Sugar-free vitamin C effervescent tablet and its preparation method and application

Abstract

The present invention provides a sugar-free vitamin C effervescent tablet and its preparation method and application, which solves the technical problem that existing vitamin C effervescent tablets cannot simultaneously meet the requirements of smooth appearance, good drinking taste, short disintegration time, and appropriate hardness. The sugar-free vitamin C effervescent tablet is composed of the following components in parts by weight: 24-30 parts of sodium bicarbonate, 25-30 parts of anhydrous citric acid, 7.73-13.73 parts of D-mannitol, 26.25 parts of vitamin C, 5 parts of magnesium lauryl sulfate, 1.5 parts of sweetener, 1.5 parts of edible flavor, and 0.02 parts of pigment. The present invention also provides a method for preparing a sugar-free vitamin C effervescent tablet, comprising the steps of weighing, preparing a binder, preparing wet granules, preparing dry granules, drying an alkali source, granulating, mixing, and tableting. The present invention also provides an application of a sugar-free vitamin C effervescent tablet in the preparation of a drug for improving human immunity. It can be widely used in the field of solid preparation technology.

Description

Technical Field

[0001] The present application relates to the technical field of solid preparations, and in particular to a sugar-free vitamin C effervescent tablet and a preparation method and application thereof. Background Art

[0002] Vitamin C, also known as L-ascorbic acid, is an essential vitamin for the human body and has antioxidant properties. Taking vitamin C can reduce the oxidation of low-density lipoprotein cholesterol, scavenging excess free radicals in the body, maintaining normal bone and tooth development and blood vessel permeability, and helping to prevent many health problems. Vitamin C effervescent tablets disintegrate quickly, are easy to take, and are rich in vitamin C, known to boost immunity, making them a popular choice.

[0003] The current production process of vitamin C effervescent tablets usually uses acid and alkali to granulate separately, then mix them with other ingredients and press them into tablets. Vitamin C effervescent tablets have the following three main problems:

[0004] (1) Anhydrous citric acid is widely used in the preparation of vitamin C effervescent tablets because it not only serves as an acid source but also significantly improves the taste and appetite. However, due to its deliquescent nature, anhydrous citric acid easily absorbs moisture and sticks to the die, resulting in an uneven surface.

[0005] (2) Using other acid sources with less deliquescent properties, such as malic acid, to completely or partially replace anhydrous citric acid solves the problem of sticking to the die and causing one-sided roughness, but the drinking taste becomes worse.

[0006] (3) As the hardness of vitamin C effervescent tablets continues to increase, the disintegration time continues to increase, and the hardness is negatively correlated with the disintegration time. In order to meet people's experience of the quick and convenient disintegration of vitamin C effervescent tablets, on the basis of ensuring the static stability of the product, the pursuit of a shorter disintegration time is ignored, while the hardness requirements of vitamin C effervescent tablets are ignored. The lower hardness can easily lead to the effervescent tablets breaking due to bumps and vibrations during production and storage and transportation, resulting in poor dynamic stability of the product. Summary of the Invention

[0007] The purpose of the present invention is to solve the deficiencies of the above-mentioned technology and provide a sugar-free vitamin C effervescent tablet and its preparation method and application, which simultaneously meet the requirements of smooth tablet appearance, good drinking taste, short disintegration time and appropriate hardness.

[0008] To this end, the present invention provides a sugar-free vitamin C effervescent tablet, which is composed of the following components in parts by weight: 24-30 parts of sodium bicarbonate, 25-30 parts of anhydrous citric acid, 7.73-13.73 parts of D-mannitol, 26.25 parts of vitamin C, 5 parts of magnesium lauryl sulfate, 1.5 parts of sweetener, 1.5 parts of edible flavor, and 0.02 part of pigment.

[0009] Preferably, it is composed of the following components in parts by weight: 24 parts of sodium bicarbonate, 30 parts of anhydrous citric acid, 11.73 parts of D-mannitol, 26.25 parts of vitamin C, 5 parts of magnesium lauryl sulfate, 1.5 parts of sweetener, 1.5 parts of edible flavor, and 0.02 parts of pigment.

[0010] Preferably, the sweetener is one of aspartame, sucralose, neotame, and steviol glycoside.

[0011] Preferably, the edible flavor is one of sweet orange powder flavor, green apple powder flavor, peach powder flavor, and pineapple powder flavor.

[0012] Preferably, the pigment is one of lemon yellow aluminum lake, fruit green aluminum lake, carmine aluminum lake, and bright blue aluminum lake.

