Preparation method of cefalexin capsule

Abstract

The invention discloses a preparation method of a cefalexin capsule, and belongs to the technical field of medicines. The method comprises the following steps of: by using cefalexin as a raw material,adding auxiliary materials into the raw material, performing mixing, carrying out dry granulation, filling and packaging to finally obtain a cefalexin capsule preparation, wherein the auxiliary materials include a microcrystalline cellulose-sodium carboxymethylcellulose compound. The national pharmacopoeia standard is met, the effect equal to the quality level of a reference preparation can be achieved, part of quality indexes are even superior to those of the reference preparation, and clinical experiments show that the cefalexin capsule preparation is clinically equivalent to the referencepreparation; and meanwhile, the product quality is improved, consistency evaluation is passed, the method has the advantages of being simple in process, suitable for large-scale industrial productionand the like, and the cefalexin capsule has been commercially produced and sold at present.

Description

technical field [0001] The invention belongs to the field of chemical medicine, and in particular relates to a preparation method of cephalexin capsules. Background technique [0002] Cefalexin belongs to the first generation of oral cephalosporin antibiotics, which was first synthesized by Eli Lilly Company of the United States in 1967. It is a drug widely used in clinical practice. The medicinal chemical name is (6R,7R)-3-methyl-7-[(R)-2-amino-2-phenylacetamido]-8-oxo-5-thia-1-azabicyclo[ 4.2.0] Oct-2-ene-2-carboxylic acid monohydrate, molecular formula C 16 h 17 N 3 o 4 S·H 2 O, with a molecular weight of 365.41, its capsule dosage form is suitable for acute tonsillitis, angina, otitis media, sinusitis, bronchitis, pneumonia and other respiratory tract infections, urinary tract infections and skin and soft tissue infections caused by sensitive bacteria. [0003] According to the "Opinions on Carrying Out the Consistency Evaluation of the Quality and Efficacy of Gene...

AI Technical Summary

Problems solved by technology

[0004] The difficulty of the present invention is that the original prescription process and quality standards cannot meet the technical requirements of the current new policy. For example, the dissolution curves of the products prepared by the prior art and the reference preparation are relatively low in similarity, and there is a risk of non-equivalent in vivo. The method also does not meet the relevant requirements of quality research and needs to be completely redeveloped, and since the consistency evaluation of the two specifications of the variety is carried out at the same time, and the small specification applies for exemption from clinical trials, the same prescription process must be applicable to products of different specifications of the variety

Images