323 results about "Injection solution" patented technology

The invention discloses a liquid chromatography method for measuring 5-hydroxymethylfurfural in a calcium gluconate and sodium chloride injection. The method comprises the following steps: measuring the calcium gluconate and sodium chloride injection as a test solution; weighing 5-hydroxymethylfurfural, and adding water to dilute the 5-hydroxymethylfurfural to form a reference solution; carrying out continuous sample introduction on the liquid chromatograph by using the reference substance solution to obtain a system applicability solution chromatogram; when the chromatogram of the applicable solution of the system meets the standard, measuring the test solution and the reference solution, respectively injecting the test solution and the reference solution into a liquid chromatograph, and recording the chromatograms; the content of 5-hydroxymethylfurfural in the calcium gluconate and sodium chloride injection is obtained through a 5-hydroxymethylfurfural content calculation formula. The method has the advantages of strong specificity, high sensitivity, good precision, strong durability and the like, and can quantitatively detect 5-hydroxymethylfurfural in the calcium gluconate and sodium chloride injection, so that the safety of clinical medication of the calcium gluconate and sodium chloride injection is improved.

This invention belongs to the pharmaceutical field and discloses a rubitetidine pharmaceutical composition, its preparation method, and its application. The pharmaceutical composition includes rubitetidine, an organic acid, and additives, wherein: rubitetidine has crystal forms including crystal form C and / or crystal form D; the additives include a lyophilization protectant or a solution stabilizer; the lyophilization protectant is a saccharide compound and / or its derivative; and the solution stabilizer is an alcohol compound. This invention focuses on rubitetidine crystal form C and rubitetidine crystal form D, and prepares a lyophilized rubitetidine formulation by adding specific organic acids and lyophilization protectants. This formulation exhibits good solubility and stability. Furthermore, by adding specific organic acids and solution stabilizers, a rubitetidine injection solution with similarly good solubility and stability can be prepared without adding lyophilization protectants or using a lyophilization-free process, optimizing the process steps and solving the problems of long production cycles and cumbersome reconstitution operations associated with traditional products.

The invention relates to a dexamethasone sodium phosphate injection and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. The preparation method comprises the following steps: 1, sequentially adding glycerol, edetate disodium and dexamethasone sodium phosphate into water for injection according to a weight ratio of (20-25): (0.08-0.12): (4-6), mixing and dissolving, and introducing nitrogen until the dissolved oxygen content is less than or equal to 1mg / L to obtain a liquid medicine 1; step 2, adding a pH regulator into the liquid medicine 1 to regulate the pH value to 7.0-8.5 to obtain liquid medicine 2; and step 3, filtering, filling and sealing the liquid medicine 2, and controlling the residual oxygen content to be less than or equal to 5% to obtain the dexamethasone sodium phosphate injection. Wherein the whole preparation process is protected by inert gas. According to the preparation method of the dexamethasone sodium phosphate injection provided by the invention, the prescription composition of an original drug does not need to be changed, and the prepared dexamethasone sodium phosphate injection can be stably stored at room temperature by adjusting a specific pH range, keeping filling of an inactive gas until the dissolved oxygen content is less than or equal to 1mg / L in the whole preparation process and controlling the residual oxygen content to be less than or equal to 5%.

The utility model relates to transfusion bottle technical field discloses a self -discharge formula glucose injection transfusion bottle bottle body, including bottle body and the pendant of fixed on bottle body, bottle body is by bottle body, bottle neck section and bottle mouth section is composed, the inner wall of bottle neck section is fixedly connected with the liquid lifting subassembly, the first envelope is equipped with in the bottle mouth section, the side wall of first envelope is fixedly connected with the support cover, one end of support cover and liquid lifting subassembly is through sliding arrangement. In the utility model, when only a small amount of glucose injection is left in the bottle body, the elasticity of the isolating sleeve makes the contraction sliding sleeve slide upward along the outer wall of the support cover, lifting the liquid level of the glucose injection in the bottle body, greatly reducing the residue of the glucose injection in the bottle body. By setting the protective cover, T-shaped column and the second through hole, the first envelope is protected and further fixed. The protective cover does not need to be removed when the infusion device needle is inserted.

