UA59449C2 - Complex infusion solution "lactoxil" - Google Patents

Abstract

The invention relates to the medicine, in particular to the complex infusion solutions providing detoxifying, rheologic, antishock, and energy supplying effects and correcting the acid-base equilibrium. The solution comprises xylitol, sodium lactate, and sodium, potassium, calcium, and magnesium as the electrolytes.

Description

Description of the invention 1. The invention relates to medicine and concerns the complex infusion solution "Lactoxyl". 2 The purpose of the invention is to create a complex infusion drug with detoxification, rheological, anti-shock, energetic action and for the correction of acid-alkaline balance. 2. Level of technology. Analogues and prototypes.

A known method of obtaining a complex buffered lactazol infusion solution (Russian Federation).

The preparation contains sodium chloride 6.2 g, potassium chloride 0.3 g, calcium chloride 0.16 g, magnesium chloride 0.1 g, sodium 70 lactate 3.36 g, sodium bicarbonate - 0.3 g and distilled water up to Tl (osmolarity - 294 mOsm/l ).

However, the disadvantage of lactazol is its instability due to the production of the main component of the drug - sodium lactate from low-quality lactic acid. The presence of sodium bicarbonate in the composition of the solution also leads to the instability of the drug after its sterilization. In the clinic, when using lactazol to correct the acid-alkaline balance, it is necessary to transfuse significant volumes of the drug and overload the vascular bed 12 of the body.

Currently, new crystalloid solutions Quintasol, Mafusol, Acesol, similar in effectiveness to Lactosol, have been created. The drugs are at the stage of development of regulatory and technical documentation and introduction into production.

Known widespread in the West, complex volume-electrolyte solutions Ionosteril lactate, Ionosteril Kk,

Normofundin, Tutofusin B, Gamafusal OPS, etc. Normofundin contains sodium chloride - 0.36395, potassium chloride - 0.13495, magnesium chloride - 0.06195, calcium chloride - 0.029590, sodium acetate - 0.5179U5, as well as sorbitol - 2.595 and xylitol 2.595.

C. The essence of the invention. The essence of this invention is the creation of a complex lactate-xylitol-salt infusion solution. with

The set goal is achieved by the fact that the composition of the Lactoxyl infusion solution contains five-atom alcohol xylitol in a concentration of 7.595, sodium lactate - 1.0595, sodium chloride - 0.28890o, potassium chloride - 0.03905, calcium chloride - 0.0195 , magnesium chloride - 0.0195. The osmolarity of the drug is 7UO0mOsm/l.

Example 1. Obtaining Lactoxyl from "food grade" xylitol To obtain, for example, 20 liters of Lactoxyl infusion solution, first prepare a 790% sodium lactate solution and a 40965% xylitol solution. at

To obtain 6 liters of 790% sodium lactate solution, dissolve 545g of calcium lactate in 500Oml of pyrogenic distilled water during boiling. Sodium bicarbonate in the amount of 315 g is added to the hot solution of calcium lactate while stirring. The resulting solution is boiled for 5 minutes, after which a white precipitate C is formed (a strongly alkaline reaction in the range of 9-10 is evidence of calcium precipitation). The hot solution is filtered (preferably through a Buchner funnel). The volume of the filter is measured and brought up to 6 liters with pyrogen-free distilled water. The pH of the 325 solution is adjusted to 6.4-7.2 using concentrated hydrochloric acid. The finished solution of sodium lactate 795 o is poured into 100, 200 and 400 ml bottles with a capacity of 100, 250 and 50 Oml, closed with corks, rolled with aluminum caps and sterilized in an autoclave for 30 minutes at 1.2 atm. Control of the solution and preservation is carried out in accordance with TFS 42-1720-87 for sodium lactate solution 7965.

To prepare 10 liters of the 4095th xylitol solution, weigh 4200 xylitol (grade "food xylitol" Z in accordance with TU 64-10-04-89) and 8O0g of sodium chloride, pour them into a measuring container and bring them up to 10 liters with a pyrogen with distilled water. Activated carbon, treated with hydrochloric acid and

From" washed repeatedly with distilled water to pH 6.0-6.5. Washed coal is dried. Dry activated carbon in the amount of ZOOg (based on the calculation of ZOOg per TL of solution) is poured into the xylitol-salt solution. The solution is mixed with coal for 15 minutes and brought to a boil. Stir the solution over low heat for 45 minutes. Then the xylitol solution is cooled to a temperature of 40-507C and filtered. In the measuring container, the volume of the solution is brought up to 10 liters with distilled water, the pH is adjusted within the range of 5.0-6.0. Transparent 4095 (Ce) solution of xylitol (on 0.895 sodium chloride) is poured into 100 and 400 ml vials with a capacity of 250 and 50 Oml. Vials are closed with rubber stoppers, rolled up with caps and sterilized in an autoclave at a temperature of 12370 (1.1 atm, ЗОхв.). The solution is checked for sterility, acute toxicity, and pyrogenicity (from "" 20 at the rate of 2 ml of 4095 xylitol solution per kg of rabbit body weight; before administration, dilute 2 times with pyrogenic distilled water or sterile isotonic sodium chloride solution). c The preparation of Lactoxyl is carried out in an isolated, boxed room, equipped with bactericidal lamps. The drug is prepared in a measuring vessel - glass, enamel or stainless steel. In a clean, dry measuring cup, pour 300Oml of sodium lactate 795 solution, 37b6O0ml of xylitol 4095 solution, and also add the following components: 40ml of 1095 calcium chloride hexahydrate solution (4 ampoules of 1Oml), magnesium

