Vitamin B effervescent tablet and preparation method thereof

Abstract

The invention relates to a vitamin B effervescent tablet and a preparation method thereof, and belongs to the field of vitamin effervescent tablet production. 5-8 parts of tea powder; 70 to 80 parts of a filling agent; 90 to 110 parts of a disintegrating agent; 0.05 to 0.12 part of a lubricant; and 1.2 to 1.8 parts of a wetting agent. According to the vitamin B effervescent tablet, disintegrating agent particles are coated with an HPMC-shellac composite film, the dual functions of humidity shielding and rapid dissolution are achieved, the vitamin B effervescent tablet is convenient to eat and does not disintegrate in advance even if being exposed in air for a certain time, meanwhile, the tea powder is used as a natural flavor agent for middle-aged and elderly people, the resistance psychology of the middle-aged and elderly people can be relieved, and the immunity of the middle-aged and elderly people can be improved. Therefore, the storage stability and attraction of the vitamin B effervescent tablet are improved.

Description

Technical Field

[0001] The invention belongs to the field of vitamin effervescent tablet production, in particular to a vitamin B effervescent tablet and a preparation method thereof. Background Art

[0002] There are more than twelve B vitamins, nine of which are universally recognized as essential. All are water-soluble, remaining in the body for only a few hours and requiring daily replenishment. B vitamins are essential nutrients for all human tissues and are key to releasing energy from food. Effervescent tablets are a relatively new pharmaceutical dosage form. Unlike conventional tablets, they utilize an organic acid and alkaline carbonate as an effervescent disintegrant. When placed in water, an instant effervescent reaction occurs, generating and releasing large amounts of carbon dioxide gas, resembling boiling water. Hence the name "effervescent tablet."

[0003] In daily life, the human body needs to supplement enough B vitamins every day. Due to the decreased absorption capacity of middle-aged and elderly people, and their daily living habits and over-refined food processing, the intake of B vitamins is insufficient, and appropriate methods are needed to supplement them.

[0004] Vitamin B effervescent tablets are easily absorbed by the human body after brewing, but middle-aged and elderly people generally have a resistance to medicines, which makes vitamin B effervescent tablets unpopular. In addition, middle-aged and elderly people are prone to improper storage of vitamin B effervescent tablets, which causes the vitamin B effervescent tablets to disintegrate prematurely and affect normal consumption. Therefore, a vitamin B effervescent tablet and a preparation method thereof are needed to meet people's needs. Summary of the Invention

[0005] The present invention provides a vitamin B effervescent tablet and a preparation method thereof, which are used to solve the defects in the prior art.

[0006] The present invention is achieved through the following technical solutions:

[0007] A vitamin B effervescent tablet comprises the following substances in parts by weight: 10 parts of vitamin B complex; 5-8 parts of tea powder; 70-80 parts of filler; 90-110 parts of disintegrant; 0.05-0.12 parts of lubricant; and 1.2-1.8 parts of wetting agent.

[0008] The vitamin B effervescent tablet as described above, wherein the vitamin B complex comprises the following substances in parts by weight: 3-5 parts of vitamin B1 (thiamine nitrate); 2-4 parts of vitamin B2 (riboflavin); 10-18 parts of vitamin B3 (niacinamide); 4-7 parts of vitamin B5 (calcium pantothenate); 3-6 parts of vitamin B6 (pyridoxine hydrochloride); 0.1-0.3 parts of vitamin B7 (biotin); 0.2-0.5 parts of vitamin B9 (folic acid); and 10-20 parts of vitamin B1 (thiamine nitrate). 12(Cyanocobalamin) 0.01 to 0.03 parts.

[0009] In the vitamin B effervescent tablet as described above, the tea powder is any one of green tea powder, oolong tea powder or Pu'er tea powder, or a mixture of any two of them in any proportion, and the particle size of the tea powder is ≤50 μm.

[0010] In the vitamin B effervescent tablet as described above, the filler is a mixture of sorbitol and mannitol in a mass ratio of 1:1.

