12 results about "Bacterial endotoxin" patented technology

This invention relates to the field of glycerol purification technology, specifically to a multi-stage distillation purification method for pharmaceutical-grade glycerol. Using industrially synthesized crude glycerol as raw material, the pretreated material is obtained through heating and degassing. Then, a first-stage molecular distillation removes low-boiling-point impurities, yielding an intermediate product. A second-stage molecular distillation further refines the product, collecting the gaseous glycerol fraction. Finally, under nitrogen protection, trace colored substances and residual polar impurities are removed through an adsorbent bed. After cooling, pharmaceutical-grade glycerol is obtained. Finally, the product is filtered and aseptically filled. This invention effectively removes aldehydes and ketones, residual solvents, and trace impurities from synthetic glycerol through the coupling of two-stage molecular distillation and adsorption processes. The resulting product has a purity ≥99.7%, total aldehyde and ketone impurities ≤0.005%, residual solvent ≤0.001%, bacterial endotoxin <2.5 EU / g, and batch-to-batch RSD <1%, meeting the standards for injection and suitable as an excipient in high-end pharmaceutical preparations.

This invention provides a drug for antagonizing bacterial endotoxins, its preparation method, and its application, belonging to the biomedical field. The composition consists of 25-55 parts of dried powdered traditional Chinese medicine extract, 25-70 parts of mixed essential oil powder, and 40-90 parts of lentinan powder. The traditional Chinese medicine extract is prepared by decoction of Scutellaria baicalensis, Lonicera japonica, Forsythia suspensa, and Isatis indigotica under reduced pressure at low temperature and spray drying. The mixed essential oil powder is prepared by encapsulating peppermint oil and eucalyptus oil with gelatin and hydroxypropyl cellulose and then spray drying under high pressure. This invention, through specific formulation and processing, significantly enhances the synergistic antagonistic effect of each component against endotoxins. Experiments show that this composition exhibits antagonistic activity far superior to ibuprofen in vitro; in vivo, it significantly reduces the endotoxin content in the plasma of 817 broiler chickens, rapidly alleviates LPS-induced fever and diarrhea, and improves decreased growth performance. Therefore, this invention is of great significance for reducing antibiotic dependence and improving the efficiency of livestock and poultry farming.

The application discloses a compound amino acid injection (15-HBC) composition and a preparation method thereof, and belongs to the technical field of medicines. The compound amino acid injection (15-HBC) composition provided by the application comprises the following components in an amount of 250mL of the composition: isoleucine 1.532-2.298g, leucine 2.756-4.134g, lysine acetate 1.160-1.740g, methionine 0.500-0.750g, phenylalanine 0.640-0.960g, threonine 0.400-0.600g, tryptophan 0.180-0.270g, valine 1.772-2.658g, alanine 0.800-1.200g, arginine 1.160-1.740g, histidine 0.320-0.480g, proline 1.260-1.890g, serine 0.660-0.990g, glycine 0.660-0.990g, cysteine hydrochloride 0.040-0.060g, and appropriate amount of glacial acetic acid for pH adjustment, and the rest is injection water. The application also provides a preparation method of the compound amino acid injection (15-HBC) without sulfite antioxidant. Meanwhile, the activated carbon adsorption process is removed in the preparation, the control of raw material packages, production processes and the like is strengthened to control bacterial endotoxins, the production process is simplified, and the product quality is ensured.

This invention discloses a sample pretreatment method for detecting bacterial endotoxins in LNP-type mRNA vaccines. The method involves unpacking the sample with a 3-10% (v / v) Triton X-100 solution, followed by a 0.9% sodium chloride solution as the diluent in the sample gradient dilution step. This effectively eliminates interference from the positive control group in the gel limit method for detecting bacterial endotoxins in mRNA vaccines. The method provides accurate and reliable results and is suitable for the quality control of bacterial endotoxins in LNP-type mRNA vaccines.

The utility model discloses a bacteria endotoxin gel method detection device based on automatic control, including work table, the upper end of work table is provided with sample holder, the right -hand member of sample holder is provided with dilution frame correspondingly, dilution frame is provided with three groups, the right -hand member of dilution frame is provided with oscillation frame correspondingly, the rear end of oscillation frame is installed tip head area correspondingly, this patent device easy operation, man -machine interface is friendly, has reduced manpower cost, has improved work efficiency, the device degree of automation is high, has reduced the risk factor that human interference possibly brings maximum limit, and whole device can realize automatic gel result determination simultaneously, result calculation can, and can real -time monitoring whole test process, realizes the traceability of metadata simultaneously, can carry out endotoxin gel method detection to a large number of samples simultaneously, adapts to the demand of large -scale detection.

The present application provides a kind of detection method of bacterial endotoxin in PHA gel filling agent.The filling agent of the present application comprises PHA microspheres, gel carrier sodium carboxymethyl cellulose, osmotic pressure regulator, pH regulator and water for injection, the present application systematically studies the influence of gel carrier and osmotic pressure regulator on the performance of composition shear viscosity and osmotic pressure, and scientifically selects the excellent and stable gel prescription.The present application accidentally finds that the combination of water and a small amount of dichloromethane can realize the sufficient release of endotoxin, and accurately detect its content.The method of the present application can effectively ensure the safety of human medicine, and has important industrial value.

