Dry-mixing and direct-pressing process for effervescent tablets

Abstract

The invention discloses an effervescent tablet dry-mixing and direct-pressing technology, and relates to the technical field of effervescent tablets, the effervescent tablet dry-mixing and direct-pressing technology comprises the following steps: screening: screening citric acid, sodium bicarbonate, sodium carbonate, sorbitol and lactose according to a specific particle size requirement to obtain a screened material; mixing: mixing the sieved material with the composition to obtain a mixture, and adding a biodegradable lubricant to obtain total mixed powder; tabletting: adding the total mixed powder into a mold, and adjusting a tablet weight preset value of a tablet press to obtain the effervescent tablets; and inspection: inspecting the effervescent tablets, and removing unqualified effervescent tablets. According to the invention, through the dry mixing and direct pressing process, the steps of soft material preparation, granulation, drying and granule finishing in the traditional effervescent tablet production are simplified, the production period is shortened, the production efficiency is improved, and secondly, due to the simplification of the process, the dependence on equipment and the waste in the production process are reduced, so that the overall production cost is reduced.

Description

Technical Field

[0001] The invention relates to the technical field of effervescent tablets, in particular to a dry-mixing direct-compression process for effervescent tablets. Background Art

[0002] Effervescent tablets are a relatively new drug dosage form in my country. Unlike ordinary tablets, effervescent tablets use the reaction of organic acids and basic carbonate (bicarbonate) salts as effervescent disintegrants. When placed in water, an effervescent reaction occurs immediately, generating and releasing a large amount of carbon dioxide gas, which looks like boiling, hence the name effervescent tablets.

[0003] The preparation process of effervescent tablets is generally a wet granulation process, which requires operations such as soft material preparation, granulation, drying, and granulation. The process is complicated, the production cycle is long, the production efficiency is low, the labor intensity of operators is high, the material loss is large, the energy consumption is high, and the wetting agent (binder) uses ethanol, and production needs to be carried out in an explosion-proof area, which poses a safety risk. Summary of the invention

[0004] In view of the problems existing in the existing multi-source power grid information fusion based on the Internet of Things, the present invention is proposed.

[0005] Therefore, the problem to be solved by the present invention is that the preparation process is relatively complicated and the production efficiency is low.

[0006] In order to solve the above technical problems, the present invention provides the following technical solutions:

[0007] In a first aspect, an embodiment of the present invention provides a dry mixing direct compression process for effervescent tablets, which comprises the following steps:

[0008] Screening: Screening citric acid, sodium bicarbonate, sodium carbonate, sorbitol and lactose according to specific particle size requirements to obtain screened materials;

[0009] Mixing: mixing the sieved material with the synthetic material to obtain a mixture, and then adding a biodegradable lubricant to obtain a total mixed powder;

[0010] Tableting: Add the total mixed powder into the mold, adjust the tablet weight of the tablet press to a predetermined value, and obtain an effervescent tablet;

[0011] Inspection: Inspect the effervescent tablets and remove those that do not meet the standards.

[0012] As a preferred solution of the dry mixing direct compression process of the effervescent tablets of the present invention, when screening the materials, the following components are selected:

[0013] Citric acid: 30 mesh-100 mesh;

[0014] Sodium bicarbonate: 30 mesh-100 mesh;

[0015] Sodium carbonate: 30 mesh-100 mesh;

[0016] Sorbitol: 30 mesh-120 mesh;

[0017] Lactose: 30 mesh-100 mesh;

[0018] Among them, the proportion of citric acid in the range of 40-80 mesh is 80%-95%, the proportion of citric acid in the range of 30-40 mesh is less than 10%, and the proportion of citric acid in the range of 80-100 mesh is less than 10%;

[0019] The proportion of sodium bicarbonate in 30-40 mesh is less than 10%, that in 40-60 mesh is 10%-20%, that in 60-80 mesh is 20%-40%, that in 80-100 mesh is 20%-40%;

[0020] The proportion of sodium carbonate in the range of 30-40 mesh is less than 10%, that in the range of 40-60 mesh is 10%-20%, that in the range of 60-80 mesh is 20%-40%, and that in the range of 80-100 mesh is 20%-40%;

[0021] The proportion of sorbitol in 30-40 mesh is less than 10%, that in 40-60 mesh is 5%-10%, that in 60-80 mesh is 60%-85%, and that in 80-120 mesh is 10%-20%;

[0022] The lactose proportion of 30-40 mesh is less than 10%, the lactose proportion of 40-60 mesh is 2%-30%, the lactose proportion of 60-80 mesh is 30%-70%, and the lactose proportion of 80-100 mesh is 10%-20%.

[0023] As a preferred solution of the dry-mix direct compression process for effervescent tablets of the present invention, the biodegradable lubricant is composed of at least one natural vegetable oil and at least one vegetable wax.

