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A kind of sterility detection reaction membrane and preparation method and culture tube using the reaction membrane
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A technology of culture tubes and reaction membranes, which is applied in the direction of analyzing materials through chemical reactions and material analysis through observation of the influence of chemical indicators. It can solve problems such as endangering the health of users, loss of life, and false negatives. Achieve the effect of fast color change, good effect and good observation
Active Publication Date: 2020-08-28
北京赛赋医药研究院有限公司
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[0004] Despite the importance of microbial indicators in drug quality, in previous revisions of the Pharmacopoeia, sterility testing still uses the method of visual turbidity for 14 consecutive days, which is easy to observe for fast-growing microorganisms, but not for most slow-growing microorganisms. It is beneficial to observe the growth of microorganisms as early as possible, so that the possibility of false negatives may occur, and even cause unqualified products to be released as qualified products, and seriously endanger the health of users
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Embodiment 1
[0033] (1) Fully stir and mix 100 parts of polymethylsiloxane and 100 parts of n-hexane to obtain detection solution A;
[0034] (2) Add 20g / L p-nitrophenol, 1 part of butyltin dilaurate, and 6 parts of tetraethyl orthosilicate to the above test solution A in sequence, adjust the pH value to 6.5-7.5, and stir well , to obtain detection solution B;
[0035] (3) Inject the above-mentioned detection solution B into the inclined culture tube, and make it adhere to the inner wall of the culture tube to obtain a sterile detection reaction film, which is sample 1.
Embodiment 2
[0037] (1) Fully stir and mix 80 parts of polymethylsiloxane and 80 parts of n-hexane to obtain detection solution A;
[0038] (2) Add 50g / L of phenolphthalein, 1.5 parts of dibutyltin dilaurate, and 10 parts of methyl orthosilicate to the above test solution A in sequence, adjust the pH to 6.5-7.5, stir evenly, and obtain the test Liquid B;
[0039] (3) Inject the above-mentioned detection solution B into the inclined culture tube, and make it adhere to the inner wall of the culture tube to obtain a sterile detection reaction film, which is sample 2.
Embodiment 3
[0041] (1) Fully stir and mix 120 parts of polymethylsiloxane and 120 parts of n-hexane to obtain detection solution A;
[0042] (2) Add 30g / L thymolphthalein, 0.2 parts of bis(dodecylsulfur)dibutyltin, and 2 parts of trimethoxysilane to the above test solution A in order to adjust the pH value to 6.5-7.5, Stir evenly to obtain detection solution B;
[0043] (3) Inject the above-mentioned detection solution B into the inclined culture tube and make it adhere to the inner wall of the culture tube to obtain a sterile detection reaction film, which is sample 3.
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Abstract
The invention discloses an aseptic detection reaction membrane and a culture tube using the same, and relates to the field of medicine detection. The invention further discloses a preparation method of the aseptic detection reaction membrane. Particularly, the preparation method is as follows: carbon dioxide is produced in the microbial growth process, the carbon dioxide is dissolved in water to lower the pH of a solution so as to change the color of the reaction membrane, and whether microbes grow is determined through color change. By the preparation method, the defects of delay and inaccuracy in the conventional method for determining microbial contamination through turbidity are overcome.
Description
technical field [0001] The invention relates to the technical field of drug sterility testing, in particular to a sterility testing reaction membrane, a preparation method and a culture tube using the reaction membrane. Background technique [0002] Drugs are directly related to the health and life safety of the people, and ensuring drug safety is the greatest livelihood of the people. Drugs are a special commodity that prevents, treats, and diagnoses human diseases, regulates human physiological functions purposefully, and specifies substances with indications or functional indications, usage and dosage. The quality and safety of drugs are directly related to people's health. and life. [0003] The dual nature of medicines, that is, to cure diseases and cause diseases. The primary factor of causing diseases is the unqualified medicines. Among the unqualified factors of medicines, the unqualified microorganisms are the most important, because microorganisms are invisible an...
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