宠物用精蛋白锌重组人胰岛素注射液的制备工艺及质量研究

Development and quality standard study of protamine zinc Recombinant Human Insulin injection for pets

关键词:  重组人胰岛素  注射剂  制备工艺  处方筛选  稳定性

Key words:  recombinant human insulin  Injection  preparation process  prescription screening  stability

摘要:

摘要：确定了宠物用精蛋白锌重组人胰岛素注射液的制备工艺并建立质量标准。采用单因素试验法，对注射液进行处方与制备工艺的优化，并采用高效液相色谱法与显微镜检查进行产品含量及晶型的质量控制，通过影响因素试验考察影响注射液稳定性的条件，拟定注射液储存条件。结果表明，最优处方中每毫升含40 IU重组人胰岛素、0.466 mg鱼精蛋白、0.088 mg氧化锌，注射液最佳制备工艺为磁力搅拌1 h，2-8℃结晶36 h；高效液相色谱法检测含量时注射液供试品与胰岛素对照品出峰一致，阴性对照无干扰；注射液储存条件为首次启用前2-8℃冷藏，启用后室温阴凉避光处储存。本试验制备工艺和质量标准为宠物用精蛋白锌重组人胰岛素注射液生产与质量控制提供了依据。

Abstract:

Abstract：The preparation process of protamine zinc Recombinant Human Insulin for injection for pets was determined and the quality standard was established. The single factor test method was used to optimize the formulation and preparation process of the injection. And the quality control of product content and crystal form was carried out by high performance liquid chromatography and microscopic examination. The conditions affecting the stability of the injection were investigated through the influencing factor test, and the storage conditions of the injection were formulated. The results showed that the optimal formula contained 40 IU Recombinant Human Insulin, 0.466 mg protamine and 0.088 mg zinc oxide per ml, and the optimal preparation process of injection was magnetic stirring for 1 h and crystallization at 2-8°C for 36 h. The results of high-performance liquid chromatography showed that the peak of the injection test sample was consistent with that of the insulin reference product, and there was no interference in the negative control. The storage conditions of the injection solution are refrigerated at 2-8°C before the first use, and stored in a cool and dark place at room temperature after use. The preparation process and quality standards of this experiment provide a basis for the production and quality control of protamine zinc Recombinant Human Insulin for injection for pets.