CN110638778A - Tablet water-soluble coating and preparation method and application thereof - Google Patents
Tablet water-soluble coating and preparation method and application thereof Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2813—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
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Abstract
The invention relates to a tablet water-soluble coating and a preparation method and application thereof. The tablet water-soluble coating comprises a film forming agent and a plasticizer; the mass fraction of the film forming agent in the water-soluble coating of the tablet is 60-90%, the mass fraction of the plasticizer is 2-10%, and the balance is one or more of a colorant or an auxiliary additive. The components and the dosage of the formula are optimized, so that the obtained water-soluble coating can be suitable for coating tablet cores of oral solid preparations, and the coated tablet cores are free from cracking and color change, easy to disintegrate, difficult to absorb moisture and good in coating effect. The preparation method provided by the invention is simple and rapid in process.
Description
Technical Field
The invention belongs to the field of coating accessories, and particularly relates to a tablet water-soluble coating as well as a preparation method and application thereof.
Background
The film coating technology is a medical auxiliary material which utilizes efficient film coating equipment to spray special high polymer materials on tablets, capsules or medicine particles so as to achieve the effects of moisture prevention, smell removal and easy recognition of a carrier, and can improve the stability of a product, prevent oxidation and moisture, cover the bitter taste of an original tablet core and regulate the release of the medicine. The water-soluble coating has water solubility, and compared with alcohol solution, the water-soluble coating can replace flammable and explosive ethanol, so that the safety risk is greatly reduced, and the wide attention is drawn, for example, patent CN101120953A discloses a water-soluble coating material which has better water solubility.
However, compared with sugar coating, the film coating material has higher requirements on the tablet core, and the hardness of the tablet core and whether the surface of the tablet core is smooth or not are the key prerequisites for obtaining ideal effects of the film coating.
(1) The tablet core must be smooth, flat, uniform: the smoothness and the uniformity of the tablet core are basic guarantee of good appearance of the film coating, and the appearance after coating is better only if the tablet core is smooth and uniform.
(2) Hardness: the film coating generally requires that the hardness of a tablet core is higher than 3kgf, the better the hardness of the tablet core is, the smaller the fluctuation range is, and the better the coating effect is.
(3) Friability: the friability of the core is required to be less than 0.3%, i.e., the more wear resistant the core, the better the coating, because if the core has poor wear resistance, even if the core is flat and hard, the coating appearance may be poor due to wear in the coating process (e.g., gouge pitted surface, etc.). The effect of friability on appearance is very large, the most critical and most easily overlooked condition.
(4) Tablet core color: also called ground color, the ground color of the core directly affects the brilliance of the colored coat. Generally, for cores with darker ground colors, a stronger hiding power should be selected, with yellow (especially lemon yellow) hiding power being the weakest of all colors.
The conventional tablet core has small fluctuation of hardness range and small friability, and is easy to coat; and the tablet cores of some special tablets, such as the gynecological herba Euphorbiae Humifusae tablet core have the hardness of 2-7 kgf and the friability of 0.1-0.5%, the tablet core of the Bazhen motherwort tablet has the hardness of 2.0-4.0 kgf and the friability of 0.2-0.4%, the fluctuation of the tablet cores is very large, and therefore, the water-soluble film coating difficulty of the gynecological herba Euphorbiae Humifusae tablet, the Bazhen motherwort tablet core and the like is very large.
Therefore, the development of a novel coating material suitable for the tablet core with large hardness fluctuation and large friability has important research significance and application value.
Disclosure of Invention
The invention aims to overcome the defects and shortcomings that a water-soluble film coating in the prior art is not suitable for coating a tablet core with large hardness fluctuation and large friability, and provides a tablet water-soluble coating. The water-soluble coating provided by the invention is suitable for tablet cores with large hardness fluctuation and large friability, and the coating has no cracking and no color change after being coated on the surfaces of the tablet cores, is easy to disintegrate, has low moisture absorption and has a better coating effect.
Another object of the present invention is to provide a process for preparing the above water-soluble coating for tablets.
Another object of the present invention is to provide the use of the above water-soluble coating for tablets for the preparation of a tablet coating.
In order to achieve the purpose, the invention adopts the following technical scheme:
a tablet water-soluble coating comprises a film-forming agent and a plasticizer; the mass fraction of the film forming agent in the water-soluble coating of the tablet is 60-90%, the mass fraction of the plasticizer is 2-10%, and the balance is one or more of a colorant or an auxiliary additive.
