Mycobacterium phlei injection and preparation method thereof

一种草分枝杆菌注射液的制备方法及草分枝杆菌注射液

Abstract

本发明提出了一种草分枝杆菌注射液的制备方法,该方法采用原始菌种-主种子批-工作种子批三级培养的方式,最后工作种子批经发酵培养,分离、纯化、灭菌,获得草分枝杆菌原液。所述原液经过聚山梨酯80和氯化钠所配制的稀释液的稀释,直接得到草分枝杆菌注射液。按照本发明所提出的草分枝杆菌注射液制备方法,具有菌种保持性好、安全程度高、成本低、生产效率高的特点。
The invention provides a preparation method of a Mycobacterium phlei injection. The preparation method includes: adopting a three-stage culture mode of original strain, master seed lot and working seed lot; subjecting the working seed lot to fermentation culture, separation, purification and sterilization to obtain Mycobacterium phlei stoste; using a diluent prepared from polysorbate and sodium chloride to dilute the stoste to directly obtain the Mycobacterium phlei injection. The preparation method has the advantages of good strain retentivity, high safety level, low cost and high production efficiency.

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