Recombinant human interleukin-12 preparation for injection and preparation method thereof

Abstract

The invention discloses a recombinant human interleukin-12 preparation for injection and a preparation method thereof, and aims to provide a preparation which has the advantages of good stability and low moisture content. The invention has the technical point that each milliliter of preparation contains 2.5-10mu g of recombinant human interleukin-12, 50mg of filling agent, 5-20mg of freeze-dried protective agent, 2.30mg of disodium hydrogen phosphate, 0.52mg of sodium dihydrogen phosphate and 7.02mg of sodium chloride. The preparation method comprises the following steps of: (1) weighing disodium hydrogen phosphate, sodium dihydrogen phosphate and sodium chloride according to the formula proportions, adding water for injection, stirring for dissolving, regulating the pH value to 6.8-7.8 with sodium hydroxide or hydrochloric acid, and metering the volume to the formula proportion; (2) taking out the solution, adding the formula proportion of the filling agent, stirring for dissolving, then adding the formula proportions of the freeze-dried protective agent and recombinant human interleukin-12, stirring until the materials are uniform, carrying out sterile filtration, and respectively packaging in bottles of 1ml; and (3) freeze-drying. The invention belongs to the technical field of medicine preparation.

Description

technical field [0001] The invention relates to a preparation and a preparation method, specifically, to a preparation of recombinant human interleukin-12 for injection and a preparation method, belonging to the technical field of medicine preparation. Background technique [0002] Interleukin-12 (IL-2) is an important cytokine in the human body, which can increase the number and activity of helper T cells to enhance the overall immune function, and regulate non-specific immunity mediated by NK cells and macrophages and Th1, The specific immune function mediated by CTL produces a series of biological effects. There have been more than 30 clinical trials of recombinant human interleukin-12 (rhIL-12) abroad, involving a variety of infectious diseases (such as hepatitis B, hepatitis C, AIDS), and various tumors (such as melanoma, kidney disease, etc.). Cancer, rectal cancer, prostate cancer, cervical cancer, etc.), autoimmune diseases and asthma, etc., but has not yet been app...

AI Technical Summary

Problems solved by technology

There have been more than 30 clinical trials of recombinant human interleukin-12 (rhIL-12) abroad, involving a variety of infectious diseases (such as hepatitis B, hepatitis C, AIDS), and various tumors (such as melanoma, kidney disease, etc.). Cancer, rectal cancer, prostate cancer, cervical cancer, etc.), autoimmune diseases and asthma, etc., but has not yet been approved for marketing. It is particularly important to prepare interleukin-12 into a dosage form that is easy to use, easy to absorb and metabolize.

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