 parts of maltodextrin, namely,
1.5 to 2.5 parts of magnesium stearate,
0.2 to 0.4 portion of lecithin,
0.2 to 0.35 part of cocoa shell pigment,
0.008 to 0.012 portion of lemon yellow,
1.8 to 4.0 parts of titanium dioxide,
2.5 to 5.0 parts of polyvinyl alcohol,
1.5 to 2.0 parts of talc, and
40000.95-1.15 parts of polyethylene glycol.
Preferably, the coated tablet consists of the following raw materials in parts by weight according to the optimal mixture ratio:
125 parts of a soybean extract, namely 125 parts of,
69 parts of vitamin C, namely vitamin C,
87 parts of white granulated sugar (87 parts),
107 parts of corn starch, namely, corn starch,
100 parts of maltodextrin, namely 100 parts of maltodextrin,
2 parts of magnesium stearate, namely 2 parts of magnesium stearate,
0.3 part of lecithin, wherein the lecithin is a mixture of lecithin and lecithin,
0.25 part of cocoa shell pigment,
0.01 part of lemon yellow,
2.74 parts of titanium dioxide, namely,
3.86 parts of polyvinyl alcohol, namely 3.86 parts of polyvinyl alcohol,
1.75 parts of talc, and
40001.09 parts of polyethylene glycol.
The present invention also provides a method for producing the coated tablet, the production method comprising:
3/5-9/10 cocoa shell pigment, lecithin, 3/5-9/10 lemon yellow, titanium dioxide, polyvinyl alcohol, talcum powder and polyethylene glycol 4000 are weighed, added into a container filled with water, stirred and mixed, and then processed by a colloid mill until the materials are uniformly mixed to obtain coating slurry for later use;
weighing the soybean extract, white granulated sugar and corn starch, and uniformly mixing to obtain mixed powder A; adding the mixed powder A into a granulator for grinding, and then adding water to prepare a soft material to obtain wet granules; putting the wet granules into a boiling dryer for boiling drying to obtain dry granules for later use;
weighing maltodextrin, vitamin C, the remaining cocoa shell pigment and the remaining lemon yellow, and uniformly mixing to obtain mixed powder B for later use;
uniformly mixing the dry granules, the mixed powder B and the magnesium stearate to obtain a total mixed material, and tabletting the total mixed material to obtain plain tablets for later use;
and putting the plain tablets into a coating pan, starting a high-efficiency coating machine, and spraying the coating slurry to coat the plain tablets with a film coating to obtain the coated tablets, wherein the weight of the coating is increased by 0.8-2%.
Optionally, in the step of preparing the coating slurry, 4/5 cocoa shell pigment, lecithin, 4/5 lemon yellow, titanium dioxide, polyvinyl alcohol, talcum powder and polyethylene glycol 4000 are weighed, added into a container filled with water, stirred and mixed, and then processed by a colloid mill until the materials are uniformly mixed to obtain the coating slurry for later use;
preferably, in the step of preparing the coating slurry, the mass of the water accounts for 90-94% of the total mass of the coating slurry.
Optionally, the stirring speed of the granulator is 100-150 r/min, the chopping speed is 1000-1500 r/min, and the grinding time is 3-10 minutes.
Optionally, in the coating step, the air inlet temperature of the coating pan is controlled to be 50-60 ℃, the air exhaust temperature is controlled to be 45-58 ℃, the temperature of the tablet bed is controlled to be 45-55 ℃, the initial rotating speed of the coating pan is 2-3 r/min, the rotating speed of the coating pan is slowly increased to 4-5 r/min in the coating process, and the spraying rotating speed of the coating slurry is 5-16 r/min.
Optionally, the moisture content of the dried granules after boiling drying is less than or equal to 7%.
Preferably, in the boiling drying step, the frequency of a fan of the boiling dryer is 20-40 Hz, the air inlet temperature is 60-80 ℃, and the material temperature is 30-50 ℃.
From the above, it can be seen that the coated tablet provided by the invention has the effect of removing chloasma. Before and after the tablet disclosed by the invention is eaten in a test way, various detection indexes of the conventional blood and biochemical kidney do not have obvious abnormal changes, and no obvious adverse reaction is observed during the eating in the test way. Moreover, when the tablet is subjected to an accelerated test for 3 months, all indexes of the tablet are not obviously changed. Wherein the content of main functional components such as soybean isoflavone, daidzin, daidzein, genistin, genistein and vitamin C is within 10%, and the content of other physical and chemical indexes and microorganism indexes is within 10%, and the coated tablet produced by the process has good stability.
