Solution agent for recombining human interleukin 12 and preparation method thereof

A technology of interleukin and solution, which is applied in the direction of non-active ingredient medical preparations, active ingredient-containing medical preparations, antiviral agents, etc., and can solve the problems that satisfactory rhIL-12 liquid injections have not yet been developed. , to achieve the effect of good appearance, good stability and simple preparation method

Active Publication Date: 2016-03-23
KANGLITAI BIOMEDICAL (QINGDAO) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] However, in view of the long-term stability of interleukin-12 injections, including pH, activity, etc., as well as the above-mentioned technical difficulties such as maintaining good drug effects, no satisfactory rhIL-12 liquid injections have yet been developed.

Method used

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  • Solution agent for recombining human interleukin 12 and preparation method thereof
  • Solution agent for recombining human interleukin 12 and preparation method thereof
  • Solution agent for recombining human interleukin 12 and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] According to pH = 6, add phosphate buffer solution PB, add appropriate amount of water to dissolve, then add NaCl to make the final concentration 150mM, after dissolving, add poloxamer 188 with a final concentration of 0.1%, after completely dissolving, wash with 1M NaOH Adjust the pH to 6.0, and add recombinant human interleukin-12 at a final concentration of 10 μg / ml to prepare the solution of the present invention. It is given as Formulation 4 in the formulation formulation screening experiments described below.

[0026] The specific preparation, components and advantages of the solution of the present invention will be described below through the formulation screening experiment.

Embodiment 2

[0028] 1. Preliminary screening of dosage forms

[0029] 1.1 Dosage Form Design

[0030] Table 1 dosage form design scheme

[0031]

[0032] The dosage form design considers both lyophilized powder and solution. The lyophilized powder is easy to store and transport, but the lyophilization process is more complicated. Therefore, both types of preparations are included in the scope of investigation.

[0033] In the initial experiment, 3 lyophilized powder and 2 solution dosage forms were designed, totaling 5 dosage forms. Detect and analyze from several aspects such as appearance, content, activity, etc., compare the stability of various dosage forms under certain conditions (25°C), and screen better dosage forms.

[0034] 1.2 Dosage Form Screening Experiment

[0035] 1.2.1 Visual inspection

[0036] Dosage forms 1, 2, and 3 are freeze-dried powders, and their appearance is as follows:

[0037] Dosage Form No. 1: most powder cakes are complete, without loose lumps or pow...

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Abstract

The invention provides a solution agent for recombining human interleukin 12 and a preparation method thereof. The solution agent comprises the human interleukin 12, a phosphate buffer (PB), NaCl and poloxamer 188, wherein pH of the solution agent is maintained to range from 6.0 to 7.2 through the phosphate buffer. The solution agent is good in stability, clear in appearance and free of insoluble substances, preservative and blood components, and the in-vitro activity of contained active polypeptide is stable; under specified conditions, the solution agent can be stably preserved for at least eight months, and compared with a powder injection, the production quality is obviously improved.

Description

technical field [0001] The invention relates to a solution of recombinant human interleukin-12 and a preparation method thereof, belonging to the field of biopharmaceuticals. Background technique [0002] Interleukin-12 (IL-12) 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 and The specific immune function mediated by Th1 and 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 approved for marketing, it is particularly important to prepare rhIL-12 into a dosage form that is easy to use, ea...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/20A61K9/08A61K47/34A61K47/04A61P37/04A61P1/16A61P31/20A61P31/14A61P31/18A61P35/00A61P37/02A61P11/06
CPCA61K9/0019A61K9/08A61K38/208A61K47/02A61K47/34
Inventor 赵毅姜会春黄冰裴秀芝卢世香
Owner KANGLITAI BIOMEDICAL (QINGDAO) CO LTD
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