Soft capsule shell composition, soft capsule, and preparation and application thereof

A soft capsule and composition technology, applied in the field of soft capsule shell composition, can solve the problems of soft capsule disintegration and dissolution effect not being obvious, and achieve the effect of reducing cross-linking aging and increasing disintegration time limit

Inactive Publication Date: 2018-11-13
SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Although the above studies have made some contributions to preventing the aging of soft capsules, these studies have not significantly improved the disintegration and dissolution effects of soft capsules

Method used

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  • Soft capsule shell composition, soft capsule, and preparation and application thereof
  • Soft capsule shell composition, soft capsule, and preparation and application thereof
  • Soft capsule shell composition, soft capsule, and preparation and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 10-13 and comparative example 8-10

[0102] Comparative examples 8, 9, and 10 refer to examples 3, 4, and 14 of Chinese patent application CN104224745A. In view of the different gelatin amounts in the three formulations and the products of different suppliers; control. Therefore, this test uses the gelatin of Baotou Dongbao Biotechnology Co., Ltd., and the dosage is 40%; the dosage of the plasticizer adopts the conventional amount (18%) of the soft capsule. Wherein, Comparative Example 8 corresponds to Example 10, Comparative Example 9 corresponds to Example 11, and Comparative Example 10 corresponds to Example 13. The components and contents of the soft capsule shell composition are specifically shown in Table 3.

[0103] Table 3. Comparative Examples 8-10 and Examples 10-13 (by weight percentage)

[0104]

[0105]

[0106] Adopt the components and content of the soft capsule capsule shell composition of comparative example 8-10 and embodiment 10-13, content is soybean oil, with the step sequence and pro...

Embodiment 14

[0111] Embodiment 14: the preparation of soft capsule

[0112] (1) Add 37.5% water into the glue tank, add 16% glycerin, 2% sorbitol, 3% glycine, and 1% fumaric acid under heating and stirring, and stir to dissolve;

[0113](2) When the temperature of the solution in the chemical glue tank reaches 60°C, slowly add 40% gelatin, continue heating and stirring, add 0.5% micronized titanium dioxide after dissolving the gelatin, stir, and mix well;

[0114] (3) When the temperature of the glue in the glue tank reaches 70°C, close all the ventilation valves of the glue tank, vacuumize, and when the temperature of the glue in the tank drops to 60°C, turn off the vacuum and discharge;

[0115] (4) Filter the glue solution through a 120-mesh nylon bag into an insulated barrel, control the temperature of the glue solution in the insulated barrel at 60° C., and keep it warm for 3 hours to obtain the soft capsule shell glue;

[0116] (5) On the soft capsule machine, the soft capsule shell...

Embodiment 15

[0118] Ibuprofen Softgels:

[0119] Content components: ibuprofen 2000g, polyethylene glycol 400 6000g, potassium hydroxide 240g, water 380g.

[0120] Content preparation: weigh polyethylene glycol 400 into a container, dissolve potassium hydroxide in water and add it to polyethylene glycol 400, stir to dissolve, then weigh ibuprofen, stir to dissolve, and obtain.

[0121] The ibuprofen soft capsules were prepared by the steps sequence and process conditions in the soft capsule shell composition of Example 5 and the preparation method of Example 14. The content of each capsule is 0.862g, and each capsule contains 200mg of ibuprofen. The prepared ibuprofen soft capsules are packaged in hard double aluminum blisters.

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Abstract

The invention discloses a soft capsule shell composition, a soft capsule, and preparation and an application thereof. The soft capsule shell composition comprises the following components, by mass: (1) 35-45% of gelatin; (2) 10-25% of a plasticizer; (3) 1-5% of glycine as an aldehyde inhibitor; (4) 0.5-3% of fumaric acid as an acidifier; and (5) 35-45% of water. The positive progress effects of the soft capsule shell composition and the soft capsule are that the soft capsule shell composition uses the glycine as the aldehyde inhibitor and the fumaric acid as the acidifier, and so the cross-linking aging effect of the gelatin in the soft capsule prepared by the soft capsule shell composition can be significantly reduced, the disintegration time limit of the soft capsule after long-term storage does not significantly increase, and the medicine dissolution behavior does not significantly change.

Description

technical field [0001] The invention relates to a soft capsule shell composition, a soft capsule and its preparation and application. Background technique [0002] Soft capsules have the advantages of beautiful appearance, accurate and uniform content, good sealing, high bioavailability, and good taste masking. Soft capsule preparations are suitable for fat-soluble drugs, insoluble drugs and traditional Chinese medicine extracts, etc. The research and development of soft capsules is gradually becoming a hot spot in the development of new drugs. [0003] However, soft capsule shell disintegration or slow rupture often occurs during storage, which is also a problem often encountered in the industrial production of soft capsules. A large number of research data show that the aging of the capsule shell is mainly caused by the crosslinking and aging of gelatin, the material of the capsule shell. After aging, a layer of water-insoluble film-like substance will appear on the inner...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K47/18A61K47/12
CPCA61K9/4825A61K47/12A61K47/18
Inventor 马晋隆倪睿史家骏杨霏霏黄乐乐徐驿刘仁亮
Owner SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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