Preparation and quality control of doxercalciferol soft capsules
文献类型:期刊论文
作者 | Sun Yuxia2; Gu Wangwen1![]() |
刊名 | Chinese Journal New Drugs
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出版日期 | 2016 |
卷号 | 25期号:24页码:2862-2867 |
关键词 | doxercalciferol soft capsule quality standards |
ISSN号 | 1003-3734 |
其他题名 | 度骨化醇软胶囊的制备与质量控制 |
文献子类 | Article |
英文摘要 | Objective: To prepare doxercalciferol soft capsules and set up its quality standards. Methods: The prescription of the content was determined by combining the experiment results with the literature at home and abroad. The best prescription of the capsule shells was selected by taking the swelling equilibrium quantity as a standard. The quality control standards were established according to the characteristics of soft capsule formulation, and used to detect the index parameters. Results: The prescription of doxercalciferol soft capsule was composed of doxercalciferol, medium chain triglycerides(MCT), ethanol, butylated hydroxyanisole(BHA), butylated hydroxytoluene(BHT), gelatin, glycerinum, sorbitol and distilled water. The packing amount of doxercalciferol soft capsule was 161.98 mg, which was in accordance with the quality control standards of SFDA. The content was (100.70.68)% (n=3), the dissolution of 30 min and 60 min were above 60% and 80%, and the disintegration time was (8.120.87) min (n=12). Conclusion: The prepared doxercalciferol soft capsules are quality controllable, and can significantly improve the problem of aging and disintegration delay of soft capsule shells in the process of long-term placement of soft capsules. |
WOS研究方向 | Pharmacology & Pharmacy (provided by Clarivate Analytics) |
语种 | 中文 |
CSCD记录号 | CSCD:5888659 |
源URL | [http://119.78.100.183/handle/2S10ELR8/269220] ![]() |
专题 | 药物制剂研究中心 |
通讯作者 | Gu Wangwen |
作者单位 | 1.Center for Pharmaceutic Preparation, Shanghai Institute of Materia Medica,Chinese Academy of Sciences, Shanghai 201203, China. 2.School of Pharmacy, Jiangsu University, Zhenjiang, Jiangsu 212013, China.; |
推荐引用方式 GB/T 7714 | Sun Yuxia,Gu Wangwen. Preparation and quality control of doxercalciferol soft capsules[J]. Chinese Journal New Drugs,2016,25(24):2862-2867. |
APA | Sun Yuxia,&Gu Wangwen.(2016).Preparation and quality control of doxercalciferol soft capsules.Chinese Journal New Drugs,25(24),2862-2867. |
MLA | Sun Yuxia,et al."Preparation and quality control of doxercalciferol soft capsules".Chinese Journal New Drugs 25.24(2016):2862-2867. |
入库方式: OAI收割
来源:上海药物研究所
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