[0013] Preferably, the mesh size of anhydrous citric acid is 30 mesh, the mesh size of vitamin C and sodium bicarbonate is 60 mesh, and the mesh size of D-mannitol, magnesium lauryl sulfate, sweetener, edible flavor, and pigment is 80 mesh.

[0014] A method for preparing a sugar-free vitamin C effervescent tablet as described in any one of the above items comprises the following steps:

[0015] (1) Weigh sodium bicarbonate, anhydrous citric acid, D-mannitol, vitamin C, magnesium lauryl sulfate, sweetener, edible flavor, and pigment according to weight;

[0016] (2) taking 0.09-0.36 parts of the magnesium lauryl sulfate weighed in step (1), mixing them uniformly with 0.76-0.9 parts of 95% ethanol and 0.68-0.81 parts of purified water to prepare an adhesive;

[0017] (3) taking the anhydrous citric acid and D-mannitol weighed in step (1), mixing and stirring with the binder prepared in step (2), and then sieving and granulating to obtain wet granules; the purpose is to form a protective film on the mixed material with magnesium lauryl sulfate to reduce the moisture absorption of the acid source;

[0018] (4) drying the wet granules obtained in step (3) to control the moisture content of the granules to ≤1.0%, and sieving the whole granules to obtain dry granules; the purpose is to reduce the moisture content in the alkali source so that the moisture can be quickly introduced into the tablet during the disintegration process. At this time, the sodium bicarbonate acts as a water absorbent, promoting the accelerated disintegration of the sugar-free vitamin C effervescent tablets;

[0019] (5) drying the sodium bicarbonate weighed in step (1) and sieving the resulting granules;

[0020] (6) The dry granules obtained in step (4), the sodium bicarbonate granulated in step (5), the vitamin C, sweetener, edible flavor, pigment, and the remaining amount of magnesium lauryl sulfate weighed in step (1) are mixed uniformly and then tableted at a tableting pressure of 50 to 55 kN to obtain sugar-free vitamin C effervescent tablets.

[0021] Preferably, in step (3), granulation is performed through a 16-mesh sieve to obtain wet granules; in step (4), granulation is performed through a 14-mesh sieve to obtain dry granules; and in step (5), the sodium bicarbonate is dried and then granulated through a 14-mesh sieve.

[0022] Preferably, in step (5), the method for drying the sodium bicarbonate is: placing the sodium bicarbonate in a drying oven at 50° C. and drying for 4 hours.

[0023] Preferably, in step (6), a mixing tank is used to mix the materials.

[0024] Use of the sugar-free vitamin C effervescent tablet as described above in preparing a medicine for improving human immunity.

[0025] The present invention has the following beneficial effects: providing a sugar-free vitamin C effervescent tablet, a preparation method thereof, and an application thereof, which adopts a sugar-free formula, uses vitamin C as an effective ingredient, sodium bicarbonate as an alkali source and water-inducing agent, and anhydrous citric acid as a single acid source to ensure a good drinking taste; D-mannitol is used as a sugar-free filler, magnesium lauryl sulfate is used as a binder and lubricant, and sweeteners, edible flavors, and pigments are added. D-mannitol and anhydrous citric acid are embedded and granulated with an alcohol aqueous solution prepared with a portion of magnesium lauryl sulfate to reduce the hygroscopicity of the acid source; sodium bicarbonate is dried to facilitate rapid introduction of moisture into the tablet during the disintegration process, thereby accelerating the disintegration speed; sodium bicarbonate is dried separately without being mixed with other materials for granulation and drying, so that during disintegration, sodium bicarbonate can be quickly dissolved in water, bicarbonate ions are hydrolyzed to produce hydroxide ions, acid-base neutralization reaction is accelerated, and disintegration time is shortened. At the same time, the hardness of the sugar-free vitamin C effervescent tablet meets the requirements of a bumpy and vibrating environment during production, storage, and transportation. This fundamentally ensures the drinking taste, smooth surface appearance, disintegration time and suitability of hardness of anhydrous citric acid as an acid source. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following briefly introduces the drawings required for use in the embodiments or descriptions of the prior art.

