Preparation method of nicorandil for injection

• Main Authors: SU YAQIN, SONG LILI, YUE HONGSHUI, HAO XIAOWEI, JU AICHUN
• Format: Patent
• Language: Chinese; English
• Published: 05.11.2021
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS

The invention relates to a preparation method of nicorandil for injection. The nicorandil for injection, disclosed by the invention, is prepared from nicorandil, mannitol, sodium citrate and water for injection through the procedures of liquid preparation and freeze drying, and the weight ratio of all the components is as follows: nicorandil: mannitol: sodium citrate: water for injection is 2: 3: 1: (300-600). The preparation method of the nicorandil for injection, disclosed by the invention, comprises the following steps: step 1, liquid preparation, and step 2, freeze-drying, wherein the freeze-drying step further comprises the following steps: step A, pre-freezing, freeze-thawing, crystallizing and annealing, and step B, sublimation stage. 本发明涉及一种注射用尼可地尔的制备方法，本发明的注射用尼可地尔由尼可地尔、甘露醇、枸橼酸钠和注射用水经过配液，冷冻干燥过程制备而成，各组分的重量配比如下：尼可地尔：甘露醇：枸橼酸钠：注射用水＝2：3：1：300-600；本发明的注射用尼可地尔的制备方法，经过以下步骤：步骤1、配液，步骤2、冻干，其中，冻干步骤进一步包括：步骤A，预冻，冻融，结晶，退火，步骤B，升华阶段。