47results about How to "Short reconstitution time" patented technology

The invention relates to panax notoginseng saponins freeze-dried powder injection and a preparation method thereof. The freeze-dried powder injection is prepared by panax notoginseng saponins and water for injection. The panax notoginseng saponins freeze-dried powder injection is free of auxiliary materials or stent agents, good in re-dissolubility, low in water content and good in appearance forming.

The invention discloses a method for preparing a high-purity human coagulation factor VIII from a cryoprecipitate of a human plasma fraction. The method comprises the following steps: (1) cryoprecipitate dissolution; (2) aluminum hydroxide gel adsorption and filter pressing; (3) S/D virus inactivation; (4) anion exchange resin column chromatography; (5) hydrophobic column chromatography; (6) ultrafiltration dialysis and concentration; (7) addition of one or more stabilizers and titer adjustment; (8) nano-membrane virus-removing filtration; (9) sterile filtration and sub-packaging; (10) freeze-drying; (11) dry-heat virus inactivation. The method has the advantages that a human coagulation factor VIII is purified through the two column chromatography steps, so that the prepared high-purity product can reach a specific activity of about 300 IU/mg, considerably higher than about 50 IU/mg in the prior art, and the product appearance and the heat stability are obviously improved; in the preparation process, three virus removing modes are adopted, so that the clinical use safety of the product can be greatly improved.

The present invention belongs to the field of chemical drug preparations and particularly relates to sotalol hydrochloride powder injection for injection and a preparation method thereof. The sotalol hydrochloride powder injection comprises sotalol hydrochloride, chitosan nanoparticles and a PH (power of hydrogen) adjusting agent, wherein the chitosan nanoparticles adopted can significantly shorten the redissolving time of the sotalol hydrochloride, and improve the dissolution rate of the sotalol hydrochloride in injection. The sotalol hydrochloride provided by the invention has the advantages of good redissolving effect, more stable quality, high safety, high reliability, good convenience in transportation, and good application to industrial production, and the like.

The invention relates to a preparation method of a cortical hormone preparation, and concretely relates to a preparation method of a betamethasone sodium phosphate freeze-dried powder injection. The method comprises the following steps: dissolving betamethasone sodium phosphate and auxiliary materials in injection, filling the obtained solution, and freeze-drying the filled solution, wherein nitrogen is introduced in the whole sublimation drying stage and desorption drying stage of freeze-drying. The method solves the problem of increase of the content of impurities in the storage process in the prior art, substantially improves the stability of the betamethasone sodium phosphate freeze-dried powder, and also solves the problem of low production efficiency in the prior art.

The invention provides a preparation method of a blood coagulation factor XIII. The preparation method has the advantages of high yield, high purity and short production period, and comprises the steps of blood plasma and blood cell separation, virus inactivation, ammonium sulfate graded sedimentation, DEAE-FF chromatographic column treatment, split charging and freeze drying, wherein an auxiliary agent is added during the virus inactivation; the graded sedimentation and dissolution process of the blood coagulation factor XIII is performed in an environment being 0 to 4 DEG C; different dissolving agents are added for performing graded dissolution on precipitates; the dissolution efficiency is improved; the production period is shortened; the bacteria breeding is reduced; and the yield and the purity of the blood coagulation factor XIII are improved. The preparation method of the blood coagulation factor XIII provided by the invention has the beneficial effects that the extraction efficiency is high; more than 10mg of the blood coagulation factor XIII can be extracted from per liter of blood plasma; in a prepared blood coagulation factor XIII freeze-drying product, the purity of the blood coagulation factor XIII is higher than 90 percent; the operation is simple; the production period is short; and the preparation of the blood coagulation factor XIII can be completed in two days.

The invention discloses a production method of a high-purity human coagulation factor IX preparation, wherein the production method is les sin process step, low in production cost and high specific activity. The method includes the steps: (1) plasma cryoprecipitation removal; (2) DEAE sephadex A50 anion exchange chromatography; (3) S/D inactivated virus; (4) non-Ca2+dependent IX factor immune affinity chromatography; (5) adding of protective agents in matched liquid; (6) virus removal by a nano-filtration membrane; (7) sub-packaging and freeze drying. According to the method, a human coagulation factor IX production process is greatly simplified by the aid of novel high-adsorption specific immune affinity chromatography, the titer of a prepared high-purity human coagulation factor IX finished product can reach 114.2IU/ml, and the specific activity of an IX factor reaches up to 196.5IU/mg protein or more. Two-step virus inactivation is implemented by an S/D method with high maturity and safety and a nano-filtration method, and safety of the finished product is effectively ensured.