The invention discloses a method for detecting anions in a phlegm-heat-clearing injection, the detection method comprises the following steps: a test solution and a reference solution are taken for detection, the phlegm-heat-clearing injection is composed of scutellaria baicalensis, bear gall powder, cornu gorais, honeysuckle, fructus forsythiae and propylene glycol; chromatographic conditions of the detection are as follows: an anion exchange chromatographic column is adopted, an eluent is an acid aqueous solution, an alkali aqueous solution and / or a buffer salt aqueous solution, the flow velocity is 0.1-2.0 ml / min, the column temperature is 20-40 DEG C, a detector is an electrical conductivity detector, the detection mode is suppression electrical conductivity detection, and the sample size is 10-40 [mu] l; and obtaining the content information of the anions in the phlegm-heat clearing injection according to the detection result. The method disclosed by the invention is simple, convenient, efficient and rapid, and provides a theoretical basis for the quality control of the phlegm-heat clearing injection and the deep research of a pharmacodynamic material basis by detecting the content of the anions.

Stable, injectable pharmaceutical compositions are provided, which are useful as ready-to-dilute (RTD) or ready-to-use (RTU) liquid injectable compositions comprising bendamustine or a pharmaceutically acceptable salt thereof, and which are suitable for intravenous administration. Preferably, solution formulations comprise (a) bendamustine, or pharmaceutically acceptable salts, solvates, or hydrates thereof, (b) at least one pharmaceutically acceptable non-aqueous solvent; (c) optionally, at least one pharmaceutically acceptable excipient, and (d) optionally, a pH adjuster, where the pharmaceutical composition is antioxidant-free, and formulated as a ready-to-dilute or ready-to-use liquid composition suitable for parenteral administration. The invention further relates to methods for manufacturing stable, antioxidant-free injectable solutions of bendamustine.

This invention discloses a carbetocin injection solution and its preparation process. The raw materials for the carbetocin injection solution include at least carbetocin, methionine, disodium edetate, an antibacterial agent, a pH adjuster, and a solvent. The pH of the carbetocin injection solution is 4.0-4.5. The concentration of carbetocin is 50 μg / ml-80 μg / ml, the concentration of methionine is 10 mg / ml-20 mg / ml, the concentration of disodium edetate is 5 mg / ml-10 mg / ml, and the concentration of the antibacterial agent is 2 mg / ml-3 mg / ml. By controlling the concentrations of carbetocin, methionine, disodium edetate, and the antibacterial agent, and simultaneously adjusting the pH of the injection solution to 4.0-4.5, this invention eliminates the need for nitrogen purging during the preparation process, thereby enabling the prepared carbetocin injection solution to exhibit high antioxidant properties and stability, allowing for long-term storage at room temperature.

The application relates to a compound cefoperazone and avibactam powder injection and a preparation method thereof. The compound powder injection is obtained by uniformly mixing cefoperazone hydrochloride and avibactam sodium, tabletting and crushing. When the powder injection is prepared into an injection solution, the powder injection is easy to disperse and dissolve, is convenient to use, ensures the content of cefoperazone, is not prone to produce beta-lactamase bacterial drug resistance, and has a good market application prospect.

This invention relates to an isosorbide dinitrate pharmaceutical composition injection and its preparation method. In addition to isosorbide dinitrate, the injection formulation also contains meglumine and glutathione. The preferred specifications are 5ml:5mg and 10ml:10mg. The isosorbide dinitrate injection prepared according to the formulation and process of this invention has the characteristics of high excipient safety, simple process, extremely high quality stability and good safety, which is significantly better than the prior art.

The application belongs to the technical field of biological medicine, and discloses a 50 ppm low-deuterium water injection and a preparation method thereof. The application realizes high-purity preparation of low-deuterium water by accurately controlling the deuterium content and optimizing a purification process, guarantees the safety, stability and drug compatibility of the injection, and enhances the clinical application performance.

