A kind of preparation method of arginine aspirin sterile powder

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...

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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