CN111956626B - Production process of anti-adhesion soft capsule and anti-adhesion combined liquid thereof - Google Patents
Production process of anti-adhesion soft capsule and anti-adhesion combined liquid thereof Download PDFInfo
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4833—Encapsulating processes; Filling of capsules
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Abstract
The invention provides a production process of an anti-bonding soft capsule, which comprises a glue solution for preparing the capsule and an anti-bonding combined solution for performing anti-bonding treatment on the capsule, wherein the glue solution comprises 100 percent of gelatin, 40-50 percent of glycerol, 5-15 percent of sorbitol solution and 95-100 percent of purified water according to the weight ratio of the components to the gelatin. The process comprises the following steps: dissolving gelatin, glycerol, sorbitol solution, purified water, etc. at a certain ratio to obtain gelatin solution for making into pill; step two, batching: preparing the contents according to the proportion of the formula, paying attention to the fineness, solid content, viscosity and fluidity of the materials when preparing the suspension soft capsule, and grinding the suspension soft capsule by a bead mill if necessary; step three, pelleting and shaping: pressing the soft capsules by a soft capsule pelleting press, and entering a shaping rotating cage for primary shaping and drying; step four, drying and spraying anti-bonding combined liquid: wrapping the anti-adhesion combination liquid on the outer surface of the rubber sheet of the soft capsule; and step five, selecting pills. Can effectively solve the technical problem of the production that the soft capsule is easy to be bonded.
Description
Technical Field
The invention relates to the technical field of soft capsule production processes, in particular to an anti-adhesion soft capsule production process and an anti-adhesion combined liquid thereof.
Background
The soft capsule is prepared by sealing a certain amount of liquid in soft capsule wall material, wherein the soft capsule wall material, namely a capsule skin, is prepared from gelatin, glycerol, purified water and the like; the gelatin skin can absorb moisture in the air or volatilize the moisture of the gelatin skin to lead the moisture accumulated on the surface of the gelatin skin to have viscosity, thereby leading the soft capsules to be mutually bonded; when the produced product is continuously kept in an environment with the temperature of more than 30 ℃ for a period of time, the product can be bonded into blocks and is not easy to shake, the bonding degree is more serious along with the prolonging of the storage time, the product can be agglomerated into blocks and can not be broken, and the balls can be deformed and broken, so that the product can not be eaten normally.
Therefore, it is necessary to develop an anti-sticking production technology for soft capsules to solve the current situation that soft capsules are frequently stuck.
Disclosure of Invention
In order to solve the problem of soft capsule adhesion in the prior production technology, the invention provides a soft capsule adhesion-preventing combination liquid and a production process thereof, which can effectively solve the production technical problem that soft capsules are easy to adhere.
In order to solve the above-mentioned existing technical problem, the invention adopts the following scheme:
an anti-adhesion soft capsule is prepared from gelatin (100 wt.%), glycerin (40-50), sorbitol (5-15) and purified water (95-100) through preparing gelatin solution and anti-adhesion composition
Step one, glue melting: dissolving gelatin, glycerol, sorbitol solution, purified water, etc. at a certain ratio to obtain gelatin solution for making into pill;
step two, batching: preparing the contents according to the proportion of the formula, paying attention to the fineness, solid content, viscosity and fluidity of the materials when preparing the suspension soft capsule, and grinding the suspension soft capsule by a bead mill if necessary;
step three, pelleting and shaping: pressing the soft capsules by a soft capsule pelleting press, and entering a shaping rotating cage for primary shaping and drying;
step four, drying and spraying anti-bonding combined liquid: wrapping the anti-adhesion combined liquid on the outer surface of the rubber sheet of the soft capsule and adsorbing the redundant anti-adhesion combined liquid on the surface of the soft capsule wrapped with the anti-adhesion combined liquid;
and step five, selecting pills.
Further, if oil leakage is found in the soft capsules after the primary sizing and drying, the soft capsules are cleaned and dried, and then are subjected to anti-adhesion treatment according to the fourth step
An anti-adhesion combined liquid for wrapping soft capsule rubber is characterized in that: the anti-adhesion combination liquid is prepared by combining anti-adhesion combination wax and soft capsule rubber lubricating oil in proportion.
Further, the anti-bonding combined wax is prepared by mixing carnauba wax, white beeswax and sunflower phospholipid according to the ratio of 7:2: 1.
