37 results about "Rocuronium" patented technology

The present invention relates to stable freeze dried rocuronium bromide preparation and its preparation process. The freeze dried rocuronium bromide preparation includes rocuronium bromide and freeze drying excipient in the weight ratio of 0.2-1. The freeze dried rocuronium bromide preparation needs no low temperature preservation and convenient storing, and is used for muscular relaxation of patient in surgical operation.

The invention encompasses substantially pure rocuronium bromide.

A novel process for preparing (2β,3α,5α,16β,17β)-17-acetoxy-3-hydroxy-2-(4-morpholinyl)-16-(1-pyrrolidinyl) androstane, a known intermediate in the synthesis of the skeletal muscle relaxant rocuronium bromide, is disclosed.

The present invention provides a rocuronium formulation having excellent stability. This formulation includes rocuronium and a buffer solution, and has a pH adjusted to 3.5 or less (for example, 2.5-3.5). The buffer solution may be a citric acid / sodium hydroxide buffer solution, a tartaric acid / sodium hydroxide buffer solution, a potassium hydrogen phthalate / hydrochloric acid buffer solution, a glycine / hydrochloric acid buffer solution or the like. This type of rocuronium formulation has a rocuronium analog C generation rate of 5% or less after being stored for six months at 40 DEG C, for example.

The invention relates to the field of analytical chemistry and discloses a method for detecting the content of bromopropylene in rocuronium bromide. Particularly, the method comprises the following steps of: taking a rocuronium bromide sample and dissolving the rocuronium bromide sample by using mixed solution with a volume ratio of acetonitrile to water of (9-6):(1-4) as a solvent to obtain tested solution; taking a bromopropylene reference substance and dissolving the bromopropylene reference substance by taking the mixed solution with the volume ratio of acetonitrile to water of (9-6):(1-4) as the solvent to obtain reference substance solution; respectively carrying out high-efficiency liquid chromatography detection on the reference substance solution and the tested solution; and analysing a measuring result by an external standard method. The method for detecting the content of the bromopropylene in the rocuronium bromide can be used for detecting the content of the bromopropylene in a rocuronium bromide product and has the limit of detection of 0.044ng. Due to the establishment of the method, in the process of preparing the rocuronium bromide, the residual amount of the bromopropylene can be detected. The method has high sensitivity, strong specificity and accurate and reliable results, so that the quality of the rocuronium bromide product is accurately evaluated and thequality of the rocuronium bromide product is ensured.

The invention discloses a process for preparing high-purity rocuronium, comprising the following steps of: mixing a low-boiling anti-solvent with the rocuronium containing organic solvents or / and impurities; and removing the organic solvents or / and the impurities which are contained in the rocuronium by utilizing a principle that the organic solvents or / and the impurities are soluble in the low-boiling anti-solvent and the rocuronium is not or hardly soluble in the low-boiling anti-solvent so that the rocuronium is precipitated or crystallized so as to obtain the high-purity rocuronium without containing the organic solvents or / and the impurities, wherein the low-boiling anti-solvent is a mixture of any one or a few of ethane, propane, butane, ethylene, propylene, trifluoromethane, trifluorochloromethane, carbon dioxide, sulfur dioxide and nitrogen in any proportion. Compared with the traditional extraction method, the process can be used for extracting and separating under the condition of adjacent normal temperature and almost retains all effective components of a product; the quantity of organic solvent residuals can be low not to be detected, and the obtained product has high purity; and in addition, the process is easy to operate and green and saves the energy.

Provided is a rocuronium preparation designed to reduce vascular pain to be induced. The rocuronium preparation contains rocuronium and a buffer solution, and has titratable acidity of 100 mEg or less. The buffer solution may be an acetate buffer solution, a citrate buffer solution, a formate buffer solution, a tartrate buffer solution, a phosphate buffer solution, a glycine-hydrochloric acid buffer solution, or a citric acid-phosphate buffer solution.

A rocuronium bromide injection solution-prefilled syringe of the present invention includes a syringe comprising an outer cylinder made of synthetic resin, a gasket which is accommodated inside the outer cylinder and liquid-tightly slidable inside the outer cylinder, and a seal member for sealing a distal end opening of the outer cylinder; and a rocuronium bromide injection solution filled inside the syringe. The gasket is formed by vulcanized chlorinated butyl rubber added calcined clay, and said calcined clay is only added as an inorganic filler classified as an inorganic reinforcing agent and an inorganic filling agent.

The invention relates to a rocuronium bromide-containing injection. The injection is prepared from rocuronium bromide serving as an active ingredient and a pharmaceutically-acceptable carrier as accessories. The pH value of a system is maintained by adding a 1-5 percent acetate buffer solution, so that the stability of the solution is enhanced, the pH value of a system is maintained at the same time, degradation of main medicaments in a preparation process is suppressed, the stability of the main medicaments is enhanced, and the quantity of rocuronium bromide impurities C in an autoclave sterilizing process is reduced. Finally, a rocuronium bromide injection which has high stability and stable quality and is suitable for storing for a long time is obtained.