[0024] Wherein, the natural vegetable oil includes olive oil, sunflower oil, palm oil, and soybean oil;

[0025] The vegetable waxes include carnauba wax, candelilla wax, Japan wax, and beeswax.

[0026] As a preferred solution of the dry mixing direct compression process for the effervescent tablets of the present invention, the natural vegetable oil accounts for 65%-75% of the biodegradable lubricant, and the vegetable wax accounts for 25%-35% of the biodegradable lubricant.

[0027] As a preferred solution of the dry-mix direct compression process of the effervescent tablet of the present invention, the synthetic material comprises sunset yellow, aspartame, sucralose, and sweet orange flavor;

[0028] When the composite is mixed, sunset yellow, aspartame and sucralose are first mixed evenly, and then mixed evenly with sweet orange flavor in an equal amount.

[0029] Wherein, the composition ratio of the composite is:

[0030] Sunset yellow: 0.3-0.6g;

[0031] Aspartame: 11-13g;

[0032] Sucralose: 3-5g;

[0033] Sweet orange essence: 100-200g.

[0034] As a preferred solution of the dry mixing direct compression process of an effervescent tablet described in the present invention, wherein: when the screened material is mixed with the composite through a mixing device, the ambient temperature of the mixing device is set at 18-26° C. and the relative humidity is less than 40%, the composite is mixed with lactose, citric acid and sorbitol, and then sodium bicarbonate or sodium carbonate is added, and then vitamin C is added, and the mixing time is set to 30-45 minutes;

[0035] Among them, lactose is taken in an amount of 400-600g;

[0036] Take 1000-1300g of citric acid;

[0037] Take 775.6-1175.6g of sorbitol;

[0038] Take 850-900g of sodium bicarbonate;

[0039] Take 550g of sodium carbonate;

[0040] Take 10-1000g of vitamin C.

[0041] As a preferred solution of the dry mixing direct compression process of the effervescent tablets of the present invention, when adding the biodegradable lubricant, the rotation speed of the mixing equipment is set to 25-60 rpm, and the biodegradable lubricant is added at a speed of 0.5 L / S-1 L / S;

[0042] Among them, natural vegetable oil is taken 30-100g;

[0043] Take 10-40g of vegetable wax.

[0044] As a preferred solution of the dry-mix direct compression process for an effervescent tablet of the present invention, wherein: during the tableting process, magnesium stearate is applied on the surface of the mold;

[0045] The magnesium stearate is 5-10g;

[0046] The rotation speed of the tablet press is set at 10-15 rpm, and the tablet weight is adjusted to 4 g.

[0047] As a preferred solution of the dry mixing direct compression process for effervescent tablets of the present invention, the step of inspecting the effervescent tablets comprises:

[0048] Take effervescent tablet samples by batch, the total number of effervescent tablet samples in each batch shall be 1% of the total number of the batch, and the total number of effervescent tablet samples in each batch shall not exceed 100;

[0049] All effervescent tablet samples are tested for weight, hardness and effervescent time;

[0050] Determine the quality status of the effervescent tablets based on the test results.

[0051] As a preferred solution of the dry mixing direct compression process for effervescent tablets of the present invention, the step of inspecting the effervescent tablets further comprises:

[0052] When the proportion of inferior effervescent tablet samples in the same batch is greater than the preset value A, the effervescent tablets in this batch are removed and the cause of the abnormality is inquired;

[0053] When the proportion of inferior effervescent tablet samples tested in the same batch is greater than a preset value B and less than or equal to a preset value A, all effervescent tablets in the batch are tested and the inferior effervescent tablets are removed;

[0054] When the proportion of inferior products in the test results of the same batch of effervescent tablets is less than or equal to the preset value B, the effervescent tablets will be packaged normally.

[0055] The beneficial effects of the present invention are:

[0056] The overall dry mixing and direct compression process simplifies the soft material preparation, granulation, drying and granulation steps in the traditional effervescent tablet production, shortens the production cycle and improves production efficiency. Secondly, due to the simplification of the process, the dependence on equipment and waste in the production process are reduced, thereby reducing the overall production cost. By controlling the particle size distribution of the raw materials and the ratio of the synthetic materials, the consistency and uniformity of the effervescent tablets are ensured, thereby improving product quality.

[0057] The use of biodegradable lubricants, which are all renewable resources and easily biodegraded, reduces the impact on the environment. The addition of natural plant oils provides lubricity to the effervescent tablets, while the addition of plant wax provides hardness, gloss and film-forming properties to the effervescent tablets, which helps to improve the stability and wear resistance of the product. BRIEF DESCRIPTION OF THE DRAWINGS

[0058] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for describing the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work. Among them:

[0059] Figure 1 The present invention is a flow chart of a dry mixing direct compression process for effervescent tablets. DETAILED DESCRIPTION

[0060] In order to make the above-mentioned purposes, features and advantages of the present invention more obvious and easy to understand, the specific implementation methods of the present invention are described in detail below in conjunction with the drawings of the specification. Obviously, the described embodiments are part of the embodiments of the present invention, but not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary persons in the art without creative work should fall within the scope of protection of the present invention.

