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Preparation method of sodium ferulate freeze-dried powder injection

A technology of freeze-dried powder injection and sodium ferulate, which is applied in the direction of freeze-dried transportation, anti-toxic agents, anti-inflammatory agents, etc. It can solve the problems of appearance collapse, poor frozen shape, difficult control of resolubility and clarity, and achieve stability Strong resistance, good resolubility, and loose texture

Inactive Publication Date: 2011-03-30
华北制药集团制剂有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method prepares sodium ferulate freeze-dried powder injection, and its appearance is collapsed, frozen shape is poor, and resolubility and clarity are difficult to control

Method used

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  • Preparation method of sodium ferulate freeze-dried powder injection
  • Preparation method of sodium ferulate freeze-dried powder injection

Examples

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Effect test

Embodiment 1

[0017] Sodium ferulate freeze-dried powder injection 0.15g sodium ferulate in water for injection per 2ml.

[0018] making process:

[0019] a. Add about 80% pre-prepared volume of water for injection into the batching tank, control the water temperature at 20°C, and operate in the dark. Pour nitrogen into the batching tank, add the prescribed amount of sodium ferulate powder, and stir while adding to make it dissolve. During the process, check the pH value to make it between 6.8 and 7.2. Add 0.1% (g / ml) activated carbon for needles to the above solution, and make up the volume with the remaining water for injection. After stirring for 30 minutes, decarbonize by adding filter paper through a plate and frame filter press. The laboratory takes samples, checks the pH value, and performs sterile pressure filtration after passing the test. Filter through a 0.22μm microporous membrane filter in the 100-class clean packaging room, fill the liquid medicine according to the liquid m...

Embodiment 2

[0030] (a) Add about 80% pre-prepared volume of water for injection in the batching tank, control the water temperature at 15°C, add the original powder of sodium ferulate, and check the pH value to make it 6.8; add 0.2% (g / ml) Activated carbon, use the remaining water for injection to make up the volume, stir to decolorize and depyrogenate, filter, test the content, and pack;

[0031] (b) freeze-dry according to the following steps:

[0032] (1) Pre-freezing: place the product on the partition of the freeze-drying box, cool the product to -45°C, and keep it warm for 6 hours;

[0033] (2) Sublimation: raise the temperature of the product to -6°C and keep it warm for 2 hours, then lower it to -40-45°C, and cool the condenser to below -45°C, vacuumize, control the vacuum degree at 10-20pa, and keep it warm for 3 hours ;

[0034] (3) Analytical drying: raise the temperature by 5°C every 1.5 hours until the temperature of the product is about -30°C, then slowly increase the temp...

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Abstract

The invention discloses a preparation method of a sodium ferulate freeze-dried powder injection, comprising the following steps of: (a) firstly, adding water for injection, with the volume being about 80 percent of the pre-compounding volume, into a compounding tank, controlling the water temperature at 15-20 DEG C, adding raw sodium ferulate powder, detecting a pH value, and enabling the pH value to be between 6.8 and 7.2; adding activated carbon, replenishing water to reach a certain volume, stirring, decoloring, removing pyrogen, filtering, detecting the content and split charging; and (b), carrying out freeze drying according to the following steps of, firstly, pre-freezing: placing a product on a clapboard of a freeze drying box, cooling the product to 40-45 DEG C below zero, keeping the temperature for 4-6h; secondly, sublimating: heating the product to 4-6 DEG C below zero, keeping the temperature for 1h, cooling to 40-45 DEG C below zero, and keeping the temperature for 2-3h; and thirdly, separating out and drying. A technical formula of the method does not contain any excipient or other adjuncts and only contains ferulic acid sodium. The prepared preparation has loose texture, good resolubility and strong stability.

Description

Technical field: [0001] The invention relates to a preparation method of medicine, in particular to a preparation method of sodium ferulate freeze-dried powder injection. Background technique [0002] Sodium ferulate is a non-peptide endothelin receptor antagonist, which can antagonize endothelin-induced vasoconstriction, pressurization and vascular smooth muscle cell proliferation, reduce vascular endothelial injury; increase NO synthesis, relax vascular smooth muscle; inhibit platelet aggregation, Anticoagulant, improve hemorheology characteristics. This product can also inhibit the synthesis of cholesterol, lower blood lipids, remove free radicals, prevent lipid peroxidation damage; enhance immune function, and have certain analgesic and antispasmodic effects. [0003] At present, when preparing sodium ferulate freeze-dried powder injection, usually a larger dose of pharmaceutical excipients is added to improve its solubility and product quality. Such as the preparation...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/192A61P7/02A61P9/10A61P3/06A61P39/06A61P37/04A61P29/00
Inventor 宋亮张峰赵辉贾立王志良赵霞路玉锋
Owner 华北制药集团制剂有限公司
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