Preparation method of micropowder for pharmaceutical preparation of loxoprofen sodium dihydrate

Abstract

A kind of manufacture method of the pharmaceutical preparation micropowder of loxoprofen sodium dihydrate, wherein, use the impact pulverizer that is built-in air classification mechanism and use pin hammer, preferably atomization pulverizer, to loxoprofen sodium Dihydrate crystals or crystalline powders are pulverized to continuously produce fine powders of loxoprofen sodium dihydrate with a volume average particle diameter measured by a laser diffraction particle size distribution meter in the range of 20 to 120 μm.

Description

technical field [0001] The present invention relates to a method for producing loxoprofen sodium dihydrate preparation micropowder, in particular, relates to high productivity production of loxoprofen sodium having a volume average particle diameter in the range of 20 to 120 μm when measured by a laser diffraction particle size distribution meter. Method for the micronization of Soprofen Sodium Dihydrate. Background technique [0002] Loxoprofen sodium (common name) (2-[4-(2-oxocyclopentane-1-ylmethyl) phenyl] sodium propionate (chemical name)) is a non-steroidal anti-inflammatory, analgesic, Antipyretics are widely used in the treatment of chronic joint rheumatism, osteoarthritis, low back pain, etc. [0003] Usually, the powder of the original drug used in the preparation of pharmaceuticals must be pulverized to an appropriate particle size. As the reason, the following i)-iii) etc. are mentioned. i) Uniform mixing with excipients and the like is facilitated by making t...

AI Technical Summary

Problems solved by technology

[0009] However, as described in Patent Documents 1 to 4, it is well known that the powder of loxoprofen sodium dihydrate has the following properties: it has a characteristic adhesion and fixation property to the substance, so that it adheres between drugs or on equipment, containers, etc. , fixed and significantly hinder processing

Therefore, in order to pulverize loxoprofen sodium to the required particle size or particle size distribution as a preparation raw material, it is necessary to prevent clogging of the pulverizer caused by loxoprofen sodium adhesion and fixation, and the resulting Due to the special consideration of quality deterioration due to melting due to frictional heat, it is necessary to produce fine powder of loxoprofen sodium even at the expense of productivity

[0010] It can be seen that there is no established technology for avoiding the attachment and fixation of loxoprofen sodium to the interior of the pulverizer and the pulverization unit during pulverization and to efficiently produce loxoprofen sodium fine powder

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