[0061] In the following description, many specific details are set forth to facilitate a full understanding of the present invention, but the present invention may also be implemented in other ways different from those described herein, and those skilled in the art may make similar generalizations without violating the connotation of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0062] Secondly, the term "one embodiment" or "embodiment" as used herein refers to a specific feature, structure, or characteristic that may be included in at least one implementation of the present invention. The term "in one embodiment" that appears in different places in this specification does not necessarily refer to the same embodiment, nor does it refer to a separate or selective embodiment that is mutually exclusive with other embodiments.

[0063] The present invention is described in detail with reference to schematic diagrams. When describing the embodiments of the present invention, for the sake of convenience, the cross-sectional diagrams showing the device structure will not be partially enlarged according to the general scale, and the schematic diagrams are only examples, which should not limit the scope of protection of the present invention. In addition, in actual production, the three-dimensional dimensions of length, width and depth should be included.

[0064] At the same time, in the description of the present invention, it should be noted that the directions or positional relationships indicated by the terms "upper, lower, inner and outer" are based on the directions or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and therefore cannot be understood as limiting the present invention. In addition, the terms "first, second or third" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0065] In the present invention, unless otherwise clearly specified and limited, the terms "install, connect, connect" should be understood in a broad sense, for example: it can be a fixed connection, a detachable connection or an integral connection; it can also be a mechanical connection, an electrical connection or a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0066] Example 1

[0067] Reference Figure 1 , which is the first embodiment of the present invention, provides a dry mixing direct compression process for effervescent tablets, comprising the following steps:

[0068] Screening: citric acid, sodium bicarbonate, sodium carbonate, sorbitol and lactose are screened according to specific particle size requirements to obtain screened materials.

[0069] When screening materials, select the following ingredients:

[0070] Citric acid: 30 mesh-100 mesh;

[0071] Sodium bicarbonate: 30 mesh-100 mesh;

[0072] Sodium carbonate: 30 mesh-100 mesh;

[0073] Sorbitol: 30 mesh-120 mesh;

[0074] Lactose: 30 mesh-100 mesh;

[0075] Among them, the proportion of citric acid in the range of 40-80 mesh is 80%-95%, the proportion of citric acid in the range of 30-40 mesh is less than 10%, and the proportion of citric acid in the range of 80-100 mesh is less than 10%;

[0076] The proportion of sodium bicarbonate in 30-40 mesh is less than 10%, that in 40-60 mesh is 10%-20%, that in 60-80 mesh is 20%-40%, that in 80-100 mesh is 20%-40%;

[0077] The proportion of sodium carbonate in the range of 30-40 mesh is less than 10%, that in the range of 40-60 mesh is 10%-20%, that in the range of 60-80 mesh is 20%-40%, and that in the range of 80-100 mesh is 20%-40%;

[0078] The proportion of sorbitol in 30-40 mesh is less than 10%, that in 40-60 mesh is 5%-10%, that in 60-80 mesh is 60%-85%, and that in 80-120 mesh is 10%-20%;

[0079] The lactose proportion of 30-40 mesh is less than 10%, the lactose proportion of 40-60 mesh is 2%-30%, the lactose proportion of 60-80 mesh is 30%-70%, and the lactose proportion of 80-100 mesh is 10%-20%.

[0080] Mixing: The sieved material is mixed with the synthetic material to obtain a mixture, and then a biodegradable lubricant is added to obtain a total mixed powder.

[0081] The biodegradable lubricant is composed of at least one natural vegetable oil and at least one vegetable wax,

[0082] Wherein, the natural vegetable oil includes olive oil, sunflower oil, palm oil, and soybean oil;

[0083] The vegetable waxes include carnauba wax, candelilla wax, Japan wax, and beeswax.

[0084] The natural vegetable oil accounts for 65%-75% of the biodegradable lubricant, and the vegetable wax accounts for 25%-35% of the biodegradable lubricant.

[0085] The composition includes sunset yellow, aspartame, sucralose, and sweet orange flavor;

[0086] When the composite is mixed, sunset yellow, aspartame and sucralose are first mixed evenly, and then mixed evenly with sweet orange flavor in an equal amount.

[0087] Wherein, the composition ratio of the composite is:

[0088] Sunset yellow: 0.4g;

[0089] Aspartame: 12g;

[0090] Sucralose: 4g;

[0091] Sweet orange flavor: 200g.

