Enteric capsule

An enteric-coated capsule and inner layer technology, applied in the field of enteric-coated capsules, can solve the problems of dissolution or disintegration, short storage time, softening of the capsule wall, etc.

Pending Publication Date: 2021-02-12
KANGMA SHANGHAI BIOTECH LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For some drugs, such as biological, protein drugs or functional proteins, the water content is very high, or even an aqueous solution, using the existing empty shell capsule filling will have the problem of softening, dissolution or disintegration of the capsule wall, and the storage time is short

Method used

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  • Enteric capsule
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Embodiment 1 cryopreservation experiment

[0022] The product of the present invention is compared with different models of commercially available capsule products SZ, KK and LF, including 0#, 2# and 3# of KM, 0# and 2# of SZ, 2# of KK, and 00# of LF , take 3 capsules for each model. Put the capsules into the plastic box containing the capsules respectively, cover the lid, and put them into -20°C refrigerator for frozen storage, and observe the integrity and color change of the capsules according to time (12h, 24h and 48h). In this example, the coating of the enteric-coated capsules is cellulose acetate phthalate CAP. The specific experimental results are shown in Table 1 below.

[0023] Table 1

[0024]

[0025]

Embodiment 2

[0026] Embodiment 2 Artificial gastric juice disintegration experiment

[0027] Product of the present invention and commercially available capsule product EK, SZ are carried out comparative experiment, respectively get 3. Capsules are respectively put into the beaker that 20ml artificial gastric juice is housed, simulate small intestine environment. In this example, the coating of the enteric-coated capsules is cellulose acetate phthalate CAP. Experimental results show that the enteric-coated capsule of the present invention will not disintegrate within 120-180 minutes under simulated artificial gastric juice conditions, and only the edge of the capsule cap slightly expands and the color becomes lighter. The specific experimental results are shown in Table 2 below.

[0028] Table 2

[0029]

Embodiment 3

[0030] Embodiment 3 artificial intestinal fluid disintegration experiment

[0031] Product of the present invention and commercially available capsule product EK, SZ are carried out comparative experiment, respectively get 3. Capsules are put into the beaker that 20ml artificial intestinal fluid is housed respectively, simulate small intestine environment. In this example, the coating of the enteric-coated capsules is hydroxypropylmethylcellulose phthalate HPMCP. Experimental results show that the enteric-coated capsule of the present invention swells, becomes lighter in color and disintegrates within 10-60 minutes in the artificial intestinal fluid environment. The specific experimental results are shown in Table 3 below.

[0032] table 3

[0033]

[0034]

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PUM

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Abstract

The invention discloses an enteric capsule which comprises a hydrophilic outer layer, a hydrophobic inner layer and a content; the content is protein particles with high water content, the hydrophobicinner layer is attached to the hydrophilic outer layer, and the hydrophilic outer layer is a coating insoluble in an acidic or neutral solution. Through the design of different hydrophilic propertiesof the outer layer and the inner layer of the capsule and the granulation of the content, the capsule preparation of the protein solution product with high water content is realized, the problem thatthe capsule product cannot be filled with the content with high water content is solved, the softening, dissolving or disintegration phenomenon of the capsule in the storage and transportation process is prevented, and the capsule can be stored for a long time. The enteric capsule can be used for medicines or health foods.

Description

technical field [0001] The invention relates to medicinal or edible capsules, more specifically, an enteric-coated capsule. Background technique [0002] Capsules are a common dosage form or carrier for medicines or health foods. Compared with pills, tablets, and injections, capsules have the advantages of convenient use, easy storage, and controllable release environment. Especially enteric-coated capsules, as a research and development hotspot in recent years, have attracted the attention of major pharmaceutical companies. Most of the existing enteric-coated capsules are tiny pills, powders or oily substances injected or filled into the empty shell cavity of the enteric-coated capsules. These drugs are characterized by no water, or a very low water content. For some drugs, such as biological, protein drugs or functional proteins, the water content is very high, or even an aqueous solution, filling with existing empty shell capsules will cause the capsule wall to soften, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K47/32A61K47/38A61K38/00A23P10/30
CPCA61K9/4816A61K9/4825A61K47/32A61K47/38A23P10/30
Inventor 郭敏雷先德于雪
Owner KANGMA SHANGHAI BIOTECH LTD
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