34 results about "Citrate buffer" patented technology

The invention relates to the technical field of biological pharmacy, and discloses a preparation method of a ready-to-use stable 3D-MLA adjuvant solution, which comprises the following steps: dissolving citric acid monohydrate and trisodium citrate dihydrate in water for injection to prepare a citrate buffer solution; adding polysorbate 80 into the citrate buffer solution while stirring, and dissolving the polysorbate 80; adding 3D-MLA into the obtained solution under stirring, and dissolving the 3D-MLA; adjusting the pH value of the solution; fixing the volume by using water for injection; sterilizing and filtering through a filter membrane, filling a container with filtrate, and sealing; and refrigerating and storing. According to the present invention, the citrate buffer solution is adopted, the pH value of the adjuvant solution is adjusted, and the combination effect of the buffer system and the pH environment is utilized, such that the chemical degradation of the 3D-MLA in the injection water is effectively inhibited, the technical problem that the solution is easily degraded is solved, and the ready-to-use preparation capable of maintaining the stability under the refrigeration storage condition is obtained.

The invention discloses a lipid nano-micelle preparation method, which comprises: (1) providing an amphiphilic lipid alcoholic solution with a concentration of 20-50 mg / mL and a buffer solution, the buffer solution being selected from a PBS buffer solution, a citrate buffer solution, a Tris-HCl buffer solution or an acetate buffer solution; (2) mixing the alcoholic solution of the amphiphilic lipid and a buffer solution according to the flow velocity ratio of the alcoholic solution of the amphiphilic lipid to the buffer solution of (2-4): 1 by adopting microfluidic mixing equipment to obtain a mixed product; and (3) carrying out liquid change on the mixed product by using a buffer solution to remove the alcohol solvent. On the premise of ensuring the small particle size of the lipid nano-micelle, the uniformity and narrow particle size distribution of the lipid nano-micelle are improved, and the target of batch-to-batch reproducibility is achieved. The method does not need to use dangerous chemicals, is high in safety, is simple to operate, is low in amplification production difficulty by combining a microfluidic technology with a liquid change technology, is low in energy consumption, can effectively improve the production efficiency, and reduces the production cost.

The application discloses a cysteine-rich protein 61 antigen storage solution, which comprises a protein protective agent, a non-ionic surfactant, a preservative, a soluble metal salt, a sugar substance and a buffer solution, wherein the buffer solution is a citric acid-citrate buffer solution, and the storage solution further comprises polyethylene glycol and polyvinylpyrrolidone; the pH value of the storage solution is in the range of 5.0-5.5; the added mass of the polyvinylpyrrolidone is 1.0-1.5 times of the mass of the polyethylene glycol; and the protein protective agent at least contains serum. The storage solution can stably store the cysteine-rich protein 61 antigen, and the cysteine-rich protein 61 antigen can be stably stored for 12 months at 2-8 DEG C and for 7 days at 37 DEG C, thereby solving the inconvenience caused by the freeze-drying storage of Cyr61 protein due to the stability and providing important support for Cyr61 as a new marker for subsequent clinical application.

This invention belongs to the field of active ingredient extraction technology, and relates to a compound algae extract, its preparation method, and its application. The preparation method includes: S1. Taking algae raw materials and soaking them in a citrate-citrate buffer solution with a pH of 3-5 at 60-80°C; S2. Cooling the obtained treated material to 50-55°C, and then performing enzymatic hydrolysis and enzyme inactivation to obtain an enzymatic hydrolysate; S3. Filtering the enzymatic hydrolysate and collecting the filtrate; S4. Performing ultrafiltration on the filtrate to obtain a concentrated solution; S5. Sterilizing and drying the concentrated solution to obtain the compound algae extract. This invention utilizes a citrate-citrate buffer solution with a specific pH range combined with enzymatic hydrolysis and ultrafiltration to extract active ingredients from algae while removing residual heavy metals, achieving a high yield of algae extract and a high heavy metal removal rate. This compound algae extract can play a dual role in anti-inflammatory and tablet adhesion in bone and joint health care compositions.