Drawings
FIG. 1 is a flow chart of a method of producing coated tablets according to an embodiment of the present invention;
FIG. 2 is a plot of the uncoated product of the same type commercially available and coated tablets of an embodiment of the present invention at 0 hours of the accelerated test;
FIG. 3 is a graph of a 1 hour accelerated test of a coated tablet according to an embodiment of the present invention and a similar uncoated commercial product;
FIG. 4 is a graph of the coated tablets of this example of the invention and a commercial similar uncoated product at 16 hours of accelerated testing.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to specific embodiments and the accompanying drawings.
The coated tablet provided by the invention is prepared from soybean extract, vitamin C, white granulated sugar, corn starch, maltodextrin, magnesium stearate, lecithin, cocoa shell pigment, lemon yellow, titanium dioxide, polyvinyl alcohol, talcum powder and polyethylene glycol 4000.
Preferably, the coated tablet is prepared from the following raw materials in parts by weight:
110-140 parts of a soybean extract,
60-80 parts of vitamin C,
85-95 parts of white granulated sugar,
92-120 parts of corn starch,
88-110 parts of maltodextrin, namely,
1.5 to 2.5 parts of magnesium stearate,
0.2 to 0.4 portion of lecithin,
0.2 to 0.35 part of cocoa shell pigment,
0.008 to 0.012 portion of lemon yellow,
1.8 to 4.0 parts of titanium dioxide,
2.5 to 5.0 parts of polyvinyl alcohol,
1.5 to 2.0 parts of talc, and
40000.95-1.15 parts of polyethylene glycol.
The invention also provides a production method of the coated tablet, which comprises the following steps:
3/5-9/10 cocoa shell pigment, lecithin, 3/5-9/10 lemon yellow, titanium dioxide, polyvinyl alcohol, talcum powder and polyethylene glycol 4000 are weighed, added into a container filled with water, stirred and mixed, and then processed by a colloid mill until the materials are uniformly mixed to obtain coating slurry for later use;
weighing the soybean extract, white granulated sugar and corn starch, and uniformly mixing to obtain mixed powder A; adding the mixed powder A into a granulator for grinding, and then adding water to prepare a soft material to obtain wet granules; putting the wet granules into a boiling dryer for boiling drying to obtain dry granules for later use;
weighing maltodextrin, vitamin C, the remaining cocoa shell pigment and the remaining lemon yellow, and uniformly mixing to obtain mixed powder B for later use;
uniformly mixing the dry granules, the mixed powder B and the magnesium stearate to obtain a total mixed material, and tabletting the total mixed material to obtain plain tablets for later use;
and putting the plain tablets into a coating pan, starting a high-efficiency coating machine, and spraying the coating slurry to coat the plain tablets with a film coating to obtain the coated tablets, wherein the weight of the coating is increased by 0.8-2%.
As an embodiment of the invention, with reference to FIG. 1, the specific production method comprises the following steps:
1) preparing coating slurry: weighing 0.16Kg of cocoa shell pigment, 0.16Kg of lecithin, 0.008Kg of lemon yellow, 2Kg of titanium dioxide, 3.5Kg of polyvinyl alcohol, 2Kg of talcum powder and 1Kg of polyethylene glycol 4000, uniformly mixing the above materials, adding the mixture into a stainless steel container filled with 110 liters of water at a stable speed, stirring and mixing for 20-30 minutes, and carrying out 2 times of treatment by a JM-L80 colloid mill until the mixture is uniformly mixed to obtain coating slurry for later use.
