Solution for injection, possessing anxiolytic action, and method of its manufacture

 

The invention relates to medicine, in particular to the pharmacy. The solution for injection contains, wt%: phenazepam 0.05 to 0.15, polyvinylpyrrolidone 0.5 to 1.2, tween-80 2,0-10,0, glycerin 5,0-15,0, sodium, peruserdictionary 0.1 to 0.3, a solution of caustic soda to pH 6,0-7,5, water the rest. Spend mixing phenazepam with tween-80, mixing the resulting mixture with glycerol at a temperature of 70-90oWith the addition of sodium preservestacktrace, polyvinylpyrrolidone, sodium hydroxide solution in an amount to provide a pH of 6.5-7, and water, re-mixing and filtering solution. The invention allows to realize the specified destination. 2 S. and 4 C.p. f-crystals, 1 table.

The invention relates to medicine, in particular to the pharmacy, and can be used in the production of injection solutions, possessing anxiolytic action, in particular for solution for injection phenazepam.

Phenazepam (Phenazepamum) with the chemical formula 7-bromo-5-(orthocarbonic)-2-3-dihydro-1H-1,4-benzodiazepine-2-it is highly domestic tranquilizer.

Phenazepam is a white or white with a white crystalline powder. It is insoluble in water and very soluble in alcohol.

equilibirum and anxiolytic action than other tranquilizers. Phenazepam in solid dosage form has proven itself as a product that provides a long lasting effect.

However, for relief of acute forms or manifestations of neurotic, neurosis, psychopathy and psychopathic States of solid dosage forms are not effective. In addition, the solid dosage forms have an irritating effect on the gastrointestinal tract of the patient, as a rule, contain harmful or ballast substances.

The closest to the invention is a solution for injection, possessing anxiolytic action, containing phenazepam in an amount of 0.1% (see encyclopedia of medicine, Moscow, RLS, 2000, S. 962). However, in the specified source of information not disclosed the composition of the solution and the method of its preparation.

The task of the invention to provide domestic product for fast relief of neurotic, nervous, psychopathic, psychopathic States, possessing the required quality and stable storage for more than 2.5 years.

The problem is solved in that the solution for injection, possessing anxiolytic action, contains phenazepam and dopolnitelni the following ratio of components, wt.%: Phenazepam - 0,05-0,15 Polyvinylpyrrolidone - 0,5-1,2 twin-80 - 2,0-10,0 Glycerin - 5,0-15,0 Sodium, peruserdictionary - 0,3-1,2 Solution of caustic soda To a pH of 6.0-7.5 the Water - the Rest of the task is also solved by a method of obtaining a solution for injection, which carry out the mixing phenazepam with tween-80, the resulting mixture was mixed with glycerol at a temperature of 70-90oTo add sodium, peruserdictionary, polyvinylpyrrolidone, sodium hydroxide solution in an amount to provide a pH of 6.5-7, and water, re-mix and filter the solution, preferably using a 0.1-1.0 M solution of caustic soda.

The problem is solved also by the fact that the mixing phenazepam with tween-80 is carried out by grinding them in a mortar.

The problem is solved also by the fact that initially add 20-40% water of the total number, mix, add the remaining water and continue mixing.

The problem is solved also by the fact that after filtering, the solution is poured into ampoules.

Qualitative and quantitative composition of the solution for injection is chosen so as to ensure that you receive the solution phenazepam.

Glycerin is introduced into the solution to improve the races is solerrain in the stated quantities provides a prolonged effect phenazepam.

Tween-80 in the stated quantities acts as a solubilizer. Sodium, peruserdictionary is an antioxidant, and caustic soda is added to obtain a desired pH.

The set of operations in the way and their modes are selected in such a way as to simplify the manufacturing method of solution for injection without compromising its quality.

Example.

The method is as follows.

In a mortar and pounded phenazepam with tween-80. The suspension is poured into a reactor. The mortar is washed with glycerin, which is also passed into the reactor.

At a temperature of 75-85oThe mixture is stirred for 1 hour. In the prepared reactor is added to water for injection (about 30% of the total), sodium, peruserdictionary, low molecular weight polyvinylpyrrolidone, and 0.1 M sodium hydroxide solution to a pH of 7-7,5.

The solution is stirred for 20 minutes, add the remaining water and again stirred for 30 minutes.

Then the solution is filtered and passed it to fill vials. After sealing are checked for tightness and sterilized ampoules.

The resulting solution is colorless or slightly colored liquid.

The table shows the three solution composition obtained in accordance with dandriyal of 0.5%, visual inspection showed no turbidity of the composition, which indicates the dissolution of phenazepam.

Claims

1. Solution for injection, possessing anxiolytic action, containing phenazepam, characterized in that it further comprises polyvinylpyrrolidone, tween-80, glycerin, sodium prosernat acid, a solution of caustic soda and water in the following ratio, wt.%:

Phenazepam 0,05-0,15

Polyvinylpyrrolidone 0.5 to 1.2

Tween-80 2,0-10,0

Glycerin 5,0-15,0

Sodium prosernat acid of 0.1-0.3

The solution of caustic soda To pH 6,0-7,5

Water the Rest

2. A method of obtaining a solution for injection, which carry out the mixing phenazepam with tween-80, the resulting mixture was mixed with glycerol at a temperature of 70-90To add sodium prosernat acid, polyvinylpyrrolidone, sodium hydroxide solution in an amount to provide a pH of 6.5-7, and water, re-mix and filter the solution.

3. The method according to p. 2, characterized in that the mixing phenazepam with tween-80 is carried out by grinding them in a mortar.

4. The method according to p. 2 or 3, characterized in that initially add 20-40% of the total water quantity is .2-5, characterized in that after filtering, the solution is poured into ampoules.

6. The method according to any of paragraphs.2-5, characterized in that the use of 0.11M sodium hydroxide solution.

 

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