尼尔雌醇片的溶出度测定条件研究

• 作 者: 陈轶兰 王友茹
• 机 构: 军事医学科学院放射医学研究所,军事医学科学院放射医学研究所
• 出 处: 军事医学科学院院刊
• 发表日期: 1993年02期
• 关键词: 尼尔雌醇片 溶出度测定 新药质量标准 新药申报 新药审批办法 溶出度检查 妇女更年期 脂溶性 溶出度试验 盐酸液

尼尔雌醇片作为治疗妇女更年期用新药,在1985年已有上海地方质量标准。实施新药审批办法后,对新药质量标准的控制方法提高了要求。作为扩大临床使用抗辐射新药——尼尔雌醇,以五类新药申报时,在原质量标准中增加了片剂溶出度检查指标。尼尔雌醇易溶于氯仿,微溶于乙醇,几乎不溶于水,即尼尔雌醇脂溶性较大,按药典规定的通用法测定尼尔雌醇片溶出度有困难。为此对尼尔雌醇片的溶出度进行了研究。

Nylestriol tablets as the treatment of women menopause with new drugs, in 1985, Shanghai has local quality standards. After the implementation of new drug approval measures, the new drug quality control methods to improve the requirements. As an expansion of clinical use of new anti-radiation drugs - nilestriol, to declare five new drugs, the original quality standards increased tablet dissolution check index. Nylestriol is easily soluble in chloroform, slightly soluble in ethanol, almost insoluble in water, that is, the solubility of nylestriol in fat is high. It is difficult to determine the dissolution of nylestriol tablets according to the general method stipulated in the pharmacopoeia. To this end, the dissolution of nilestriol tablets was studied.