2) Preparing dry particles: respectively sieving the soybean extract, the white granulated sugar and the corn starch by a sieve of 80 meshes, weighing 120Kg of the soybean extract, 90Kg of the white granulated sugar and 100Kg of the corn starch, mixing for 20-40 min in a three-dimensional mixer, and uniformly mixing to obtain mixed powder A; the mixed powder A is put into a granulator for grinding, the stirring speed of the granulator is 120r/min, the cutting speed of the granulator is 1200r/min, and the grinding time is 5 minutes; then, continuously adding water into the granulator to prepare soft materials (the water addition amount is determined by the degree that the water is held by hands to be agglomerated and then is dispersed), wherein the stirring speed of the granulator is 100r/min, the cutting speed is 1200r/min, and the grinding time is 3 minutes, so as to obtain wet granules; and finally, putting the wet granules into a boiling dryer for boiling drying, wherein the frequency of a fan of the boiling dryer is 30Hz, the air inlet temperature is 70 ℃, and the material temperature is 40 ℃, so as to obtain dry granules with the water content less than or equal to 7% for later use.
3) Straightening: and putting the dry particles into a granulator, and sieving by a 20-mesh sieve for granulation for later use.
4) Preparing mixed powder B: the maltodextrin, the vitamin C, the cocoa shell pigment and the lemon yellow are respectively sieved by a 80-mesh sieve, then 110Kg of maltodextrin, 80Kg of vitamin C, 0.04Kg of cocoa shell pigment and 0.002Kg of lemon yellow are weighed and evenly mixed to obtain mixed powder B for later use.
5) Total mixing: and mixing the finished granules, the mixed powder B and 2.2Kg of magnesium stearate (sieved by a 80-mesh sieve) in a three-dimensional mixer for about 30min to obtain a total mixed material with the water content less than or equal to 7%.
6) Tabletting: tabletting the total mixed material on a rotary tabletting machine according to 490mg per tablet, and checking the tablet weight (the tablet weight is controlled at 490mg +/-5%/tablet) in time to obtain plain tablets for later use.
7) Coating: putting the plain tablets into a coating pan, starting an efficient coating machine, controlling the air inlet temperature of the coating pan to be 54 +/-2 ℃, the air outlet temperature to be 52 +/-2 ℃, the temperature of a tablet bed to be 52 +/-1 ℃, the initial rotating speed of the coating pan to be 2.5r/min, slowly increasing the rotating speed of the coating pan to be 4.6r/min and the rotating speed of a spraying liquid of coating slurry to be 8-12 r/min in the coating process, and coating the plain tablets with a film to obtain the coated tablets, wherein the weight of the coating is increased by 1.5%.
8) Finally, the finished product which can be sold is obtained after packaging and inspection.
As another embodiment of the invention, with reference to FIG. 1, the specific production method comprises the following steps:
1) preparing coating slurry: weighing 0.2Kg of cocoa shell pigment, 0.3Kg of lecithin, 0.008Kg of lemon yellow, 2.74Kg of titanium dioxide, 3.86Kg of polyvinyl alcohol, 1.75Kg of talcum powder and 1.09Kg of polyethylene glycol 4000, uniformly mixing the above materials, adding the mixture into a stainless steel container filled with 102 liters of water at a stable speed, stirring and mixing for 20-30 minutes, and carrying out 2 times of treatment by a JM-L80 colloid mill until the mixture is uniformly mixed to obtain coating slurry for later use.
2) Preparing dry particles: respectively sieving the soybean extract, the white granulated sugar and the corn starch by a sieve of 80 meshes, weighing 125Kg of the soybean extract, 87Kg of the white granulated sugar and 107Kg of the corn starch, mixing for 20-40 min in a three-dimensional mixer, and uniformly mixing to obtain mixed powder A; the mixed powder A is put into a granulator for grinding, the stirring speed of the granulator is 130r/min, the cutting speed of the granulator is 1300r/min, and the grinding time is 4 minutes; adding water to make into soft material (water content is determined by hand-held agglomeration and kneading dispersion), stirring at 120r/min, cutting at 1300r/min, and grinding for 5 min to obtain wet granule; and finally, putting the wet granules into a boiling dryer for boiling drying, wherein the frequency of a fan of the boiling dryer is 36Hz, the air inlet temperature is 65 ℃, and the material temperature is 45 ℃, so as to obtain dry granules with the water content less than or equal to 6% for later use.
3) Straightening: and putting the dry particles into a granulator, and sieving by a 20-mesh sieve for granulation for later use.
4) Preparing mixed powder B: the maltodextrin, the vitamin C, the cocoa shell pigment and the lemon yellow are respectively sieved by a sieve of 80 meshes, and then 100Kg of maltodextrin, 69Kg of vitamin C, 0.05Kg of cocoa shell pigment and 0.002Kg of lemon yellow are weighed and evenly mixed to obtain mixed powder B for later use.