The existing water-soluble film coating material is generally prepared by matching a plurality of components (such as a film forming agent, a plasticizer, a coloring agent, a surfactant, a color stabilizer and the like), wherein the mass fraction of the film forming agent is generally 15-55%, and the mass fraction of the plasticizer is generally 10-25%. For the conventional tablet core, the coating can be better coated under the condition of the mixture ratio, but if the coating is applied to the tablet core with large hardness fluctuation and large friability (such as the gynecological Qianjin tablet, the Bazhen motherwort tablet and the like), the problems of easy cracking, difficult disintegration and easy moisture absorption exist after the coating due to the large fluctuation of the hardness of the tablet core and the large friability.
The invention adjusts the formula of the water-soluble coating so as to better coat the tablet core with large hardness fluctuation and large friability, in particular to the tablet core of the gynecological Qianjin tablet and the Bazhen motherwort tablet.
On one hand, repeated researches show that the tablet core is suitable for coating tablet cores with large hardness fluctuation and large friability, in particular to coating of gynecological Qianjin tablet cores, Bazhen motherwort tablet cores and the like by regulating and controlling the dosage of the film forming agent and the plasticizer; on the other hand, on the basis of the adjustment of the dosage of the film forming agent and the plasticizer, the tablet core with large hardness fluctuation and large friability, in particular to the coating of the tablet core of the gynecological Qianjin tablet, the tablet core of the Bazhen Yimu tablet and the like can be realized without adding additional surfactant, color stabilizer and the like, the process is simpler, and the cost is low.
It will be appreciated that the water soluble coatings of the present invention, such as those used for other conventional cores with less fluctuation in hardness and less friability, also have very superior coating results.
Of course, the corresponding properties of the coating can be further improved by adding further auxiliary agents.
The water-soluble coating tablet core provided by the invention has no cracking and color change, is easy to disintegrate, is not easy to absorb moisture and has a better coating effect.
Preferably, the tablet water-soluble coating consists of the following components in percentage by mass:
more preferably, the tablet water-soluble coating consists of the following components in percentage by mass:
further preferably, the tablet water-soluble coating consists of the following components in percentage by mass:
preferably, the film forming agent is one or more of hypromellose, hyprolose, polyvinyl alcohol PVA or copovidone.
Preferably, the plasticizer is one or more of PEG-6000, PEG-4000 or propylene glycol.
Preferably, the colorant is one or more of green lake, red ferric oxide or titanium dioxide.
Preferably, the auxiliary additive is one or more of talcum powder, magnesium stearate, magnesium oxide or silicon dioxide.
More preferably, the film forming agent is hypromellose and polyvinyl alcohol PVA; the plasticizer is PEG-6000; the colorant is titanium dioxide and green lake; the auxiliary additive is talcum powder.
According to the invention, researches show that the water-soluble coating prepared by selecting the components of the specific types has a more excellent coating effect, does not crack, has shorter disintegration time and is less prone to moisture absorption.
Most preferably, the tablet water-soluble coating consists of the following components in percentage by mass:
the water-soluble coating obtained under the conditions of the components and the dosage has the best effect.
Preferably, the solid content of the water-soluble coating of the tablet is 12-20%.
More preferably, the solid content of the water-soluble coating of the tablet is 14-18%.
The preparation method of the water-soluble coating of the tablet comprises the following steps: mixing the film forming agent, the plasticizer, the colorant, the auxiliary additive and water, and stirring to obtain the product.
The components are mixed, the process of premixing the coloring agent and the auxiliary additive in advance is not needed, and the process is simpler and quicker.
Preferably, the stirring time is 30-60 min.
The coating liquid obtained after stirring can be directly used for coating, and the coating process is as follows: pouring tablet cores (such as the tablet cores of the Qianjin tablets and the tablet cores of the Bazhen motherwort tablets for gynecology) into a coating machine for coating, wherein the air inlet temperature of the coating is 80-100 ℃, the air outlet temperature is 40-60 ℃, the large-flow spray coating is carried out, the spray speed is 0.1-0.8L/min, the coating liquid is attached to the surfaces of the tablets as much as possible so as not to stick the tablets, the temperature is reduced after the coating is finished, the tablets continue to rotate for 5-10 min until the surfaces of the tablets are bright, the appearance of the film-coated tablets is.
The use of the above-described water-soluble coating for tablets for preparing a tablet coating is also within the scope of the present invention.