[0011] In the vitamin B effervescent tablet as described above, the disintegrant comprises an acidic compound and an alkaline compound, and the mass ratio of the acidic compound to the alkaline compound is 10:6.

[0012] In the vitamin B effervescent tablet as described above, the acidic compound is a mixture of citric acid and ammonium tartrate in a mass ratio of 7:3.

[0013] In the above-mentioned vitamin B effervescent tablet, the alkaline compound is sodium bicarbonate.

[0014] In the vitamin B effervescent tablet as described above, the lubricant is polyethylene glycol 6000.

[0015] In the vitamin B effervescent tablet as described above, the wetting agent is a mixture of purified water and edible alcohol in a mass ratio of 2.5:2.

[0016] In the vitamin B effervescent tablet as described above, the tea powder is microencapsulated and coated, the coating material is β-cyclodextrin, and the coating weight gain is 15-20%.

[0017] In the vitamin B effervescent tablet described above, the surface of the disintegrant particles is covered with an isolation layer of a protective film agent, the thickness of the isolation layer is 0.5 to 2 μm, the protective film agent comprises hydroxypropyl methylcellulose and shellac, and the mass ratio of the hydroxypropyl methylcellulose to shellac is 3:1.

[0018] The vitamin B effervescent tablet described above further includes a vitamin B complex stabilizer, which includes the following crushed substances by weight: 0.1-0.3% L-sodium ascorbate and 0.5-1.0% silicon dioxide. The stabilizer system and the vitamin B complex are jointly fluidized bed microencapsulated.

[0019] A method for preparing a vitamin B effervescent tablet comprises the following steps:

[0020] Step 1: Vitamin B complex pretreatment

[0021] Vitamin B complex and vitamin B complex stabilizer are mixed in a mass ratio of 1:0.15-0.25, and spray-coated with 10% HPMC ethanol solution in a fluidized bed at an inlet air temperature of 35°C and a coating weight gain of 15%;

[0022] Step 2: Inactivation of tea powder

[0023] The tea powder was sterilized by steam and then mixed with β-cyclodextrin at a ratio of 1:0.2 and ground;

[0024] Step 3: Disintegrant Coating

[0025] The disintegrant is placed in a bottom spray fluidized bed and sprayed with 5% sodium alginate-chitosan ethanol solution to form an isolation film to obtain a coated disintegrant;

[0026] Step 4: Ingredient processing

[0027] The filler is crushed and passed through an 80-mesh sieve to obtain a processed filler, each component is weighed according to the prescribed amount, the wetting agent and the filler obtained in step 1 are mixed to prepare a soft material, and the wet granules are passed through a 24-mesh sieve to prepare wet granules, the wet granules are dried at 45-55° C. to a moisture content of ≤0.8%, and passed through a 30-mesh sieve to prepare granules;

[0028] Step 5: Mix

[0029] The microencapsulated vitamin B complex, coating disintegrant, and processed tea powder are added in stages and mixed at 10-15 rpm for ≤25 min.

[0030] Step 6: Tablet pressing

[0031] Spray the lubricant onto the die surface of the tablet press at a speed of 80-130 g / h, and press the tablets at a machine speed of (50-120) × 1000 tablets / hour.

[0032] In the method for preparing a vitamin B effervescent tablet as described above, the operation temperature of the steam instantaneous sterilization in step 2 is 120° C. and the operation time is 3 seconds.

[0033] In the method for preparing a vitamin B effervescent tablet as described above, the film thickness of the coated disintegrant in step three is 0.8 to 1.2 μm, and the angle of repose of the coated disintegrant particles is ≤25°.

[0034] In the above-mentioned method for preparing a vitamin B effervescent tablet, the mixing process in step 5 is carried out in an environment with a relative humidity of ≤30%.

[0035] In the above-mentioned method for preparing a vitamin B effervescent tablet, the dew point temperature of the tableting environment in step 6 is controlled to be ≤-10°C.