The purpose of the present disclosure is to provide a protective agent excellent in a protective effect of a phospholipid membrane. This liquid composition for protecting a phospholipid membrane comprises (A) a magnesium salt, (B) an acetate buffer solution, a citrate buffer solution, a carbonate buffer solution, and / or a succinate buffer solution, and preferably further contains at least any of (C) a polyhydric alcohol, (D) a saccharide and / or a sugar alcohol, (E) polyethylene glycol, and (F) an amino acid. The liquid composition for protecting the phospholipid membrane is excellent in the protective effect of the phospholipid membrane.

The invention relates to the field of biomedical technologies and pharmaceutical preparations, and discloses a TLR9 + HA201 composite adjuvant and a preparation method and application thereof, and the TLR9 + HA201 composite adjuvant freeze-drying preparation comprises the following components: a TLR9 + HA201 composite adjuvant, a TLR9 + HA201 composite adjuvant, a TLR9 + HA201 composite adjuvant freeze-drying agent, a TLR9 + HA201 composite adjuvant freeze-drying agent, a TLR9 D-(+)-trehalose; l-glutamic acid; a citrate buffer solution; the pH value of the aqueous solution to be freeze-dried is 6.5-7.5, the concentration of the D-(+)-trehalose is 8% w / v-12% w / v, the concentration of the L-glutamic acid is 0.8% w / v-1. 5% w / v, and the concentration of the citrate buffer solution is 15-25 mM. Through the synergistic effect of D-(+)-trehalose and L-glutamic acid in a specific citrate buffer system, efficient protection on the biological activity of the TLR9 + HA201 composite adjuvant is achieved, and the freeze-dried preparation shows the immune activation ability basically consistent with that before freeze-drying after being redissolved.

The present application relates to the technical field of nasal spray, in particular to a kind of nasal use of shangxiangyuan leaf composite spray and its preparation process.The preparation process includes the following steps: the system mass ratio is 1.5-2% of nano microspheres, 2.5-3% of glycerol, 0.3-0.5% of hydroxyethyl cellulose, 0.2-0.3% of phenoxyethanol and 20-25% of citrate buffer are mixed and the rest is made up with pure water, stirred until uniform, encapsulated to obtain nasal use of shangxiangyuan leaf composite spray.The present application carries out esterification reaction of glycerophosphocholine and lauric acid to synthesize glycerophosphocholine-lauric acid ester, glycerophosphocholine-lauric acid ester is the skeleton structure with glycerol, and ester bond is formed, so that glycerophosphocholine retains the structure of glycerophosphocholine while introducing the long chain of lauric acid, has better bioavailability and lower mucous membrane irritation, and provides stable structure and encapsulation efficiency for subsequent formation of liposome coating structure and loading shangxiangyuan leaf extract.

The present invention relates to an IgM antibody formulation and uses thereof. In particular, the IgM antibody formulation comprises an IgM antibody, which is an IgM antibody formed by a nanobody fusion protein and a J chain, the nanobody fusion protein is a fusion protein comprising a nanobody and an Fc fragment, which are optionally linked by a linker, wherein the formulation further comprises a buffer selected from a citrate buffer system, optionally the formulation further comprises one or more of a stabilizer, an osmotic pressure regulator and a surfactant.