Compared with the prior art, the invention has the following beneficial effects:
the components and the dosage of the formula are optimized, so that the obtained water-soluble coating is suitable for tablet cores with large hardness fluctuation and large friability (such as gynecological Qianjin tablets, Bazhen motherwort tablets and the like), and the coated tablet cores are free from cracking and color change, are easy to disintegrate, are not easy to absorb moisture and have a good coating effect.
The preparation method provided by the invention is simple and rapid in process.
Detailed Description
The present invention will be further described with reference to the following examples. These examples are merely representative descriptions of the present invention, but the present invention is not limited thereto. The test methods used in the following examples are, unless otherwise specified, all conventional methods, and the raw materials, reagents and the like used are, unless otherwise specified, all commercially available raw materials and reagents from conventional markets and the like.
The invention takes the tablet core of the gynecological Qianjin tablet, the tablet core of the eight-treasure motherwort tablet and the senile cough and asthma tablet as examples, and the performance of the water-soluble coating of the tablet is measured.
The tablet core of the gynecological thousand gold tablets selected in each embodiment of the invention is produced by Qianjin pharmaceutical industry, Inc. of Tazhou thousand gold, and the hardness range is 2-7 kgf and the friability is 0.1-0.5% through measurement.
The tablet core of the Bazhen motherwort tablet selected in each embodiment of the invention has the hardness range of 2-4 kgf and the friability of 0.2-0.4%.
The tablet core of the senile cough and asthma treating tablet selected in each embodiment of the invention has the hardness ranging from 3kgf to 5kgf and the friability ranging from 0.2% to 0.3%.
Of the 3 types of tablet cores, the hardness fluctuation of the tablet core of the gynecological Qianjin tablet is the largest, and the friability fluctuation is the largest; the tablet core of the eight-treasure motherwort tablet is treated with times; the tablet core hardness fluctuation of the senile cough and asthma tablet is small, and the friability fluctuation is small.
Examples 1 to 9
This example provides a series of water soluble coatings, as in table 1, for their formulation.
Table 1 formulation of water soluble coating (wt.%, total mass 10kg)
Weighing the components according to the formula ratio, mixing at a high speed of over 20000 r/min, and sieving with a sieve of over 80 meshes to obtain the coating auxiliary material. Weighing 4-6 times (by mass) of water of the coating auxiliary materials, pouring the water into a stirrer, adding the coating auxiliary materials while stirring, and continuously stirring for 30-60 min after the addition is finished to obtain a coating solution for later use; and starting the coating machine, pouring the tablets into the coating machine for coating, wherein the air inlet temperature of the coating is 80-100 ℃, the air outlet temperature of the coating is 40-60 ℃, the large-flow spray coating is carried out, the spray speed is 0.1-0.8L/min, the coating liquid is attached to the surfaces of the tablets as much as possible so as not to stick the tablets, the tablets are cooled after the coating is finished, the tablets continue to rotate for 5-10 min until the surfaces of the tablets are bright, the appearances of the film-coated tablets are checked, and the tablets are taken out.
Comparative examples 1 to 4
This comparative example provides a series of water soluble coatings, and the formulations of comparative examples 1-2 are shown in table 1. Specifically, the method comprises the following steps:
the mass fraction of the film forming agent in comparative example 1 was 50.0%, and the mass fraction of the plasticizer was 34.1%.
The mass fraction of the film forming agent in comparative example 2 was 70.0%, and the mass fraction of the plasticizer was 12.0%.
Comparative example 3 is a conventional water soluble coating, the specific formulation is as follows: 20.6 percent of hydroxypropyl methylcellulose, 34.3 percent of polyvinyl alcohol PVA, 15.3 percent of PEG-4000, 11.9 percent of talcum powder, 15.3 percent of titanium dioxide and 2.6 percent of green lake.
Comparative example 4 is a conventional water soluble coating, and the specific formulation is as follows: 15.0 percent of hydroxypropyl methylcellulose, 25.0 percent of propylene glycol, 5.0 percent of magnesium stearate, 20.8 percent of titanium dioxide, 30.0 percent of talcum powder and 4.2 percent of green lake.
The operation of coating the cores with the water-soluble coating provided in the comparative example is in accordance with the examples.
The film-coated tablets obtained with the water-soluble coatings of the respective examples and comparative examples were subjected to the following tests.
Firstly, coating tablet cores of the gynecological Qianjin tablets
In the coating process, the tablets are gynecological Euphorbiae Lathyridis semen tablet cores, and the number of the tablets is 100.