[0092] When the sieved material is mixed with the composite through a mixing device, the ambient temperature of the mixing device is set at 18-26°C and the relative humidity is less than 40%, the composite is mixed with lactose, citric acid and sorbitol, and then sodium bicarbonate or sodium carbonate is added, and then vitamin C is added, and the mixing time is set to 30 minutes;

[0093] Among them, 600g of lactose is taken;

[0094] Take 1000g of citric acid;

[0095] Take 775.6g of sorbitol;

[0096] Take 900g of sodium bicarbonate;

[0097] Take 500g of vitamin C.

[0098] When adding the biodegradable lubricant, the speed of the mixing device is set to 25-60 rpm. In this embodiment, the speed is set to 25 rpm, and the biodegradable lubricant is added at a speed of 0.5 L / S;

[0099] Among them, natural vegetable oil takes 30g;

[0100] Take 10g of vegetable wax.

[0101] Tableting: Add the total mixed powder into the mold, adjust the tablet weight preset value of the tablet press, and obtain effervescent tablets.

[0102] During tableting, magnesium stearate is applied to the die surface;

[0103] The magnesium stearate is taken at 5 g;

[0104] The rotation speed of the tablet press was set at 10 rpm, and the tablet weight was adjusted to 4 g.

[0105] Inspection: Inspect the effervescent tablets and remove those that do not meet the standards.

[0106] Example 2

[0107] Reference Figure 1 , which is the second embodiment of the present invention, provides a dry mixing direct compression process for effervescent tablets, comprising the following steps:

[0108] Screening: citric acid, sodium bicarbonate, sodium carbonate, sorbitol and lactose are screened according to specific particle size requirements to obtain screened materials.

[0109] When screening materials, select the following ingredients:

[0110] Citric acid: 30 mesh-100 mesh;

[0111] Sodium bicarbonate: 30 mesh-100 mesh;

[0112] Sodium carbonate: 30 mesh-100 mesh;

[0113] Sorbitol: 30 mesh-120 mesh;

[0114] Lactose: 30 mesh-100 mesh;

[0115] Among them, the proportion of citric acid in the range of 40-80 mesh is 80%-95%, the proportion of citric acid in the range of 30-40 mesh is less than 10%, and the proportion of citric acid in the range of 80-100 mesh is less than 10%;

[0116] The proportion of sodium bicarbonate in 30-40 mesh is less than 10%, that in 40-60 mesh is 10%-20%, that in 60-80 mesh is 20%-40%, that in 80-100 mesh is 20%-40%;

[0117] The proportion of sodium carbonate in the range of 30-40 mesh is less than 10%, that in the range of 40-60 mesh is 10%-20%, that in the range of 60-80 mesh is 20%-40%, and that in the range of 80-100 mesh is 20%-40%;

[0118] The proportion of sorbitol in 30-40 mesh is less than 10%, that in 40-60 mesh is 5%-10%, that in 60-80 mesh is 60%-85%, and that in 80-120 mesh is 10%-20%;

[0119] The lactose proportion of 30-40 mesh is less than 10%, the lactose proportion of 40-60 mesh is 2%-30%, the lactose proportion of 60-80 mesh is 30%-70%, and the lactose proportion of 80-100 mesh is 10%-20%.

[0120] Mixing: The sieved material is mixed with the synthetic material to obtain a mixture, and then a biodegradable lubricant is added to obtain a total mixed powder.

[0121] The biodegradable lubricant is composed of at least one natural vegetable oil and at least one vegetable wax,

[0122] Wherein, the natural vegetable oil includes olive oil, sunflower oil, palm oil, and soybean oil;

[0123] The vegetable waxes include carnauba wax, candelilla wax, Japan wax, and beeswax.

[0124] The natural vegetable oil accounts for 65%-75% of the biodegradable lubricant, and the vegetable wax accounts for 25%-35% of the biodegradable lubricant.

[0125] The composition includes sunset yellow, aspartame, sucralose, and sweet orange flavor;

[0126] When the composite is mixed, sunset yellow, aspartame and sucralose are first mixed evenly, and then mixed evenly with sweet orange flavor in an equal amount.

[0127] Wherein, the composition ratio of the composite is:

[0128] Sunset yellow: 0.4g;

[0129] Aspartame: 12g;

[0130] Sucralose: 4g;

[0131] Sweet orange flavor: 100g.

[0132] When the sieved material is mixed with the composite through a mixing device, the ambient temperature of the mixing device is set at 18-26°C and the relative humidity is less than 40%, the composite is mixed with lactose, citric acid and sorbitol, and then sodium bicarbonate or sodium carbonate is added, and then vitamin C is added, and the mixing time is set to 30 minutes;

[0133] Among them, 400g of lactose is taken;

[0134] Take 1000g of citric acid;

[0135] Take 925.6g of sorbitol;

[0136] Take 550g of sodium carbonate;

[0137] Take 1000g of vitamin C.