[0036] In the above-mentioned method for preparing a vitamin B effervescent tablet, the tableting hardness in step 6 is controlled at 3-5 kp.

[0037] The advantages of the present invention are: the present invention adopts an HPMC-shellac composite film to coat disintegrant particles, achieving the dual functions of "humidity shielding + rapid dissolution", making the vitamin B effervescent tablet easy to eat and not disintegrating prematurely even if exposed to air for a certain period of time; at the same time, for the middle-aged and elderly population, the present invention uses tea powder as a natural flavoring agent to alleviate the resistance of the middle-aged and elderly population, thereby improving the storage stability and attractiveness of the vitamin B effervescent tablet; at the same time, the present invention uses microencapsulation technology, uses vitamin B group and a stabilizer for fluidized bed coating, uses a 10% HPMC ethanol solution, operates at a low temperature of 35°C, and achieves a coating weight gain of 15%, thereby forming an antioxidant moisture barrier, preventing the vitamin B group from coming into contact with the tea powder too early to reduce its activity; at the same time, the production process is simplified, production costs can be reduced, and the yield rate of the vitamin B group effervescent tablet can be improved. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following is a brief introduction to the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[0039] Figure 1 It is a flow chart of the present invention. DETAILED DESCRIPTION

[0040] To make the objectives, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts shall fall within the scope of protection of the present invention.

[0041] A vitamin B effervescent tablet comprises the following substances in parts by weight: 10 parts of vitamin B complex; 5-8 parts of tea powder; 70-80 parts of filler; 90-110 parts of disintegrant; 0.05-0.12 parts of lubricant; and 1.2-1.8 parts of wetting agent.

[0042] Preferably, the vitamin B complex described in this embodiment includes the following substances in parts by weight: 3-5 parts of vitamin B1 (thiamine nitrate); 2-4 parts of vitamin B2 (riboflavin); 10-18 parts of vitamin B3 (niacinamide); 4-7 parts of vitamin B5 (calcium pantothenate); 3-6 parts of vitamin B6 (pyridoxine hydrochloride); 0.1-0.3 parts of vitamin B7 (biotin); 0.2-0.5 parts of vitamin B9 (folic acid); 12 (Cyanocobalamin) 0.01 to 0.03 parts.

[0043] Preferably, the tea powder described in this embodiment is any one of green tea powder, oolong tea powder or Pu'er tea powder, or a mixture of any two of them in any proportion, and the particle size of the tea powder is ≤50 μm.

[0044] Preferably, the filler described in this embodiment is a mixture of sorbitol and mannitol in a mass ratio of 1:1.

[0045] Preferably, the disintegrant described in this embodiment includes an acidic compound and a basic compound, and the mass ratio of the acidic compound to the basic compound is 10:6.

[0046] Preferably, the acidic compound described in this embodiment is a mixture of citric acid and ammonium tartrate in a mass ratio of 7:3.

[0047] Preferably, the alkaline compound described in this embodiment is sodium bicarbonate.

[0048] Preferably, the lubricant described in this embodiment is polyethylene glycol 6000.

[0049] Preferably, the wetting agent described in this embodiment is a mixture of purified water and edible alcohol in a mass ratio of 2.5:2.

[0050] Preferably, the tea powder described in this embodiment is microencapsulated and coated, the coating material is β-cyclodextrin, and the coating weight gain is 15-20%.

[0051] Preferably, the surface of the disintegrant particles described in this embodiment is covered with an isolation layer of a protective film agent, the thickness of the isolation layer is 0.5 to 2 μm, the protective film agent includes hydroxypropyl methylcellulose and shellac, and the mass ratio of the hydroxypropyl methylcellulose to shellac is 3:1.

[0052] Preferably, this embodiment further includes a vitamin B complex stabilizer, which includes the following crushed substances by weight: 0.1-0.3% L-sodium ascorbate, 0.5-1.0% silicon dioxide, and the stabilizer system and the vitamin B complex are jointly subjected to fluidized bed microencapsulation coating.