The invention discloses a nano drug-loaded nasal spray composition for treating nasosinusitis. The nano drug-loaded nasal spray composition is prepared from the following raw materials: nano silver, PVP (Polyvinyl Pyrrolidone), baicalin, flos magnoliae volatile oil, chitosan, PLGA (Poly (Lactic-co-Glycolic Acid), sodium hyaluronate, a citrate buffer solution and the balance of sterile normal saline. The invention also discloses a preparation method of the nano drug-loaded nasal spray composition for treating nasosinusitis, the preparation method comprises the following steps: firstly preparing PVP modified nano silver suspension, then preparing baicalin nanoparticles and magnolia flower volatile oil nanoparticles by adopting an emulsification-solvent evaporation method, and PVP is used as a stabilizer of nano silver to ensure the long-term dispersion stability of nano silver, so that the stability of the nano silver is ensured, and the stability of the nano silver is ensured. Finally, all the components are mixed in a sterile operation table, the pH is adjusted, filtration sterilization is conducted through a 0.22-micron sterile filter membrane, terminal sterilization is conducted through gamma-ray irradiation after split charging is conducted, and the final product can be prepared into quantitative spray or sterile nose drops to meet different clinical requirements.

The present invention relates to a pharmaceutical composition comprising a radiohybrid comprising a fluorinated silicon and a chelating group, wherein either the fluorine is 18 F, or the chelating group comprises a chelated radioactive metal, wherein the composition has a pH of 4.0-6.0 and further comprises: 0.1-200 mM citrate buffer; 1-100 mg / mL ethanol; and 5-10 mg / mL sodium chloride.

The present invention provides a formulation that includes a therapeutically effective amount of phenylephrine or a pharmaceutically acceptable salt thereof, and a method for preparing the formulation. In some embodiments, the formulation includes a tonicity agent, a citrate buffer, water, and has an initial pH of from 5.6 to 6.0. In other embodiments, the formulation includes a tonicity agent, a citrate buffer, an antioxidant, water, and has an initial pH of from 3.6 to 4.8. The formulation of the invention is sterile, stable, ready-to-administer and packaged into a polymeric syringe.

The invention relates to a cordyceps militaris extract and an extraction process thereof, and belongs to the technical field of traditional Chinese medicine extraction. The extraction efficiency is improved through the synergistic effect of enzymolysis, pulse ultrasound and supercritical extraction. The method specifically comprises the following steps: mixing a cordyceps militaris raw material with cellulase and pectinase for enzymolysis, and adding a protective agent containing glutathione and ascorbic acid and an ethanol-citrate buffer solution under the protection of inert gas for pulse ultrasonic treatment; and concentrating the extracting solution, performing supercritical CO2 extraction to remove fat-soluble impurities, and performing freeze drying to obtain the extract. The cordycepin content of the obtained extract is larger than or equal to 0.8%, and the mass ratio of cordycepin to cordycepic acid is stabilized to be 1: 0.2-1. The process solves the problems of serious damage to active components and low efficiency of a traditional method.

The invention discloses a nano iron oxide injection based on a synergistic stabilization mechanism and a preparation method of the nano iron oxide injection. The injection comprises nano iron oxide particles, carboxyl-terminated methoxypolyethylene glycol, an amino acid stabilizer, a citrate buffer agent and an isotonic agent. The preparation method comprises the following steps: synthesizing an oleic acid modified nano iron oxide core; performing ligand exchange at 0-4 DEG C to form a PEG anchoring layer; then, under the temperature of 6-8 DEG C, through programmed feeding and low-temperature shearing, amino acid and citrate are synergistically embedded, and a stable structure is constructed. According to the invention, a triple stable system of PEG anchoring layer-synergistic chelating layer-buffer microenvironment is constructed, and a whole-course low-temperature controllable process is adopted, so that the defects of poor long-term stability, high iron ion release rate, poor process reproducibility and poor moist heat sterilization resistance of the existing nano iron oxide contrast agent are overcome. The obtained product has excellent colloidal stability, extremely low ion release rate and good biological safety, and is suitable for magnetic resonance imaging.

