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Refining method of sodium carboxymethylcellulose for injection routes

A technology of carmellose sodium and carmellose, which is applied in the field of medicine, can solve problems such as poor patient compliance, low viscosity, and difficult injections, and achieve the effects of reduced synthetic by-products, simple refining methods, and rapid dissolution

Active Publication Date: 2021-04-06
ZHEJIANG SUNDOC PHARMA SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] However, the commercially available carmellose sodium in Ashland has the following problems: (1) the carmellose sodium circulating on the market is all non-injectable carmellose sodium, and in principle even the pharmaceutical grade auxiliary materials cannot be directly applied In the injection medium, it needs to be refined to remove by-products, insoluble fibers, etc., so as to improve its quality for injection; (2) Ashland's carmellose sodium is not easy to disperse in aqueous solution and dissolves slowly, and it takes a long time Stirring or swelling can disperse and dissolve evenly. It usually takes 2-4 hours, and some even need 16-24 hours. It is inconvenient to use.
[0010] CN104761647B discloses a preparation method of instant grade carmellose sodium, which adopts ethylene glycol as a surfactant to endow the product with instant dissolving characteristics, thereby solving the problem that carmellose sodium is very easy to cluster during use so that the dissolution time long question
However, the introduction of diethyl ether makes carmellose sodium excipients not suitable for the field of medicine
[0011] CN110483808A discloses a method for rapidly dissolving carmellose sodium, which is first soaking and dispersing carmellose sodium by ethylene carbonate, and then dissolving in deionized water, which can make carmellose sodium dissolve quickly, However, this method is only applicable to the technical field of lithium electronic battery preparation, and is not suitable for the field of medicine.
But its purification yield is low, and economic efficiency is relatively poor, only 50~60%, and this is because the carmellose sodium of its low molecular weight can not separate out completely in the purification process, so the purification steps disclosed in this patent The side effect of viscosity is particularly obvious. After the practice of our team, we found that the viscosity of the 2% sodium carboxymethylcellulose aqueous solution after purification has doubled compared with that before purification, so the refining method mentioned in the patent has changed the product. key attributes of
Especially for injection excipients, low-viscosity products (30-60cp) are required, and the viscosity range of injection solvents is required to be narrow. If the viscosity is too high, it will cause injection difficulties and poor patient compliance. If the viscosity is too low, good particle suspension effect cannot be achieved.

Method used

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  • Refining method of sodium carboxymethylcellulose for injection routes
  • Refining method of sodium carboxymethylcellulose for injection routes
  • Refining method of sodium carboxymethylcellulose for injection routes

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Disperse 2.00kg carmellose sodium in 4.00kg ethanol, stir and disperse to make carmellose sodium fully wet, then add carmellose sodium ethanol dispersion to 40.00kg water to obtain carboxymethylcellulose with a certain viscosity Sodium carmellose ethanol-water solution; the above-mentioned carmellose sodium ethanol-water solution is evenly dispersed into 675L pure ethanol in the precipitation tank at a rate of 500mL / min, and the carmellose sodium precipitate is obtained on the 38 μm sieve of the precipitation tank; Transfer the above precipitate to the cleaning tank in pure ethanol for cleaning, and collect it again through a 38 μm sieve; vacuum-dry the carmellose sodium precipitate from which ethanol and water have been removed at 35°C for 24 hours, take out the dried product, and preliminarily adjust Store in a sealed bag after pelleting to obtain 1.98kg of carmellose sodium.

[0058] Among them, such as figure 1 As shown, the height-to-diameter ratio of the above se...

Embodiment 2

[0061] Disperse 1.50kg carmellose sodium in 2.50kg ethanol, stir and disperse to make carmellose sodium fully wet, then add carmellose sodium ethanol dispersion to 20.00kg water to obtain carboxymethylcellulose with a certain viscosity Sodium methylcellulose ethanol-water solution; the above-mentioned sodium carmellose ethanol-water solution is uniformly dispersed in 400L pure ethanol in the precipitation tank at a rate of 150mL / min, and sodium carmellose precipitate is obtained on the 72 μm sieve of the precipitation tank; Transfer the above precipitates to the cleaning tank in pure ethanol for cleaning, and collect them again through a 72 μm sieve; vacuum-dry the carmellose sodium precipitates from which ethanol and water have been removed at 40°C for 10 hours, take out the dried product, and preliminarily adjust Store in a sealed bag after pelleting to obtain 1.46 kg of carmellose sodium.

Embodiment 3

[0063] Disperse 2.00kg carmellose sodium in 4.00kg ethanol, stir and disperse to make carmellose sodium fully wet, then add carmellose sodium ethanol dispersion to 40.00kg water to obtain carboxymethylcellulose with a certain viscosity Sodium methylcellulose ethanol-water solution; the above-mentioned sodium carmellose ethanol-water solution is uniformly dispersed in 450L pure ethanol in the precipitation tank at a rate of 600mL / min, and sodium carmellose precipitate is obtained on the 38 μm sieve of the precipitation tank; Transfer the above precipitate to the cleaning tank in pure ethanol for cleaning, and collect it again through a 38 μm sieve; vacuum-dry the carmellose sodium precipitate from which ethanol and water have been removed at 35°C for 24 hours, take out the dried product, and preliminarily adjust Store in a sealed bag after pelleting to obtain 1.90 kg of carmellose sodium.

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Abstract

The invention relates to the technical field of medicines, and discloses a refining method of sodium carboxymethyl cellulose for injection routes, which comprises the steps of dispersion, dissolution, alcohol precipitation, washing and drying. By refining the sodium carboxymethyl cellulose, the sodium carboxymethyl cellulose which meets the standard of auxiliary materials for injection, is fluffy and soft and has quick solubility can be obtained at a high yield; the aqueous solution is clear and transparent, does not contain visible foreign matters or color substances, the synthetic by-product is remarkably reduced, the solubility is remarkably improved, the viscosity of the product is basically not changed, and the product can be directly applied to the field of pharmaceutical injections with strict requirements on auxiliary materials.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a method for refining carmellose sodium for injection. Background technique [0002] Sodium carboxymethylcellulose (CMC) is a water-soluble fiber derivative made from natural fiber, which is alkalized and etherified with chloroacetic acid under alkaline conditions. Sodium carboxymethylcellulose has many properties , can be used as binder, emulsifier, thickener, film-forming agent, dispersant and drug carrier, etc. It is widely used in various industries, such as textile, paper, food, beverage, daily use, medicine, natural gas extraction, etc. . However, due to the different requirements for the properties of carmellose sodium in various industries, especially in the field of pharmaceutical injections, the requirements for the indicators of auxiliary materials are very strict, and the preparation of injection grade carmellose sodium is very important for expanding and extending ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B11/12C08B11/22
CPCC08B11/12C08B11/22
Inventor 于崆峒蒋朝军孙亚厅刘洁杰荆志宇
Owner ZHEJIANG SUNDOC PHARMA SCI & TECH CO LTD