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Lactulose oral solution is a hypertonic oral liquid formulation composed of lactulose (a synthetic disaccharide polymer of galactose and fructose). It is usually a colorless to light brown clear and viscous liquid with a slightly sweet taste. As an inert sugar that is not absorbed by the human small intestine, it exerts therapeutic effects through a complete pharmacological mechanism: after oral administration, it directly reaches the colon, is decomposed by the intestinal flora into low-molecular organic acids, thereby significantly reducing the pH value in the colon, and utilizing its osmotic effect to retain water in the intestinal cavity, gently softening the stool, increasing its volume, and stimulating intestinal peristalsis, thereby achieving a laxative effect. It is mainly used to treat chronic or habitual constipation, especially suitable for elderly, pregnant women, and infants. In addition, it can promote the conversion of ammonia in the intestinal tract into ammonium ions and their excretion with the feces, so it is also a key drug for treating hepatic encephalopathy and reducing blood ammonia.
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Chemical Formula |
C12H22O11 |
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Exact Mass |
342 |
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Molecular Weight |
342 |
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m/z |
342 (100.0%), 343 (13.0%), 344 (2.3%) |
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Elemental Analysis |
C, 42.11; H, 6.48; O, 51.41 |
Lactulose is a substance with multiple physiological functions, mainly synthesized from D-galactose and fructose. The following are the main functions of lactulose:
Promote intestinal peristalsis: Lactulose can soften feces by increasing the osmotic pressure of intestinal contents, attracting water into the intestine. Meanwhile, it can also be fermented by beneficial bacteria in the intestine, producing gas that further stimulates intestinal peristalsis and helps alleviate constipation, especially suitable for patients with chronic or habitual constipation.
Regulating gut microbiota: Lactulose is a type of prebiotic that can be utilized by beneficial gut bacteria such as bifidobacteria and lactobacilli to promote their growth and reproduction, while inhibiting the growth of harmful bacteria, thereby regulating gut microbiota balance and maintaining gut health.
Lowering blood sugar: Lactulose oral solution has a lower sweetness and is not digested or absorbed in the human body, so it can be used as a low-energy sweetener. At the same time, lactulose can reduce the glycemic index of food and help diabetes patients control blood sugar levels.
Antioxidant: Lactulose has a certain antioxidant effect, which can clear free radicals in the body, reduce oxidative stress, and protect cells from oxidative damage. This helps to slow down the aging process and prevent oxidative stress-related diseases such as cardiovascular disease.
Improving intestinal environment: Lactulose can lower intestinal pH, create an environment that is not conducive to the growth of harmful bacteria, reduce ammonia production, and lower liver burden. In addition, it can enhance the barrier function of the intestine, reduce the absorption of toxins and the invasion of pathogens.
Adjuvant treatment for liver disease: Lactulose helps prevent and treat hepatic encephalopathy by reducing intestinal pH, inhibiting the activity of protein degrading bacteria, and reducing the production and absorption of toxic substances such as ammonia. Lactulose plays an important therapeutic role in patients with hepatic encephalopathy, hepatic coma, and pre coma.
Lactulose oral solution, also known as isolactose, lactulose, or galactose fructose, is a disaccharide formed by the β -1,4-glycosidic bond between galactose and fructose. In 1929, isomerized lactose, also known as lactulose, was first discovered in heated milk. Lactulose generally does not exist in nature and is an artificially synthesized disaccharide. It is a white powder substance that is easily soluble in water and has a higher sweetness than lactose.
1. Chemical method
This system mainly uses sodium hydroxide, potassium hydroxide, potassium carbonate, and tertiary amine as catalysts, and the conversion rate of lactulose is around 20%. This type of alkaline reagent acts on lactose, causing it to isomerize and produce lactulose. However, it also generates a considerable amount of degradation products such as galactose and fructose, which are difficult to separate and often have darker colors. The production of by-products and pigments not only reduces the yield of lactulose, but also poses difficulties for further purification and crystallization of syrup.
This system involves adding boric acid to the reaction system. Under alkaline conditions, boric acid can cause lactulose to form lactulose borate complexes, shifting the equilibrium of the reaction towards the direction favorable for lactulose production. The formation of complexes and the shift of reaction equilibrium minimize the generation of degradation products to the greatest extent possible. Only a small portion of lactulose will be converted into by-products during the entire reaction process, with a lactulose conversion rate of around 70% and a maximum of 75%. After the conversion is completed, the pH of the reaction system is converted to acidic, and the complex will decompose to produce lactulose and borate. After removing the borate, pure lactulose can be obtained. Due to the fact that borate is a weak acid salt, conventional anion exchange resins are almost unable to remove it below safety standards, requiring the use of ion exchange resins that specifically remove boric acid, which are relatively expensive. The preparation of lactulose by acid-base synergistic catalysis reduces the generation of by-products, improves the yield of lactulose, and is beneficial for the purification and refinement of lactulose. This is also the main method for industrial production of lactulose at present.
