A process for the continuous production of gelatin soft capsules

Abstract

The application discloses a gelatin soft capsule continuous production process. The process uses a vacuum stirring defoaming device to actively defoam the glue solution, and adds a monitoring point after defoaming. According to the real-time situation, the process parameters are adjusted, so that the defoamed gelatin can reach the production standard without standing, thereby further completing the continuous production of the gelatin soft capsule. The application has important significance for improving the yield and quality of the soft capsule.

Description

TECHNICAL FIELD

[0001] The present application relates to a gelatin soft capsule continuous production process. BACKGROUND

[0002] Gelatin is widely used in food, pharmaceutical, medical and other industries due to its good physicochemical properties. In the production process of soft capsules, gelatin plays an indispensable role as a drug carrier. Viscosity, as one of the important physicochemical properties of gelatin, is an important indicator that determines the quality of soft capsules in the production process. The current soft capsule production process is to dissolve the gelatin required for capsule production on the same day at one time. Glycerin is added during the dissolution process and continuous stirring is required. Due to the stirring process, a large number of air bubbles are brought in, which need to be left for 4 hours to reach the capsule production standard and then kept warm for standby. After the dissolution is completed, the gel liquid is used in batches according to the subsequent capsule production process. The problems existing in this process are: the dissolved gel liquid cannot be used in one capsule production, the capsule production requires a certain time, and the gel liquid that is not used after several production processes will not be used due to the viscosity reduction caused by long-term preservation. If the gelatin dissolved at one time is too small, the gelatin that needs to be dissolved again needs to be left for a long time before it can be used for capsule production, which significantly reduces the production efficiency. In addition, the adhesive tape after preparing soft capsules is denatured due to one heating, stirring and shearing, and the quality of the gel liquid prepared by the traditional gel dissolving process is deteriorated and not suitable for reuse, resulting in a large amount of waste of gelatin raw materials. Therefore, the current research on gelatin viscosity is not comprehensive enough, and there are defects such as unstable gel liquid viscosity, inability to recycle, long production time and low efficiency in the production process. SUMMARY

[0003] The present application is directed to the above problems, and proposes a gelatin soft capsule production process. The process uses a vacuum stirring defoaming device to actively defoam the gel liquid, and adds a monitoring point after defoaming. According to the real-time situation, the process parameters are adjusted to make the defoamed gelatin meet the production standard without standing, so as to further complete the continuous production of gelatin soft capsules. The present application has important significance for improving the yield and quality of soft capsules.

[0004] The technical scheme of the present application is:

[0005] A gelatin soft capsule continuous production process, which comprises the following steps:

[0006] A gelatin soft capsule continuous production process, and the specific process steps are as follows:

[0007] S1, according to the production capacity of the pill press, the required amount of gelatin particles and the amount of purified water are put into the sol unit for stirring and dissolving, wherein the gelatin is subjected to water absorption swelling and dissolution operations, and two-fifths of the mass of the gelatin is put into glycerol during the dissolution process, the laminar flow stirring is strengthened to strengthen the dissolution and defoaming process, and the preparation of the glue liquid is completed.

[0008] S2, the gel liquid after dissolution is filtered under heat preservation conditions and a certain vacuum degree to remove impurities;

[0009] S3, the dissolved glue liquid is introduced into a vacuum defoaming stirrer, the vacuum degree is controlled at-0.07-0.08MPa, a special laminar flow stirrer is used, the stirring speed is adjusted, and the defoaming is actively forced in the laminar flow state without generating secondary bubbles, the time is controlled at 30min, and a sampling point is arranged at the outlet of the vacuum defoaming stirring tank to detect the viscosity, rheological shear force and water content, so that the glue liquid meets the requirements of soft capsule filling production, and enters the pill press for preparation and packaging of soft capsules;

[0010] S4, the defoamed gelatin glue liquid is adjusted according to the production parameters of the market pill press, the amount of gelatin particles, water and glycerol is adjusted, and more than two pill presses can be used for feeding at the same time to adapt to different production capacity requirements.

[0011] The shearing time and heating time in step S1 are about 30min, the heating temperature is between 65-70℃, and the laminar flow stirring speed is controlled between 50-180r / min according to different production capacity and equipment volume;

[0012] The vacuum degree in step S2 is-0.02MPa or more

[0013] The monitoring point detection standard in step S3 is that the water content is kept at 40%-50%, and the viscosity is 2500-3000mpa·s;

[0014] If the water content is too high, the temperature is appropriately increased, the stirring time is still kept at 30min, and the stirring speed is adjusted. If the viscosity is too low, the temperature is appropriately reduced, the stirring time is still kept at 30min, and the stirring speed is adjusted.

[0015] Compared with the prior art, the present application has the following beneficial effects:

[0016] 1. The present application has good economic benefits, shortens the heating and heat preservation time, improves the utilization of gelatin raw materials, saves energy, and significantly improves the quality of the glue liquid and the soft gel product preparation and packaging.

[0017] 2、The application can improve production efficiency, and the long time required for standing and defoaming process is one of the main factors for making gelatin molecules denature, viscosity decrease and restricting the continuous production of gelatin. In view of this problem, the vacuum defoaming stirrer used in the application can complete bubble elimination within 30 minutes and meet the requirements of capsule production, so that the dissolution process and the defoaming process take the same time, ensure that each equipment continuously produces, improve the production capacity, avoid the waste caused by dissolving excessive gelatin at one time, and realize the continuous production of capsule production.

