Drug Freeze Drying Machine Drug Freeze Drying Machine

Pharmaceutical freeze-drying machine: The freeze-drying process has the characteristics of low temperature, low pressure, and low moisture content, which makes it widely used in many fields such as biopharmaceuticals. However, various stresses generated during the entire freeze-drying process can cause cell damage or even death. Therefore, how to maintain the activity and stability of biological preparations before and after freeze-drying has become an important issue in the production process of such drug preparations.

　　Drug Freeze Drying Machine Drug Freeze Drying MachineThe freeze-drying process has the characteristics of low temperature, low pressure, and low moisture content, which makes it widely used in many fields such as biopharmaceuticals. However, various stresses generated during the entire freeze-drying process can cause cell damage or even death. Therefore, how to maintain the activity and stability of biological preparations before and after freeze-drying has become an important issue in the production process of such drug preparations.

The damage mechanism of freeze-drying on cells mainly includes mechanical damage of ice crystals, damage caused by changes in electrolyte content leading to cell shrinkage, and damage caused by dehydration leading to changes in cell membrane permeability and protein activity. The commonly used freeze-drying protectants can be classified into sugars, alcohols, inorganic salts, polymers, etc. based on their chemical properties. Among them are commonly used sucrose, glucose, and lactose that we are familiar with.

In the selection of freeze-drying protectants for drug freeze-drying machines, the following points need to be considered:

1. The protective effect of a single protective agent component is limited and cannot provide the necessary protection for biological agents. Therefore, it is necessary to mix several protective agents with different protective effects in a certain proportion to form a composite formula;

2. In order to give the freeze-dried product an ideal appearance, the composite formula should contain a certain amount of excipients, such as sucrose; Due to long-term transportation and storage considerations, an appropriate amount of antioxidants should be added. For bacteria that are sensitive to pH changes, pH regulators such as potassium dihydrogen phosphate and sodium dihydrogen phosphate need to be added to maintain the pH of the product within the suitable range for the bacteria;

3. The total solid content in the protective compound formula will affect the freeze-drying process. If the solid mass fraction is less than 2%, the mechanical properties of the freeze-dried drug structure will be unstable due to the lack of skeleton support; When the solid mass fraction in the formula exceeds 10%, the resistance to removing moisture during the drying process increases, which increases the difficulty of freeze-drying the product. Therefore, the content of protective agents should be coordinated with the appearance shrinkage of the product;

4. Ingredients with higher disintegration temperatures should be selected as much as possible to facilitate freeze-drying. Low disintegration temperature will prolong the drying time of the product and increase production costs;

5. In the face of some bacterial drug preparations, specific nutritional factors should be added according to the growth characteristics of different bacteria.