The mechanism of action of this system is similar to that of boric acid. Sodium aluminate can undergo complexation reaction with lactulose generated by isomerization reaction, and the conversion rate of lactulose is about 60%; However, in general, the generation rate of by-products in aluminate systems is higher than that in borate systems, and the removal of aluminum ions is more difficult. In recent years, some scholars have used heterogeneous catalysts including zeolite, sepiolite, eggshell powder, oyster shell powder, etc. to prepare lactulose, and found that a conversion rate of 20% of lactulose can be obtained at a dosage of 15g/L and 90 ℃; Using eggshell powder as a catalyst, a conversion rate of 18% -21% of lactulose was obtained after 120 minutes of reaction at 96 ℃ with a dosage of 12g/L. Although catalysts such as zeolite, sepiolite, eggshell powder, and oyster shell powder have low conversion rates for lactulose, they remain in a solid state and are easily removed through filtration. Therefore, the preparation of lactulose using heterogeneous catalysts has strong potential for development.
2. Biological Law
Enzymatic method is the main method for producing Lactulose oral solution by biological methods, and the enzymes used are mainly β - galactosidase. Its principle is to hydrolyze lactose into galactose and glucose through the hydrolytic activity of β - galactosidase, and transfer galactose to fructose receptors through the transglycosylation activity of β - galactosidase to generate lactulose. β - galactosidase, also known as β - D-galactosylgalactose hydrolase, not only has high activity in hydrolyzing lactose, but also has high transglycosylation activity in transferring galactose to fructose receptors. Early studies have shown that the active site on β - galactosidase has two functional groups: the thiol group of Cys and the imidazole group of His, which play an important role in the hydrolysis of lactose by β - galactosidase. It is speculated that the sulfur group can act as a generalized acid to protonate the oxygen atom of galactoside, while the imidazole group can act as a nucleophile to attack the nucleophilic center on the first carbon atom of the galactose molecule, forming a covalent intermediate containing a carbon hydrogen bond. After the imidazole group is cleaved, the thiol anion extracts one proton from the water molecule, forming - OH to attack C. β - galactosidase mainly comes from animals, plants, and microorganisms. Such as lactic acid bacteria, Bacillus subtilis, Escherichia coli, Streptococcus thermophilus, and gas producing intestinal bacteria in bacteria; Aspergillus oryzae, Aspergillus niger, Ryukyu Aspergillus, Penicillium flavum, Charcoal Aspergillus, etc. in fungi; Crispy walled Kruve's yeast, lactic acid Kruve's yeast, tropical Candida, etc. in yeast; Streptomyces coelicolor and other actinomycetes all produce β - galactosidase. Due to the biological characteristics of rapid growth and efficient metabolism of microorganisms, β - galactosidase derived solely from microorganisms has industrial application value; Commercial enzyme sources are generally considered to be the safest, followed by Aspergillus niger. At present, due to the low activity of β - galactosidase in transglycosylation and the low conversion rate of lactulose, the application of biological methods in the preparation of lactulose is limited. Some scholars at home and abroad have conducted research on this, with the aim of screening microbial strains with high β - galactosidase transglycosylation activity as much as possible. Using genetically modified heat-resistant lactase, lactose and fructose were used as substrates to produce 50mg/mL lactulose after 6 hours of reaction at 80 ℃. Due to the fact that enzymatic preparation of lactulose can overcome the difficulties in separating the large amount of colored by-products generated by chemical methods, the high cost of separating these by-products, and the degradation of lactulose during the separation process, it has strong theoretical and practical significance. This is an important direction for the future development of lactulose preparation.
Lactulose oral solution, also known as isolactose or lactulose, has unique physiological functions such as regulating gut microbiota, enhancing immunity, and improving metabolism. It can also reduce blood ammonia and diarrhea, and is used for the prevention and treatment of various liver diseases. In terms of food, it can be used as a low calorie sweetener and functional food additive. It is a functional oligosaccharide that can be used for both medicine and food. In recent years, it has been widely applied in the fields of medicine and healthcare.
Every year, the world receives 4 million tons of lactose from cheese production, but only 25% of it can be further utilized. The remaining 3 million tons of lactose are wasted and cause environmental pollution problems. Moreover, about 70% of the world's population has lactose intolerance, which can cause serious gastrointestinal problems after consuming lactose. The efficient utilization of lactose has become an urgent problem that needs to be solved. The emergence of lactulose has successfully solved this problem. People convert lactose into lactulose through hydrolysis and other methods, turning it into a usable resource, breaking the limitation that lactose cannot be fully utilized directly, and avoiding the emission of unused lactose into the environment, which can cause environmental pollution and resource waste.
Thanks to its excellent physiological functional characteristics and environmental advantages, lactulose has been increasingly favored by companies in the biopharmaceutical and food industries. It has been widely used in the clinical pharmaceutical industry in the form of oral liquid, and in the food and animal feed industry as a health food ingredient. At present, lactulose syrup is mainly used as a drug in the market to treat various intestinal diseases such as chronic constipation and hepatic encephalitis. It is also used in the food industry in Japan, such as functional foods.
The two largest producers of lactulose in the world are the Dutch company Solvay and the Japanese company Morinaga Dairy. Solvay is the earliest enterprise in the world to engage in lactulose production, with a production history of over 50 years and a market share of about 50%. Its products are mainly used in the pharmaceutical industry and have two global lactulose production factories in the Netherlands and Canada; Senyong Dairy Company mainly applies lactulose to the food industry and animal feed industry.
The global annual demand for lactulose in healthcare is about 6000 tons, but the annual production of high-purity medicinal grade lactulose is only 27 tons. China started relatively late in the research and production of lactulose, which still relies on chemical methods and produces low purity lactulose syrup. Medicinal grade high-purity lactulose still relies almost entirely on imports. The production of lactulose in China started relatively late and there have not yet been large-scale lactulose production enterprises.
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