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Sodium menadiol diphosphate ester and its pharmaceutical formulation

A technology of Naphthalene Hydroquinone Diphosphate Sodium and Naphthalene Hydroquinone Diphosphate, which is applied in the field of Menadione Hydroquinone Diphosphate Sodium Injection and its preparation, and can solve the problems of difficult long-term storage of preparations and poor chemical stability.

Inactive Publication Date: 2008-05-28
周卓和
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Sodium menadione diphosphate is a vitamin K substance with poor chemical stability, and it is difficult for general preparations to be stored for a long time

Method used

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  • Sodium menadiol diphosphate ester and its pharmaceutical formulation
  • Sodium menadiol diphosphate ester and its pharmaceutical formulation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1: menahydroquinone diphosphate sodium injection of 5mg specification

[0029] Menahydroquinone diphosphate sodium 5g, sodium metabisulfite 2.5g, sodium chloride 7.7g, water for injection was added to 1000ml. Measure 40% of the prepared water for injection, add the prescribed amount of sodium metabisulfite and sodium chloride and stir to dissolve, then add the main drug menahydroquinone diphosphate sodium, heat to dissolve, add 1g of activated carbon for needles at 60°C Insulate and absorb for 30 minutes, filter and decarburize when cooled to 45°C, add water for injection to 80% of the prepared amount, adjust the pH to 8.0 with 1mol / L sodium hydroxide, add water for injection to the full amount, measure the intermediate content and pH value, Then fine filter with 0.22μm microporous membrane, fill in ampoules after passing the test, 1ml each, fill with nitrogen, seal, steam sterilize, inspect, pack, and get ready.

Embodiment 2

[0030] Embodiment 2: menahydroquinone diphosphate sodium injection of 10mg specification

[0031] Menahydroquinone sodium diphosphate 10g, sodium metabisulfite 2.5g, sodium chloride 6.4g, water for injection was added to 1000ml. The preparation was prepared according to the same method as described in Example 1, and a 10 mg specification of menahydroquinone diphosphate sodium injection was prepared.

Embodiment 3

[0033] 3a) Except not containing sodium metabisulfite, the rest are the same as in Example 1, and the injection is prepared;

[0034] 3b) Except that the sodium metabisulfite was replaced with an equivalent amount of sodium bisulfite, the rest were the same as in Example 1, and the injection was prepared;

[0035] Strong light irradiation and high temperature stability tests were carried out. As a result, the 3a preparation without stabilizer had obvious discoloration and other phenomena, indicating that menahydroquinone diphosphate sodium was oxidatively degraded, and the stability of the preparation was poor, which did not meet the requirements of clinical medication. The 3b preparation containing sodium bisulfite also showed discoloration, and the content of sodium menahydroquinone diphosphate decreased. However, the preparation of Example 1 of the present invention using sodium pyrosulfite as a stabilizer has basically no discoloration phenomenon, and the content of sodium...

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Abstract

The invention relates to a menadiol diphosphonate sodium compound and pharmaceutical preparation for treating hypoprothrom-binemia caused by various reasons, particularly to a menadiol diphosphonate sodium freeze-dried injection and its preparing process by using sodium metabisulfite as the stabilizer, sodium chloride as the isotonic agent, the prepared menadiol diphosphonate sodium freeze-dried injection has good stability and pharmaceutical effect, thus can be applied clinically.

Description

technical field [0001] The invention relates to a menadione diphosphate sodium compound and its pharmaceutical preparation for treating hypoprothrombinemia caused by various reasons, in particular to menadione diphosphate sodium injection and its preparation method . Background technique [0002] Vitamin K is an essential substance for the liver to synthesize prothrombin (factor II), and is also involved in the synthesis of factor VII, factor IX and factor X. Lack of vitamin K can cause the synthesis of the above coagulation factors, affecting the coagulation process and causing bleeding. [0003] Sodium Menadione Diphosphate as Vitamin K 3 Synthetic products of , which are converted in the body to menadione (vitamin K 3 ), can be used for patients with biliary tract or liver diseases related to biliary function, and some patients have gastrointestinal dysfunction related to vitamin K deficiency or severe sepsis. [0004] Sodium menadione diphosphate belongs to vitamin K...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07F9/12A61K31/6615A61K9/08
Inventor 周卓和
Owner 周卓和
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