A method of obtaining a solution "glosoli"

 

(57) Abstract:

The invention relates to the field of pharmaceutical industry. Sodium chloride, potassium chloride, sodium acetate dissolved in water for injection at a temperature of 60-80oC. Bring the solution pH to 6.8 to 7.2 with 1M or 2M hydrochloric acid. Sterilize the resulting solution at a temperature 120-122oC for 20 minutes is Filtered through a membrane filter having a pore diameter of 0.2 to 0.22 μm under a pressure of 0.2 MPa. Packed and sterilized solution at 120oFor 8-20 minutes the Invention improves the stability of the product. 1 C.p. f-crystals.

The invention relates to the field of pharmaceutical industry and relates to a method of obtaining solution "Global" ("Chlosolum").

For the treatment of intoxication of an organism at different conditions, primary replenish the lost blood, normalization of water-electrolyte balance in infectious diseases apply balanced combination of drugs containing sodium chloride and other salts, such as solutions "Acesol", "Trial", "Global", "Lacteal".

Solution "Global" is a balanced combination drug containing 1 l of DINAMIChESKOE action slimming hypovolemia, prevents thickening of the blood and the development of metabolic acidosis, improves capillary circulation, increases diuresis, has a detoxifying effect.

Used to combat dehydration and intoxication in various diseases (acute dysentery, foodborne diseases, including cholera El tor).

Impose solutions intravenous (bolus or drip) in an amount necessary to recover the amount of fluid lost with feces, vomit, urine and sweat.

In severe forms of the disease begin with the introduction of an inkjet, then move on to drip. Before introducing the solution is heated to 36, 38oC. With long-term use of the solution should take into account the possibility of the development of hyperpotassemia (Mashkovsky M. D. Medicines, Moscow, 2000, so 2, page 137).

Of great importance in the development of new ways to obtain drugs in the form of solutions given to stability, sterility and apirogennost, in particular stability during sterilization.

It is known that the stability of drugs is influenced by various factors: the physical state of a substance, article, package.

A method of obtaining solution "Global" in the pharmacy New pharmacy, No. 5, 2001, pp. 65-66, guidelines. Technology, quality control and shelf life of the solution "Glosoli" for injection, manufactured in pharmacies).

The solution was prepared under aseptic conditions massoobmyena way. Salt (sodium chloride of 4.75 g/l, potassium chloride 1.5 g/l sodium acetate 3.6 g/l), dissolved in 2/3 of the volume of water for injection. Then the volume of the solution was adjusted with water for injection to the desired and mix.

The solution is filtered through a membrane filter of type "Vladipor", Packed in 200 or 400 ml, sterilized with saturated steam under pressure at 120oC for 12 min retention solution of 3 months.

The disadvantages of the presented method include the lack of stability of the obtained solution and, as a consequence, a short shelf life - 3 months. In addition, for infusion solutions are, as a rule, special requirements apirogennost, which, in this case, may be insufficient.

The objective of the proposed invention is to obtain stable during prolonged storage of the solution, exhibiting a minimum of side effects.oral sodium, potassium chloride, sodium acetate dissolved in water for injection at a temperature of 60-80oWith, bring the solution pH to 6.8 to 7.2 with 1 M or 2 M hydrochloric acid, the resulting solution is sterilized at a temperature 120-122oC for 20 minutes, filtered through a membrane filter having a pore diameter of 0.20 to 0.22 μm under a pressure of 0.2 MPa, with the subsequent packing and sterilization of the solution at 120oFor 8-20 minutes.

The introduction of an additional stage - sterilization of salt solution before filtering, which is absent in the method-analogue, allows to achieve a high degree of sterility of the drug. In addition, the stated modes of cleaning and sterilization allow you to get almost pyrogen-free solution and help to increase the shelf - 2 years. In addition, the pH value is optimal for stabilization during sterilization.

Below is a specific example embodiment of the invention.

Example

In the prepared device trying to enter a specified volume of water for injection.

The water in the apparatus is heated by steam through the jacket and boil at a temperature of from 100 to 105oC for 30 minutes.

After boiling the water in the apparatus is cooled to within 30-60 min until complete dissolution of the components. The calculation of the weight of the loaded components is conducted on the basis of the preparation of 1 liter of solution, g:

Sodium chloride - 4,75

Potassium chloride and 1.5

Sodium acetate - 3,6

If necessary, make adjustments to the solution by adding salts or water for injection.

Bring the solution pH to a value of 6.8 to 7.2 with 1M or 2M hydrochloric acid solution.

The prepared solution "Glosoli" sterilized at a temperature 120-122oWith constant stirring for 20 min, for which the solution in the apparatus heated by steam through the jacket. After sterilization of the contents of the apparatus are cooled water through the jacket to a temperature of 20-30oC.

Analyze the quality of the obtained solution and its compliance with all indicators conduct sterilizing filtration through a membrane filter with a pore diameter of 0.2 to 0.22 μm and a pressure of 0.2 MPa.

In some cases, to protect sterilizing membrane before the membrane filter is additionally installed cartridge filter for pre-filtering solution.

The resulting solution was Packed in modified bottles of 100, 200, 400 ml. of the Finished product is sterilized 8-20 minutes at 120oC.

the thief "Global", namely, that the sodium chloride, potassium chloride and sodium acetate dissolved in water for injection, filtered, Packed, sterilized, characterized in that the sodium chloride, potassium chloride, sodium acetate dissolved in water for injection at 60-80C, bring the solution pH to 6.8 to 7.2 with 1M or 2M hydrochloric acid, the resulting solution is sterilized at 120-C for 20 min, filtered through a membrane filter having a pore diameter of 0.2 to 0.22 μm under a pressure of 0.2 MPa, with the subsequent packing and sterilization of the solution at 120C for 8-20 minutes

2. A method of obtaining a solution "Glosoli" under item 1, characterized in that prior to filtration through a membrane filter, the solution is optionally filtered through a cartridge filter.

 

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