[0027] Figure 1 This is a photo of the sugar-free vitamin C effervescent tablets prepared in Example 1;

[0028] Figure 2 This is a photo of the sugar-free vitamin C effervescent tablets prepared in Example 2;

[0029] Figure 3 This is a photo of the sugar-free vitamin C effervescent tablets prepared in Example 3;

[0030] Figure 4 This is a photo of the sugar-free vitamin C effervescent tablets prepared in Example 4;

[0031] Figure 5 This is a photo of the sugar-free vitamin C effervescent tablets prepared in Example 5;

[0032] Figure 6 This is a photo of the sugar-free vitamin C effervescent tablets prepared in Comparative Example 1;

[0033] Figure 7 This is a photo of the sugar-free vitamin C effervescent tablets prepared in Comparative Example 2;

[0034] Figure 8 This is a photo of the sugar-free vitamin C effervescent tablets prepared in Comparative Example 3;

[0035] Figure 9 This is a photo of the sugar-free vitamin C effervescent tablets prepared in Comparative Example 4;

[0036] Figure 10 This is a photo of the sugar-free vitamin C effervescent tablets prepared in Comparative Example 5;

[0037] Figure 11 This is a photo of the sugar-free vitamin C effervescent tablets prepared in Comparative Example 6. DETAILED DESCRIPTION

[0038] In order to make the technical problems, technical solutions and beneficial effects to be solved by this application more clearly understood, the present application is further described in detail below with reference to the accompanying drawings and examples. It should be understood that the specific embodiments described herein are merely for the purpose of explaining this application and are not intended to limit this application. The methods used in this invention are conventional methods unless otherwise specified; the raw materials and devices used are conventional commercially available products unless otherwise specified.

[0039] Example 1

[0040] This embodiment provides a method for preparing a sugar-free vitamin C effervescent tablet, comprising the following steps:

[0041] (1) Weigh 24 kg of sodium bicarbonate, 30 kg of anhydrous citric acid, 11.73 kg of D-mannitol, 26.25 kg of vitamin C, 5 kg of lauryl magnesium sulfate, 1.5 kg of aspartame, 1.5 kg of sweet orange powder flavor, and 0.02 kg of lemon yellow aluminum lake respectively; wherein, the mesh size of anhydrous citric acid is 30 mesh, the mesh size of vitamin C and sodium bicarbonate is 60 mesh, and the mesh size of D-mannitol, lauryl magnesium sulfate, aspartame, sweet orange powder flavor, and lemon yellow aluminum lake is 80 mesh;

[0042] (2) 0.09 kg of the magnesium lauryl sulfate weighed in step (1) was mixed evenly with 0.9 kg of 95% ethanol and 0.81 kg of purified water to prepare an adhesive; that is, a 50% ethanol solution of magnesium lauryl sulfate having a mass concentration of 5% was prepared;

[0043] (3) taking the anhydrous citric acid and D-mannitol weighed in step (1), mixing them with the binder prepared in step (2), and then passing them through a 16-mesh sieve for granulation to obtain wet granules;

[0044] (4) drying the wet granules obtained in step (3) to control the moisture content of the granules to ≤1.0%, and passing the granules through a 14-mesh sieve to obtain dry granules;

[0045] (5) drying the sodium bicarbonate weighed in step (1) in a drying oven at 50° C. for 4 hours; and passing through a 14-mesh sieve to size particles;

[0046] (6) The dry granules obtained in step (4), the sodium bicarbonate granulated in step (5), the vitamin C, aspartame, sweet orange powder essence, lemon yellow aluminum lake, and the remaining amount of magnesium lauryl sulfate are mixed uniformly and then tableted at a tableting pressure of 50 to 55 kN to obtain sugar-free vitamin C effervescent tablets.

[0047] Example 2

[0048] This embodiment provides a method for preparing a sugar-free vitamin C effervescent tablet, comprising the following steps:

[0049] (1) The content of this step is the same as that of step (1) in Example 1 and will not be repeated here;

[0050] (2) 0.18 kg of the magnesium lauryl sulfate weighed in step (1) was mixed evenly with 0.85 kg of 95% ethanol and 0.77 kg of purified water to prepare an adhesive; that is, a 50% ethanol solution of magnesium lauryl sulfate having a mass concentration of 10% was prepared;

[0051] The contents of steps (3) to (6) are the same as those of steps (3) to (6) of Example 1, and are not repeated here.

[0052] The final result is sugar-free vitamin C effervescent tablets.

[0053] Example 3

[0054] This embodiment provides a method for preparing a sugar-free vitamin C effervescent tablet, comprising the following steps:

[0055] (1) The content of this step is the same as that of step (1) in Example 1 and will not be repeated here;

[0056] (2) 0.36 kg of the magnesium lauryl sulfate weighed in step (1) was mixed evenly with 0.76 kg of 95% ethanol and 0.68 kg of purified water to prepare an adhesive; that is, a 50% ethanol solution of magnesium lauryl sulfate having a mass concentration of 20% was prepared;

[0057] The contents of steps (3) to (6) are the same as those of steps (3) to (6) of Example 1, and are not repeated here.

