CHEWABLE TABLET CONTAINING VITAMIN C SODIUM AND PREPARATION METHOD THEREOF

Abstract

The present application provides a chewable tablet containing vitamin C sodium. The chewable tablet includes the following components in parts by weight: 20-100 parts of vitamin C sodium, 100-500 parts of starch, 10-30 parts of sweetener, 5-20 parts of mannitol, 30-100 parts of microcrystalline cellulose, 5-20 parts of povidone K-30, 20-60 parts of sodium carboxymethyl starch, 5-20 parts of sodium dodecyl sulfate, 1-5 parts of magnesium stearate and 0.1-0.5 part of mint essence. The present application is easy to prepare, sweet in taste and stable in quality.

Claims

1. A chewable tablet containing vitamin C sodium, comprising the following components in parts by weight: 20-100 parts of vitamin C sodium, 200-500 parts of starch, 5-20 parts of mannitol, 30-100 parts of microcrystalline cellulose, 5-20 parts of povidone K-30, 10-60 parts of sodium carboxymethyl starch, 5-20 parts of sodium dodecyl sulfate, 1-5 parts of magnesium stearate, 10-30 parts of sweetener and 0.1-0.5 part of mint essence.

2. The chewable tablet containing vitamin C sodium according to claim 1, comprising the following components in parts by weight: 30 parts of vitamin C sodium, 361.75 parts of starch, 10 parts of mannitol, 60 parts of microcrystalline cellulose, 10 parts of povidone K-30, 40 parts of sodium carboxymethyl starch, 10 parts of sodium dodecyl sulfate, 3 parts of magnesium stearate, 20 parts of sweetener and 0.25 part of mint essence.

3. The chewable tablet containing vitamin C sodium according to claim 1, wherein the sweetener is selected from the group consisting of aspartame, neotame, and mogroside.

4. A preparation method of the chewable tablet containing vitamin C sodium according to claim 1, comprising the following steps: S1: respectively taking vitamin C sodium, starch, mannitol, microcrystalline cellulose, povidone K-30, sodium carboxymethyl starch, sodium dodecyl sulfate and sweetener, pulverizing, and sieving with a 100-mesh sieve for later use; S2: respectively weighing the raw and auxiliary materials in step S1 according to the formula amount, and uniformly mixing by an equal increment method to obtain mixed powder; S3: taking the mixed powder in step S2, adding 70-80% ethanol solution while stirring to prepare a damp mass, granulating and sieving, drying for 4 hours, controlling the moisture content to be 2-4%, and sizing to obtain granules; and S4: weighing magnesium stearate and mint essence according to the formula amount, evenly mixing with the granules in step S3, and compressing the granules into tablets.

5. The preparation method of the chewable tablet containing vitamin C sodium according to claim 4, wherein the drying temperature in step S3 is 60-65 C.

6. The preparation method of the chewable tablet containing vitamin C sodium according to claim 4, wherein a screen used for sieving in step S3 is a 14-30 mesh screen.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0022] Although the specification concludes with claims particularly pointing out and distinctly claiming the protection of the present application, it is believed that the following description will facilitate a better understanding of the present application.

[0023] As used herein, the word preferred and variants thereof refer to embodiments of the present application which are capable of providing specific benefits under specific circumstances. However, other embodiments may also be preferred under the same or other circumstances. Furthermore, the detailed description of one or more preferred embodiments does not indicate that other embodiments are useless and is not intended to exclude other embodiments from the scope of the present application.

[0024] I. Selection of Preparation Conditions

[0025] 1. Selection of Wetting Agent

[0026] A wetting agent can wet powder particles to obtain viscosity so as to facilitate the preparation of the granules and compress the granules into tablets. In the present application, dry tabletting and wet granulation and tabletting are compared, and since dry tabletting has a high requirement for equipment and cannot generate a good effect by adopting a common tabletting machine, wet granulation and tabletting is adopted herein. In the experiment, 20% maltodextrin, 30% starch slurry, 40% sucrose syrup, 5% hydroxypropyl methylcellulose aqueous solution and 80% ethanol were compared as the wetting agent. Results are shown in Table 1.

TABLE-US-00001 TABLE 1 Investigation Results of Wetting Agent Serial Granule number Adhesive Granulation condition appearance 1 20% maltodextrin slightly clustering, relatively agglomerating easily hard during granulation granules 2 30% starch slurry clustering, agglomerating hard granules easily during granulation 3 40% sucrose syrup clustering, agglomerating hard granules easily during granulation 4 5% hydroxypropyl clustering, agglomerating hard granules methylcellulose easily during granulation aqueous solution 5 80% ethanol clustering, not appropriate agglomerating during granule granulation tightness

[0027] From the test results in Table 1, it can be seen that 80% ethanol used in the present application has the best granulation effect, so in the present application, ethanol is selected as the wetting agent. The present application continues to optimize the concentration of ethanol, and the test results are shown in Table 2.

