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

A technology for interleukin and injection, which is applied in the field of preparation and preparation, recombinant human interleukin-12 preparation and preparation for injection, and can solve hepatitis, hepatitis C, AIDS), various tumors (such as melanoma) , kidney cancer, rectal cancer, prostate cancer, cervical cancer, etc.), autoimmune diseases and asthma, etc., to achieve the effects of good appearance, low water content and simple preparation method

Active Publication Date: 2011-09-14
广州市茵良强生物科技有限公司
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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, recta

Method used

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

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Embodiment

[0020] Clinical studies have shown that the clinical dose of recombinant human interleukin-12 (rhIL-12) is 1-500ng / kg, but at the dose level of 300-500ng / kg, some people show toxic side effects such as abnormal liver function and oral ulcers , the relatively safe and effective dose is 50ng-250ng / kg, and according to the weight of Chinese people around 50-60kg, the single bottle specification of this product is: rhIL-122.5, 5 or 10μg / preparation unit.

[0021] The preparation formed by the preparation formula is a freeze-dried powder injection, and the appearance and properties of the freeze-dried powder, as well as the determination of rhIL-12 content and biological activity are used as the screening basis when the formula is screened.

[0022] rhIL-12 is a glycoprotein formed by combining two subunits through disulfide bonds. It is easily soluble in water and stable in phosphate buffer at pH 7.4. Therefore, disodium hydrogen phosphate and sodium dihydrogen phosphate were used ...

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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...

Claims

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Application Information

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IPC IPC(8): A61K38/20A61K9/19A61K47/42A61K47/36A61K47/26A61P31/00A61P31/12A61P31/18A61P35/00A61P37/02A61P11/06
Inventor 张宜俊李平汤俊荣叶英传李水生王增松王翠玲谢飞群
Owner 广州市茵良强生物科技有限公司
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