14 results about "Histidine Hydrochloride" patented technology

The invention provides a preserving fluid for preserving adipose tissue-derived stem cell extracellular vesicles and a formula of a corresponding preparation, and particularly, the formula comprises sodium chloride, cane sugar, polysorbate 80, histidine and histidine hydrochloride. According to the formula, the storage stability of the extracellular vesicles secreted by adipose tissue can be improved, substances in the extracellular vesicles are prevented from being degraded, convenience is provided for clinical application of the extracellular vesicles, and good market prospects are achieved.

Provided are a stable secukinumab injection and a preparation method therefor. The stable secukinumab injection is composed of the following ingredients: 50 mg / ml-300 mg / ml of secukinumab, 5 mmol / L-50 mmol / L of histidine and a histidine hydrochloride, 5 mmol / L-50 mmol / L of methionine, 150 mmol / L-400 mmol / L of a low-sugar alcohol, and 0.01%-0.02 of polysorbate 80, wherein the balance is water for injection, and the pH is 5.0-7.0. Stability tests prove that the quality of the stable secukinumab injection is stable, wherein the stability thereof is superior to that of commercial varieties on the market, and same has various indicators that meet the relevant regulations of the Chinese Pharmacopoeia, and has good application prospects.

The invention discloses a preparation method of a compound amino acid injection 18AA, and relates to the field of preparation methods of compound amino acid injections.The preparation method comprises the following steps that S1, after water for injection is added into a preparation tank, nitrogen is continuously introduced, and heating is conducted; s2, feeding tyrosine, aspartic acid, isoleucine, leucine, threonine, valine, histidine hydrochloride, methionine, lysine hydrochloride, phenylalanine, alanine, arginine hydrochloride, proline, serine, glycine and sorbitol into the preparation tank by adopting a closed feeding tank, and stirring to dissolve the tyrosine, the aspartic acid, the isoleucine, the leucine, the threonine, the valine, the histidine hydrochloride, the methionine, the lysine hydrochloride, the phenylalanine, the alanine, the arginine hydrochloride, the proline, the serine, the glycine and the sorbitol; s3, pre-dissolving cystine in a hydrochloric acid solution, and then adding into the preparation tank for mixing; and S4, adding a sodium hydroxide solution into the preparation tank, mixing, and adjusting the pH value to obtain the compound amino acid injection 18AA. According to the invention, the purpose of improving the product safety is achieved by improving the process without adding sodium hydrogen sulfite and adopting a direct dilution method and an activated carbon-free process.

The present invention provides an anti-aPC monoclonal antibody formulation, which has a buffer system of histidine / histidine hydrochloride or acetic acid / sodium acetate, and which contains at least two of the following protectant components: a. a sugar selected from trehalose and sucrose or a sugar alcohol selected from sorbitol and mannitol, b. an amino acid selected from arginine hydrochloride or aspartic acid, and c. sodium chloride, and which has a pH of 5.0 to 6.3. The anti-aPC monoclonal antibody formulation of the present invention ensures long-term stability of the anti-aPC monoclonal antibody under storage conditions, and a formulation that can maintain this stability can be obtained.

The invention provides a liquid preparation of an anti-RANKL antibody. The liquid preparation comprises the following components: 60-80 g / l of the anti-RANKL antibody, 50-100 g / l of sugar or sugar alcohol, 0.1-0.3 g / l of a surfactant and 10-30 mM / l of amino acid, the buffer system is selected from a histidine-histidine hydrochloride buffer system. The aggregation and degradation of protein can be effectively reduced, and the stability is good.

The invention discloses a histidine hydrochloride refining process, which relates to the technical field of biological medicine, and comprises the steps of ultrasonic-assisted dissolution, double synergistic purification, precise pH-temperature coupling crystallization and optimized drying. By limiting the resin crosslinking degree to be 8%, the column height-volume ratio to be 1: 5, the cation exchange flow rate to be 3.0 BV / h, the activated carbon adsorption flow rate to be 2.0 BV / h, the crystallization pH to be 2.35 + / -0.02, a three-stage cooling procedure and other key parameters, full-process closed-loop control is achieved. By adopting the process, the histidine hydrochloride product with the purity of more than or equal to 99.95%, uniform crystal form, extremely low impurity residue and excellent physical stability can be obtained, the unification of deep impurity removal and accurate crystal structure regulation and control in the histidine hydrochloride refining process is realized, and the fundamental contradiction that the purity, the crystal form and the reproducibility cannot be considered in the prior art is solved.

The invention discloses a pharmaceutical composition containing an anti-CD73 antibody and application of the pharmaceutical composition. The pharmaceutical composition is a liquid preparation containing an anti-CD73 antibody, and the liquid preparation comprises the following components: (A) 10-150 mg / mL of the anti-CD73 antibody or an antigen binding fragment of the anti-CD73 antibody; (B) 10 to 50 mM of a histidine-histidine hydrochloride buffer solution; (C) 150 to 280 mM of sucrose; (D) 5 to 20 mM of methionine; (E) 0.005% to 0.5% of a surface active agent; and (F) 0.005 to 0.1 mg / mL of a complexing agent. The pharmaceutical composition provided by the invention can provide better physical and chemical stability of the anti-CD73 antibody, and has a wide industrial application prospect.

