摘要
目的:提高完善复方利血平片的质量标准。方法:采用化学方法建立了处方中利血平、氢氯噻嗪、盐酸异丙嗪、维生素B_1维生素B_6、KCl、泛酸钙、三硅酸镁的鉴别项,并对其作空白对照,专属性良好;采用HPLC法建立了利血平、氢氯噻嗪、盐酸异丙嗪三个成分的含量测定项目。结果:定性定量准确、专属性强、重现性好。结论:提高后的质量标准可有效地控制该产品的内在质量。
Objective:To improve the quality standards for Compound Reserpine Tablets. Methods:Reserpine,Hydrochlothiazide,Promethazine Hydrochlothiazide,Vitamin B1,Vitamin B6,KCl,Calcium Pantothenate,Magnesium Trisilicate were identified by chemical method and do the negative tests, respectively ; The content of Reserpine, Hydrochlothiazide, Promethazine Hydrochlothiazide were determined by HPLC;Results:The idenification and content determination methods were accurate,respectively,and with good reproducibility. Conclusion: The improving quality standards can control the quality of this product effectively.
出处
《中国药品标准》
CAS
2006年第2期58-61,共4页
Drug Standards of China