The present application relates to a kind of cordyceps militaris extract and its extraction process, belong to traditional Chinese medicine extraction technical field.The present application is through enzymolysis, pulse ultrasonic and supercritical extraction synergistic effect to improve extraction efficiency.Specifically including: cordyceps militaris raw materials and cellulase, pectinase mixed enzymolysis, under the protection of inert gas, adding the protective agent containing glutathione and ascorbic acid and ethanol-citrate buffer solution is treated by pulse ultrasonic;Extract liquid is concentrated after supercritical CO2 extraction removes fat-soluble impurities, freeze-drying obtains extract.The obtained extract cordycepin content is ≥0.8%, and the mass ratio of cordycepin and cordycepic acid is stably at 1:0.2-1.The process solves the problem of serious damage of active ingredient in traditional method, low efficiency.

The application relates to the technical field of biological pharmacy, and discloses a preparation method of a ready-to-use stable 3D-MLA adjuvant solution, which comprises the following steps: dissolving citric acid monohydrate and trisodium citrate dihydrate in water for injection to prepare a citrate buffer; under stirring, adding polysorbate 80 into the citrate buffer to dissolve the polysorbate 80; under stirring, adding 3D-MLA into the obtained solution to dissolve the 3D-MLA; adjusting the pH value of the solution; using water for injection to fix the volume; performing sterilization filtration through a filter membrane, filling the filtrate into a container and sealing the container; and cold storage. Through the citrate buffer and the adjustment of the pH value of the adjuvant solution, the combination of the buffer system and the pH environment effectively inhibits the chemical degradation of the 3D-MLA in the water for injection, the technical problem that the solution is prone to degradation is solved, and a ready-to-use preparation which can be stably stored under cold storage conditions is obtained.

The present invention relates to a pharmaceutical composition comprising a radiohybrid agent containing a silicon-fluoride and a chelating group wherein either the fluorine is 18F or the chelating group contains a chelated radioactive metal, wherein the composition has a ph of 4.0-6.0 and further comprises: 0.1-200 mM citrate buffer; 1-100 mg / ml ethanol; and 5-10 mg / ml sodium chloride.

The present invention relates to a pharmaceutical composition comprising a radiohybrid agent containing silicon fluoride and a chelating group wherein the fluorine is 18F or the chelating group contains a chelated radioactive metal, wherein the composition has a pH of 4.0-6.0 and further comprises: 0.1-200 mM citrate buffer; 1-100 mg / mL ethanol; and 5-10 mg / mL sodium chloride.

An improved adenovirus formulation comprising: a) a recombinant adenovirus; b) a citrate buffer; c) a cyclodextrin compound; and d) a salt, said formulation having a pH ranging from about 5.5 to about 6.5, and wherein said formulation is free of non-ionic detergent. The invention also relates to a method of preserving an adenovirus which comprises preparing said formulation.

The invention provides a pharmaceutical composition for preventing and / or treating tetanus as well as a preparation method and application of the pharmaceutical composition. The pharmaceutical composition comprises a recombinant tetanus toxin C fragment as a unique antigen component, an adjuvant and a solvent, wherein the adjuvant is selected from one or more of an aluminum adjuvant, a Toll-like receptor stimulant and saponin, preferably the aluminum adjuvant, and / or the solvent is selected from one or more of a phosphate buffer solution, a citrate buffer solution, a histidine salt buffer solution and a sodium chloride solution, preferably the phosphate buffer solution and / or the sodium chloride solution. The adopted recombinant tetanus natural C fragment (Hc) is non-toxic, formaldehyde inactivation is not needed, meanwhile, the possibility of toxicity reversion is avoided, and the pharmaceutical composition can induce mammals to generate high immune response against tetanus and has good immune persistence.

A detergent may include a citrate buffer. A detergent may include a surfactant component. A detergent may include a chelator component, wherein a pH of the detergent composition is in a range of from about 6.5 to about 9, and at least one of the citrate buffer, surfactant component and the chelator component are biodegradable.