5) Total mixing: and mixing the finished granules, the mixed powder B and 2Kg of magnesium stearate (sieved by a 80-mesh sieve) in a three-dimensional mixer for about 30min to obtain a total mixed material with the water content less than or equal to 6%.
6) Tabletting: tabletting the total mixed material on a rotary tabletting machine according to 490mg per tablet, and checking the tablet weight (the tablet weight is controlled at 490mg +/-5%/tablet) in time to obtain plain tablets for later use.
7) Coating: putting the plain tablets into a coating pan, starting an efficient coating machine, controlling the air inlet temperature of the coating pan to be 52 +/-2 ℃, the air outlet temperature to be 50 +/-2 ℃, the temperature of a tablet bed to be 48 +/-1 ℃, the initial rotating speed of the coating pan to be 2.8r/min, slowly increasing the rotating speed of the coating pan to be 4.4r/min and the rotating speed of spray liquid of coating slurry to be 6-13 r/min in the coating process, and coating the plain tablets with a film to obtain the coated tablets, wherein the weight of the coating is increased by 1.2%.
8) Finally, the finished product which can be sold is obtained after packaging and inspection.
As another embodiment of the present invention, referring to FIG. 1, the specific production method comprises the following steps:
1) preparing coating slurry: weighing 0.18Kg of cocoa shell pigment, 0.25Kg of lecithin, 0.009Kg of lemon yellow, 3.2Kg of titanium dioxide, 4.5Kg of polyvinyl alcohol, 1.9Kg of talcum powder and 0.95Kg of polyethylene glycol 4000, uniformly mixing the above materials, adding the mixture into a stainless steel container filled with 130 liters of water at a stable speed, stirring and mixing for 20-30 minutes, and carrying out 2 times of treatment by a JM-L80 colloid mill until the mixture is uniformly mixed to obtain coating slurry for later use.
2) Preparing dry particles: respectively sieving the soybean extract, the white granulated sugar and the corn starch by a sieve of 80 meshes, weighing 130Kg of the soybean extract, 82Kg of the white granulated sugar and 110Kg of the corn starch, mixing for 20-40 min in a three-dimensional mixer, and uniformly mixing to obtain mixed powder A; the mixed powder A is put into a granulator for grinding, the stirring speed of the granulator is 125r/min, the cutting speed of the granulator is 1250r/min, and the grinding time is 6 minutes; then, continuously adding water into the granulator to prepare soft materials (the water addition amount is determined by the degree that the water is held by hands to be agglomerated and then is dispersed), wherein the stirring speed of the granulator is 120r/min, the cutting speed is 1200r/min, and the grinding time is 5 minutes, so as to obtain wet granules; and finally, putting the wet granules into a boiling dryer for boiling drying, wherein the frequency of a fan of the boiling dryer is 33Hz, the air inlet temperature is 70 ℃, and the material temperature is 46 ℃, so as to obtain dry granules with the water content of less than or equal to 6% for later use.
3) Straightening: and putting the dry particles into a granulator, and sieving by a 20-mesh sieve for granulation for later use.
4) Preparing mixed powder B: the maltodextrin, the vitamin C, the cocoa shell pigment and the lemon yellow are respectively sieved by a sieve of 80 meshes, and then 95Kg of maltodextrin, 75Kg of vitamin C, 0.02Kg of cocoa shell pigment and 0.001Kg of lemon yellow are weighed and evenly mixed to obtain mixed powder B for later use.
5) Total mixing: and mixing the finished granules, the mixed powder B and 1.8Kg of magnesium stearate (sieved by a 80-mesh sieve) in a three-dimensional mixer for about 30min to obtain a total mixed material with the water content less than or equal to 6%.
6) Tabletting: tabletting the total mixed material on a rotary tabletting machine according to 490mg per tablet, and checking the tablet weight (the tablet weight is controlled at 490mg +/-5%/tablet) in time to obtain plain tablets for later use.
