Netilmicin sulfate lyophiled powder injection and preparation method thereof

Abstract

The invention discloses netilmicin sulfate lyophiled powder injection and a preparation method of the netilmicin sulfate lyophiled powder injection. Netilmicin sulfate and additives are added with water to be prepared into netilmicin sulfate injectable suspension, and the netilmicin sulfate lyophiled powder injection is obtained through freeze drying, wherein the additives are inclusion moleculesand pH conditioning agents, the inclusion molecules are selected from bletilla striata polysaccharide, beta-cyclodextrin, urea, thiourea, beta-cyclodextrin derivatives, deoxycholic acid and starch, and the pH conditioning agents are selected from sodium carbonate, sodium bicarbonate, ammonia water, sulfuric acid and phosphoric acid. Required auxiliary materials are few, the preparation process issimple, the freeze drying process is particularly screened and optimized, and the netilmicin sulfate lyophiled powder injection and the preparation method has the characteristics that the stability is high, the biological availability is high, the production cost is low, the quality is safe and reliable, and the like.

Description

technical field

[0001] The invention belongs to a pharmaceutical preparation, and in particular relates to the preparation of netilmicin sulfate freeze-dried powder for antibiotic injection by using clathrate technology and a preparation method thereof. Background technique

[0002] Netilmicin Sulfate, NTM is a new generation of semi-synthetic aminoglycoside antibiotics introduced in 1994, which works by inhibiting the normal protein synthesis of sensitive microorganisms. It is mainly used for infections in the respiratory tract, digestive tract, genitourinary system, skin and soft tissue, bone and joints, abdominal cavity and other parts caused by Gram-negative bacteria such as Escherichia coli, Klebsiella, Proteus, and Enterobacter. It has a strong effect on drug-resistant bacteria and β-lactam-resistant bacteria, and has become the drug of choice for clinical application indications of aminoglycosides. Netilmicin sulfate is not easy to absorb when taken orally, but it is...

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