Isosorbide dinitrate freeze dried powder ampoule and its preparation method

A technology of isosorbide dinitrate and freeze-dried powder injection, applied in freeze-dried delivery, powder delivery, drug combination and other directions, can solve problems such as poor stability and change in properties, and achieve stable product quality and less non-aqueous phase content. , the effect of simple preparation process

Inactive Publication Date: 2005-03-09
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

A freeze-dried powder injection of sorbide nitrate is prepared from the sorbide nitrate and tween as surfactant through proportionally and thermally dissolving the sorbide nitrate in the aqueous solution of tween and freeze drying.

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 significant 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...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/35A61P9/04A61P9/10
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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