Furthermore, the preparation method of the anti-bonding combination wax comprises the steps of heating carnauba wax and white beeswax to 85 ℃ to melt, adding sunflower lecithin, and mixing and stirring uniformly.
Furthermore, the soft capsule rubber lubricating oil is one of light liquid paraffin, octyl and tricaprin.
Further, the anti-bonding combination liquid comprises the following components in percentage by weight:
100% of soft capsule rubber lubricating oil;
the anti-bonding combined wax accounts for 1 to 5 percent of the weight of the rubber lubricant
The preparation method of the anti-adhesion combination liquid comprises adding the soft capsule rubber lubricating oil into a heat-insulating barrel, adding the anti-adhesion combination wax when heating to 85 ℃, stirring until the anti-adhesion combination wax is completely dissolved, stopping heating, and cooling to 18-24 ℃ for use.
Further, the anti-adhesion combination liquid is mixed in a proportion that the anti-adhesion combination wax accounts for 3.5 percent of the weight of the rubber lubricating oil.
Compared with the prior art, the invention has the beneficial effects that:
a layer of protective film can be formed on the surface of the rubber of the soft capsule, so that the rubber of the soft capsule is prevented from absorbing moisture in the air or volatilizing the moisture of the rubber, the mutual adhesion of the outer surface of the soft capsule caused by moisture accumulation is prevented, and the soft capsule is well protected in a larger temperature range; the technology is suitable for the production of all soft capsules, is simple to operate, has stable property of the anti-adhesion combination wax, is slightly influenced by temperature, has no influence on the production of the soft capsules, can prevent the soft capsules from having any caking phenomenon in the environment of 45 ℃ and below after the surface of the rubber sheet of the soft capsules is wrapped by the anti-adhesion combination liquid, has strong high-temperature resistance, greatly ensures the quality of the soft capsules, and fundamentally solves the problem of caking of the soft capsules.
Detailed Description
The present invention is further described below with reference to specific embodiments, and it should be noted that, without conflict, any combination between the embodiments or technical features described below may form a new embodiment.
An anti-adhesion soft capsule is prepared from gelatin (100 wt.%), glycerin (40-50), sorbitol (5-15) and purified water (95-100) through preparing gelatin solution and anti-adhesion composition
Step one, glue melting: dissolving gelatin, glycerol, sorbitol solution, purified water, etc. at a certain ratio to obtain gelatin solution for making into pill;
step two, batching: preparing the contents according to the proportion of the formula, paying attention to the fineness, solid content, viscosity and fluidity of the materials when preparing the suspension soft capsule, and grinding the suspension soft capsule by a bead mill if necessary;
step three, pelleting and shaping: pressing the soft capsules by a soft capsule pelleting press, and entering a shaping rotating cage for primary shaping and drying;
step four, drying and spraying anti-bonding combined liquid: polishing and wrapping the soft capsule subjected to primary shaping and drying by using an anti-adhesion combined solution, and adsorbing the redundant anti-adhesion combined solution on the surface of the soft capsule;
and step five, selecting pills.
Further, if oil leakage is found in the soft capsules after the primary sizing and drying, cleaning and drying are firstly carried out, and then anti-adhesion treatment is carried out according to the fourth step.
In the actual use process, if oil leakage occurs in the soft capsules after the primary shaping and drying, the soft capsules are cleaned and dried, then put into a soft capsule polishing machine, sprayed with the anti-adhesion combination liquid for anti-adhesion treatment, and then put into an oil absorption cloth to absorb the redundant anti-adhesion combination liquid on the surface of the rubber sheet.
In the glue dissolving process in the first step, the concrete operations are as follows: setting the upper limit of the temperature of a gelatin melting tank to be 75 ℃, the lower limit of the temperature of the gelatin melting tank to be 60 ℃, setting the speed of a stirring paddle in the tank to be 45 r/min, pumping purified water into the gelatin melting tank, pumping glycerol into the gelatin melting tank, starting heating and stirring, pumping gelatin when the temperature is 70 ℃, stirring and melting for 10min, setting the upper limit of the vacuum degree to be-0.07 Mpa, the lower limit of the vacuum degree to be-0.05 Mpa, maintaining the vacuum degree to be in a negative pressure state of-0.05 to-0.07 Mpa, then carrying out sol-dissolving for 20-30min, in order to ensure that the freezing force of a gelatin solution is not damaged as much as possible, controlling the temperature in the whole sol-dissolving process to be not more than 75 ℃, adjusting the vacuum degree to be-0.095 Mpa after the sol-dissolving is finished (no particles are dissolved), carrying out defoaming, pumping out moisture accounting for 6-11%, controlling the viscosity of the glue solution to be 9.0-13Pa.s, then putting the glue solution into a heat-preserving tank through a 120-mesh filter bag, reserving a gap on a tank cover, preserving the heat at 55 ℃ for more than 4 hours, so that micro bubbles generated during glue release can float upwards, and the glue solution can reach a stable state after being released and preserved for 4 hours. The high viscosity of the glue solution can also cause the final product to be bonded in different degrees, but the viscosity of the glue solution is required to reach 9.5-13Pa.s during pelleting so as to ensure that two sections of rubber can be firmly bonded during pelleting.
