34 results about "Sodium fusidate" patented technology

The invention relates to a sodium fusidate combination and the preparation method of freeze dried formulation. Weight ratio of the sodium fusidate, the excipient and the stabilizing agent / pH regulator in the sodium fusidate combination is 25 to 100 : 2 to 100 : 1 to 50, wherein, preferred excipient is glucose and / or mannitol; the stabilizing agent /pH regulator is one from arginine, ethylene diamine tetraacetic acid disodium and EDTA calcium disodium or the mixture. The preparation method is characterized in that: water is used as solvent; the sodium fusidate, the excipient and the stabilizing agent / pH regulator are made into clear and transparent solution before filtered and subpacked, thereby producing freeze dried formulation being suitable for requirement of injection through drying by sublimation, wherein, pH value of the formulation is 7.5 to 9.0 and the formulation of each unit dose comprises 125 to 500mg sodium fusidate. The sodium fusidate combination and the preparation method of freeze dried formulation have the advantages of good stability, convenient use, improvement of drugs tolerance upon patients and simple medical operation, strong practicability, simple technology and good stability of finished product.

The invention provides a sodium fusidate crystallization method which comprises the following steps: a, preparing a sodium fusidate solution by taking a acetone water solution as solvent; b, heating the sodium fusidate solution, feeding acetone while stirring, reducing the feeding rate when the sodium fusidate solution is turbid, and standing for crystallization after the feeding operation is finished; and performing solid-liquid separation, leaching the obtained solids with acetone, and then drying to obtain sodium fusidate crystals. According to the invention, the method is simple to operate and low in cost; and the sodium fusidate crystals prepared by the method are stable in crystal form and favorable in flowability.

The present invention is directed to a medicinal composition for treating bacterial skin infections and related wounds, and also other skin wounds including those caused by burns. The cream also causes skin rejuvenation through an epithelisation process. The cream comprises a) a biopolymer in the form of Chitosan, b) an Active Pharmaceutical Ingredient (API), in the form of fusidic, c) a cream base, and d) water. The invention also discloses a process to make the medicinal cream in which Fusidic acid which is formed in situ from Sodium Fusidate as the starting raw material, by converting it into Fusidic acid under oxygen-free environment created using inert gas, preferably nitrogen. The cream produced by the process of the present invention has greater shelf-life stability and the finer particle size of the API than the conventional creams containing Fusidic acid and found to be surprisingly superior for use against skin infections with allergy & itching, & wounds on human skin than alternative creams currently available.

The invention relates to a sodium fusidate crystal and a preparation method thereof. The X-ray powder diffraction spectrum characteristic peaks of the sodium fusidate crystal newly provided by the invention, represented by 2theta+/-0.2 degrees, are at 6.960, 7.117, 8.180, 8.355, 11.895, 14.460, 15.176, 16.389, 16.574, 24.837, 28.967 and 36.344. The preparation method comprises the following steps of: 1) dissolving fusidic acid in a low alcohol solution to obtain a sodium fusidate solution; 2) feeding an ethyl acetate solution into the sodium fusidate solution to crystallize sodium fusidate, and collecting a solid phase; and 3) drying the solid phase, thus obtaining a sodium fusidate crystal. The sodium fusidate crystal provided by the invention has the advantages of being glittering and translucent in appearance, uniform in granule, stable in crystal form, favorable for sub-package and storage, and the like. The method provided by the invention has the advantages that the prepared sodium fusidate crystal is good in stability, the process is simple in process and environment-friendly, and the adopted solvent is reusable and recoverable, low in production cost and the like.

The invention relates to a sodium fusidate powder-injection pharmaceutical composition for injection and a preparation method. Specifically, the invention belongs to the technical field of medicines, relates to a medicine which can be used for treating various infections such as osteomyelitis, sepsis, endocarditis, repeatedly infected cystic fibrosis, pneumonia, skin and soft tissue infections, surgical and traumatic infections and the like caused by various sensitive bacteria, especially staphylococcus, and particularly relates to a pharmaceutical composition such as a freeze-dried powder injection prepared by taking sodium fusidate as an active component. The invention also relates to a preparation method of the pharmaceutical composition. In an implementation scheme, the invention relates to a sodium fusidate powder-injection pharmaceutical composition for injection, which comprises sodium fusidate, a neutral amino acid and an alkaline amino acid. The pharmaceutical composition has excellent pharmaceutical properties.

