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正交试验优化复方体外培育牛黄凝胶的处方工艺
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| 篇名： | 正交试验优化复方体外培育牛黄凝胶的处方工艺 |
| TITLE： | |
| 摘要： | 目的：优选复方体外培育牛黄凝胶的制备工艺。方法：以超声功率、超声时间与间歇时间比、超声总时间为考察因素，以离心稳定性常数（KE）为评价指标，正交试验优化超声乳化工艺；采用超声乳化法将丹皮酚、盐酸小檗碱、桉油制成O/W 型乳剂，将体外培育牛黄粉末加入O/W型乳剂中研匀，再与卡波姆（940）凝胶基质混合均匀制成凝胶剂。以卡波姆（940）、甘油、三乙醇胺处方中用量为考察因素，以成形性等制剂评分及体外释放度组合的综合评分为指标，正交试验优化凝胶剂处方；对优化处方所制凝胶剂进行验证试验、稳定性考察及胆红素的含量测定。结果：超声乳化最优工艺为超声功率450 W、超声时间与间歇时间比2 ∶ 1、超声总时间5 min；最优凝胶剂处方为卡波姆（940）0.5％、甘油15％、三乙醇胺0.20％（g/100 g）；验证试验中KE均值为0.175、制剂综合评分均值为98.67（RSD＜2％，n＝3），稳定性试验中制剂外观无明显变化，胆红素占标示含量平均值为100.8％。结论：优化的凝胶处方及制备工艺可行，所制凝胶稳定性好、质量可控。 |
| ABSTRACT： | OBJECTIVE： To optimize the preparation technology of Compound bovis calculus sativus gel. METHODS： The ultrasonic emulsifying technology was optimized by orthogonal test using ultrasonic power， ratio of ultrasonic time to interval time， total ultrasonic time as factors， using centrifugal stability constant （KE） as index.Ultrasonic emulsifying method was applied to prepare O/W emulsions using paeonol， berberine hydrochloride and eucalyptus oil； then calculus bovis sativus powder was added into O/W emulsions， and then mixed with carbomer （940） gel matrix to prepare gel. The formulation of gel was optimized by orthogonal test with the amount of carbomer （940）， glycerool and triethanolamine as factors， using compactibility score， comprehensive score of release rate in vitro as index. Validation test， stability test and content determination of bilirubin were conducted for gel prepared by optimized technology. RESULTS： The optimal ultrasonic emulsifying technology was as follows as ultrasonic power 450 W， ratio of ultrasonic time to interval time 2 ∶ 1， and total ultrasonic time 5 min. The optimal formulation of gel was as follows as carbomer （940） 0.5％， glycerool 15％， triethanolamine 0.20％ （g/100 g）. The average of KE of validation test and average comprehensive score were 0.175 and 98.67 （RSD＜2％， n＝3）； the appearance of the preparation had no obvious change in stability test， and average percentage of bilirubin in labeled content was 100.8％. CONCLUSIONS： The optimal formulation and preparation technology of gel is feasible， and the prepared gel is stable and controllable in quality. |
| 期刊： | 2016年第27卷第10期 |
| 作者： | 程璐，宋志龙，熊鑫，伍彬 |
| AUTHORS： | CHENG Lu，SONG Zhilong，XIONG Xin，WU Bin |
| 关键字： | 复方体外培育牛黄凝胶；超声乳化工艺；处方优化；正交试验；胆红素 |
| KEYWORDS： | Compound bovis calculus sativus gel； Ultrasonic emulsifying technology； Formulation optimization； Orthogonal test； Bilirubin |
| 阅读数： | 354 次 |
| 本月下载数： | 7 次 |
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