| 布南色林口腔崩解片的制备及其主药和有关物质的含量测定 |
| |
| 引用本文： | 邱凯锋,姚少毅,廖华卫. 布南色林口腔崩解片的制备及其主药和有关物质的含量测定[J]. 中国药房, 2011, 0(17): 1592-1594 |
| |
| 作者姓名： | 邱凯锋 姚少毅 廖华卫 |
| |
| 作者单位： | 中山大学孙逸仙纪念医院;广东药学院中药学院; |
| |
| 摘 要： | 目的:制备布南色林口腔崩解片并建立其主药与有关物质含量测定方法。方法:以微晶纤维素、乳糖、羧甲基淀粉钠等为辅料制备口腔崩解片,并考察其崩解时间和脆碎度等;采用高效液相色谱法测定主药和有关物质含量,色谱柱为KromasilC18,流动相为乙腈-甲醇-25mmol·L-1的磷酸二氢钠溶液(内含25mmol·L-1庚烷磺酸钠,用磷酸调节pH=3.0)=35∶30∶35,检测波长为236nm。结果:所制崩解片平均崩解时间为10.3s,平均脆碎度为0.21%。布南色林检测浓度线性范围为0.1069～0.5343μg·μL-1(r=0.9999),平均回收率为100.1%,RSD=0.3%;3批样品中主药的平均标示含量为99.6%(RSD=0.7%),有关物质的总含量小于0.32%。结论:布南色林口腔崩解片制备工艺合理,可操作性强,定量方法简便、准确、专属性强、精密度好、回收率高。
|
| 关 键 词： | 布南色林口腔崩解片 制备 高效液相色谱法 有关物质 含量测定 |
Preparation of Blonanserin Orally Disintegrating Tablets and Content Determination of Main Component and Its Related Substances |
| |
| QIU Kai-feng,YAO Shao-yi LIAO Hua-wei. Preparation of Blonanserin Orally Disintegrating Tablets and Content Determination of Main Component and Its Related Substances[J]. China Pharmacy, 2011, 0(17): 1592-1594 |
| |
| Authors: | QIU Kai-feng YAO Shao-yi LIAO Hua-wei |
| |
| Affiliation: | QIU Kai-feng,YAO Shao-yi(Sun Yat-sen Memorial Hospital,Sun Yat-sen University,Guangzhou 510120,China) LIAO Hua-wei(School of Traditional Chinese Medicine,Guangdong Pharmaceutical University,Guangzhou 510006,China) |
| |
| Abstract: | OBJECTIVE:To prepare Blonanserin orally disintegrating tablets,and to establish a method for the content determination of main component and its related substances.METHODS:The orally disintegrating tablet was prepared with microcrystalline cellulose,lactose,and sodium carboxymethyl starch as excipients.The disintegrating time and friability of orally disintegrating tablets were investigated.The contents of main component and its related substance were determined by HPLC.The determination was performed on Kr... |
| |
| Keywords: | Blonanserin orally disintegrating tablets Preparation HPLC Related substances Content determination |
| 本文献已被 CNKI 维普 等数据库收录！ |
|