The invention relates to the field of pharmaceutical preparation, and particularly discloses sodium fusidate freeze-dried powder injection and a preparation method thereof. The sodium fusidate freeze-dried powder injection disclosed by the invention is prepared from sodium fusidate, dimercaprol dimercaptopropanol, erythorbic acid, cysteine hydrochloride, phenylalanine, arginine and injection water in a freeze-drying manner. Preferably, the arginine, the dimercaprol dimercaptopropanol, erythorbic acid, cysteine hydrochloride and phenylalanine are taken as auxiliary materials of the sodium fusidate freeze-dried powder injection; stable performance of the sodium fusidate freeze-dried powder injection is improved by synergistic effect; the content of related substances is reduced; the characters of a product are maintained in a normal requirement; and safe use and long-term storage of clinical drugs are facilitated.

The invention relates to the technical field of medicine crystals, in particular to a sodium fusidate novel crystal form and a preparation method and application thereof. In an X-ray powder diffraction spectrogram of the novel crystal form, the sodium fusidate novel crystal form has characteristic peaks at the positions of 9.646 degrees, 10.882 degrees, 11.034 degrees, 13.840 degrees, 14.046 degrees, 16.577 degrees, 17.318 degrees, 17.687 degrees, 18.072 degrees, 19.868 degrees, 23.036 degrees, 25.489 degrees and 27.400 degrees as shown in 2 theta+/-0.2 degrees. The novel sodium fusidate crystal form prepared by the invention has the advantages of good fluidity, convenience in subpackage and preservation and the like, can be used for preparing a sodium fusidate injection, and is favorable for improving the medicine quality and the like.

The invention belongs to the technical field of medicines, and mainly relates to a sodium fusidate ointment medicine composition and a preparing method thereof. The composition comprises, by weight, 1%-10% of sodium fusidate, 80%-90% of ointment matrix, 0.2%-15% of emulgator, 0.1%-5% of antioxygen and the balanced distilled water and ethyl alcohol. The preparing method includes the steps of oil phase preparation, aqueous phase preparation, ointment mixing, ointment filling and the like. By means of the sodium fusidate ointment medicine composition and the preparing method, the problem that sodium fusidate is easily oxidized and degraded under the influences of the high temperature in the ointment preparation process is solved, generation of impurities is effectively controlled, the content of the sodium fusidate in the product can be stably kept, the product quality is improved, the local untoward effect of the skin during clinical medication is reduced, and the effectiveness and the safety of the medicine in clinic application are better guaranteed.

The invention discloses a dermaceutical cream containing steroids and an antibacterial agent in the form of Fusidic acid, which Fusidic acid is formed in situ from Sodium Fusidate as the starting raw material, wherein Sodium Fusidate is converted into Fusidic acid under oxygen-free environment. The cream of the present invention has greater shelf-life stability and the finer particle size of the API than the conventional creams containing Fusidic acid. The cream of the present invention contains Fusidic acid as the API that has been formed in situ from Sodium Fusidate, and steroids in a cream base comprising an acid, a co-solvent, an emulsifier and a waxy material along with water, preferably purified water.

The invention discloses local anesthesia gel preparation and a preparation method thereof. The local anesthesia gel preparation is prepared from, by weight, 8-20 parts of Celastrus orbiculatus, 8-20 parts of benzoin, 2-2.8 parts of bee venom, 0.1-2.0 parts of etamsylate, 0.3-1.0 part of benzoate, 3-5 parts of menthol, 2-3.6 parts of diclofenac, 1.0-1.5 parts of sodium fusidate, 1.5-3.5 parts of local anesthetic, 2.3-4.0 parts of viscous polymer, 0.05-0.3 part of preservative, 0.05-0.1 part of antioxidant, 0.2-0.6 part of surfactant and 10-16 parts of gel matrix. The local anesthesia gel preparation can be used for local administration of trauma or during small external surgery, can play a good role in controlling pain, resisting bacteria, diminishing inflammation and preventing wound infection, can reduce local damage, has high affinity with skin and is convenient to use and quick in action; anesthetic action generated by the local anesthesia gel preparation can quickly seep into collenchyme and can last for a long time, and the local anesthesia gel preparation is safe and nontoxic, simple in preparation process and low in cost.

The present invention is directed to a medicinal composition for treating skin inflammations, fungal/bacterial skin infections and related wounds, and also other skin wounds including those caused by burns. The cream also causes skin rejuvenation through an epithelisation process. The cream comprises:

• a) a biopolymer in the form of Chitosan, b) active Pharmaceutical Ingredients (APIs), in the form of fusidic acid that has been generated in situ from sodium fusidate Hydrocortisone acetate & clotrimazole, c) a cream base containing primary and secondary emulsifiers, waxy materials, co-solvents, acids, preservatives, buffering agents, anti oxidants, chelating agents, and humectants and d) water. The invention also discloses a process to make medicinal cream containing Fusidic acid formed in situ from Sodium Fusidate by converting it into Fusidic acid under oxygen-free environment. The cream has greater shelf-life and the finer particle size of the API than the conventional creams containing Fusidic acid.