[0018] 3、The property of the gel solution after defoaming is a key indicator to determine the quality of the final soft capsule. The application sets up an online monitoring point of gelatin performance parameters after gelatin dissolution and defoaming, and can adjust the process parameters of gelatin dissolution and vacuum defoaming process in real time according to the viscosity, rheological shear force and water content of the gel solution after defoaming, so as to ensure the quality of the gel solution and avoid the appearance of unqualified products in the continuous production process.

[0019] 4、When the gelatin dissolution and defoaming efficiency is improved, the processing capacity of gelatin dissolution and vacuum defoaming is designed according to the requirements of soft gel preparation and packaging capacity. The application can realize one-to-many feeding mode of one or more pelletizing machines, so as to greatly improve the production efficiency and product quality. BRIEF DESCRIPTION OF DRAWINGS

[0020] Figure 1 The application is a gelatin capsule preparation process flow chart, wherein the numbers behind the words represent the nth production. DETAILED DESCRIPTION

[0021] The embodiments of the application are described below through specific examples. Those skilled in the art can easily understand other advantages and effects of the application from the disclosure. The application can also be implemented or applied through different specific embodiments, and the details in the specification can be modified or changed based on different views and applications without departing from the spirit of the application.

[0022] Example 1

[0023] S1, use YWJ100-II type full-automatic soft capsule machine to produce capsules, according to the specifications of the pelletizing machine, put 20 kg of gelatin and 20 kg of purified water into the stirring tank for stirring and dissolving, wherein the gelatin should be first soaked and swollen for 30 minutes, 8 kg of glycerol is put into the dissolution process, the heating temperature is controlled to be 65 DEG C, the stirring speed is 150 r / min, and the gelatin is completely dissolved after stirring for 30 minutes;

[0024] S2, the gel solution after dissolution is filtered for 30 min under a vacuum degree of -0.02 MPa;

[0025] S3, the dissolved gel solution is introduced into a vacuum defoaming stirrer for stirring, wherein the vacuum degree is controlled at -0.075 MPa, the stirring speed is adjusted according to the efficiency of the defoaming stirrer so that the stirring time is controlled at 30 min, a sampling point is arranged at the outlet of the stirrer to detect the viscosity, the water content is kept at 40%-50%, the viscosity is 2500-3000 mpa·s, if the water content is too high, the temperature is appropriately increased and the stirring time is kept at 30 min to adjust the stirring speed, if the viscosity is too low, the temperature is appropriately decreased and the stirring time is kept at 30 min to adjust the stirring speed, at the same time, 20 kg of gelatin is absorbed and swelled, and 20 kg of the swelled gelatin, 20 kg of purified water and 8 kg of glycerol are introduced into the stirring tank in S1 again for stirring and dissolving;

[0026] S4, the rotating speed of the rolling die of the YWJ100-II type full-automatic soft capsule machine is adjusted to 4 r / min, two pill pressing machines are used to work simultaneously, the first batch of defoamed gel solution is introduced into the pill pressing machine A, a new batch of gel solution is introduced into the pill pressing machine B after 30 min, the gelatin production of the pill pressing machine A is completed after 1 h, the third batch of gel solution is introduced into the pill pressing machine A, and the above process is repeated until the capsule production meets the demand.

[0027] Comparative Example 1: the vacuum defoaming stirrer in step S3 is replaced by static defoaming, and the other steps are the same as those in Example 1.

[0028] Comparative Example 2: the two pill pressing machines in step S4 are replaced by one, and the other steps are the same as those in Example 1.

[0029] The comparison results are shown in the following table:

[0030] Yield (grains / hour) Example 1 21800 Comparative Example 1 4000 Comparative Example 2 10800

[0031] From the above results, it can be seen that the production per hour is greatly improved by introducing the vacuum stirring defoaming equipment and using two pill pressing machines for common production.

[0032] The remaining matters of the application are known technologies.

Claims

1. A continuous production process for gelatin soft capsules, characterized in that, Includes the following steps: S1. According to the specifications of the pellet press, add the required amount of gelatin and an equal amount of purified water to the mixing tank and stir to dissolve. The gelatin should be pre-soaked and swollen for 30 minutes. During the dissolution process, add glycerin equal to two-fifths of the gelatin's weight. The stirring step should be completed within 30 minutes. S2. Filter the dissolved adhesive solution using a filter screen for 30 minutes under a certain vacuum. S3. Pass the dissolved adhesive solution into a vacuum defoaming mixer for stirring. Control the vacuum degree at -0.07-0.08MPa and adjust the stirring speed to control the defoaming time at 30min. Set up a sampling point at the mixer outlet to test the viscosity and water content to ensure that the adhesive solution meets the capsule production standards. At the same time, absorb water again to swell an equal amount of gelatin, and add the required amount of gelatin and glycerin to the mixing tank in S1 again for stirring and dissolving. S4. Adjust the rolling speed of the defoamed gelatin solution according to the production parameters of the commercially available shot press machine. Control the completion time of this step to 1 hour. Use two shot press machines to work at the same time. The first batch of gelatin solution is fed into shot press machine A. After 30 minutes, the new batch of gelatin solution is fed into shot press machine B. After 1 hour, shot press machine A completes the gelatin production. The third batch of gelatin solution is fed into shot press machine A, and so on.

2. The continuous production process for gelatin soft capsules as described in claim 1, characterized in that, The heating temperature is controlled at 65-70℃; the stirring rate is 120-180 r / min.

3. The continuous production process for gelatin soft capsules as described in claim 1, characterized in that, The vacuum level in step S2 is -0.02 MPa.

4. The continuous production process for gelatin soft capsules as described in claim 1, characterized in that, In step S3, the monitoring point detection standard is that the water content is maintained at 40%-50% and the viscosity is 2500-3000 mPa•s.

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