Method for preparing therapeutic hydrogel

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine, namely to a method for preparing a therapeutic hydrogel material involving mixing an aqueous solution of sodium alginate and a drug preparation, dispersing a cross-linking agent that is presented by calcium sulphate in glycerol in the concentration of 0.8-2.5%, mixing the dispersion with the prepared mixture of sodium alginate with the drug preparation in ratio 1-2:4-6, placing the prepared product into a tiling pattern and keeping it till form-stable, conducting gamma sterilisation; the formation process involves the mechanical stability measurements with the diametral compression of the formed hydrogel; the hydrogel is considered to be formed once a thickness of the formed hydrogel varies with the diametral compression by 10-30%.

EFFECT: invention provides the wider medical variation of the drug concentrations, preparing high-thixotropy soft hydrogel materials (tablets) easy to administer, including through rectum, preparing the materials that preserve its all their physical-technical and mechanical properties after the gamma sterilisation along with the sterility.

4 cl, 10 ex

 

The invention relates to medicine, namely to obtain formoustojchivy polymer hydrogels used for controlled, prolonged, controlled deciding on medicines, manifesting sensitizing, wound healing, analgesic, anti-inflammatory, immunostimulatory or antioxidant effect.

A method of obtaining hydrophilic gel (RF Patent No. 2422133, IPC A61K 9/00, publ. 2011) by mixing chitosan with polyanionic a hydrocolloid, which previously entered the stabilizer and auxiliary substances. Hydrogel layer is applied to the biocompatible film of water-insoluble polymer.

The disadvantage of this method of obtaining hydrogel is that the use of the gel are provided only as a superficial wound cover skin damage. In addition, the process of obtaining a hydrophilic gel time-consuming and complex, requiring large expenditures of time and money.

A method of obtaining a polymer hydrogel (RF Patent No. 2342147, IPC A61K 31/727, publ. 2008) by immobilization of physiologically active substances in the volume of cross-linked polymer, crosslinked polymer is produced by chemical modification.

The disadvantage of this method of obtaining hydrogel is that the process of obtaining polymeric hydrogels tie the n with the necessity of modifying the cross-linked polymer by ovomucoid and inhibitor of α-amylase, what complicates the technological process, as initial components require special quality control, as are animal products. Also provided only by the oral administration of the resulting hydrogel. Not provided for sterilization of the final product, which narrows the range of possibilities of its use.

The closest is a method of obtaining a hydrogel medical purposes on the basis of alginate (RF Patent No. 2432954, IPC A61K 31/73800, publ. 2011), which includes mixing an aqueous solution of sodium alginate and drug with cross-linking agent, the placement of product produced in a cellular form and extract it to achieve its shape.

The disadvantage of this method is the difficulty of obtaining particles of a cross-linking agent, requires special equipment to obtain particles of crosslinking agent required size, in addition to the use of aqueous colloidal solution complicates the control of the formation of crosslinking of the hydrogel, leading to deterioration of the quality of the product. If necessary, further sterilization of the finished product is a high probability of destruction formed crosslinks in the gel structure, which leads to loss of shape.

The task of the invention is to remedy these disadvantages, the creation of a technologically advanced, the ski effective method of obtaining a highly structured formoustojchivy hydrogel products on the basis of sodium alginate with high water-holding capacity, resistant to gamma sterilization, designed for directional, extended and controlled release of drugs into the affected cavities, for example, in gynecology, proctology and oropharyngeal areas. Ensuring the desired shape and desired for medical reasons prolongation is due to the control of mechanical strength.

For this purpose, the method of producing a hydrogel therapeutic purposes, comprising mixing an aqueous solution of sodium alginate, a medicinal product, a crosslinking agent, placing the resulting product in a cellular form and extract it to achieve the shape, it is proposed to carry out the dispersion of the calcium sulphate in glycerol at a concentration of 0.8-2.5% depending on the intended use of therapeutic hydrogel material (gynecology, proctology, origingally region). Then this dispersion should be mixed with the previously obtained mixture of sodium alginate and drug in the ratio of 1-2:4-6, the resulting product is poured into a honeycomb shape and maintained to achieve the shape at room temperature 20-25°C from 0.5 to 1.5 hours, while in the molding process carried out measurements of mechanical strength at diametrically compressing the formed guide is ogele. The hydrogel is considered to be formed when reaching changes in the thickness of the formed hydrogel in diametral compression 10-30%.

