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Sodium menadiol diphosphate ester and its pharmaceutical formulation

The technology of sodium menadione diphosphate and sodium naphthoquinone diphosphate is applied in the field of sodium menadione diphosphate lyophilizer and its preparation, and can solve the problem of poor chemical stability, difficult long-term storage of preparations, etc. question

Inactive Publication Date: 2009-06-10
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
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Effect test

Embodiment 1

[0028] Embodiment 1: Menahydroquinone Diphosphate Sodium Freeze-dried Agent of 5mg Specification

[0029] Menahydroquinone diphosphate sodium 5g, sodium thiosulfate 3g, mannitol 80g, water for injection was added to 1500ml. Measure 80% of the prepared water for injection in the batching tank, then weigh the prescribed amount of menadione hydroquinone diphosphate sodium, slowly add it to the batching tank, stir while adding to dissolve, then add the prescribed amount of thiosulfate Sodium sulfate and mannitol, stir to dissolve, adjust the pH to 8.0 with 1mol / L sodium hydroxide, add water for injection to 1500ml, stir well, add 2g of needles and use activated carbon to absorb at 60°C for 30 minutes, and decarbonize by suction filtration. Then fine filter with 0.22μm microporous membrane, measure the intermediate content and pH value, fill in 2ml control bottles after passing the test, each bottle is 1.5ml, put it into a plate, send the sample into the freeze dryer, pre-freeze, a...

Embodiment 2

[0030] Embodiment 2: lyophilized agent of sodium menadione hydroquinone diphosphate of 10 mg specification

[0031] Menahydroquinone diphosphate sodium 10g, sodium thiosulfate 3g, mannitol 75g, water for injection was added to 1500ml. The preparation was prepared according to the same method as described in Example 1, and a lyophilized preparation of menahydroquinone diphosphate sodium with a specification of 10 mg was obtained.

Embodiment 3

[0033] 3a) except that it does not contain sodium thiosulfate, all the other are the same as in Example 1, and are prepared into a freeze-dried agent;

[0034] 3b) Except replacing the sodium thiosulfate wherein with an equivalent amount of sodium bisulfite, the rest are the same as in Example 1 to prepare a freeze-dried agent;

[0035] Carry out strong light irradiation and high temperature stability test, result does not contain the 3a preparation of stabilizer, obvious phenomena such as discoloration occur, illustrate that menadione hydroquinone diphosphate sodium is oxidatively degraded, and preparation stability is poor. 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 thiosulfate as a stabilizer has basically no discoloration phenomenon, and the content of sodium menadione hydroquinone diphosphate has basic...

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PUM

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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 hyposulfite as the stabilizer, mannitol as supporting body or matrix 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 a menadione diphosphate sodium freeze-dried agent 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...

Claims

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Application Information

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IPC IPC(8): C07F9/12A61K31/6615A61K9/19A61K9/00
Inventor 周卓和
Owner 周卓和
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