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Pidotimod effervescent tablet and preparation method thereof

A technology of pidotimod and effervescent tablets, applied in the field of pharmaceutical preparations, can solve the problems of low bioavailability, and achieve the effects of easy patient acceptance, good quality stability, and wide application

Inactive Publication Date: 2017-11-24
SUZHOU XINEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the technical problem to be solved in the present invention is to overcome the low bioavailability defect of pidotimod preparations in the prior art, thereby providing a new dosage form with high bioavailability, good stability and good taste

Method used

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  • Pidotimod effervescent tablet and preparation method thereof
  • Pidotimod effervescent tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Embodiment 1: 1000 pieces of specifications

[0037] prescription:

[0038] Pidotimod 380g

[0039] Microcrystalline Cellulose 150g

[0040] Lactose 50g

[0041] Citric acid 20g

[0042] Sodium bicarbonate 130g

[0043] Sodium chloride 15g

[0044] Stevia 8g

[0045] food flavor 6g

[0046] Magnesium stearate 8g

[0047] 8% PVPK30 aqueous solution appropriate amount

[0048] Preparation method:

[0049] (1) Weigh the prescribed amount of pidotimod, microcrystalline cellulose, and lactose through an 80-mesh sieve and mix evenly;

[0050] (2) Add sodium chloride to 8% PVPK30 aqueous solution, and then add to the above powder to make soft material;

[0051] (3) Pass the soft material through a 24-mesh sieve to make granules;

[0052] (4) Put the plate into a drying oven at 60°C to dry after laying the tray, and take it out after measuring the moisture content;

[0053] (5) Add citric acid, sodium bicarbonate, stevia, food flavor, magnesium stearate and mix eve...

Embodiment 2

[0055] Embodiment 2: 1000 pieces of specifications

[0056] prescription:

[0057] Pidotimod 400g

[0058] Microcrystalline Cellulose 150g

[0059] Mannitol 50g

[0060] Citric acid 22g

[0061] Sodium bicarbonate 143g

[0062] Sodium chloride 15g

[0063] Aspartame 8g

[0064] food flavor 6g

[0065] Magnesium stearate 8g

[0066] 8% PVPK30 aqueous solution appropriate amount

[0067] Preparation method:

[0068] (1) Weigh the prescribed amount of pidotimod, microcrystalline cellulose, and mannitol and pass through an 80-mesh sieve and mix evenly;

[0069] (2) Add sodium chloride to 8% PVPK30 aqueous solution, and then add to the above powder to make soft material;

[0070] (3) Pass the soft material through a 24-mesh sieve to make granules;

[0071] (4) Put the plate into a drying oven at 60°C to dry after laying the tray, and take it out after measuring the moisture content;

[0072] (5) Add citric acid, sodium bicarbonate, aspartame, food flavor, magnesium ste...

Embodiment 3

[0074] Embodiment 3: 1000 pieces of specifications

[0075] prescription:

[0076] Pidotimod 420g

[0077] Mannitol 150 g

[0078] Lactose 50g

[0079] Citric acid 21g

[0080] Sodium bicarbonate 136.5g

[0081] Sodium chloride 15g

[0082] Stevia 8g

[0083] food flavor 6g

[0084] Talc powder 8 g

[0085] 8% PVPK30 aqueous solution appropriate amount

[0086] Preparation method:

[0087] (1) Weigh the prescribed amount of pidotimod, mannitol, and lactose through an 80-mesh sieve and mix evenly;

[0088] (2) Add sodium chloride to 8% PVPK30 aqueous solution, and then add to the above powder to make soft material;

[0089] (3) Pass the soft material through a 24-mesh sieve to make granules;

[0090] (4) Put the plate into a drying oven at 60°C to dry after laying the tray, and take it out after measuring the moisture content;

[0091] (5) Add citric acid, sodium bicarbonate, stevia, food flavor, talcum powder and mix evenly, measure the content of intermediates;

...

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Abstract

The invention discloses a pidotimod effervescent tablet and a preparation method thereof. The pidotimod effervescent tablet comprises the following components in parts by weight: 300 to 500 parts of pidotimod, 100 to 400 parts of filling agent, 100 to 200 parts of effervescent disintegrating agent, 5 to 15 parts of essence, 6 to 10 parts of lubricant, and a proper amount of adhesive. The preparation method comprises the following steps: weighing pidotimod and a filling agent according to abovementioned formula, sieving pidotimod and the filling agent by an 80-mesh sieve, evenly mixing, adding sodium chloride into a PVPK30 water solution (8%), then adding the solution into powder to prepare a soft material, sieving the soft material by a 24-mesh sieve, preparing granules, paving the granules on a disc, drying the granules in a drying box at a temperature of 60 DEG C, taking out the granules until the water content of the granules is qualified, adding an effervescent disintegrating agent, a flavoring agent, and a lubricant, evenly mixing, measuring the intermediate content, pressing the mixture to obtain tablets, and finally carrying out detection and packaging. The provided pidotimod effervescent tablet and the preparation method have the advantages that the concentration of pidotimod in the blood of human body is high, the bioavailability of pidotimod is increased, at the same time, the stability of the pidotimod effervescent tablet is very high, and the pidotimod effervescent tablet can be stored stably.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a pidotimod effervescent tablet 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. 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 effectively reduce the frequency and degree of...

Claims

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Application Information

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IPC IPC(8): A61K9/46A61K38/05A61K31/427A61K47/12A61K47/02A61K47/38A61K47/32A61P37/04A61P31/10A61P31/04A61P31/12
CPCA61K38/05A61K9/0007A61K9/0095A61K9/2013A61K9/2027A61K9/2054A61K31/427
Inventor 居丽娜
Owner SUZHOU XINEN PHARMA
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