In the second step, the suspension soft capsule is prepared by ensuring that the material liquid is smooth and has no particles so as to prevent the leakage of the finished product in the placing process and the mutual adhesion of the capsules caused by the seepage of the suspension material liquid and the attachment of the suspension material liquid on the surface of the soft capsule.
And in the third step, the specific operation is that the glue storage box on the cooling drum wheel of the pellet press is heated and insulated to 55-60 ℃, glue is supplied by connecting the glue conveying hose with the glue storage box of the pellet press, the rotating speed of the pellet press is adjusted to 4 revolutions per minute, the temperature of the cooling drum wheel for spreading and forming the glue skin is adjusted to 21-23 ℃, the temperature of the spray body of the pellet press is adjusted to 44-47 ℃, the temperature of the pellet press room is controlled to be 22 +/-1 ℃, the humidity is 20-30%, the temperature of the spray body of the pellet press and the cooling drum wheel is adjusted according to the principle that the glue skin is slightly warm and can not be sticky and soft, if the temperature of the drum wheel and the spray body is higher, the extruded pellets can be stuck together, and the extruded pellets enter a rotating cage for shaping and drying.
The concrete operation of the step four is as follows: after the balls are shaped and dried in the rotary cage for 1 hour, anti-adhesion combined liquid is sprayed into the shaping rotary cage through a spray can, 2-3 pieces of oil absorption cloth are put into the rotary cage and each subsequent rotary cage, and redundant anti-adhesion combined liquid on the surface of the rubber is absorbed. If the oil leakage exists in the ball, 95% ethanol is needed to be used for cleaning, then the cleaned ball is put into a soft capsule polishing machine, and then the anti-adhesion combination liquid is sprayed for anti-adhesion treatment, and then the oil absorption cloth is placed to absorb the redundant anti-adhesion combination liquid on the surface of the rubber sheet.
In the pill picking process in the fifth step, the temperature between the pill picking is controlled to be 18-24 ℃, the humidity is below 40%, and the temperature cannot be higher than that of the shaping and drying room, so that when the pills are picked, because the temperature on the surface of the capsule is low, the temperature between the pill picking is high, the moisture in the air is liquefied on the surface of the capsule, attached to the rubber, absorbed by the rubber, and the rubber is soft and sticky, so that the adhesion is generated.
The invention also comprises an anti-adhesion combination liquid for wrapping the soft capsule rubber, wherein the anti-adhesion combination liquid is prepared by combining the anti-adhesion combination wax and the soft capsule rubber lubricating oil in proportion.
Further, the anti-bonding combined wax is prepared by mixing carnauba wax, white beeswax and sunflower phospholipid according to the ratio of 7:2: 1.
Furthermore, the preparation method of the anti-bonding combination wax comprises the steps of heating carnauba wax and white beeswax to 85 ℃ to melt, adding sunflower lecithin, and mixing and stirring uniformly.
Furthermore, the soft capsule rubber lubricating oil is one of light liquid paraffin oil and caprylic/capric glyceride.
Further, the anti-bonding combination liquid comprises the following components in percentage by weight:
100% of soft capsule rubber lubricating oil;
the anti-bonding combined wax accounts for 1 to 5 percent of the weight of the rubber lubricant
The preparation method of the anti-adhesion combination liquid comprises adding the soft capsule rubber lubricating liquid into a heat-insulating barrel, adding the anti-adhesion combination wax when heating to 85 ℃, stirring until the anti-adhesion combination wax is completely dissolved, stopping heating, and cooling to 18-24 ℃ for use.
Further, the anti-adhesion combination liquid is mixed in a proportion that the anti-adhesion combination wax accounts for 3.5 percent of the weight of the rubber lubricating oil.