[0053] A method for preparing a vitamin B effervescent tablet comprises the following steps:

[0054] Step 1: Vitamin B complex pretreatment

[0055] Vitamin B complex and vitamin B complex stabilizer are mixed in a mass ratio of 1:0.15-0.25, and spray-coated with 10% HPMC ethanol solution in a fluidized bed at an inlet air temperature of 35°C and a coating weight gain of 15%;

[0056] Step 2: Inactivation of tea powder

[0057] The tea powder was sterilized by steam and then mixed with β-cyclodextrin at a ratio of 1:0.2 and ground;

[0058] Step 3: Disintegrant Coating

[0059] The disintegrant is placed in a bottom spray fluidized bed and sprayed with 5% sodium alginate-chitosan ethanol solution to form an isolation film to obtain a coated disintegrant;

[0060] Step 4: Ingredient processing

[0061] The filler is crushed and passed through an 80-mesh sieve to obtain a processed filler, each component is weighed according to the prescribed amount, the wetting agent and the filler obtained in step 1 are mixed to prepare a soft material, and the wet granules are passed through a 24-mesh sieve to prepare wet granules, the wet granules are dried at 45-55° C. to a moisture content of ≤0.8%, and passed through a 30-mesh sieve to prepare granules;

[0062] Step 5: Mix

[0063] The microencapsulated vitamin B complex, coating disintegrant, and processed tea powder are added in stages and mixed at 10-15 rpm for ≤25 min.

[0064] Step 6: Tablet pressing

[0065] Spray the lubricant onto the die surface of the tablet press at a speed of 80-130 g / h, and press the tablets at a machine speed of (50-120) × 1000 tablets / hour.

[0066] Preferably, the operating temperature of the steam instantaneous sterilization in step 2 of this embodiment is 120° C., and the operating time is 3 seconds.

[0067] Preferably, the film thickness of the coated disintegrant in step 3 of this embodiment is 0.8-1.2 μm, and the angle of repose of the coated disintegrant particles is ≤25°.

[0068] Preferably, the mixing process in step five of this embodiment is performed in an environment with a relative humidity of ≤30%.

[0069] Preferably, the tableting environment in step six of this embodiment is controlled to have a dew point temperature of ≤-10°C.

[0070] Preferably, in step six of this embodiment, the tableting hardness is controlled at 3-5 kp.

[0071] Example

[0072] First, weigh the substances according to the following weight ratio: 10 parts of vitamin B complex; 6.5 parts of green tea powder (particle size ≤ 50 μm); 75 parts of filler (a mixture of sorbitol and mannitol in a mass ratio of 1:1); 100 parts of disintegrant (a mixture of citric acid, ammonium tartrate and sodium bicarbonate in a mass ratio of 7:3:6); 0.08 parts of polyethylene glycol 6000; and 1.5 parts of wetting agent (a mixture of purified water and edible alcohol in a mass ratio of 2.5:2).

[0073] The vitamin B complex includes the following substances in parts by weight: 3 to 5 parts vitamin B1; 2 to 4 parts vitamin B2; 10 to 18 parts vitamin B3; 4 to 7 parts vitamin B5; 3 to 6 parts vitamin B6; 0.1 to 0.3 parts vitamin B7; 0.2 to 0.5 parts vitamin B9; and vitamin B 12 0.01~0.03 parts.

[0074] The surface of the disintegrant particles is covered with an isolation layer of a protective film agent, the thickness of the isolation layer is 0.5 to 2 μm, the protective film agent includes hydroxypropyl methylcellulose and shellac, and the mass ratio of the hydroxypropyl methylcellulose and shellac is 3:1.

[0075] The preparation method comprises the following steps:

[0076] Step 1: Vitamin B complex pretreatment

[0077] Vitamin B complex and vitamin B complex stabilizer were mixed in a mass ratio of 1:0.2, and spray-coated with 10% HPMC ethanol solution in a fluidized bed at an inlet air temperature of 35°C and a coating weight gain of 15%.

