Preparing and assaying method of staphylococcus aureus filtrate preparation

Abstract

The invention provides the preparing and assaying method of staphylococcus aureus filtrate preparation characterized in that, a purfication process is added after the degerming and filtering procedure, thus removing the macromolecular isosource substance having no clinic curative effect in the original product.

Description

Technical field [0001] The invention belongs to the field of biological products, and in particular relates to a method for manufacturing and testing a staphylococcus aureus filtrate preparation. Background technique [0002] Staphylococcus aureus filtrate preparation is a light yellow clear liquid prepared by culturing, sterilizing and filtering Staphylococcus aureus. It is used for treating fractures, can promote bone callus growth, and accelerate fracture healing. In addition, it has a certain protective effect on leukopenia caused by radiotherapy and chemotherapy, can improve the immune function of the body, and can be used as an adjuvant treatment for malignant tumor patients with radiotherapy and chemotherapy. As a new drug of biological products, its manufacturing and testing methods have been included in the 2000 provisional edition of the "China Biological Products Regulations". However, there are serious deficiencies in the original manufacturing and testing metho...

AI Technical Summary

Problems solved by technology

However, there are serious deficiencies in the original manufacturing and testing methods, mainly as follows: 1. In the original manufacturing and testing methods, the active ingredients of the product are not clear. Active ingredients as product quality control indicators

After a large number of clinical applications and tests, it has been confirmed that plasma protein coagulase is not the active ingredient of the product. At room temperature, its activity decreases rapidly, but the clinical therapeutic effect contained in the product is very stable at room temperature. The difference between the two There is no certain relationship between them, and the detection method of plasma protein coagulase activity itself has many unstable factors, so it is impossible to control the quality of the product and correctly evaluate the clinical treatment by measuring the activity of plasma protein coagulase contained in the product. The purpose of the effect

2. In the original manufacturing and verification method, there was no corresponding quality index control for the preparation of production medium, resulting in large quality differences between batches of raw liquid produced, which affected the stability of product quality

3. In the original manufacturing and verification method, the filtrate preparation of Staphylococcus aureus was cultured for 40 to 48 hours, then filtered through 0.22 μm for sterilization, and then adjusted to pH and osmotic pressure before subpackaging into finished products. There are a large number of macromolecular heterologous substances in the finished product, which are injected into the human body through intramuscular injection, which will easily cause antagonistic reactions in the human body, resulting in local swelling, pain, fever and other adverse reactions in the patient.

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