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Esmolol Hydrochloride freeze dried powder for injection and its preparation method

A technology of esmolol hydrochloride and freeze-dried powder injection, which is applied in the field of esmolol hydrochloride freeze-dried powder injection for injection and its preparation, which can solve the problems of decreased curative effect, inconvenience in transportation and storage of injection preparations, and unstable active ingredients and other issues, to achieve the effect of reasonable composition, long validity period and convenient transportation

Inactive Publication Date: 2005-07-06
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, only its injection preparations are in use in China. Because the injections can destabilize the active ingredients during high-temperature sterilization, the curative effect is reduced, and the injection preparations are also inconvenient in transportation and storage.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Embodiment 1: 0.1g / bottle specification, 1000 freeze-dried powder injection formulations:

[0015] Esmolol Hydrochloride 100g

[0016] Mannitol 50g

[0017] Add water for injection to 2000ml, make 1000 tubes in total

[0018] Wherein, esmolol hydrochloride is the main agent, and the specification in this embodiment is that each bottle contains 0.1 g of esmolol hydrochloride.

[0019] Mannitol is an excipient, and is used as a skeleton supporting part of the esmolol powder injection for injection. According to literature reports and combined with our company's production practice experience of other freeze-dried preparations. The experiment was carried out by simulating the actual production, and the ratio of the main drug to the mannitol was determined: the ratio of 10:5. Water for injection is used as a solvent for dissolving raw materials, and an appropriate amount is added according to the concentration of the liquid medicine and the loading capacity of each medi...

Embodiment 2

[0023] Embodiment 2: 0.3g / bottle specification, 1000 freeze-dried powder injection formulations:

[0024] Esmolol Hydrochloride 300g

[0025] Mannitol 500g

[0026] Add water for injection to 4000ml, make 1000 tubes in total

[0027] Wherein, esmolol hydrochloride is the main drug, and the specification in the present embodiment is that each bottle contains 0.3 g of esmolol hydrochloride.

[0028] Mannitol is an excipient, and is used as a skeleton supporting part of the esmolol powder injection for injection. According to literature reports and combined with our company's production practice experience of other freeze-dried preparations. The experiment was carried out by simulating the actual production, and the ratio of the main drug to the mannitol was determined: the ratio of 30:50. Water for injection is used as a solvent for dissolving raw materials, and an appropriate amount is added according to the concentration of the liquid medicine and the loading capacity of e...

Embodiment 3

[0032] Embodiment 3: 0.05g / bottle specification, 1000 freeze-dried powder injection formulations:

[0033] Esmolol Hydrochloride 50g

[0034] Mannitol 100g

[0035] Add water for injection to 2000ml, make 1000 tubes in total

[0036] Wherein, esmolol hydrochloride is the main agent, and the specification in the present embodiment is that each bottle contains 0.05 g of esmolol hydrochloride.

[0037] Mannitol is an excipient, and is used as a skeleton supporting part of the esmolol powder injection for injection. According to literature reports and combined with our company's production practice experience of other freeze-dried preparations. A test was carried out by simulating the actual production, and the ratio of the main drug to mannitol was determined: the ratio of 5:10. Water for injection is used as a solvent for dissolving raw materials, and an appropriate amount is added according to the concentration of the liquid medicine and the loading capacity of each medicin...

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Abstract

The invention discloses an Esmolol Hydrochloride freeze dried powder for injection and its preparation method, wherein the esmolol hydrochloride freeze dried injection is prepared from esmolol hydrochloride as active compound, pharmacologically acceptable freeze dried excipient and water for injection. The weight ratio of esmolol hydrochloride and freeze dried excipient is 5-30 : 5-50, the preparing process is also disclosed by the invention.

Description

technical field [0001] The invention belongs to esmolol hydrochloride pharmaceutical preparations, in particular to an esmolol hydrochloride freeze-dried powder for injection and a preparation method thereof. Background technique [0002] Esmolol hydrochloride is an extremely short-acting beta 1 Receptor blockers, the selectivity gradually disappears in large doses, and the β of blood vessels and bronchial smooth muscle 2 Receptors also play a role. The drug has no membrane stability and no intrinsic mimetic activity. Anti-arrhythmic mechanism: The drug exerts anti-arrhythmic function by inhibiting the stimulation of adrenaline to the cardiac pacemaker and slowing down the atrioventricular node conduction. Its main action site is the sinoatrial node and the atrioventricular node conduction system. Intravenous administration produces hemodynamic effects (lowering heart rate and systolic blood pressure) similar to propranolol, and affects left and right ventricular function...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/135A61P9/06
Inventor 陈庆财赵俊
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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