HF) of chloride hexahydrate - 4.28 g, potassium chloride - b.0 g, sodium chloride - 27.6 g (3.0 g of sodium chloride is contained in 3.76 liters of 4095 xylitol solution). o The solution is stirred until the reagents are completely dissolved, brought up to 20 liters with pyrogen-free water, mixed thoroughly. With the help of 2 N hydrochloric acid solution, the pH is brought to 7.1 - 7.3. The resulting solution 60 is filtered through sterile cotton-gauze filters (8 layers) or cellulose-membrane filter Mb.

Filtration of the drug is carried out until the smallest suspension is absent in the filtered solution. The drug is poured with a dispenser or with the help of a measuring cylinder of 200 and 400 ml into glass vials with a capacity of 2500 ml and 5000 ml. Vials are closed with rubber stoppers and rolled with aluminum caps.

Then the vials with the drug are placed in calico two-layer bags for sterilization. The entire process of making the Lactoxyl solution before the start of sterilization should not exceed 4 hours. Vials with Lactoxyl are sterilized in a steam autoclave at a temperature of 1217C for 30 minutes.

Example 2. Obtaining Lactoxyl from xylitol of the "Pharmacopoeia" brand Sodium lactate solution 796 is prepared in the same way as described in example 1. To prepare Lactoxyl (20 liters), pour 300 ml of sodium lactate solution 795, 50000 ml of pyrogenic distilled water into a measuring container with a capacity of 20 liters of water and add the following components: 1575g xylitol of "pharmacopoeia" qualification, 4Oml 1095 solution of calcium chloride hexahydrate (4 ampoules of 1Oml), magnesium chloride hexahydrate - 4.28g, potassium chloride - 6.0Og, sodium chloride - 57.6g.

The solution is stirred until the reactants are completely dissolved, brought up to 20 liters with pyrogen-free water, thoroughly mixed.

All subsequent stages of preparation are carried out similarly, as described in example 1.

Lactoxyl contains the alkalizing agent sodium lactate in a concentration of 1.0595 (dFOmmol/l), which is 3 times higher than its content in lactasol and Ringer's lactate solution. This concentration of lactate makes it possible to compensate metabolic acidosis with a smaller volume of infusion solution. At the same time, this concentration is slightly less than /5 In the previously developed Sorbilact and Reosorbilact solutions (16O0mmol/l) and 2 times less than in the Lactoprotein and Lactosorbal drugs approved for medical use (180mmol/l), which removes the restrictions in use of significant volumes of Lactoxyl in some pathological conditions.

In addition, for the preparation of such a component of Lactoxyl as sodium lactate, not contaminated lactic acid (produced in the Russian Federation) is used, but sufficiently purified raw materials in the form of calcium lactic acid of the "h" or "medical" qualification.

Unlike complex solutions containing sodium bicarbonate similar to the proposed drug (Lactoxyl), the alkalizing component of Lactoxyl sodium lactate has a neutral reaction. Lactate in the body is catabolized and the correction of metabolic acidosis occurs more slowly, as it is incorporated into the metabolism, without causing sharp fluctuations in pH. high school

As can be seen from the prescription, we include xylitol in Lactoxyl at a concentration of 7.5965 (which is 1.5 times higher than the isotonic concentration). Xylitol when administered intravenously does not cause a decrease in i) adenine nucleotides in the liver, and it is also safe for administration to patients who cannot tolerate fructose. Being an excellent source of energy and possessing an insulin-independent metabolism, as well as a pronounced antiketogenic and lipotropic effect, xylitol is recommended for use as a means for parenteral nutrition of patients, Ge! especially those who underwent operations on the gastrointestinal tract.

Materials from the preclinical study of Lactoxyl have been sent to the Pharmacological Center of the Ministry of Health of Ukraine to obtain permission to conduct clinical trials of the drug. "Mr

Claims (1)

The formula of the invention 35 IC c) Complex infusion preparation containing sodium lactate, electrolytes of sodium, potassium, calcium, magnesium, which is distinguished by the fact that it additionally contains xylitol at the following ratio of components, wt. 9o: " xylitol 6.5-8.5 - in sodium lactate 0.85-12.5 with sodium chloride 0.24 - 0.34; - potassium chloride 0.025-0.035 calcium chloride (in terms of dry matter) 0.007-0.013 s magnesium chloride (in terms of dry matter) - 0.007-0.013 is), distilled water the rest. ChK» t» 50 Official Bulletin "Industrial Property". Book 1 "Inventions, useful models, topographies of integrated microcircuits", 2003, M 9, 15.09.2003. State Department of Intellectual Property of the Ministry of Education and Science of Ukraine. F) name) 60 b5