The application relates to the technical field of pharmaceutical preparations, and particularly discloses a dyphylline injection and a preparation method thereof. The dyphylline injection provided by the application comprises the following components: hydroxypropyl-beta-cyclodextrin, glycine, dyphylline and water for injection. By adding the hydroxypropyl-beta-cyclodextrin and the glycine into the dyphylline injection, the two components synergistically act, the stability of the dyphylline injection after long-term storage can be obviously improved, the increase of the content of impurities in the injection after long-term storage can be effectively prevented, and thus the quality and the pharmaceutical effect of the dyphylline injection product can be effectively improved.

The invention discloses a tinidazole sodium chloride injection difficult to crystallize at low temperature as well as a preparation method and application of the tinidazole sodium chloride injection. Belongs to the technical field of pharmaceutical preparations. The preparation method of the tinidazole sodium chloride injection is adjusted and improved, the tinidazole at a specific nano level is prepared by performing high-pressure homogenization treatment on the tinidazole, and then the tinidazole is dissolved in a specific solvent to prepare a tinidazole solution. The preparation method comprises the following steps: preparing a tinidazole solution, pretreating the tinidazole solution with a polyvinyl alcohol modified solution, and finally mixing the tinidazole solution with a sodium chloride solution to prepare the tinidazole sodium chloride injection, so that the temperature stability of the injection is effectively improved, and the injection is not easy to crystallize at low temperature; according to the invention, the content of tinidazole in the injection is ensured not to be greatly changed, the number of particles is kept at a certain level, the quality of the product is effectively improved, and the safety is improved.

The application provides a paclitaxel liposome injection and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. The injection is prepared from the following injection-grade raw and auxiliary materials: paclitaxel, phospholipid, cholesterol, gamma-aminobutyric acid, potassium lactate, a buffer, a freeze-drying protective agent and water for injection. The gamma-aminobutyric acid and the potassium lactate are simultaneously added as the liposome membrane stabilizer, the two synergistically act, the compactness and the stability of the lipid bilayer are significantly enhanced, the paclitaxel encapsulation rate is improved, the drug leakage rate is reduced, and the long-term storage stability of the preparation is improved.

The utility model discloses a single medicine injection liquid's paper support device, both sides of the support mechanism all are provided with first folding section, and the first folding section is 90 degrees bending to the inside of support mechanism, the below of first folding section is provided with second folding section, the second folding section is 90 degrees bending to the inside of support mechanism, the second folding section is located the side away from first folding section and is provided with third folding section, the third folding section is 120 degrees bending to the outside of support mechanism, the top of third folding section is provided with bonding section, the outer surface of bonding section and first folding section are fixed with glue bonding, first folding section, second folding section, third folding section and bonding section are all integrated, and the support mechanism for placing medicine injection liquid bottle takes three layers of corrugated paper as raw material, compared with the traditional material such as plastic bracket, foam, the packaging material cost is reduced greatly, and the corrugated paper is easy to obtain, and the price is low, is favorable to large -scale popularization and application.

The invention discloses a preparation process of a high-stability dipyridamole sodium chloride injection. The preparation process comprises the following steps: S1, weighing raw materials and auxiliary materials: weighing 1g of dipyridamole, 90g of sodium chloride, 10-30g of sodium citrate and 30-70g of propylene glycol; s2, adding water for injection accounting for 70% of the prescription dosage into a liquid preparation tank, then adding sodium chloride, sodium citrate and propylene glycol accounting for the prescription dosage, and completely dissolving in a stirring state; s3, adding a proper amount of a hydrochloric acid solution, adjusting the pH value to 2.5, adding dipyridamole according to the prescription amount, and dissolving dipyridamole in a stirring state; s4, adding a proper amount of a sodium hydroxide solution, adjusting the pH value to 4.0, and fixing the volume to the prescription dosage by using the water for injection; s5, filtering the prepared solution, filling the filtered liquid medicine into a glass bottle, filling nitrogen into the bottle, plugging and capping; s6, sterilizing the filled sample; the stability of the prepared sample is obviously higher than that of a commercially available preparation, DP-II degradation impurities are avoided, obvious advantages are achieved, and the safety risk in the use process of the product can be obviously reduced.

