Netilmicin sulfate aerosol

A netilmicin sulfate, aerosol technology, applied in aerosol delivery, respiratory diseases, organic active ingredients, etc., can solve the problems of complex preparation process of injections, large ototoxic side effects, and poor patient compliance. The effect of improving medication compliance, reducing ototoxicity, and reducing dosage

Pending Publication Date: 2022-03-15
ZHUOHE PHARM GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the injection preparation process is complicated, the dosage is large, the patient's compliance is poor, and the problem of systemic effect is inevitable when used for local treatment, and the side effects such as ototoxicity and nephrotoxicity are relatively large.

Method used

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  • Netilmicin sulfate aerosol
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] This embodiment is based on the prescription of 100ml of pharmaceutical preparations, including 10g of naftilmicin sulfate, and the dosages of the two compositions in the additives are different, see the table below for details.

[0018]

[0019]

[0020] Preparation method: a, take 60%-70% of the prescription amount of water, add the amount of the additive in serial number 1, stir and dissolve; ice bath makes the temperature of the preparation drop below 25°C; add the prescription amount of naftilmicin sulfate, stir Dissolve; add water below 25°C to the full amount, and stir evenly; keep the pH of the preparation at 5.0-6.5.

[0021] b. Fill the preparation prepared in step a into an aerosol bottle, first remove the air in the aerosol bottle, make the residual oxygen in the aerosol bottle between 0.5-1.5%, and quantitatively press nitrogen into the aerosol bottle , to obtain netilmicin sulfate aerosol (embodiment 1-1).

[0022] The amounts of the additives in th...

Embodiment 2

[0024] This embodiment is based on the prescription of 100ml of pharmaceutical preparations, including 5g of naftilmicin sulfate, and the dosages of the two compositions in the additives are different, see the table below for details.

[0025]

[0026] The preparation method is the same as that in Example 1, and will not be repeated here. The netilmicin sulfate aerosols prepared according to the amount of additives in the above-mentioned table Nos. 1-6 are respectively Examples 2-1 to 2-6.

[0027] In the two embodiments, the additive is selected from the composition of anhydrous sodium sulfite and sodium metabisulfite, and the dosage thereof should make the pH of the netilmicin sulfate aerosol be 5.0-6.5, so as to ensure the stability of the formulation.

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Abstract

The invention provides a netilmicin sulfate aerosol. The netilmicin sulfate aerosol is prepared from the following raw materials: 5 to 10g of netilmicin sulfate, 100 to 200ml of solvent, a propellant and 0.05 to 0.5 g of additive. According to the netilmicin sulfate aerosol provided by the invention, the medicine can directly reach the acting part, the netilmicin sulfate aerosol is uniform in distribution, quick in action, convenient to use, free of drinking water, suitable for people of all ages and beneficial to improving the medication compliance of patients, and the netilmicin sulfate aerosol can be pressed once. On the other hand, due to the fact that the medicine is used for local action, the administration dosage is obviously reduced, and the occurrence rate of side effects such as ototoxicity and renal toxicity is reduced.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a netilmicin sulfate aerosol. Background technique [0002] Netilmicin sulfate is an aminoglycoside antibiotic listed by Schering-Plough, which can be used for pleuropulmonary infections: bronchitis, bronchopneumonia, pleurisy, empyema. Lung infection is one of the most common secondary infections, with the highest incidence rate (64.7%), and has become one of the main causes of death of patients. Therefore, the correct and timely selection of effective antibiotics is particularly important. [0003] Because of its high water solubility, netilmicin sulfate is hardly absorbed after oral administration. At present, there are injection and freeze-dried formulations in clinical use, and the absorption is rapid and complete after intramuscular injection. However, the preparation process of the injection is complicated, the dosage is relatively large, the patient...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/12A61K31/7048A61K47/02A61P11/00
CPCA61K9/0078A61K9/12A61K31/7048A61K47/02A61P11/00
Inventor 黄红红朱丽薛丹露张峰
Owner ZHUOHE PHARM GRP CO LTD
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