Cefalexin oil suspension and preparation method thereof

Abstract

The invention discloses a cefalexin oil suspension. Every 100mL of the suspension contains the following raw and auxiliary materials: 2-30g of cefalexin, 0.9-1.0g of surfactant, 1.0-5.0g of colloid protective agent, 7.5-12.5g of suspending agent, 0-0.1% of antioxidant and the balance of oil phase. Under the condition of adopting specific auxiliary material varieties and proportions, the prepared suspension has the advantages of favorable physical stability, favorable needle penetrability and favorable redispersibility, and does not have the condition of quality reduction after being stored in a 4-60-DEG C environment for 3 months, which indicates stable quality.

Description

technical field [0001] The invention relates to a cephalexin oil suspension and a preparation method thereof, belonging to the field of medicine. Background technique [0002] Cephalexin, a β-lactam antibiotic, is a white or milky yellow crystalline powder; slightly odorous, it can inhibit the synthesis of cell walls, make the contents of cells swell to rupture and dissolve, and kill bacteria. Cephalexin is a first-generation cephalosporin, which has antibacterial effects on both Gram-positive and Gram-negative bacteria, and is a commonly used veterinary drug. [0003] Oil suspension is a heterogeneous liquid preparation formed by dispersing insoluble drugs in the oil phase. Its biggest feature is to prolong the drug's action time, reduce the frequency of medication, reduce labor intensity and reduce stress on the body. However, the preparation of oil suspensions, especially oil suspensions for injection, is relatively difficult. To obtain products with better physical stab...

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Problems solved by technology

However, the preparation of oil suspensions, especially oil suspensions for injection, is relatively difficult. To obtain products with better physical stability, needle penetration and redispersibility, it is very critical to determine the type and amount of suitable excipients. Moreover, oil Suspensions have high requirements on the storage environment, and improving their storage stability is also a factor that needs to be considered during the preparation process

[0004] The cephalexin oil suspension is included in the standards issued by the Ministry of Agriculture (New Veterinary Drug Review Center of the Ministry of Agriculture. Compilation of Veterinary Drug Quality Standards [S]. China Agricultural Press Color, 2013), its specification is 10%, but the commercially available Cefalexin oil suspensions are prone to problems of flocculation, poor needle penetration, and caking that cannot be dispersed after settling. It is unstable and often cannot be used due to flocculation problems, resulting in a large amount of waste of medicines

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