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Dexamethasone sodium phosphate injection and preparing method thereof

A technology of dexamethasone sodium phosphate and injection, which is applied in the fields of pharmaceutical formula, drug delivery, inorganic non-active ingredients, etc. It can solve the problems of unqualified foreign matter, precipitation of insoluble matter, unstable pH value, etc., and achieve stable pH value, The effect of prolonged storage time

Inactive Publication Date: 2017-11-24
BEIJING LISHIDA PHARMA
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Problems solved by technology

[0002] Dexamethasone sodium phosphate injection is a product listed in the Veterinary Pharmacopoeia of the People's Republic of China. It is mainly used for allergic and autoimmune inflammatory diseases, and is mostly used for connective tissue diseases. However, the existing dexamethasone sodium phosphate injection product, After several months of storage, the pH value is often unstable and insoluble matter is precipitated, resulting in unqualified visible foreign matter
[0003] Due to the many problems existing in the existing dexamethasone sodium phosphate injection, users have repeatedly returned the product and scrapped the product, resulting in a waste of production resources. While causing adverse effects on customers, the company's reputation has also been questioned

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  • Dexamethasone sodium phosphate injection and preparing method thereof
  • Dexamethasone sodium phosphate injection and preparing method thereof
  • Dexamethasone sodium phosphate injection and preparing method thereof

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Embodiment Construction

[0022] In order to have a further understanding of the technical solution and beneficial effects of the present invention, the technical solution of the present invention and its beneficial effects will be described in detail below.

[0023] The present invention provides a kind of preparation method of dexamethasone sodium phosphate injection, mainly aimed at the phenomenon that the pH value is unstable and insolubles are separated out after the existing dexamethasone sodium phosphate injection is stored for several months, thereby The problem of unqualified visible foreign matter is caused. By adjusting the amount of propylene glycol and adding anhydrous sodium sulfite, the prepared product has excellent stability. Specifically, it includes the following steps:

[0024] S1: Add a predetermined amount of water for injection into the configuration container;

[0025] S2: adding a predetermined amount of sodium bisulfite and anhydrous sodium sulfite to dissolve them in the abov...

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Abstract

The invention relates to dexamethasone sodium phosphate injection and a preparing method thereof. The preparing method comprises the following steps that 1, pre-quantitative water for injection is added, 2, pre-quantitative sodium hydrogen sulfite is added, 3, the pH value of a solution is adjusted, and the pH value is between 7.5-8.0; 4, dexamethasone phosphate and propylene glycol are added in sequence, after the dexamethasone phosphate and the propylene glycol are dissolved fully, then the water for injection is added to reach preset volume, and a semi-finished product is obtained; 5, the semi-finished product is filtered; and 6, sterilization is conducted. According to the preparing method of the dexamethasone sodium phosphate injection, the prepared dexamethasone sodium phosphate injection is stable in pH value, precipitate is not precipitated after the dexamethasone sodium phosphate injection is stored above two years, various indexes are qualified within the expiration date of the product, the product accords with the quality standard of novel dexamethasone sodium phosphate injection of the People's Republic of China, and the storage time is prolonged.

Description

technical field [0001] The invention relates to the field of animal husbandry and pharmacy, in particular to a dexamethasone sodium phosphate injection and a preparation method thereof. Background technique [0002] Dexamethasone sodium phosphate injection is a product listed in the Veterinary Pharmacopoeia of the People's Republic of China. It is mainly used for allergic and autoimmune inflammatory diseases, and is mostly used for connective tissue diseases. However, the existing dexamethasone sodium phosphate injection product, After several months of storage, the pH value is often unstable and insoluble matter is precipitated, resulting in unqualified visible foreign matter. [0003] Due to the many problems existing in the existing dexamethasone sodium phosphate injection, users have repeatedly returned products and discarded products, resulting in a waste of production resources. While causing adverse effects on customers, the company's reputation has also been question...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/661A61K47/10A61K47/02A61P37/08A61P37/02A61P29/00
CPCA61K9/08A61K9/0019A61K31/661A61K47/02A61K47/10
Inventor 徐海鸥张殿奎薛磊方泰云
Owner BEIJING LISHIDA PHARMA
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