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Preparation method of sodium ferulate freeze dried powder injection

A technology for freeze-dried powder injection and sodium ferulate, which is applied in freeze-dried delivery, antidote, powder delivery, etc., and can solve the problem of high unqualified rate of clarity, poor product quality stability, and instability of sodium ferulate, etc. It can achieve good solubility, reduce vascular endothelial damage, and inhibit the synthesis of cholesterol.

Inactive Publication Date: 2006-09-13
巴里莫尔制药(通化)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the sodium ferulate freeze-dried powder injections in the domestic market are produced by many companies, all of which are prepared by traditional techniques. The existing products have poor quality stability, strong liquid irritation, poor solubility, and unqualified rate of clarity. High, pH value drop, content drop, color deepening, curative effect instability and other problems can not be solved
The main reason is that some impurities such as protein and tannin are not completely removed during the preparation process of sodium ferulate, and the instability of sodium ferulate itself causes

Method used

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  • Preparation method of sodium ferulate freeze dried powder injection

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Effect test

Embodiment 1

[0024] A) Take fresh water for injection with a preparation amount of 50%, cool it down to 40° C., feed nitrogen for 30 minutes, add sodium ferulate in the prescription in the dark, stir and dissolve it fully, and filter it with an ultrafiltration membrane with a molecular weight cut-off of 30,000. Filter to obtain an ultrafiltrate.

[0025] B) Preparation of mannitol filtrate: take 10% fresh water for injection, add mannitol in the prescription to dissolve, add 0.5% activated carbon, heat and boil for 15 minutes, circulate and cool the medicinal solution to 40°C, decarbonize and filter with a 0.45 μm filter membrane , and the filtrate is set aside.

[0026] C) Add the above-mentioned ultrafiltrate into the mannitol filtrate, mix evenly, constant volume, and adjust the pH value to 7.0. After the intermediate product is qualified, the liquid is sterilized and filtered through a terminal 0.22 μm filter membrane, and then filled with nitrogen under dark conditions. Filling in vi...

Embodiment 2

[0028] A) Take fresh water for injection with a preparation amount of 80%, cool it down to 20° C., feed nitrogen gas for 10 minutes, add sodium ferulate in the prescription in the dark, stir and dissolve it fully, and filter it with an ultrafiltration membrane with a molecular weight cut-off of 20,000. Filter to obtain an ultrafiltrate.

[0029] B) Preparation of mannitol filtrate: take 30% fresh water for injection, add mannitol in the prescription to dissolve, add 0.1% activated carbon, heat and boil for 30 minutes, circulate and cool the liquid medicine by 50°C, decarbonize and filter with a 0.45 μm filter membrane , and the filtrate is set aside.

[0030] C) Add the above-mentioned ultrafiltrate into the mannitol filtrate, mix evenly, constant volume, adjust the pH value to 7.2, after passing the inspection of the intermediate product, sterilize and filter the medicinal solution through a terminal 0.22 μm filter membrane, and fill it with nitrogen under dark conditions Fi...

Embodiment 3

[0032] A) Take fresh water for injection with a preparation amount of 60%, cool it down to 35° C., feed nitrogen gas for 25 minutes, add sodium ferulate in the prescription in the dark, stir and dissolve it fully, and filter it with an ultrafiltration membrane with a molecular weight cut-off of 10,000. Filter to obtain an ultrafiltrate.

[0033] B) Preparation of mannitol filtrate: take 15% fresh water for injection, add mannitol in the prescription to dissolve, add 0.4% activated carbon, heat and boil for 25 minutes, circulate and cool the medicinal solution to 46°C, decarbonize and filter with a 0.45 μm filter membrane , and the filtrate is set aside.

[0034] C) Add the above-mentioned ultrafiltrate into the mannitol filtrate, mix evenly, constant volume, adjust the pH value to 6.7, after passing the inspection of the intermediate product, sterilize and filter the medicinal solution through a terminal 0.22 μm filter membrane, and fill it with nitrogen under dark conditions ...

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Abstract

A freeze-dried powder injection of sodium ferulate for treating atherosclerosis, coronary heart disease, cerebrovascular disease, glomerulus disease, pulmonary hypertension, vasculitis, etc is prepared from sodium ferulate through ultrafiltration, mixing with filtered mannitol in N2 atmosphere and dark condition, pouring in containers, freeze drying and sealing.

Description

technical field [0001] The present invention relates to a kind of preparation method of sodium ferulate freeze-dried powder injection, specifically, relate to a kind of freeze-dried powder injection with sodium ferulate as the main component, after sodium ferulate is processed by ultrafiltration technology, then It is prepared with mannitol filtrate under the condition of avoiding light and nitrogen gas, filled, freeze-dried, crimped and packaged to make a freeze-dried powder injection finished product, which belongs to the field of chemical preparations. It has been proved by clinical experiments that this product can be injected intravenously, can antagonize non-peptide endothelin receptors, can antagonize endothelin-induced vasoconstriction, boost blood pressure and proliferation of vascular smooth muscle cells, reduce vascular endothelial damage; increase NO synthesis, relax Vascular smooth muscle; inhibit platelet aggregation, anticoagulation, improve hemorheological char...

Claims

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Application Information

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IPC IPC(8): A61K31/192A61K9/19A61P7/02A61P9/10A61P3/06A61P39/06A61P25/06A61P25/04
Inventor 郭智华
Owner 巴里莫尔制药(通化)有限公司
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