49results about How to "Batch-to-batch stability" patented technology

The invention discloses a gastrin-17 enzymatic chemiluminescence immunoassay kit and belongs to the technical field of chemiluminescence immunoassay analysis. The kit comprises an enzyme label liquid, a gastrin-17 standard, gastrin-17 monoclonal antibody-coated immunomagnetic beads, a sample diluent, a chemiluminescent substrate liquid and a washing liquid. The principle of the gastrin-17 enzymatic chemiluminescence immunoassay kit comprises that a gastrin-17 monoclonal antibody is connected to the surface of a magnetic bead so that a solid phase agent is obtained, and through capture of gastrin-17 in a sample and use of an enzyme-labeled anti-gastrin-17 monoclonal antibody, a solid phase-antibody-antigen-enzyme-labeled antibody sandwiched immune complex is formed. Through combination of a chemiluminescence technology and an immunomagnetic bead technology, the prepared kit has the advantages of high sensitivity, good specificity, wide linearity range and good stability and can satisfy clinical requirements on stomach function detection.

The invention discloses an ambroxol hydrochloride liquid preparation and a preparation method thereof. The method comprises the steps: dissolving ambroxol hydrochloride, stabilizing agent and osmotic pressure regulator into water used for injection, and evenly mixing together to obtain solution I; then, filtering the solution I, and obtaining the ambroxol hydrochloride liquid preparation. The preparation method does not introduce active carbon, so as to avoid the danger of hurting human body since active carbon particle is introduced into the preparation; meanwhile, the active ingredients in the preparation is ensured to be stable, and the safety (namely, the chemical stability of the ambroxol hydrochloride can be effectively improved, the particle content in the preparation is reduced, and the purity of the preparation is improved) of the finished product can be guaranteed.

The invention relates to an aptamer modified triazine covalent organic framework composite material and a preparation method and application thereof. The aptamer modified triazine covalent organic framework composite material disclosed by the invention comprises a triazine covalent organic framework, gold nanoparticles and an aptamer, wherein the gold nanoparticles are supported on the triazine covalent organic framework; and the aptamer is bonded onto the surface of the gold nanoparticles. When the sequence of the aptamer is 5'-SH-(CH2)6-(ACAG4TGTG4)2-3', the composite material disclosed by the invention can be applied to enrichment of insulin in biological samples. The aptamer modified triazine covalent organic framework composite material disclosed by the invention combines the advantages of the covalent organic framework such as large specific surface area and multiple adsorbable sites and the advantage of the aptamer such as specific recognition, has excellent selectivity, and canprovide an economic, high-efficiency and high-sensitivity biological analysis method.

The invention discloses a puerarin liquid preparation and a preparation method thereof. The method comprises the following steps: puerarin is dissolved in water and then added with an iso-osmotic regulator, thus obtaining a solution I by mixing evenly; the solution I is filtered with the aperture of 0.22 Mum, thus obtaining a filtering solution a; the filtering solution a is treated with ultrafiltration by an ultrafiltration membrane with the MWCO of 10000 Dalton, thus obtaining a filtering solution b; the filtering solution b is filtered by the aperture of 0.22 Mum, thus obtaining a filtering solution c; and the filtering solution c is filtered by the aperture of 0.22 Mum, thus obtaining the puerarin liquid preparation. The preparation method of the puerarin liquid preparation overcomes the defect that the existing preparation has a plurality of untoward reaction factors. Experiments prove that the preparation prepared by the method does not contain a solubilizing agent, the content of other particles and bacteria is low, the puerarin has high purity and good stability; in addition, products of each batch produced by the method of the invention meet quality standards, have batch to batch stability and reliable quality; the method of the invention has simple process and is convenient for production operation and control and suitable for mass production.

The invention belongs to the technical field of cell culture in vitro and particularly relates to a glycyrrhiza polysaccharide-containing and animal origin-free low protein culture medium. The culture medium is prepared from the following components: glycyrrhiza polysaccharide, glucose, soybean hydrolysate, putrescine, spermine, ornithine, sodium pyruvate, amino acid, biotin, vitamin D, folic acid, ferrous sulfate, ferric nitrate, EDTA (Ethylene Diamine Tetraacetic Acid).2Na, cholamine, glycerinum, oleum morrhuae, cholesterol, linoleic acid, thymidine, hypoxanthine, hydrocortisone, sodium selenite, tocopherol, sodium bicarbonate, calcium chloride, magnesium chloride, magnesium sulfate, potassium chloride, sodium dihydrogen phosphate, sodium chloride, disodium hydrogen phosphate, zinc sulfate and copper sulfate. The culture medium disclosed by the invention comprises added glycyrrhiza polysaccharide, and does not contain any added supplementary animal origin protein and/or recombinant animal protein; rapid proliferation of cells can be realized, and the expression ability of the cells is effectively improved.