An anti-B7H3 antibody-eribulin conjugate formulation, a preparation method therefor, and use thereof. The formulation contains trehalose, polysorbate 20, histidine, histidine hydrochloride, and an anti-B7H3 antibody-eribulin conjugate or a pharmaceutically acceptable salt or solvate thereof. A specific formulation formula is designed for the anti-B7H3 antibody-eribulin conjugate. By means of using the synergistic cooperation of specific component excipients and a buffer system, the stability of the formulation is significantly improved. Moreover, the preparation process is further verified scientifically and systematically, which proves that the well-developed anti-B7H3 antibody-eribulin conjugate formulation and the preparation process thereof maintain the purity, coupling rate, and free drug of the finished product stable, reduce molecular degradation and aggregates, have strong process stability, and can be applied on a large scale, thereby promoting the application of the anti-B7H3 antibody-eribulin conjugate.

Provided is a transfection reagent, comprising a solvent, organic substances, amino acids, vitamins and inorganic salts, wherein the organic substances comprise D-glucose, sodium pyruvate, i-inositol, phenol red and choline chloride; the amino acids comprise glycine, L-glutamine, L-valine, L-isoleucine, L-leucine, L-threonine, L-lysine hydrochloride, L-phenylalanine, L-serine, L-tyrosine disodium salt, L-arginine hydrochloride, L-methionine, L-cystine dihydrochloride, L-histidine hydrochloride and L-tryptophan; the vitamins comprise nicotinamide, pyridoxine hydrochloride, thiamine hydrochloride, folic acid, D-calcium pantothenate and riboflavin; and the inorganic salts comprise sodium chloride, sodium bicarbonate, potassium chloride, calcium chloride, sodium dihydrogen phosphate, magnesium sulfate, hydrochloric acid and ferric nitrate. The transfection reagent is suitable for a wide range of applications, achieves the rapid onset of transfection, and has a good transfection effect.

The invention discloses a CHO cell culture medium and application thereof, and belongs to the technical field of cell culture mediums. The CHO cell culture medium is prepared from the following components in parts by weight: amino acid, vitamins, inorganic salt, trace elements, carbohydrates and other molecular compounds. The amino acid is prepared from the following components: L-arginine, L-histidine, L-asparagine monohydrate, L-asparaginic acid, L-glutamic acid, L-glycine, L-histidine hydrochloride monohydrate, L-methionine, L-cysteine, L-isoleucine, L-leucine, L-lysine hydrochloride, L-methionine, L-phenylalanine, L-alanine, L-arginine hydrochloride and L-threonine; l-tryptophan, L-tyrosine, L-valine, L-cysteine monohydrate hydrochloride, L-proline, L-serine, L-aspartic acid, L-asparagine, L-lysine and L-glutamine are added into the culture medium, and the culture medium is prepared from the following components: L-tryptophan, L-tyrosine, L-valine, L-cysteine monohydrate hydrochloride, L-proline, L-serine, L-asparagine, L-lysine and L-glutamine. An EmCD CHO 908 perfusion culture medium is adopted as the basic culture medium.

The present invention relates to a stable secukinumab injection, characterized in that it comprises 50-250 mg / ml of secukinumab, 5-50 mmol / l of histidine and histidine hydrochloride, 5-40 mmol / l of methionine, 150-370 mmol / l of low molecular weight sugar alcohol and polysorbate 80 at 0.01%-0.02% (v / v), in water for injection, pH 5.0-7.0, wherein the low molecular weight sugar alcohol is xylitol.

A pharmaceutical formulation containing 10-80 mg / ml bevacizumab is provided. The buffer system of the pharmaceutical formulation is preferably 10-30 mM histidine hydrochloride-sodium acetate buffer, contains 25-50 mg / mL sucrose or sorbitol as a stabilizer, and the surfactant Tween 80, with a pH of 5.0-5.6. The formulation of the present invention was tested under repeated freeze-thaw and accelerated conditions at 40°C, and the protein stability was good, which was superior to other similar formulation recipes.

The invention relates to an anti-B7H3 antibody-imine conjugate preparation as well as a preparation method and application thereof. The preparation contains trehalose, polysorbate 20, histidine, histidine hydrochloride and an anti-B7H3 antibody-imine brurin conjugate or a pharmaceutically acceptable salt or solvent compound of the anti-B7H3 antibody-imine brurin conjugate. According to the anti-B7H3 antibody-imine conjugate and the preparation method thereof, a specific preparation formula is designed for the anti-B7H3 antibody-imine conjugate, the stability of the preparation is remarkably improved by virtue of synergistic cooperation of specific component auxiliary materials and a buffer system, and the preparation process is further scientifically and systematically verified, so that the development of the good anti-B7H3 antibody-imine conjugate preparation and the preparation process thereof is proved, and the preparation method has the advantages that the preparation process is simple and convenient, and the application prospect is wide. The purity, the coupling rate and free drugs of the finished product are kept stable, the conditions of molecular degradation and aggregation are reduced, the process stability is high, large-scale application can be realized, and the application of the anti-B7H3 antibody-imine conjugate is promoted.

The invention discloses a high-concentration antibody preparation and application thereof, and belongs to the technical field of antibody pharmaceutical preparations, the preparation takes an antibody as an active ingredient, adopts glutamic acid and histidine hydrochloric acid buffer solution, is matched with non-ionic saccharide and sugar alcohol auxiliary materials, and uses a non-ionic buffer system to maintain the pH value of the system stable; and the stability risk caused by the ionic auxiliary material is reduced. The preparation can realize high-concentration preparation of more than 100mg / mL, obviously inhibits antibody aggregation, fragmentation and oxidative degradation, improves purity, stability and injection convenience, and is suitable for subcutaneous injection. The problems that a traditional high-concentration antibody preparation is prone to aggregation, high in viscosity, poor in stability and the like are solved, the prescription is scientific and controllable, and the method is suitable for clinical transformation and large-scale production.