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Preparation method of soft capsule

A soft capsule and glue technology, which is applied in the directions of capsule delivery, medical preparations with non-active ingredients, and pharmaceutical formulations, can solve problems such as leakage of soft capsules, and achieve the effect of reducing the leakage rate and improving the anti-leakage effect.

Pending Publication Date: 2021-11-26
SHINEWAY PHARMA GRP LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The purpose of the embodiments of the present application is to provide a method for preparing soft capsules. By establishing the control of the sealing degree parameters of the soft capsules, the control of the particle size of the drug liquid in the soft capsules is established, and the colloid milling method for the preparation of soft capsules is established. Number control, thus effectively solving the problem of easy leakage of existing soft capsules

Method used

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  • Preparation method of soft capsule
  • Preparation method of soft capsule
  • Preparation method of soft capsule

Examples

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preparation example Construction

[0037] The preparation method of the soft capsule provided in the embodiment of the present application includes: S101-preparation of the mixture glue and S102-compression molding of the soft capsule.

[0038] S101-The preparation of the mixture glue includes the preparation of capsule material glue and the preparation of the content medicine solution, the preparation of the content medicine solution includes establishing the particle size control of the content medicine solution, and establishing the control of the colloid used for the preparation of soft capsules Grinding mesh control. The establishment of the particle size control of the content medicinal liquid and the control of the colloid mill mesh number used to prepare the soft capsule, wherein the establishment of the particle size control of the content medicinal liquid includes: controlling the content of the The particle size of the liquid medicine is 60-90 μm; the establishment of the control of the mesh number o...

Embodiment 1

[0057] The preparation method of a soft capsule provided in Example 1 includes S101-preparation of the mixture glue and S102-compression molding of the soft capsule.

[0058] S101-Preparation of the mixture glue includes capsule material glue preparation and content drug solution preparation. The preparation of the capsule material glue specifically includes: putting gelatin (freezing power of 180 Bloomg), glycerin and water into the glue tank according to the mass ratio of 1:0.3:1.2, stirring and heating to melt the gel material Afterwards, keep warm for 1-2 hours, let it stand until the foam rises, and then keep warm and filter to get the capsule material glue (freezing force is 160B Loomg), which is ready for use. The preparation of the content medicinal solution specifically includes: placing the content raw material of the soft capsule and an appropriate amount of water in a colloid mill and grinding for 10-30 minutes, so that the content raw material forms a medicinal li...

Embodiment 2

[0061] The preparation method of a soft capsule provided in Example 1 includes S101-preparation of capsule material glue and S102-compression molding of soft capsule.

[0062] S101-Preparation of the mixture glue includes capsule material glue preparation and content drug solution preparation. The preparation of the capsule material glue specifically includes: putting gelatin (freezing power of 150 Bloomg), glycerin, water and other components into the glue tank according to the mass ratio of 1:0.3:1.2, stirring and heating to melt the gel material Afterwards, keep warm for 1-2 hours, let it stand until the foam rises, and then keep warm and filter to obtain the capsule material glue (freezing force is 120B Loomg), which is ready for use. The preparation of the content medicinal solution specifically includes: placing the content raw materials of the soft capsule and an appropriate amount of water in a colloid mill to grind for 10-30 minutes, so that the content raw materials ...

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Abstract

The invention discloses a preparation method of a soft capsule, and belongs to the field of soft capsule preparation processes. The preparation method of the soft capsule comprises preparation of a mixture glue solution and compression molding of the soft capsule, the preparation of the mixture glue solution comprises preparation of a capsule material glue solution and preparation of a content liquid medicine, the preparation of the content liquid medicine comprises establishment of particle size control of the content liquid medicine, specifically, the particle size of the content liquid medicine is controlled to be 60-90 microns; establishment of the mesh number control of a colloid mill for preparing the soft capsules, specifically, the mesh number of the colloid mill is controlled to be 170-240 meshes; and compression molding of the soft capsule comprises establishment of sealing degree parameter control over the soft capsule, specifically, the sealing degree of the soft capsule is controlled to be larger than or equal to 40%. According to the preparation method of the soft capsule provided by the invention, parameters in a soft capsule preparation process are refined and controlled, so that the leakage rate of the prepared soft capsule finished product is further reduced, and the anti-leakage effect of the soft capsule is improved.

Description

technical field [0001] The embodiment of the present application relates to the technical field of soft capsule preparation technology, in particular to a preparation method of soft capsule. Background technique [0002] Soft capsule refers to the pharmaceutical dosage form made by injecting oily drug, drug solution or drug suspension, paste or even drug powder quantitatively and encapsulating it in an elastic soft film. It has high bioavailability, sealing Safety, precise dosage, beautiful appearance, etc., especially suitable for unstable medicinal substances, such as chemical components that are sensitive to light, volatile, unstable when exposed to heat and humidity, and easily oxidized, as well as pharmaceuticals with unpleasant taste and bad smell. Effective substances. Soft capsules have become one of the main dosage forms in the research and development of traditional Chinese medicine. However, during the preparation process of soft capsules, due to the gradual dive...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K47/42A61K47/10A61K47/04
CPCA61K9/4825A61K47/10A61K47/02A61K9/4833
Inventor 李瑾赵鹏陈艳王姣
Owner SHINEWAY PHARMA GRP LTD
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