Preparation technique of sodium phosphocreatine powder and injection preparation

Abstract

The invention relates to a preparation process of a creatine phosphate sodium powder injection, which is characterized in that, the freeze-drying process is adopted for preparation, the process is that: 1 part of the formulated amount of creatine phosphate sodium is taken, 3 to 6 parts of water for injection is added, the creatine phosphate sodium is dissolved by stirring, 0.1 percent of the solution amount of activated carbon with needle use is added, the filtration for carbon removal and sterilization is carried out, thus forming clarified liquid, the water for injection is supplemented till the sufficient amount, a micro-porous membrane of 0.22Mum is used for filtration, and the filling is carried out after the content is 90 percent to 110 percent by measurement; the freeze-drying and the cover pressing are carried out; the well filled injection is arranged in a freeze-drying machine, the pre-freezing is firstly carried out till minus 50 DEG C to minus 35 DEG C, the temperature is kept for 1 to 5 hours, the vacuum pumping is carried out, the temperature raises to minus 10 DEG C to minus 3 DEG C within 15 to 30 hours, the temperature further raises to 15 to 50 DEG C within 2 to 10 hours, and the temperature is continuously kept for 3 to 10 hours, thus obtaining the creatine phosphate sodium powder injection. The preparation process has the advantages that the preparation process does not adopt ethanol, the clarity of the injection liquid is good, the operation is simple and the preparation process is applicable to mass production.

Description

A kind of preparation technology of creatine phosphate sodium powder injection technical field The invention relates to a preparation process of creatine phosphate sodium powder injection, which can be used for myocardial protection and belongs to the technical field of medicines. Background technique Creatine Phosphate (CP) is an active substance in the human body and an important source of energy for the human body. It replenishes energy for ATP, the most important energy source in the process of cell metabolism. CP widely exists in various tissues in the body, and the content in muscle tissue is the highest, reaching 90% of the total amount in the body. Pharmacokinetic evidence shows that heart, skeletal muscle, brain and kidney can absorb exogenous CP. Its structural formula is: Studies have found that creatine phosphate has important pharmacological effects, especially its sodium salt compound creatine sodium phosphate has been widely used in clinical practice. A...

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Problems solved by technology

Sodium creatine phosphate is easily soluble in water. The current preparations are mainly powder injections for injection. The production process adopts solvent crystallization, which is usually the method of dissolvi...

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