TABLE-US-00002 TABLE 2 Investigation Results of Ethanol Concentration Serial Granule number Wetting agent Granulation condition appearance 1 50% ethanol clustering, hard to granulate tight granules 2 60% ethanol clustering, hard to granulate tight granules 3 70% ethanol clustering, not agglomerating appropriate during granulation granule tightness 4 80% ethanol clustering, not agglomerating appropriate during granulation granule tightness 5 90% ethanol not clustering, hard to loose granules granulate

[0028] From the test results in Table 2, it can be seen that the 70%-80% ethanol used in the present application has a good granulation effect, tightness is too high for a lower concentration but too low for a higher concentration, which both affect granulation, so in the present application, the 70%-80% ethanol is selected as the wetting agent.

[0029] 2. Lubricant Selection

[0030] During tabletting, in order to increase granule fluidity, and ensure good filling and even distribution of tablet density, a certain amount of lubricant needs to be added to solve the problems of poor granule fluidity and sticking during tabletting. In the experiment of the present application, tabletting conditions when magnesium stearate, micro-powder silica gel, talcum powder, sodium dodecyl sulfate and mannitol were used as the lubricant were compared, and results are shown in Table 3.

TABLE-US-00003 TABLE 3 Lubricant Trial Results Tabletting Tablet weight Lubricant Fluidity condition difference Appearance Hardness Friability taste mannitol good non-sticking meeting intact and smooth 54 N 0.39% crisp, fluidity specification tablet surface, not uniform color gritty micro-powder good non-sticking meeting tablet surface not 29 N 1.21% too silica gel fluidity specification intact and smooth crisp, enough, not nonuniform color gritty talcum poor sticking meeting tablet surface not 98 N 0.12% hard powder fluidity specification intact and smooth and enough, gritty nonuniform color sodium good non-sticking meeting intact and smooth 59 N 0.42% crisp, dodecyl fluidity specification tablet surface, not sulfate uniform color gritty magnesium good non-sticking meeting intact and smooth 49 N 0.34% crisp, stearate fluidity specification tablet surface, not uniform color gritty

[0031] From the test results in Table 3, it can be seen that when magnesium stearate, sodium dodecyl sulfate and mannitol are used, fluidity is good and sticking during tabletting is avoided, and prepared tablets have appropriate hardness and smooth and beautiful surfaces; when micro-powder silica gel is added, fluidity is good and sticking during tabletting is avoided, but the hardness of prepared tablets is low; and when talcum powder is added, fluidity is poor and sticking occurs during tabletting, and prepared tablets have large hardness. Therefore, magnesium stearate, sodium dodecyl sulfate and mannitol are selected as the lubricant in the present application. In order to adjust the taste of the chewable tablets and in consideration of production costs, in the experiment of the present application, the proportion of magnesium stearate to sodium dodecyl sulfate to mannitol was also compared, and the results show that the taste is the best when the proportion of magnesium stearate to sodium dodecyl sulfate to mannitol is 3:3:1 or 4:4:1.

[0032] 4. Selection of Flavoring Agent

[0033] Only chewable tablets with good taste can be easily accepted by people, so flavor and taste are very important, and this is often realized through the selection of flavoring agents such as sweetener and essence. In the experiment of the present application, the following sweeteners were compared: sucrose, lactose, glucose, stevioside, disodium glycyrrhizinate, aspartame, saccharin sodium, sodium cyclamate, mogroside, neotame and aclame. The results show that when aspartame, mogroside and neotame were used in combination with mint essence within the range of 10-30 parts of sweetener, taste and flavor were good, sweetness was moderate and no discomfort was caused, where aspartame produced the best taste. Therefore, aspartame, mogroside and neotame are selected as sweeteners in the present application, and the addition amount thereof is specified to be 10-30 parts.

[0034] II. Preparation Method of Chewable Tablet Containing Vitamin C Sodium

Embodiment 1

[0035] A preparation method of the chewable tablet containing vitamin C sodium includes the following steps:

[0036] S1: respectively taking vitamin C sodium, starch, mannitol, microcrystalline cellulose, povidone K-30, sodium carboxymethyl starch, sodium dodecyl sulfate and neotame, pulverizing, and sieving with a 100-mesh sieve for later use;

[0037] S2: respectively weighing the following raw and auxiliary materials in step S1 in parts by weight: 30 kg of vitamin C sodium, 361.75 kg of starch, 10 kg of mannitol, 60 kg of microcrystalline cellulose, 10 kg of povidone K-30 kg, 40 kg of sodium carboxymethyl starch, 10 kg of sodium dodecyl sulfate and 20 kg of neotame, and uniformly mixing by an equal increment method to obtain mixed powder;

[0038] S3: taking the mixed powder in step S2, adding 80% ethanol solution while stirring to prepare a damp mass, sieving with a 20-mesh sieve and granulating, drying for 4 hours at 62 C., controlling the moisture content to be 2-4%, and sieving with a 20-mesh sieve and sizing to obtain granules; and

[0039] S4: weighing the following components in parts by weight: 3 kg of magnesium stearate and 0.25 kg of mint essence, evenly mixing with the granules in step S3, and compressing the granules into tablets.

