A kind of preparation method of arginine aspirin sterile powder

A technology of arginine aspirin and aspirin, which is applied in the field of preparation of arginine aspirin, can solve problems such as stability problems, long dissolution time, clogged filter, etc., achieve fast speed, shorten dissolution time, and clear dissolution and clarification boundaries Effect

Active Publication Date: 2016-06-08
蚌埠丰原涂山制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are some problems with this method: ①Arginine powder is not uniform in thickness, contains 30-50% of particles above 40 mesh, and takes a long time to dissolve. The phenomenon that arginine is not completely dissolved and arginine aspirin has begun to precipitate , the filtering window period is short or absent, and the sterile filtration cannot be completed
②If the amount of water added is slightly larger, although the filtration window period is long, the subsequent process cannot be precipitated; if less water is added and the dissolution is slow, the filtration window period is short or not, and arginine aspirin crystals have been precipitated during the filtration process, blocking the filter
[0006] The usual preparation method of arginine aspirin adopts freeze-drying such as CN201110028957.3 (publication number is CN102146030A), and solid powder can be obtained, but compared with the method of crystallization in solution, the degradation products cannot be removed in the process, and free salicyl The acid is high, and the moisture content of the freeze-dried product is generally large, and the stability will be problematic
[0007] Although the method of said patent is novel and easy to obtain non-sterile products in small tests, it cannot solve the problem of filtration window period and cannot realize spontaneous nucleation and crystallization in large-scale production, so it is impossible to prepare sterile products

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Embodiment 1: the preparation method of arginine aspirin sterile powder

[0034] 1) Add 100kg of absolute ethanol, 10.3kg of aspirin, 10kg of arginine (80 mesh particle size) and 4kg of water into a 200-liter dissolution kettle, control the temperature at 18-20°C, stir and dissolve, and the solution is clarified for about 10 minutes, and then quickly After pressure filtration through a 0.22 μm filter to a 300-liter crystallization kettle, add 20 g of seed crystals to the crystallization kettle during the pressure filtration process (the amount of seed crystals added is 0.99% of the theoretical amount of arginine aspirin), and adjust the temperature of the crystallization kettle to 28- 30°C, after the pressure filtration is over, continue to heat and crystallize for 2 hours;

[0035] 2) Add 100kg of absolute ethanol to the crystallized liquid in step 1), then cool down to about 5°C at 10°C / hour, and keep warm for 6 hours;

[0036] 3) Shake filtration, wash with absolute...

Embodiment 2

[0037] Embodiment 2: the preparation method of arginine aspirin sterile powder

[0038] 1) Add 80kg of absolute ethanol, 10.3kg of aspirin, 10kg of arginine (with a particle size of 100 mesh) and 6kg of water into a 200-liter dissolution kettle, control the temperature at 18-20°C, stir and dissolve, the solution is clarified for about 10 minutes, and then quickly After pressure filtration through a 0.22 μm filter to a 300-liter crystallization kettle, add 60 g of seed crystals to the crystallization kettle during the pressure filtration process (the amount of seed crystals added is 2.96% of the theoretical amount of arginine aspirin), and adjust the temperature of the crystallization kettle to 28- 30°C, after the pressure filtration is over, continue to heat and crystallize for 2 hours;

[0039] 2) Add 80kg of absolute ethanol to the crystallized liquid in step 1), then cool down to about 5°C at 10°C / hour, and keep warm for 6 hours;

[0040] 3) Shake filtration, wash twice wi...

Embodiment 3

[0041] Embodiment 3: the preparation method of arginine aspirin sterile powder

[0042] 1) Add 50kg of absolute ethanol, 10.3kg of aspirin, 10kg of arginine (with a particle size of 120 mesh) and 8kg of water into a 200-liter dissolution kettle, control the temperature at 18-20°C, stir and dissolve, the solution is clarified in about 10 minutes, and passes through quickly Press filter through a 0.22μm filter to a 300-liter crystallization kettle, add 100g of seed crystals to the crystallization kettle during the press filtration process (the amount of seed crystals added is 4.93% of the theoretical amount of arginine aspirin), and adjust the temperature of the crystallization kettle to 28-30°C , press filtration finishes, continue insulation and crystallization for 2 hours,

[0043] 2) Add 50kg of absolute ethanol to the crystallized liquid in step 1), then cool down to about 5°C at 10°C / hour, and keep warm for 6 hours;

[0044] 3) Shake filtration, wash twice with absolute e...

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Abstract

The invention relates to a preparing method of arginine aspirin sterile powder. The method includes following steps of: reacting absolute ethyl alcohol, aspirin, arginine and water, performing filter pressing, adding a crystal seed, adding absolute ethyl alcohol, cooling, washing and drying. The method is an improvement based on a scheme provided by the prior art, and is compact in crystallization temperature-maintaining time and total preparation time, thus further reducing production of free salicylic acid in a process.

Description

technical field [0001] The invention relates to a preparation method of arginine aspirin, in particular to a preparation method of arginine aspirin aspirin powder. Background technique [0002] Arginine Aspirin (Arginine Aspirin) is a double salt formed by L-arginine and aspirin, also known as aspirin arginine salt. Its pharmacological effect is the same as that of aspirin. It is used for symptomatic treatment of fever and mild to moderate pain. Because of its good water solubility, it can be made into injections for intramuscular or intravenous injection, and the onset of action is relatively fast and strong. [0003] Existing preparation methods and disadvantages: [0004] Arginine aspirin is usually obtained by reacting an aqueous solution of arginine with an alcohol solution of aspirin at 30-40°C, adding distilled water to make the solution clear, sterile filtering, crystallization and filtration. However, the amount of water added in this method is relatively high, an...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07C69/157C07C67/28C07C67/52C07C279/14C07C277/08
Inventor 谢延许祥雷吴慧龙顾有劲
Owner 蚌埠丰原涂山制药有限公司
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