7) Coating: putting the plain tablets into a coating pan, starting an efficient coating machine, controlling the air inlet temperature of the coating pan to be 57 +/-2 ℃, the air outlet temperature to be 55 +/-2 ℃, the temperature of a tablet bed to be 50 +/-1 ℃, the initial rotating speed of the coating pan to be 2.2r/min, slowly increasing the rotating speed of the coating pan to be 4.7r/min and the rotating speed of spraying liquid of coating slurry to be 10-16 r/min in the coating process, and coating the plain tablets with a film to obtain the coated tablets, wherein the weight of the coating is increased by 1.8%.
8) Finally, the finished product which can be sold is obtained after packaging and inspection.
The coated tablet provided by the invention is subjected to a human body eating trial test for removing chloasma, subjects are randomly divided into a eating trial combination control group according to the chloasma color and area condition, and the tablet and the placebo are respectively eaten (the tablet group formula does not contain soybean extract and vitamin C and is replaced by maltodextrin).
The detection basis is as follows: inspection and evaluation of health food (2003 edition)
Two groups of chloasma color change conditions:
as shown in Table 1, the evaluation of the chloasma color integral of the test group after the test eating is reduced by 0.40 point, and the difference is significant (P is less than 0.05) compared with that before the test eating and also significant (P is less than 0.05) compared with that of the control group.
TABLE 1 comparison of chloasma color variation (integral, x. + -. s)
| Grouping | Before testing | After the test | Difference value |
| Control group | 2.57±0.37 | 2.54±0.39 | 0.03±0.30 |
| Test food group | 2.59±0.34 | 2.20±0.25*# | 0.40±0.20# |
Note: control # P < 0.05 between self-control P < 0.05 groups
The change conditions of the chloasma area of two groups are as follows:
as shown in Table 2, the average chloasma area of the test-eating group is reduced by 606.6mm after the test-eating2(a) the difference is significant compared with the difference before the test feedingP is less than 0.05), and the difference is also significant compared with the control group (P is less than 0.05).
TABLE 2 comparison of change in chloasma area (mm)2，x±s)
| Grouping | Before testing | After the test | Difference value | Percent reduction (%) |
| Control group | 5250.4±1085.9 | 5164.9±1027.6 | 85.5±316.3 | 1.63 |
| Test food group | 5247.9±1048.6 | 4641.3±929.9*# | 606.6±191.5# | 11.56 |
Note: self control P < 0.05; control # P < 0.05 between groups
Evaluation of efficacy:
as shown in Table 3, the total effective rate of clinical observation of the test group after the test feeding is 75.47%, and the difference is significant compared with the control group (9.43%) (P is less than 0.05).
TABLE 3 comparison of chloasma-removing efficacy
| Grouping | Number of examples | Is effective | Invalidation | The total effective rate% |
| Control group | 53 | 5 | 48 | 9.43 |
| Test food group | 53 | 40 | 13 | 75.47# |
Note: control # P < 0.05 between groups
Loss rate:
after 45 days of test, 2 subjects in the control group are screened out because of taking test articles discontinuously or being unable to judge the effect; in the test group, 2 subjects were screened for the intermittent taking of the test article or failure to judge the effect. Finally, 53 control groups and 53 test groups of effective test population are obtained. See table 4.
TABLE 4 test loss
| Group of | Comparison number (example) | Test food group (example) |
| Before tasting | 55 | 55 |
| Number of loss | 2 | 2 |
| Loss rate | 3.64％ | 3.64％ |
The subjects are randomly divided into a test-feeding combined control group according to the chloasma color and the area condition, the tablets and the placebo are respectively eaten, and the results after 45 days show that: the chloasma color integral of the test-eating group has significance (P is less than 0.05) compared with the difference of the control group and the group before self test-eating; compared with several control groups before self-test eating, the chloasma area has significance (P is less than 0.05), and the chloasma area of the test eating group is reduced by 11.56% on average; the total effective rate of the test group for removing chloasma is 75.47%, compared with the control group (9.43%), the difference is significant (P is less than 0.05), and no new chloasma is generated. The coated tablet provided by the invention has the effect of removing chloasma. Before and after the tablet disclosed by the invention is eaten in a test way, various detection indexes of the conventional blood and biochemical kidney do not have obvious abnormal changes, and no obvious adverse reaction is observed during the eating in the test way.
The coated tablet provided by the invention is subjected to a human body eating test for removing chloasma, a health food efficacy component and accelerated stability test and hygiene detection.
