The necessity of analysis of freeze-drying protective agent by Beijing four ring freeze-drying machine

The necessity of Beijing four ring freeze-drying machine to analyze freeze-drying protectors freeze-drying is a drying method that pre freeze the drug solution to be dried into a solid, and then directly sublimate and remove water from the frozen state without liquid under low temperature and pressure Because the whole process is in a low temperature state, this method is especially suitable for the preparation of heat-sensitive protein drugs The freeze-dried protein drugs are loose cake like, which is not only beneficial to the preservation but also beneficial to the renaturation of protein drugs after re dissolution Obviously, freeze-drying technology provides an effective preparation method for protein pharmaceutical preparations with unstable physical and chemical properties However, freeze-drying process is a complex phase change process There are many factors inducing protein denaturation in drugs in the process of freezing, freeze-thawing, drying and storage Therefore, some protectors are often used to stabilize the protein in the prescription Because there are many kinds of stress damage in the freeze-drying process of freeze-drying machine, the mechanism of protecting drug activity by protective agent is also different, which can be divided into low-temperature protection and freeze-drying protection The following four ring freeze-drying is to summarize the applications and functions of different fields of freeze-drying protectors: 1 Bacteria, viruses and other microorganisms need to grow and reproduce in specific culture media, but these culture media and microorganisms are often difficult to separate, they can be successfully freeze-dried in these culture media Such as broth, skim milk and protein 2 The concentration of some lyophilized preparations is very low, and the dry matter content is very little The dried part will be taken away by sublimation air flow In order to improve the concentration, increase the content of dry matter, and make the freeze-dried products form ideal agglomerates, so it is necessary to add filler materials, so that the concentration of solid matter is between 4% and 25% These fillers or excipients are sucrose, lactose, inositol, skimmed milk, hydrolyzed protein, dextran, sorbitol, polyvinylpyrrolidone (PVP), etc 3 Some bioactive substances are particularly vulnerable and may be damaged due to physical or chemical reasons during freezing and drying Therefore, some protective agents need to be added to reduce the damage in freezing and drying For example, DMSO, glycerin, dextran, sugars and PVP, etc 4 Adding some substances can improve the disintegration temperature of the product and make it easy to freeze dry They are mannitol, glycine, dextran, xylitol and PVP 5 In order to change the pH value of lyophilized preparation, so as to improve the eutectic point and facilitate the lyophilization They are sodium bicarbonate, sodium hydroxide, etc 6 In order to improve the stability of product storage, increase the storage temperature and extend the storage time They are antioxidants such as vitamin C, vitamin E, amino acids, sodium thiosulfate, thiourea, lecithin and hydrolyzed protein 7 Adding some substances can eliminate free groups and increase the stability of freeze-dried products They are amino acids, vitamin K, vitamin C, thiourea, sulfite compounds, sodium aspartate, etc