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Urapidil hydrochloride freeze-dried powder for injection and preparing method thereof

A technology of urapidil hydrochloride and freeze-dried powder, which is applied in the field of medicine, can solve the problems of drug influence, achieve the effects of increasing curative effect, eliminating first-pass effect, and easy storage

Active Publication Date: 2008-07-30
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Similarly, the preparation process should not have the slightest ambiguity, such as the pre-freezing time, temperature, and heating time of the sublimation stage during the freeze-drying process, all of which will have a great impact on the drug.

Method used

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  • Urapidil hydrochloride freeze-dried powder for injection and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Add 27.35g of urapidil hydrochloride and 150g of mannitol into the liquid mixing tank, add 1500ml of water for injection and stir to dissolve, adjust the pH value of the solution to 5-6.5 with hydrochloric acid or sodium hydroxide, then add water for injection to 2000ml, add 0.05% (W / V) Medical activated carbon was stirred at room temperature for 40 minutes to decolorize. After decolorization, use a 0.22 μm sterilizing microporous filter membrane to fine filter. The filtrate was measured for pH value and content. The solution was frozen to -55°C for 5 hours, vacuumed to 6Pa after freezing, and slowly heated to -5°C for a heating time of 15 hours, kept at the temperature for 4 hours, then raised to 45°C for 4 hours, and then kept for 2 hours , Plugging, capping, and full inspection are packaged into the finished product warehouse.

Embodiment 2

[0054] Add 54.71g of urapidil hydrochloride and 100g of mannitol into the liquid mixing tank, add 1500ml of water for injection and stir to dissolve, adjust the pH value of the solution to 4 with hydrochloric acid or sodium hydroxide, then add water for injection to 2000ml, add 0.05% (W / V) Medical activated carbon is stirred at room temperature for 15 minutes to decolorize, and after decolorization, use a 0.22 μm sterilizing microporous filter membrane to fine filter, measure the pH value and content of the filtrate, divide it into 50 mg, half-stoppered, and freeze the divided solution to -55°C for 5 hours, vacuumize to 6Pa after freezing, slowly heat to -5°C, heating time is 15 hours, keep the temperature and heat for 4 hours, then raise the temperature to 45°C, heating time is 4 hours, then hold for 2 hours, press Plugging, capping, and full inspection are packaged into the finished product warehouse.

Embodiment 3

[0056] Add 54.71g of urapidil hydrochloride and 100g of mannitol into the liquid mixing tank, add 1500ml of water for injection and stir to dissolve, adjust the pH value of the solution to 6.5 with hydrochloric acid or potassium hydroxide, then add water for injection to 2000ml, add 0.05% (W / V) Medical activated carbon is stirred at room temperature for 15 minutes to decolorize, and after decolorization, use a 0.22 μm sterilizing microporous filter membrane to fine filter, measure the pH value and content of the filtrate, divide it into 50 mg, half-stoppered, and freeze the divided solution To -60°C, 3 hours, vacuumize to 10Pa after freezing, slowly heat to 0°C, heating time 20 hours, keep the temperature and heat for 6 hours, then heat up to 40°C, heating time 6 hours, then keep warm for 3 hours, press the plug , crimping, and full inspection are packaged into the finished product warehouse.

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Abstract

The invention relates to an urapidil hydrochloride freeze-dried powder used for injection and a preparation method. The freeze-dried powder consists of the urapidil hydrochloride and excipents in proportion. The preparation is realized according to the following steps: dissolving the main materials and excipents in water, decolorizing activated carbon, being frozen to minus 60 to minus 30 DEG C and for 3 to 8 hours, vacuum pumping, slow heating to 0 to 20 DEG C, the heating time is from 10 hours to 20 hours, keeping the heating temperature for 2 to 6 hours, rising temperature to 20 to 50 DEG C, the temperature rising time is 2 to 6 hours, heating insulation for 0.5 to 4 hours, being packaged and put in the stock room after tamponade, capping and qualified and complete test. The method utilizes gradient cooling processes and the prepared products are full in exterior, good in solubility, easy to transport and good in stability.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a medicine for treating cardiovascular and cerebrovascular diseases and a preparation method thereof, more specifically to a freeze-dried urapidil hydrochloride powder for injection and a preparation method thereof. Background technique [0002] Hypertension is a kind of common disease, frequently-occurring disease. With the improvement of people's living standards, the number of hypertensive patients is increasing day by day, especially the number of hypertensive crisis and severe hypertensive patients is constantly increasing, but there are few safe and effective injection drugs clinically used for this type of disease. High blood pressure affects work and life, and high blood pressure is the most important risk factor for coronary heart disease and cerebrovascular disease. 50% of myocardial infarction patients are hypertensive patients, and 76% of stroke patients have a histor...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/506A61K47/36A61K47/10A61P9/12A61P9/04
Inventor 刘保起李明华郭中明
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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