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Method for removing pyrogen from injections

An injection and filtration technology, applied in the field of medicine, can solve the problems of backward production technology, affecting the penetration of excipient ingredients and drug ingredients, and affecting industrial development, etc.

Inactive Publication Date: 2010-03-31
NANJING UNIVERSITY OF TRADITIONAL CHINESE MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the backward production process of traditional Chinese medicine injections, it generally contains some allergic substances, pyrogens or irritating impurities, which seriously affects the development of the industry; although the application of modern ultrafiltration technology can effectively remove pyrogens in injections, it will generally affect The excipients contained in injections and the penetration of pharmaceutical ingredients, based on this reason, it is extremely important to tackle the common problems in the production process of injections, and to study the production common technology research on the safety of injections

Method used

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  • Method for removing pyrogen from injections

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0011] Example 1: Different molecular weight cut-off ultrafiltration membranes remove pyrogen test in tap water

[0012] Take 10L of tap water respectively, add a certain amount of Escherichia coli (containing endotoxin) culture solution to make it contain a certain amount of bacterial endotoxin, use 1-500,000 Dalton ultrafiltration membrane to ultrafilter, sample the original solution and ultrafiltration For the filtrate, the content of pyrogens before and after ultrafiltration of the liquid medicine was detected by dynamic turbidity method. The results are shown in Table 1.

[0013] Table 1 The effect of ultrafiltration membranes with a membrane pore size of 150,000-200,000 Daltons in removing pyrogens from tap water

[0014]

[0015] The results show that the ultrafiltration membrane with a membrane pore size of 10,000 to 500,000 Daltons has a high removal efficiency for endotoxin as an indicator of pyrogens. It is speculated that although the molecular weight of pyroge...

Embodiment 2

[0016] Example 2: Adaptability of active ingredients of traditional Chinese medicine injection to ultrafiltration membranes with different membrane pore sizes

[0017] Ultrafiltration experiment and sampling: select representative medicinal solutions (V) of various types of ingredients, put them in ultrafiltration membrane systems of 10,000 to 500,000 Daltons, and balance the ultrafiltration cycle for 30 minutes, and sample the equilibrium solution (V 平 ). After the ultrafiltration, when the ultrafiltration begins, the volume of the ultrafiltrate is 1 / 3 of the total volume of the stock solution and the volume of the ultrafiltrate is 2 / 3 of the total volume of the stock solution, the retentate and the ultrafiltrate are sampled respectively (V 0截 -V 0 , V 1 / 3截 -V 1 / 3 , V 2 / 3截 -V 2 / 3 ). Detect the concentration of C 0截 -C 0 、C 1 / 3截 -C 1 / 3 、C 2 / 3截 -C 2 / 3 . C 0 / C 0截 ×100%, C 1 / 3 / C 1 / 3截 ×100%, C 2 / 3 / C 2 / 3截 ×100% is the dynamic transmittance at the beginning of ...

Embodiment 3

[0021] Example 3: Adaptability of macromolecular drugs and injection excipients to ultrafiltration membranes with different membrane pore sizes

[0022] Ultrafiltration experiment and sampling: Take the experimental solution (V) of each injection excipient, put them in an ultrafiltration membrane system of 10,000 to 500,000 Daltons, and balance the ultrafiltration cycle for 30 minutes, and sample the equilibrium solution (V 平 ). After the ultrafiltration, when the ultrafiltration begins, the volume of the ultrafiltrate is 1 / 3 of the total volume of the stock solution and the volume of the ultrafiltrate is 2 / 3 of the total volume of the stock solution, the retentate and the ultrafiltrate are sampled respectively (V 0截 -V 0 , V 1 / 3截 -V 1 / 3 , V 2 / 3截 -V 2 / 3 ). Detect the concentration of C 0截 -C 0 、C 1 / 3截 -C 1 / 3 、C 2 / 3截 -C 2 / 3 . C 0 / C 0截 ×100%, C 1 / 3 / C 1 / 3截 ×100%, C 2 / 3 / C 2 / 3截 ×100% is the dynamic transmittance at the beginning of ultrafiltration, when the vo...

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Abstract

The invention relates to a method for removing pyrogen from injections, which adopts an ultrafiltration membrane filtering method. According to the ultrafiltration membrane filtering method, iquid medicine passes through an ultrafiltration membrane piece, the liquid passing through the ultrafiltration membrane piece is collected and prepared into the injections. The invention aims to overcome theprejudices of the prior theory and technology and design the membrane aperture of the ultrafiltration membrane piece to be 100000-500000 Daltons. The prior theory considers that the molecular weight of the pyrogen is below 100000 Daltons, and all technicians at home and abroad use the membrane with the aperture in the molecular weight range below 100000 Daltons for ultrafiltration, although the pyrogen can be effectively removed, for some specific injections, such as injections containing macromolecular medicines or auxiliary materials, or most of Chinese medicine injections containing complexcomponents, the effective medicine components can be lost in the ultrafiltration process. The ultrafiltration membrane with the membrane aperture of 100000-500000 Daltons not only can remove the pyrogen from the injections, but also can keep the effective components and auxiliary materials in the injections more effectively.

Description

technical field [0001] The invention relates to a method for removing pyrogens, in particular to a method for removing pyrogens for injections, and belongs to the technical field of medicine. Background technique [0002] Pyrogen, also known as endotoxin, is produced in the outer cell walls of Gram-nagative bacteria, that is, fragments of bacterial corpses. It is a lipopolysaccharide substance (Lipopoly-saccharide), referred to as LPS, its relative molecular mass ranges from several thousand to tens of thousands, depending on the type of bacteria that produces it. It has recently been revealed that its lipids are the main structure that constitutes pyrogens and harms the human body. [0003] Pyrogen in injections is an exogenous impurity, such as microbial metabolites introduced during raw material production, storage and transportation, or preparation preparation. Typical substances are endotoxins produced by Gram-negative bacteria. These substances can significantly incr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K36/00B01D61/14B01D71/68
Inventor 彭国平郑云枫段金廒
Owner NANJING UNIVERSITY OF TRADITIONAL CHINESE MEDICINE
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