286 results about "Bacterial endotoxin" patented technology

The invention provides a kit for detecting a fungus (1-3)-beta-D glucan in human body fluid. The kit can be industrially produced, and is accurate and high in speed and specificity. The kit is characterized by comprising a main reactant, a body fluid treating agent, an alkaline diluent, an acidic diluent, sterile water, lyophilized serum and a (1-3)-beta-D glucan quality control substance, wherein the main reactant contains a tachypleus tridentatus blood cell G factor, coagulating zymogen and an activator. A detection method is convenient, rapid, safe and high in specificity, the (1-3)-beta-D glucan in body fluid samples of 10 persons can be detected within 80 minutes, a discrimination coincidence rate reaches 100 percent, and the fungus (1-3)-beta-D glucan and bacterial endotoxin can be discriminated within the same reaction time.

A method of removing bacterial endotoxin from a pharmaceutical process solution is disclosed. In one embodiment, the method comprises treating the solution with a surfactant effective to dissociate the endotoxin from a pharmaceutical drug or vaccine substance in the solution, and then filtering the solution through a molecular cut-off filter having a pore size effective to retain the pharmaceutical drug or vaccine substance but allow the dissociated bacterial endotoxin to pass therethrough.

The invention provides a specific limulus reagent and a preparation method thereof. The preparation method comprises steps of blood collection, cell separation, cell lysis, cell wall separation, addition of an activator and a G factor inhibitor, so as to prepare a semi-finished product. The invention further provides a detection kit for blood bacterial endotoxin, wherein the kit contains the specific limulus reagent, and further comprises a humoral treatment agent I, a humoral treatment agent II, bacterial endotoxin controls and inspection water. The specific limulus reagent and the detection kit provided by the invention can qualitatively identify a gel reaction of the limulus reagent with the bacteria endotoxin and glucan type substances, thereby improving reliability of the detection results of the blood bacterial endotoxin, and realizing quantitative detection for the blood bacterial endotoxin. By using the specific limulus reagent and the detection kit, the detection of the blood bacterial endotoxin is characterized by high sensitivity, reliable detection result and high detection efficiency.

The invention discloses a freeze-dried vaccine protective agent, a freeze-dried varicella attenuated live vaccine and preparation methods of the freeze-dried vaccine protective agent and the freeze-dried varicella attenuated live vaccine, belongs to the field of vaccine production and preparation processes, and solves the problem that an existing freeze-dried vaccine protective agent of a varicella vaccine contains gelatin, or contains dextranum and still contains human serum albumin even if the gelatin is removed, so that a potential hazard still exists in the safety of medication of the vaccine. The freeze-dried vaccine protective agent contains mycose, sodium glutamate, urea, L-arginine and a 199 culture medium, and does not contain macromolecular allergen ingredients such as gelatin, dextranum and human serum albumin; the bacterial endotoxin content is low; the varicella vaccine prepared by using the protective agent is low in endotoxin content and residual content of bovine serum albumin and antibiotics, good in stability, safe and effective; the main point is direct infection after passage; the cells are cleaned in the next day after infection, and are replaced with a serum-free maintenance fluid; the operation is simple; the cost is low; regular and uniform formation of cytopathy is facilitated; and the residual content of the bovine serum albumin can be greatly lowered.

The invention relates to a method for using luminous intensity to test the bacterial endotoxin content of glucosum anhydricum, belonging to the analytical chemistry technical field. The technical scheme is that: using luminous intensity to test the reaction time from the reaction of limulus polyphemus agent and the endotoxin to the turbidity of the mixture reaching a preset absorbency; finding the endotoxin content of the object glucosum anhydricum sample. According to the scheme, the method dilutes an endotoxin operation standard sample of known content into operation standard sample series of different contents, tests the times of different endotoxin content standards reaching the preset absorbency, and draws a standard curve; and tests the time of the object glucosum anhydricum sample reaching the preset value, to find the content of the endotoxin of the glucosum anhydricum sample.

The invention relates to hyaluronic acid, in particular to method for purifying hyaluronic acid by pre-laying filter aid. In the step of kieselguhr and active carbon absorption and filtration, after the kieselguhr is pre-laid on a titanium bar filter as a filter layer, the enzymolysis solution or fermentation solution is filtered. When the method is used for preparing hyaluronic acid, the filtration assisting and absorbing effects of the kieselguhr are increased, the light transmittance of the filtrate can be improved, the bacterial endotoxin content of medicinal liquid is lowered effectively, and the impurities introduced to the medicinal liquid with the use of the kieselguhr are avoided. Compared with the overseas plate type coarse filtering method, the method reduces production cost, achieves the same effect and is particularly suitable for industrial production.

