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Novel oral capsule preparation for treating cancer and AIDS

A technology of AIDS and capsules, which is applied in the field of new capsule oral preparations of polypeptide drugs, can solve the problems of large side effects and limit the clinical application of interleukin 2, and achieve the effects of improving penetration, increasing intestinal half-life, and increasing transportation

Inactive Publication Date: 2009-11-25
单宝华
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the current injection dosage forms (intravenous, subcutaneous, and intramuscular injection, etc.) have severe side effects, especially the fatal vascular leak syndrome (Vascular Leak Syndrome), which limits the clinical application of interleukin 2

Method used

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  • Novel oral capsule preparation for treating cancer and AIDS
  • Novel oral capsule preparation for treating cancer and AIDS
  • Novel oral capsule preparation for treating cancer and AIDS

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Such as figure 1 As shown, a new oral capsule preparation for the treatment of cancer and AIDS has a double-layer structure, with drug layer 1, water-soluble capsule 2 and enteric-coated capsule 3 in sequence from inside to outside. The drug layer is a mixture of protein drugs, absorption aids and protease inhibitors.

[0045] The protein drug used was interleukin-2, the absorption aids were taurodeoxycholic acid and lauroylcarnitine, and the protease inhibitor was citric acid.

[0046] The preparation method is as follows:

[0047] 1. Mix evenly 0.5 g of interleukin-2 freeze-dried product, 5 g of taurodeoxycholic acid, 5 g of lauroyl carnitine and 40 g of granulated citric acid. This amount is used to prepare 100 unit doses.

[0048] 2. The medicine prepared above is evenly wrapped in 100 water-soluble capsules according to the conventional process. Capsules can adopt any capsule material that can be dissolved in water in the prior art.

[0049] 3. Preparation of e...

Embodiment 2

[0052] Such as figure 2 As shown, a new oral capsule preparation for the treatment of cancer and AIDS has a multi-layer structure, which consists of a drug layer 1, a water-soluble capsule 2 and an enteric-coated capsule 3 from the inside to the outside. The drug layer 1 is a mixture composed of several small capsules 4 and protease inhibitors 5, and the small capsules are coated with protein drugs and absorption aids.

[0053] The protein drug used was interleukin-2, the absorption aids were taurodeoxycholic acid and lauroylcarnitine, and the protease inhibitor was citric acid.

[0054] The preparation method is as follows:

[0055] 1. Mix 1.0 g of interleukin-2 polypeptide freeze-dried product, 2.5 g of taurodeoxycholic acid and 2.5 g of lauroyl carnitine, and make microcapsules of 100-200 microns by fluidized layer spray coating method. Figure 4 The basic process of the fluidized-bed spray coating method is shown. First use air flow 11 to make the mixture of interleuki...

Embodiment 3

[0059] Such as image 3 As shown, a novel oral capsule preparation for treating cancer and AIDS has a multi-layer structure, including drug layer 1, water-soluble capsule 2 and enteric-coated capsule 3 from inside to outside. The drug layer 1 is a mixture composed of several small capsules 4 and a mixture 6 of protease inhibitors and some absorption aids, wherein the small capsules are coated with protein drugs and the rest of the absorption aids.

[0060] The protein drug used was interleukin-2, the absorption aids were taurodeoxycholic acid and lauroylcarnitine, and the protease inhibitor was citric acid.

[0061] The preparation method is as follows:

[0062] 1. Mix 5 grams of interleukin-2 freeze-dried product, 5 grams of taurodeoxycholic acid and 5 grams of lauroyl carnitine, and make microcapsules of 100-200 microns by fluidized layer spray coating method. Figure 4 The basic process of the fluidized-bed spray coating method is shown. First use air flow 11 to make the...

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Abstract

The invention relates to a novel oral capsule preparation for treating cancer and AIDS. The technical scheme is achieved as follows: the capsule preparation adopts a double-layer capsule structure which is sequentially provided with a medicine layer, a water-soluble capsule and an enteric capsule from inside to outside. The novel oral capsule preparation comprises the following components according to the weight per unit: 5-50mg of protein medicine, 20-150mg of assistant absorbent and 300-600mg of protease inhibitor. The protein medicine is interleukin 2. The assistant absorbent is bezoar deoxycholic acid or lauryl novain. The protease inhibitor is citric acid. The preparation method comprises the following steps: uniformly mixing the protein medicine, the enteric canal assistant absorbent and the protease inhibitor according to a certain proportion; encapsuling the water-soluble capsule in mixture, and then applying the enteric capsule. The invention solves the problem of low absorption rate of the protein medicine, releases the problem that the protein oral medicine is degraded by the protease in the enteric canal and increases the absorption rate of the protein medicine in the enteric canal so as to lead the interleukin 2 oral medicine to be capable of achieving the treatment concentration in the human body.

Description

Technical field: [0001] The invention relates to the field of medicines, in particular to a novel capsule oral preparation of polypeptide drugs with a double-layer or multi-layer structure for treating cancer, AIDS and other infectious diseases. Background technique: [0002] Interleukin 2 (IL-2, interleukin 2) is a cytokine secreted by cells such as CD4+ and CD8+ T cells. Its function is to stimulate immune cells, including T-cells, NK cells (natural killer cells, natural killer cells), LAM (lymphokine activated killer cells) and so on. The stimulated cell activity is enhanced, the growth period is prolonged, and the body's ability to resist bacteria, viruses, and tumors is greatly enhanced. Interleukin 2 can also induce T cells to secrete IFN-γ, TNF, CSF and other cytokines, further amplifying their ability to resist infectious diseases and tumors. The amino acid sequence of mature IL-2 is as follows: [0003] 1 0 2 0 3 0 4 0 ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K38/20A61K47/28A61K47/18A61K47/12A61P35/00A61P31/18
Inventor 单宝华蔺新力
Owner 单宝华
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