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Soft capsule shell and soft capsule

A technology of soft capsules and capsule shells, which is applied in the directions of capsule transportation, food forming, medical preparations with inactive ingredients, etc., can solve problems such as poor formability, easy pre-gelling, rough and uneven rubber skin

Pending Publication Date: 2021-09-17
SIRIO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

EP3010493A1 proposes a film composition for gastric acid-resistant soft capsules, which is obtained by mixing high-acyl gellan gum, low-acyl gellan gum, starch and plasticizers. It is easy to pre-gel in the process of soft capsule skin, which makes the rubber skin rough and uneven, poor in formability, and easy to leak oil
[0004] To sum up, the application of enteric-coated soft capsules with gelatin system is currently limited, and the scope of application of the contents is small. In some areas, synthetic resins in the carrageenan system cannot be added to soft capsules. The formability of gellan gum system is poor, and it is easy to oil spill etc.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-8

[0078] Soft capsules were prepared with ingredients and contents as described in Table 2, and tested and scored. The measurement results are shown in Table 2.

[0079] According to Table 2, it can be known that Examples 1-8 use specific viscosity gellan gum and starch in combination, and the formed rubber has better strength, toughness and molding adhesion, while Comparative Examples 1-2 use the same combination of the film-forming composition of the present invention. content, when comparative example 1 adopts gellan gum with higher viscosity and starch combination, the rubber skin strength formed is weaker, has certain toughness, but molding bonding is general; comparative example 2 adopts gellan gum and starch with lower viscosity When combined, the rubber is basically viscous and has poor toughness, so it cannot be pressed and molded into soft capsules.

Embodiment 9-23

[0081] Soft capsules were prepared with ingredients and contents described in Table 3 and Table 4, and tested and scored. The measurement results are shown in Table 3 and Table 4. The soft capsules prepared in Example 9, Example 10 and the above-mentioned Example 4 can all achieve the enteric-coating effect. Compared with Example 9, due to the addition of granular starch, the comprehensive evaluation of the soft capsules made in Example 10 and the above-mentioned Example 4 becomes better, but when the granular starch is increased to 3%, the soft capsules made in the stomach All disintegrated. Therefore, the addition of less than 2% (such as 1.7%) of cross-linked starch, such as hydroxypropyl distarch phosphate, has achieved unexpected effects on the comprehensive evaluation and enteric solubility of soft capsules.

[0082]

[0083]

[0084]

[0085]

[0086]

[0087] Examples 9-23 illustrate that gellan gum of specific viscosity is combined with various types ...

Embodiment 24-31

[0090] The ingredients and contents described in Table 5 were prepared into soft capsules, and tested and scored. The measurement results are shown in Table 5.

[0091]

[0092]

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Abstract

The invention relates to a soft capsule shell and a soft capsule. The invention provides the soft capsule shell. The soft capsule shell is prepared from a film-forming composition comprising 1.5-5 wt% of a first gelling agent, 30-40 wt% of starch, 10-25 wt% of a plasticizer, and 35-55 wt% of water, where the first gelling agent is gellan gum having the following properties that when measured by a rotational viscometer, the gellan gum solution obtained by dissolving 1.5 wt% of gellan gum in water at 90 DEG C for 30 minutes has a viscosity in range of 10-60 mPa.s, the soft capsule shell contains 0-3 wt% of starch particles, and the starch particles are starch particles with an average particle size of 10-50 microns. The soft capsule shell has an enteric effect, and disintegration time limit of the soft capsule shell conforms to regulations of pharmacopoeia at home and abroad.

Description

technical field [0001] The invention relates to the field of food or medicine, in particular to a soft capsule shell and a soft capsule. Background technique [0002] Traditional enteric-coated soft capsules are mainly coated. Soft capsules are produced first and then coated to obtain the effect of enteric coating. However, research in recent years has mainly adopted one-step molding for the preparation of enteric-coated soft capsules, that is, adding enteric-coated materials during the sol process, pressing pellets into pellets, and finally drying. It comes in uncoated form which does not require a separate coating. This type of non-coated enteric-coated soft capsule can improve the storage durability of the coated soft capsule, and compared with the traditional preparation process, the process is simplified, the efficiency is improved, and the cost is reduced. [0003] The non-coated enteric soft capsule can be prepared by using gelatin and pectin composition, carrageena...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K47/36A23P10/30
CPCA61K9/4816A61K47/36A23P10/30
Inventor 陈洁伟李绪发
Owner SIRIO PHARMA CO LTD
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