Isosorbide dinitrate freeze dried powder ampoule and its preparation method

A technology of isosorbide dinitrate and freeze-dried powder injection, which is applied in the direction of freeze-dried transportation, medical preparations containing active ingredients, powder transportation, etc., can solve the problems of property change and poor stability, and achieve non-aqueous phase content Less, stable product quality, and convenient for industrial production

Inactive Publication Date: 2006-11-08
BEIJING SIHUAN KEBAO PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is believed that heating will dissolve isosorbide dinitrate, resulting in changes in properties and poor stability

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Isosorbide Dinitrate 5mg

[0033] Tween-80 50mg

[0034] Mannitol 100mg

[0035] Water for injection to 1ml

[0036] According to the method of appendix IX A of "Chinese Pharmacopoeia 2000 Edition (Part II)", place it in a Nessler colorimetric tube, and inspect it under fluorescent light. Compared with water, it is clear and transparent, not deeper than No. 1 turbidimetric solution.

Embodiment 2

[0038] Isosorbide Dinitrate 5mg

[0039] Tween-80 30mg

[0040] Mannitol 250mg

[0041] Water for injection to 2.5ml

[0042] According to the method of appendix IX A of "Chinese Pharmacopoeia 2000 Edition (Part II)", place it in a Nessler colorimetric tube, and inspect it under fluorescent light. Compared with water, it is clear and transparent, not deeper than No. 1 turbidimetric solution.

Embodiment 3

[0044] Isosorbide Dinitrate 5mg

[0045] Tween-80 50mg

[0046] Mannitol 100mg

[0047] Water for injection to 1.5ml

[0048] According to the method of appendix IX A of "Chinese Pharmacopoeia 2000 Edition (Part II)", place it in a Nessler colorimetric tube, and inspect it under fluorescent light. Compared with water, it is clear and transparent, not deeper than No. 1 turbidimetric solution.

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PUM

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Abstract

The invention discloses a pharmaceutical composition for freeze-dried powder injection, which contains therapeutically effective doses of isosorbide dinitrate and Tween surfactant, wherein the concentration of Tween surfactant in the solution before freeze-drying is 20mg~500mg / ml. The invention also discloses a preparation method of the pharmaceutical composition, comprising dissolving isosorbide dinitrate in an aqueous solution of Tween surfactant with a concentration of 20mg-500mg / ml under heating at 40-100°C, and then freeze-drying to prepare The pharmaceutical composition of freeze-dried powder injection. Adding Tween can significantly improve the solubility of the isosorbide dinitrate solution and meet the requirements for preparing freeze-dried powder injection.

Description

technical field [0001] The invention relates to a freeze-dried powder preparation of isosorbide dinitrate and a preparation method thereof. Background technique [0002] Isosorbide dinitrate is a nitrate drug mainly used in the treatment of angina pectoris and congestive heart failure. Its basic pharmacological effect is to directly relax smooth muscle, especially vascular smooth muscle; the relaxation effect on post-capillary veins is more durable than that of arteries. No obvious direct effect on the myocardium. Due to volumetric vasodilation, venous return to the heart decreases, reducing the preload of the heart, while peripheral resistance blood vessels dilate and blood pressure drops, reducing left ventricular ejection resistance and reducing cardiac afterload. Decreased cardiac preload and postload reduce myocardial oxygen consumption. [0003] Isosorbide dinitrate is difficult to dissolve in water, which greatly limits its clinical application. When preparing iso...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/345A61K9/19A61P9/04A61P9/10A61K31/35
Inventor 张建勋张建强盛爱武吴亚录曹相林张建立
Owner BEIJING SIHUAN KEBAO PHARM CO LTD
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