The invention discloses a preparation method of a levosimendan injection, and relates to the field of pharmaceutical preparations, the levosimendan injection is composed of a levosimendan solid preparation composition and a special dilution stabilizer; the solid preparation composition is prepared from active ingredients including levosimendan, povidone, a cosolvent and a stable protection additive, the stable protection additive is selected from one or more of mannitol, trehalose and glycine; the preparation method of the levosimendan injection comprises the following specific steps: firstly, forming a levosimendan povidone compound solution; then adding water for injection and fixing the volume to full dose; and drying to obtain the levosimendan solid preparation. A levosimendan solid preparation is matched with glucose or a sodium chloride solution, the levosimendan injection is obtained after uniform shaking, and the effect of improving the stability of the medicine is achieved by optimizing the adding mode, variety and physical state of the stable protection additive.

This invention relates to the field of pharmaceutical injection technology, specifically to a neostigmine methylsulfate injection and its preparation method. The preparation method of the neostigmine methylsulfate injection of this invention includes the following steps: S1 pretreatment of water for injection, S2 preparation, S3 filtration, S4 filling and sealing, and S5 sterilization. This invention features a simple process, high yield, and low cost. It effectively reduces the generation of impurity I in the neostigmine methylsulfate injection, improves the storage stability of the product, reduces potential medication safety hazards caused by impurities, and ensures drug quality and medication safety.

The invention discloses a preparation method of an intestinal canal filling temperature-sensitive gel injection for gastrointestinal anastomosis guided by an ultrasonic endoscope, and belongs to the technical field of regenerative medicine. According to the specific method, poloxamer, chitosan, polycarbophil, polyvinylpyrrolidone, iohexol and methylene blue are utilized to construct the novel intestinal canal filling temperature-sensitive gel injection. The injection can be injected into the anastomotic intestinal segment of the small intestine by using a conventional nasobiliary drainage tube which is clinically used at present, and the injection becomes viscous immediately under the action of the pH value of the small intestine after injection, so that the injection is inhibited from spreading all around. Meanwhile, the injection is quickly converted into high-strength hydrogel under the action of body temperature, and the hydrogel is adhered to small intestine mucosa to inhibit gel sliding. Therefore, the injection can form a section of gel on a target small intestine section, local immobilization filling and supporting of the target small intestine section are achieved, development can be achieved, the operation difficulty of intestinal tube puncture and stent placement in gastrointestinal anastomosis guided by an ultrasonic endoscope can be greatly reduced, the operation efficiency and the success rate are improved, and the operation cost is reduced. The dosage is less than that of normal saline which is conventionally used clinically, and the effect is better. Moreover, the gel temperature can be reduced by injecting low-temperature normal saline after the operation, so that the gel is thoroughly dissolved into a solution and discharged out of the body, and the phenomenon that the gel remains in the intestinal canal after the operation to cause obstruction is avoided. Therefore, the novel intestinal canal filling temperature-sensitive gel injection has very important clinical practical application value for gastrointestinal anastomosis guided by an ultrasonic endoscope.

The invention relates to a calcium chloride injection and a production method thereof, and relates to the technical field of calcium chloride injection production, a solvent of the calcium chloride is water for injection, and the injection contains the following components: 80-120 g / L of calcium chloride; the concentration of the water for injection is 800-1200 g / L; hydrochloric acid is a proper amount of component for adjusting the pH value to 5.3-5.8; and the sodium hydroxide is a proper amount of component used for adjusting the pH value to 5.3-5.8. According to the calcium chloride injection and the production method thereof, the problems of solution turbidity, calcium ion precipitation, oxidative degradation and the like caused by insufficient dissolution and local supersaturation of calcium chloride in the prior art are effectively solved by accurately controlling the concentration of calcium chloride and adopting a nitrogen protection dissolution process. Meanwhile, a 0.22 mu m polyethersulfone two-stage filter element series connection filtering process, an integrity testing process with the foaming point larger than or equal to 3450 kPa and a sterilization and leak detection integrated process are adopted, the sterility guarantee level and stability of the product are remarkably improved, the endotoxin of the finished product is smaller than 0.5 EU / mL, the number of visible foreign matter larger than or equal to 10 mu m is reduced by larger than or equal to 60%, and the clinical safety and effectiveness of the injection are ensured.

