Full-pyrogen detection method for pyrogenicsubstance content in injection

Abstract

The invention discloses a total pyrogen detection method of pyrogenicsubstance content in injection. The method is characterized in that the method comprises the following steps: a) preparing human whole blood test liquid; b) diluting bacterial endotoxin working standard product by normal saline, namely 0.9 percent sodium chloride injection to carry out linear investigation, thereby obtaining a standard curve; c) selecting a proper injection dilution concentration; d) determining the content of pyrogenicsubstance in an injection sample; and e) judging whether the pyrogenicsubstance in the injection sample exceeds standard, during which, the content of pyrogenicsubstance in the injection sample is compared with the concrete standard specifications of pyrogenicsubstance so as to reach a conclusion whether the safety quality inspection of the pyrogen of the injection sample is qualified. The total pyrogen detection method is suitable for the detection of all pyrogen substances; moreover,the method not only can control medicine pyrogen substances, but also can substantially reduce the cost of animal test, thereby improving medication safety for patients and having enormous market space and economic benefits.

Description

technical field [0001] The invention relates to a biomedical detection technology, in particular to an all-pyrogen detection method for the content of pyrogenic substances in injections. Background technique [0002] Since the emergence of injection drugs more than 100 years ago, the harm of pyrogens in parenteral medical products to the human body, that is, the pyrogen reaction, has been well known. Clinically, the main symptoms are as follows: fever, chills, nausea, vomiting, headache , waist and joint pain, pale complexion, decreased white blood cells, increased vascular permeability, and severe cases cause coma or even shock and death. Therefore, all products for parenteral use, including drugs, biological products and medical devices, should be inspected for pyrogens. Effective control and inspection of their pyrogens is an important guarantee for safe use in clinical practice. [0003] Pyrogens refer to substances that can cause the body to heat up, and are mainly div...

AI Technical Summary

Problems solved by technology

Its disadvantages are: (1) due to a series of problems in the current domestic rabbit breeding, feeding management, etc., the species and individual differences of rabbits are relatively large, resulting in poor repeatability, and the fever of rabbits and humans is not the same. It is completely consistent; (2) the sensitivity is low, and it is easy to cause false negative test results; (3) for some products that can affect the normal physiology of rabbits, especially body temperature, such as cytokines, virus products, antibiotics, laxatives, certain sedatives, Normal detection of analgesics, cytoplasmic proteins and radiopharmaceuticals is also impossible; (4) The test cost and daily maintenance cost are high, and the detection time is long (usually 5 hours), especially when the pyrogen content is seriously exceeded and the When toxicity occurs, the body temperature of rabbits drops, and the results cannot be correctly reflected

Its disadvantages are: (1) The thermogenic activity of each pyrogen and the relationship between them are not fully understood; (2) In actual work, after the exogenous pyrogen enters the blood, it may lead to a variety of factors. The unbalanced release of a single factor needs to be further studied and evaluated to determine whether a single factor can represent its complete pyrogenic activity; (3) how to remove pyrogens from the reagents, culture medium, serum, etc. used in the test, and how different laboratory (4) In addition to bacterial endotoxin, there are no standard products for other pyrogenic substances, and the human pyrogenic threshold is not clear, and its limit value is not easy to determine; ( 5) Substances with intrinsic pyrogen secretion or inhibition are not suitable for detection by this method; (6) Since the detection cells used have their own advantages and disadvantages, and there are differences in the sensitivity of the human body to pyrogens, the detection indicators used have not yet been tested. affirmation, unity

These shortcomings also limit the popularization and application of the in vitro pyrogen test method, which has not been officially recorded by any national pharmacopoeia, so this method is not yet a statutory pyrogen detection method

Images