The method of obtaining the immunoglobulin preparation with recombinant alpha 2-interferon

 

(57) Abstract:

The invention relates to pharmaceutical industry and relates to a method of obtaining soft medicinal forms with antiviral action. The invention consists in the fact that prior to manufacture of the drug mixed liquid substance immunoglobulins and liquid substance of recombinant alpha 2-interferon and filler. You can mix the liquid substance of immunoglobulins and lyophilized recombinant alpha 2-interferon. The invention provides improved antiviral activity of aqueous extract obtained soft medicinal forms 2 times higher than the antiviral activity of an aqueous extract of suppositories containing the same number of lyophilised instrumentation and recombinant alpha 2-interferon. 1 C.p. f-crystals.

The invention relates to pharmaceutical industry and relates to a method of obtaining soft dosage forms containing the antibodies and recombinant alpha 2-interferon.

Known only similar way to obtain suppositories for rectal and intravaginal injection containing immunoglobulins consisting of the group of 20-30 min, subsequent sterilization, adding sterile paraffin and dry biomass of immunoglobulins at a certain ratio [1].

The disadvantage of this method is the lack of preparation of the water component, which reduces its compatibility with secreting mucous membranes (e.g., vagina) and does not correspond to the water-lipid coating of the skin. The proposed method for soft dosage forms containing the antibodies and recombinant alpha 2-interferon, which are new and are not described in literature.

The basis of the invention is to develop a method of obtaining adapted for use in secreting mucous membranes soft dosage forms containing the antibodies and recombinant alpha 2-interferon.

The problem is solved by the fact that way prior to manufacture of the drug mixed liquid substance immunoglobulins and liquid substance of recombinant alpha 2-interferon.

You can mix the liquid substance of immunoglobulins and lyophilized recombinant alpha 2-interferon.

As the liquid substance immunoglobulins can be used in the liquid substance is already known to them who rata) [2].

As the liquid substance recombinant alpha 2-interferon can be used prefabricated recombinant alpha 2-interferon.

According to the invention adding in soft dosage form liquid substances containing antibodies and recombinant alpha 2-interferon, adapts better drug for secreting mucous membrane, improving the output of the medicinal substance from a mild form of drug in a hydrophilic environment, and eliminates the well-known loss of activity of the drug in his lyophilization.

Example 1. All the operations for the preparation of ointments and its packaging is carried out in Boxing, following the rules of asepsis. To get 160-170 g ointment mix 20-30 g of liquid substances - semi - sediment instrumentation and 0.3 to 3.0 g of the liquid substance intermediate product of recombinant alpha 2-interferon activity 5107IU/g While maintaining a constant temperature 37-39oTo add mixed liquid substance in 120 g of sterile lanolin (GF X Art. 373, MEAs.1) and mix thoroughly. Add at 37-39oWith 20 g of vaseline and mix thoroughly. Then the prepared drug is Packed in sterile jars and tubes and sealed them.

Composition /SUP>-106IU per 1 g of ointment of 0.2 to 1.9; lanolin 70,2-75,0; vaseline to 11.8 to 12.5.

Antiviral activity of an aqueous extract obtained ointment was 2 times higher than the antiviral activity of an aqueous extract ointment containing a similar number of lyophilised instrumentation and recombinant alpha 2-interferon.

Example 2. All the operations for the preparation of ointments and its packaging is carried out in Boxing, following the rules of asepsis. To get 160-170 g ointment mix 20-30 g of liquid substances - semi - sediment instrumentation and 1,6107- 1,7108IU lyophilized recombinant alpha 2-interferon. While maintaining a constant temperature 37-39oTo add mixed liquid substance in 120 g of sterile lanolin (GF X Art. 373, MEAs.1) and mix thoroughly. Add at 37-39oWith 20 g of vaseline and mix thoroughly. Then the prepared drug is Packed in sterile jars and tubes and sealed them.

The composition of the obtained ointment, wt.%: sediment KIP 12,5-17,6; prefabricated recombinant alpha 2-interferon activity 105-106IU per 1 g of ointment of 0.2 to 1.9; lanolin 70,6-75,0 vaseline to 11.8 to 12.5.

