A simulated digestive system device and method for testing microorganisms in medicines
A digestive system and microorganism technology, which is applied in the field of simulated digestive system devices for testing microorganisms in medicines, can solve the problems of time-consuming, labor-intensive, non-existent, and inability to detect microorganisms, and achieves the effect of reducing test operation steps and simplifying the test process.
Active Publication Date: 2022-03-29
SHANDONG INST FOR FOOD & DRUG CONTROL
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Problems solved by technology
The original intention of this test method is to rule out the possibility of antibacterial properties of the drug itself. The general method is to increase the dilution factor of the sample and use membrane filtration. In addition to the time-consuming and labor-intensive operation and the need to prepare an appropriate amount of additional microorganisms in advance , the problem still exists in this verification method is: a certain amount of microorganisms added is not necessarily contained in the drug itself, but the microorganisms cannot be detected due to the bacteriostatic properties of the drug itself
After searching, there is no method for the above-mentioned microorganisms in drugs, and there is no device for simulating the digestive system of drugs that meets the above-mentioned inspection requirements.
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[0026] The technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, not all of them. Based on the embodiments of the present application, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the protection scope of the present application.
[0027] The artificial gastric juice involved in the present invention can be commercially available aseptic artificial gastric juice, or the following preparation method: take dilute hydrochloric acid with a concentration of 1 mol / ml, dilute it with water, and adjust the pH to 1.5. Add 1g of pepsin to every 100ml of liquid, mix well, filter and sterilize before use.
[0028] The artificial intestinal juice involved in the present inventio...
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The invention discloses a simulated digestive system device and method for testing microorganisms in medicines, comprising a first reaction tank and a second reaction tank connected to each other, the two reaction tanks are connected through a connecting pipe, the first reaction tank and the connecting pipe A one-way valve is arranged between them, a liquid feeding and sampling port is arranged on the side of each reaction tank, a filter valve is arranged on the bottom side of the first reaction tank, and a heating and oscillating box is arranged outside each reaction tank. Each structure of the device has a detection hole that can extract samples, which can detect the microbial status in different parts of the device at any time, and realize real-time monitoring of the samples to be tested. There is no need to add known bacteria to verify whether the samples have antibacterial properties The operation of discharging the excess reaction liquid during the process to eliminate the added microorganisms can simplify the test process and reduce the test operation steps.
Description
technical field [0001] The invention relates to the field of medicine and food inspection and detection, in particular to a simulated digestive system device and method for testing microorganisms in medicine. Background technique [0002] The inspection of microorganisms in medicines in the current "Chinese Pharmacopoeia" is based on the inspection of microbial limits in medicines, that is, to check whether the total number of microbial colonies in a certain amount of medicines exceeds the limit standard stipulated in the Pharmacopoeia. This inspection method is to dissolve or dilute a certain amount of the drug to be tested with a certain amount of buffer solution, place it in a petri dish, pour it into the corresponding medium, and count the number of microorganisms on the petri dish after cultivating for a period of time. This method can only check the number of microorganisms that may be contaminated in the drug, and cannot detect the microorganisms that are still alive ...
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IPC IPC(8): C12M1/34C12M1/12C12M1/02C12M1/00C12Q1/06G01N33/15
CPCC12M23/58C12M27/16C12M29/04C12M33/14C12M37/04C12M41/22C12M41/36C12Q1/06G01N33/15
Inventor 曲见松丁勃李军祝清芬邢晟任丽宏冯丹阳
Owner SHANDONG INST FOR FOOD & DRUG CONTROL