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陈皮复方止咳含片制备工艺优化及质量控制
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| 篇名： | 陈皮复方止咳含片制备工艺优化及质量控制 |
| TITLE： | |
| 摘要： | 目的： 优化陈皮复方止咳含片的制备工艺，并建立测定其中橙皮苷含量的方法。方法：以含片口感、外观、崩解时限和硬度评分为指标，采用正交试验筛选生姜用量、乳糖-甘露醇质量比、薄荷油用量、甜菊糖用量及硬脂酸镁用量，以优化陈皮复方止咳含片的制备工艺。采用高效液相色谱法测定橙皮苷的含量，色谱柱为InfinityLab Poroshell 120 EC-C18，流动相为甲醇-醋酸-水（35 ∶ 4 ∶ 61，V/V/V），流速为1.0 mL/min，检测波长为283 nm，柱温为25 ℃，进样量为5 μL。结果：最佳制备工艺1倍量处方中生姜用量为7 g，乳糖-甘露醇质量比为2 ∶ 1，薄荷油用量为1 mL，甜菊糖用量为0.15％（以药材粉末和填充剂总质量计），硬脂酸镁用量为0.5％（以制得干颗粒质量计）。橙皮苷检测质量浓度线性范围为0.045 0～0.450 0 mg/mL（r＝0.999 9）；定量限为3.50 ng，检测限为1.05 ng；精密度、稳定性、重复性试验的RSD均小于1％；加样回收率为97.99％～101.65％（RSD＝1.53％，n＝6）。结论：该工艺制备的陈皮复方止咳含片口感好，外观完整光洁、色泽均匀，崩解时限适宜，硬度较高，制备工艺稳定、可行。 |
| ABSTRACT： | OBJECTIVE： To optimize the preparation technology of Compound Citrus reticulata buccal tablets， and to establish a method for content determination of hesperidin. METHODS： Using the taste， appearance， disintegrating time and hardness score as evaluation indexes， L9（34）orthogonal test was used to screen the amount of Zingiber officinale， ratio of lactose-mannitol. The preparation technology of Compound C. reticulata buccal tablets was optimized. The content of hesperidin was determined by HPLC. The determination was performed on InfinityLab Poroshell 120 EC-C18 column with mobile phase consisted of methanol-acetic acid-water （35 ∶ 4 ∶ 61，V/V/V） at the flow rate of 1.0 mL/min. The detection wavelength was set at 283 nm， and column temperature was 25 ℃. The sample size was 5 μL. RESULTS： The optimal preparation technology included Z. officinale 7 g， lactose-mannitol ratio of 2 ∶ 1， peppermint oil 1 mL， stevioside 0.15％ （by total amount of medicinal powder and filler）， magnesium stearate 0.5％ （by the weight of dry granule）. The linear range of hesperidin was 0.045 0-0.450 0 mg/mL （r＝0.999 9）. The quantitation limit was 3.50 ng， and detection limit was 1.05 ng. RSDs of precision， stability and repeatability tests were all lower than 1％； the recoveries was 7.99％-101.65％（RSD＝1.53％， n＝6）. CONCLUSIONS： Compound C. reticulata buccal tablets prepared by this technology are good in taste， complete and smooth in appearance， uniform in color， suitable in disintegration time and high hardness. The preparation technology is stable and feasible. |
| 期刊： | 2018年第29卷第14期 |
| 作者： | 谭娥玉，唐兴荣，叶国强，王贤儿，关琴笑 |
| AUTHORS： | TAN Eyu，TANG Xingrong，YE Guoqiang，WANG Xianer，GUAN Qinxiao |
| 关键字： | 陈皮复方止咳含片；制备工艺；优化；正交试验设计；橙皮苷；含量测定；质量控制 |
| KEYWORDS： | Compound Citrus reticulata buccal tablets； Preparation technology； Optimization； Orthogonal test； Hesperidin； Content determination； Quality control |
| 阅读数： | 323 次 |
| 本月下载数： | 5 次 |
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