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A kind of preparation method of budesonide sterile raw material and its suspension for inhalation

A technology for suspension and raw materials, which can be applied to medical preparations without active ingredients, medical preparations containing active ingredients, pharmaceutical formulas, etc., can solve the problems of unstable budesonide aseptic raw materials and low sterility assurance. , to achieve the effect of high sterility guarantee and good sterilization effect of finished products

Active Publication Date: 2020-09-11
苏州西克罗制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] On the one hand, the present invention can solve the problem that the sterile raw material of the water-insoluble drug budesonide is unstable when the sterilization temperature is higher than 160°C in dry heat sterilization, and on the other hand, it can solve the problem that the sterile raw material of the water-insoluble drug budesonide is sterilized at a temperature of 100-100°C. Dry heat sterilization at 130°C has a low sterility guarantee. It can be seen that this method is especially suitable for the preparation of nebulized inhalation budesonide suspension

Method used

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  • A kind of preparation method of budesonide sterile raw material and its suspension for inhalation
  • A kind of preparation method of budesonide sterile raw material and its suspension for inhalation
  • A kind of preparation method of budesonide sterile raw material and its suspension for inhalation

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preparation example Construction

[0040] A kind of preparation method of budesonide suspension provided by the invention comprises:

[0041] Step 1: Prepare a suspension: disperse the sterile raw material of the water-insoluble drug budesonide in the sterilized auxiliary material solution, and the dispersion speed is 2000-20000 rpm to obtain a suspension containing budesonide;

[0042] Step 2: High-pressure homogenization: The suspension containing budesonide in step 1 is wet-micronized by a high-pressure homogenizer to a suitable particle size distribution, and the budesonide suspension is obtained by constant volume with water for injection, wherein the high-pressure homogenization The qualitative pressure is 100~

[0043] 1500bar, high-pressure homogenization of the suspension until the particle size distribution is d(v, 0.5) = 1-3 μm, d(v, 0.5) < 5 μm;

[0044] Step 3: potting: potting the budesonide suspension obtained in step 2 into an ampoule to prepare a budesonide suspension for inhalation.

Embodiment 1

[0047] Comparison of physical and chemical properties of bulk drug budesonide before and after nitrogen filling sterilization

[0048] In this embodiment, a series of experiments were carried out to confirm the effects of sterilization temperature, time and nitrogen filling on the content of budesonide bulk drug and related substances.

[0049] The specific measures are as follows:

[0050]Sterilize in a hot air disinfection box, the model of the hot air disinfection box is BGZ-30, fill the raw material of budesonide with nitrogen, heat and sterilize the budesonide after filling with nitrogen, and the sterilization condition of 1# sample is 160 ° C × 190 min (filling with nitrogen) Nitrogen), the sterilization condition of 2# sample is 170°C×120min (nitrogen filled), the sterilization condition of 3# sample is 130°C×120min (not filled with nitrogen), the sterilization condition of 4# sample is 160°C×120min (not filled with nitrogen). After the sterilization treatment, the ch...

Embodiment 2

[0055] Comparison of physical and chemical properties of bulk drug budesonide before and after nitrogen filling sterilization

[0056] In this embodiment, a series of experiments were carried out to confirm the influence of sterilization temperature, time and nitrogen filling on the crystal form of budesonide bulk drug.

[0057] The specific measures are as follows:

[0058] Sterilize with a hot air disinfection box, the model of the hot air disinfection box is BGZ-30, fill the bulk drug of budesonide with nitrogen, heat and sterilize the budesonide after nitrogen filling, and the sterilization condition of sample 1 is 160 ° C × 190min (nitrogen filling ), the sterilization condition of sample 2 is 170°C×120min (nitrogen filling), see Table 2 below for details.

[0059] Table 2: Conditions for dry heat sterilization of Budesonide API

[0060] Numbering raw material 1# 2# temperature / ℃ / 160 170 time / min / 190 120 Whether to fill nitrogen / ...

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Abstract

The invention provides a preparation method of a budesonide sterile material and suspension thereof for atomization inhalation. On one hand, the problem of instability generated when dry heat sterilization adopts water insoluble medicine-the budesonide sterile material of which the sterilization temperature is higher than 160 DEG C can be solved, and on the other hand, the problem of low sterile guarantee when the water insoluble medicine-the budesonide sterile raw material adopts dry heat sterilization of 100-130 DEG C is solved. Therefore, the method is especially suitable for preparing thebudesonide suspension used for atomization inhalation.

Description

technical field [0001] The invention relates to a water-insoluble drug budesonide aseptic raw material and a preparation method thereof for atomized inhalation suspension. Background technique [0002] Atomization inhalation therapy uses an atomization device to disperse the drug into tiny droplets, suspend it in the gas, and inhale it into the respiratory tract and lungs, so as to achieve the purpose of cleaning and humidifying the airway, local treatment and systemic treatment. Due to the advantages of easy use, quick onset, small drug dosage and less systemic side effects, especially in the past ten years, due to the continuous improvement of atomization devices and the development and development of various inhalable drugs, this therapy has become the most popular treatment for respiratory diseases today. One of the important methods of treatment. [0003] Budesonide suspension for inhalation is a short-acting and quick-acting glucocorticoid with strong anti-inflammator...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/72A61K9/10A61K31/58A61K47/26A61P11/00A61P5/44
CPCA61K9/0078A61K9/10A61K31/58A61K47/26
Inventor 陶少林周渊陈孝果刁翔翔郑世智
Owner 苏州西克罗制药有限公司
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