High-bioavailability pidotimod oral liquid preparation and preparation method thereof

A technology for oral liquid and liquid preparation of domoda is applied in the field of oral liquid preparation of high bioavailability pidotimod and its preparation, which can solve the problems of low bioavailability and the like, achieve high blood drug concentration, stable storage, The effect of improving bioavailability

Active Publication Date: 2016-05-04
SUZHOU SIXTH PHARMA PLANT OF JIANGSU WUZHONG PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Therefore, the technical problem to be solved by the present invention is to overcome the low bioavailability defect of pidotimod oral solution preparations in the prior art, thereby providing a sugar-free product with high bioavailability, good stability and good taste. pidotimod oral solution

Method used

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  • High-bioavailability pidotimod oral liquid preparation and preparation method thereof
  • High-bioavailability pidotimod oral liquid preparation and preparation method thereof
  • High-bioavailability pidotimod oral liquid preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] The oral liquid preparation of high bioavailability pidotimod of the present invention, prescription comprises,

[0039]

[0040] Add 50% of the prepared water, add 2500g of sodium caprate and 2500g of sorbitol and stir to dissolve, then add 400g of pidotimod, stir and dissolve, let stand for 10 minutes, then add 3g of disodium edetate, trimethylol Aminomethane 193g, sodium hydroxide 3g, sodium chloride 6g, stevioside 12g, food essence 4g, stir while adding, above-mentioned substances are fully dissolved, stir evenly, use 10wt% sodium hydroxide to fine-tune the pH value to 6.0-6.5, add purified water to 10000ml, stir well, filter with filter element, fill, and sterilize to prepare pidotimod oral liquid preparation with a specification of 0.4g / 10ml.

Embodiment 2

[0042] The oral liquid preparation of high bioavailability pidotimod of the present invention, prescription comprises,

[0043]

[0044]

[0045]Add 50% of the prepared water, add 2250 g of sodium caprate and 2750 g of sorbitol and stir to dissolve, then add 400 g of pidotimod, stir and dissolve, let stand for 15 minutes, then add 2 g of disodium edetate, 1 g of glycerin, Tris 200g, stevioside 3g, aspartame 5g, food essence 5g, stir while adding, the above-mentioned substances are fully dissolved, stir well, fine-tune the pH value to 7.0 with 10wt% sodium hydroxide ~7.5, add purified water to 10000ml, stir well, filter with a filter element, fill, and sterilize to prepare a pidotimod oral liquid preparation with a specification of 0.4g / 10ml.

Embodiment 3

[0047] The oral liquid preparation of high bioavailability pidotimod of the present invention, prescription comprises,

[0048]

[0049]

[0050] Add 50% of the prepared water, add sodium caprate 2000g, sorbitol 3000g to it and stir to dissolve, then add pidotimod 400g, stir and dissolve, let it stand for 15 minutes, then add calcium sodium edetate 2g, glycerin 1g, 180g of trishydroxymethylaminomethane, 6g of sodium hydroxide, 5g of sodium chloride, 10g of natural fruit flavor, 5g of essence for food, stir while adding, make the above-mentioned substances fully dissolve, stir evenly, add 10wt% sodium hydroxide Fine-tune the pH value to 6.0-6.5, add purified water to 10000ml, stir well, filter with a filter element, fill, and sterilize to prepare a pidotimod oral liquid preparation with a specification of 0.4g / 10ml.

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Abstract

The invention discloses a high-bioavailability pidotimod oral liquid preparation and a preparation method thereof. The oral liquid preparation is prepared from the following components in parts by weight: 300 to 500 parts of pidotimod, 2000 to 8000 parts of absorption promoting stabilizer, 1 to 4 parts of chemical stabilizer, and 150 to 250 parts of pH regulator, wherein the absorption promoting stabilizer is prepared from sodium caprate and sorbitol, and the mass ratio of the sodium caprate to the sorbitol is (1-4):(1-4). According to the oral liquid preparation disclosed by the invention, the content of the components such as the pidotimod, the absorption promoting stabilizer, a carrier, the chemical stabilizer, the pH regulator and the like is reasonably designed, the synergistic effect of all the components is achieved, the high-bioavailability is provided for a main drug pidotimod, which is beneficial to a pH value environment of storage of the pidotimod, so that the pidotimod has higher plasma concentration in vivo, the bioavailability of the pidotimod is improved, and meanwhile the oral liquid preparation is enabled to have extremely high stability, and can be stably stored.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an oral liquid preparation of pidotimod with high bioavailability and a preparation method thereof. Background technique [0002] Pidotimod is a safe and effective immune function enhancer, which can promote both specific immune response and non-specific immune response. Both animal experiments and clinical experiments have shown that although pidotimod has no direct antibacterial and antiviral activity, it can significantly exert its therapeutic effect on bacteria (pneumococcus, Escherichia coli, Pseudomonas aeruginosa, Proteus, etc.) Etc.), fungus, virus (influenza virus, herpes simplex virus, myocarditis virus and Menge virus, etc.) infection. Therefore, it can be used for patients with recurrent upper and lower respiratory tract infection, otitis media, urinary system infection and gynecological infection whose cellular immune function is suppressed. It can effecti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/05A61K31/427A61K9/08A61K47/12A61K47/26A61K47/18A61K47/02A61K47/46A61P37/04
CPCA61K9/0053A61K9/08A61K31/427A61K38/05A61K47/02A61K47/12A61K47/18A61K47/183A61K47/26A61K47/46
Inventor 王丹梅黄春荣相宇孙田江冯志英高怡蓉汤德华杨南林
Owner SUZHOU SIXTH PHARMA PLANT OF JIANGSU WUZHONG PHARMA GROUP
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