Provided herein are liquid pharmaceutical formulations comprising exendin (9-39) or a pharmaceutically acceptable salt thereof and a tonicity modifier in a physiologically acceptable buffer having a pH in the range of about 5 to about 6. In some embodiments, the buffered liquid formulation comprises exendin (9-39) or a pharmaceutically acceptable salt thereof in an acetate buffer or a citrate buffer. Methods of treating or preventing hyperinsulinemic hypoglycemia in a subject comprising administering to the subject the buffered liquid formulation are also provided.

A composition containing levosimendan, one or more solubilizing and / or stabilizing agents, and one or more additional pharmaceutically acceptable additives. The one or more solubilizing and / or stabilizing agents may be a cyclodextrin or a cyclodextrin derivative. The cyclodextrin derivative may be a derivative of an alpha-cyclodextrin, or beta-cyclodextrin, or a gamma-cyclodextrin. The cyclodextrin derivative may contain a butyl ether spacer group, an alkyl ether space group, or both. The one or more additional pharmaceutically acceptable additives may be a non-citrate buffer. The composition may be used in a method of treating a health condition, such as heart failure, pulmonary hypertension, chronic kidney disease, amyotrophic lateral sclerosis, stroke, in advance of a planned cardiac surgery, or other health conditions for which a minimally invasive or repeated administration of levosimendan may be beneficial. The composition may be administered subcutaneously.

The invention discloses a method for detecting an impurity I in an amikacin sulfate injection, which adopts a sulfonic strong ion exchange chromatographic column and a specific buffer solution for gradient elution, and can realize high-sensitivity detection without an ampere detector. Wherein a chromatographic column adopts a sulfonyl strong cation sodium system exchange column, gradient elution is performed by using a mobile phase, the mobile phase consists of a first buffer solution, a second buffer solution and a regeneration solution, and the first buffer solution is a citrate buffer solution I; the second buffer solution is a citrate buffer solution II; the regeneration liquid is an ethylenediaminetetraacetic acid sodium hydroxide solution. By screening and optimizing chromatographic conditions such as flow velocity, temperature, wavelength and the like, accurate quantitative detection of the impurity is realized. According to systematic methodology verification, the method has the advantages of high specificity, high sensitivity, good precision, high accuracy and the like, and the impurity I in the amikacin sulfate injection can be quantitatively or qualitatively detected, so that the safety of clinical medication of the amikacin sulfate injection is improved.

This invention relates to the field of protein extraction technology, specifically disclosing a method for the simultaneous co-production and extraction of egg white lysozyme and ovotransferrin, comprising: (1) Egg white pretreatment: after dilution, adjust the pH to 4.5, filter out the ovomucin precipitate, and then adjust the supernatant to pH 8.0-9.0. (2) Cation exchange separation of lysozyme: adsorb onto a cation exchange column of the pretreatment solution, collect the permeate and eluent as the egg white flow-through solution; elute the lysozyme, and obtain the lysozyme product by concentration, desalting, sterilization, and drying. (3) Anion exchange separation of ovotransferrin: after adjusting the flow-through solution to pH 5.5-6.0, load onto an anion exchange column, elute to remove impurities, and collect the permeate containing ovotransferrin. (4) Iron removal and drying: concentrate by ultrafiltration, dialyze with citrate buffer for desalting and preliminary iron removal, then remove bound iron by chelating resin, and dry to obtain the iron-free ovotransferrin product.

Provided is a liquid preparation containing an anti-IL-17 antibody at a concentration of 20 mg / mL to 200 mg / mL, a citrate buffer at a concentration of 10 mM to 50 mM, a sucrose at a concentration of 20 mg / mL to 120 mg / mL or arginine at a concentration of 50 mM to 250 mM, and polysorbate 80 at a concentration of 0.1 mg / mL to 5 mg / mL. In addition, the liquid preparation has a pH of 6.0±0.5, wherein the anti-IL-17 antibody is an anti-IL-17A / F monoclonal antibody. The liquid preparation can be a stable subcutaneous injection preparation, and can be used to treat IL-17A and / or IL-17F related diseases, such as psoriasis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, osteoarthritis or inflammatory bowel disease.

