Netilmicin sulfate inhalation powder and preparation method thereof

A technology of netilmicin sulfate and inhalation powder spray, applied in the field of netilmicin sulfate inhalation powder spray and its preparation, can solve the problems of inevitable systemic action, complicated preparation process of injection, poor compliance, etc. Reduced ototoxicity, high effective site deposition, fast onset effect

Active Publication Date: 2013-03-06
GUANGZHOU NEWORLD PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The injection preparation process is complicated, the patient's compliance is poor, and when used for local treatment, it is inevitable that the whole body will play a role, and the side effects are relatively large

Method used

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  • Netilmicin sulfate inhalation powder and preparation method thereof
  • Netilmicin sulfate inhalation powder and preparation method thereof
  • Netilmicin sulfate inhalation powder and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0050] The preparation method of netilmicin sulfate inhalation powder mist of the present invention comprises the following steps: mixing netilmicin sulfate or netilmicin sulfate with amino acid glidants, passing through jet pulverizer, fluidized bed supersonic airflow Grinding in a pulverizer, ball mill, vibrating mill, critical solvent recrystallization or spray drying to obtain a powder with a particle size of 0.1-10 μm, and then fill it into a capsule (preferably No. 3 hydroxypropyl methylcellulose-HPMC) Or in an aluminum blister, ie.

[0051] In the experiment, it was found that the inlet temperature of the spray drying would affect the moisture content of the powder and the particle size of the particles. Reducing the airflow will prolong the time for the droplets to evaporate, and the drying efficiency and yield will also decrease at the same time, because there is less air for evaporating the droplets, and the atomized particles cannot be blown into the cyclone separat...

Embodiment 1

[0059] The raw material composition of netilmicin sulfate inhalation powder mist described in the present embodiment is as follows:

[0060]

[0061] Get 30g of netilmicin sulfate and pulverize it with a micro-jet mill, so that the average particle size of the drug particles is 1-10 μm. After measuring the particle size, pack it into a capsule. The loading capacity of each capsule is about 20mg, containing 20.00mg of netilmicin sulfate.

Embodiment 2

[0063] The raw material composition of netilmicin sulfate inhalation powder mist described in the present embodiment is as follows

[0064]

[0065]

[0066] According to the above formula, take 50g of netilmicin sulfate, dissolve it in deionized water, and prepare a solution of 1670ml. 3 / min, the atomization pressure is 240kpa, and the liquid supply speed is 7ml / min to obtain spray-dried micropowder with a particle size of 1-10μm. After continuing to dry for 15min, collect it in a desiccator for preservation. Determination of drug content, loaded into capsules. The loading capacity of each capsule is about 20mg, containing 20.00mg of netilmicin sulfate.

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Abstract

The invention discloses netilmicin sulfate inhalation powder and a preparation method thereof. The powder consists of the following raw materials:, namely netilmicin sulfate or a mixture of the netilmicin sulfate and an amino acid glidant, wherein the weight ratio of the netilmicin sulfate to the amino acid glidant is 10-30:1. The method has the advantages that the preparation technology is simple, no organic solvent or preservative is used in the preparation process, the flowability of the prepared powder is greatgood, the deposit rate at effective parts is high, and the problems that the netilmicin sulfate has high water solubility and cannot be absorbed when isbeing orally taken are solved; and meanwhile, as the inhalation powder is used as a medicine performing a local function, the dosage of administration is obviously reduced, and the occurrence rate of side effects related to an aminoglycoside dosage, such as ototoxicity and renal toxicity is reduced.

Description

technical field [0001] The invention belongs to the field of pharmacy, in particular to a netilmicin sulfate inhalation powder mist and a preparation method thereof. Background technique [0002] Lower respiratory tract infection is the most common infectious disease, and the pathogen causing the infection must be identified in order to select effective antibiotics. Clinically, there are more and more antibiotics to choose from, and the drug-resistant strains have also increased significantly. Due to the application of high-dose cephalosporins, nosocomial infections, especially Pseudomonas aeruginosa and Enterococcus infections, are increasing. Advances in serology and molecular biology research have greatly improved people's understanding of mycoplasma, chlamydia infection or Legionella infection. Fluoroquinolones and macrolides have attracted people's attention. [0003] Pulmonary infection is one of the most common secondary infections, with the highest incidence rate (...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K9/14A61K31/7036A61K47/18A61K47/22A61P31/04A61P11/00
CPCY02A50/30
Inventor 吴传斌王雯潘昕
Owner GUANGZHOU NEWORLD PHARMA CO LTD
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