Urapidil hydrochloride injection and preparation method thereof

A technology of urapidil hydrochloride and injection, which is applied in the field of medicine, can solve problems such as greater influence of temperature, influence on product quality, and influence on product efficacy, so as to avoid pollution, optimize pH value stability, and improve sterility assurance level Effect

Pending Publication Date: 2022-04-15
WUHAN DOCAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

In the process of preparing urapidil hydrochloride injection, both pH conditions and temperature will affect the quality of the product, and then affect the efficacy of the product, and the temperature has a greater impact

Method used

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  • Urapidil hydrochloride injection and preparation method thereof
  • Urapidil hydrochloride injection and preparation method thereof
  • Urapidil hydrochloride injection and preparation method thereof

Examples

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preparation example Construction

[0028] figure 1 It is a schematic flow sheet of the preparation method of urapidil hydrochloride injection provided by the embodiment of the application, refer to figure 1 , the preparation method provided by the application comprises the following steps:

[0029] Step S101, weighing the water for injection, vacuuming and filling with nitrogen and cooling the water for injection to below 30°C, adding urapidil hydrochloride, co-solvent and buffer to the water for injection, stirring until completely dissolved to obtain the first mixed solution, stirring During the dissolution process, cooling water is passed into the jacket during the liquid preparation process to ensure that the temperature of the first mixed solution is lower than 30°C; the latent solvent is one of ethanol, 1,2-propylene glycol, glycerin, polyethylene glycol or Several kinds; the buffer is a mixture of potassium dihydrogen phosphate / potassium chloride / sodium chloride, a mixture of disodium hydrogen phosphate...

Embodiment 1

[0036] Embodiment 1 of the present application provides a preparation method of urapidil hydrochloride injection, comprising the following steps:

[0037] (1), take by weighing 50%-80% of the water for injection of the full prescription, vacuumize and fill with nitrogen, and cool the water for injection so that the temperature is lower than 10°C;

[0038] (2), add 5.47g urapidil hydrochloride in water for injection, stir until dissolving completely, obtain urapidil hydrochloride solution, pass into cooling water in the jacket of liquid holding container in stirring process and guarantee that the temperature of medicinal solution is lower than 10°C;

[0039] (3), add 0.28g disodium hydrogen phosphate, 1.8g sodium dihydrogen phosphate to urapidil hydrochloride solution, stir until completely dissolved, obtain the first mixed solution, pass into the jacket of the liquid container during stirring Cooling water ensures that the temperature of the liquid medicine is lower than 10°C...

Embodiment 2

[0044]Embodiment 2 of the present application provides a kind of preparation method of urapidil hydrochloride injection, comprises the following steps:

[0045] (1), take by weighing 50%-80% of the water for injection of the full prescription, vacuumize and fill with nitrogen, and cool the water for injection so that the temperature is lower than 30°C;

[0046] (2), add 5.47g urapidil hydrochloride in water for injection, stir until dissolving completely, obtain urapidil hydrochloride solution, pass into cooling water in the jacket of liquid holding container in stirring process and guarantee that the temperature of medicinal solution is lower than 30°C;

[0047] (3), add 100g 1,2-propanediol, 0.28g disodium hydrogen phosphate, 1.8g sodium dihydrogen phosphate to the urapidil hydrochloride solution, stir until completely dissolved to obtain the first mixed solution, in the stirring process Cooling water is passed into the jacket of the container to ensure that the temperature...

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Abstract

The invention relates to the technical field of medicines, in particular to urapidil hydrochloride injection and a preparation method thereof. The preparation method provided by the invention comprises the following steps: weighing water for injection, cooling to 30 DEG C or below, vacuumizing and filling nitrogen, adding urapidil hydrochloride, a latent solvent and a buffer agent into the water for injection, stirring until the urapidil hydrochloride, the latent solvent and the buffer agent are completely dissolved to obtain a first mixed solution, and ensuring that the temperature of the first mixed solution is lower than 30 DEG C in the stirring and dissolving process; adding water for injection of which the temperature is lower than 30 DEG C into the first mixed solution to make the volume constant, stirring until the materials are uniformly mixed to obtain a second mixed solution, and ensuring that the temperature of the second mixed solution is lower than 30 DEG C in the stirring process; filtering the second mixed solution through a filter element to obtain filtrate; and filling nitrogen into the filtrate, encapsulating, sterilizing, cooling, carrying out lamp inspection, and carrying out leak detection to obtain the urapidil hydrochloride injection.

Description

technical field [0001] The application relates to the technical field of medicine, in particular to a urapidil hydrochloride injection and a preparation method thereof. Background technique [0002] The main component of Urapidil Hydrochloride Injection is Urapidil, the chemical name is 6-{3-[4-(2-methoxyphenyl)-1-piperazinyl]propyl}amino-1,3-di Methyl-2,4(1H,3H)-pyrimidinedione for the treatment of hypertensive crisis (such as acute blood pressure rise), severe and very severe hypertension, and refractory hypertension; control perioperative hypertension. In the process of preparing urapidil hydrochloride injection, both pH conditions and temperature will affect the product quality, and then affect the efficacy of the product, and the temperature has a greater impact. Therefore, it is very important to provide a preparation method to obtain urapidil hydrochloride injection with stable performance and low impurity content. Contents of the invention [0003] The embodimen...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/02A61K47/10A61K31/513A61P9/12
CPCA61K9/08A61K9/0019A61K47/02A61K47/10A61K31/513A61P9/12
Inventor 黄岭向文殿赵豪吴俊谭玉梅尹磊张可马金龙
Owner WUHAN DOCAN PHARMA
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