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Isosorbide mononitrate liquid preparation and preparing method thereof

A technology of isosorbide dinitrate and liquid preparations, which is applied in the field of isosorbide mononitrate liquid preparations and its preparation, can solve problems such as allergies, pyrogens, tumor-like reactions, contamination particles and impurities, and improve the level of sterility assurance, Effect of increasing solubility and preventing the generation of bacteria

Active Publication Date: 2010-02-03
上海华源药业(宁夏)沙赛制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, activated carbon has a charge. After entering the injection, it will disperse in the water for injection to form a colloidal solution, which can pass through the filter rod or filter membrane, so that the injection will be contaminated with new particulate impurities. Such particles cannot be metabolized in the body, so it may cause granulation. Swelling, pulmonary edema, phlebitis, thrombosis, tissue necrosis, allergies, pyrogens, tumor-like reactions, etc.

Method used

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  • Isosorbide mononitrate liquid preparation and preparing method thereof
  • Isosorbide mononitrate liquid preparation and preparing method thereof
  • Isosorbide mononitrate liquid preparation and preparing method thereof

Examples

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Effect test

Embodiment 1

[0038] Embodiment 1: the preparation of isosorbide mononitrate injection (1000ml amount)

[0039] One, the preparation of isosorbide mononitrate injection (1000ml amount)

[0040] In a sterile operating room, dissolve 4 g of isosorbide mononitrate in 400 ml of water for injection at a water temperature of 50°C, then add 9 g of sodium chloride and stir until fully dissolved, add 300 ml of propylene glycol, and stir evenly to obtain solution I;

[0041] Adjust the pH value of solution I to 7.0 with citric acid and sodium hydroxide;

[0042] In the aseptic operation room, the temperature of the above solution I was lowered to 40° C., and then the solution I was filtered with a 0.22 μm pore size filter to obtain the filtrate a.

[0043] The filtrate a is ultrafiltered by ultrafiltration with a molecular weight cut-off of 10,000 Daltons to obtain filtrate b.

[0044] Make up the filtrate b to 1000ml with water for injection, and then filter with a 0.22 μm pore size filter to obta...

Embodiment 2

[0084] Embodiment 2, the preparation of isosorbide mononitrate injection (1000ml amount)

[0085] The preparation process is carried out in the 10,000-class clean area, and the filling process is carried out under the local 100-class clean area of ​​the 10,000-class clean area.

[0086] One, the preparation of isosorbide mononitrate injection

[0087] In a sterile operating room, dissolve 12.5 g of isosorbide mononitrate in water for injection at 65° C., add 26 g of glycerin and stir until fully dissolved, and add 200 ml of propylene glycol to obtain solution I.

[0088] Adjust the pH of solution I to 6.8 with phosphoric acid or disodium hydrogen phosphate.

[0089] In the aseptic operation room, the temperature of the above solution I was lowered to 40° C., and then the solution I was filtered with a 0.22 μm filter to obtain the filtrate a.

[0090] The filtrate a is ultrafiltered with an ultrafilter with a molecular weight cut-off of 10,000 Daltons to obtain a filtrate.

...

Embodiment 3

[0115] Embodiment 3, the preparation of isosorbide mononitrate injection (1000ml amount)

[0116] The preparation process is carried out in the 10,000-class clean area, and the filling process is carried out under the local 100-class clean area of ​​the 10,000-class clean area.

[0117] One, the preparation of isosorbide mononitrate injection

[0118] In a sterile operating room, dissolve 15 g of isosorbide mononitrate in water for injection at 70° C., then add 9 g of sodium chloride and stir until fully dissolved, and add 100 ml of propylene glycol to obtain solution I.

[0119] Adjust the pH of Solution I to 7.2 with glacial acetic acid or disodium hydrogen phosphate.

[0120] In the aseptic operation room, the temperature of the above solution I was lowered to 45° C., and then the solution I was filtered with a 0.22 μm filter to obtain the filtrate a.

[0121] Filtrate a was ultrafiltered with an ultrafilter with a molecular weight cutoff of 10,000 Daltons to obtain filtr...

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Abstract

The invention discloses an isosorbide mononitrate liquid preparation and a preparing method thereof. The method comprises the steps: dissolving isosorbide mononitrate, stabilizing agent and osmotic pressure regulator into water used for injection, and evenly mixing together to obtain solution I; then, filtering the solution I, and obtaining isosorbide mononitrate injection. As active carbon is notintroduced into the preparing method, the active carbon particles are prevented from being introduced into the preparation to be harmful to the human body, and the stability of the active ingredientsin the preparation as well as the safety of the finished product can be ensued (namely, the chemical stability of the isosorbide mononitrate is effectively improved, the particulate content in the preparation is reduced, and the purity of the preparation is increased).

Description

technical field [0001] The invention relates to a liquid preparation of isosorbide mononitrate and a preparation method thereof. Background technique [0002] Isosorbide Mononitrate, the chemical name is 1,4:3,6-dianhydro-D-sorbitol-5-mononitrate, and the relative molecular weight is 191.14. The chemical structural formula is: [0003] [0004] Isosorbide mononitrate (ISMN) is the main biologically active metabolite of isosorbide dinitrate. Like other organic nitrates, the main pharmacological effect is to relax vascular smooth muscle. ISMN releases nitric oxide (NO), which is the same as endothelial relaxation factor, activates guanylate cyclase, increases cyclic guanylate (cGMP) in smooth muscle cells, relaxes vascular smooth muscle, and dilates peripheral arteries and veins. It has a stronger dilating effect on veins. Venous dilation causes blood to remain in the periphery, reducing blood return to the heart, and reducing left ventricular end-diastolic pressure and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/34A61K47/34A61K47/10A61K47/02A61P9/10
Inventor 刘伟强芦莉娜侯辉
Owner 上海华源药业(宁夏)沙赛制药有限公司
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