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rhTNK-tPA lyophilized preparation for injection and preparation method of rhTNK-tPA lyophilized preparation for injection

A technology for freeze-dried preparations and injections, applied in the field of biopharmaceuticals, can solve the problems of low activity recovery rate of target protein, achieve high purity and recovery rate, good appearance, and avoid stratification

Inactive Publication Date: 2018-10-26
石药集团明复乐药业(广州)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the specific activity of the target protein obtained by the current separation and purification method can reach more than 500,000 IU / mg, the target protein accounts for more than 98% of the total protein content, and the monomer purity is greater than 95%, but the activity recovery rate of the target protein is low

Method used

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  • rhTNK-tPA lyophilized preparation for injection and preparation method of rhTNK-tPA lyophilized preparation for injection
  • rhTNK-tPA lyophilized preparation for injection and preparation method of rhTNK-tPA lyophilized preparation for injection
  • rhTNK-tPA lyophilized preparation for injection and preparation method of rhTNK-tPA lyophilized preparation for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Example 1, a rhTNK-tPA freeze-dried preparation for injection and its preparation method

[0036] A) separation and purification:

[0037] S1, Blue Sepharose 6FastFlow affinity chromatography: before performing chromatography, the chromatography column is equilibrated with 2.5 times column volume buffer ①, and its components are 20mM phosphate buffer and 0.04% polysorbate 80, pH7.2; for sample loading, use 2.5 times the column volume of buffer ② to wash out the impurity protein, the components are: 20mM phosphate buffer, 2M sodium chloride and 0.04% polysorbate 80, pH7.2; use 3 times The target protein was obtained by eluting with the column volume of eluent I. The components of eluent I were 20mM phosphate buffer, 1M sodium chloride, 2M urea and 0.04% polysorbate 80, and the pH value of the eluent was 7.0;

[0038] S2. Lysine HyperD affinity column chromatography: The equilibration and sample loading process is the same as that of the B column above. After completion,...

Embodiment 2

[0055] Example 2, a rhTNK-tPA freeze-dried preparation for injection and its preparation method

[0056] The difference between Example 2 and Example 1 is that the separation and purification steps become: through Blue Sepharose 6FastFlow affinity chromatography, Sephadex G-25 gel filtration chromatography, lysine affinity chromatography and Capto Q anion chromatography to obtain For the purified rhTNK-tPA, other parameters are the same as in Example 1.

[0057] After purification, the activity recovery rate of the target protein was detected, and the activity recovery rate of rhTNK-tPA was 96.2%.

Embodiment 3

[0058] Example 3, a rhTNK-tPA freeze-dried preparation for injection and its preparation method

[0059] The difference between embodiment 3 and embodiment 1 is that in the pre-freezing stage, the step of pre-freezing at -15°C is removed, and other parameters are the same as in embodiment 1.

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Abstract

The invention belongs to the field of biopharmacy and particularly relates to an rhTNK-tPA lyophilized preparation for injection and a preparation method of the rhTNK-tPA lyophilized preparation for injection. The preparation method includes steps of separation and purification, liquid compounding, sterilization and filtration, filling and partial stoppering and lyophilization. The lyophilized preparation prepared according to the preparation method is great in appearance, uniform, free of layering, evident shrinkage, shedding and the like, and high rhTNK-tPA activity, purity and recovery rateare achieved. Compared with the prior art, the rhTNK-tPA lyophilized preparation for injection and the preparation method have the advantage of remarkable progress.

Description

technical field [0001] The invention belongs to the technical field of biopharmaceuticals, and in particular relates to a rhTNK-tPA freeze-dried preparation for injection and a preparation method thereof. Background technique [0002] The morbidity and mortality of thrombosis have always been at the top of various diseases, seriously threatening human life and health. At present, one of the most effective methods for treating thrombotic diseases is thrombolysis. Among the thrombolytic drugs that have been marketed, PA drugs dominate, and the representative is the third-generation thrombolytic produced by Guangzhou Mingkang Bioengineering Co., Ltd. The emergency drug "Mingfule" is the safest, most effective, life-saving thrombolytic drug so far. [0003] Vacuum freeze-drying (hereinafter referred to as freeze-drying) has become the preferred method of drying products in this industry because it can complete the dehydration and drying of biological products at low temperature...

Claims

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Application Information

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IPC IPC(8): A61K38/48A61K9/19A61P7/02
CPCA61K9/0019A61K9/19A61K38/482A61P7/02C12Y304/21068
Inventor 黄少翠邓肇斌徐飞胡家华吴宜南
Owner 石药集团明复乐药业(广州)有限公司
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