[0138] When adding the biodegradable lubricant, the speed of the mixing device is set to 25-60 rpm. In this embodiment, the speed is set to 30 rpm, and the biodegradable lubricant is added at a speed of 0.5 L / S;

[0139] Among them, natural vegetable oil takes 60g;

[0140] Take 25g of vegetable wax.

[0141] Tableting: Add the total mixed powder into the mold, adjust the tablet weight preset value of the tablet press, and obtain effervescent tablets.

[0142] During tableting, magnesium stearate is applied to the die surface;

[0143] The magnesium stearate is 6 g;

[0144] The rotation speed of the tablet press was set at 10 rpm, and the tablet weight was adjusted to 4 g.

[0145] Inspection: Inspect the effervescent tablets and remove those that do not meet the standards.

[0146] Example 3

[0147] Reference Figure 1 , which is the third embodiment of the present invention, provides a dry mixing direct compression process for effervescent tablets, comprising the following steps:

[0148] Screening: citric acid, sodium bicarbonate, sodium carbonate, sorbitol and lactose are screened according to specific particle size requirements to obtain screened materials.

[0149] When screening materials, select the following ingredients:

[0150] Citric acid: 30 mesh-100 mesh;

[0151] Sodium bicarbonate: 30 mesh-100 mesh;

[0152] Sodium carbonate: 30 mesh-100 mesh;

[0153] Sorbitol: 30 mesh-120 mesh;

[0154] Lactose: 30 mesh-100 mesh;

[0155] Among them, the proportion of citric acid in the range of 40-80 mesh is 80%-95%, the proportion of citric acid in the range of 30-40 mesh is less than 10%, and the proportion of citric acid in the range of 80-100 mesh is less than 10%;

[0156] The proportion of sodium bicarbonate in 30-40 mesh is less than 10%, that in 40-60 mesh is 10%-20%, that in 60-80 mesh is 20%-40%, that in 80-100 mesh is 20%-40%;

[0157] The proportion of sodium carbonate in the range of 30-40 mesh is less than 10%, that in the range of 40-60 mesh is 10%-20%, that in the range of 60-80 mesh is 20%-40%, and that in the range of 80-100 mesh is 20%-40%;

[0158] The proportion of sorbitol in 30-40 mesh is less than 10%, that in 40-60 mesh is 5%-10%, that in 60-80 mesh is 60%-85%, and that in 80-120 mesh is 10%-20%;

[0159] The lactose proportion of 30-40 mesh is less than 10%, the lactose proportion of 40-60 mesh is 2%-30%, the lactose proportion of 60-80 mesh is 30%-70%, and the lactose proportion of 80-100 mesh is 10%-20%.

[0160] Mixing: The sieved material is mixed with the synthetic material to obtain a mixture, and then a biodegradable lubricant is added to obtain a total mixed powder.

[0161] The biodegradable lubricant is composed of at least one natural vegetable oil and at least one vegetable wax,

[0162] Wherein, the natural vegetable oil includes olive oil, sunflower oil, palm oil, and soybean oil;

[0163] The vegetable waxes include carnauba wax, candelilla wax, Japan wax, and beeswax.

[0164] The natural vegetable oil accounts for 65%-75% of the biodegradable lubricant, and the vegetable wax accounts for 25%-35% of the biodegradable lubricant.

[0165] The composition includes sunset yellow, aspartame, sucralose, and sweet orange flavor;

[0166] When the composite is mixed, sunset yellow, aspartame and sucralose are first mixed evenly, and then mixed evenly with sweet orange flavor in an equal amount.

[0167] Wherein, the composition ratio of the composite is:

[0168] Sunset yellow: 0.5g;

[0169] Aspartame: 11g;

[0170] Sucralose: 4g;

[0171] Sweet orange flavor: 120g.

[0172] When the sieved material is mixed with the composite through a mixing device, the ambient temperature of the mixing device is set at 18-26°C and the relative humidity is less than 40%, the composite is mixed with lactose, citric acid and sorbitol, and then sodium bicarbonate or sodium carbonate is added, and then vitamin C is added, and the mixing time is set to 30 minutes;

[0173] Among them, 500g of lactose is taken;

[0174] Take 1200g of citric acid;

[0175] Take 1175.6g of sorbitol;

[0176] Take 900g of sodium bicarbonate;

[0177] Take 1000g of vitamin C.

[0178] When adding the biodegradable lubricant, the speed of the mixing device is set to 25-60 rpm. In this embodiment, the speed is set to 50 rpm, and the biodegradable lubricant is added at a speed of 0.5 L / S;

[0179] Among them, natural vegetable oil takes 60g;

[0180] Take 25g of vegetable wax.