And (3) filling the anti-bonding combination liquid into an alcohol spray can, then performing spraying treatment, then putting an oil absorption cloth, wiping and polishing, and wrapping a layer of protective film on the surface of the soft capsule rubber to prevent the soft capsule from bonding.
The anti-adhesion combination liquid is wrapped on the rubber sheet of the soft capsule, and a layer of protective film can be formed on the surface of the rubber sheet of the soft capsule, so that the soft capsule rubber sheet is prevented from absorbing moisture in the air or volatilizing the moisture of the rubber sheet, the mutual adhesion of the outer surface of the soft capsule caused by moisture accumulation is prevented, and the soft capsule is well protected in a larger temperature range; from the concrete implementation results, the anti-bonding effect of the combined liquid prepared by the anti-bonding combined wax accounting for 3.5 percent of the weight of the rubber lubricating oil is optimal and economical. The technology is suitable for producing all soft capsules, is simple to operate, has stable property of the anti-bonding combination wax, is slightly influenced by temperature, has no influence on the production of the soft capsules, has strong high-temperature resistance of the produced soft capsules, greatly ensures the quality of the soft capsules, and fundamentally solves the problem of bonding and agglomeration of the soft capsules.
In the above process, the temperature and humidity of the shaping and drying room are controlled between 22-24 deg.C and 20-30% to slowly evaporate water in the rubber sheet, so that the water content of the rubber sheet is uniform. Detecting the water content of the capsule skin, collecting the water content of the pill by 9-13%, and drying for 12-16H (if the drying is too fast, the hardness of the capsule surface is too hard, the water content of the inner side rubber is high, after the pill is placed for a period of time, the water content of the inner side rubber is transferred to the outer side, the rubber has soft cotton phenomenon, and can cause slight caking), after the drying is finished, collecting the soft capsule into a medical low-density polyethylene bag, tightening the bag opening, reducing the contact time of the soft capsule and air, and placing the soft capsule in a drying room.
The technical solutions in the specific examples of the process for producing anti-adhesion soft capsules according to the present invention are fully described below, and the described examples are representative parts, but not all of the examples in the specific examples of the present invention.
The paraffin oil pellets of the following examples were pressed by a pellet press, the content of the pellets was light liquid paraffin oil, the rubber was transparent rubber, and the paraffin oil pellets were dried in a tumbler to obtain dried paraffin oil pellets.
Example 1
The embodiment of the invention provides a specific implementation mode of a soft capsule anti-bonding production technology, which comprises the following steps:
1. 1020g of anti-adhesion combined liquid is prepared, wherein the anti-adhesion combined liquid comprises 1000g of soft capsule rubber lubricating oil and 20g of anti-adhesion combined wax;
2. directly putting the transparent paraffin oil ball into the anti-bonding combination liquid, stirring for 10 seconds, taking out, and wiping the ball with an oil absorption cloth.
3. The paraffin oil pellets obtained in example 1 were subjected to a soft capsule adhesion test, and the results are shown in table 1.
Example 2
The embodiment of the invention provides a specific implementation mode of a soft capsule anti-bonding production technology, which comprises the following steps:
1. preparing 1030g of anti-adhesion combined liquid, wherein the anti-adhesion combined liquid comprises 1000g of soft capsule rubber lubricating oil and 30g of anti-adhesion combined wax;
2. directly putting the transparent paraffin oil ball into the anti-bonding combination liquid, stirring for 10 seconds, taking out, and wiping the ball with an oil absorption cloth.
3. The paraffin oil pellets obtained in example 2 were subjected to a soft capsule adhesion test, and the results are shown in table 1.
Example 3
The embodiment of the invention provides a specific implementation mode of a soft capsule anti-bonding production technology, which comprises the following steps:
1. 1035g of anti-adhesion combined liquid is prepared, and the anti-adhesion combined liquid comprises 1000g of soft capsule rubber lubricating oil and 35g of anti-adhesion combined wax;
2. directly putting the transparent paraffin oil ball into the anti-bonding combination liquid, stirring for 10 seconds, taking out, and wiping the ball with an oil absorption cloth.
3. The paraffin oil pellets obtained in example 3 were subjected to a soft capsule adhesion test, and the results are shown in table 1.
