The method of conservation of solutions of drugs

 

(57) Abstract:

The invention relates to pharmacology, and relates to a method of preservation solutions of medicines by introducing them as a preservative colloidal silicic acid solution with a pH of 7.5-8.5 at a concentration of silicic acid in the obtained system of 4-6%. Formed a hard gel does not allow bacteria to develop. 1 C.p. f-crystals.

The invention concerns a method for the preservation of aqueous solutions of drugs subject to bacterial action, in particular, protein or carbohydrate nature, and can be used in medical, nutritional and microbiological industry.

There are several basic methods of preservation of aqueous solutions of drugs. They are all, first and foremost, aimed at suppressing the growth and development of bacteria, for which these solutions can be the source of life.

One of the most common methods of preservation is thermal treatment of aqueous solutions of drugs. It is effective against vegetative forms of bacteria. At the same time, some spore-forming bacteria is stable at 120oSecond, whereas the number of S="ptx2">

After heat treatment, the aqueous preparations can be stored for a long time without bactericides at room temperature, but in a sealed package. When storing solutions of drugs in non-sterile conditions heat treatment may prolong the shelf life is only from a few hours to a few days.

Quite effective way of storing aqueous solutions of drugs, in particular enzymes is that they are stored frozen at -70oC.

However, this type of storage requires special refrigeration equipment is very expensive.

The most common method of preservation of aqueous solutions of drugs is additive in the solution of biocides that kill bacteria [1]. In this case, the aqueous drug solutions can be stored for a long time in the open form at room temperature.

The number of such bactericides is large enough, however, first, their presence may cause side effects, and secondly, they can enter into a chemical reaction with medicines, third, additive in drugs most active bacteriostatic carbohydrate - hialuronowy acid in the treatment of eye diseases [2]. The concentration of the preservative in the solution, usually by several orders of magnitude higher than the concentration of conserved funds [3].

The aim of the invention is the shelf life of aqueous solutions of drugs protein or carbohydrate nature at room temperature under non-sterile conditions.

This goal is achieved by the fact that aqueous solutions of drugs as preservative injected colloidal solution (or Hydrosol) of silicic acid with a pH of 7.5-8.5; at lower values of pH drugs is the rapid transformation of the solution into a rigid three-dimensional gel. The content of silicic acid in the mixture is 4-6%.

In this way the formed gel on the basis of silicic acid is the only preservative. It is chemically inert to the vast majority of organic compounds and does not react with other medicines. Thus, drugs that are in solution, after the addition of a silicic acid does not undergo chemical change. The greatest strength of the gel and therefore continue the data silicic acid and having a pH of 5.5 and 7.5 at a concentration of silicic acid is not lower than 4%, is that the size of the cells of a three-dimensional gel allows for growth in bacteria. At the same time, water soluble compound with a maul. weighing up to 500000 is not pushed out of the gel and in aqueous solution at pH 5.5 and 7.5 is not adsorbed on its surface.

At the indicated concentration and the pH phenomenon of syneresis, typical of hard gels, minimal and is not higher than 0,001% per day, which can be stored in this form of the drug in non-sterile conditions at room temperature for several months. The temperature increase leads only to strengthen the gel and does not increase the likelihood of bacterial contamination. Lowering the temperature leads to decreased activity of bacteria, which further reduces the likelihood of bacterial contamination.

If necessary, the obtained gel can be easily selected source solution. Because the gel is inelastic, it is easily destroyed by mechanical mixing to form two phases - liquid, representing a solution of a medicinal product, and the firm representing the destruction of the polysilicon lattice acid. At the same time, if the container is completely filled with the gel, the gel is not razrushaet destruction of the gel can be easily separated by filtration. The purpose of the minimum losses of a solution of a medicinal substance in its regeneration amount of the silicic acid in the system, it is advisable not to increase above 6%. Thus, the optimum quantity of silicic acid preservative solutions of drugs in the form of a gel - 4-6% in the system.

Example 1. 0.1 g of insulin (mol. weight 5800 isolated from the pancreas, dissolved in 20 ml of water with pH 5,35, add 20 ml of a colloidal solution with a pH of 8.5, containing 12% of silicic acid, the mixture is shaken to the formation of homogeneous solution and incubated for 5-10 minutes before turning the solution into a hard gel. To accelerate the gelation solution may be heated to a temperature below the temperature decontamination medicines. The obtained gel was incubated for two months at room temperature, break intensive stirring with a glass rod and filtered. According to amino acid analysis, the composition of the initial insulin and insulin, stored in specified conditions, identical.

Example 2. The mixture of monosaccharides, 0.1 g glucose, galactose and mannose dissolved in 10 ml of water with pH 6.0, add 10 ml of a colloidal solution with pH 8.0, containing 8% silica. the acetates of sugars, quantitative and qualitative composition of the mixture of regenerated sugars identical to the original.

Example 3. 1 g of bacterial polysaccharide xanthan gum (mol. weight approx. 500000) dissolved in 100 ml of water with pH 6.5, was added 100 ml of 10% colloidal silicic acid solution with a pH of 7.5. Further treatment is carried out as in example 1. After filtration, the solution evaporated twice and add the ethyl alcohol in the ratio of 1: 1. The precipitated polysaccharide was separated, washed with ethyl alcohol and dried. Gain of 0.85 g of the polysaccharide. According to the dynamic viscosity of 0.05% solutions of the original and selected after keeping in the gel of xanthan gum, a polysaccharide degradation occurred.

Literature

1. RF patent 2091068, A 61 K 31/21, 27.09.1997.

2. RF patent 2051154, 08 At 37/08, 27.12.1995.

3. RF patent 2008354, C 12 N 9/96, 28.02.1994.

1. The method of conservation of aqueous solutions of drugs by administering them in preservative, characterized in that as preservative use of colloidal silicic acid solution with a pH of 7.5-8.5 at a concentration of silicic acid in the mixture of 4-6%, with subsequent transformation of the resulting mixture in a rigid gel.

2. The method according to p. 1, characterized in that the allocation of water rauramo drug.

 

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