[0058] The final result is sugar-free vitamin C effervescent tablets.

[0059] Example 4

[0060] This embodiment provides a method for preparing a sugar-free vitamin C effervescent tablet, comprising the following steps:

[0061] (1) Weigh 27 kg of sodium bicarbonate, 25 kg of anhydrous citric acid, 13.73 kg of D-mannitol, 26.25 kg of vitamin C, 5 kg of lauryl magnesium sulfate, 1.5 kg of aspartame, 1.5 kg of sweet orange powder flavor, and 0.02 kg of lemon yellow aluminum lake respectively; wherein, the mesh size of anhydrous citric acid is 30 mesh, the mesh size of vitamin C and sodium bicarbonate is 60 mesh, and the mesh size of D-mannitol, lauryl magnesium sulfate, aspartame, sweet orange powder flavor, and lemon yellow aluminum lake is 80 mesh;

[0062] (2) 0.09 kg of the magnesium lauryl sulfate weighed in step (1) was mixed evenly with 0.9 kg of 95% ethanol and 0.81 kg of purified water to prepare an adhesive; that is, a 50% ethanol solution of magnesium lauryl sulfate having a mass concentration of 5% was prepared;

[0063] The contents of steps (3) to (6) are the same as those of steps (3) to (6) of Example 1, and are not repeated here.

[0064] The final result is sugar-free vitamin C effervescent tablets.

[0065] Example 5

[0066] This embodiment provides a method for preparing a sugar-free vitamin C effervescent tablet, comprising the following steps:

[0067] (1) Weigh 30 kg of sodium bicarbonate, 28 kg of anhydrous citric acid, 7.73 kg of D-mannitol, 26.25 kg of vitamin C, 5 kg of lauryl magnesium sulfate, 1.5 kg of aspartame, 1.5 kg of sweet orange powder flavor, and 0.02 kg of lemon yellow aluminum lake respectively; wherein, the mesh size of anhydrous citric acid is 30 mesh, the mesh size of vitamin C and sodium bicarbonate is 60 mesh, and the mesh size of D-mannitol, lauryl magnesium sulfate, aspartame, sweet orange powder flavor, and lemon yellow aluminum lake is 80 mesh;

[0068] (2) 0.09 kg of the magnesium lauryl sulfate weighed in step (1) was mixed evenly with 0.9 kg of 95% ethanol and 0.81 kg of purified water to prepare an adhesive; that is, a 50% ethanol solution of magnesium lauryl sulfate having a mass concentration of 5% was prepared;

[0069] The contents of steps (3) to (6) are the same as those of steps (3) to (6) of Example 1, and are not repeated here.

[0070] The final result is sugar-free vitamin C effervescent tablets.

[0071] Comparative Example 1

[0072] This comparative example provides a method for preparing a sugar-free vitamin C effervescent tablet, comprising the following steps:

[0073] (1) The content of this step is the same as that of step (1) in Example 1 and will not be repeated here;

[0074] (2) 0.95 kg of 95% ethanol and 0.85 kg of purified water were mixed to prepare an adhesive; that is, a 50% ethanol solution with a mass concentration of 0% magnesium lauryl sulfate was prepared;

[0075] The contents of steps (3) to (5) are respectively the same as those of steps (3) to (5) of Example 1 and are not repeated here;

[0076] (6) The dry granules obtained in step (4), the sodium bicarbonate granulated in step (5), the vitamin C, aspartame, orange powder flavor, lemon yellow aluminum lake, and magnesium lauryl sulfate weighed in step (1) are mixed evenly and tableted at a tableting pressure of 50 to 55 kN to obtain sugar-free vitamin C effervescent tablets.

[0077] Comparative Example 2

[0078] This comparative example provides a method for preparing a sugar-free vitamin C effervescent tablet. Compared with the content of Example 1, the only difference is step (5): the sodium bicarbonate weighed in step (1) is not dried, but directly sieved through a 14-mesh sieve to form whole particles; the other contents are the same as those of Example 1 and will not be repeated here;

[0079] The final result is sugar-free vitamin C effervescent tablets.

