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Milrinone lactate freezing-dried powder injection and preparation method thereof

A technology of milrinone lactate and needle injections, which is applied in freeze-dried delivery, powder delivery, pharmaceutical formulations, etc. It can solve problems that affect product safety and effective use, short valid period of use, short storage time, etc., and reduce clinical adverse reactions And side effects, enhanced stability, safe and convenient clinical use

Inactive Publication Date: 2008-03-19
张刘森
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Existing injections are filled with 10ml per ampule. Since milrinone lactate has poor stability in water and is inconvenient to transport, aqueous solution injections have the disadvantages of short storage time, transportation, etc., and short validity period, which affects the safety and quality of the product. effective use

Method used

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  • Milrinone lactate freezing-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Embodiment 1: Preparation of milrinone lactate freeze-dried powder injection

[0035] Milrinone Lactate 20g

[0036] Mannitol 120g

[0037] Water for injection 4000ml

[0038] Made into 1000 bottles of freeze-dried product

[0039] Dosing: Weigh the mannitol that has been sterilized and depyrogenated in advance, and add water for injection to dissolve it. Then add milrinone lactic acid raw material for injection to dissolve, then add water for injection to a specified volume, such as 4000ml, so that the content of milrinone lactic acid is 0.005g / ml, and the content of mannitol is 0.03g / ml.

[0040] Pyrogen removal: add activated carbon for injection to the above medicinal solution (the amount of activated carbon is 0.05-0.3% of the weight of the medicinal solution), filter at room temperature for 30 minutes, and collect the filtrate.

[0041] Sterilization: The above-mentioned filtrate is subjected to positive pressure sterilization filtration with a sterile filter ...

Embodiment 2

[0045] Embodiment 2: Preparation of milrinone lactate freeze-dried powder injection

[0046] Milrinone Lactate 20g

[0047] Low Molecular Dextran 120g

[0048] Water for injection 4000ml

[0049] A total of 1000 bottles of freeze-dried products were made

[0050] The preparation method is the same as in Example 1, except that the auxiliary materials added are different. Example 3: Preparation of milrinone lactate freeze-dried powder injection

[0051] Milrinone Lactate 20g

[0052] Mannitol 60g

[0053] Low Molecular Dextran 60g

[0054] Water for injection 4000ml

[0055] A total of 1000 bottles of freeze-dried products were made

[0056] The preparation method is the same as in Example 1 except that the auxiliary materials added are different. The preparation method is the same as in Example 1 except that the auxiliary materials added are different.

Embodiment 4

[0057] Embodiment 4: Preparation of milrinone lactate freeze-dried powder injection

[0058] Milrinone Lactate 20g

[0059] Glycine 120g

[0060] Water for injection 4000ml

[0061] A total of 1000 bottles of freeze-dried products were made

[0062] The preparation method is the same as that of Example 1, Example 5, except that the added auxiliary materials are different. Example 5: Preparation of Milrinone Lactic Acid Lyophilized Powder Injection

[0063] Milrinone Lactate 20g

[0064] Cyclodextrin 120g

[0065] Water for injection 4000ml

[0066] A total of 1000 bottles of freeze-dried products were made

[0067] The preparation method is the same as in Example 1 except that the auxiliary materials added are different.

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Abstract

A freeze-dry powder injection of lactic acid milrinone used for injecting and the preparation method of the injection belong to the medical technical field. The specification of the injection is 1 to 200mg (on the milrinone basis) of the lactic acid milrinone, which can be 5mg, 10mg, 20mg or 100mg etc., wherein one kind or more one kinds is of mannitol, low-molecular dextran, cyclodextrin, soluble starch, glucide matter, sodium chloride, benzoic acid, cellulose matter or water are selected as a carrier which is acceptable for the drug. The invention also relates to the method of preparing the freeze-dry powder injection of lactic acid milrinone, and the method includes the steps of preparing liquid medicine, removing pyrogen, removing bacterium, filling into a tank, freeze-drying etc., and white or nearly white loose block-shaped matter or powder of the product is obtained. The freeze-dry powder injection of the invention has good dissolubility, high biological utilization degree and good stability and ensures that the clinical use is safer and more convenient and can be used for vein dripping; the freeze-dry powder injection of the invention is applicable to the acute heart failure, the chronic heart failure, the intractable heart failure and the congestive heart failure which are caused by various reasons and have no effect or bad effect by the treatments of a digitalis, a diuretic and a vasodilator.

Description

1. Technical field [0001] The present invention relates to the field of medicines and their preparations. Specifically, the present invention relates to milrinone lactate freeze-dried powder injection for treating acute and chronic refractory congestive heart failure caused by various reasons and its preparation method, belonging to the technical field of medicine . 2. Background technology [0002] Milrinone Lactate (Milrinone Lactate) is a new type of non-cardiac glycoside, non-catecholamine cardiotonic drug, it is a congestive heart failure treatment agent developed by Sterling Company of the United States, and it is a bispyridine derivative of Amrinone (Amrinone). The drug belongs to the phosphodiesterase III (PDEIII) inhibitor, and has both positive inotropic and peripheral vasodilation effects. Its activity is 10 to 75 times that of amrinone. Milrinone lactate is mainly suitable for short-term intravenous administration of congestive heart failure. Recent studies hav...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/444A61K9/19A61K47/40A61K47/38A61K47/26A61K47/14A61K47/10A61K47/02A61K47/36A61P9/04
Inventor 张刘森
Owner 张刘森
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