The present invention relates to primary and secondary bacterial skin infections and in particular it relates to the treatment of these infections using a Fusidic acid cream that has been made using Sodium fusidate as the starting Active Pharmaceutical Ingredient (API). The invention discloses a dermaceutical cream containing Fusidic acid which is formed in situ from Sodium Fusidate as the starting raw material, wherein Sodium Fusidate is converted into Fusidic acid under oxygen-free environment. The cream of the present invention has greater shelf-life stability and the finer particle size of the API than the conventional creams containing Fusidic acid.

The invention provides a freeze-dried sodium fusidate powder for injection with double auxiliary materials, relates to the field of pharmaceutical preparations and preparation methods, and mainly solves the problem of excipients in the production formula of sodium fusidate freeze-dried powder for injection in the prior art The disadvantages of long freeze-drying time during production, high drying temperature, high energy consumption, and low pass rate of finished product clarity and solution color. The sodium fusidate freeze-dried powder for injection uses double excipients, the excipients include mannitol and hydroxyethyl starch 130/0.4, the main drug is sodium fusidate, and the weight ratio of the main drug sodium fusidate to the auxiliary materials 100:100‑100:120, the weight ratio between mannitol and hydroxyethyl starch 130/0.4 is 100:70‑100:90. The above main drug and auxiliary materials are used to prepare sodium fusidate freeze-dried powder for injection. The sodium fusidate freeze-dried powder for injection provided by the invention is stable in quality, safe and effective, simple in production process, short in freeze-drying time during production, low in drying temperature, low in energy consumption, high in the clarity of the finished product and high pass rate of solution color .

The invention relates to the field of pharmaceutical preparations, and particularly discloses a special injection for a sodium fusidate freeze-dried powder injection, and a preparation method of the special injection. The special injection for the sodium fusidate freeze-dried powder injection comprises nitrilotriacetic acid, methionine, sodium potassium tartrate tetrahydrate, sodium metabisulfite, disodium hydrogen phosphate and water for injection. Preferably, the nitrilotriacetic acid, methionine, sodium potassium tartrate tetrahydrate, sodium metabisulfite and disodium hydrogen phosphate are adopted as compositions of the special injection for the sodium fusidate freeze-dried powder injection and are synergized so as to improve the stability performance of the dissolved sodium fusidate freeze-dried powder injection, maintain the content of sodium fusidate and the product character within the normal requirement, and be beneficial for safety use of clinical pharmaceuticals.

The invention discloses a process to make dermaceutical gel containing Fusidic acid which is formed in situ from Sodium Fusidate as the starting raw material, wherein Sodium Fusidate is converted into Fusidic acid under oxygen-free environment comprising an inert gas, preferably nitrogen. The gel produced by the process of the present invention has greater shelf-life stability and the finer particle size of the API than the conventional creams containing Fusidic acid. The gel also contains Fusidic acid as the API that has been formed in situ from Sodium Fusidate, in a gel base; said gel base comprising a natural, semi-synthetic or synthetic polymers, a preservative, an acid, an alkali, a co-solvent, along with water, preferably purified water. The gel produced by the process of the present invention further optionally contains an ingredient selected from a group comprising, an anti oxidant, a chelating agent, and a humectant, or any combination thereof.

The invention provides a sodium fusidate pharmaceutical composition for injection, and a preparation method thereof, wherein the composition comprises sodium fusidate, basic amino acid and a proper amount of an acid for adjusting pH value, and is prepared through a freeze-drying process. According to the invention, the composition product does not need to be provided with a special buffer salt solvent, and cannot generate precipitation or turbidity after direct compatibility with 0.9% sodium chloride injection or 5% glucose injection and the like during use, so that the preparation link for the special buffer salt solvent is omitted in production so as to substantially simplify the production process, improve the operation compliance of medical staff, reduce the safety risk in the medicinecompatibility process and improve the use safety of the product.

The invention discloses sodium fusidate lipidosome injection and a preparation method thereof. The lipidosome injection is prepared from sodium fusidate, soya bean lecithin, cholesteryl succinate, poloxamer188, povidone and mannitol. The lipidosome injection has the advantages of small particle size and even distribution of lipidosome, excellent stability of preparation, good encapsulation efficiency and lower leakage rate, reduces the impurities and the toxic and side effects, and improves the product quality and the curative effect.