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Hollow soft capsule and preparation method thereof

A technology of hollow soft capsules and soft capsules, applied in the field of medicine and food, which can solve the problems of high production cost, low production efficiency, and starch molecule damage, and achieve the effects of low cost, good sealing, and avoiding liquid leakage

Inactive Publication Date: 2015-06-10
刘凯培
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Filling fat-soluble liquids into soft capsules is already a mature process, but the operation is more complicated, and the rubber treatment and the content packaging must be carried out at the same time
However, when using hollow hard capsules to fill liquids, since the hard capsules have a two-body structure and are made of hard materials, the sealing performance of the seal is not good, leakage is prone to occur, and the quality cannot be guaranteed.
Using thixotropic gel or hot melt to fill hard capsules does not require sealing, but some active ingredients will be limited in application due to inadaptable physical and chemical properties or bioavailability problems
[0003] In recent years, plant gum soft capsules and plant hollow hard capsules have been developed a lot. CN1695600 introduces the method for preparing soft capsules by extruding plasticized starch as the main material. Softeners and plasticizers are also extrusion molding. Although the above two methods form thermoplastic heat-melt bodies, they have high requirements for extrusion and plasticization processes. If the parameters are not well controlled, it is easy to cause excessive damage to starch molecules. High production cost and low production efficiency

Method used

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  • Hollow soft capsule and preparation method thereof
  • Hollow soft capsule and preparation method thereof
  • Hollow soft capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Add instant agar and maltose syrup (DE value 55) at a ratio of 1:0.4 to 5 times the weight of instant agar in deionized water, heat until the materials are completely dissolved, evaporate the water to 5%, cool, calender, and place after film formation Yu Ru figure 2 , image 3 Molding in the mold shown, respectively make concave side half-capsule and convex side half-capsule, and heat-synthesized to make hollow soft capsule with injection tube. The material of the capsule has a melting point of 80°C, a tensile strength of 4.5 MPa, and an elongation at break of 156%. According to the test method stipulated in the 2010 edition of "Chinese Pharmacopoeia" of the gelatin hollow capsule quality standard, the friability of the above-mentioned samples is 0, and the disintegration time is 8 minutes.

Embodiment 2

[0038] Pullulan (molecular weight 2×10 5) and agar oligosaccharides with a degree of polymerization of 2~10, add deionized water 5 times the weight of pullulan polysaccharide at a ratio of 1:0.6, heat until the material is completely dissolved, evaporate the water to 5% moisture content, and cool. Calendering, the hollow soft capsule is made with the step of embodiment 1 after film formation. The material of the capsule has a melting point of 75°C, a tensile strength of 3.9MPa, and an elongation at break of 172%. According to the test method stipulated in the 2010 edition of "Chinese Pharmacopoeia" of the quality standard for gelatin hollow capsules, the friability of the above-mentioned samples is 0, and the disintegration time is 5 minutes.

Embodiment 3

[0040] Add expanded konjac gum and mannose oligosaccharide at a ratio of 1:0.2 to deionized water that is 6 times the weight of expanded konjac gum, heat until the material is completely dissolved, evaporate the water to 5%, cool, calender, and the same after forming a film. The step of embodiment 1 makes hollow soft capsule. The material of the capsule has a melting point of 85°C, a tensile strength of 4.2MPa, and an elongation at break of 159%. According to the test method stipulated in the 2010 edition of "Chinese Pharmacopoeia" of the gelatin hollow capsule quality standard, the friability of the above sample is 0, and the disintegration time is 7 minutes.

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Abstract

The invention relates to a hollow soft capsule. A medicine injection opening is formed on the capsule body and is a medicine filling pipe protruding from one end of the soft capsule; the thermo-compression bonding temperature of a soft capsule material is 50-100 DEG C. The preparation method of the hollow soft capsule comprises the following steps: (1) preparing a plastic suction mold, which comprises a plastic suction upper half mold and a plastic suction lower half mold; (2) dispersing soluble plant polysaccharide and a plasticizer in deionized water according to the mass ratio of 1:(0.1-0.6), heating to 120-160 DEG C, and carrying out evaporation of water until the water content is lower than 5-10%, so as to obtain a membrane material; (3) preparing a concave-edge half capsule and a convex-edge half capsule by using the membrane material prepared in the step (2) through the plastic suction mold; (4) performing thermoform on the concave-edge half capsule and the convex-edge half capsule to prepare the hollow soft capsule with the medicine filling pipe. Through the adoption of the hollow soft capsule provided by the invention, the purposes of the new drug research and development in a laboratory and the convenience for small-amount manufacture of the soft capsule in the medical institution clinical preparation field can be achieved; meanwhile, the fast sealing after the filling can be achieved without liquid leakage.

Description

technical field [0001] The invention relates to the field of medicine and food, in particular to a hollow soft capsule used for filling food, spices and medicines and a preparation method thereof. Background technique [0002] At present, the preparation of soft capsules and hard capsule shell materials mainly utilizes the gel properties of gelatin or vegetable gum. Filling fat-soluble liquids into soft capsules is a mature process, but the operation is relatively complicated, and the rubber treatment and the content packaging must be carried out at the same time. However, if the hollow hard capsule is filled with liquid, since the hard capsule has a two-body structure and is made of hard material, the sealing performance of the seal is not good, and leakage is prone to occur, so the quality cannot be guaranteed. Using thixotropic gel or hot melt to fill hard capsules does not require sealing, but some active ingredients will be limited in application due to inadaptable phy...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61J3/07A23P1/04A23P10/30
Inventor 刘凯培
Owner 刘凯培