When obtaining hydrogel material for use in the oropharyngeal area, carry out the dispersion of the calcium sulphate in glycerol at a concentration of 1.3-2.1%, the hydrogel is considered to be formed at diametrically compressed by 25-30%.

When obtaining hydrogel material for use in gynecological area, carry out the dispersion of the calcium sulphate in glycerol at a concentration of 0.8-1.2%, the hydrogel is considered to be formed at diametrically compressed by 10-15%.

When obtaining hydrogel material for use in the anal area carry out the dispersion of the calcium sulphate in glycerol at a concentration of 1.8 to 2.5%, the hydrogel is considered to be formed at diametrically compression on 16-24%.

The proposed method allows to obtain formoustojchivy hydrogel products for directional, extended and controlled release of drugs subject to the requirements for mechanical strength and thixotropy hydrogel material and the rate of release of drugs depending on the application.

The method is as follows.

Preparing joint aqueous solution of sodium alginate 2-3% of the mass. and 0.25-20% massmeeting of the drug, respectively, which can be applied lidocaine, Derinat sodium, propolis, 5-fluorouracil, dioxidine, metronidazol or Mexidol in therapeutically effective doses. Depending on the preparation process of mixing the wire by known technologies, for example on THE other. As the mixture is injected dispersed in glycerol crosslinking agent, such as calcium sulfate in a concentration of from 0.8 to 2.5 wt%. Dispersed in glycerol crosslinking agent is introduced into a mixed solution of sodium alginate and drug in a volume ratio of 1-2:4-6, with stirring. The resulting mixture is poured into a honeycomb shape and held it up to the achievements of shape, as a rule, from 0.5 to 2 hours.

The time to reach the initial shape of the solution of sodium alginate containing the drug after injection of the dispersion of a crosslinking agent glycerin is defined as the mass fraction of the input salt (from 0.8 to 2.5% by weight of the composition), and the number taken dispersion of a crosslinking agent (1-2:4-6). In the molding process carried out measurements of mechanical strength when diametrical compression of the hydrogel, the hydrogel is formed when reaching changes in the thickness of the formed hydrogel in diametral compression by 10-30%. Measurements performed on the device to determine the physical and mechanical characteristics of GI is rogalevich polymeric materials (for example, the texture analyser Brookfield FTZ).

The implementation of the method is demonstrated on clinical examples.

Therapeutic hydrogel material for use in the gynecological field.

Example 1.

In a bowl of water with a volume of 50 ml asleep 1 g of sodium alginate, mix thoroughly, leave for 4 hours. Then under stirring enter 2% of the mass, lidocaine and leave for 2 hours. Then, glycerol was dispersed calcium sulfate in a concentration of 0.8%, slowly stirred for 5 minutes, and then this dispersion is mixed with the previously obtained mixture of sodium alginate and drug in the ratio of 1:4, is slowly stirred for 2 minutes, placed in a mesh form, can withstand before reaching the initial shape 0.5 hour.

In the molding process carried out measurements of mechanical strength at diametrically compressing the formed hydrogel, consider the hydrogel is formed when reaching changes in the thickness of the formed hydrogel in diametral compression of 10%.

Then sealed blister packaging and is sterilized by radiation method.

Example 2.

In capacity fall asleep 0.9% wt. dioksidina, topped up with distilled water to 50 ml, mix, and leave to dissolve for 1 hour. Then poured with stirring, 1 g of sodium alginate, leave for 2 hours. Then added with stirring to 2 wt%, lidocaine leave for 1 hour. The resulting composition is stirred, add dispersed in glycerol calcium sulfate in a concentration of 0.9% in the ratio of 1:5, slowly stirred for 1 minute, placed in a mesh form, kept in shape before reaching the initial shape 1 hour. In the molding process carried out measurements of mechanical strength at diametrically compressing the formed hydrogel, consider the hydrogel is formed when reaching changes in the thickness of the formed hydrogel in diametral compression of 15%. Then sealed blister packaging and is sterilized by radiation method.

Example 3.