[0080] Comparative Example 3

[0081] This comparative example provides a method for preparing a sugar-free vitamin C effervescent tablet, comprising the following steps:

[0082] (1) The content of this step is the same as that of step (1) in Example 1 and will not be repeated here;

[0083] (2) 0.54 kg of the magnesium lauryl sulfate weighed in step (1) was mixed evenly with 0.66 kg of 95% ethanol and 0.6 kg of purified water to prepare an adhesive; that is, a 50% ethanol solution of magnesium lauryl sulfate having a mass concentration of 30% was prepared;

[0084] The contents of steps (3) to (6) are respectively the same as those of steps (3) to (6) of Example 1 and are not repeated here.

[0085] The final result is sugar-free vitamin C effervescent tablets.

[0086] Comparative Example 4

[0087] This embodiment provides a method for preparing a sugar-free vitamin C effervescent tablet, comprising the following steps:

[0088] (1) Weigh 20 kg of sodium bicarbonate, 35 kg of anhydrous citric acid, 10.73 kg of D-mannitol, 26.25 kg of vitamin C, 5 kg of lauryl magnesium sulfate, 1.5 kg of aspartame, 1.5 kg of sweet orange powder flavor, and 0.02 kg of lemon yellow aluminum lake, wherein the mesh size of anhydrous citric acid is 30 mesh, the mesh size of vitamin C and sodium bicarbonate is 60 mesh, and the mesh size of D-mannitol, lauryl magnesium sulfate, aspartame, sweet orange powder flavor, and lemon yellow aluminum lake is 80 mesh;

[0089] The contents of steps (2) to (6) are respectively the same as those of steps (2) to (6) of Example 1 and are not repeated here.

[0090] The final result is sugar-free vitamin C effervescent tablets.

[0091] Comparative Example 5

[0092] This embodiment provides a method for preparing a sugar-free vitamin C effervescent tablet, comprising the following steps:

[0093] (1) Weigh 35 kg of sodium bicarbonate, 20 kg of anhydrous citric acid, 10.73 kg of D-mannitol, 26.25 kg of vitamin C, 5 kg of lauryl magnesium sulfate, 1.5 kg of aspartame, 1.5 kg of sweet orange powder essence, and 0.02 kg of lemon yellow aluminum lake, wherein the mesh size of anhydrous citric acid is 30 mesh, the mesh size of vitamin C and sodium bicarbonate is 60 mesh, and the mesh size of D-mannitol, lauryl magnesium sulfate, aspartame, sweet orange powder essence, and lemon yellow aluminum lake is 80 mesh;

[0094] The contents of steps (2) to (6) are respectively the same as those of steps (2) to (6) of Example 1 and are not repeated here;

[0095] The final result is sugar-free vitamin C effervescent tablets.

[0096] Comparative Example 6

[0097] This comparative example provides a method for preparing a sugar-free vitamin C effervescent tablet, comprising the following steps:

[0098] (1) The content of this step is the same as that of step (1) in Example 1 and will not be repeated here;

[0099] (2) 0.09 kg of the magnesium lauryl sulfate weighed in step (1) was mixed evenly with 0.9 kg of 95% ethanol and 0.81 kg of purified water to prepare an adhesive; that is, a 50% ethanol solution of magnesium lauryl sulfate having a mass concentration of 5% was prepared;

[0100] (3) taking the anhydrous citric acid weighed in step (1) and half the mass of D-mannitol, mixing them with the binder prepared in step (2), and granulating them through a 16-mesh sieve to obtain acid wet granules;

[0101] (4) adding 0.9 kg of 95% ethanol and 0.81 kg of purified water to the sodium bicarbonate and the other half of the D-mannitol weighed in step (1), mixing and stirring, and then granulating through a 16-mesh sieve to obtain alkaline-wet granules;

[0102] (5) drying the acid-wet granules obtained in step (3) and the alkali-wet granules obtained in step (4) respectively, controlling the moisture content of the granules to ≤1.0%, and passing the granules through a 14-mesh sieve to obtain acid-dried granules and alkali-dried granules, respectively;

[0103] (6) The acid dry granules and the alkali dry granules obtained in step (5) are mixed uniformly with the vitamin C, aspartame, sweet orange powder essence, lemon yellow aluminum lake, and the remaining mass of magnesium lauryl sulfate, and then tableted. The tableting pressure is controlled at 50 to 55 kN to obtain sugar-free vitamin C effervescent tablets.

[0104] Experimental testing:

[0105] 1. Surface finish test

[0106] The appearance of the sugar-free vitamin C effervescent tablets prepared in Examples 1 to 5 and Comparative Examples 1 to 6 was observed with the naked eye.

