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With the advent of more and more new enzyme preparations, medical enzymes will become a new bright spot in the international pharmaceutical market. There are only a few varieties of domestic medical enzymes such as multi-enzyme tablets. Enzyme is a general term for important protein and biochemical substances. Enzymes exist in plants and animals.

As early as more than 100 years ago, Western scientists have isolated trypsin with physiological effects from animal digestive tract fluids. This substance can break down various proteins into amino acids in test tubes. Because of its extensive participation in various physiological activities, enzymes have become more and more widely used in medicine. Due to the small demand for industrial enzymes, the fermentation method for industrial production of enzymes, namely the fermentation method, did not come out until the 1950s.

Although there are at least thousands of enzymes discovered by scientists at present, there are only dozens of enzymes that are actually put into industrial production, and some enzymes are directly extracted from plants or prepared by bioengineering technology. Enzyme is an ecological and efficient catalyst, and has a strong specificity that one enzyme can only catalyze and transform one substance. At present, the global total production of industrial enzymes has exceeded 1 million tons, and China’s annual production of enzymes accounts for about 1/3 of the world’s total output.

It is estimated that in 2007, the total global market sales of enzymes reached 5 billion to 6 billion US dollars. The most important uses of enzymes are concentrated in the food industry. In addition, they are also widely used in the pharmaceutical industry, feed and other industries. In terms of consumption, the food industry consumes about two-thirds of the world’s total enzyme production, and the total consumption of enzymes in other industries accounts for the remaining one-third.

It plays an important role in the production of β-lactam antibiotics. The application of enzymes in the pharmaceutical industry began in the early 1980s. With the advent of cephalosporin β-lactam antibiotics, the serious environmental pollution caused during the production of cephalosporin products is worrying. At that time, British and Dutch scientists first reformed the chemical lysis method that has been used for many years into a clean and efficient “enzymatic lysis”-the enzyme used was penicillin lyase and cephalosporin lyase, thereby eliminating the production of semi-synthetic penicillin or cephalosporin Environmental pollution caused by bacteriocin products. These two enzymes can be used to prepare a series of semi-synthetic penicillins such as ampicillin and amoxicillin and other key raw materials for cephalosporins. With the implementation of the enzymatic cracking process, antibiotic production has entered a brand new “enzymatic production era”.

In recent years, some newly developed therapeutic enzyme preparations abroad such as antibacterial enzymes, fibrinolytic enzymes, mucolytic enzymes, analgesic enzymes, antitumor enzymes, immune activator enzymes, etc. In addition, Western researchers have also found that protease preparations compatible use with existing antibiotics such as ampicillin, tetracycline, SMP-CO and fluoroquinolones can greatly improve the antimicrobial effect of these drugs and reduce the drug resistance of bacteria.

According to reports, some hospitals have combined enzyme preparations with antibiotic preparations to achieve good results in the treatment of refractory urinary tract infections. These new clinical uses have laid a solid foundation for the medical market for enzyme preparations. Medical enzyme preparations have become a new breed of therapeutic agents. With the advent of more and more new enzyme preparations, medical enzymes such as diagnostic enzymes will become a new bright spot in the international pharmaceutical market. The enzymes produced now are mainly concentrated in the food industry, accounting for about 96% of the domestic enzyme production value, and there are very few varieties for treatment. At present, there are only a few varieties such as multi-enzyme tablets and lumbrokinase. It is believed that, driven by the new trend of international drug use, domestic development of new medical enzyme production will have broad market prospects.

Bioengineering is a high technology of modern science and technology, and it is one of the most promising disciplines today. Enzyme engineering is an important part of bioengineering. As a biocatalyst, enzymes are widely used in more than 20 fields such as food, brewing, starch sugar, tanning, textile, printing, medicine, and petrochemicals. It can improve product quality, improve product technology, reduce labor intensity, save raw materials and energy, protect the environment, and produce huge economic and social benefits.

Globally, 55% of the total enzyme preparation is hydrolase, which is mainly used in baked goods, wine making, starch processing, alcohol and textile industries. 35% are proteases, mainly used in detergent, tanning and dairy industries; the rest are pharmaceutical enzyme preparations, reagent-grade enzyme preparations and tool enzymes.

Enzyme engineering technology is the technology that uses the catalytic function of enzymes and cells or organelles to produce products required by humans, including the development and production of enzymes, the immobilization of enzymes and cells or organelles, the modification and modification of enzyme molecules, and biosensors.

Enzyme production

Enzyme production is a process of optimization and combination of various biotechnology. It is divided into three types: biological extraction method, biosynthesis method and chemical synthesis method. Among them, the biological extraction method is the earliest method and is still in use today. It refers to the extraction of enzymes from animals, plants, organs, cells or microbial cells using various extraction, separation and purification techniques. Biosynthesis is the main method of enzyme production since the 1960s. It refers to the technical process of obtaining the enzymes needed by people using the life activities of microbial cells, plant cells or animal cells. The chemical synthesis method, because of its high cost, can only synthesize enzymes whose chemical structure has been clarified, so it is difficult to carry out industrial production and is still in the laboratory research stage.

Enzyme purification

Enzyme purification belongs to a post-treatment process, including a crude process and a refining process. Concentrating and refining superenzyme solution is an important part of producing high-quality enzyme preparations. The purification method is generally established based on the size, shape, charge properties, solubility, specific binding site and other properties of the enzyme. To obtain pure enzymes, various methods are generally used in combination. The most commonly used purification method is precipitation based on solubility characteristics. Ion exchange chromatography based on charge polarity, isoelectric focusing electrophoresis, etc. Centrifugation, dialysis, ultrafiltration, etc. according to size or weight. Affinity chromatography and covalent chromatography according to the affinity site.

3.Enzyme immobilization technology

The chemical nature of the enzyme is protein, and its biggest disadvantage is instability. It is prone to denaturation of the enzyme protein to acid, alkali, heat and organic solutions, thereby reducing or losing activity. In addition, the enzyme often reacts in the solution, which will remain in the solution system after the reaction and is not easy to recover, causing troubles in the separation and purification of the final product. In addition, the enzyme reaction can only be carried out in batches, which is difficult to be continuous and automated. This greatly hinders the development and application of enzyme engineering. In order to overcome the above disadvantages, the free enzyme needs to be immobilized before application.

The enzyme immobilization technology is to immobilize the enzyme extracted from the organism on the carrier by artificial methods. This is the core of enzyme engineering, which brings the enzyme engineering to a new level. Since the first use of solid-phase enzyme technology in the world in 1969, it has more than 40 years of history. Since the movement of the immobilized enzyme is restricted by chemical or physical methods, it can be recovered from the reaction medium, so in principle the enzyme can be reused in batch operations or continuous operations.

The immobilized enzyme has the following properties: the stability of the enzyme is improved; the optimum pH value is changed; the enzyme activity and catalytic substrate are changed; the optimum temperature is increased, and the sensitivity to inhibitors and proteases is reduced; After the reaction is completed, it can be recovered by a simple method and the enzyme activity remains unchanged. At the same time, because the enzyme is not released into the product, it is convenient for the separation and purification of the product; the possibility of implementing batch or continuous operation models can be carried out in industrialized, continuous, and automated production.