Example 4
The embodiment of the invention provides a specific implementation mode of a soft capsule anti-bonding production technology, which comprises the following steps:
1. 1040g of anti-adhesion combined liquid is prepared, and the anti-adhesion combined liquid comprises 1000g of soft capsule rubber lubricating oil and 40g of anti-adhesion combined wax;
2. directly putting the transparent paraffin oil ball into the anti-bonding combination liquid, stirring for 10 seconds, taking out, and wiping the ball with an oil absorption cloth.
3. The paraffin oil pellets obtained in example 4 were subjected to a soft capsule adhesion test, and the results are shown in table 1.
Comparative example
The above examples 2-4 are similar to example 1 except that the anti-sticking wax composition is added in the same ratio.
The embodiment of the invention is used for making a comparative example, and the steps are as follows:
1. 1000g of paraffin oil liquid is prepared without adding other components.
2. And directly putting the transparent paraffin oil ball into paraffin oil, stirring for 10 seconds, taking out, and wiping the ball with an oil absorption cloth.
3. The paraffin oil pellets obtained in the comparative example were subjected to a soft capsule adhesion test, and the results are shown in table 1.
TABLE 1
As can be seen from table 1, in examples 1 to 4, compared with the comparative example, which is a conventional soft capsule preparation process, the anti-adhesion effect of the anti-adhesion combination liquid containing the anti-adhesion combination wax is very obvious, the dosage of the carnauba wax is very low, and the adhesion problem of the soft capsule is solved; the production technology of the invention still has the anti-bonding effect in the environment of 40-45 ℃.
The soft capsule is prepared from gelatin and the following components in proportion by weight:
the following is a comparison of a specific example of applying the anti-adhesion composition for wrapping the soft capsule rubber of the invention to the soft capsule, wherein the glue solution in the following examples comprises the following components in parts by weight: the glue solution comprises 100 parts of gelatin, 40-50 parts of glycerol, 5-15 parts of sorbitol solution and 95-100 parts of purified water, wherein 100 parts of gelatin is taken as a 100% reference in the embodiment, and the other components are calculated by taking the gelatin as a basis in percentage:
example 1
100% of gelatin, 40% of glycerol, 5% of sorbitol solution, 97% of purified water, 7% of vacuum water extraction proportion, 9.7Pa.s of rotary viscosity of glue solution, 44 ℃ of spraying body temperature, 23 ℃ of refrigeration temperature, 1% of anti-bonding combined wax in mass percentage of the rubber lubricating oil, 22-24 ℃ of temperature between shaping and drying, 20-30% of humidity between shaping and drying, 14H of drying completion time, and 1000mg of fish oil as capsule filler in each capsule.
2 ten thousand soft capsule products are produced by the process, 6000 soft capsule products are selected, double-layer medical low-density polyethylene bags are used for packaging 2 soft capsule products, an air heater is used for sealing, and the 2 soft capsule products are placed into an acceleration box with the temperature of 40 ℃ and the RH of 75% for accelerated observation.
Example 2
100% of gelatin, 40% of glycerol, 5% of sorbitol solution, 97% of purified water, 8% of vacuum extracted water, 10.3Pa.s of rotational viscosity of glue solution, 44 ℃ of spraying body temperature, 23 ℃ of refrigeration temperature, 2.5% of anti-bonding combined wax in mass percentage of the rubber lubricating oil, 22-24 ℃ of setting and drying room temperature, 20-30% of setting and drying room humidity, 13.5H of drying completion time, and 1000mg of capsule filler in each capsule.
2 ten thousand soft capsule products are produced by the process, 6000 soft capsule products are selected, double-layer medical low-density polyethylene bags are used for packaging 2 soft capsule products, an air heater is used for sealing, and the 2 soft capsule products are placed into an acceleration box with the temperature of 40 ℃ and the RH of 75% for accelerated observation.
Example 3
100% of gelatin, 40% of glycerol, 5% of sorbitol solution, 97% of purified water, 11% of vacuum extracted water, 12.3Pa.s of rotational viscosity of glue solution, 44 ℃ of spraying body temperature, 23 ℃ of refrigeration temperature, 2.5% of anti-bonding combined wax in mass percentage of the rubber lubricating oil, 22-24 ℃ of setting and drying room temperature, 20-30% of setting and drying room humidity, 13.1H of drying completion time, and 1000mg of capsule filler in each capsule.
2 ten thousand soft capsule products are produced by the process, 6000 soft capsule products are selected, double-layer medical low-density polyethylene bags are used for packaging 2 soft capsule products, an air heater is used for sealing, and the 2 soft capsule products are placed into an acceleration box with the temperature of 40 ℃ and the RH of 75% for accelerated observation.
