The basic principle of freeze drying is based on the three-state change of water. Water has solid, liquid and gaseous states, and the three phases can be converted and coexisted. When the water is at a triple point (temperature is 0.01 ° C, water vapor pressure is 610.5 Pa), water, ice, and water vapor can coexist and balance each other. Under the high vacuum state, the sublimation principle is adopted to make the moisture in the pre-frozen material not directly melted by ice, and is directly removed into the water vapor by the ice state, thereby achieving the purpose of freeze-drying. The freeze-dried product has a sponge shape, no shrinkage, excellent rehydration, and very little water content. After storage, it can be stored and transported at room temperature for a long time. Since vacuum freeze-drying has unparalleled advantages in other drying methods, it has become more and more popular since its inception, and has become increasingly popular in medicine, biological products and food. Biological products such as serum, strains, Chinese and Western medicine are mostly biologically active substances, and vacuum freeze-drying technology also provides a good solution for preserving biological activity.
Advantages There are various drying methods, such as drying, boiling, drying, spray drying and vacuum drying, but common drying methods are usually carried out at temperatures above 0 ° C or higher. The products obtained by drying generally have the problems of shrinking size and hardening of the texture. Most of the volatile components are lost, some heat-sensitive substances are denatured and deactivated, and some substances are even oxidized. Therefore, the dried product has a large difference in properties compared with that before drying.
The lyophilization method is basically carried out below 0 ° C, that is, in the state where the product is frozen, and only when the residual moisture content of the product is lowered in the later stage, the product is allowed to rise to a temperature above 0 ° C, but generally does not exceed 40 ° C. Under vacuum conditions, when the water vapor is directly sublimated, the drug remains in the frozen ice shelf, forming a sponge-like porous structure, so the volume after drying is almost constant. Before using it again, as soon as you add water for injection, it will dissolve immediately.
Compared to conventional methods, lyophilization has the following advantages:
* Many heat sensitive substances do not degenerate or inactivate.
* When drying at low temperatures, some of the volatile components in the material are lost.
* During the lyophilization process, the growth of microorganisms and the action of enzymes cannot be carried out, so that the original traits can be maintained.
* Since it is dried in a frozen state, the volume is almost constant, and the original structure is maintained, and concentration does not occur.
* Since the moisture in the material exists in the form of ice crystals after pre-freezing, the inorganic salt-soluble substances originally dissolved in water are evenly distributed in the material. When sublimating, the dissolved substances dissolved in water are precipitated, which avoids the phenomenon that the inorganic salt carried by the internal moisture migration to the surface in the general drying method is precipitated on the surface to cause surface hardening.
* The material after drying is porous and spongy. After adding water, it dissolves quickly and completely, and almost immediately restores its original character.
* Since drying is carried out under vacuum, there is very little oxygen, so some easily oxidizable substances are protected.
* Drying can remove 95% to 99% of water, so that the dried product can be preserved for a long time without deterioration.
*Because the material is in a frozen state, the temperature is very low, so the temperature of the heat source for heating is not high, and the heater with normal temperature or low temperature can meet the requirements. If the freezing chamber and the drying chamber are separated, the drying chamber does not need to be insulated, and there is not much heat loss, so the utilization of heat energy is economical.
The so-called lack of perfect technology, the main disadvantage of vacuum freeze drying technology is the high cost. Because it requires vacuum and low temperature conditions, the vacuum freeze dryer is equipped with a vacuum system and a low temperature system, so the investment cost and running cost are relatively high.
The application of vacuum freeze-drying technology has a wide range of applications in the fields of bioengineering, pharmaceutical industry, food industry, materials science and deep processing of agricultural and sideline products.
Freeze drying of drugs includes two parts: western medicine and traditional Chinese medicine. Western medicine freeze-drying has been developed in China, and many larger pharmaceutical plants have freeze-drying equipment. In terms of injection, the freeze-drying process is used more, which improves the quality and shelf life of the drug, and brings benefits to both doctors and patients. However, there are currently few varieties of freeze-dried drugs, the prices of products are high, and the drying process is not advanced. In terms of traditional Chinese medicine, it is still limited to lyophilization of a small amount of Chinese medicinal materials such as ginseng, velvet, yam, and Cordyceps sinensis. A large number of proprietary Chinese medicines have not been freeze-dried, which is far from the foreign countries. A few years ago, Japan launched the "Western Chinese Medicine" system, which changed the method of tanning of traditional Chinese medicine, solved the tradition that Chinese medicine could not be made into injection or tablet, and solved the problem of Chinese medicine not treating acute illness. Therefore, the Chinese traditional medicine freeze-drying process And product research has great potential to dig.
In the field of biotechnology products, freeze-drying technology is mainly used for the production of drugs such as serum, plasma, vaccines, enzymes, antibiotics, hormones; biochemical inspection drugs, immunology and bacteriology; drugs; blood, bacteria, arteries, bones Long-term preservation of skin, cornea, nerve tissue and various organs.
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