Pharmaceutical composition of enterosorbent and prebiotics, dosage forms, and the method for prevention and treatment of gastrointestinal disorders
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A composition and form of technology, applied in the field of veterinary medicine, medicine, and medicine, can solve the problem of slow curative effect
Inactive Publication Date: 2009-06-17
亚历山大·弗拉基米罗维奇·迪科夫斯基
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[0013] The disadvantage of this known technical solution is that it is slow to achieve curative effect and its experimental data is obtained with guinea pigs as experimental subjects, and the intestinal flora of guinea pigs is quite different from that of human intestinal flora
These limited data are based on certain formulations and dosage forms of enteric adsorbents and prebiotics, and no clinical studies have directly demonstrated the efficacy of said adsorbents and prebiotics in different etiologies in humans
Method used
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example 1
[0031] Example 1. Preparation of a usable dosage form in the form of a moist powder. The powder composition comprises: 80% by weight of hydrolyzed lignin with a particle size of 0.15-0.55mm and a water content of 55%; is a 45% solution of lactulose; and short-chain fructo-oligosaccharides. After mixing the resulting mixture in a rotor mixer, the resultant was dried to a moisture content of 50% and packed into bags made of laminated foil, which were previously sterilized.
[0032] Example 2. Following the technique described in Example 1: a dosage form was prepared in the form of a moist hydrolyzed lignin powder with a moisture content of 65%, which consisted of 0.15-0.55 mm particles and 90% by weight. 10% by weight of 55% lactulose and short-chain fructo-oligosaccharides are added to the hydrolyzed lignin. The mixture was dried to a moisture content of 70% and packed into pouches made of laminated foil and then sterilized.
[0033] Example 3. According to the technique desc...
example 5
[0035] Example 5. Preparation of a mixture of hydrolyzed lignin, aqueous lactulose and short chain fructooligosaccharides comprising particles of 0.15-0.55 mm. After careful mixing in a rotor mixer, the obtained pasty mixture with a water content of 75% was packed into test tubes and sterilized.
example 6
[0036] Example 6. Clinical trials of the lactulose-containing lignin formulations described in Examples 1-5 of the present invention were carried out at the Moscow Institute of Pediatrics and Pediatric Surgery Sciences. The tests were carried out on children aged 3-15 years with differences in their intestinal flora. The children were under the supervision of gastroenterologists, who were diagnosed and treated by the hospital for "digestive disorders". Symptoms of the disease are intermittent abdominal pain, diarrhea, and flatulence. Microbiology showed low levels of bifidobacteria in the patient's large intestine (no more than 10 2 CFU / g). Testing also included clinical evaluation and instrumental observation (endoscopic examination, abdominal ultrasound scan, and bacteriological stool examination).
[0037] Sixty children were divided into experimental and control groups, comprising 45 and 15 participants, respectively. Children from the test group took compound tablets ...
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Abstract
The pharmaceutical composition is a combination of hydrolytic lignin with moisture of 55% to 65% consisting of the particles measuring 0.15 mm to 0.55 mm, a 45% to 55% aqueous lactulose solution, and a 50% to 55% aqueous oligosaccharide solution at the following ingredient ratio (weight percent): 10-60 of an aqueous lactulose solution; 10-60 of oligosaccharides; sufficient quantity of hydrolytic lignin. Hydrolytic lignin, lactulose and fructose oligosaccharides are sequentially added and mixed using a rotor blender. The composition is administered orally for no less than 14 days and no more than 30 days, two to four times a day, depending on the patient's weight and age. The composition is used as a medicine for treatment of the gastrointestinal disorders, including bacterial, viral, protozoal enteric infections, food poisoning, acute and chronic hepatitis and cirrhosis, diarrhea, peptic ulcer, Crohn's disease, ulcerative colitis, irritable bowel syndrome, mineral disorders with Ca / Mg deficiency, including osteoporosis and other alterations of the bone formation, as an immunomodulator in atopic dermatitis and immunodeficiency conditions, for protection and recovery of intestinal flora after antibiotic therapy, chemotherapy, and radiotherapy. The result is accelerated achievement of the effect and the enhanced action on the state of intestinal microbiocenosis as well as increased effectiveness of treatment of hepatitis and liver cirrhosis, elimination of undesired adverse effects in clinical usage, and extension of indications, i.e. the extended spectrum of usage in prevention and treatment.
Description
technical field [0001] The present invention relates to the fields of medicine, veterinary medicine and medicine and applies to the prevention and treatment of digestive tract disorders using biologically active preparations. Background technique [0002] Compositions currently known for the preparation of enterosorbent-useful dosage forms comprise enterosorbent (activated charcoal) and an aqueous solution of sugar (sucrose) (RF Medicinal drug register., Moscow, Infarmkhim, 1993, item 856, column 1). [0003] However, the above available formulations prepared from known ingredients are susceptible to bacterial contamination due to the presence of sucrose, a type of carbon source utilized by microorganisms as a medium. [0004] Hydrolyzed lignin is a known effective enteric sorbent (RF Patent No. 2125463, cl. A 61 K 35 / 78, 1998). [0005] Hydrolyzed lignin is a mixture that contains lignin from plant cells, some polysaccharides, a set of humus complex components, unwashed mo...
Claims
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Application Information
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