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Powder injection for injection and preparation method thereof

A technology of injection powder and water for injection, applied in the field of pharmaceutical preparations

Active Publication Date: 2015-04-01
CVIE THERAPEUTICS COMPANY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the drug does not yet have a corresponding injection powder product on the market, so it is of great practical significance to develop a Istaroxime injection powder and its preparation method

Method used

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  • Powder injection for injection and preparation method thereof
  • Powder injection for injection and preparation method thereof
  • Powder injection for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] The preparation of embodiment 1 injection powder

[0049] Weigh 100 mg of lactose monohydrate, add 3 mL of water for injection, and dissolve it. Weigh 50 mg of the compound shown in formula I, add it to the above-mentioned lactose monohydrate solution, add 2 mL of water for injection at the same time, stir for 10 minutes to dissolve it, dilute it to 10 mL with water for injection, fill it after double filtration, and pre-stopper , placed in a freeze dryer for freeze-drying, the freeze-drying process is: freezing at -50°C for 2.5h; primary drying at 10°C and 200μbar for 13.5h; , Under the condition of a pressure of 200μbar, the secondary drying was performed for 10.5h. After the drying is finished, stoppering is obtained;

[0050]

[0051] Formula I.

Embodiment 2

[0052] The preparation of embodiment 2 injection powder

[0053] Weigh 250 mg of glucose, add 6 mL of water for injection, and dissolve it. Use 0.1mol / L NaOH solution to adjust the pH value to 5.25-5.75. Weigh 20mg of the compound shown in formula I, add it to the above glucose solution, and supplement 2.5mL of water for injection at the same time, stir for 10min to dissolve it, dilute it to 10mL with water for injection, fill it after double filtration, pre-stopper, put Put it into a lyophilizer for freeze-drying. The freeze-drying process is: freezing at a temperature of -40°C for 3.5h; primary drying at a temperature of 20°C and a pressure of 200μbar for 12.5h; Under the condition of 200μbar, the secondary drying takes 9.5h. After the drying is finished, stoppering is obtained;

[0054]

[0055] Formula I.

Embodiment 3

[0056] The preparation of embodiment 3 injection powder

[0057] Weigh 200 mg of mannitol, add 4 mL of water for injection, and dissolve it. Use 0.1mol / L disodium hydrogen phosphate solution to adjust the pH value to 5.25-5.75. Weigh 40mg of the compound shown in formula I, add it to the above-mentioned mannitol solution, and supplement 2.2mL of water for injection at the same time, stir for 10min to dissolve it, dilute it to 10mL with water for injection, fill it after double filtration, pre-stopper, Put it into a freeze dryer for freeze-drying. The freeze-drying process is as follows: freezing for 3 hours at a temperature of -45°C; primary drying for 13 hours at a temperature of 15°C and a pressure of 200 μbar; Under the condition of 200μbar, the secondary is dried for 10h. After the drying is finished, stoppering is obtained;

[0058]

[0059] Formula I.

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Abstract

The invention relates to the field of a drug preparation, and particularly relates to a powder injection for injection and a preparation method thereof. The powder injection for injection comprises a compound shown in the formula I and a freeze-drying protective additive, wherein the weight ratio of the compound shown in the formula I to the freeze-drying protective additive is (20-50): (100-250). The powder injection for injection provided by the invention is stable in quality, and high in treatment safety, and can be used for effectively treating deterioration of heart failure with a decreased left ventricular systolic function; and the preparation technology of the powder injection for injection is simple and convenient, controllable, and suitable for industrial production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a powder for injection and a preparation method thereof. Background technique [0002] After entering the 21st century, with the change of lifestyle of Chinese residents, chronic diseases headed by cardiovascular disease have become the main diseases that seriously threaten the health of Chinese residents. Heart failure (HF) is the final stage of various cardiovascular diseases. It is caused by various primary cardiovascular diseases such as coronary heart disease under the condition of normal venous return. A syndrome that requires tissue metabolism. The clinical manifestations are pulmonary congestion, cough, sputum, hemoptysis, fatigue, fatigue, mental abnormalities, oliguria, and renal impairment. The causes of heart failure mainly include primary myocardial damage, hypertension, valvular stenosis, valvular regurgitation, blood regurgitation, left and right heart s...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/5685A61P9/04
Inventor G·毕安祺P·费拉里李小羿戴向荣张国辉
Owner CVIE THERAPEUTICS COMPANY
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