Methylphenidate hydrochloride pharmaceutical composition and preparation method thereof

Abstract

The invention discloses methylphenidate hydrochloride pharmaceutical composition and a preparation method thereof. The composition contains methylphenidate hydrochloride and mannitol. The preparation method comprises the following steps: 1), preparation is performed: ambroxol hydrochloride and mannitol are placed into a preparation tank in a weight ratio of 1:(1-20), water for injection is added, and the mixture is stirred until complete dissolution and uniform mixing are achieved; 2), sterile filtration, subpackaging and half stoppering are performed; and 3), vacuum freeze drying is performed to obtain a product. The composition and the preparation method have the advantages that the formula is simple, the technology is advanced, the quality is uniform and stable, moisture drying is thorough, and the redissolution performance is better.

Description

technical field [0001] The invention belongs to the field of medical technology preparation, and in particular relates to a methylphenidate hydrochloride composition for injection and a preparation method thereof. Background technique [0002] Methylphenidate hydrochloride is a central nervous system stimulant, and its mechanism of action in the treatment of attention deficit hyperactivity disorder is not clear. Methylphenidate is thought to act by blocking the reuptake of norepinephrine and dopamine by presynaptic neurons and by increasing the release of these monoamines into the extraneuronal space. At present, it is mainly used clinically for the treatment of ADHD in children. [0003] The basic information of methylphenidate hydrochloride is as follows: [0004] English name: Methylphenidate Hydrochloride [0005] CAS number: 298-59-9 [0006] Chemical name: methyl a-phenyl-2-piperidine acetate hydrochloride [0007] Chemical Structure: [0008] [0009] Molecul...

AI Technical Summary

Problems solved by technology

Using the traditional freeze-drying process, because part of the HCl in methylphenidate hydrochloride is sucked away under high vacuum conditions, the salt formation of methylphenidate hydrochloride is not complete, and part of methylphenidate exists in the form of bases, which cannot be completely dissolved in clinical use , visible foreign matter, insoluble particles and unqualified clarity, these phenomena all indicate that there may be more tiny particles in methylphenidate hydrochloride for injection prepared by traditional freeze-drying process

Among these particles, particles with a diameter of 5-20 microns and above can block blood flow when passing through pulmonary capillaries, thereby causing complications such as pulmonary embolism and even death. Exogenous particles can also form phlebitis at the injection site, At the same time, it may also cause venous vascular obstruction and patient injury, and there is a large clinical safety hazard.

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