摘要
国内丙戊酸钠已上市剂型仅有普通片、缓释片、糖浆、口服溶液和粉针剂,无注射液剂型上市,预期市场广阔。本文论述了丙戊酸钠注射液处方工艺研究方法,内容包括参比制剂的选择、参比制剂的研究内容、原料药质量标准、原料药研究、制剂处方工艺研究。
In the domestic market,sodium valproate has only ordinary tablets,sustained-release tablets,syrups,oral solutions and powder injections,and no injection formulations.The market is expected to be broad.This article discusses the research methods for the formulation of sodium valproate injection,including the selection of reference preparations,the research content of the reference preparations,the quality standards of the raw materials,the research of the raw materials,and the research on the formulation and technology of the preparations.
作者
黄俊龙
王丽群
梁裕
Huang Junlong;Wang Liqun;Liang Yu(DiQi Pharmaceuticals Co.,Ltd.,Guangzhou 510000,China)
出处
《广东化工》
CAS
2021年第1期49-50,63,共3页
Guangdong Chemical Industry
关键词
丙戊酸钠注射液
参比制剂
仿制药
处方工艺
sodium valproate injection
reference preparation
generic drug
prescription technology