(1) Film-coated tablet appearance inspection
As shown in Table 2, the film-coated tablets had the same appearance. As can be seen from Table 2, none of examples 1 to 9 had cracks; in comparative examples 1-2, due to improper dosage control, partial cracking occurs, and better coating of the gynecological herba Euphorbiae Humifusae tablet core with large hardness fluctuation and large friability cannot be realized; and in the comparative examples 3-4, a conventional water-soluble coating is selected, so that a severe cracking phenomenon occurs, and a better coating of the gynecological Qianjin tablet core with large hardness fluctuation and large friability cannot be realized.
TABLE 2 apparent shape of film-coated tablet
| Total number of film coated tablets | Film coating cracking number (piece) | Cracking Rate (%) | |
| Example 1 | 100 | 0 | 0 |
| Example 2 | 100 | 0 | 0 |
| Example 3 | 100 | 0 | 0 |
| Example 4 | 100 | 0 | 0 |
| Example 5 | 100 | 0 | 0 |
| Example 6 | 100 | 0 | 0 |
| Example 7 | 100 | 0 | 0 |
| Example 8 | 100 | 0 | 0 |
| Example 9 | 100 | 0 | 0 |
| Comparative example 1 | 100 | 15 | 15 |
| Comparative example 2 | 100 | 12 | 12 |
| Comparative example 3 | 100 | 20 | 20 |
| Comparative example 4 | 100 | 18 | 18 |
(2) Other Performance detection
1. Disintegration time limit
The properties and disintegration time limit of the film coat are tested under the conditions of high temperature test (temperature 60 ℃), illumination test (4500lx +/-500 lx) and accelerated test (temperature 40 +/-2 ℃ and temperature 75% +/-5%).
As shown in Table 3, the disintegration time under each condition is shown. As is clear from the table, the film-coated tablets of examples 1 to 9 were satisfactory in disintegration time under each condition (disintegration time should not exceed 60 min); in comparative examples 1 to 4, however, the disintegration time after the acceleration of the bare chip for 1 month did not meet the requirement, and in comparative examples 3 to 4, the disintegration time after the acceleration for 1 month was long despite the blister pack, and was close to the pass line of the disintegration time of the tablet.
TABLE 3 disintegration time test results
2. Moisture absorption test
The moisture absorption rate was measured under high humidity test conditions (temperature 25 ℃, humidity 92.5%, temperature 40 ℃, humidity 92.5%).
The test results are shown in Table 4. As can be seen from Table 4, the moisture absorption of the film coatings of examples 1-9 is low, and is controlled within 35%, wherein the moisture absorption of examples 1 and 2 is relatively low. The film-coated tablets of comparative examples 1 to 4 had high moisture absorption, and the moisture absorption rate after 10 days was 35% or more.
Table 4 moisture absorption test results
3. Change in appearance
The film coating properties were determined by high temperature test (temperature 60 ℃), light test (4500lx + -500 lx), high humidity test (temperature 25 ℃, humidity 92.5% and temperature 40 ℃, humidity 92.5%), and accelerated test (temperature 40 ℃ + -2 ℃, temperature 75% + -5%).
As shown in Table 5, the film-coated tablets (100 tablets) provided for each example and comparative example were changed in appearance under different storage conditions. As can be seen from the table, examples 1 to 9 all had good appearance and no splinters; in comparative examples 1 to 4, the cracks occurred in different degrees.
TABLE 5 appearance Change
From the test results, the coating materials in the comparative examples 1 to 4 have the problems of easy cracking and high moisture absorption when being used for coating the gynecological herba euphorbiae lathyris tablet, and are not suitable for coating the tablet core of the gynecological herba euphorbiae lathyris tablet. The water-soluble coating provided by each embodiment of the invention can be suitable for coating the tablet core of the gynecological Qianjin tablet, and the tablet core is free from cracking and color change after being coated, is easy to disintegrate, is not easy to absorb moisture and has a better coating effect. The components and the use amounts in the water-soluble coatings provided in examples 1 and 2 are optimal conditions, and are superior to those of the water-soluble coatings obtained by selecting other use amounts in examples 3 to 6, and are superior to those of the water-soluble coatings obtained by selecting other film-forming agents, plasticizers or auxiliary additives in examples 7 to 9.
Secondly, coating the tablet core of the eight-treasure motherwort tablet
Taking the water-soluble coatings provided in examples 1, 5 and 6 and comparative examples 1-4 as examples, for the eight-treasure motherwort tablet core, in the coating process, the tablet is the eight-treasure motherwort tablet core, and the number of the tablet is 100.
