Etamsylate injection and preparation method thereof

A technology of sulfoethylamine and a manufacturing method, applied in the field of sulfoethylamine injection and its manufacturing, can solve problems such as user's return, unqualified foreign matter, pH instability, etc., to ensure product quality, simple manufacturing steps, and prolonged production. Effect of storage time

Inactive Publication Date: 2017-11-03
BEIJING LISHIDA PHARMA
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  • Abstract
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  • Claims
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Problems solved by technology

[0003] However, after this existing product is stored for several months, the pH instability will occur, resulting in flocs in the product, which will lead to the failure of visible foreign matter
Due to the existence of t

Method used

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  • Etamsylate injection and preparation method thereof

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Embodiment 1

[0052] The manufacture method of the fensulfame injection of the present embodiment, it may further comprise the steps:

[0053] S1: Add 600 ml (milliliters) of water for injection with a predetermined volume into the preparation container, and start stirring;

[0054] S2: Add 125 g of phensulfame into the preparation container;

[0055] S3: Take an appropriate amount of water for injection, dissolve 1.75 g of sodium bisulfite and 0.25 g of sodium sulfite, and prepare a premix;

[0056] S4: adding the premix solution obtained in step S3 into the preparation container;

[0057] S5: Add water for injection to 995ml in the preparation container, adjust the pH value in the preparation container to 4.5-6.0, and keep stirring for a certain period of time; preferably, adjust the pH with sodium hydroxide solution or hydrochloric acid, and use sodium hydroxide solution Or the concentration of hydrochloric acid can be selected according to actual conditions, such as 0.1mol / L. Finally...

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Abstract

The present invention relates to a kind of ethylamine injection and preparation method thereof, the components of ethylamine injection are proportioned according to the following concentration: ethylamine is 120g/L to 130g/L; sodium bisulfite 1.65g/L to 1.85g/L; sodium sulfite 0.23g/L to 0.27g/L; solvent is water for injection.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a fensulfame injection and a manufacturing method thereof. Background technique [0002] Etamsulfame injection is a product listed in the Veterinary Pharmacopoeia of the People's Republic of China and has been produced for many years. Traditional acesulfame injections mainly include acesulfame and other auxiliary materials. [0003] However, after this existing product is stored for several months, the phenomenon of pH instability will occur, resulting in the appearance of flocs in the product, which in turn leads to the failure of visible foreign matter. Due to the existence of this phenomenon, users may return goods, and these returned goods need to be scrapped. This not only causes a lot of waste, but also has adverse effects on customers, and the reputation of manufacturers has been questioned. Contents of the invention [0004] In order to solve the deficiencies of the prior art...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/02A61K31/205
CPCA61K9/08A61K9/0019A61K31/205A61K47/02
Inventor 徐海鸥张殿奎薛磊方泰云
Owner BEIJING LISHIDA PHARMA
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