Stable cefaclor granule medical composition

Abstract

The invention relates to a stable cefaclor granule medical composition, belongs to the technical field of a pharmaceutical preparation, and provides the stable cefaclor granule medical composition. The cefaclor granule medical composition disclosed by the technical scheme comprises components in percentage by mass of (based on unit dosage) 6.5%-17.8% of cefaclor (based on C15H14ClN3O4S ), 1%-5% ofsilicon dioxide, 65%-90% of a stuffing agent, 1%-5% of an adhesion agent, and 1%-5% of a disintegrant.

Description

technical field [0001] The invention relates to a stable pharmaceutical composition of cefaclor granules, which belongs to the technical field of pharmaceutical preparations. Background technique [0002] Cefaclor, developed by Eli Lilly Laboratories, is a second-generation cephalosporin with broad-spectrum antibacterial effects. Its mechanism of action is the same as that of other cephalosporins, and its bactericidal effect is mainly achieved by inhibiting the synthesis of cell walls. They were listed in the United States, Japan and other countries, and are now sold in many countries around the world including China. The main product names are Ceclor, Ceclor ® , Distaclor, kefral, keflor, Koofola, etc. At present, there are various dosage forms such as dry suspensions, capsules, tablets and granules for sale in my country. [0003] According to the cefaclor fine granule IF document and patent CN108743547A disclosed by Japan Shionogi Company, cefaclor is not very stable to...

AI Technical Summary

Problems solved by technology

Drug content is a key indicator of drug efficacy, and drug impurities are an important source of drug side effects and adverse reactions. The poor stability of cefaclor has brought hidden dangers to the effectiveness and safety of drugs

[0004] CN103330685B and CN108743547A adopt drug inclusion technology, utilize the mode of clathrate wrapping main drug to process main drug cefaclor, reduce the speed of drug degradation, but above-mentioned process adopts drug inclusion technology to need to increase step such as decompression drying, Increased process complexity and increased production costs

[0006] CN201510905949.0 proposes a method with a relatively high ratio (the mass ratio of butylphthalide and silicon dioxide is 0.1-4:1, that is, silicon dioxide accounts for up to 90.9% of the total weight in the drug loading process), strong adsorption The silicon dioxide powder is used as a drug carrier to absorb liquid butylphthalide, which solves the problems of complex components of butylphthalide solid dosage form, small drug loading, poor drug stability, complicated and time-consuming preparation process, but It is necessary to choose silica with high pore volume as the carrier (such as SYLOID®244 FP or CAB-O-SIL®M-5P), which is expensive, and because of the high pore volume, the particle size of silica is very fine, and it is easy to form a high dust environment when the amount is large , the risk of dust explosion needs to be paid attention to during the production of products, and there is a high demand for explosion-proof equipment and operations, and at the same time, there is a risk of potential respiratory tract irritation and even pulmonary fibrosis for production personnel

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