Preparation method of nicodil freeze-dried powder injection for injection

The invention relates to a preparation method of a Nicodil freeze-dried powder injection for injection, which comprises the following steps: 1, preparing a basic solution, and adjusting the pH value of the basic solution to 7.78-7.98; 2, freeze drying is conducted, specifically, freeze drying in the step 2 comprises the steps of pre-freezing, vacuumizing, sublimation drying, limit drying, pressure rising, nitrogen charging, plug pressing and nitrogen flattening, pH value adjustment in the basic solution preparation stage is combined with the preparation method, and it is achieved that the impurity content is reduced while good stability is guaranteed; the content of the Nicodil is increased within a quality standard range, so that the quality of the medicine is improved. 本发明涉及一种注射用尼可地尔冻干粉针的制备方法，该方法包括步骤1：制备基础溶液，基础溶液调节pH值为7.78～7.98之间；步骤2：冷冻干燥，步骤2中冷冻干燥包括：预冻，抽真空，升华干燥，极限干燥，压力升，充氮，压塞，氮气压平，采用在制备基础溶液阶段调节pH值与本申请制备方法相结合实现了在保证较好的稳定性的同时，减少杂质含量，在质量标准范围内提升尼可地尔的含量，使药品质量提升。