Preparation technique for sodium phosphocreatine freeze-dried injection

Abstract

The invention relates to a technique for preparing a sodium phosphocreatine frozen-dried powder injection agent, which is characterized in that: the sodium phosphocreatine frozen-dried powder injection agent is prepared by sodium phosphocreatine, human serum albumin and injection water. The technique comprises the following steps that: 1 portion of the sodium phosphocreatine is taken and added into 1 to 4 portions of the injection water; the human serum albumin or mannite or low molecular dextrose is added into the mixture which is then stirred for uniform dissolution; active carbon for needle use is added into the mixture which is then stirred; a titanium alloy bar is used for filtration and decarburization; the injection water is supplemented; a microporous membrane is used for filtration and sterilization, and filtrate is separately loaded into aseptic glass bottles; butyl rubber stoppers are arranged in the aseptic glass bottles, and sublimating channels are preserved; the aseptic glass bottles are placed into a freezedryer for vacuum-pumping, and the strip temperature is controlled to between 10 DEG C below zero and 20 DEG C below zero and maintained for 10 to 20 hours after which the vacuum degree is controlled to between 3 and 12 Pa; the strip temperature is gradually raised to between 20 and 40 DEG C; after a product temperature curve and a strip temperature curve are overlapped for 20 to 60 minutes, injection piston and stoppage are performed; and a product is taken out and a cover is tied, and then the sodium phosphocreatine frozen-dried powder injection agent is obtained. The technique has the advantages that: no ethanol is used during the preparation technique; the finished product has no ethanol residue; the brightness of the injection after compound melting is good; the operation is simple and convenient; and the technique is suitable for mass production.

Description

technical field [0001] The invention relates to a preparation process of creatine phosphate sodium freeze-dried powder injection, which can be used for myocardial protection and belongs to the technical field of medicines. Background technique [0002] Creatine Phosphate (CP) is an active substance in the human body and an important energy supply source 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: [0003] [0004] 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. As a new type of high-efficienc...

AI Technical Summary

Problems solved by technology

The creatine phosphate sodium powder injection produced by this process often has problems such as poor clarity, residual ethanol in the finished product, and easy contamination.

Images