论文部分内容阅读
目的:研究适合注射用丁香苦苷冻干粉针的处方配比和制备工艺。方法:以产品外观,复水性,含量等为指标,运用正交试验法优化其处方配比;采用真空冷冻干燥法制备其样品,用高效液相色谱法检测其含量,并对制备条件如装量、共晶点、预冻温度、升华温度、解吸温度等进行研究。结果:经优化,确定丁香苦苷含量为8%(A2),赋形剂用量为5%甘露醇(B2),装量为2.5mL(C3),西林瓶规格为7mL(D1);生产工艺为pH值为7.0,-45℃下预冻、-30℃下升华干燥和25℃时解吸干燥。结论:该工艺制备的丁香苦苷冻干粉针符合《中国药典》(2005版)冻干粉针的相关规定。
Objective: To study the prescription ratio and preparation process of syringomycin lyophilized powder for injection. Methods: Using the appearance, rehydration and content of the product as the index, orthogonal design was used to optimize the prescription ratio. The samples were prepared by vacuum freeze-drying method and the content was determined by high performance liquid chromatography (HPLC) Volume, eutectic point, pre-freezing temperature, sublimation temperature, desorption temperature were studied. Results: After optimization, it was confirmed that the content of syringomycin was 8% (A2), the amount of excipients was 5% mannitol (B2), the volume was 2.5mL (C3), and the flask was 7mL Pre-freeze at -45 ° C, pH-7.0, sublimation -30 ° C and desorption at 25 ° C. Conclusion: The syringomycin lyophilized powder prepared by this process is in accordance with the relevant provisions of the Chinese Pharmacopoeia (2005 edition) freeze-dried powder.