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Method for preparing injection of sodium ferulate

A technology of sodium ferulate and injection, applied in the new field of medicine, can solve the problems of poor sterility assurance level, unstable and unreachable sodium ferulate injection, etc.

Inactive Publication Date: 2010-07-07
BEIJING HOPE HUGE PHARM SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Sodium ferulate injections currently on the market are not very stable, and the sterilization parameters used at the same time are not ideal
At present, there are many manufacturers with approval documents for this variety, but they are able to produce, and the level of sterility assurance is relatively poor, especially for 100ml and 250ml infusions, the current sterilization level is very low, and it is almost impossible to reach the level of F0 value > 8

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1: 100 bottles of specifications

[0029] 1. Prescription:

[0030] Sodium Ferulate 300g

[0031] Propylene glycol 30g

[0032] Methionine 50g

[0033] Sodium metabisulfite 50g

[0034] Sodium Calcium Oxalate Tetraacetate 5g

[0035] Sodium chloride 90g

[0036] Add water for injection to 10000ml

[0037] 2. Preparation method:

[0038] a) Add sodium chloride, sodium pyrosulfite, calcium sodium oxalate tetraacetate, propylene glycol, and methionine in the prescribed amount into 80% water for injection (after cooling down), and stir to dissolve.

[0039] b) After filling the above solution with nitrogen saturation, add the prescribed amount of sodium ferulate and stir to dissolve, and place it at room temperature (keep filling with nitrogen during the operation).

[0040] c) Keep filling with nitrogen, add 1.5g of activated carbon for adsorption for 30 minutes, decarburize, add water for injection filled with nitrogen to the full amount.

[0041] d) D...

Embodiment 2

[0044] Embodiment 2: 2000 specifications

[0045] prescription:

[0046] Sodium Ferulate 200g

[0047] Propylene glycol 20g

[0048] Methionine 40g

[0049] Sodium metabisulfite 40g

[0050] Calcium Sodium Oxalate Tetraacetate 3g

[0051] Add water for injection to 10000ml

[0052] Preparation method:

[0053] 1. Add sodium metabisulfite, calcium sodium oxalate tetraacetate, propylene glycol, and methionine into 80% water for injection and stir to dissolve.

[0054] 2. After filling the above solution with nitrogen gas saturation, add the prescribed amount of sodium ferulate and stir to dissolve, and place it at room temperature (the nitrogen gas should always be filled during the operation and should go deep under the liquid surface).

[0055] 3 Keep filling with nitrogen, add 1.5g of activated carbon to absorb for 30 minutes, decarburize, add water for injection saturated with nitrogen to the full amount.

[0056] 4 Filling, filling with nitrogen, stoppering and capp...

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PUM

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Abstract

The invention discloses a method for preparing an injection of sodium ferulate, belongs to the field of industrialized production of medicaments and relates to an injection of sodium ferulate. The method is characterized in that: the injection contains sodium ferulate, propylene glycol, amino acid and derivatives thereof and sodium metabisulfite. The invention discloses a method for preparing the injection of sodium ferulate, which is characterized in that the injection contains sodium ferulate, propylene glycol, methionine and sodium metabisulfite in a weight ratio of 1.0:0.05-5.0:0.01-5.0:0.01-1.0.

Description

technical field [0001] The invention belongs to the field of new medicine technology, and relates to a preparation method of sodium ferulate injection, which is used for blood vessels such as arteriosclerosis, coronary heart disease, cerebrovascular disease, glomerular disease, pulmonary hypertension, diabetic vasculopathy, vasculitis, etc. Adjuvant treatment of diseases and leukopenia and thrombocytopenia can also be used for the treatment of migraine and vascular headache. Background technique [0002] Sodium ferulic acid is the sodium salt of ferulic acid, its chemical name is 3-methylhydrocinnamic acid sodium, its molecular formula is C10H904Na, and its molecular weight is 216.17. The sodium ferulic acid injection synthesized by modern technology can ensure the purity of medicine Under the premise of the drug, the natural activity of the drug is retained to the greatest extent, so that the effect of promoting blood circulation and removing stasis is more stable and lasti...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/192A61P9/10A61P9/12A61P7/00A61P25/06
Inventor 王翰斌王丹索志新
Owner BEIJING HOPE HUGE PHARM SCI
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