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Method for removing impurities in pharmaceutical preparation based on biological medicine

A technology for biomedicine and biological preparations, applied in the field of biomedicine, can solve problems such as difficulty in meeting the needs of the biomedical industry, blockage of ultrafiltration membranes, and impact on the impurity removal effect of pharmaceutical preparations, and achieve the effect of improving the impurity removal effect and high promotion value.

Inactive Publication Date: 2021-11-05
CHENGDU CYNOGEN BIO-PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0002] Biomedical engineering is the comprehensive application of the principles and methods of life science and engineering science. From the perspective of engineering, it understands the structure, function and other life phenomena of the human body at multiple levels in molecules, cells, tissues, organs and even the entire human body system. The general term for artificial materials, products, devices, and system technologies for disease treatment, human body function assistance, and health care. At present, when pharmaceutical preparations are produced through biomedical engineering, there are often certain impurities in the preparation liquid, and the current removal of pharmaceuticals Most of the methods of impurity in the preparation are to filter the preparation liquid directly through the ultrafiltration membrane, and this kind of filtration method, because the impurity in the preparation liquid is not subjected to pretreatment such as adsorption and purification during membrane filtration, so it is extremely difficult. It is easy to cause clogging of the ultrafiltration membrane and affect the impurity removal effect of pharmaceutical preparations, making it difficult to meet the needs of the biomedical industry

Method used

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  • Method for removing impurities in pharmaceutical preparation based on biological medicine

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Effect test

Embodiment 1

[0023] The method for removing impurities in pharmaceutical preparations based on biomedicine comprises the following steps:

[0024] Step S1, pretreatment: adding the biomedical preparation liquid into the container, and putting the container into a sterilization box for high-temperature steam sterilization at a temperature of 120 degrees Celsius for 20 minutes;

[0025] Step S2, oscillating: add the adsorbent to the pretreated biological preparation liquid, and place the container on the shaker for shaking and mixing. The impurities in the medium are fully adsorbed;

[0026] Step S3, static precipitation: the shaken container is left to stand for 15 minutes, so that the adsorbent in the biological preparation liquid in the container is gradually precipitated to the lower liquid layer, and the biological preparation liquid after the impurities are absorbed in the upper layer of the container is extracted;

[0027] Step S4, filtering and purifying: putting the extracted biolo...

Embodiment 2

[0031] The method for removing impurities in pharmaceutical preparations based on biomedicine comprises the following steps:

[0032] Step S1, pretreatment: adding the biomedical preparation liquid into the container, and putting the container into a sterilization box for high-temperature steam sterilization at a temperature of 130 degrees Celsius for 30 minutes;

[0033] Step S2, oscillating: add the adsorbent to the pretreated biological preparation liquid, and place the container on the shaker for shaking and mixing. The impurities in the medium are fully adsorbed;

[0034] Step S3, static precipitation: the shaken container is left to stand for 15 minutes, so that the adsorbent in the biological preparation liquid in the container is gradually precipitated to the lower liquid layer, and the biological preparation liquid after the impurities are absorbed in the upper layer of the container is extracted;

[0035] Step S4, filtering and purifying: putting the extracted biolo...

Embodiment 3

[0039] The method for removing impurities in pharmaceutical preparations based on biomedicine comprises the following steps:

[0040] Step S1, pretreatment: adding the biomedical preparation liquid into the container, and putting the container into a sterilization box for high-temperature steam sterilization at a temperature of 140 degrees Celsius for 35 minutes;

[0041] Step S2, oscillating: add the adsorbent to the pretreated biological preparation liquid, and place the container on a shaker for shaking and mixing. The impurities in the medium are fully adsorbed;

[0042] Step S3, static precipitation: the shaken container is left to stand for 15 minutes, so that the adsorbent in the biological preparation liquid in the container is gradually precipitated to the lower liquid layer, and the biological preparation liquid after the impurities are absorbed in the upper layer of the container is extracted;

[0043] Step S4, filtering and purifying: putting the extracted biologi...

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Abstract

The invention discloses a method for removing impurities in a pharmaceutical preparation based on biological medicine. The method comprises the following steps: step S1, pretreatment; step S2, oscillating; step 3, standing and precipitating; step S4, filtering and purifying; and step 5, final treatment. Before membrane filtration, an adsorbent is added into a pretreated biological agent liquid, the biological agent liquid is placed on an oscillator to be oscillated and mixed uniformly, so that impurities in the biological agent liquid are fully adsorbed and purified by the adsorbent, and then the biological agent liquid is subjected to standing for 15 min, thus the adsorbent in the biological agent liquid in the container is gradually precipitated to the lower layer of the liquid, the biological agent liquid adsorbing impurities on the upper layer of the container is extracted, and then the extracted biological agent liquid on the upper layer is filtered through an ultrafiltration membrane, so that the biological agent liquid is subjected to pre-treatment such as adsorption and purification in advance, and the biological preparation liquid is prevented from being directly subjected to membrane filtration to block an ultrafiltration membrane. Therefore, the impurity removal effect of the pharmaceutical preparation liquid is greatly improved, and the industrial requirements of biological medicines are met.

Description

technical field [0001] The invention relates to the technical field of biomedicine, in particular to a method for removing impurities in pharmaceutical preparations based on biomedicine. Background technique [0002] Biomedical engineering is the comprehensive application of the principles and methods of life science and engineering science. From the perspective of engineering, it understands the structure, function and other life phenomena of the human body at multiple levels in molecules, cells, tissues, organs and even the entire human body system. The general term for artificial materials, products, devices, and system technologies for disease treatment, human body function assistance, and health care. At present, when pharmaceutical preparations are produced through biomedical engineering, there are often certain impurities in the preparation liquid, and the current removal of pharmaceuticals Most of the methods of impurity in the preparation are to filter the preparati...

Claims

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Application Information

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IPC IPC(8): B01D61/14B01D15/00A61L2/07A61L2/04A61L2/26
CPCB01D15/00B01D61/145A61L2/0023A61L2/04A61L2/26A61L2202/21A61L2202/23
Inventor 蒋煜
Owner CHENGDU CYNOGEN BIO-PHARM TECH CO LTD
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