[0078] The vitamin B complex stabilizer comprises the following crushed substances by weight: 0.1-0.3% sodium L-ascorbate, 0.5-1.0% silicon dioxide;

[0079] Step 2: Inactivation of tea powder

[0080] The tea powder was sterilized by steam (operating temperature 120°C, operating time 3s) and then mixed with β-cyclodextrin at a ratio of 1:0.2;

[0081] Step 3: Disintegrant Coating

[0082] Placing a disintegrant in a bottom-spray fluidized bed, spraying a 5% sodium alginate-chitosan ethanol solution to form an isolation film to obtain a coated disintegrant, wherein the film thickness of the coated disintegrant is 0.8 to 1.2 μm, and the angle of repose of the coated disintegrant particles is ≤25°;

[0083] Step 4: Ingredient processing

[0084] The filler is crushed and passed through an 80-mesh sieve to obtain a processed filler. Each component is weighed according to the prescribed amount. The wetting agent and the filler obtained in step 1 are mixed to prepare a soft material. The soft material is passed through a 24-mesh sieve to prepare wet granules. The wet granules are dried at 50° C. to a moisture content of 0.5%, and passed through a 30-mesh sieve to prepare granules.

[0085] Step 5: Mix

[0086] The microencapsulated vitamin B complex, the coating disintegrant, and the treated tea powder were added in stages and mixed at 13 rpm for 18.5 minutes in an environment with a relative humidity of ≤30%.

[0087] Step 6: Tablet pressing

[0088] The lubricant was sprayed onto the die surface of the tablet press at a speed of 105 g / h. The dew point temperature of the tablet pressing environment was controlled to be ≤-10°C, the tableting hardness was controlled to be 3-5 kp, and the tablets were pressed at a machine speed of 85×1000 tablets / hour.

[0089] The difference data between Comparative Examples 1-4 and Examples are shown in Table 1.

[0090]

[0091] Table 1

[0092] The difference data between Comparative Examples 5-8 and the embodiment are shown in Table 2.

[0093]

[0094] Table 2

[0095] The performance and cost comparison data of the embodiment and comparative examples 1, 2, 5 and 6 are shown in Table 3.

[0096]

[0097]

[0098] Table 3

[0099] From the data in Table 1, Table 2 and Table 3, it can be seen that in Comparative Example 1, moisture penetration triggers acid-base pre-reaction, gas production causes tablets to expand and crack during storage, and CO2 release is not concentrated during dissolution; in Comparative Example 2, tea polyphenols, especially catechins and vitamin B 12The redox reaction with vitamin B6 to generate insoluble polymers is the main cause of solution turbidity; in Comparative Example 3, hydrophobicity leads to wetting difficulties, and calcium stearate precipitation is generated with the acidic disintegrant, which is the source of the floating oil film; in Comparative Example 4, a Maillard reaction occurs, and lactose browns with nicotinamide during granulation and drying, and moisture absorption causes sticking; in Comparative Example 6, the membrane dissolution must first absorb water and swell, delaying the disintegrant contact reaction time, and the HPMC-shellac membrane dissolves slowly when pH>4. However, the embodiments of the present invention have relatively excellent performance, and the taste is more suitable for elderly people to take, which facilitates wide promotion and application.

[0100] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the various embodiments of the present invention.

Claims

1. A vitamin B effervescent tablet, characterized in that: The invention comprises the following substances in parts by weight: 10 parts of vitamin B complex; 5-8 parts of tea powder; 70-80 parts of filler; 90-110 parts of disintegrant; 0.05-0.12 parts of lubricant; and 1.2-1.8 parts of wetting agent.

2. A vitamin B effervescent tablet according to claim 1, characterized in that: The vitamin B complex comprises the following substances in parts by weight: 3 to 5 parts vitamin B1; 2 to 4 parts vitamin B2; 10 to 18 parts vitamin B3; 4 to 7 parts vitamin B5; 3 to 6 parts vitamin B6; 0.1 to 0.3 parts vitamin B7; 0.2 to 0.5 parts vitamin B9; vitamin B 12 0.01~0.03 parts.