The invention provides a gB subunit recombinant protein of a porcine pseudorabies virus, and a preparation method and application of the gB subunit recombinant protein. The preparation method comprises the following steps of 1) cloning an optimized gB gene sequence into an eukaryotic expression vector to obtain a recombinant plasmid containing a gB subunit protein coding gene of the pseudorabies virus; 2) transfecting the recombinant plasmid containing the gB subunit protein coding gene of the pseudorabies virus into an expression cell; 3) culturing, screening and domesticating the expressioncell in the step 2) to obtain a highly expressed cell strain; and 4) fermenting and culturing the cell strain in the step 3), and performing purification to obtain the gB subunit protein of the pseudorabies virus. The invention provides the gB subunit protein of the porcine pseudorabies virus, and the gB subunit protein can be industrially produced in a large scale; the preparation method is simple; the cost is low; and the yield is much higher than that of an existing baculovirus expression system.

The invention discloses a process approach suitable for mammalian cell culture and rapidly and effectively improving the ADCC activity of monoclonal antibodies. The process is characterized in that the glycosylation of monoclonal antibodies is controlled by adding nucleosides and metal ions during the culture process level, and increase the ADCC activity of the monoclonal antibody. The process has the characteristics of good stability, strong operability, easy scale-up, and small difference in results between batches. It can be applied to large-scale mammalian cell culture to express monoclonal antibodies, especially for industrial production of therapeutic monoclonal antibodies.

The invention relates to the field of food, and particularly provides soybean peptide effervescent tablets and a preparation method thereof. The soybean peptide effervescent tablets provided by the invention are prepared from acid particles, alkali particles and mixed auxiliary materials in parts by weight, wherein the alkali particles are prepared from, in parts by weight, 600-700 parts of soybean peptide powder, 250-330 parts of lactose, 45-55 parts of a sweetening agent, 450-550 parts of sodium carbonate and 50-100 parts of potassium chloride; the acid particles are prepared from, in partsby weight, 250-300 parts of maltodextrin, 1600-1750 parts of citric acid and 100-250 parts of glucose; and the mixed auxiliary materials are prepared from, in parts by weight, 150-250 parts of fruit juice powder, 35-50 parts of essence and 15-65 parts of a bean product defoaming agent. The soybean peptide effervescent tablets are better in tablet shape, accessible to more people and short in disintegration time. Most importantly, according to the formula, the proportion of effective nutrient substance soybean peptides in the soybean peptide effervescent tablets is greatly increased, and the overall efficacy of a product is improved.

The invention relates to the technical field of detection of active ingredients of ginkgo leaves, in particular to a method for determining total lignans in a Shuxuening injection. The determination method adopts ultraviolet dual-wavelength spectrophotometry, and comprises the following steps of: providing a Shuxuening injection; removing flavonoid components in the Shuxuening injection; and detecting the Shuxuening injection without the flavonoid components as a test solution. The method provided by the invention can accurately determine the content of the total lignans in the Shuxuening injection, so that the content of the total lignans in the Shuxuening injection is effectively controlled, and the uniformity and stability among batches of products are ensured.

The invention discloses a free triiodothyronine measurement kit and a fabrication method thereof, and belongs to the technical field of vitro inspection. By the free triiodothyronine measurement kit,the technical problems of long reaction time, slow measurement speed, narrow of linear range and hook effect easy to generate of the prior art when a tested substance is high in concentration are solved. The kit comprises the following reagents of a solid-phase reagent 1 and a liquid-phase reagent, wherein the solid-phase reagent R1 is a suspension liquid including a T3 analogue-coated paramagnetism microsphere, the liquid-phase reagent R2 is a suspension liquid including an acridinium ester labeled T3 antibody, the paramagnetism microsphere in the R1 is Fe3O4 with a surface wrapped by a carboxyl active group, and the particle size of the paramagnetism microsphere is 0.1-5 micrometers. With the free triiodothyronine measurement kit and the fabrication method thereof, provided by the invention, free triiodothyronine in blood/plasma is quantitatively detected by a chemiluminescence immunity analysis method, the kit has the advantages of high sensitivity, rapid detection, wide linear range, low cost and the like and is simple and convenient to operate, and automation is facilitated.