The present invention provides a liquid pharmaceutical formulation comprising exendin (9-39) or a pharmaceutically acceptable salt thereof and a tonicity adjusting agent in a physiologically acceptable buffer having a pH ranging from about 5 to about 6. In some embodiments, the liquid pharmaceutical formulation comprises exendin (9-39) or a pharmaceutically acceptable salt thereof in an acetate buffer or a citrate buffer. Also provided are methods of treating or preventing hyperinsulinemic hypoglycemia in a subject, the method comprising administering the liquid pharmaceutical formulation to the subject.

Provided herein are drug products adapted for nasal delivery comprising a device and a pharmaceutical composition comprising an opioid receptor antagonist, wherein the claimed invention provides a unit dose of an aqueous pharmaceutical solution, or aqueous pharmaceutical composition, housed in a device configured for intranasal administration to a patient, wherein the aqueous pharmaceutical solution consists of, or the aqueous pharmaceutical composition consists essentially of: (i) naloxone hydrochloride in an amount of about 9% by weight based on the total weight of the aqueous pharmaceutical solution; (ii) glycerin in an amount of about 1.4% by weight based on the total weight of the aqueous pharmaceutical solution; (iii) a citrate buffer system adjusted by hydrochloric acid and / or sodium hydroxide; and (iv) United States Pharmacopeia (USP)-grade Purified Water; wherein the pH of the aqueous pharmaceutical solution is from about 3.5 to about 4.7; and wherein the hydrochloric acid and the sodium hydroxide may each be independently present in the aqueous pharmaceutical solution, as required, to achieve the pH from about 3.5 to about 4.7.

Provided herein are liquid pharmaceutical formulations comprising exendin (9-39) or a pharmaceutically acceptable salt thereof and a tonicity modifier in a physiologically acceptable buffer having a pH in the range of about 5 to about 6. In some embodiments, the buffered liquid formulation comprises exendin (9-39) or a pharmaceutically acceptable salt thereof in an acetate buffer or a citrate buffer. Methods of treating or preventing hyperinsulinemic hypoglycemia in a subject comprising administering to the subject the buffered liquid formulation are also provided.

This invention provides a method for producing microencapsulated activators that are robust, protect encapsulated probiotic bacteria, and have storage stability. [Solution] The method comprises the steps of preparing a protein suspension containing denatured plant protein, preparing a suspension of hydrated probiotics, mixing the protein suspension and the hydrated probiotics suspension to encapsulate the probiotics in a denatured pea protein matrix, and polymerizing the denatured plant protein matrix with calcium salts. The mixing step may include extruding the protein suspension and the hydrated probiotics suspension to form microdroplets, and the polymerization step includes curing the extruded microdroplets in a curing bath containing calcium citrate buffer having a pH of 6.5 and a molar concentration of 0.05 to 0.15 M.

A composition containing levosimendan, one or more solubilizing and / or stabilizing agents, and one or more additional pharmaceutically acceptable additives. The one or more solubilizing and / or stabilizing agents may be a cyclodextrin or a cyclodextrin derivative. The cyclodextrin derivative may be a derivative of an alpha-cyclodextrin, or beta-cyclodextrin, or a gamma-cyclodextrin. The cyclodextrin derivative may contain a butyl ether spacer group, an alkyl ether space group, or both. The one or more additional pharmaceutically acceptable additives may be a non-citrate buffer. The composition may be used in a method of treating a health condition, such as heart failure, pulmonary hypertension, chronic kidney disease, amyotrophic lateral sclerosis, stroke, in advance of a planned cardiac surgery, or other health conditions for which a minimally invasive or repeated administration of levosimendan may be beneficial. The composition may be administered subcutaneously.