The detection basis is as follows:
sensory: Q/NNFLX0206S Pb GB/T5009.12-2010 arsenic: GB/T5009.11-2003 moisture: GB5009.3-2010 ash: net content and negative deviation of GB 5009.4-2010: JJF1070-2005 disintegration time limit: the second six, nasal drops drop in 2010 edition of the pharmacopoeia of the people's republic of China: GB/T5009.19-2003 lemon yellow: GB/T5009.35-2003 vitamin C: GB/T5009.86-2003 soy isoflavones: total number of colonies in health food detection and evaluation technical Specification (2003): GB4789.2-2010 coliform group: GB/T4789.3-2003 molds and yeasts: GB4789.15-2010 salmonella: GB4789.4-2010 Shigella: GB/T4789.5-2003 Staphylococcus aureus: GB4789.10-2010 hemolytic streptococcus: GB/T4789.11-2003
And (4) checking items: testing functional components of health food
Test results
And (4) checking items: accelerated stability test
Test results (temperature: 38. + -. 1 ℃ C., relative humidity: 75%)
Lot number first lot
And (4) checking items: accelerated stability test
Test results (temperature: 38. + -. 1 ℃ C., relative humidity: 75%)
Lot number second lot
And (4) checking items: accelerated stability test
Test results (temperature: 38. + -. 1 ℃ C., relative humidity: 75%)
Lot number third lot
And (4) checking and concluding: accelerated tests of 3 batches of the tablets of the invention were carried out for 3 months (38. + -. 1 ℃ C., 75% relative humidity) without any significant change in the respective indices. Wherein the content of main functional components such as soybean isoflavone, daidzin, daidzein, genistin, genistein and vitamin C is within 10%, the content of other physical and chemical indexes and microorganism indexes is within 10%, and the variation range is within the error range of the detection method. Therefore, the coated tablet produced by the process has good stability.
Experimental items: accelerated stability control test
Experimental conditions (temperature: 38 + -1 deg.C, relative humidity: 75%, constant temperature and humidity cabinet)
Control tests were carried out on the coated tablets of the examples and on similar uncoated products on the market, and the results are shown in FIGS. 2-4. Fig. 2 is a comparison before the acceleration test, i.e. at 0h acceleration, wherein the left panel is a coated tablet according to the invention and the right panel is a commercial uncoated product of the same type. Fig. 3 is a graph showing the acceleration at 1 hour, wherein the left graph shows a coated tablet according to the present invention and the right graph shows a similar uncoated product on the market. Fig. 3 is a graph showing the acceleration at 16 hours, wherein the left graph shows a coated tablet according to the present invention and the right graph shows a similar uncoated product on the market.
The accelerated moisture absorption rate of the coated tablets of the invention and similar uncoated products on the market are shown in the following table:
| acceleration time | 1h | 2h | 16h |
| Coating film | 1.19％ | 2.11％ | 5.02％ |
| Uncoated | 1.72％ | 2.73％ | 5.18％ |
And (4) experimental conclusion: when the coated tablet and the similar uncoated product in the market are subjected to an accelerated moisture absorption control test for 0-16 hours (38 +/-1 ℃ and relative humidity of 75%), the moisture absorption weight gain rate of the coated tablet is obviously lower than that of the uncoated tablet, the coated tablet has almost no sensory color change, and the sensory color of the similar uncoated tablet in the market is obviously changed. Therefore, the coated tablet produced by the process overcomes the defects of easy moisture absorption and easy oxidative discoloration of the tablet, and has the advantages of obvious moisture absorption resistance and oxidative discoloration resistance.
And (4) checking items: hygiene test
Test results
Those of ordinary skill in the art will understand that: the invention is not to be considered as limited to the specific embodiments thereof, but is to be understood as being modified in all respects, all changes and equivalents that come within the spirit and scope of the invention.