Example 4
100% of gelatin, 40% of glycerol, 5% of sorbitol solution, 97% of purified water, 8% of vacuum extracted water, 10.3Pa.s of rotational viscosity of glue solution, 46 ℃ of spraying temperature, 25 ℃ of refrigeration temperature, 2.5% of anti-adhesion combined wax in mass percentage of the rubber lubricating oil, 22-24 ℃ of setting and drying room temperature, 20-30% of setting and drying room humidity, 13.3H of drying completion time, and 1000mg of capsule filler in each capsule.
2 ten thousand soft capsule products are produced by the process, 6000 soft capsule products are selected, double-layer medical low-density polyethylene bags are used for packaging 2 soft capsule products, an air heater is used for sealing, and the 2 soft capsule products are placed into an acceleration box with the temperature of 40 ℃ and the RH of 75% for accelerated observation.
Example 5
100% of gelatin, 40% of glycerol, 0% of sorbitol solution, 97% of purified water, 8% of vacuum extracted water, 10Pa.s of rotational viscosity of glue solution, 44 ℃ of spraying body temperature, 23 ℃ of refrigeration temperature, 2.5% of anti-bonding combined wax in mass percentage of rubber lubricating oil, 22-24 ℃ of temperature between shaping and drying, 20-30% of humidity between shaping and drying, 12.5H of drying completion time, and 1000mg of fish oil serving as capsule filler per granule.
2 ten thousand soft capsule products are produced by the process, 6000 soft capsule products are selected, double-layer medical low-density polyethylene bags are used for packaging 2 soft capsule products, an air heater is used for sealing, and the 2 soft capsule products are placed into an acceleration box with the temperature of 40 ℃ and the RH of 75% for accelerated observation.
Example 6
100% of gelatin, 40% of glycerol, 0% of sorbitol solution, 97% of purified water, 11.5% of vacuum water extraction proportion, 13.5Pa.s of rotary viscosity of glue solution, 47 ℃ of spraying body temperature, 26 ℃ of refrigeration temperature, 3.5% of anti-adhesion combined wax in mass percentage of the rubber lubricating oil, 24-26 ℃ of setting and drying room temperature, 15-20% of setting and drying room humidity, 8H of drying completion time, and 1000mg of capsule filler in each capsule.
2 ten thousand soft capsule products are produced by the process, 6000 soft capsule products are selected, double-layer medical low-density polyethylene bags are used for packaging 2 soft capsule products, an air heater is used for sealing, and the 2 soft capsule products are placed into an acceleration box with the temperature of 40 ℃ and the RH of 75% for accelerated observation.
Example 7
100% of gelatin, 40% of glycerol, 10% of sorbitol solution, 97% of purified water, 7% of vacuum extracted water, 10.1Pa.s of rotational viscosity of glue solution, 44 ℃ of spraying body temperature, 23 ℃ of refrigeration temperature, 20-30% of humidity in the shaping and drying process, 14.5H of drying completion time, and 1000mg of fish oil in capsule filler per granule.
2 ten thousand soft capsule products are produced by the process, 6000 soft capsule products are selected, double-layer medical low-density polyethylene bags are used for packaging 2 soft capsule products, an air heater is used for sealing, and the 2 soft capsule products are placed into an acceleration box with the temperature of 40 ℃ and the RH of 75% for accelerated observation.
Example 8
100% of gelatin, 40% of glycerol, 5% of sorbitol solution, 97% of purified water, 8% of vacuum extracted water, 10.3Pa.s of rotational viscosity of glue solution, 44 ℃ of spraying body temperature, 23 ℃ of refrigeration temperature, 2.5% of anti-bonding combined wax in mass percentage of the rubber lubricating oil, 24-26 ℃ of setting and drying room temperature, 15-20% of setting and drying room humidity, 9H of drying completion time, and 1000mg of capsule filler in each capsule.
2 ten thousand soft capsule products are produced by the process, 6000 soft capsule products are selected, double-layer medical low-density polyethylene bags are used for packaging 2 soft capsule products, an air heater is used for sealing, and the 2 soft capsule products are placed into an acceleration box with the temperature of 40 ℃ and the RH of 75% for accelerated observation.