(1) Film-coated tablet appearance inspection
As shown in Table 6, the film-coated tablets had the same outer shape. As can be seen from Table 2, examples 1, 5 and 6 all had no splinters; in comparative examples 1-2, due to improper dosage control, partial cracking occurs, and good coating of the tablet core of the eight-treasure motherwort tablet with large hardness fluctuation and large friability cannot be realized; the conventional water-soluble coatings are selected in the comparative examples 3 and 4, so that the severe cracking phenomenon occurs, and the good coating of the tablet core of the eight-treasure motherwort tablet cannot be realized.
TABLE 6 shape of film-coated tablet
| Total number of film coated tablets | Film coating cracking number (piece) | Cracking Rate (%) | |
| Example 1 | 100 | 0 | 0 |
| Example 5 | 100 | 0 | 0 |
| Example 6 | 100 | 0 | 0 |
| Comparative example 1 | 100 | 8 | 8 |
| Comparative example 2 | 100 | 6 | 6 |
| Comparative example 3 | 100 | 12 | 12 |
| Comparative example 4 | 100 | 12 | 12 |
(2) Other Performance detection
1. Disintegration time limit
The properties and disintegration time limit of the film coat are tested under the conditions of high temperature test (temperature 60 ℃), illumination test (4500lx +/-500 lx) and accelerated test (temperature 40 +/-2 ℃ and temperature 75% +/-5%).
As shown in Table 7, the disintegration time under each condition is shown. As can be seen from the table, the film-coated tablets of examples 1, 5 and 6 satisfied the disintegration time (the disintegration time should not exceed 60 min); the disintegration time limits of comparative examples 1 to 4 were not satisfactory when the bare chips were accelerated by 1 month.
TABLE 7 disintegration time limit test results
2. Moisture absorption test
The moisture absorption rate was measured under high humidity test conditions (temperature 25 ℃, humidity 92.5%, temperature 40 ℃, humidity 92.5%).
The test results are shown in Table 8. As is clear from Table 8, the film-coated tablets of examples 1, 5 and 6 all had a low moisture absorption of 40%, whereas the film-coated tablets of comparative examples 1 to 4 all had a higher moisture absorption than those of examples 1, 5 and 6, and had a moisture absorption rate of 40% or more after 10 days at a temperature of 40 ℃ and a humidity of 92.5%.
Table 8 moisture absorption rate test results
3. Change in appearance
The film coating properties were measured under high temperature test (temperature 60 ℃), light test (4500lx + -500 lx), high humidity test (temperature 25 ℃, humidity 92.5% and temperature 40 ℃, humidity 92.5%), and accelerated test (temperature 40 ℃ + -2 ℃, temperature 75% + -10%).
As shown in Table 9, the film-coated tablets (100 tablets) provided for each example and comparative example were changed in appearance under different storage conditions. As can be seen from the table, examples 1, 5 and 6 all had good appearance, no splinters and no discoloration; in comparative examples 1 to 4, the cracks occurred in different degrees.
TABLE 9 appearance Change
Thirdly, coating the core of the cough and asthma tablet for the aged
Taking the water-soluble coatings provided in examples 1, 5 and 6 and comparative examples 1-4 as examples, the tablets are aged cough and asthma tablet cores in the coating process, and the number of the tablets is 100.
(1) Appearance shape detection
As shown in Table 10, the film-coated tablets had the same outer shape. As can be seen from Table 10, examples 1, 5 and 6, and comparative examples 1 to 4 all have no splinters, and can achieve better coating of the core of the senile cough and asthma tablet.
TABLE 10 apparent shape of film-coated tablet
| Total number of film coated tablets | Film coating cracking number (piece) | Cracking Rate (%) | |
| Example 1 | 100 | 0 | 0 |
| Example 5 | 100 | 0 | 0 |
| Example 6 | 100 | 0 | 0 |
| Comparative example 1 | 100 | 0 | 0 |
| Comparative example 2 | 100 | 0 | 0 |
| Comparative example 3 | 100 | 0 | 0 |
| Comparative example 4 | 100 | 0 | 0 |
(2) Other Performance detection
1. Disintegration time limit
The properties and disintegration time limit of the film coat are tested under the conditions of high temperature test (temperature 60 ℃), illumination test (4500lx +/-500 lx) and accelerated test (temperature 40 +/-2 ℃ and temperature 75% +/-10%).
