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Preparation method of group A streptococcus medicine for injection

A group A streptococcus, injection technology, applied in the field of medicine and biology, can solve the problems of drug failure, increased clinical side effects, bacterial death and other problems, and achieve the effect of restoring physiological activity

Active Publication Date: 2018-08-14
国药集团鲁亚(山东)制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Group A streptococcus is a pathogenic bacterium if it is not inactivated. After inactivation, if there is no suitable protection condition, the bacteria will easily die during the preparation and freeze-drying of the drug, or the bacteria will reactivate, causing the drug Ineffective or increased clinical side effects

Method used

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  • Preparation method of group A streptococcus medicine for injection
  • Preparation method of group A streptococcus medicine for injection
  • Preparation method of group A streptococcus medicine for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] The following formulations take 10,000 pieces as an example, each with 1KE specifications:

[0040] a. Group A Streptococcus freezing tube activation and blood agar slant culture: take a freeze-dried tube, directly add sterile saline to dissolve, insert 5% yeast powder medium and activate at 37±0.5°C for 18-24 hours, then smear microscopic examination, after confirming that the streptococcus grows normally and without contamination, put the strains into the blood agar slant and incubate at 37±0.5°C for 18-24 hours;

[0041] b. Inoculation culture: adopt the three-level culture method, the first-level culture system is to inoculate the bacteria from the blood agar slant into the first-level yeast extract powder medium and cultivate it at 37±0.5°C for 20 hours, and the culture solution is examined by smear microscope After confirming that the streptococcus grows normally and has no pollution, insert the inoculation amount of 5% v / v into the secondary yeast extract powder ...

Embodiment 2

[0052] Also take the preparation of 10,000 bottles as an example, each with a specification of 1KE: only when adding sterile methionine solution to 10,000 ml in step d, the concentration of the added sterile methionine solution is 2%, and the rest of the steps are the same as in Example 1 . The test results of three batches of finished products are as follows:

[0053] Batch number: 20140517 Specification: 1KE

[0054]

[0055] Batch number: 20140518 Specification: 1KE

[0056]

[0057] Batch number: 20140519 Specification: 1KE

[0058]

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Abstract

The invention discloses a group A streptococcus drug for injection and a preparation method of the group A streptococcus drug. The group A streptococcus drug comprises the following components in percentage by weight: 3%-6% (W / W) of group A streptococcus, 13%-26% (W / W) of maltose, 55%-75% (W / W) of methionine, 0.3%-0.5% (W / W) of sodium chloride and 6%-12% (W / W) of penicillin G potassium. The preparation method comprises the following steps: activating group streptococcus freezing pipe, carrying out blood slant culture and inoculated culture, inactivating, preparing, and carrying out freeze drying. According to the drug disclosed by the invention, the group A streptococcus is not completely killed in the inactivation process of the penicillin G potassium; the antitumor activity of tumor cell lysis is reserved; a stable equilibrium state of cell wall defect after the group A streptococcus is inactivated by penicillin is kept; the clinical curative effect when the group A streptococcus is used under the condition of restoring an active low side effect can be achieved; and a stable product can be prepared by the preparation method.

Description

Technical field: [0001] The invention belongs to the field of medical biotechnology, and mainly relates to a group A streptococcus drug for injection and a preparation method thereof. status issue. Background technique: [0002] Group A streptococcus is a low-toxic strain of β-hemolytic streptococcus SIPI722#, which is similar to OK-432 (Picibanil) produced in Japan. It was first used clinically by Japanese scholars Toyate and others in 1967. The product plays a role by activating macrophages, NK cells, and inducing soluble cytokines (IFN-γ, TNF-α, IL-2). At the same time, it can also hinder the translation of DNA and RNA synthesis protein products to degenerate tumor cells , disintegration, resulting in a direct tumor-killing effect. At present, it is mainly used clinically for the treatment of malignant pleural effusions. Intratumoral and systemic medications have certain curative effects on solid tumors. They are often used in conjunction with surgery, radiotherapy or c...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K35/744A61K9/19A61K47/22A61P35/00
Inventor 邢晋华王成华张守洋宋昭震李京平
Owner 国药集团鲁亚(山东)制药有限公司
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