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Traditional Chinese medicine injection macromolecular impurity removing technology evaluation method

A technology for impurity removal and evaluation methods, which is applied in pharmaceutical formulations, medical preparations containing active ingredients, drug delivery, etc., and can solve the problems of unclear methods for removing polymer impurities and lack of evaluation methods

Active Publication Date: 2013-09-18
哈药集团中药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The present invention is to solve the problem that the method of polymer impurity removal process is not clear in the existing traditional Chinese medicine injection production process, or the problem that the known polymer impurity removal method lacks an effective evaluation method for verification or proof

Method used

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  • Traditional Chinese medicine injection macromolecular impurity removing technology evaluation method
  • Traditional Chinese medicine injection macromolecular impurity removing technology evaluation method
  • Traditional Chinese medicine injection macromolecular impurity removing technology evaluation method

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Experimental program
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specific Embodiment approach 1

[0021] Embodiment 1: The evaluation method of polymer impurity removal process in a kind of traditional Chinese medicine injection of this embodiment is carried out according to the following steps:

[0022] Prepare the extracts from each process of the extraction and purification process of Chinese herbal medicines in traditional Chinese medicine injections into a liquid to be tested in which the concentration of dry solids is greater than or equal to 100mg / mL, and then evaluate the final product by detecting polymer impurities in the liquid to be tested Whether it is up to standard;

[0023] Wherein, the detection method of the macromolecular impurities is as follows: the extracts before and after the treatment of each process in the extraction and purification process of Chinese herbal medicines are detected one by one for the macromolecular impurities, if the detection results of the macromolecular impurities before and after each process show high If the molecular impurit...

specific Embodiment approach 2

[0027]Specific embodiment 2: The difference between this embodiment and specific embodiment 1 is that the extract of each process obtained by adopting the hydroalcohol treatment technology is the concentrated extract of the decoction of medicinal materials, and ethanol is recovered in the supernatant of primary alcohol precipitation. After the extract, the extract obtained by washing the supernatant with water once, the extract after recovering ethanol from the supernatant of the second alcohol precipitation, and the finally obtained extract or dry extract powder. Other steps and parameters are the same as those in Embodiment 1.

specific Embodiment approach 3

[0028] Specific embodiment three: the difference between this embodiment and specific embodiment one or two is that high performance liquid chromatography combined with evaporative light scattering detector is used to extract and purify Chinese medicinal materials in traditional Chinese medicine injections through dextran gel chromatographic columns. The extracts from the process were tested for polymer impurities. Other steps and parameters are the same as those in Embodiment 1 or Embodiment 2.

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Abstract

The invention discloses a traditional Chinese medicine injection macromolecular impurity removing technology evaluation method, relates to a macromolecular impurity removing technology evaluation method, and aims to solve a problem that a macromolecular impurity removing technological method of a conventional traditional Chinese medicine injection production technological process is not exact or no effective evaluation method is provided for inspecting or testing the known macromolecular impurity removing method. According to the method, the extracts of various traditional Chinese medicine extraction and purification technological processes of the traditional Chinese medicine injection and a concentrated liquid medicine in an ultra-filtration process of the traditional Chinese medicine injection concentrated liquid medicine are subjected to macromolecular impurity detection, and a macromolecular impurity removing path in a whole technological process is clear; the method is utilized to evaluate the macromolecular removing effect of the corresponding process as well as the technological reasonability and scientificity; and the method can also be utilized to evaluate an industrial production line and is provided for applying an ultra-filtration technology in the traditional Chinese medicine injection preparation field.

Description

technical field [0001] The invention relates to an evaluation method for removing polymer impurities from traditional Chinese medicine injections. Background technique [0002] Traditional Chinese medicine injections are made by extracting and refining one or more kinds of herbal medicines or animal medicines. During the extraction process, there are some high-molecular substances, such as proteins, polysaccharides, and tannins. Once such substances are introduced into finished traditional Chinese medicine injections in large quantities, it will cause a series of adverse reactions or adverse events of traditional Chinese medicine injections. Therefore, the State Food and Drug Administration pointed out in the "Technical Principles of Production Process Evaluation for Safety Re-evaluation of Traditional Chinese Medicine Injections (Trial)" that "macromolecular impurities should be controlled during the production process. For example, ultrafiltration and other methods are use...

Claims

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Application Information

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IPC IPC(8): A61K36/00A61K9/08A61K9/19A61K36/537A61K36/634
Inventor 裴福成李文春李长新崔仁海解黎雯付饶单钰毓苏德龙王英新
Owner 哈药集团中药有限公司
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