Comparative example
The glue solution comprises the following components in percentage by weight of the components in the gelatin:
100% of gelatin, 40% of glycerol, 0% of sorbitol solution, 97% of purified water, 6% of vacuum water extraction ratio, 9.4Pa.s of rotational viscosity of glue solution, 44 ℃ of spraying body temperature, 23 ℃ of refrigeration temperature, 20-30% of humidity in the shaping and drying process, 12.5H of drying completion time, and 1000mg of fish oil in capsule filler per granule.
2 ten thousand soft capsule products are produced by the process, 6000 soft capsule products are selected, double-layer medical low-density polyethylene bags are used for packaging 2 soft capsule products, an air heater is used for sealing, and the 2 soft capsule products are placed into an acceleration box with the temperature of 40 ℃ and the RH of 75% for accelerated observation.
The products of examples 1 to 8 and comparative examples were all prepared by encapsulating 11% water-containing gelatin skin pills in a double-layered medical low-density polyethylene bag, performing an acceleration test in an acceleration box at 40 ℃ and 75% RH for 72 hours, taking out, cooling to room temperature, and observing the capsule adhesion. See Table 2 below
TABLE 2
TABLE 3
Table 3 shows the results of the various examples in comparison with one another
The results of the accelerated test in table 2 show that:
in the embodiment 1, the sorbitol solution is added in an amount of 5%, and when the anti-adhesion combined wax in the anti-adhesion combined solution component accounts for 1% of the rubber lubricating oil by mass, the produced product is adhered in an accelerated test result;
example 2 compared with example 1, when the anti-adhesion combination wax in the anti-adhesion combination liquid component accounts for 2.5% of the mass percent of the rubber lubricant, although the water extracted by the rubber melting is increased, so that the viscosity of the rubber liquid is increased, the product is not bonded after the accelerated test;
compared with the example 2, the comparison of the example 3 and the example 2 shows that the viscosity of the glue solution is increased due to the increase of the water extracted from the glue solution, the anti-adhesion combined wax in the anti-adhesion combined liquid component accounts for 2.5 percent of the mass percentage of the rubber lubricating oil, the finished product is slightly bonded, and the finished product is slightly bonded due to the overhigh viscosity of the glue solution;
comparing example 4 with example 2, the increase of the spray body and the refrigeration temperature is large during pelleting, and the product is slightly bonded after an accelerated test;
compared with the example 2, the sorbitol solution is not added into the glue solution, the anti-adhesion combined wax in the anti-adhesion combined liquid component accounts for 2.5 percent of the mass of the rubber lubricating oil, and the product is slightly bonded after an acceleration test, so that the sorbitol solution has a certain anti-adhesion effect;
comparing the embodiment 6 with the embodiments 3, 4, 5 and 8, the sorbitol solution is not added into the glue solution, the water content of the glue solution is increased by melting and extracting, the viscosity of the glue solution is increased, the spraying body and the refrigeration temperature are correspondingly increased, the drying temperature is increased, the drying humidity is reduced, the drying speed is accelerated, when the mass percentage of the anti-adhesion combination wax in the anti-adhesion combination liquid component in the rubber lubricating oil is increased to 3.5%, the final product still cannot be bonded through an accelerated test, and therefore the anti-adhesion combination liquid plays a critical role in preventing the product from being bonded;
comparing example 7 with example 2, the anti-bonding combination liquid is not used for polishing, the dosage of the sorbitol liquid is adjusted to 10%, the water extraction proportion is reduced during glue melting, the glue solution viscosity is reduced, the final product is slightly bonded after an acceleration test, and the sorbitol liquid can only reduce the bonding degree of the soft capsule but can not avoid bonding;
compared with the example 2, the temperature of the shaping and drying room is increased, the humidity is reduced, the soft capsule drying speed is accelerated, the final product is slightly bonded after an acceleration test, and the drying speed is too high, the moisture content of the inner side and the outer side of the rubber is not uniform, and the rubber is softened after being placed for a period of time and slightly bonded;
if the sorbitol solution is not added into the glue solution component and the anti-bonding combined solution is not used for polishing during shaping and drying, the product produced by the process is seriously bonded and cannot be scattered after an accelerated test.
By comparison, it can be seen that sorbitol solution is added to the glue solution component, anti-caking combined solution is used for polishing during shaping and drying, and a relatively low-temperature pelleting process is adopted during pelleting, so that the produced product has stable quality, and no caking phenomenon still occurs in an environment with a temperature as high as 40 ℃ and a humidity of 75%.