The invention discloses application of a pUDK-HGF injection in preparation of a medicine. The medicine is used for treating limb resting pain of an object. The pUDK-HGF injection provided by the invention can be used for effectively treating the limb resting pain, reducing the complete pain disappearance time of a patient, improving the complete pain disappearance proportion of the patient and increasing the pain NRS score decline value of the patient.

The invention discloses an alfacalcidol emulsion and a preparation method thereof, the pH value of the alfacalcidol emulsion is 6.5-8.0, and each 1000 ml of the alfacalcidol emulsion comprises 1-30 g of alfacalcidol, 100-300 g of oil for injection, 6-20 g of a phospholipid emulsifier, 0-20 g of poloxamer 188, 20-30 g of an osmotic pressure regulator and a proper amount of water. The preparation method of the drug-loaded fat emulsion injection comprises the following steps: preparing an oil phase; preparing a water phase; preparing a primary emulsion; performing high-pressure homogenization; adjusting the pH value; and sterilizing and storing. The alfacalcidol serves as an oil-soluble substance, can be dissolved in small oil drops (emulsion particles) of the emulsion or on an interfacial film, and can keep stable physicochemical properties and enhance the slow release performance in the storage process under certain conditions, so that the drug effect time is prolonged.

The application belongs to the technical field of medicine preparation, and relates to a stable sucrose injection for medicine and a preparation method thereof. The application provides a preparation method of the stable sucrose injection for medicine, which comprises the following steps: mixing sucrose iron and initial water for injection, and then heating the mixture in a closed state at 100-105 DEG C for 1.5-2 hours; then adding iron citrate and sodium gluconate, and heating the mixture in a closed state at 150-160 DEG C for 1-3 minutes; after cooling to room temperature, adding sucrose, and then heating and evaporating the mixture at 115-120 DEG C for 1.5-2 hours; after cooling, adding water for injection to a concentration of 20 mg Fe / mL, adjusting the pH to 10.5-11.0, and then sterilizing and filtering to obtain the sucrose injection for medicine. The application aims to solve the technical problem that the injection is prone to degradation during long-term storage at high temperature.

This invention provides an injectable cefminox sodium preparation and its preparation method, belonging to the field of pharmaceutical preparation technology. The preparation, by weight, comprises: 1 part of refined cefminox sodium, 0.5 parts of sodium lactate Ringer's solution, 0.2 parts of vitamin B12 injection, 0.1-0.3 parts of a modified composite antioxidant, and 3 parts of physiological saline. The preparation method of the modified composite antioxidant is as follows: S1, add 1 part by weight of poloxamer to 20 parts by weight of distilled water and stir for 6-8 minutes to obtain a solution; S2, after passing 1 part by weight of natural vitamin C through a 100-mesh sieve, mix it into the solution obtained in S1, and sonicate for 10-15 minutes to obtain a vitamin C solution; S3, mix 0.5 parts by weight of vitamin D into the vitamin C solution obtained in S2, and sonicate for 15-20 minutes to obtain the modified composite antioxidant. The formulation of this invention exhibits excellent stability and stable content of cefminox sodium when exposed to environments of 35℃±2℃, 65%±5%RH and natural light, ensuring the safety and reliability of medication.

The invention belongs to the field of pharmaceutical preparations, and relates to a multi-trace element injection and a preparation method thereof. The multi-trace element injection comprises effective components, a stabilizer and water, the effective components comprise chromium chloride, copper chloride, ferric chloride, manganese chloride, sodium molybdate, sodium selenite, zinc chloride, potassium iodide and sodium fluoride, and the stabilizer comprises xylitol, a pH regulator and an additive; and the additive is PEG (Polyethylene Glycol) 400 or PEG 600. The multi-trace element injection provided by the invention can effectively inhibit the loss of iodine in the sterilization process, and the stability, economical efficiency and production controllability of the multi-trace element injection are fundamentally improved.