The invention discloses an isosorbide mononitrate liquid preparation and a preparing method thereof. The method comprises the steps: dissolving isosorbide mononitrate, stabilizing agent and osmotic pressure regulator into water used for injection, and evenly mixing together to obtain solution I; then, filtering the solution I, and obtaining isosorbide mononitrate injection. As active carbon is notintroduced into the preparing method, the active carbon particles are prevented from being introduced into the preparation to be harmful to the human body, and the stability of the active ingredientsin the preparation as well as the safety of the finished product can be ensued (namely, the chemical stability of the isosorbide mononitrate is effectively improved, the particulate content in the preparation is reduced, and the purity of the preparation is increased).

The invention discloses a kit for determining thyrotropin and a preparation method of the kit. The kit comprises the following reagents of: a reagent R1, including a streptavidin magnetic particle solution, a reagent R2 including a chemiluminescence marker-labelled thyrotropin antibody, and a reagent R3 including a biotin-labeled thyrotropin antibody, wherein the mass percent of streptavidin magnetic particles in the reagent R1 is 0.07-0.2% and the particle sizes are 1-3 microns; the molar ratio of the thyrotropin antibody to a chemiluminescence marker in the reagent R2 is 1:1.5 to 1:10; and the molar ratio of the thyrotropin antibody to biotin in the reagent R3 is 1:5 to 1:50. The kit has the advantages of being high in sensitivity, high in specificity, free of a catalyst, stable in labelled conjugate, free of radioisotope damage and contamination, short in luminous time, stable in luminous intensity, high in reaction speed and high in specificity, and does not affect binding of a to-be-determined object after being connected with the antibodies.

The invention discloses a CHO-K1 cell strain, which contains a gene capable of efficiently secreting and expressing PG II recombinant protein. The invention also discloses a method for preparing the CHO-K1 cell strain, and the method comprises the following steps: 1) cloning a gene sequence as shown in SEQ ID NO.1 into an eukaryotic expression vector to obtain a recombinant plasmid containing the gene encoding the PG II recombinant protein; (2) transfecting the recombinant plasmid into a CHO-K1 cell, so as to obtain a CHO-K1 cell strain; and 3) culturing, screening and domesticating the CHO-K1 cell strain in the step 2) to obtain the cell strain capable of efficiently secreting and expressing the PG II recombinant protein. The invention also discloses an anti-PG II monoclonal antibody, wherein the antigen epitope combined with a monoclonal antibody 1 is located at aa78-aa90 of the pepsinogen II; and the antigen epitope combined with a monoclonal antibody 2 is located at aa280-aa291 of the pepsinogen II. The protein provided by the invention is high in expression quantity, good in quality and low in cost; the monoclonal antibody can be paired and used for detecting the PG II protein, and is good in specificity and high in sensitivity.

The present application provides an immunological composition and a subunit vaccine. The immunological composition comprises: a swine transmissible gastroenteritis virus S1 protein encoded by a nucleic acid molecule of SEQ ID NO:1 or a nucleic acid molecule of 95% or more identical to the nucleotide sequence of the SEQ ID NO:1. The vaccine uses an eukaryotic expression of CHO cells, is sufficientin protein glycosylation, good in antigen protein immunogenicity, and also very high in expression levels, and reaches 2-3 g/L. The recombinant cells can be subjected to suspension cultivation in a large scale, which greatly reduces complexity of vaccine preparation and saves production costs.

The present invention belongs to the technical field of animal vaccines and veterinary biological products, and particularly relates to a subunit H protein of a peste des petits ruminants virus and apreparation method and application of the subunit H protein. The subunit H protein is a truncated head functional protein of an H protein of the peste des petits ruminants virus, amino acid sequencesof the subunit H protein are an amino acid sequence (1) as shown as SEQ ID NO.1 and a derived amino acid sequence (2) having the immunogenicity and obtained by performing substitution, deletion or addition of multiple amino acids on the sequence SEQ ID NO.1, and the derived amino acid sequence and the sequence SEQ ID NO.1 have the sequence identity of 80-100%. The subunit H protein is prepared mainly by constructing recombinant plasmids, transfecting cell strains with the recombinant plasmids, screening the high-expression cell strains and purifying the subunit H protein of the peste des petits ruminants virus, can be better suitable for subunit vaccines or diagnostic reagents of peste des petits ruminants viruses, and has the characteristics of efficient secretory expression, high proteinpurity, easy purification, low production cost, high safety performance and the like.

The invention provides a genetic engineering subunit vaccine of the avian infectious bronchitis. The genetic engineering subunit vaccine of the avian infectious bronchitis comprises avian infectious bronchitis virus S1 protein and S2 protein coded respectively by nucleic acid molecules shown as SEQ ID NO:1 or nucleic acid molecules identical with more than 95% of a nucleic acid sequence of SEQ IDNO:1 and nucleic acid molecules shown as SEQ ID NO:2 or nucleic acid molecules identical with more than 95% of a nucleic acid sequence of SEQ ID NO:2. A heterodimer structure can be formed between theS1 protein and the S2 protein and is similar to a virus surface structure, the S1 protein and the S2 protein are in eukaryotic expression and are sufficient in protein glycosylation, high in antigenprotein immunogenicity and quite high in expression quantity reaching 2-3g/L, recombinant cells are supportive of large-scale suspension culture, vaccine preparation complexity is lowered greatly, andproduction cost is lowered.