[0181] Tableting: Add the total mixed powder into the mold, adjust the tablet weight preset value of the tablet press, and obtain effervescent tablets.

[0182] During tableting, magnesium stearate is applied to the die surface;

[0183] The magnesium stearate is taken as 8g;

[0184] The rotation speed of the tablet press was set at 10 rpm, and the tablet weight was adjusted to 4 g.

[0185] Inspection: Inspect the effervescent tablets and remove those that do not meet the standards.

[0186] Example 4

[0187] Reference Figure 1 , which is the fourth embodiment of the present invention, provides a dry mixing direct compression process for effervescent tablets, comprising the following steps:

[0188] Screening: citric acid, sodium bicarbonate, sodium carbonate, sorbitol and lactose are screened according to specific particle size requirements to obtain screened materials.

[0189] When screening materials, select the following ingredients:

[0190] Citric acid: 30 mesh-100 mesh;

[0191] Sodium bicarbonate: 30 mesh-100 mesh;

[0192] Sodium carbonate: 30 mesh-100 mesh;

[0193] Sorbitol: 30 mesh-120 mesh;

[0194] Lactose: 30 mesh-100 mesh;

[0195] Among them, the proportion of citric acid in the range of 40-80 mesh is 80%-95%, the proportion of citric acid in the range of 30-40 mesh is less than 10%, and the proportion of citric acid in the range of 80-100 mesh is less than 10%;

[0196] The proportion of sodium bicarbonate in 30-40 mesh is less than 10%, that in 40-60 mesh is 10%-20%, that in 60-80 mesh is 20%-40%, that in 80-100 mesh is 20%-40%;

[0197] The proportion of sodium carbonate in the range of 30-40 mesh is less than 10%, that in the range of 40-60 mesh is 10%-20%, that in the range of 60-80 mesh is 20%-40%, and that in the range of 80-100 mesh is 20%-40%;

[0198] The proportion of sorbitol in 30-40 mesh is less than 10%, that in 40-60 mesh is 5%-10%, that in 60-80 mesh is 60%-85%, and that in 80-120 mesh is 10%-20%;

[0199] The lactose proportion of 30-40 mesh is less than 10%, the lactose proportion of 40-60 mesh is 2%-30%, the lactose proportion of 60-80 mesh is 30%-70%, and the lactose proportion of 80-100 mesh is 10%-20%.

[0200] Mixing: The sieved material is mixed with the synthetic material to obtain a mixture, and then a biodegradable lubricant is added to obtain a total mixed powder.

[0201] The biodegradable lubricant is composed of at least one natural vegetable oil and at least one vegetable wax,

[0202] Wherein, the natural vegetable oil includes olive oil, sunflower oil, palm oil, and soybean oil;

[0203] The vegetable waxes include carnauba wax, candelilla wax, Japan wax, and beeswax.

[0204] The natural vegetable oil accounts for 65%-75% of the biodegradable lubricant, and the vegetable wax accounts for 25%-35% of the biodegradable lubricant.

[0205] The composition includes sunset yellow, aspartame, sucralose, and sweet orange flavor;

[0206] When the composite is mixed, sunset yellow, aspartame and sucralose are first mixed evenly, and then mixed evenly with sweet orange flavor in an equal amount.

[0207] Wherein, the composition ratio of the composite is:

[0208] Sunset yellow: 0.6g;

[0209] Aspartame: 13g;

[0210] Sucralose: 5g;

[0211] Sweet orange flavor: 150g.

[0212] When the sieved material is mixed with the composite through a mixing device, the ambient temperature of the mixing device is set at 18-26°C and the relative humidity is less than 40%, the composite is mixed with lactose, citric acid and sorbitol, and then sodium bicarbonate or sodium carbonate is added, and then vitamin C is added, and the mixing time is set to 30 minutes;

[0213] Among them, 600g of lactose is taken;

[0214] Take 1300g of citric acid;

[0215] Take 1116.6 g of sorbitol;

[0216] Take 850g of sodium bicarbonate;

[0217] Take 10g of vitamin C.

[0218] When adding the biodegradable lubricant, the speed of the mixing device is set to 25-60 rpm. In this embodiment, the speed is set to 60 rpm, and the biodegradable lubricant is added at a speed of 0.5 L / S;

[0219] Among them, natural vegetable oil takes 60g;

[0220] Take 25g of vegetable wax.

[0221] Tableting: Add the total mixed powder into the mold, adjust the tablet weight preset value of the tablet press, and obtain effervescent tablets.

[0222] During tableting, magnesium stearate is applied to the die surface;

[0223] The magnesium stearate is taken as 8g;

[0224] The rotation speed of the tablet press was set at 10 rpm, and the tablet weight was adjusted to 4 g.

