Isosorbide dinitrate sodium chloride injection

A technology of isosorbide dinitrate and sodium chloride injection, which is applied in directions such as active ingredients of heterocyclic compounds, drug combinations, medical preparations of non-active ingredients, etc. The effect of precipitation of crystals and related substances, improving stability and increasing solubility

Active Publication Date: 2014-09-10
JIANGXI DONGFU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The applicant obtained the new drug certificate and production approval document for "Isosorbide Dinitrate Sodium Chloride Injection" in 1998, and it has been mass-produced for the first time since November 19, 1998. There are problems such as incomplete dissolution of isosorbide dinitrate, complete crystallization of the product during storage, and related substances of the product. The applicant is constantly improving the technology

Method used

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  • Isosorbide dinitrate sodium chloride injection
  • Isosorbide dinitrate sodium chloride injection
  • Isosorbide dinitrate sodium chloride injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Embodiment 1 Isosorbide Dinitrate Sodium Chloride Injection

[0026] Isosorbide Dinitrate 1250mg

[0027] Sodium chloride 12000mg

[0028] A mixture of 0.1mol / L sorbic acid and 0.1mol / L ascorbic acid (the molar ratio of the two is 7:1) to adjust the pH to 5.2 L-cysteine ​​hydrochloride 680mg

[0029] Add water for injection to 2000ml.

[0030] Preparation Process:

[0031] The injection preparation process includes two steps: concentrated preparation and diluted preparation. The concentrated preparation is mainly to dissolve the raw materials to minimize the amount of solvent used, and the diluted preparation is the process of diluting and constant volume.

[0032] Concentrated preparation: add an appropriate amount of fresh water for injection to the concentrated preparation tank, add the calculated amount of sodium chloride, stir to dissolve, add 2% (W / W) activated carbon for needles and keep boiling for 15 minutes, then filter to remove carbon, and leave the chlor...

Embodiment 2

[0036] Isosorbide Dinitrate 1200mg

[0037] Sodium chloride 9000mg

[0038] 0.1mol / L sorbic acid to adjust the pH to 5.0

[0039] L-cysteine ​​hydrochloride 650mg

[0040] Add water for injection to 2000ml.

[0041] Preparation process: with embodiment 1.

Embodiment 3

[0043] Isosorbide Dinitrate 1300mg

[0044] Sodium chloride 15000mg

[0045] A mixture of 0.1mol / L sorbic acid and 0.1mol / L ascorbic acid (the molar ratio of the two is 7:1) to adjust the pH to 5.1L-cysteine ​​hydrochloride 700mg

[0046] Add water for injection to 2000ml.

[0047] Preparation process: with embodiment 1.

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Abstract

The invention relates to an isosorbide dinitrate sodium chloride injection which comprises the following components in effective dose: 1200-1300mg of isosorbide dinitrate, 9000-15000mg of sodium chloride, 650-700mg of a cosolvent and the balance of water for injection, wherein a pH adjustor adjusts the pH to 5.0-5.5, and the water for injection is added until the volume of the injection is 2000ml. The isosorbide dinitrate sodium chloride injection provided by the invention has good water solubility and stability.

Description

technical field [0001] The invention relates to an injection of isosorbide dinitrate and sodium chloride. Background technique [0002] Isosorbide dinitrate is a widely used vasodilator at present. It can dilate venous volume vessels at low doses, and dilate coronary vessels and resistance vessels at larger doses, reducing the preload and afterload of the heart and improving heart function. coronary circulation. It is therefore often administered sublingually to relieve angina and to prevent angina by oral administration. After oral administration of isosorbide dinitrate, the blood drug concentration in the body reaches the peak quickly, but due to the large first-pass effect of the drug, the bioavailability after oral administration is very low, only 3% of the bioavailability of intravenous injection. Therefore, sublingual administration and injection administration are the most ideal routes of administration. However, for patients requiring intensive treatment, when sub...

Claims

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Application Information

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IPC IPC(8): A61K31/34A61K9/08A61K47/12A61K47/16A61P9/08A61P9/10
Inventor 王大冲翟绪武王建何榕王雪梅吴对荣
Owner JIANGXI DONGFU PHARMA CO LTD
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