In a bowl of water with a volume of 50 ml asleep 1 g of sodium alginate, mix thoroughly, leave for 4 hours. Then under stirring enter 8,6% of the mass. 5-fluorouracil. Then, glycerol was dispersed calcium sulfate in a concentration of 1%, slowly stirred for 5 minutes, and then this dispersion is mixed with the previously obtained mixture of sodium alginate and drug in the ratio of 1:4, is slowly stirred for 2 minutes, placed in a mesh form, can withstand before reaching the initial shape 1 hour.

In the molding process carried out measurements of mechanical strength at diametrically compressing the formed hydrogel, consider the hydrogel is formed when reaching changes in thickness formed geroge what I diametral compression of 14%. Then sealed blister packaging and is sterilized by radiation method.

Example 4.

In a bowl of water with a volume of 50 ml asleep 1 g of sodium alginate, mix thoroughly, leave for 4 hours. Then under stirring entering 0.25% of the mass. Derinat sodium and leave for 1 hour. Then, glycerol was dispersed calcium sulfate in a concentration of 1.2%, slowly stirred for 5 minutes, and then this dispersion is mixed with the previously obtained mixture of sodium alginate and drug in the ratio of 1:6, is slowly stirred for 2 minutes, placed in a mesh form, can withstand before reaching the initial shape of 0.5 hours. In the molding process carried out measurements of mechanical strength at diametrically compressing the formed hydrogel, consider the hydrogel is formed when reaching changes in the thickness of the formed hydrogel in diametral compression of 12%. Then sealed blister packaging and is sterilized by radiation method.

Therapeutic hydrogel material for use in oropharyngeal area.

Example 5.

In a bowl of water with a volume of 50 ml asleep 1 g of sodium alginate, mix thoroughly, leave for 4 hours. From the resulting solution is taken ½ part and when heating is not more than 40°C. and vigorous stirring enter pre-crushed propolis in the amount of 5% of the mass, p is borrow heated at 40°C for 5-10 minutes. The resulting mass is cooled, filtered, and add the rest of the solution of sodium alginate. Then, glycerol was dispersed calcium sulfate 2.0%) and slowly stirred for 5 minutes, and then this dispersion is mixed with the previously obtained mixture of sodium alginate and drug in the ratio 2:5, is slowly stirred for 2 minutes, placed in a mesh form, can withstand before reaching the initial shape 1.5 hours. In the molding process carried out measurements of mechanical strength at diametrically compressing the formed hydrogel, consider the hydrogel is formed when reaching changes in the thickness of the formed hydrogel in diametral compression of 30%. Then sealed blister packaging and is sterilized by radiation method.

Example 6.

In a bowl of water with a volume of 50 ml asleep 1 g of sodium alginate, mix thoroughly, leave for 4 hours. Then under stirring entering 0.25% of the mass. Derinat sodium and leave for 1 hour. Then enter when mixing 2 wt%, lidocaine and leave for 2 hours. Then, glycerol was dispersed calcium sulfate at a concentration of 1.3%, slowly stirred for 5 minutes, and then this dispersion is mixed with the previously obtained mixture of sodium alginate and drug in the ratio of 1.5:5, slowly stirred for 2 minutes, placed in a mesh shape, stand up to the achievements of the initial shape 1.5 hours. In the molding process carried out measurements of mechanical strength at diametrically compressing the formed hydrogel, consider the hydrogel is formed when reaching changes in the thickness of the formed hydrogel in diametral compression of 25%. Then sealed blister packaging and is sterilized by radiation method.

Example 7.

In a bowl of water with a volume of 50 ml asleep 1 g of sodium alginate, mix thoroughly, leave for 4 hours. Then under stirring enter 8,6% of the mass. 5-fluorouracil. Then, glycerol was dispersed calcium sulfate at a concentration of 2.1%, slowly stirred for 5 minutes, and then this dispersion is mixed with the previously obtained mixture of sodium alginate and drug in the ratio of 1.5:6, slowly stirred for 2 minutes, placed in a mesh form, can withstand before reaching the initial shape 1 hour. In the molding process carried out measurements of mechanical strength at diametrically compressing the formed hydrogel, consider the hydrogel is formed when reaching changes in the thickness of the formed hydrogel in diametral compression of 28%. Then sealed blister packaging and is sterilized by radiation method.

Therapeutic hydrogel material for use in the anal area.

Example 8.

