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Method and equipment for adopting variable-frequency alternating current electric field for assisting freeze drying of drug liposome powder

一种交流电场、脂质体粉的技术，应用在脂质体输送、照明和加热设备、冻干输送等方向，能够解决品质均匀性得不到保证、干燥时间长、冷冻时间长等问题，达到避免灭菌处理工作、干燥升华阶段减短、冷冻结晶时间减少的效果

Active Publication Date: 2015-06-03
SOUTH CHINA UNIV OF TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] (1) Ordinary freeze-drying methods cannot control the growth of ice crystals in the freezing stage, that is, nucleation randomness, shape individuality, etc., and the size of the ice crystals further affects the time of the drying stage, and larger ice crystals may be punctured during the freezing process cells, leading to loss of efficacy
Inconsistently sized ice crystals leading to inconsistent quality
[0008] (2) The freeze-drying method of adding nucleating reagents, additionally added nucleating reagents, complex parameters, difficult operation and high cost
[0009] (3) The emerging ultrasound-assisted freeze-drying technology is prone to damage to the drug effect due to the instantaneous large amount of latent heat brought by ultrasound; and the ultrasound function can only be brought into play when there is an ultrasound medium, and the existence of this medium will It greatly affects the design of the ultrasonic-freeze-drying machine, which brings great inconvenience; in addition, the noise caused by ultrasonic is also extremely harsh
[0010] (4) The condensing refrigeration system of conventional water replenisher has slow heat transfer and long freezing time; the heating system composed of conventional ordinary heating plates has long drying time and energy consumption, which has a certain impact on the quality of finished products

Method used

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  • Method and equipment for adopting variable-frequency alternating current electric field for assisting freeze drying of drug liposome powder

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] figure 1 It is a schematic diagram of the equipment for assisted freeze-drying of drug liposome powder by frequency-variable alternating electric field in this embodiment. figure 1 As shown, it includes a preparation tank 1, a metering pump 2, a dehydrator 3, and a high / low temperature treatment chamber 4 connected in sequence; an electrode plate 32 is respectively arranged on the upper and lower sides of the sample tank 31 in the dehydrator 3; An electrode plate 42 is respectively arranged above and below the sample tank 41 in the high / low temperature processing chamber 4; the electrode plate is connected with the high-voltage frequency conversion AC power supply control box 8; the high / low temperature processing chamber 4 is also connected with a vacuum pump 5 connection; the high / low temperature processing chamber is used for freeze-drying and heating-drying of samples.

[0043]The sample tank 41 of the high / low temperature processing chamber 4 is provided with a se...

Embodiment 2

[0048] The method for the assisted freeze-drying of drug liposome powder of the frequency conversion alternating electric field of the present embodiment may further comprise the steps:

[0049] Weigh a certain amount of breviscapine, egg yolk lecithin, cholesterol, surfactant, and stabilizer in appropriate amounts, add a small amount of ethanol to ultrasonic to dissolve, decompress and rotary evaporate until the ethanol evaporates to dryness, and use a hydration medium containing mannitol and antioxidants Hydrate to obtain scutellarin liposome suspension (water content is 55%), the total volume is 3L. Flow into the sample tank of the dehydrator through the metering pump, give 4kV, 1kHz high-voltage alternating current treatment for 8min (at this time, the alternating current pulse occupies 40%), and demulsify and dehydrate to the water content of 25%; when preparing scutellarin liposome suspension At the same time, turn on the semiconductor power supply control box, directly ...

Embodiment 3

[0051] Weigh a certain amount of docetaxel, appropriate amount of soybean lecithin, cholesterol, surfactant, and mannitol, add a small amount of ethanol and sonicate until dissolved, reduce pressure and rotary evaporate until the ethanol evaporates to dryness, and use a hydration medium containing mannitol and antioxidants Hydrate to obtain a docetaxel liposome suspension (with a water content of 40%), with a total volume of 4 L. Place in the sample tank of the dehydrator, give 5kV, 500Hz high-voltage alternating current treatment 10min (at this time, the alternating current pulse is 50% empty), demulsification and dehydration to water content 18%; in the preparation of docetaxel liposome suspension At the same time, turn on the semiconductor power supply control box, directly connected to the refrigeration control system, and set the temperature at -30°C; the dehydrated sample flows into the sample tank of the high / low temperature processing room through the pipeline pump (the...

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Abstract

The invention discloses a method for adopting a variable-frequency alternating current electric field for assisting freeze drying of drug liposome powder. The method comprises the following steps that (1) a drug-liposome suspension sample is prepared; (2) under the condition of 1-10kHz and 3-10kV high-voltage alternating current treatment, samples are dewatered; (3) after 10-25kHz 0.2-1kV high-voltage alternating current treatment is carried out at -20-40 DEG C, the samples after being processed in the step (2) are subjected to freeze drying until the freezing is completed; (4) the samples are subjected to heating drying under the vacuum conditions until the sublimation and the analysis are completed, and the drug liposome freeze drying powder is obtained. The method has the advantages that the freezing and drying time is greatly shortened, in addition, the nucleation and ice crystal size is controlled, and the quality of the freeze drying powder is further ensured.

Description

technical field [0001] The invention relates to the technical field of freeze-drying of pharmaceutical preparations, in particular to a method and equipment for assisted freeze-drying of drug liposome powder by a variable-frequency alternating electric field. Background technique [0002] Vacuum freeze-drying (vacuum freeze-drying), also known as freeze-drying (freeze-drying), referred to as freeze-drying, is to freeze the material below the eutectic point temperature, and remove the moisture in the material by sublimation under low pressure. Drying method; especially suitable for extending the shelf life and improving the quality of biological agents, such as proteins, vaccines, microorganisms, etc. The general drying method is to change the moisture in the material from liquid to gas, while freeze drying is to change the moisture in the material from liquid to solid and then from solid to gas. The freezing of water is an exothermic process, and the sublimation of ice is a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): F26B7/00F26B20/00
CPCF26B5/06F26B3/347F26B3/34F26B25/22F26B20/00F26B7/00A61K9/1277A61K9/19F26B5/041
Inventor 孙大文程丽娜朱志伟曾新安王启军张孜
Owner SOUTH CHINA UNIV OF TECH
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