8 results about "Sterility test" patented technology

The invention relates to the technical field of biological medicines, in particular to a soluble skin-adhering microneedle for delivering an inactivated enterovirus vaccine as well as a preparation method and application of the soluble skin-adhering microneedle. Sodium hyaluronate is adopted as a film forming material to wrap an enterovirus 71 type (EV71)-coxsackie virus A16 (CA16) type bivalent inactivated vaccine antigen, and a needle body layer of the soluble microneedle is formed; the substrate layer is prepared from a pullulan material, so that the microneedle patch with a stable overall structure is formed. The technology provided by the invention is completed in a clean environment, and the vaccine patch which is qualified through sterility detection is obtained. The soluble microneedle disclosed by the invention has good antigen stability under the condition of 2-8 DEG C. In animal experiments, the microneedle is attached to the skin surface of a mouse for skin-adhering immunization, a strong immune response reaction can be induced, good immunogenicity is shown, and a novel, safe and effective vaccine delivery way is provided for prevention and control of the infantile hand-foot-and-mouth disease.

A rapid sterility test method that reduces inhibition of the nucleic acid amplification reaction of target nucleic acid due to human nucleic acid. The rapid sterility test method can detect the presence of bacterial nucleic acid included in a test sample including human nucleic acid by a nucleic acid amplification method, where an oligoset that is used in the nucleic acid amplification method includes (1) one or more probes selected from the group consisting of a probe group PM1, a probe group PM2, and a probe group PM3 and (2) one or more reverse primer in a primer group RM.

The utility model provides a high-activity medicine sterility examination isolator which comprises a glove box, a first air inlet device, a second air inlet device, a first air exhaust device, an air return channel and a filtering air outlet channel. A filtering component and a second air exhaust device are sequentially arranged in the filtering air outlet channel. A channel switching mechanism is arranged among the glove box, the air return channel and the filtering air outlet channel, and the communication state among the glove box, the air return channel and the filtering air outlet channel is controlled through the channel switching mechanism; an air return valve is arranged between the filtering air outlet channel and the air return channel and located between the air exhaust fan and the air exhaust valve. According to the utility model, the requirements of two modes of conventional sterility examination and high-activity medicine sterility examination can be met at the same time, and the power of the air inlet device (fan) can be reduced in the high-activity medicine sterility examination mode.

The invention relates to a cartridge for performing a nucleic acid amplification test of sterility on a sample, wherein the cartridge and all components are nucleic acid contamination-free. The cartridge is suitable for processing biological samples, whereas the nucleic acid sterility test detects all clinically relevant bacterial and / or fungal species. Further, the invention relates to a use of said cartridge for performing a nucleic acid amplification test and for detecting at least one fungal and / or at least one bacterial contamination. The invention also relates to a method of producing said cartridge in a nucleic-acid free environment and optionally with DNA-depleted and optionally disinfected components. Further, the invention relates to a kit or a kit of parts comprising at least one nucleic acid contamination-free nucleic acid amplification reagent. The invention also relates to a device comprising said cartridge.

The invention belongs to the field of medicine detection, and particularly relates to a sterility test method for a levofloxacin injection. The invention provides a sterility test method for a levofloxacin injection. The inhibition effect of the levofloxacin injection on microorganisms is eliminated by screening conditions such as the concentration of a neutralizing agent in a test solution and a flushing solution, the flushing amount, the flushing times and the like. Under optimal conditions, the sterility test method meets the requirement of the general rule 1101 of the fourth part of Chinese pharmacopoeia on the applicability of the sterility test method, the effectiveness and reliability of sterility test of the levofloxacin injection are improved, a basis is provided for drug detection and antibiotic quality verification, and the application prospect is good.

The invention relates to a high-purity subtilucent 37 peptide reference substance and a production method and application thereof based on biosynthesis industrialization, and belongs to the field of biomedicine.The production method comprises the steps that bacillus subtilis serves as a production strain, and fermentation liquor is obtained through primary seed tank fermentation and seed tank fermentation; carrying out ceramic membrane separation, double-effect concentration, salting-out and tubular centrifugation on the fermentation liquid to obtain a precipitate which is a crude product of the tri17 peptide; the preparation method comprises the following steps: redissolving a crude product of the withered grass tri17 peptide with a 20% ethanol aqueous solution, centrifuging, filtering, dewatering, carrying out ion exchange chromatography, carrying out ultrafiltration concentration, freeze-drying, and subpackaging to obtain a reference substance of the withered grass tri17 peptide; wherein the elution step of hydrophobic chromatography is water-5% ethanol water-50% ethanol water elution. Reversed phase chromatography, ion exchange chromatography and size exclusion chromatography detection results show that the purity of the reference substance is greater than 99.9%, the endotoxin is less than 10 EU / mL, the sterility test and the abnormal toxicity meet the high-purity bulk drug standard, and the reference substance can be used as a crude drug of the triticin.

- 71 - Abstract The invention relates to a cartridge for performing a nucleic acid amplification test of sterility on a sample, wherein the cartridge and all components are nucleic acid contamination-free. The cartridge is suitable for processing biological samples, whereas the nucleic acid sterility test detects all clinically relevant bacterial and / or fungal species. Further, the invention 5 relates to a use of said cartridge for performing a nucleic acid amplification test and for detecting at least one fungal and / or at least one bacterial contamination. The invention also relates to a method of producing said cartridge in a nucleic-acid free environment and optionally with DNA-depleted and optionally disinfected components. Further, the invention relates to a kit or a kit of parts comprising at least one nucleic acid contamination-free 10 nucleic acid amplification reagent. The invention also relates to a device comprising said cartridge.

The invention relates to a cartridge for performing a nucleic acid amplification test of sterility on a sample, wherein the cartridge and all components are nucleic acid contamination-free. The cartridge is suitable for processing biological samples, whereas the nucleic acid sterility test detects all clinically relevant bacterial and / or fungal species. Further, the invention relates to a use of said cartridge for performing a nucleic acid amplification test and for detecting at least one fungal and / or at least one bacterial contamination. The invention also relates to a method of producing said cartridge in a nucleic-acid free environment and optionally with DNA-depleted and / or disinfected components. Further, the invention relates to a kit or a kit of parts comprising at least one nucleic acid contamination-free nucleic acid amplification reagent. The invention also relates to a device comprising said cartridge.