The invention belongs to the technical field of biological pharmacy and blood products, and especially relates to a preparation method of a human coagulation factor VIII. According to the invention, apreparation process of the human coagulation factor VIII is subjected to total research, cryoprecitation preparation, dissolution, washing liquid and an eluate are screened, after elution, the residual quantity of sorbate 80 and tributyl phosphate can achieve the requirement of current pharmacopeia; a dialysate is screened, the finally obtained product has the advantages of no collapse, no atrophy, and fast redissolving time, and FVIII titer after dry heat inactivation is 28.9 IU/ml. The processes for preparing the human coagulation factor VIII are optimized and screened, an optimum scheme isobtained, the recovery rate of each process is calculated, the recovery rate of FVIII is 28.91%, the efficiency for preparing FVIII by blood plasma is effectively increased, and a rear blood plasma resource is indirectly saved.

The invention provides a preparation method of a cytidine disdoium triphosphate freeze-dried powder injection. The preparation method comprises the following steps of: (a) mixing cytidine disdoium triphosphate, an excipient with first water for injection, and adjusting the pH value to obtain mixed solution A; and (b) mixing the mixed solution A with second water for injection, and filtering, freezing and drying in sequence so as to obtain the cytidine disdoium triphosphate freeze-dried powder injection, wherein the mass ratio of the first water for injection to the second water for injection is 6:(3-5). Compared with the prior art, the preparation method provided by the invention can be used for effectively controlling the content of impurities in the cytidine disdoium triphosphate freeze-dried powder injection and increasing the mass stability and the yield of products; and experimental results show that the impurity content of the cytidine disdoium triphosphate freeze-dried powder injection prepared through the preparation method provided by the invention is below 0.41%.

The invention discloses a temozolomide lyophilized powder preparation, which includes an antitumor active component temozolomide and its pharmaceutically acceptable salt, an aqueous diluent, a filler, a pH regulator and at least one solubilizing agent. Specifically, the solubilizing agent is one of niacinamide and biuret or is a mixture of them. After optimization, niacinamide or biuret is adopted as the solubilizing agent in the invention. The prepared temozolomide lyophilized powder preparation has the advantages of rapid re-dissolution and good stability during placing. The invention also discloses a preparation method of the temozolomide lyophilized powder preparation.

The invention relates to the technical field of medicine technology, in particular to sugammadex sodium freeze-dried powder injection and a preparation method thereof. The preparation method of the sugammadex sodium freeze-dried powder injection comprises the following steps: adding sugammadex sodium into water for injection according to a prescription dosage, and stirring until sugammadex sodium is completely dissolved; adding a prescription amount of freeze-drying protection solution into the solution, stirring until the solution is completely dissolved, adjusting the pH value, stirring, filtering, filling and freeze-drying to obtain the target product. according to the method, the sugammadex sodium freeze-dried powder injection for injection is provided, and the problems that API serving as a cyclic molecular structure is unstable, and a large number of impurities are easily generated after high-temperature sterilization are solved; inert gas (nitrogen) is filled for protection after freeze-drying is finished, so that oxygen is effectively isolated, and the prepared sugammadex sodium freeze-dried powder injection has fewer impurities and is more stable; through optimization of a freeze-drying process, the prepared freeze-dried powder is shortest in redissolution time, the clarity and insoluble particles meet the requirements, the stability is higher, and the freeze-dried powder is suitable for industrial production.

The invention discloses a cetrorelix pharmaceutical composition and a preparation method thereof, and relates to the technical field of biological medicine. The preparation method comprises the steps that cetrorelix acetate is dissolved with hydrochloric acid, and a cetrorelix acetate hydrochloric acid solution is obtained; wherein in the cetrorelix acetate hydrochloric acid solution, the final concentration of hydrochloric acid is 0.05-3 mol/L. The cetrorelix medicine prepared by the preparation method provided by the invention has higher stability, can be stored for a long time at room temperature or ambient temperature, obviously shortens the redissolution time, and improves the safety during clinical medication.