[0107] The appearance observation results of the sugar-free vitamin C effervescent tablets prepared in Examples 1 to 5 are shown in Table 1, and the corresponding photos are shown in Table 1. Figures 1 to 5 The appearance observation results of the sugar-free vitamin C effervescent tablets prepared in Comparative Examples 1 to 6 are shown in Table 2, and the corresponding photos are shown in Table 2. Figures 6-11 shown.

[0108] Table 1 Observation results of the appearance of sugar-free vitamin C effervescent tablets of Examples 1 to 5

[0109] Example 1 Example 2 Example 3 Example 4 Example 5 Smooth surface Smooth surface Smooth surface Smooth surface Smooth surface

[0110] Table 2 Observation results of the appearance of comparative examples 1 to 6 sugar-free vitamin C effervescent tablets

[0111] Comparative Example 1 Comparative Example 2 Comparative Example 3 Comparative Example 4 Comparative Example 5 Comparative Example 6 The surface is bumpy and not smooth Surface light knot The surface is bumpy and not smooth Smooth surface Smooth surface Smooth surface

[0112] 2. Disintegration time limit

[0113] The test method is: General Rules of Part III of the 2020 edition of the Chinese Pharmacopoeia (0921 Disintegration Time Test Method).

[0114] Six sugar-free vitamin C effervescent tablets prepared in Examples 1 to 5 and Comparative Examples 1 to 6 were taken and tested according to the above test method. The test results of Examples 1 to 5 are shown in Table 3, and the test results of Comparative Examples 1 to 6 are shown in Table 4.

[0115] Table 3 Disintegration time of sugar-free vitamin C effervescent tablets of Examples 1 to 5

[0116]

[0117] Table 4 Disintegration time of comparative examples 1 to 6 sugar-free vitamin C effervescent tablets

[0118]

[0119] 3. Hardness test

[0120] Hardness test method 1:

[0121] The ambient temperature is 18-26°C and the relative humidity is ≤65%. Place the tablet in the track slot of the YD-35 tablet hardness tester, start the equipment, and read the tablet hardness directly after the test is completed.

[0122] Ten sugar-free vitamin C effervescent tablets prepared in Examples 1 to 5 and Comparative Examples 1 to 6 were taken, and tested according to the above test method. The test results of Examples 1 to 5 are shown in Table 5, and the test results of Comparative Examples 1 to 6 are shown in Table 6.

[0123] Table 5 Hardness test results of Examples 1 to 5 Sugar-free Vitamin C effervescent tablets

[0124]

[0125] Table 6 Hardness test results of comparative examples 1 to 6 sugar-free vitamin C effervescent tablets

[0126]

[0127] Hardness test method 2:

[0128] Under ambient temperature of 18-26°C and relative humidity ≤65%, 250 tablets each of the sugar-free vitamin C effervescent tablets prepared in Examples 1-5 and Comparative Examples 1-6 were placed in a fully automatic vibrating tablet counter, set to a vibration frequency of 50 Hz, and oscillated back and forth three times. The test results are shown in Tables 7 and 8. The breakage rate was calculated as: number of broken tablets / 250 tablets × 100%.

[0129] Table 7 Breakage rate of sugar-free vitamin C effervescent tablets in Examples 1 to 5

[0130] Example 1 Example 2 Example 3 Example 4 Example 5 0％ 0％ 0％ 0％ 0％

[0131] Table 8 Comparative Examples 1 to 5 Sugar-Free Vitamin C Effervescent Tablet Breakage Rate

[0132] Comparative Example 1 Comparative Example 2 Comparative Example 3 Comparative Example 4 Comparative Example 5 Comparative Example 6 0％ 0％ 29％ 0％ 34％ 0％

[0133] Hardness test method 3:

[0134] At room temperature, two packages of sugar-free vitamin C effervescent tablets (250 tablets / package, totaling 500 tablets) prepared in Examples 1-5 and Comparative Examples 1-6 were placed on a simulated automobile vibration table. The vibration frequency was set to 25 Hz, the device was turned on, and the table was run for 24 hours. The test results are shown in Tables 9 and 10. The breakage rate was calculated as: number of broken tablets / 500 tablets × 100%.

