Isosorbide mononitrate freeze-dried power injection and preparation method thereof

A technology of isosorbide dinitrate and freeze-dried powder injection is applied to the field of freeze-dried powder injection of isosorbide mononitrate and its preparation, which can solve the problem that the safety of the stabilizer is not fully guaranteed, the hydrolysis of the drug is unavoidable, and the product is stable. Good reconstitution, improved drug safety, and stable content

Active Publication Date: 2010-09-01
鲁南新时代生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] During the long-term storage of the existing isosorbide mononitrate injections on the market, isosorbide mononitrate is prone to degradation, resulting in a decrease in the content of the preparation and an increase in related substances. The reason for this phenomenon is that isosorbide mononitrate is easy to Hydrolysis in acidic or alkaline environment, in order to inhibit the hydrolysis of isosorbide mononitrate, the manufacturer added propylene glycol, glycerin, etc. Bacteria, the stability of the product is not good, the relevant substances increase significantly after sterilization, and the hydrolysis of the drug is inevitable during the storage process

Method used

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  • Isosorbide mononitrate freeze-dried power injection and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] 1. Prescription composition:

[0038] Isosorbide Mononitrate 20g

[0039] Sorbitol 40g

[0040] Phosphate buffer (pH 6.5) 100ml

[0041] Add sterile water for injection to 2000ml

[0042]

[0043] Freeze-dried to make a total of 1000 bottles

[0044] 2. Preparation method:

[0045] (1) Preparation: get 1600ml water for injection and add sorbitol to make it dissolve completely, add gac, absorb at normal temperature for 30min, filter to remove charcoal, add the isosorbide mononitrate of the prescription amount under room temperature, then add the phosphate buffer saline of pH 6.5 ( Take 0.68g of potassium dihydrogen phosphate, add 15.2ml of 0.1mol / L sodium hydroxide solution, dilute to 100ml with water) 100ml, add water for injection to the full amount to obtain an intermediate solution, and filter to sterilize with a 0.22um sterile microporous membrane;

[0046] (2) Check the clarity of the ...

Embodiment 2

[0050] 1. Prescription composition:

[0051] Isosorbide Mononitrate 20g

[0052] Sorbitol 100g

[0053] Phosphate buffer (pH 7.5) 200ml

[0054] Add sterile water for injection to 2000ml

[0055]

[0056] Freeze-dried to make a total of 1000 bottles

[0057] 2. Preparation method:

[0058] (1) Preparation: Take 1600ml of water for injection and add excipients to dissolve it completely, add activated carbon, absorb at room temperature for 30 minutes, filter to remove carbon, add the prescribed amount of isosorbide mononitrate at room temperature, and then add phosphate buffer with pH 6.6 (Take 1.74g of potassium dihydrogen phosphate, 2.7g of disodium hydrogen phosphate and 1.7g of sodium chloride, add water to dissolve to 400ml) 200ml, add water for injection to the full amount to obtain an intermediate solution, filter and sterilize with a 0.22um sterile microporous membrane ;

[0059] (2) Check ...

Embodiment 3

[0063] 1. Prescription composition:

[0064] Isosorbide Mononitrate 20g

[0065] Sorbitol 80g

[0066] Phosphate buffer (pH 7.0) 100ml

[0067] Add sterile water for injection to 2000ml

[0068]

[0069] Freeze-dried to make a total of 1000 bottles

[0070] 2. Preparation method:

[0071] (1) Preparation: get 1600ml water for injection and add sorbitol to make it dissolve completely, add gac, absorb at room temperature for 30min, filter to remove charcoal, add prescription amount of isosorbide mononitrate at room temperature, then add the phosphate buffer saline of pH 7.0 ( Take 0.68g of potassium dihydrogen phosphate, add 29.1ml of 0.1mol / L sodium hydroxide solution, add water to dilute to 100ml) 100ml, add water for injection to the full amount to obtain an intermediate solution, and filter to sterilize with a 0.22um sterile microporous membrane;

[0072] (2) Check the clarity of the i...

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Abstract

The invention belongs to the technical field of pharmaceutical preparation and provides an isosorbide mononitrate freeze-dried power injection and a preparation method thereof. In the preparation process of the isosorbide mononitrate freeze-dried power injection of the invention, sorbic alcohol is used as a propping agent and the pH value of the solution of a middle body is adjusted to between 6.5 and 7.5 by acidic or alkaline buffer solution, so the hydrolysis of a main medicament is restrained and the stability of the main medicament is improved; and a pre-freezing initial temperature is controlled to be below 50 DEG C below zero, and the second sublimation temperature in a free-drying process is controlled to be between 5 and 15 DEG C, so the medicament content and the stability of related substances are improved. The stable isosorbide mononitrate freeze-dried power injection prepared by the method has reduced toxicity and good clinical effects.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a freeze-dried powder injection of isosorbide mononitrate and a preparation method thereof. Background technique [0002] Isosorbide mononitrate is a commonly used drug for the treatment of coronary heart disease and angina pectoris, and has been clinically used for many years with definite curative effect. Its main mechanism of action is to expand the venous volume vessels and peripheral resistance vessels, reduce the preload and postload of the heart, and reduce the myocardial oxygen consumption. The drug has the characteristics of high bioavailability, small individual differences, long half-life, and significant curative effect. And the prevention of angina pectoris is better than nitroglycerin and indigestion. Studies in recent years have shown that the dilation of isosorbide mononitrate plays an important role in anti-angina, especially anti-myocardial ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/34A61K47/26A61P9/10
Inventor 赵志全
Owner 鲁南新时代生物技术有限公司
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