3. A vitamin B effervescent tablet according to claim 1, characterized in that: The tea powder is any one of green tea powder, oolong tea powder or Pu'er tea powder, or a mixture of any two of them in any proportion, and the particle size of the tea powder is ≤50 μm; The filler is a mixture of sorbitol and mannitol in a mass ratio of 1:1; The disintegrant comprises an acidic compound and an alkaline compound, and the mass ratio of the acidic compound to the alkaline compound is 10:6; The acidic compound is a mixture of citric acid and ammonium tartrate in a mass ratio of 7:3; The alkaline compound is sodium bicarbonate; The lubricant is polyethylene glycol 6000; The wetting agent is a mixture of purified water and edible alcohol in a mass ratio of 2.5:

2.

4. A vitamin B effervescent tablet according to claim 1, characterized in that: The tea powder is processed by microencapsulation coating, the coating material is beta-cyclodextrin, and the coating weight gain is 15-20%.

5. A vitamin B effervescent tablet according to claim 1, characterized in that: The surface of the disintegrant particles is covered with an isolation layer of a protective film agent, the thickness of the isolation layer is 0.5 to 2 μm, the protective film agent includes hydroxypropyl methylcellulose and shellac, and the mass ratio of the hydroxypropyl methylcellulose to shellac is 3:

1.

6. A vitamin B effervescent tablet according to claim 1, characterized in that: It also includes a vitamin B complex stabilizer, which includes the following crushed substances by weight: 0.1-0.3% L-sodium ascorbate and 0.5-1.0% silicon dioxide. The stabilizer system and the vitamin B complex are jointly subjected to fluidized bed microencapsulation coating.

7. A method for preparing a vitamin B effervescent tablet, characterized in that: The following steps are involved: Step 1: Vitamin B complex pretreatment Vitamin B complex and vitamin B complex stabilizer are mixed in a mass ratio of 1:0.15-0.25, and spray-coated with 10% HPMC ethanol solution in a fluidized bed at an inlet air temperature of 35°C and a coating weight gain of 15%; Step 2: Inactivation of tea powder The tea powder was sterilized by steam and then mixed with β-cyclodextrin at a ratio of 1:0.2 and ground; Step 3: Disintegrant Coating The disintegrant is placed in a bottom spray fluidized bed and sprayed with 5% sodium alginate-chitosan ethanol solution to form an isolation film to obtain a coated disintegrant; Step 4: Ingredient processing The filler is crushed and passed through an 80-mesh sieve to obtain a processed filler, each component is weighed according to the prescribed amount, the wetting agent and the filler obtained in step 1 are mixed to prepare a soft material, and the wet granules are passed through a 24-mesh sieve to prepare wet granules, the wet granules are dried at 45-55° C. to a moisture content of ≤0.8%, and passed through a 30-mesh sieve to prepare granules; Step 5: Mix The microencapsulated vitamin B complex, coating disintegrant, and processed tea powder are added in stages and mixed at 10-15 rpm for ≤25 min. Step 6: Tablet pressing Spray the lubricant onto the die surface of the tablet press at a speed of 80-130 g / h, and press the tablets at a machine speed of (50-120) × 1000 tablets / hour.

8. The method for preparing a vitamin B effervescent tablet according to claim 7, wherein: The operating temperature of the steam instantaneous sterilization in step 2 is 120° C. and the operating time is 3 seconds.

9. The method for preparing a vitamin B effervescent tablet according to claim 7, wherein: The film thickness of the coated disintegrant in step 3 is 0.8 to 1.2 μm, and the angle of repose of the coated disintegrant particles is ≤ 25°; The mixing process in step 5 is carried out in an environment with a relative humidity of ≤30%.

10. The method for preparing a vitamin B effervescent tablet according to claim 7, wherein: The tableting environment in step 4 is controlled to have a dew point temperature of ≤-10°C; In the step 6, the tableting hardness is controlled at 3-5 kp.

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