The invention relates to the technical field of veterinary drugs, and particularly provides a veterinary carprofen injection and a preparation method thereof, the veterinary carprofen injection comprises carprofen, emodin, galuteolin, coumarin, Radix Astragali, wolfberry, Schisandra chinensis, resveratrol and other components. According to the veterinary carprofen injection, emodin and luteoloside are added for compound anti-inflammation, the dosage of carprofen is reduced, the kidney burden is relieved, meanwhile, drug resistance is not likely to be generated, radix astragali, fructus lycii and fructus schizandrae extracts are added for protecting the kidney, regulating immunity and avoiding renal function damage, and finally the effects of compound anti-inflammation and renal function damage avoiding are achieved.

To provide an injection chemical composition that can achieve both curability in water and foaming and curability in non-water environments, even after being exposed to high temperature and high humidity environments. [Solution] An injection solution composition comprising a first agent (A) and a second agent (B), wherein the first agent (A) comprises an aqueous solution of sodium silicate (A-1), an organic polyol (A-2), and a tertiary amine catalyst (A-3), and the second agent (B) comprises an organic polyisocyanate containing a mixture of diphenylmethane diisocyanate and polymethylene polyphenyl polyisocyanate having 3 or more isocyanate functional groups (B-1), or a reaction product (B-1') of an active hydrogen group-containing compound and a mixture (B-1), at least one acid component (B-2) selected from the group consisting of phosphate monoesters and phosphate diesters, and at least one hydrolyzable component (B-3) selected from the group consisting of orthoester compounds and acetal compounds.

The invention discloses a preparation method of a bumetanib injection, and belongs to the technical field of medicines. The method comprises the following steps: (1) preparing materials, namely respectively weighing bumetanib, xylitol, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dihydrate and benzoic anhydride modified polyoxyethylated castor oil according to prescription amounts for later use; (2) preparing a solution: weighing water for injection, adding xylitol, sodium dihydrogen phosphate dihydrate and disodium hydrogen phosphate dihydrate according to the prescription dosage in a stirring state, stirring and dissolving, then adding benzoic anhydride modified polyoxyethylated castor oil and bumetanib according to the prescription dosage, and stirring until the materials are completely dissolved; and (3) fixing the volume: supplementing the water for injection to the total amount of the prescription, and uniformly stirring and mixing. According to the bumetanib injection disclosed by the invention, the polyoxyethylated castor oil is modified by benzoic anhydride, so that the dissolution rate of bumetanib is effectively improved, and meanwhile, the high-temperature and illumination stability of the bumetanib injection is remarkably enhanced.

The present application relates to the technical field of medicine, in particular to a safe and stable nimodipine for injection and a preparation method thereof, and provides a nimodipine cyclodextrin freeze-dried powder injection containing sulfobutyl ether-beta-cyclodextrin, which can significantly improve the solubility, drug safety and dilution stability of nimodipine, increase the compliance of patients and the convenience of clinical use. Compared with the commercially available nimodipine injection, the safety and dilution stability of the present application are significantly improved, and the present application has obvious advantages.

The invention relates to the technical field of pharmaceutical preparations, in particular to a concentrated solution for injection of edaravone dextroborneol and a preparation method of the concentrated solution. According to the invention, the sulfonic acid antioxidant and the amino acid antioxidant are compounded and added into the edaravone dextroborneol injection solution, so that a synergistic effect is generated on inhibition of compound oxidative degradation of edaravone dextroborneol, and the prepared edaravone dextroborneol injection concentrated solution has high stability in accelerated and long-term stability tests; related substances grow slowly, the content of main components is not obviously reduced, the appearance of the solution is almost unchanged, and the validity period of the product is obviously prolonged. The preparation method provided by the invention is stable in process and easy for industrial production, and ensures the consistency of batch-to-batch quality through the combination of nitrogen charging protection and a specific antioxidant system.