[0135] Table 9 Breakage rate of sugar-free vitamin C effervescent tablets in Examples 1 to 5

[0136] Example 1 Example 2 Example 3 Example 4 Example 5 0％ 0％ 0％ 0％ 0％

[0137] Table 10 Breakage rate of comparative examples 1 to 5 sugar-free vitamin C effervescent tablets

[0138] Comparative Example 1 Comparative Example 2 Comparative Example 3 Comparative Example 4 Comparative Example 5 Comparative Example 6 0％ 24％ 0％ 0％ 22％ 0％

[0139] Test analysis and conclusion:

[0140] By comparing Example 1, Example 4, Example 5 with Comparative Example 4, Comparative Example 5, it was determined that the disintegration time was faster when the proportion of anhydrous citric acid was in the range of 25-30% and the proportion of sodium bicarbonate was in the range of 24-30%.

[0141] By comparing Examples 1 to 3 with Control Example 1, it was determined that embedding and granulating the mixture of anhydrous citric acid and D-mannitol with a 50% ethanol solution having a mass concentration of 5% to 20% magnesium lauryl sulfate can reduce the moisture absorption of the acid source and solve the problem of uneven tablet surface caused by sticking to the die during tableting.

[0142] By comparing Example 1 with Control Example 2, it was determined that drying the sodium bicarbonate can accelerate the disintegration time of the effervescent tablet.

[0143] By comparing Examples 1 to 3 with Control Example 3, it was determined that a 50% ethanol solution of 5% to 20% lauryl magnesium sulfate was suitable for embedding and granulating the mixture of anhydrous citric acid and D-mannitol. Using a 50% ethanol solution of a higher concentration of lauryl magnesium sulfate for embedding and granulation resulted in a smaller amount added during the total mixing, poor lubrication effect, low hardness of the plain tablets, and sticking to the die during tableting, resulting in uneven and uneven tablet surfaces.

[0144] By comparing Example 1 with Comparative Example 6, it was determined that drying sodium bicarbonate alone resulted in a shorter disintegration time for the effervescent tablets than drying the effervescent tablets produced by granulating sodium bicarbonate with other materials.

[0145] By using a 5% to 20% mass concentration of magnesium lauryl sulfate in 50% ethanol solution to encapsulate and granulate anhydrous citric acid and D-mannitol and drying sodium bicarbonate separately, the two major problems of effervescent tablets sticking to the die, resulting in rough tablet surface and long disintegration time, are solved.

[0146] Currently, the vitamin C content in general vitamin C effervescent tablets (tablet weight: 4g) on ​​the market is about 400mg / tablet, while the vitamin C effervescent tablets (tablet weight: 4g) of the present invention have a vitamin C content of 1000mg / tablet and adopt a sugar-free formula to meet the human body's vitamin C content requirements. The vitamin C effervescent tablets of the present invention are rich in vitamin C. Taking the vitamin C effervescent tablets helps to supplement vitamin C and improve human immunity. Therefore, the sugar-free vitamin C effervescent tablets prepared in the above embodiment of the present invention can be used in the preparation of drugs for improving human immunity.

[0147] The present invention provides a sugar-free vitamin C effervescent tablet and its preparation method and application. Vitamin C is used as an effective ingredient, sodium bicarbonate is used as an alkali source and water-inducing agent, and anhydrous citric acid is used as a single acid source to ensure a good drinking taste. D-mannitol is used as a sugar-free filler, magnesium lauryl sulfate is used as a binder and lubricant, and sweeteners, edible flavors, and pigments are added. D-mannitol and anhydrous citric acid are embedded and granulated with an alcohol-water solution prepared with a portion of magnesium lauryl sulfate to reduce the hygroscopicity of the acid source. The sodium bicarbonate is dried to facilitate the rapid introduction of moisture into the tablet during the disintegration process, thereby accelerating the disintegration rate. The sodium bicarbonate is not mixed with other materials for granulation. During disintegration, the sodium bicarbonate can be quickly dissolved in water, and bicarbonate ions are hydrolyzed to produce hydroxide ions, accelerating the acid-base neutralization reaction and shortening the disintegration time. At the same time, the hardness of the sugar-free vitamin C effervescent tablet meets the requirements of the bumpy and vibrating environment during production, storage, and transportation. This fundamentally ensures the drinking taste, smooth surface appearance, disintegration time and suitability of hardness of anhydrous citric acid as an acid source.

[0148] It should be noted that:

[0149] (1) In the above embodiment, the mesh size of anhydrous citric acid is 30 mesh, the mesh size of vitamin C and sodium bicarbonate is 60 mesh, and the mesh size of D-mannitol, vitamin C, magnesium lauryl sulfate, aspartame, sweet orange powder flavor, and lemon yellow aluminum lake is 80 mesh. In actual production, the appropriate mesh size can also be selected according to the actual situation.