[0225] Inspection: Inspect the effervescent tablets and remove those that do not meet the standards.

[0226] Table 1 Performance test results:

[0227] Weight Difference hardness Effervescent time limit Example 1 +0.2％-+1.3％ 15-17KN 75S Example 2 -0.5％-+0.7％ 13-15KN 110S Example 3 -0.4％-+0.9％ 19-21KN 135S Example 4 +0.1％-+1.4％ 18-20KN 140S

[0228] As can be seen from Table 1, the dissolution time of the effervescent tablet proposed by the present invention is guaranteed to be less than 140S, the set tablet weight is 4g, the actual tablet weight is slightly different from the set value, and magnesium stearate is applied to the mold surface to prevent sticking during the entire tableting process. The addition of a biodegradable lubricant can also ensure the stability of the performance of the effervescent tablet.

[0229] In summary, the overall dry mixing and direct compression process simplifies the soft material preparation, granulation, drying and granulation steps in the traditional effervescent tablet production, shortens the production cycle and improves production efficiency. Secondly, due to the simplification of the process, the dependence on equipment and waste in the production process are reduced, thereby reducing the overall production cost. By controlling the particle size distribution of the raw materials and the ratio of the synthetic materials, the consistency and uniformity of the effervescent tablets are ensured, thereby improving the product quality.

[0230] The use of biodegradable lubricants, which are all renewable resources and easily biodegraded, reduces the impact on the environment. The addition of natural plant oils provides lubricity to the effervescent tablets, while the addition of plant wax provides hardness, gloss and film-forming properties to the effervescent tablets, which helps to improve the stability and wear resistance of the product.

[0231] Example 5

[0232] This embodiment provides a test procedure for a dry mixing direct compression process of an effervescent tablet, comprising the following steps:

[0233] Take effervescent tablet samples by batch, the total number of effervescent tablet samples in each batch shall be 1% of the total number of the batch, and the total number of effervescent tablet samples in each batch shall not exceed 100;

[0234] All effervescent tablet samples are tested for weight, hardness and effervescent time;

[0235] Determine the quality status of the effervescent tablets based on the test results.

[0236] The steps for testing effervescent tablets also include:

[0237] When the proportion of inferior effervescent tablet samples in the same batch is greater than the preset value A, the effervescent tablets in this batch are removed and the cause of the abnormality is inquired;

[0238] When the proportion of inferior effervescent tablet samples tested in the same batch is greater than a preset value B and less than or equal to a preset value A, all effervescent tablets in the batch are tested and the inferior effervescent tablets are removed;

[0239] When the proportion of inferior products in the test results of the same batch of effervescent tablets is less than or equal to the preset value B, the effervescent tablets will be packaged normally.

[0240] During the test, randomly select 1% of the effervescent tablet samples, use an electronic balance to measure the weight of each effervescent tablet, record the data, use a hardness tester to test the hardness of each effervescent tablet, record the data, put the effervescent tablet into a dissolution test container, and record the time required for each effervescent tablet to completely dissolve;

[0241] The preset value A is set to 5%, the preset value B is set to 1%, and the proportion of inferior effervescent tablets is calculated according to the test results. If the proportion of inferior effervescent tablets is greater than the preset value A (5%), all effervescent tablets in this batch are isolated and the cause of the abnormality is analyzed. If the proportion of inferior effervescent tablets is between the preset value B (1%) and the preset value A (5%), the entire batch of effervescent tablets is re-inspected and the inferior effervescent tablets are removed. If the proportion of inferior effervescent tablets is less than or equal to the preset value B (1%), the quality of this batch of effervescent tablets is considered to be qualified and normal packaging is performed.

[0242] 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 preferred embodiments, those skilled in the art should understand that the technical solutions of the present invention can be modified or replaced by equivalents without departing from the spirit and scope of the technical solutions of the present invention, which should all be included in the scope of the present invention.

Claims

1. A dry mixing direct compression process for effervescent tablets, characterized in that: The following steps are included: Screening: Screening citric acid, sodium bicarbonate, sodium carbonate, sorbitol and lactose according to specific particle size requirements to obtain screened materials; Mixing: mixing the sieved material with the synthetic material to obtain a mixture, and then adding a biodegradable lubricant to obtain a total mixed powder; Tableting: Add the total mixed powder into the mold, adjust the tablet weight of the tablet press to a predetermined value, and obtain an effervescent tablet; Inspection: Inspect the effervescent tablets and remove those that do not meet the standards.