The application provides a fast-acting flunixin meglumine injection and a preparation method thereof, and belongs to the technical field of veterinary medicine, and contains the following components: flunixin meglumine 5-10 (w / v) %, alpha-pyrrolidone 10-30 (w / v) %, hydrophilic solvent 0.5-1 (w / v) %, antioxidant 0.1-0.3 (w / v) % and the balance of water for injection. The application takes flunixin meglumine as the main drug, matches alpha-pyrrolidone as a solvent and a targeting guide distribution component, uses a hydrophilic solvent to assist dissolution and promote absorption, and uses an antioxidant to inhibit the oxidative degradation of the main drug, so that the dissolution and absorption rate of the main drug and the target tissue distribution efficiency can be effectively improved, the storage stability can be ensured, the bacterial endotoxin and the injection site redness rate meet the requirements, the acute inflammation and pain of livestock and poultry can be quickly and efficiently relieved, and the demand for instant intervention in large-scale breeding can be met.

The utility model relates to biological medicine technical field especially, and it is degerming treatment device, including the reaction kettle of fixed installation on the ground, raw and auxiliary material filter cylinder and reaction liquid post filter cylinder, the export of raw and auxiliary material filter cylinder is connected to the entrance of reaction kettle through pipeline and delivery pump, and the export of reaction kettle is connected to the entrance of reaction liquid post filter cylinder through pipeline and delivery pump, the inner wall of raw and auxiliary material filter cylinder is fixedly connected with the placement strip, and the filter membrane is installed on the placement strip, and the flow guide assembly that can carry out the compression firm of filter membrane is provided on the filter membrane, and the same filter membrane and flow guide assembly of raw and auxiliary material filter cylinder are provided in reaction liquid post filter cylinder. The utility model adds 0.45 microns degerming filtration step before raw and auxiliary material feeding, sets up 0.22 microns degerming grade filter in the most critical position before spray drying, can filter the vast majority of bacteria cadaver and microparticle that possibly exist in polymerization reaction liquid, directly and efficiently reduces bacterial endotoxin content.

The application relates to the technical field of biological medicine, in particular to a bacterial endotoxin removing device. The removing column comprises a column body and a shaking mechanism; the inside of the column body is provided with a cavity, a plurality of activated carbon particles wrapped with cellulose acetate membranes are filled in the cavity, the two ends of the column body are respectively provided with openings, and a plurality of 0.22-micron microporous filter membranes are arranged at the ends of the column body at intervals; the shaking mechanism clamps and fixes the column body and is used for shaking the column body, so that the solution entering the inside of the column body fully contacts the activated carbon particles. The removing column can remove bacterial endotoxins in various product solutions, does not use stimulating solvents, does not damage the components in the product solutions, is simple to operate, is widely applicable, and is high in practicality.

This invention discloses a method for detecting bacterial endotoxins in gelatin microcarriers used for cell culture, comprising the following steps: (1) rechecking the sensitivity of the Limulus Amebocyte Lysate (LAL) reagent to ensure that the sensitivity result of the LAL reagent is between 0.5 and 2.0 λ; (2) determining the limit value and minimum dilution concentration of bacterial endotoxins in the gelatin microcarriers; (3) enzymatically digesting the PBS solution of the gelatin microcarriers to be tested with collagenase solution to obtain an enzymatic digest; (4) checking for bacterial endotoxins in the gelatin microcarriers: mixing a magnesium ion regulator and the LAL reagent to obtain a reconstituted LAL reagent, mixing the enzymatic digest obtained in step (3) with the reconstituted LAL reagent to obtain a mixed solution, and using the gelation method to determine whether bacterial endotoxins are present. By combining the pretreatment enzymatic digestion step with the LAL reagent reconstituted with a magnesium ion regulator, the gelatin microcarriers can be effectively enzymatically digested, fully releasing endotoxins, and the interference of phosphate ions can be effectively eliminated by the magnesium ion regulator, thereby improving the specificity and accuracy of the detection.

This invention discloses a gel detection method for bacterial endotoxins in high molecular weight biodegradable polyester materials, eliminating adsorption interference, belonging to the field of biomaterial safety testing technology. The method first uses dichloromethane to completely dissolve the polyester, disrupting its solid structure and releasing potentially adsorbed endotoxins. Then, liquid-liquid extraction is performed using water for bacterial endotoxin testing to transfer the endotoxins to the aqueous phase. Finally, a specific endotoxin dispersant is used to dilute the aqueous extract, effectively shielding the re-adsorption of free endotoxins by the hydrophobic groups of the polyester. The treated sample can be directly detected using the highly sensitive Limulus Amebocyte Lysate (LAL) gel electrophoresis method. This method is simple to operate, has good reproducibility, completely eliminates adsorption interference, and accurately and reliably controls the bacterial endotoxin limits of high molecular weight biodegradable polyester materials, ensuring their safety as medical materials.

1. The name of the design product: bacterial endotoxin detector. 2. The use of the design product: for bacterial endotoxin culture monitoring detector. 3. The design points of the design product: in shape. 4. The picture or photo that best indicates the design points: perspective drawing.