The invention provides a subunit fusion protein mG on the surface of rabies virus as well as a preparation method and application of the subunit fusion protein mG. The preparation method comprises thesteps: 1) cloning a gene sequence shown as SEQ ID NO.4 into an eukaryotic expression vector to obtain a recombinant plasmid containing a fusion protein MBP-G encoding gene; 2) transfecting the recombinant plasmid containing the fusion protein MBP-G encoding gene into an expression cell; 3) culturing, screening and domesticating the expression cell in the step 2) to obtain highly expressed cell strains; and 4) fermenting and culturing the cell strain in the step 3), and purifying to obtain the subunit fusion protein mG. MG can be expressed in a large amount in a soluble mode, protein is stable, the problems that rabies virus surface G protein cannot be expressed on a large scale and the like in the prior art are solved, and the preparation method is simple and low in cost.

The invention provides a subunit fusion protein tG on the surface of a rabies virus, and a preparation method and application of the subunit fusion protein tG. The preparation method comprises the following steps of 1) cloning a gene sequence shown as SEQ ID NO.4 into an eukaryotic expression vector to obtain a recombinant plasmid containing a fusion protein tG coding gene; 2) transfecting the recombinant plasmid containing the fusion protein tG coding gene into an expression cell; 3) culturing, screening and domesticating the expression cell in the step 2) to obtain a highly expressed cell strain; and 4) fermenting and culturing the cell strain in the step 3), and after purification, obtaining the subunit fusion protein tG. The tG can be expressed in a large amount in a soluble manner; the protein is stable; various problems that the G protein on the surface of the rabies virus cannot be expressed in a large scale and the like in the prior art are solved; and the preparation method issimple, and the cost is low.

The present invention belongs to the field of stem cell biology, relates to lineage-specific differentiation of human multipotential or pluripotent stem cells, and particularly relates to a mesenchymal stem cell, and a preparation method and an application thereof. The method for preparing the mesenchymal stem cell comprises the following steps: S1, human multipotential stem cells form embryoid bodies; S2, the embryoid bodies differentiate into mesoderm cells; and S3, the mesodermal cells differentiate into the mesenchymal stem cells. The preparation method has a clear cell differentiation path, high differentiation efficiency, and stable differentiation effect and does not use serum-containing culture system or trophoblast cells, and the obtained cell population has high purity and largenumber, and thus is suitable for subsequent production and application of clinical-grade cell preparations.

The invention provides a method for industrially preparing high-purity ergothioneine. The method comprises the following steps of: carrying out hot water treatment on mycelium, carrying out solid-liquid separation, and performing collecting to obtain feed liquid containing ergothioneine; carrying out vacuum concentration, filtration, ultrafiltration, decoloration, desorption and concentration on the feed liquid containing ergothioneine; performing chromatographic purification on an ergothioneine desorption concentrated solution, collecting a target peak, performing concentrating until the solution is dry, and dissolving a product in water to obtain an ergothioneine sample solution; desalting and decolorizing the ergothioneine sample solution through ion exchange resin, and performing collecting to obtain a desalted ergothioneine concentrated solution; and carrying out coarse crystallization and recrystallization on the desalted ergothioneine concentrated solution, and performing drying to obtain high-purity ergothioneine crystal powder. According to the method, a large amount of high-purity ergothioneine is prepared from the mycelia of the pleurotus ostreatus CGMCC No.23071, the product quality of the ergothioneine is ensured. The method is particularly suitable for large-scale production of the ergothioneine, so that the requirements of the product in the fields of food, cosmetics, health care, medicine and the like are met.

The invention relates to a swine fever virus recombinant antigen as well as a preparation method and application thereof. The swine fever virus recombinant antigen is E2 protein modified by protein, wherein the protein modification comprises point mutation, and the point mutation is used for mutating 166th amino acid of the E2 protein into asparagine and mutating 229th amino acid into alanine. According to the swine fever virus recombinant antigen, the 229th Asn amino acid of a key glycosylation locus of the E2 protein is mutated into Ala, so that glycosylation can be removed; and furthermore,the 166th Asp amino acid is mutated into Asn, a new glycosylation locus is introduced, so that the immunogenicity of the protein can be increased, and the anaphylactic reaction of the protein can bereduced.