The invention provides methods and compositions for the detection and/or quantification of a microbial contaminant, for example, a bacterial endotoxin or a glucan, in a sample. In particular, the invention provides a test cartridge useful in the practice of hemocyte lysate-based assays for the detection and/or quantification of a microbial contaminant in a sample. In addition, the invention provides methods of making and using such cartridges. In addition, the invention provides a rapid, sensitive, multi-step kinetic hemocyte lysate-based assay for the detection and/or quantification of a microbial contaminant in a sample. In addition, the invention provides a glucan-specific lysate that can be used in a variety of assay formats, including, for example, a test cartridge, optionally configured to perform a kinetic assay.

This invention relates to a method for producing recombined human granular leukocyte colony stimulating factors including: fermenting, breaking bactrriums, extracting occlusion bodies, chromatographing with molecular sieves, renaturating, exchanging anions, exchanging cations to get the raw fluid, in which, BL21 is selected as the host bacterium and the engineering bacterium type is got in high expression volume, quick reproduction and stable passage, several purification steps greatly reduce the residural toxin in the bacterium and the specific activity is increased greatly, a dialysis method is applied for the renaturation to reduce the concentration of the denaturalization agent steadily so the renaturation rate is at high level.

The invention provides Chinese medicinal (honeysuckle, baikal skullcap root and forsythia) toothpaste and a preparation method thereof. Each 100 grams of Chinese medicinal toothpaste contains 0.03 to 10 grams of honeysuckle extract, 0.03 to 10 grams of baikal skullcap root extract and 0.03 to 10 grams of weeping forsythia extract. The Chinese medicinal toothpaste has strong anti-inflammatory, antibacterial, anti-virus, immunity regulating, free radical clearing and anti-oxidation effects. The baikal skullcap root can inhibit caries bacteria, can effectively degrade bacterial endotoxin, and can be used for preventing and treating peridentitis; and the honeysuckle has antibacterial effect of different degree on most pathogenic bacteria, and the use of the honeysuckle for local medication isan effective means for preventing and treating oral diseases. The baikal skullcap root, the honeysuckle and the forsythia have the effects of clearing heat, detoxifying and dispelling wind and heat from the body; and the three Chinese medicinal extracts used together have synergistic effect, and can effectively inhibit the propagation of bacteria which generate peculiar smell in the oral cavity. Oral bacterial sensitivity test proves that the Chinese medicinal toothpaste has obvious effect of inhibiting related pathogenic bacteria in bacterial plaque of the gingival part.

The invention discloses a reduced-type glutathione freeze dried injection and making technique, which is characterized by the following: loading 95.0%-105.0% reduced-type glutathione (C10H17N3O6S) to display white block and powder; testing nitrosoferric sodium cyanide to display red; keeping the consistent reserving time of main peak of sample solution as comparison sample solution with pH value at 5.0-6.5; making dried weight not over 5.0% and the content of relative material not more than 4%; limiting the content of bacterial endotoxin less than 0.125EU; making other items satisfy the standard.

The invention provides an improved cell free amplification method capable of producing large quantities of therapeutic-quality nucleic acids and methods of using the synthesized nucleic acid in research, therapeutic and other applications- The methods combine several different state-of-the-art procedures and coordinate their applications to affordably synthesize nucleic acids for therapeutic purposes. It combines in vitro rolling circle amplification, high fidelity polymerases, high affinity primers, and streamlined template specifically designed for particular applications. For expression purposes, the templates contain an expression cassette including a eukaryotic promoter, the coding sequence for the gene of interest, and a eukaryotic termination sequence. Following amplification, concatamers are subsequently processed according to their intended use and may include: restriction enzyme digestion for the production of short expression cassettes (SECs); ligation steps to circularize the SEC (CNAs); and/or supercoiling steps to produce sCNAs. The final product contains nearly non-detectable levels of bacterial endotoxin.

The present invention discloses a kind of deproteinized calf serum injection and its preparation process. Of the deproteinized calf serum injection, each milliliter contains solid 0.035-0.055 g, free amino acid 0.6-1.5 mg, and polypeptide 0.4-3.0 mg. The injection of the present invention has bacterial endotoxin content lower than 1 EU, and has pH value of 6.0-8.0. The injection has high effective component content, high bioactivity, high purity and low impurity content. Tests show that the injection of the present invention has high clinical curative effect, no any toxic side effect and no allergic reaction.

The present invention relates to homologous system model method for quantitatively detecting bacterial endotoxin of blood, and aims at solving the problem of difference or interference caused by different system property. In the system model method, one new concept is proposed for solving the BET interference of the sample, i. e., all the unkown interference factors are considered as systematic deviation. Once the systematic deviation is eliminated, the said BET interference of the sample will be eliminated. In some reaction system, digital model is established and sample is detected in the same system, the difference caused by different system property will be eliminated.