2. A dry mixing direct compression process for effervescent tablets as claimed in claim 1, characterized in that: When screening materials, select the following ingredients: Citric acid: 30 mesh-100 mesh; Sodium bicarbonate: 30 mesh-100 mesh; Sodium carbonate: 30 mesh-100 mesh; Sorbitol: 30 mesh-120 mesh; Lactose: 30 mesh-100 mesh; Among them, the proportion of citric acid in the range of 40-80 mesh is 80%-95%, the proportion of citric acid in the range of 30-40 mesh is less than 10%, and the proportion of citric acid in the range of 80-100 mesh is less than 10%; The proportion of sodium bicarbonate in 30-40 mesh is less than 10%, that in 40-60 mesh is 10%-20%, that in 60-80 mesh is 20%-40%, that in 80-100 mesh is 20%-40%; The proportion of sodium carbonate in the range of 30-40 mesh is less than 10%, that in the range of 40-60 mesh is 10%-20%, that in the range of 60-80 mesh is 20%-40%, and that in the range of 80-100 mesh is 20%-40%; The proportion of sorbitol in 30-40 mesh is less than 10%, that in 40-60 mesh is 5%-10%, that in 60-80 mesh is 60%-85%, and that in 80-120 mesh is 10%-20%; The lactose proportion of 30-40 mesh is less than 10%, the lactose proportion of 40-60 mesh is 2%-30%, the lactose proportion of 60-80 mesh is 30%-70%, and the lactose proportion of 80-100 mesh is 10%-20%.

3. A dry mixing direct compression process for effervescent tablets as claimed in claim 2, characterized in that: The biodegradable lubricant is composed of at least one natural vegetable oil and at least one vegetable wax, Wherein, the natural vegetable oil includes olive oil, sunflower oil, palm oil, and soybean oil; The vegetable waxes include carnauba wax, candelilla wax, Japan wax, and beeswax.

4. A dry mixing direct compression process for effervescent tablets as claimed in claim 3, characterized in that: The natural vegetable oil accounts for 65%-75% of the biodegradable lubricant, and the vegetable wax accounts for 25%-35% of the biodegradable lubricant.

5. A dry mixing direct compression process for effervescent tablets as claimed in claim 4, characterized in that: The composition includes sunset yellow, aspartame, sucralose, and sweet orange flavor; When the composite is mixed, sunset yellow, aspartame and sucralose are first mixed evenly, and then mixed evenly with sweet orange flavor in equal amounts; Wherein, the composition ratio of the composite is: Sunset yellow: 0.3-0.6g; Aspartame: 11-13g; Sucralose: 3-5g; Sweet orange essence: 100-200g.

6. A dry mixing direct compression process for effervescent tablets as claimed in claim 5, characterized in that: When the sieved material is mixed with the synthetic material through a mixing device, the ambient temperature of the mixing device is set at 18-26°C and the relative humidity is less than 40%, the synthetic material is mixed with lactose, citric acid and sorbitol, and then sodium bicarbonate or sodium carbonate is added, and then vitamin C is added, and the mixing time is set to 30-45 minutes; Among them, lactose is taken in an amount of 400-600g; Take 1000-1300g of citric acid; Take 775.6-1175.6g of sorbitol; Take 850-900g of sodium bicarbonate; Take 550g of sodium carbonate; Take 10-1000g of vitamin C.

7. A dry mixing direct compression process for effervescent tablets as claimed in claim 6, characterized in that: When adding the biodegradable lubricant, set the speed of the mixing equipment to 25-60 rpm, and add the biodegradable lubricant at a rate of 0.5 L / S-1 L / S; Among them, natural vegetable oil is taken 30-100g; Take 10-40g of vegetable wax.

8. A dry mixing direct compression process for effervescent tablets as claimed in claim 7, characterized in that: During tableting, magnesium stearate is applied to the die surface; The magnesium stearate is 5-10g; The rotation speed of the tablet press is set at 10-15 rpm, and the tablet weight is adjusted to 4 g.

9. A dry mixing direct compression process for effervescent tablets as claimed in claim 8, characterized in that: The steps for testing effervescent tablets include: Take effervescent tablet samples by batch, the total number of effervescent tablet samples in each batch shall be 1% of the total number of the batch, and the total number of effervescent tablet samples in each batch shall not exceed 100; All effervescent tablet samples are tested for weight, hardness and effervescent time; Determine the quality status of the effervescent tablets based on the test results.

10. A dry mixing direct compression process for effervescent tablets as claimed in claim 9, characterized in that: The steps for testing effervescent tablets also include: When the proportion of inferior effervescent tablet samples in the same batch is greater than the preset value A, the effervescent tablets in this batch are removed and the cause of the abnormality is inquired; When the proportion of inferior effervescent tablet samples tested in the same batch is greater than a preset value B and less than or equal to a preset value A, all effervescent tablets in the batch are tested and the inferior effervescent tablets are removed; When the proportion of inferior products in the test results of the same batch of effervescent tablets is less than or equal to the preset value B, the effervescent tablets will be packaged normally.

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