Method for preparing amiodarone hydrochloride injection

A technology of amiodarone hydrochloride and injection, applied in the field of medicine, can solve the problems of high impurity content in injection, insoluble amiodarone hydrochloride and production efficiency, and achieve the effect of eliminating crystallization and high production efficiency

Active Publication Date: 2021-03-12
太阳升(亳州)生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] In view of the problems of the prior art, the inventor has carried out in-depth research and found that by controlling the liquid temperature and the order of addition in the liquid preparation process, the solution of hydrochlor...

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  • Method for preparing amiodarone hydrochloride injection
  • Method for preparing amiodarone hydrochloride injection
  • Method for preparing amiodarone hydrochloride injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Weigh 150 g of amiodarone hydrochloride, 60 g of benzyl alcohol, 300 g of polysorbate 80 (II) and 3 L of water for injection. Take 80% by volume of water for injection, and control the temperature of the water for injection at 70°C, fill with nitrogen, control the dissolved oxygen <2mg / L, add polysorbate 80 (II) to the water for injection until it is completely dissolved, and then add ammonium hydrochloride The iodine ketone is completely dissolved, the liquid is cooled to room temperature, benzyl alcohol is added until the liquid is completely dissolved, and the volume is adjusted to the total amount of the liquid.

[0031] Use a 0.2 μm PVDF microporous membrane to filter the liquid medicine. Fill the liquid medicine into a 5ml colorless medium borosilicate glass ampoule while filling nitrogen gas, the filling volume is 3.2ml, control the dissolved oxygen <2mg / L, and the residual oxygen <3%; put the sample in an oven at 70°C , heat preservation 1h.

Embodiment 2

[0033] Weigh 150 g of amiodarone hydrochloride, 60 g of benzyl alcohol, 300 g of polysorbate 80 (II) and 3 L of water for injection. Take 80% by volume of water for injection, and control the temperature of the water for injection at 70°C, fill with nitrogen, control the dissolved oxygen <2mg / L, add polysorbate 80 (II) to the water for injection until it is completely dissolved, and then add ammonium hydrochloride The iodine ketone is completely dissolved, the liquid is cooled to room temperature, benzyl alcohol is added until the liquid is completely dissolved, and the volume is adjusted to the total amount of the liquid.

[0034] Use a 0.2 μm PVDF microporous membrane to filter the liquid medicine. Fill and seal the liquid medicine in a 5ml colorless medium borosilicate glass ampoule bottle while filling with nitrogen gas, the filling volume is 3.2ml, control the dissolved oxygen < 2mg / L, and the residual oxygen < 3%; put the sample in the sterilizer 70°C, keep warm for 0.5...

Embodiment 3

[0036] Weigh 150 g of amiodarone hydrochloride, 60 g of benzyl alcohol, 300 g of polysorbate 80 (II) and 3 L of water for injection. Take 80% by volume of water for injection, and control the temperature of the water for injection at 60°C, fill with nitrogen, control the dissolved oxygen <2mg / L, add polysorbate 80 (II) to the water for injection until it is completely dissolved, and then add ammonium hydrochloride The iodine ketone is completely dissolved, the liquid is cooled to room temperature, benzyl alcohol is added until the liquid is completely dissolved, and the volume is adjusted to the total amount of the liquid.

[0037] Use a 0.2 μm PVDF microporous membrane to filter the liquid medicine. Fill the liquid medicine into a 5ml colorless medium borosilicate glass ampoule while filling nitrogen gas, the filling volume is 3.2ml, control the dissolved oxygen <2mg / L, and the residual oxygen <3%; put the sample in an oven at 70°C , heat preservation 1h.

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Abstract

The invention provides a method for preparing an amiodarone hydrochloride injection. The method comprises the following steps: a weighing step: weighing polysorbate, amiodarone hydrochloride, benzyl alcohol and water for injection according to a prescription dosage; a liquid preparation step: controlling a part of the water for injection at a temperature within a range of 60-75 DEG C while introducing nitrogen, adding polysorbate to obtain a polysorbate solution, adding amiodarone hydrochloride into the polysorbate solution to obtain an amiodarone hydrochloride solution, then cooling the amiodarone hydrochloride solution to room temperature, adding benzyl alcohol, and supplementing the rest of the water for injection to obtain a liquid medicine; a filtering step: sterilizing and filteringthe liquid medicine; and a filling and sealing step: filling and sealing the filtered liquid medicine into a container while filling nitrogen, wherein the method does not adopt a sterilization step. According to the method, the amiodarone hydrochloride injection with low impurity content can be prepared with high production efficiency.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a method for preparing amiodarone hydrochloride injection. Background technique [0002] Amiodarone hydrochloride injection is one of the commonly used drugs for clinical arrhythmia and angina pectoris. Amiodarone hydrochloride injection can selectively expand coronary blood flow, reduce myocardial oxygen consumption, slow down heart rate, and reduce atrioventricular conduction velocity. The effect is similar to that of β-receptor blockers. Tachycardia, paroxysmal atrial flutter and fibrillation, pre-excitation syndrome, intractable paroxysmal tachycardia, chronic coronary insufficiency and angina pectoris have excellent therapeutic effects. [0003] The production cost of the existing amiodarone hydrochloride injection preparation process is relatively high, and its impurity content is relatively high, thereby causing hidden dangers to drug safety. [0004] Therefore, it is v...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/26A61K47/10A61P9/10A61P9/06
CPCA61K9/08A61K9/0019A61K47/26A61K47/10A61P9/10A61P9/06
Inventor 方小东郭鸿旭
Owner 太阳升(亳州)生物医药科技有限公司
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