Preparation method of enteric-coated soft capsules

A technology of enteric-coated soft capsules and soft capsule shells, which is applied in the field of preparation of enteric-coated soft capsules, can solve the problems of easy erosion of rubber skin by liquid medicine, easy oil leakage, and limited ability of soft capsules to resist extrusion and collision, etc. Achieve the effect of increasing shelf life, increasing disintegration time and good stability

Pending Publication Date: 2017-09-01
山东禹王制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The soft capsule prepared by this method only forms a coating layer on the surface of the capsule, and there is no coating layer between the content (fish oil) and the rubber. Capsules have limited anti-extrusion and anti-collision capabilities, especially when the contents of the drug solution corrode the rubber, it is more prone to oil leakage and other situations

Method used

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  • Preparation method of enteric-coated soft capsules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] A kind of preparation method of enteric-coated soft capsule, the mass percentage of each group of raw materials is as follows:

[0040] Contents: 2% garlic oil, 98% fish oil; stir and mix evenly in a dispensing tank;

[0041] Coating solution: 15% acrylic resin polymer, 2.25% citrate triester, 1.05% propylene glycol, 1.7% talcum powder, 80% purified water; mix evenly in a container.

[0042] Rubber components: gelatin 50%, glycerin 17%, water 33%.

[0043] The preparation steps are as follows:

[0044] Weigh glycerin and water according to the ratio, put them into the plastic tank, turn on the heating tank and raise the temperature to 75°C, then add the prepared coating solution, stir evenly, add gelatin, vacuum pressure -0.06~-0.7MPa, keep the pressure Sol, and then vacuumize the glue to make the glue free of bubbles (vacuum pressure -0.8MPa); then, let the glue stand at 65°C for about 2 hours, and the viscosity is 12000Pa. The glue solution of S is measured at 65°C...

Embodiment 2

[0048] A kind of preparation method of enteric-coated soft capsule, the mass percentage of each group of raw materials is as follows:

[0049] Softgel contents: 18 / 12 fish oil (EPA18 / DHA12) 100%

[0050] Coating liquid: 13% of acrylic resin polymer, 3.25% of citrate triester, 1.05% of propylene glycol, 2% of talcum powder, 80.7% of purified water, and 1% of absolute ethanol.

[0051] Rubber components: 45% gelatin, 17% glycerin, 38% water.

[0052] The preparation steps are as follows:

[0053] Glue configuration: Weigh glycerin and water according to the ratio, put them into the glue tank, turn on the heating tank to raise the temperature to 70°C, then add the prepared coating solution, stir well and add gelatin, vacuum pressure -0.07~- 0.8MPa, pressurize the sol, then vacuumize (vacuum pressure-0.9MPa) to make the glue free of bubbles, keep the glue at 65°C for 2.5h, and get a viscosity of 13000Pa. S glue. The resulting glue solution is used to form soft capsule shells i...

Embodiment 3

[0056] A kind of preparation method of enteric-coated soft capsule, the mass percentage of each group of raw materials is as follows:

[0057] Contents: VD3 oil 3%, 50 / 25 fish oil 97%; stir and mix well in a dispensing tank.

[0058] Coating liquid: 14% of acrylic resin polymer, 2.75% of citrate triester, 1.55% of propylene glycol, 2.7% of talc, 80% of purified water.

[0059] Rubber components: gelatin 40%, glycerin 19%, water 41%.

[0060] The preparation steps are as follows:

[0061] Glue configuration: Weigh glycerin and water according to the ratio, put them into the glue tank, turn on the heating tank to raise the temperature to 75°C, then add the prepared coating solution, stir well and add gelatin, vacuum pressure -0.07~- 0.8MPa, pressurize the sol, then vacuumize (vacuum pressure -0.85MPa) to make the glue free of bubbles, keep the glue at 65°C for 2 hours, and get a viscosity of 12500Pa. S glue.

[0062] Preparation of soft capsules: Use a 250-type automatic sof...

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Abstract

The present invention relates to a preparation method of enteric-coated soft capsules. The enteric-coated soft capsules comprise contents and capsule shells. The contents are fish oil or a combination of the fish oil and other components. The preparation method comprises the following steps: coating liquid is added in a process of glue melting of glue skin, vacuum-pumping and pressure maintaining glue melting are conducted, then the vacuum-pumping is conducted to enable glue liquid to be free of bubbles, and the glue liquid is put still at 65-70 DEG C to be subjected to a heat preservation for a standby application; the obtained glue liquid is used to form the soft capsule shells; and the contents are wrapped in the soft capsule shells formed by the glue liquid using a pill pressing machine to prepare the enteric-coated soft capsules. The obtained enteric-coated soft capsules can prevent corrosion of the glue skin by medicinal liquid, increase a shelf life of the products, show no oil leakage and penetration phenomena, increase disintegration time and are full of toughness.

Description

technical field [0001] The invention relates to a preparation method of enteric-coated soft capsules, belonging to the technical field of soft capsule preparations. Background technique [0002] At present, soft capsule preparations are developing rapidly in China, and there are hundreds of various soft capsule preparations, including VE soft capsules, evening primrose soft capsules, lecithin soft capsules, Duoxikang soft capsules, deep-sea fish oil soft capsules, etc. Wait. Commonly used varieties and various types of soft capsules of health care preparations such as VD3 soft capsules, olive oil soft capsules and so on. Many oily, liquid, suspension liquids and other pasty original drug solutions can be processed into soft capsules. Although soft capsule preparations have developed rapidly in China, many technical problems have also occurred at the same time. For example, the shell of soft capsules is now mainly made of animal gelatin and glycerin as a plasticizer, which...

Claims

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Application Information

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IPC IPC(8): A23L33/12A23P10/30
CPCA23L33/12A23P10/30
Inventor 刘汝萃刘锡潜范书琴张建全宗俊爱闫亚兵
Owner 山东禹王制药有限公司
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