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Oral isoprinosine preparation and preparation method thereof

A technology for isoproinosine and oral preparations, which is applied in the field of oral preparations of isoproinosine, can solve the problems of low dissolution rate and bioavailability, poor stability, influence on curative effect, etc., and achieves accelerated and stable disintegration and dispersion speed. High performance and improved bioavailability

Active Publication Date: 2015-02-11
北京赛而生物药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But because isoprinosine has stronger hygroscopicity, thereby tablet and capsule all have the shortcoming of poor stability, and existing isoprinosine preparation all exists to disintegrate slowly, dissolution rate and bioavailability are low, thereby Issues Affecting Treatment

Method used

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  • Oral isoprinosine preparation and preparation method thereof
  • Oral isoprinosine preparation and preparation method thereof
  • Oral isoprinosine preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Synthetic isoprinosine, concrete operation is as follows:

[0046] 1. In a 100L reaction kettle, add 25.65kg of p-acetamidobenzoic acid, add 39.6L of absolute ethanol to dissolve, add dropwise 16.35kg of dimethylaminoisopropanol, and the reaction is exothermic. React at 40°C to 50°C for 2 hours. Cool, separate, wash with ethyl acetate, and dry to obtain a white crystalline powder. Recrystallize with mixed solvents. Obtain 37.5kg, yield 92.6%. That is, dimethylaminoisopropanol-p-acetamidobenzoate, with a melting point of 146-148°C.

[0047] 2. In a 100L reaction kettle, add 12.3kg of dimethylaminoisopropanol-p-acetamidobenzoate prepared in step 1, and add 24.0L of ethanol to dissolve. Take 3.9kg of inosine, dissolve it in 7.8L of water and add it. Evaporate to dryness under reduced pressure with stirring. Add ethyl acetate for azeotropic dehydration until anhydrous and distill out, suspend, separate, wash, and dry to obtain 16.1 kg of white solid powder with a reac...

Embodiment 2

[0062] 1. Prescription

[0063]

[0064] 2. Preparation process

[0065] The raw materials and auxiliary materials are respectively pulverized through a 120-mesh sieve, and the prescription amount of raw materials and auxiliary materials is taken, and fully mixed evenly. Add binder to make soft material, granulate with 20-mesh screen, ventilate and dry at 60°C, granulate with 16-mesh screen, coat the granules with moisture-proof coating powder, control the pot temperature at 45-55°C, The rotating speed of the pot is controlled at 40-50rpm, according to the weight gain of the particles by 11%, the concentration is 15% alcohol-soluble coating solution, and the liquid is sprayed and coated at an appropriate flow rate. After the coating is finished, it is dried, and the obtained particles can be directly Pack into capsules or bags to make granules, or add appropriate amount of lubricant to compress into tablets.

Embodiment 3

[0067] 1. Prescription

[0068]

[0069]

[0070] 2. The preparation process is the same as in Example 2.

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Abstract

The invention provides an oral isoprinosine preparation. The preparation comprises isoprinosine, a disintegrating aid, a disintegrating agent and an adhesive which are used as raw materials, wherein the weight ratio of the isoprinosine, the disintegrating aid to the disintegrating agent is 1:(0.1-0.2):(0.08-0.2). The oral preparation is quick in disintegration and dissolution and high in stability.

Description

[0001] This application is a divisional application for the parent application (application number: 2009100818724, invention name: a preparation method of isoprinosine and its oral preparation) technical field [0002] The invention relates to a preparation method of isoprinosine. [0003] The present invention also relates to an oral preparation of isoprinosine. Background technique [0004] Isoprinosine is a complex of inosine and dimethylaminoisopropanol-acetamidobenzoate (1:3). [0005] This product has been marketed in more than 50 countries and regions including Europe, Italy, Canada, Japan, etc. It has remarkable clinical curative effect and little side effects. It is an antiviral and immune function modulator with definite curative effect. Isoprinosine is an antiviral drug, which has curative effect on human herpes, influenza and rhinovirus infection. It is effective for patients with herpes simplex virus infection. It is believed that the antiviral efficacy of th...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K31/7076A61P31/14A61P31/16A61P31/22A61P37/04
Inventor 马骉温冬焱孙爽栾美丽喻赞伟
Owner 北京赛而生物药业有限公司
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