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Medicine composition for treating respiratory diseases and preparation method thereof

A technology for respiratory diseases and compositions, which is applied in the field of pharmaceutical compositions for the treatment of respiratory diseases and its preparation, can solve problems such as inapplicable clinical needs, tooth calcium loss, practicability of undescribed pharmaceutical compositions, etc., and meet clinical requirements. Drug demand, reduction of excessive dosage, effect of product drug safety

Pending Publication Date: 2019-04-12
SHANGHAI FANGYU HEALTH PHARMA TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Oral overdose of edetate disodium may lead to the loss of tooth calcium. WHO sets the daily acceptable dosage of edetate disodium as no more than 2.5mg / kg. CIPLA’s product prescription contains 0.05% edetate Disodium acid disodium, the maximum daily dosage is about 5mg, for infants and adolescents with light weight and taking into account individual differences, there is a certain risk, and it is not suitable for clinical needs
At the same time, the patent does not describe the practicability of the pharmaceutical composition in terms of effects

Method used

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  • Medicine composition for treating respiratory diseases and preparation method thereof
  • Medicine composition for treating respiratory diseases and preparation method thereof
  • Medicine composition for treating respiratory diseases and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034]

[0035]According to the prescription in Example 1, add solvent, sodium chloride, edetate disodium, pH regulator, raw materials to the liquid mixing tank in turn, the temperature of water for injection is 30 ° C, and the microbial contamination level is reduced by filter + single After high-grade filtration sterilization, it is aseptically filled with low-density polyethylene bottles. In this embodiment, the integrity of the filter needs to be checked before and after production. The product quality is stable and controllable, and meets the aseptic requirements.

Embodiment 2

[0037]

[0038] According to the prescription in Example 2, add solvent, sodium chloride, disodium edetate, raw materials, and pH regulator to the liquid mixing tank in sequence, and the temperature of water for injection is 40°C. Low-density polyethylene bottles are used for aseptic filling. In this example, the integrity of the filter needs to be checked before and after production. The product quality is stable and controllable, and meets the aseptic requirements.

Embodiment 3

[0040]

[0041] According to the prescription in Example 3, add solvent, sodium chloride, disodium edetate, raw materials, and pH regulator to the liquid mixing tank in turn, and the temperature of water for injection is 20 ° C. During the preparation process, the microbial contamination level is reduced by using a filter + two After stage series filtration and sterilization, it is aseptically filled with low-density polyethylene bottles. In this embodiment, the integrity of the filter needs to be checked before and after production, and the product quality is stable and controllable, meeting the aseptic requirements.

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PUM

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Abstract

The present invention relates to a medicine composition for treating a respiratory disease, and a preparation method thereof. The medicine composition comprises a beta-2 receptor agonist with a singleconfiguration, ipratropium bromide or a monohydrate thereof, a stabilizer, an osmotic pressure adjusting agent, a pH adjusting agent and a dispersion medium, wherein the stabilizer is one or more selected from sodium edetate and ascorbic acid, and the usage amount of the stabilizer is 0.002% to 0.02%.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a pharmaceutical composition for treating respiratory diseases and a preparation method thereof. Background technique [0002] In recent years, the incidence of asthma and chronic obstructive pulmonary disease (COPD) in China has increased significantly, and there are obvious differences between urban and rural areas, regions, and populations, and there is a huge demand for clinical medication. Inhalation therapy is the first choice for the treatment of asthma and COPD. The Global Initiative for Asthma (GINA) believes that direct administration in the airway is the main advantage of inhalation therapy. The Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) also recommends inhalation as COPD The preferred mode of administration for treatment. The inhalation route of administration has two obvious advantages: maximizing the drug concentration ...

Claims

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Application Information

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IPC IPC(8): A61K45/06A61K31/216A61K9/72A61K9/08A61K47/18A61K47/22A61P11/00A61P11/06A61K31/137
CPCA61K9/0078A61K9/08A61K31/137A61K31/216A61K45/06A61K47/183A61K47/22A61P11/00A61P11/06A61K2300/00
Inventor 金方连晓培闻聪王冬梅
Owner SHANGHAI FANGYU HEALTH PHARMA TECH CO LTD
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