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Orlistat soft capsule and preparation method thereof

A technology for orlistat and soft capsules, applied in the field of medicine, can solve the problems of poor stability of orlistat, unfavorable orlistat efficacy, easy hydrolysis, etc. low content effect

Active Publication Date: 2018-11-13
ZHONGSHAN WANHAN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the poor stability of orlistat, it will be easily hydrolyzed or degraded by heat during storage, especially when stored in humid air or humid air above 65°C, which is not conducive to the efficacy of orlistat play

Method used

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  • Orlistat soft capsule and preparation method thereof
  • Orlistat soft capsule and preparation method thereof
  • Orlistat soft capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Embodiment 1, the preparation of fish gelatin

[0044] A pulverizes the cleaned and dried tilapia fish scales to 10 meshes to obtain fish scale powder;

[0045] B. Add the fish scale powder obtained in step A into deionized water at a temperature of 55°C and soak for 2 hours. The solid-to-liquid ratio of the deionized water to the fish scale powder is 1g:8ml. Pick it up, drain, and then put it into the treatment solution for processing 2h, the treatment solution is composed of polysorbate 80 and vitamin E polyethylene glycol succinate in a weight ratio of 3:2, the solid-liquid ratio of the treatment solution and fish scale powder is 1g:2ml, and then the concentration of 1mol is added The citric acid solution of / L is soaked 2h, and the solid-to-liquid ratio of described citric acid solution and fish scale powder is 1g:4ml, adjusts pH value to be 5, picks up and drains, obtains fish scale gel;

[0046] C place the fish scale gel obtained in step B for treatment for 15 m...

Embodiment 2

[0047] Embodiment 2, a kind of orlistat soft capsule

[0048] Described orlistat soft capsule comprises content and rubber skin, and described content is made up of following component and parts by weight thereof:

[0049] Orlistat 100 parts, polysorbate 8030 parts and vitamin E polyethylene glycol succinate 100 parts;

[0050] The film is composed of fish gelatin, glycerin and purified water in a weight ratio of 2:1:2; the fish gelatin is the fish gelatin prepared in Example 1.

[0051] Preparation:

[0052] S1 Heat orlistat to 43°C to dissolve, then heat polysorbate 80 to 43°C, add to the dissolved orlistat and stir evenly to obtain mixed solution I;

[0053] S2 Heat vitamin E polyethylene glycol succinate to 95°C and keep it warm for 60 minutes, then cool it down to 43°C, add it into the mixture I obtained in step S1 to homogeneously emulsify, cool it down to 30°C and keep it warm, and keep it under vacuum condition of -0.09MPa Degas for 60 minutes to get the content;

...

Embodiment 3

[0057] Embodiment 3, a kind of orlistat soft capsule

[0058] Described orlistat soft capsule comprises content and rubber skin, and described content is made up of following component and parts by weight thereof:

[0059] 120 parts of orlistat, 8040 parts of polysorbate and 200 parts of vitamin E polyethylene glycol succinate.

[0060] The film is composed of fish gelatin, glycerin and purified water in a weight ratio of 2:1:3; the fish gelatin is the fish gelatin prepared in Example 1.

[0061] The preparation method is similar to Example 2.

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Abstract

The invention belongs to the technical field of medicines and in particular relates to an orlistat soft capsule and a preparation method thereof. The orlistat soft capsule consists of a content and capsule skin, wherein the content consists of orlistat, polysorbate 80 and vitamin E polyethylene glycol succinate; the capsule skin consists of fish gelatin, glycerinum and purified water. The orlistatsoft capsule provided by the invention has the advantages of being high in dissolution rate, low in related substance content, high in stability and low side effect, the medicinal effect of orlistatcan be effectively improved, meanwhile, the orlistat soft capsule has no problem of adhesion, pasting or re-accumulation in a production process, is easy to control and is beneficial to large-scale production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an orlistat soft capsule and a preparation method thereof. Background technique [0002] Orlistat (orlistat) is a lipase inhibitor weight-loss drug developed by Roche Pharmaceuticals. Its trade name is Xenical. FDA-approved switch to over-the-counter drug. Its chemical name is N-formyl-L-leucine(s)-1[(2s,3s)3-hexyl-4oxy-2-epoxypropylmethyl]dodecyl ester, also known as tetrahydro Tetrahydrolipstatin (Tetrahydrolipstatin, THL), is a semi-synthetic lipstatin derivative, its chemical structure is shown in the following formula: [0003] [0004] Orlistat is available in capsules and tablets of its Ⅱ crystal form. It is also the only chemical weight-loss drug at home and abroad that does not affect appetite and does not act on the central nervous system. It has superior safety characteristics. Bray GA in An article titled Management of Obesity published in The Lance...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K47/26A61K47/22A61K31/365A61P3/04
CPCA61K9/4808A61K9/4825A61K9/4858A61K9/4866A61K31/365A61P3/04
Inventor 郑明泽杜志博彭韪
Owner ZHONGSHAN WANHAN PHARM CO LTD
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