The above embodiments are only preferred embodiments of the present invention, and the protection scope of the present invention is not limited thereby, and any insubstantial changes and substitutions made by those skilled in the art based on the present invention are within the protection scope of the present invention.
Claims (4)
1. An anti-adhesion combined liquid for wrapping soft capsule rubber is characterized in that: the anti-bonding combination liquid comprises the following components in percentage by weight:
100% of soft capsule rubber lubricating oil;
the anti-bonding combined wax accounts for 1-5% of the weight of the soft capsule rubber lubricating oil;
the preparation method of the anti-adhesion combination liquid comprises the steps of adding the soft capsule rubber lubricating liquid into a heat-insulating barrel, adding the anti-adhesion combination wax when the temperature is heated to 85 ℃, stirring until the anti-adhesion combination wax is completely dissolved, stopping heating, and cooling to 18-24 ℃ for use;
wherein the anti-bonding combined wax is prepared by mixing carnauba wax, white beeswax and sunflower phospholipid according to the proportion of 7:2: 1; the preparation method of the anti-bonding combined wax comprises the steps of heating carnauba wax and white beeswax to 85 ℃ to melt, adding sunflower phospholipid, and mixing and stirring uniformly;
the soft capsule rubber lubricating oil is light liquid paraffin.
2. The anti-adhesion combination liquid for wrapping the rubber sheet of the soft capsule according to claim 1, which is characterized in that: the anti-adhesion combined liquid is mixed in a proportion that the anti-adhesion combined wax accounts for 3.5 percent of the weight of the rubber lubricating oil.
3. A production method of an anti-adhesion soft capsule is characterized by comprising the following steps: comprises glue solution for preparing capsules and the anti-bonding combination solution for anti-bonding treatment of the capsules as claimed in claim 1, wherein the glue solution comprises 100 percent of gelatin, 40 to 50 percent of glycerol, 5 to 15 percent of sorbitol solution and 95 to 100 percent of purified water according to the weight ratio of the components to the gelatin
The production process comprises the following steps of,
step one, glue melting: dissolving gelatin, glycerol, sorbitol solution, purified water, and making into gelatin solution for pelleting;
step two, batching: preparing the contents according to the proportion of the formula, paying attention to the fineness, solid content, viscosity and fluidity of the materials when preparing the suspension soft capsule, and grinding the suspension soft capsule by a bead mill if necessary;
step three, pelleting and shaping: pressing the soft capsules by a soft capsule pelleting press, and entering a shaping rotating cage for primary shaping and drying;
step four, drying and spraying anti-bonding combined liquid: wrapping the anti-adhesion combined liquid on the outer surface of the rubber sheet of the soft capsule and adsorbing the redundant anti-adhesion combined liquid on the surface of the soft capsule wrapped with the anti-adhesion combined liquid;
and step five, selecting pills.
4. The method for producing anti-adhesion soft capsules according to claim 3, wherein: and polishing and wrapping the soft capsule subjected to primary shaping and drying by using an anti-adhesion combined liquid, and adsorbing the redundant anti-adhesion combined liquid on the surface of the soft capsule.
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| CN113424892A (en) * | 2021-07-05 | 2021-09-24 | 艾兰得营养品泰州有限公司 | Multifunctional anti-sticking oil for sugar-free gel soft sweets and preparation method thereof |
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| CN116998704B (en) * | 2023-08-30 | 2025-07-25 | 晨光生物科技集团股份有限公司 | Soft capsule external coating powder composition, soft capsule external coating layer and preparation method thereof |
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| CN101966167A (en) * | 2010-09-16 | 2011-02-09 | 杭州海王生物工程有限公司 | Melatonin soft capsules and preparation method thereof |
| CN108451922A (en) * | 2018-05-03 | 2018-08-28 | 汤臣倍健股份有限公司 | A kind of soft capsule prevents adhesion technique |
| CN109645414A (en) * | 2019-02-22 | 2019-04-19 | 江西汪氏蜜蜂园有限公司 | A kind of royal jelly selenium soft capsule and preparation process thereof |
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| CN101966167A (en) * | 2010-09-16 | 2011-02-09 | 杭州海王生物工程有限公司 | Melatonin soft capsules and preparation method thereof |
| CN108451922A (en) * | 2018-05-03 | 2018-08-28 | 汤臣倍健股份有限公司 | A kind of soft capsule prevents adhesion technique |
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