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金蕾胶囊的制备及其质量评价研究
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| 篇名： | 金蕾胶囊的制备及其质量评价研究 |
| TITLE： | |
| 摘要： | 目的：制备金蕾胶囊，并对其质量进行评价。方法：采用湿法制粒，以药-辅比、辅料配比和乙醇体积分数作为考察因素，以颗粒成型率、水分、流动性的综合评分为评价指标进行正交试验，优化金蕾胶囊内容颗粒的成型工艺。根据2015版《中国药典》（四部）（以下简称“药典”）对所制胶囊性状、水分、装量差异、崩解时限进行测定；采用薄层色谱法对金蕾胶囊中湿生扁蕾和金钱草进行定性鉴别，采用高效液相色谱法对金蕾胶囊中木犀草素和山柰酚进行定量分析。结果：金蕾胶囊内容颗粒的最优成型工艺为辅料麦芽糊精与微粉硅胶按10 ∶ 1混合后与药粉按1 ∶ 0.5混合，再用90％的乙醇湿法制粒。金蕾胶囊的性状、水分、装量差异、崩解时限的测定结果均符合药典标准。供试品薄层色谱在对照品色谱相应的位置上显相同颜色的斑点，木犀草素和山柰酚的检测质量浓度线性范围分别为4.4～88.0、9.6～96.0 μg/mL（r均＝0.999 9），精密度试验（n＝6）、重复性试验（n＝6）、稳定性试验（18 h，n＝7）的RSD均≤2.5％，平均回收率分别95.74％、99.77％（RSD分别为1.50％、2.72％，n＝6），含量分别为2.52、0.34 mg/g。结论：优化后的金蕾胶囊成型工艺稳定、可行，所制金蕾胶囊质量可控。 |
| ABSTRACT： | OBJECTIVE： To prepare Jinlei capsule and evaluate its quality. METHODS： Wet granulation was adopted. The molding technology of Jinlei capsule content granule was optimized with drug-excipient ratio， excipient ratio and ethanol volume fraction as factors， using comprehensive score of particle forming rate， moisture content and fluidity as the evaluation index. According to 2015 edition of Chinese Pharmacopoeia （part Ⅳ）， the characters， moisture， volume difference， disintegration time limit were checked. Qualitative identification of Gentianopsis paludosa and Lysimachia christinale were analysed by TLC， and quantitative analysis of luteolin and kaempferol were analysed by HPLC. RESULTS： The optimal molding technology of Jinlei capsule content granule was that the maltodextrin and the micro-silica gel are mixed as a mixed auxiliary material according to 10 ∶ 1 and then mixed with the drug powder by 1 ∶ 0.5， using the wet granulation method with 90％ ethanol as wetting agent. The characters， moisture， volume difference and disintegration time limit of Jinlei capsule were in line with Chinese Pharmacopoeia. TLC showed the same color spots on the corresponding positions of the reference chromatogram. The linear range of luteolin and kaempferol were 4.4-88.0 μg/mL and 9.6-96.0 μg/mL （all r＝0.999 9）. RSD of precision （n＝6）， reproducibility （n＝6） and stability （18 h， n＝7） tests were all lower than 2.5％. The average recoveries were 95.74％ and 99.77％ （RSD＝1.50％， 2.72％， n＝6）； the content of them were 2.52， 0.34 mg/g. CONCLUSIONS： The optimal molding technology of Jinlei capsule is stable and feasible； prepared Jinlei capsule in controllable in quality. |
| 期刊： | 2019年第30卷第21期 |
| 作者： | 柳娜，张旭东，陈舜东，张夙萍，景明，陈杰，白德涛 |
| AUTHORS： | LIU Na，ZHANG Xudong，CHEN Shundong，ZHANG Suping，JING Ming，CHEN Jie，BAI Detao |
| 关键字： | 金蕾胶囊；制备工艺；木犀草素；山柰酚；质量评价；含量测定 |
| KEYWORDS： | Jinlei capsule； Preparation technology； Luteolin； Kaempferol； Quality evaluation； Content determination |
| 阅读数： | 510 次 |
| 本月下载数： | 1 次 |
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