In a bowl of water with a volume of 50 ml poured 1.5 g algina the sodium, mix thoroughly, leave for 4 hours. Then under stirring enter 8,6% of the mass. 5-fluorouracil. Then, glycerol was dispersed calcium sulfate at a concentration of 1.8%, slowly stirred for 5 minutes, and then this dispersion is mixed with the previously obtained mixture of sodium alginate and drug in the ratio 2:4, is slowly stirred for 2 minutes, placed in a mesh form, can withstand before reaching the initial shape of 0.5 hours. In the molding process carried out measurements of mechanical strength at diametrically compressing the formed hydrogel, consider the hydrogel is formed when reaching changes in the thickness of the formed hydrogel in diametral compression of 20%. Then sealed blister packaging and is sterilized by radiation method.

Example 9.

In a bowl of water with a volume of 50 ml poured 1.5 g of sodium alginate, mix thoroughly, leave for 4 hours. Then under stirring entering 0.25% of the mass. Derinat sodium and leave for 1 hour. Then enter when mixing 2 wt. -%, lidocaine and leave for 2 hours. Then, glycerol was dispersed calcium sulfate in a concentration of 2.5%, slowly stirred for 5 minutes, and then this dispersion is mixed with the previously obtained mixture of sodium alginate and drug in the ratio of 2.5:4,5, slowly stirred for 2 minutes, placed in a mesh of four who, withstand before reaching the initial shape 1.5 hours. In the molding process carried out measurements of mechanical strength at diametrically compressing the formed hydrogel, consider the hydrogel is formed when reaching changes in the thickness of the formed hydrogel in diametral compression of 16%. Then sealed blister packaging and is sterilized by radiation method.

Example 10.

In a bowl of water with a volume of 50 ml poured 1.5 g of sodium alginate, mix thoroughly, leave for 4 hours. Then under stirring entering 0.25% of the mass. Derinat sodium and leave for 1 hour. Then introduced with stirring 2% of the mass. lidocaine and leave for 2 hours. Then, glycerol was dispersed calcium sulfate in a concentration of 2.0%, slowly stirred for 5 minutes, and then this dispersion is mixed with the previously obtained mixture of sodium alginate and drug in the ratio 1:4,5, slowly stirred for 2 minutes, placed in a mesh form, can withstand before reaching the initial shape 1.5 hours. In the molding process carried out measurements of mechanical strength at diametrically compressing the formed hydrogel, consider the hydrogel is formed when reaching changes in the thickness of the formed hydrogel in diametral compression of 23%. Then sealed blister packaging and is sterilized by radiation is ion method.

The proposed method allows a broader vary the concentration of the drug for medical reasons. To get a soft hydrogel materials (tablets) with a high degree of thixotropy suitable for introduction, including rectal. The resulting material after gamma sterilization along with sterility retain their physico-technical and mechanical properties.

1. A method of obtaining a hydrogel material for therapeutic purposes, comprising mixing an aqueous solution of sodium alginate, a medicinal product, a crosslinking agent, placing the resulting product in a cellular form and extract it to achieve its shape, gamma sterilization, characterized in that as the cross-linking agent is calcium sulfate is used, which is pre-dispersed in the glycerin at a concentration of 0.8-2.5%, then this dispersion is mixed with the previously obtained mixture of sodium alginate with the medicinal product in the ratio of 1-2:4-6, in the molding process carried out measurements of mechanical strength at diametrically compressing the formed hydrogel, consider the hydrogel is formed when achieving changes in the thickness of the formed hydrogel in diametral compression by 10-30%.

2. The method according to claim 1, characterized in that for obtaining hydrogel material for the application of the oropharyngeal area carry out the dispersion of the calcium sulphate in glycerol at a concentration of 1,3-2,1%, the hydrogel is considered to be formed at diametrically compressing PA 25-30%.

3. The method according to claim 1, characterized in that for obtaining hydrogel material for use in gynecological effected by dispersing calcium sulphate in glycerol at a concentration of 0.8-1.2%, the hydrogel is considered to be formed at diametrically compressed by 10-15%.

4. The method according to claim 1, characterized in that for obtaining hydrogel material for use in the anal area carry out the dispersion of the calcium sulphate in glycerol at a concentration of 1.8 to 2.5%, the hydrogel is considered to be formed at diametrically compression on 16-24%.



 

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