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Tetrodotoxin oral preparation, tetrodotoxin freeze-dried tablet and application of tetrodotoxin oral preparation

A technology for tetrodosine and oral preparations, applied in the field of oral preparations of tetrodosine, can solve the problems of not being able to show the antitumor effect of tetrodoxine, and that the drug concentration cannot reach the in vitro concentration.

Pending Publication Date: 2021-04-27
江苏宏锦天药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Although the researchers mentioned that tetradoxine may inhibit the growth of tumor cells, it was only an in vitro experiment, and the drug concentration in vivo could not reach the in vitro concentration designed for the experiment.
And tetradosin is only used as one of the drug prescriptions, and Atractylodes macrocephala, turmeric, etc. all have anti-tumor effects, so it does not mean that tetradosin itself has tumor growth inhibitory or anti-tumor effects

Method used

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  • Tetrodotoxin oral preparation, tetrodotoxin freeze-dried tablet and application of tetrodotoxin oral preparation
  • Tetrodotoxin oral preparation, tetrodotoxin freeze-dried tablet and application of tetrodotoxin oral preparation
  • Tetrodotoxin oral preparation, tetrodotoxin freeze-dried tablet and application of tetrodotoxin oral preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] Embodiment 1: Preparation of freeze-dried material of tetradosin and stabilizer lactose (abbreviated as tetradosin freeze-dried material)

[0069]

[0070] 1) Weigh 2200g of lactose, add 16kg of water, stir to dissolve.

[0071] 2) Weigh 42 g of citric acid and 58 g of sodium citrate, add 20 kg of water, stir to dissolve, and measure the pH to be 4.5 to 4.6; add 4.0 g of tetrodocine, stir to dissolve.

[0072] 3) Mix the above two solutions evenly, and the measured pH should be 4.5-4.9; add about 4kg of water to a total weight of about 43kg.

[0073] 4) The above-mentioned mixed solution is divided into containers, placed in a lyophilizer, and freeze-dried to obtain a tetradosin freeze-dried material.

Embodiment 2

[0074] Embodiment 2: preparation tetradoxine tablet

[0075]

[0076] 1) Take the above-mentioned prescription amount of tetradosin freeze-dried material, pass through a 24-mesh sieve, and set aside.

[0077] 2) Take the pregelatinized starch of the above prescription amount, pass through an 80-mesh sieve, add 8% starch slurry and use a 16-mesh sieve to make wet granules; after drying at 80°C, sieve the granules with a 24-mesh sieve for later use.

[0078] 3) Mix the above-mentioned two kinds of granules with the prescription amount of povidone K30 and magnesium stearate evenly, and compress into tablets (0.5g / tablet) to obtain 1000 tablets of tetrodosin tablets.

Embodiment 3

[0079] Embodiment 3: Preparation of Tetradosin Lyophilized Tablets

[0080]

[0081] 1) Take the citric acid, sodium citrate, lactose, mannitol, and sodium alginate in the above prescription amount, add them to the fully dissolved xanthan gum solution, mix well, and then add the above prescription amount of tetradol Simultaneously mix well to form a homogeneous solution.

[0082] 2) After degassing the above solution, pour it into the mold accurately; pre-freeze at -40°C to -170°C for 1 to 60 minutes, then transfer it to a lyophilizer. Freeze-drying at -30°C for 1 hour to 10 hours can give Tetradosin freeze-dried tablets.

[0083] In the above method, after the pre-freezing step, before transferring to the lyophilizer, an ice crystal incubation step can also be added, that is, the mold filled with the solution after pre-freezing is placed in a low-temperature environment of -5°C to -60°C for 0.5h to 15h.

[0084] The freeze-dried tablet prepared by this method disinteg...

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Abstract

The invention discloses a tetrodotoxin oral preparation, a tetrodotoxin freeze-dried tablet and application of the tetrodotoxin oral preparation. The tetrodotoxin oral preparation comprises an active component, a stabilizer and auxiliary additive components, wherein the active component is tetrodotoxin; the stabilizer comprises one or more of lactose, sucrose and glucose; and the auxiliary additive components include pharmaceutically acceptable auxiliary materials or carriers. The tetrodotoxin oral preparation disclosed by the invention can be suitable for various solid tumors and blood tumors, has the characteristics of being convenient to take orally and use, definite in curative effect, slight in side reaction, high in patient compliance and the like, effectively prolongs the lifetime of tumor patients, and improves the life quality of the patients.

Description

technical field [0001] The present application relates to the technical field of medical research and development, and more specifically, relates to an oral preparation of tetradosin, freeze-dried tablets of tetradosin and their application in the field of tumor treatment. Background technique [0002] The research trend of modern tumor drugs is the transition from traditional treatment to modern treatment and prevention. Traditional treatments directly attack rapidly proliferating tumor cells. Its action is characterized by non-specificity, targeting all cells. Modern treatment is a biological, immune, and molecular targeted therapy. This kind of targeted therapy is targeted therapy for specific tumors, and targeted therapy for molecules. In addition, the role of prevention is now being emphasized, including chemopreventive drugs. The occurrence of cancer is a chronic process. From normal to dysplasia and then to cancer, a series of genes and cytokines have regulatory e...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/529A61K47/38A61K47/36A61K47/26A61K47/42A61K47/32A61K47/02A61K47/04A61P35/00
CPCA61K9/0056A61K9/2018A61K9/2054A61K9/205A61K9/2027A61K9/2009A61K9/2095A61K9/2063A61K31/529A61P35/00
Inventor 宣坚钢李天山
Owner 江苏宏锦天药业有限公司
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