The invention provides a clean production method of medium molecular weight hydroxyethyl starch, in particular to a clean production method in the refining process of chemical raw materials hydroxyethyl starch 200/0.5 and hydroxyethyl starch 130/04 used for plasma expanders. Bacterial endotoxin is the key toxic substance leading to clinical infusion pyrogenic reaction. The bacterial endotoxin in the raw material drug of hydroxyethyl starch exceeds the limit, which can easily lead to the limit of bacterial endotoxin in the final product of the preparation, hydroxyethyl starch injection, and the unqualified rate increases. The method of the invention is controlled by necessary process conditions such as clean air spray drying under clean conditions, microbial control under high temperature conditions, and on-line cleaning and disinfection of equipment, so that the quality of the bacterial endotoxin index of the obtained final product is obviously better than the current national drug quality standards. At the same time, it provides the necessary conditions for the direct preparation method of raw materials without microfiltration, which is helpful for the qualification of the insoluble particle index of the preparation, shortens the process flow of the final preparation, and reduces the probability of pollution.

The invention belongs to the field of a pharmaceutical preparation, and particularly relates to a mixed carbohydrate-electrolyte injection and a preparation method thereof. A pH modifier of the injection is citric acid, and pH is 4.0-4.4. By controlling the dosage range of the pH modifier, the pH range of the finished product can meet the specification only by regulating the pH value for one time in the preparation process. In addition, according to the method, activated carbon is added only in the step, and the activated carbon is not added in the preparation process, so that the risk of introducing metal ions and other impurities through the activated carbon can be effectively avoided, and toxins in bacteria of the finished product are qualified. According to the method, the technology is further simplified, the production time and cost can be shortened and lowered, and the sterilized product has no crystallization or precipitation phenomenon. After being stored for 24 months, the 5-hydroxymethyl-furfural range of the injection is within 0.03-0.05, and the impurities are controlled at the extremely low level; after being stored for 24 months, the injection almost has no character change and is still colorless clear liquid compared with the injection which is stored for zero day.

The invention discloses a recombinant limulus three-factor reagent which comprises the following components: endotoxin-free water, a heat-resource-free Tris buffer liquid, Tween-20, a fluorescent substrate, a recombinant limulus factor C, a recombinant limulus factor B and a recombinant limulus proclotting enzyme factor. The invention provides the recombinant limulus three-factor reagent and a method for detecting endotoxin with the same, three recombinant limulus factors (the proclotting enzyme factor, the recombinant limulus factor B and the recombinant limulus factor C) can be expressed by using an insect baculovirus expression system, the reagent can be used for detecting bacterial endotoxin, and by adopting the method, bypass interference of a factor G can be eliminated, so that the possibility of false positive caused by glucan is effectively avoided; moreover, the defects that the number of limulus is limited and different batches of limulus reagents are not stable are avoided, and thus the reagent can be used as a novel endotoxin detection reagent.

The invention discloses a plant extract compound capable of inhibiting bacteria, resisting inflammation, stopping bleeding and relieving pain and an application of the plant extract compound. The plant extract compound is prepared from callicarpa nudiflora extract and flavonoids according to a mass ratio of (1-5) to (5-1). The callicarpa nudiflora extract has the functions of resisting inflammation, inhibiting bacteria, resisting viruses, stopping blood, relieving pain, adjusting immunity, removing free radicals and resisting oxidation; the callicarpa nudiflora extract has an effect of resisting most of pathogenic bacteria to different extents. The flavonoids have the effects of inhibiting dental caries, effectively degrading bacterial endotoxin, and preventing and treating periodontitis. The antibacterial, anti-inflammatory, analgesia and hemostasis experiments prove that the plant extract compound is exact in therapeutic effect, natural, healthy and easy to produce; the use effect of the plant extract compound is obviously superior to that of the components of oral cavity cleaning products. Therefore, the plant extract compound has a good market development prospect.

The invention discloses a method for detecting bacterial endotoxin in a citric acid raw material. The method comprises the following steps of firstly carrying out interference test to determine the sensitivity of tachypleus amebocyte lysate selected to detect the bacterial endotoxin in the citric acid raw material; and then diluting the to-be-detected citric acid raw material to prepare a to-be-detected solution, adding the tachypleus amebocyte lysate determined in the interference test and detecting the bacterial endotoxin. By virtue of the method for detecting bacterial endotoxin in the citric acid raw material, which is disclosed by the invention, the problem of detection of the bacterial endotoxin in the citric acid raw material for a newly developed injection product is solved; the quality of a sterile product is controlled at the source and the method is of great significance for ensuring the safety of the injection product. Since the method has a theoretical basis of biochemistry, the method is more scientific; molecular and biochemical reactions of an enzyme are applied and the method has the advantages of high specificity, strong reproducibility, high accuracy and sensitivity, no need of special instrument and equipment and strong practicability and is simple and quick to operate.