As shown in Table 11, the disintegration time under each condition is shown. As can be seen from the table, the film-coated tablets of examples 1, 5 and 6 all satisfied the disintegration time (the disintegration time should not exceed 60 min); while the disintegration time of the bare chips of comparative examples 1-4 accelerated for 1 month is satisfactory, the disintegration rate is relatively slow, and the disintegration time of comparative examples 3-4 accelerated for 1 month by the blister sheet is also relatively slow.
TABLE 11 disintegration time limit test results
2. Moisture absorption test
The moisture absorption rate was measured under high humidity test conditions (temperature 25 ℃, humidity 92.5%, temperature 40 ℃, humidity 92.5%).
The test results are shown in Table 12. As is clear from Table 12, the film coatings of examples 1, 5 and 6 all had low moisture absorption and were controlled to be within 35%, whereas the film coated tablets of comparative examples 1 to 4 had higher moisture absorption rates than those of the examples under the same conditions.
Table 12 moisture absorption test results
3. Change in appearance
The film coating properties were measured under high temperature test (temperature 60 ℃), light test (4500lx + -500 lx), high humidity test (temperature 25 ℃, humidity 92.5% and temperature 40 ℃, humidity 92.5%), and accelerated test (temperature 40 ℃ + -2 ℃, temperature 75% + -10%).
As shown in Table 13, the film-coated tablets (100 tablets) provided for each example and comparative example were changed in appearance under different storage conditions. As can be seen from the table, examples 1, 5 and 6, and comparative examples 1 to 4 all had good appearance, no cracking, and no color change.
TABLE 13 appearance Change
The above-mentioned embodiments are intended to illustrate the objects, technical solutions and advantages of the present invention in further detail, and it should be understood that the above-mentioned embodiments are merely exemplary embodiments of the present invention, and are not intended to limit the scope of the present invention, and any modifications, equivalent substitutions, improvements and the like made within the spirit and principle of the present invention should be included in the scope of the present invention.
Claims (10)
1. A tablet water-soluble coating, which is characterized by comprising a film-forming agent and a plasticizer; the mass fraction of the film forming agent in the water-soluble coating of the tablet is 60-90%, the mass fraction of the plasticizer is 2-10%, and the balance is one or more of a colorant or an auxiliary additive.
2. The water-soluble coating for tablets according to claim 1, consisting of the following components in mass fraction:
3. the water-soluble coating for tablets according to claim 2, consisting of the following components in mass fraction:
preferably:
4. the water-soluble coating for tablets according to claim 1, wherein the film-forming agent is one or more of hypromellose, hyprolose, polyvinyl alcohol PVA, or copovidone; the plasticizer is one or more of PEG-6000, PEG-4000 or propylene glycol; the colorant is one or more of green lake, red ferric oxide or titanium dioxide; the auxiliary additive is one or more of talcum powder, magnesium stearate, magnesium oxide or silicon dioxide.
5. The water-soluble coating for tablets according to claim 4, wherein said film-forming agent is hypromellose and polyvinyl alcohol PVA; the plasticizer is PEG-6000; the colorant is green lake and titanium dioxide; the auxiliary additive is talcum powder.
6. The water-soluble coating for tablets according to claim 3 or 5, characterized in that it consists of the following components in mass fraction:
7. the water-soluble coating for tablets of claim 1 to 6, wherein the solids content of the water-soluble coating for tablets is 12 to 20%.
8. The water-soluble coating for tablets according to claim 7, wherein the solid content of the water-soluble coating for tablets is 14-18%.
9. A process for the preparation of a water-soluble coating for tablets as claimed in any one of claims 1 to 8, comprising the steps of: mixing the film forming agent, the plasticizer, the colorant, the auxiliary additive and water, and stirring to obtain the product.
10. Use of a water soluble coating for a tablet according to any one of claims 1 to 8 for the preparation of a tablet coating.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910803344.9A CN110638778A (en) | 2019-08-28 | 2019-08-28 | Tablet water-soluble coating and preparation method and application thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910803344.9A CN110638778A (en) | 2019-08-28 | 2019-08-28 | Tablet water-soluble coating and preparation method and application thereof |
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| Publication Number | Publication Date |
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| CN110638778A true CN110638778A (en) | 2020-01-03 |
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| CN201910803344.9A Pending CN110638778A (en) | 2019-08-28 | 2019-08-28 | Tablet water-soluble coating and preparation method and application thereof |
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