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Natural enteric soft capsule and preparation method thereof

The technology of enteric-coated soft capsules and soft capsules is applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, plant raw materials, etc., and can solve problems such as hidden safety hazards, poor adhesion and flexibility of coating films, and poor stability, etc. To achieve the effect of safe production process, ensure enteric function and good adhesion

Active Publication Date: 2012-08-01
SIRIO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] 1) It has not passed the US GRAS certification and cannot be used in food or medicine at will
[0008] 2) The coating solvent in the above-mentioned polymer synthetic materials needs to use organic solvents such as ethanol, which has a low boiling point, is flammable and explosive, and has toxicity and potential safety hazards. Explosion-proof and flame-proof measures need to be strengthened
[0009] 3) The coating film of the produced soft capsules has poor adhesion and flexibility, and has poor stability in long-term storage. When it is shaken, impacted or squeezed, it is prone to problems such as cracking and falling off of the coating film, and the enteric coating function of the product cannot be guaranteed.

Method used

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  • Natural enteric soft capsule and preparation method thereof
  • Natural enteric soft capsule and preparation method thereof
  • Natural enteric soft capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0075] A garlic enteric soft capsule, comprising a soft capsule and an enteric coating layer; the soft capsule includes a content and a rubber;

[0076] The contents of the soft capsule include the following raw materials in parts by weight:

[0077] Garlic oil 5.00 parts,

[0078] 95.00 parts of soybean oil;

[0079] The soft capsule rubber includes the following raw materials in parts by weight:

[0080] 27.00 parts of gelatin,

[0081] 11.00 parts of glycerin,

[0082] 25.00 parts of pure water;

[0083] The soft capsule enteric coating layer includes the following raw materials in parts by weight:

[0084] Glycerol caprylate: 0.80 parts,

[0085] Oleic acid: 0.50 parts,

[0086] Sodium alginate: 0.85 parts,

[0087] Stearic acid: 0.05 parts,

[0088] Cellulose: 3.80 parts,

[0089] Pure water: 60.00 parts.

[0090] The preparation method of the above garlic enteric-coated soft capsule includes the following steps:

[0091] 1. Preparation of soft capsules

[0092] 1.1 Glue preparation: Weigh 11....

Embodiment 2

[0102] A fish oil enteric soft capsule, comprising a soft capsule and an enteric coating layer; the soft capsule includes a content and a rubber skin;

[0103] The contents of the soft capsule include the following raw materials in parts by weight:

[0104] Fish oil (EPA30 / DHA40): 100.00 parts;

[0105] The soft capsule rubber includes the following raw materials in parts by weight:

[0106] 26.00 parts of gelatin,

[0107] Sorbitol 10.00 parts,

[0108] 24.00 parts of pure water;

[0109] The enteric coating layer includes the following raw materials in parts by weight:

[0110] Glycerol caprylate: 0.81 parts,

[0111] Oleic acid: 0.52 parts,

[0112] Sodium alginate: 0.86 parts,

[0113] Stearic acid: 0.06 parts,

[0114] Cellulose: 3.82 parts,

[0115] Pure water: 60.05 parts.

[0116] The method for preparing the above-mentioned fish oil enteric-coated soft capsule includes the following steps:

[0117] 1. Preparation of soft capsules

[0118] 1.1 Glue preparation: Weigh 10.00 parts of sorbito...

Embodiment 3

[0128] A natto enteric-coated soft capsule, comprising a soft capsule and an enteric coating layer; the soft capsule includes a content and a rubber;

[0129] The contents of the soft capsule include the following raw materials in parts by weight:

[0130] 10.00 servings of natto,

[0131] 82.00 parts of soybean oil,

[0132] 8.00 parts of beeswax;

[0133] The soft capsule rubber includes the following raw materials in parts by weight:

[0134] 22.00 parts of gelatin,

[0135] 14.00 parts of Sorbitol,

[0136] Titanium dioxide 0.06 parts

[0137] Caramel color 0.15 parts

[0138] 20.00 parts of pure water;

[0139] The coating layer of the enteric soft capsule includes the following raw materials in parts by weight:

[0140] 0.16 parts of glycerin,

[0141] 2.96 parts of ammonium shellac,

[0142] 0.25 parts of acetylated monoglyceride,

[0143] 0.33 parts of potassium sorbate,

[0144] 0.50 parts of polysorbate 80,

[0145] 1.70 parts of sodium alginate,

[0146] 0.10 parts of stearic acid,

[0147...

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Abstract

The invention discloses a natural enteric soft capsule which comprises a soft capsule body and an enteric coating layer. The soft capsule body comprises content and a capsule shell; the content comprises the following raw materials as per parts by weight: 0.10 to 100.00 parts of active ingredient; the capsule shell comprises the following materials as per parts by weight: 20.00 to 30.00 parts of gelatin, 6.00 to 20.00 parts of capsule shell humectant, and 15.00 to 30.00 parts of water; and the enteric coating layer comprises the following materials as per parts by weight: 1.0 to 10.00 parts of film former, 1.0 to 10.00 parts of coating humectant, and 10.00 to 100.00 parts of water. The invention further discloses a preparation method of the natural enteric soft capsule. The natural enteric soft capsule has the benefits that firstly, main components of the natural enteric soft capsule pass the U.S. GRAS certification and can be safely applied to food and drug; secondly, coating material takes water as solvent, so that potential safety hazard, such as toxicity, inflammability, explosion hazard and the like, does not exist, and the production is safer; thirdly, a coating film of the enteric coating soft capsule has more tenacity and better adhesive force, and the stability is better during long-term storage; and the coating film is not cracked and falls off when being vibrated, impacted or squeezed.

Description

Technical field [0001] The invention relates to a soft capsule and a preparation method thereof, in particular to a natural enteric-coated soft capsule and a preparation method thereof. Background technique [0002] At present, enteric-coated soft capsule technology is widely used, and it is mainly used in the following products: [0003] 1. The active ingredients of soft capsules contain bad odors, which are easy to make users nauseous and affect appetite. For example, products containing fish oils, most people cannot accept the bad odors, and these products are made into enteric-coated soft capsules to avoid taking them. Nausea caused by hiccups in fish oil products. [0004] 2. The active ingredients of the soft capsules contain substances that are irritating to the stomach, such as allicin or lipoic acid products. These products are made into enteric-coated soft capsules to avoid allicin's irritation to the stomach. [0005] 3. The active ingredients of soft capsules contain subs...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/66A61K47/44A61K36/8962A61K36/534A61K35/60
Inventor 陈琼陈铭佳方素琼邓长凤
Owner SIRIO PHARMA CO LTD
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