Embodiment 2

[0040] A preparation method of the chewable tablet containing vitamin C sodium includes the following steps:

[0041] S1: respectively taking vitamin C sodium, starch, mannitol, microcrystalline cellulose, povidone K-30, sodium carboxymethyl starch, sodium dodecyl sulfate and aspartame, pulverizing, and sieving with a 100-mesh sieve for later use;

[0042] S2: respectively weighing the following raw and auxiliary materials in step S1 in parts by weight: 20 kg of vitamin C sodium, 200 kg of starch, 5 kg of mannitol, 30 kg of microcrystalline cellulose, 5 kg of povidone K-30 kg, 10 kg of sodium carboxymethyl starch, 5 kg of sodium dodecyl sulfate and 10 kg of aspartame, and uniformly mixing by an equal increment method to obtain mixed powder;

[0043] S3: taking the mixed powder in step S2, adding 70% ethanol solution while stirring to prepare a damp mass, sieving with a 30-mesh sieve and granulating, drying for 4 hours at 60 C., controlling the moisture content to be 2-4%, and sieving with a 30-mesh sieve and sizing to obtain granules; and

[0044] S4: weighing the following components in parts by weight: 1 kg of magnesium stearate and 0.1 kg of mint essence, evenly mixing with the granules in step S3, and compressing the granules into tablets.

Embodiment 3

[0045] A preparation method of the chewable tablet containing vitamin C sodium includes the following steps:

[0046] S1: respectively taking vitamin C sodium, starch, mannitol, microcrystalline cellulose, povidone K-30, sodium carboxymethyl starch, sodium dodecyl sulfate and mogroside, pulverizing, and sieving with a 100-mesh sieve for later use;

[0047] S2: respectively weighing the following raw and auxiliary materials in step S1 in parts by weight: 100 kg of vitamin C sodium, 500 kg of starch, 20 kg of mannitol, 100 kg of microcrystalline cellulose, 20 kg of povidone K-30, 60 kg of sodium carboxymethyl starch, 20 kg of sodium dodecyl sulfate and 30 kg of mogroside, and uniformly mixing by an equal increment method to obtain mixed powder;

[0048] S3: taking the mixed powder in step S2, adding 75% ethanol solution while stirring to prepare a damp mass, sieving with a 14-mesh sieve and granulating, drying for 4 hours at 65 C., controlling the moisture content to be 2-4%, and sieving with a 14-mesh sieve and sizing to obtain granules; and

[0049] S4: weighing the following components in parts by weight: 5 kg of magnesium stearate and 0.5 kg of mint essence, evenly mixing with the granules in step S3, and compressing the granules into tablets.

[0050] III. Stability Test

[0051] Samples from Embodiments 1-3 were packaged with double-layer aluminum-plastic composite films respectively, and placed in a stability acceleration test chamber for a three-month acceleration test, where the temperature is 402 C., and the relative humidity is 755%. Results show that compared with the test results of the samples at time 0, the samples from Embodiments 1-3 have no obvious changes in terms of key stability indexes such as appearance, taste, hardness, friability and main component content, and taste and flavor are not changed either, indicating that the samples from Embodiments 1-3 of the present application are stable in quality and can meet stability requirements for storage, transportation, and use. The test results are shown in Table 4.

TABLE-US-00004 TABLE 4 Stability Test Results of Chewable Tablet Containing Vitamin C Sodium Vitamin C sodium content (by marked Embodiment Time Appearance Taste Hardness Friability amount %) Embodiment 1 month intact and sweet and 49 N 0.32% 99.75 0 smooth tablet palatable, crisp, surface, not gritty uniform color month intact and sweet and 51 N 0.35% 99.82 1 smooth tablet palatable, crisp, surface, not gritty uniform color month intact and sweet and 52 N 0.39% 99.94 2 smooth tablet palatable, crisp, surface, not gritty uniform color month intact and sweet and 52 N 0.39% 99.61 3 smooth tablet palatable, crisp, surface, not gritty uniform color Embodiment 2 month intact and sweet and 53 N 0.39% 99.12 0 smooth tablet palatable, crisp, surface, not gritty uniform color month intact and sweet and 51 N 0.37% 99.04 1 smooth tablet palatable, crisp, surface, not gritty uniform color month intact and sweet and 54 N 0.41% 98.96 2 smooth tablet palatable, crisp, surface, not gritty uniform color month intact and sweet and 54 N 0.41% 99.07 3 smooth tablet palatable, crisp, surface, not gritty uniform color Embodiment 3 month intact and sweet and 43 N 0.31% 100.04 0 smooth tablet palatable, crisp, surface, not gritty uniform color month intact and sweet and 42 N 0.29% 100.12 1 smooth tablet palatable, crisp, surface, not gritty uniform color month intact and sweet and 44 N 0.33% 99.88 2 smooth tablet palatable, crisp, surface, not gritty uniform color month intact and sweet and 44 N 0.34% 99.79 3 smooth tablet palatable, crisp, surface, not gritty uniform color