Claims (6)
1. The coated tablet is characterized by comprising the following raw materials in parts by weight:
100-150 parts of a soybean extract,
50-90 parts of vitamin C,
74-100 parts of white granulated sugar,
90-124 parts of corn starch,
80-120 parts of maltodextrin, namely 80-120 parts of maltodextrin,
1-3 parts of magnesium stearate,
0.1 to 0.5 portion of lecithin,
0.1-0.4 part of cocoa shell pigment,
0.006 to 0.014 parts of lemon yellow,
1.24 to 4.24 parts of titanium dioxide,
2.36 to 5.36 parts of polyvinyl alcohol,
1.25 to 2.25 parts of talc, and
40000.89-1.29 parts of polyethylene glycol;
the main functional components of the soybean extract are as follows: total soy isoflavones, daidzin, daidzein, genistin or genistein;
the production method of the coated tablet comprises the following steps:
4/5 cacao shell pigment, lecithin, 4/5 lemon yellow, titanium dioxide, polyvinyl alcohol, talcum powder and polyethylene glycol 4000 are weighed, added into a container filled with water, stirred and mixed, and then processed by a colloid mill until the materials are uniformly mixed to obtain coating slurry for later use;
weighing the soybean extract, white granulated sugar and corn starch, and uniformly mixing to obtain mixed powder A; adding the mixed powder A into a granulator for grinding, and then adding water to prepare a soft material to obtain wet granules; putting the wet granules into a boiling dryer for boiling drying to obtain dry granules for later use;
weighing maltodextrin, vitamin C, the remaining cocoa shell pigment and the remaining lemon yellow, and uniformly mixing to obtain mixed powder B for later use;
uniformly mixing the dry granules, the mixed powder B and the magnesium stearate to obtain a total mixed material, and tabletting the total mixed material to obtain plain tablets for later use;
putting the plain tablets into a coating pan, starting a high-efficiency coating machine, and spraying the coating slurry to coat the plain tablets with a film coating to obtain the coated tablets, wherein the weight of the coating is increased by 0.8-2%;
in the coating step, the air inlet temperature of the coating pan is controlled to be 50-60 ℃, the air exhaust temperature is controlled to be 45-58 ℃, the temperature of the tablet bed is controlled to be 45-55 ℃, the initial rotating speed of the coating pan is 2-3 r/min, the rotating speed of the coating pan is slowly increased to 4-5 r/min in the coating process, and the rotating speed of the spray liquid of the coating slurry is 5-16 r/min.
2. The coated tablet of claim 1, wherein the coated tablet comprises the following raw materials in parts by weight:
125 parts of a soybean extract, namely 125 parts of,
69 parts of vitamin C, namely vitamin C,
87 parts of white granulated sugar (87 parts),
107 parts of corn starch, namely, corn starch,
100 parts of maltodextrin, namely 100 parts of maltodextrin,
2 parts of magnesium stearate, namely 2 parts of magnesium stearate,
0.3 part of lecithin, wherein the lecithin is a mixture of lecithin and lecithin,
0.25 part of cocoa shell pigment,
0.01 part of lemon yellow,
2.74 parts of titanium dioxide, namely,
3.86 parts of polyvinyl alcohol, namely 3.86 parts of polyvinyl alcohol,
1.75 parts of talc, and
40001.09 parts of polyethylene glycol.
3. The coated tablet according to claim 1, wherein the water accounts for 90 to 94% by mass of the total mass of the coating syrup in the step of preparing the coating syrup.
4. The coated tablet according to claim 1, wherein the stirring speed of the granulator is 100 to 150r/min, the cutting speed is 1000 to 1500r/min, and the grinding time is 3 to 10 minutes.
5. The coated tablet of claim 1, wherein the moisture content of the fluid-dried dry granules is less than or equal to 7%.
6. The coated tablet according to claim 5, wherein in the fluidized drying step, the fan frequency of the fluidized dryer is 20 to 40Hz, the inlet air temperature is 60 to 80 ℃ and the material temperature is 30 to 50 ℃.
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| CN1360612A (en) * | 1999-07-09 | 2002-07-24 | 伯温德药品服务公司 | Film coatings and film coating compositions based on polyvinyl alcohol |
| CN103702654A (en) * | 2011-04-19 | 2014-04-02 | 伊诺瓦实验室 | Use of a combination of carotenoid, phytoestrogen and vitamin c for the prevention and/or treatment of pigmentation disorders |
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| CN1360612A (en) * | 1999-07-09 | 2002-07-24 | 伯温德药品服务公司 | Film coatings and film coating compositions based on polyvinyl alcohol |
| CN103702654A (en) * | 2011-04-19 | 2014-04-02 | 伊诺瓦实验室 | Use of a combination of carotenoid, phytoestrogen and vitamin c for the prevention and/or treatment of pigmentation disorders |
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