Recombinant human interferon alpha 2b gel and preparation method thereof

Abstract

The invention discloses a recombinant human interferon alpha 2b gel. A preparation method of the recombinant human interferon alpha 2b gel comprises the following steps: (a) putting Carbomer into water for injection for swelling over night; (b) weighing and mixing propylene glycol, Tween 80, EDTA (ethylene diamine tetraacetic acid), glycerol and ethylparaben, adding water for injection, of which the weight is 1-2 times of the weight of the mixture, heating and stirring under the water bath condition of 70-80 DEG C until ethylparaben is completely dissolved, adding the dissolved solution into the swollen Carbomer matrix solution, uniformly mixing, adding triethanolamine to adjust the pH value to be 5.0-7.5, and carrying out moist heat sterillization for 0.5-2 hours to obtain a Carbomer matrix for later use; (c) dissolving pharmaceutical gelatin by a pH buffer solution, carrying out sterilization treatment under pressurized and heated conditions, cooling to the temperature lower than 25 DEG C, then adding recombinant human interferon alpha 2b for dissolving, and stirring uniformly for later use; (d) adding the recombinant human interferon alpha 2b gelatin solution into the Carbomer matrix, stirring uniformly, and then putting the mixture into a hose or a gynecological syringe, thereby obtaining a finished product. The recombinant human interferon alpha 2b gel prepared by the method disclosed by the invention has the advantages of low cost and good stability.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a recombinant human interferon α2b gel and a preparation method thereof. Background technique [0002] Recombinant human interferon α2b gel is a water-based gel preparation formed from recombinant human interferon obtained by genetic engineering technology, and stabilizers, moisturizers, and thickeners that can stabilize the activity of recombinant human interferon α2b. Its indications are for the treatment of cervical erosion, genital warts, herpes zoster, herpes labialis and genital herpes. The clinical curative effect of recombinant human interferon α2b gel is mainly related to the biological activity of recombinant human interferon α2b, but as a protein, recombinant human interferon α2b is affected by various factors, its structure is often destroyed and loses its biological activity. Therefore, in the traditional production process of preparations, human serum alb...

AI Technical Summary

Problems solved by technology

The clinical curative effect of recombinant human interferon α2b gel is mainly related to the biological activity of recombinant human interferon α2b, but as a protein, recombinant human interferon α2b is affected by various factors, its structure is often destroyed and loses its biological activity. Therefore, in the traditional production process of preparations, human serum albumin needs to be added as a protective agent to maintain its biological activity. However, the market supply of human serum albumin is tight, the source is difficult, and the price is expensive, which greatly increases the cost of medicines. Therefore, It is urgent and important to screen suitable stabilizers to replace human serum albumin

[0003] The applicant previously applied for two inventions named "recombinant human interferon α2b suppository and its preparation method (patent No. CN101612144A)" and "recombinant human interferon α2b cream and its preparation method (patent No. CN102657851A)" Patents, the recombinant human interferon α2b suppositories and creams disclosed in these two patents use medicinal gelatin as a stabilizer to replace human albumin used in traditional preparation methods. Based on the technical solutions of these two invention patents, the applicant It is thought that pharmaceutical gelatin is directly used instead of human serum albumin to prepare recombinant human interferon α2b gel, but after a large number of experimental studies, it is found that although the two dosage forms disclosed earlier are compatible with recombinant human interferon α2b gel The formulations are different, but medicinal gelatin is actually used as a stabilizer, and combined with the existing conventional gel matrix raw materials for the preparation of recombinant human interferon α2b gel, it is found that in addition to the two raw materials of medicinal gelatin and recombinant human interferon α2b In addition, the selection of raw materials such as the gel matrix and the selection of the addition ratio will have a great impact on the stability and efficacy of the gel, such as in the 2008 Volume 8, No. 9 of the Chinese journal "Chinese Medicine and Clinic". The article "Preparation and Quality Control of Recombinant Human Interferon α2b Carbomer Gel" records that the prescription of the gel consists of recombinant human interferon α2b, carbomer, glycerin, menthol, propylene glycol, absolute ethanol, Sodium hydroxide, ethylparaben, and water are appropriate, but the specific addition ratio or range of the above-mentioned raw materials is not given in the preparation method of the gel disclosed in this article, and the applicant only uses the prescription and preparation method disclosed in this article. It is difficult to form the gel prepared by combining the conventional carbomer, glycerin, propylene glycol and other raw materials.

Images