[0150] (2) In the above embodiments, in addition to aspartame, sucralose, neotame, and steviol glycosides can also be used as sweeteners.

[0151] (3) In the above embodiment, in addition to the sweet orange powder flavor, the edible flavor can also be replaced by green apple powder flavor, peach powder flavor, or pineapple powder flavor.

[0152] (4) In the above embodiments, in addition to lemon yellow aluminum lake, fruit green aluminum lake, carmine aluminum lake, and bright blue aluminum lake can also be used as pigments.

[0153] The above description is only a preferred embodiment of the present application and is not intended to limit the present application. Any modifications, equivalent replacements and improvements made within the spirit and principles of the present application should be included in the scope of protection of the present application.

Claims

1. A sugar-free vitamin C effervescent tablet, characterized in that: The invention is composed of the following components in parts by weight: 24-30 parts of sodium bicarbonate, 25-30 parts of anhydrous citric acid, 7.73-13.73 parts of D-mannitol, 26.25 parts of vitamin C, 5 parts of magnesium lauryl sulfate, 1.5 parts of sweetener, 1.5 parts of edible flavor, and 0.02 parts of pigment; The method for preparing the sugar-free vitamin C effervescent tablet comprises the following steps: (1) Weigh sodium bicarbonate, anhydrous citric acid, D-mannitol, vitamin C, magnesium lauryl sulfate, sweetener, edible flavor, and pigment according to weight; (2) taking 0.09 to 0.36 parts of the magnesium lauryl sulfate weighed in step (1), mixing them evenly with 0.76 to 0.9 parts of 95% ethanol and 0.68 to 0.81 parts of purified water to prepare an adhesive; (3) taking the anhydrous citric acid and D-mannitol weighed in step (1), mixing them with the binder prepared in step (2), and then sieving and granulating them to obtain wet granules; (4) drying the wet granules obtained in step (3) to control the moisture content of the granules to ≤1.0%, and sieving the granules to obtain dry granules; (5) drying the sodium bicarbonate weighed in step (1) and sieving the resulting granules; (6) The dry granules obtained in step (4), the sodium bicarbonate granulated in step (5), the vitamin C, sweetener, edible flavor, pigment, and the remaining mass of magnesium lauryl sulfate weighed in step (1) are mixed evenly and tableted at a tableting pressure of 50 to 55 kN to obtain the sugar-free vitamin C effervescent tablets.

2. A sugar-free vitamin C effervescent tablet according to claim 1, characterized in that The invention is composed of the following components in parts by weight: 24 parts of sodium bicarbonate, 30 parts of anhydrous citric acid, 11.73 parts of D-mannitol, 26.25 parts of vitamin C, 5 parts of lauryl magnesium sulfate, 1.5 parts of sweetener, 1.5 parts of edible flavor and 0.02 parts of pigment.

3. A sugar-free vitamin C effervescent tablet according to claim 1 or 2, characterized in that: The sweetener is one of aspartame, sucralose, neotame and steviol glycoside.

4. A sugar-free vitamin C effervescent tablet according to claim 1 or 2, characterized in that: The edible flavor is one of sweet orange powder flavor, green apple powder flavor, peach powder flavor, and pineapple powder flavor.

5. A sugar-free vitamin C effervescent tablet according to claim 1 or 2, characterized in that: The pigment is one of lemon yellow aluminum lake, fruit green aluminum lake, carmine red aluminum lake and bright blue aluminum lake.

6. A sugar-free vitamin C effervescent tablet according to claim 1 or 2, characterized in that: The mesh size of the anhydrous citric acid is 30 mesh, the mesh size of the vitamin C and sodium bicarbonate is 60 mesh, and the mesh size of the D-mannitol, magnesium lauryl sulfate, sweetener, edible flavor, and pigment is 80 mesh.

7. The sugar-free vitamin C effervescent tablet according to claim 1, characterized in that: In the step (3), the granulation is performed through a 16-mesh sieve to obtain wet granules; in the step (4), the granules are sieved through a 14-mesh sieve to obtain dry granules; in the step (5), the sodium bicarbonate is dried and then sieved through a 14-mesh sieve to obtain granules.

8. The sugar-free vitamin C effervescent tablet according to claim 1, characterized in that: In step (5), the method for drying the sodium bicarbonate is as follows: placing the sodium bicarbonate in a drying oven at 50° C. and drying for 4 hours.

9. Use of the sugar-free vitamin C effervescent tablet according to any one of claims 1 to 8 in the preparation of a drug for improving human immunity.

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