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Freeze-dried powder and preparation method and application thereof

A technology of freeze-drying and powder, which is applied in the direction of pharmaceutical formulations, preparations for in vivo tests, echo/ultrasonic imaging agents, etc., can solve the problems of limited production batches, difficulties in large-scale production, and high energy consumption in production, and achieve the number of microbubbles Ideal particle size, increased production volume, and reduced production energy consumption

Active Publication Date: 2021-09-28
NKD PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this technology requires a pre-freezing temperature of -45°C and low-temperature quick-freezing, which is very demanding on equipment in industrial production. Too low quick-freezing temperature not only consumes a lot of energy for production, but also limits the production batch, making industrialized large-scale production There are difficulties, as described in the patent CN112165959A, its production batch can only reach several thousand

Method used

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  • Freeze-dried powder and preparation method and application thereof
  • Freeze-dried powder and preparation method and application thereof
  • Freeze-dried powder and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0031] This experimental example provides a method for preparing freeze-dried microbubbles in the prior art, and compares the effects of the two freeze-drying methods on the effect of the product.

[0032] 1. Preparation of lyophilized microbubbles:

[0033] Prepare freeze-dried microbubbles according to the method disclosed in Example 2 of Patent CN112165959 A: add 190mg DSPC, 190mg DPPG-Na and 40mg PA to 84ml hexane / ethanol (8 / 2, v / v) mixed solvent, stir until dissolved, Evaporate the solvent to dryness under vacuum, add 24.56g PEG4000, add 500ml tert-butanol after mixing, heat up to about 60°C to dissolve, filter with a 0.22μm filter membrane, fill it into an 8ml injection bottle, half-press the stopper, and use quick-freezing (pre- Freezing temperature -45°C) and slow freezing (pre-freezing temperature -30°C) for freeze-drying, the specific freeze-drying procedures are: 1) Pre-freezing: the shelf is pre-cooled to -45°C or -30°C and placed in The sample was maintained for ...

Embodiment 1

[0041] This example provides a preparation method of the freeze-dried powder of the present invention, and its effect is verified.

[0042] 1. Preparation and Evaluation of Lyophilized Microbubbles

[0043]The preparation of layered phospholipids and the steps of mixing with PEG4000 are the same as those in Experimental Example 1. After that, add 500ml of tert-butanol / 2-methyl-2-butanol (97 / 3, v / v) mixed solvent, heat up to about 60°C to dissolve, filter with a 0.22μm membrane, and fill it into an 8ml injection bottle. The freeze-dried microbubbles were prepared by the pre-freezing method of slow freezing (-30°C) (the specific freeze-drying procedure was the same as that of Experimental Example 1). 6 Saturate and seal the injection vial with a rubber stopper. The evaluation method of the aerated microbubble suspension is the same as that of Experimental Example 1.

[0044] 2. Results analysis, see Table 2:

[0045] Table 2

[0046]

Embodiment 2

[0048] This example provides a preparation method of the freeze-dried powder of the present invention, and its effect is verified. The specific preparation and evaluation method of freeze-dried microbubbles are the same as those in Example 1, except that the freeze-drying solvent is selected from tert-butanol and 2-methyl-2-butanol, the volume ratio of the two is 95:5.

[0049] The evaluation results are shown in Table 3:

[0050] table 3

[0051]

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Abstract

The invention relates to the technical field of medical preparations, and particularly discloses freeze-dried powder and a preparation method and application thereof. According to the preparation method of the freeze-dried powder, the freeze-dried powder contains layered phospholipid, and during freeze-drying, the pre-freezing temperature is minus 20 to minus 40 DEG C; the freeze-drying solvent is a mixed solvent composed of tert-butyl alcohol and an auxiliary solvent; and the auxiliary solvent is one or two of cyclohexane, DMSO, 1, 4-dioxane, cyclohexanol and 2-methyl-2-butanol, and the auxiliary solvent accounts for 1%-9% of the volume of the mixed solvent. According to the method, the concentration and the number of microbubbles of the product prepared when the tert-butyl alcohol is independently used as the freeze-drying solvent can be achieved, the pre-freezing temperature is effectively increased, and industrial production is facilitated.

Description

technical field [0001] The invention relates to the technical field of medical preparations, in particular to a freeze-dried powder and a preparation method and application thereof. Background technique [0002] Ultrasound contrast agent is a solution in which air bubbles with a diameter of several micrometers are suspended. It is a diagnostic reagent used to enhance the detection signal of medical ultrasound. The first generation of ultrasound contrast agents is air-encapsulated microbubble contrast agents, such as commercialized products such as Levovist and Albune. Due to their small molecular weight, short duration and easy rupture due to the influence of arterial pressure, their clinical application has been limited. limits. The second-generation ultrasound contrast agent is mainly obtained by wrapping fluorocarbon or sulfur hexafluoride gas in the shell membrane of various materials, such as the commercialized products SonoVue, Optison, FS069 and Echogen, etc. These c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K49/22
CPCA61K49/223A61K49/222
Inventor 穆树花左保燕马丽端陈成军
Owner NKD PHARMA CO LTD
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