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Dispersing tablet containing tegafur, gimeracil and oteracil potassium

A technology of oteracil potassium and gimeracil, which is applied in the field of western medicine preparations, can solve the problems of increasing the complexity of the process, the inability to ensure the mixing uniformity of tegafur drug-loaded microspheres, and uneven tablet content.

Active Publication Date: 2010-05-26
鲁南新时代生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the process is changed to tablet-coating of drug granules separately, that is to say, if S-1 dispersible tablets are prepared according to this process, tegafur, gimeracil and oteracil potassium need to be prepared into drug-loaded microspheres respectively, This obviously increases the complexity of the process, and more importantly, it cannot guarantee the mixing uniformity between tegafur drug-loaded microspheres, gimeracil drug-loaded microspheres and oteracil potassium drug-loaded microspheres, resulting in different tablets. The content is uneven, especially for drugs for the treatment of gastric cancer such as S-1 compound preparations, dose control is particularly important

Method used

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  • Dispersing tablet containing tegafur, gimeracil and oteracil potassium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Embodiment 1 The preparation of the dispersible tablet containing tegafur, gimeracil and oteracil potassium of the present invention

[0053] 1. Prescription

[0054] Name of raw material Amount / g

[0055]

[0056] Drug-loaded pellets:

[0057] Tegafur 20

[0058] Blank lactose core 40

[0059] Ethanol 200ml

[0060] water 300ml

[0061] Isolation layer:

[0062] Hypromellose 20

[0063] Triacetin 2.5

[0064] Talc 5

[0065] Coating layer:

[0066] Gimeracil 5.8

[0067] Oteracil Potassium 19.6

[0068] Hypromellose 20

[0069] Triacetin 2.5

[0070] Talc 5

[0071] Other accessories:

[0072] Crospovidone 20

[0073] Low-substituted hydroxypropyl methylcellulose 18

[0074] Orange Flavor 2

[0075] Magnesium Stearate 2.5

[0076] Sucrose 15

[0077] Lactose 79.6

[0078]

[0079] A total of 1000 pieces were made

[0080] 2. Preparation process

[0081] (1) The blank lacto...

Embodiment 2

[0088] Embodiment 2 Preparation of dispersible tablets containing tegafur, gimeracil and oteracil potassium of the present invention

[0089] 1. Prescription

[0090] Name of raw material Amount / g

[0091]

[0092] Drug-loaded pellets:

[0093] Tegafur 20

[0094] Blank lactose core 60

[0095] Ethanol 200ml

[0096] water 300ml

[0097] Isolation layer

[0098] Polyvinyl alcohol 20

[0099] Triacetin 2.5

[0100] Talc 5

[0101] Coating layer:

[0102] Gimeracil 5.8

[0103] Oteracil Potassium 19.6

[0104] Polyvinyl alcohol 20

[0105] Triacetin 2.5

[0106] Talc 5

[0107] Other accessories:

[0108] Croscarmellose Sodium 18

[0109] Low-substituted hydroxypropyl methylcellulose 20

[0110] Orange Flavor 2

[0111] Magnesium Stearate 2.5

[0112] Sucrose 15

[0113] Microcrystalline cellulose 59.6

[0114]

[0115] A total of 1000 pieces were made

[0116] 2. The ...

Embodiment 3-6

[0118] Prepare the drug-loaded pellets of tegafur according to the first step in Example 1, then prepare the coating solution according to the ingredients listed in Table 4, coat the tegafur pellets according to the process of Example 1, and press into tablets , the hardness of the dispersible tablet of Example 3-6 is between 45-65N. The weight gain of the isolation layer is 2%, 3%, 4%, and 10% in turn.

[0119] The preparation of table 4 Siggio dispersible tablets

[0120] Ingredients (g)

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Abstract

The invention belongs to the technical field of western medicament preparations, and relates to a dispersing tablet containing tegafur, gimeracil and oteracil potassium, in particular to a novel tegafur dispersing tablet containing a drug bearing microsphere. The drug bearing microsphere consists of tegafur drug bearing micro-pills, an isolating layer, and a coating layer containing the gimeracil and the oteracil potassium. Through the laminated structure design of the tegafur dispersing tablet, the bitterness of a tegafur basic remedy is successfully covered up, and simultaneously, the stability of a composition of three active components of the tegafur is ensured.

Description

technical field [0001] The invention relates to an oral preparation for treating cancer, in particular to a dispersible tablet containing tegafur, gimeracil and oteracil potassium, and belongs to the technical field of western medicine preparations. Background of the invention [0002] Tegafur (FT, FT207) is one of the pyrimidine anticancer drugs. It is the prodrug of 5-fluorouracil (5-FU), and has inhibitory effect on most solid tumors. In the body, it can interfere and block the biosynthesis of DNA, RNA and protein, thereby producing its anticancer effect. Basic medical research and clinical observation have proved that tegafur has less toxic and side effects, higher chemotherapy index, less effect on immunosuppression and related immune organs, and is a safe drug that can be used continuously in clinical practice. It is mainly used for gastric cancer, biliary tract cancer, rectal cancer, colon cancer, pancreatic cancer, liver cancer, breast cancer, lung cancer and head a...

Claims

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Application Information

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IPC IPC(8): A61K31/53A61K31/513A61K31/4412A61K9/28A61P35/00
Inventor 赵志全郝贵周陈小伟
Owner 鲁南新时代生物技术有限公司
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