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Dispersible tablet of pidotimod and its preparing process and use

A technology of pidotimod and dispersible tablets, which is applied in the pharmaceutical field to achieve the effects of good dispersion state, fast absorption and rapid drug dissolution

Inactive Publication Date: 2007-08-08
山东益康药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] However, the dosage forms of pidotimod for clinical application are only ordinary tablets, oral solutions and granules. In order to increase the choice of clinical application, we have developed pidotimod dispersible tablets

Method used

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  • Dispersible tablet of pidotimod and its preparing process and use

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Embodiment 1: the preparation method of pidotimod dispersible tablet

[0052] (1) According to the optimal prescription quantity provided by the present invention, all raw materials and auxiliary materials are accurately weighed, and the raw materials are pulverized through a 100 mesh sieve; when making wet granules, pass through a 30 mesh sieve and granulate with a 30 mesh sieve.

[0053] (2) Microcrystalline cellulose and low-substituted hydroxypropyl cellulose disintegrants and fillers are used, and the method of internal and external addition is used to improve the disintegration speed of the tablet and the dissolution rate of pidotimod. Crystalline cellulose and low-substituted hydroxypropyl cellulose are divided into internally added and externally added parts, and the ratio of internally added to externally added is 2:1 by weight.

[0054] (3) Use a 50% ethanol solution of polyvinylpyrrolidone as an adhesive, and the concentration is generally 2% to 10%.

[0055...

Embodiment 2

[0060] Embodiment 2: the preparation of pidotimod dispersible tablet

[0061]1) Accurately weigh all raw materials and auxiliary materials according to the optimal prescription quantity provided by the present invention, the raw materials pass through a 120-mesh sieve, and the auxiliary materials pass through a 100-mesh sieve; wherein microcrystalline cellulose and low-substituted hydroxypropyl cellulose are divided into internally added and The external part, microcrystalline cellulose and low-substituted hydroxypropyl cellulose internal and external parts are weighed separately, and marked; the ratio of microcrystalline cellulose and low-substituted hydroxypropyl cellulose internal and external parts is 3 : 1, weight ratio;

[0062] 2) Put the pidotimod raw materials and all the internally added auxiliary materials in a mixer and mix them uniformly; add an appropriate amount of 50% ethanol solution of 5% polyvinylpyrrolidone, continue mixing, and make a suitable soft materia...

Embodiment 3

[0066] Embodiment 3: Orthogonal experiment

[0067] Get 40g of pidotimod and pharmaceutical excipients (excipients refer to microcrystalline cellulose, low-substituted hydroxypropyl cellulose, polyvinylpyrrolidone), with the amount of microcrystalline cellulose, low-substituted hydroxypropyl cellulose, polyethylene The concentration of pyrrolidone and the ratio of internal and external excipients (the ratio of internal and external excipients is 2:1) were factors, and three levels were designed for screening. The results are shown in Table 1.

[0068] Table 1. Four-factor three-level table for prescription optimization

[0069]

[0070] Wherein, the amount of microcrystalline cellulose and low-substituted hydroxypropyl cellulose is the total weight, and the ratio of internal and external auxiliary materials is 2:1.

[0071] Get pidotimod and auxiliary materials, cross 100 mesh sieves, according to the orthogonal test table, accurately weigh all raw materials, wherei...

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Abstract

The invention relates to a method for preparing pidomud disperser and relative application. The invention comprises the active components as pidomud, adhesive, disintegration agent, stuff, and lubricant and sweat agent. The invention also provides relative preparation and application. The inventive disperser has better disperse state, short disintegration time and quick release, or the like, while it can be orally taken, eaten or mixed in water.

Description

technical field [0001] The invention belongs to the field of pharmacy and relates to pidotimod dispersible tablets and a preparation method and application thereof. Background technique [0002] Pidotimod is a newly synthesized immunomodulator whose structure is similar to dipeptide. Pharmacodynamic studies have shown that pidotimod is an immune enhancer, which can promote both non-specific and specific immune responses. Animal experiments and clinical trials have shown that although pidotimod has no direct antibacterial and antiviral activity, it can play a significant role in treating bacterial and viral infections by promoting the body's immune function. Animals infected with bacteria such as Bacillus have a strong protective effect, and can significantly prolong the survival time of animals infected with Mengo virus, herpes virus and influenza A virus. Clinically, pidotimod is used to treat patients with recurrent respiratory tract infections, recurrent ear, nose and t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/427A61P37/04
Inventor 高肇林张兴柱满其永史永强
Owner 山东益康药业股份有限公司
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