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Preparation method of pidotimod injection preparation

A technology of pidotimod and preparations, which is applied in the field of preparation of pidotimod injection preparations, and can solve the problems of no powder injection and sales of injections

Inactive Publication Date: 2010-09-29
南京威尔曼药物研究所有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] At present, the domestic marketed dosage forms mainly include oral solutions, granules, tablets, etc., and there are no sales of powder injections and injections

Method used

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  • Preparation method of pidotimod injection preparation
  • Preparation method of pidotimod injection preparation
  • Preparation method of pidotimod injection preparation

Examples

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Effect test

Embodiment 1

[0016] Example 1: Pidotimod for injection, 200mg specification

[0017] Weigh 300g of mannitol into a suitable container, add 1600ml of water for injection, stir to fully dissolve it; weigh 200g of pidotimod and 100g of trishydroxymethylaminomethane, add it to the above solution, stir to completely dissolve the drug, add water for injection to 2000ml, and the pH value of the solution is about 6.0. Add 2g of activated carbon for needles, stir at room temperature for 15min, decarbonize, filter through 0.45um, 0.22um microporous membranes until clarified, detect the pH value and content of the intermediate solution, and carry out the subpackage-lyophilization operation after determining the subpackage volume ( The freeze-drying process is as follows), and at last it is sealed and capped, and the semi-finished product is packaged after passing the inspection to obtain uniform loose lumps.

[0018]

Embodiment 2

[0019] Embodiment 2: Pidotimod injection, 400mg specification

[0020] Weigh 400g of pidotimod and 200g of Tris, add 5000ml of water for injection, stir to dissolve the drug completely; add 3g of sodium bisulfite and 0.3g of sodium EDTA to dissolve completely, and add water for injection to 6000ml. Add 6g of activated carbon for needles, stir at room temperature for 15 minutes, decarbonize, filter through 0.45um and 0.22um microporous membranes until clarified, the pH value of the intermediate solution is 5.5-6.5, after the content is determined, the filling volume is determined and the potting is brown Ampoule, sterilized at 121°C for 15 minutes to make injection solution.

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Abstract

The invention discloses a preparation method of a pidotimod injection preparation, which is characterized by utilizing alkaline cosolvent tris-hydroxy-methyl-aminomethane to dissolve pidotimod, and has the advantages that the pH value of the solution does not need to be adjusted, an optimal pH value can be obtained after the completeness of the preparation, the operation is convenient and time-saving, and the method is easy for industrialized production.

Description

technical field [0001] The invention belongs to a production method of a freeze-dried preparation for drug injection and an injection, and in particular relates to a method for dissolving pidotimod. Background technique [0002] Pidotimod: [0003] Chemical name: (R)-3-[(S)-(5-oxo-2-pyrrolidinyl)carbonyl]-tetrahydrothiazole-4-carboxylic acid [0004] Chemical Structure: [0005] [0006] Molecular formula: C 9 h 12 N 2 o 4 S [0007] Molecular weight: 244.27 [0008] Pidotimod is a safe and effective immune function enhancer, which is mainly used to fight against bacterial and viral infections, promote non-specific and specific immune responses of the human body, and enable the human body to exert resistance against bacteria and viruses. Although this product has no direct bactericidal and antiviral effects, it can enhance specific and non-specific immune functions. It is suitable for patients with low cellular immunity: such as repeated respiratory tract infectio...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/08A61K38/05A61K47/18A61P37/04
Inventor 任金山霍立茹赵晖张峰
Owner 南京威尔曼药物研究所有限公司
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