Freeze-dried protective agent
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Briefly: Bo Yikang has been committed to the R&D and production of small-scale, pilot-scale, production-type vacuum freeze-drying equipment. In the process of long-term customer service, it was found that the majority of lyophilizers did not understand the mechanism of the lyophilized protective agent. In view of the above situation, the collection of freeze-drying protective agent information is available for the majority of users.
In freeze-dried liquid preparations, in addition to those active, toxic or therapeutically effective ingredients, they are collectively referred to as lyoprotectants. It is different from the adjuvant, the adjuvant has a therapeutic effect, and the protective agent has no therapeutic effect.
Some liquid products can be lyophilized separately, but some liquid products are often not easily lyophilized. In order to make certain products successfully freeze-dried, improve the solubility and stability of the freeze-dried products, or make the freeze-dried products have an aesthetic appearance, it is necessary to add some additional substances to the products, which are protective agents, sometimes called The protective agent is a suspending medium, a filler, an excipient, a buffer, a base, and the like. The protectant must be chemically inert to the lyophilized product.
The role of protective agents:
1. Bacteria and viruses need to grow under specific culture media, but some culture media are often difficult to separate from bacteria and viruses, and they are generally successfully lyophilized in these culture media. For example, broth, skim, protein, etc.
2. Some active substances have a very small concentration and very little dry matter. Substances that have dried during lyophilization are carried away by the sublimated gas stream. In order to improve the concentration and increase the dry matter content, the lyophilized product can form a better agglomerate. Therefore, it is necessary to add a filler such that the concentration of the solid matter is between 4 and 25 %. These fillers or excipients are: sucrose, lactose defatting, protein and hydrolysate, povidone, dextran, sorbitol, and the like.
3. Some active substances are particularly fragile and may be harmed by physical or chemical reasons during freeze-drying. Therefore, some protective agents or antifreeze agents are added to reduce damage in freeze-drying. For example, dimethyl sulfoxide, glycerin, dextran (dextran), saccharides, povidone, and the like are added.
4. Adding certain substances can increase the disintegration temperature of the product to obtain a good product and easy to freeze. They are mannitol, glycine, dextran, xylitol, povidone and the like.
5. In order to change the pH of the lyophilized liquid preparation, thereby changing the eutectic point to facilitate lyophilization, they are sodium hydrogencarbonate, sodium hydroxide and the like.
6. In order to change the stability of product storage, increase storage temperature and increase storage time, they are: antioxidants such as vitamin C , vitamin E , amino acids, sodium thiosulfate, thiourea, and the like.
The range of protective agents is quite wide and varied, but no ideal protective agent can be found. There is also no universal formulation of a protective agent for different lyophilized products. Suitable protective agents for each product are subject to repeated testing.
The types of protective agents can be classified into the following categories according to their chemical composition:
Composite
2. Sugar
3. Salt
4. Alcohols
5. Acids
6 alkalis
7. Polymer
Skim milk
gelatin
Protein and hydrolysate
Peptide
yeast
broth
dextrin
Methylcellulose
serum
Peptone
sucrose
lactose
maltose
glucose
Raffinose
fructose
Ethyl sugar
Sodium sulfate
Calcium lactate
Sodium glutamate
Sodium chloride
Potassium chloride
Sodium thiosulfate
Ammonium acetate
Ammonium chloride
Sorbitol
Ethanol
glycerin
Mannitol
Inositol
Xylitol
Citric acid
Phosphate
tartaric acid
Amino acid
Ethylenediaminetetraacetic acid ( EDTA )
Sodium hydroxide
Sodium bicarbonate
Glucan
Polyethylene glycol
Povidone