Antiviral activity of an aqueous extract obtained ointment was 2 times the bathrooms instrumentation and recombinant alpha 2-interferon.

Example 3. All the operations for the preparation of candles and their packaging is carried out in Boxing, following the rules of asepsis. To obtain a series of candles in the amount of 100 doses hitch 100-126 g confectionery fat (OST 18-197-74) treated by bubbling with 232-235oWith and increase the amount of live steam to 20%, placed in a sterile glass jar, cover with a cotton stopper and subjected to sterilization in an autoclave at 110-120o(Pressure of 0.5-1.0 ATM) for 20-30 minutes Under the conditions of asepsis add sterile paraffin in the amount of 10.0-12.5 g, the mixture is cooled to 38-40oC and transferred into a sterile mixer or a porcelain mortar. Mix 20-30 g of liquid substances - semi - sediment instrumentation and 0.2-2.0 g of the liquid substance intermediate product of recombinant alpha 2-interferon activity 5107IU/g Add mixed liquid substance in the body the basis for the maintenance of a constant temperature 37-39oWith and mix thoroughly. Forms for making candles smeared vaseline oil and put to cool in a refrigerator at 2 to 6oWith 15-20 minutes Then prepared a mixture of instrumentation and recombinant alpha 2-interferon with fat basis is poured into molds and kept in the refrigerator at 2 to 6oWith VCAT recombinant alpha 2-interferon activity 105-106IU per 1 g of candles 0,2-2,0; confectionery fat 61,5-81,3; paraffin 6,3-9,1.

Antiviral activity of an aqueous extract obtained candles was 2 times higher than the antiviral activity of an aqueous extract of suppositories containing the same number of lyophilised instrumentation and recombinant alpha 2-interferon.

Example 4. All the operations for the preparation of candles and their packaging is carried out in Boxing, following the rules of asepsis. To obtain a series of candles in the amount of 100 doses hitch 100-126 g confectionery fat (OST 18-197-74) treated by bubbling with 232-235oWith and increase the amount of live steam to 20%, placed in a sterile glass jar, cover with a cotton stopper and subjected to sterilization in an autoclave at 110-120o(Pressure of 0.5-1.0 ATM) for 20-30 minutes Under the conditions of asepsis add sterile paraffin in the amount of 10.0-12.5 g, the mixture is cooled to 38,40oC and transferred into a sterile mixer or a porcelain mortar. Mix 20-30 g of liquid substances - semi - sediment instrumentation and 1,6107- 1,7108IU lyophilized recombinant alpha 2-interferon. Add mixed liquid substance in the body the basis for the maintenance of a constant temperature is jut for cooling in a refrigerator at 2 to 6oWith 15-20 minutes Then prepared a mixture of instrumentation and recombinant alpha 2-interferon with fat basis is poured into molds and kept in the refrigerator at 2 to 6oC for 20-30 min until fully cured.

The composition of the candles, wt. %: sediment KIP 12,2-18,4; prefabricated recombinant alpha 2-interferon activity 105-106IU per 1 g of candles 0,2 -2,0 ; confectionery fat 62,5-81,3; paraffin 6,2-9,1.

Antiviral activity of an aqueous extract obtained candles was 2 times higher than the antiviral activity of an aqueous extract of suppositories containing the same number of lyophilised instrumentation and recombinant alpha 2-interferon.

Thus, the proposed method provides the best yield drug substances of soft medicinal forms in a hydrophilic environment, allows to exclude a known loss of activity of the drug in his lyophilization, in accordance with the reduced cost of the drug.

Sources of information

1. Abstracts of the IV Russian national Congress "Man and medicine" 8-12 April 1997, Moscow, RI "Formatinfo", 08.04.1997, S. 245.

2. RF patent 1815820, class a 61 K 39/395, 1990.

1. The method of receiving maggioni and filler, characterized in that when mixed to the liquid substance immunoglobulins add liquid substance recombinant alpha 2-interferon at the rate of 105- 106IU per 1.0 g of the drug.

2. The method according to p. 1, wherein the liquid substance immunoglobulins add lyophilized recombinant alpha 2-interferon.

 

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