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李朝,夏新华,周宇,张驰,颜红.黄芩苷的处方前研究[J].湖南中医药大学学报英文版,2016,36(7):51-54.[Click to copy
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| 黄芩苷的处方前研究 |
| 李朝,夏新华,周宇,张驰,颜红 |
| (湖南中医药大学药学院, 湖南 长沙 410208) |
| 摘要: |
| 目的 通过处方前研究，阐明黄芩苷原料药（质量分数为85.5%）的基本理化性质。方法 采用HPLC法测定黄芩苷含量，分别进行黄芩苷的平衡溶解度、油水分配系数、破坏性试验、吸湿性考察等处方前研究。结果 原料药中黄芩苷在水中的平衡溶解度为0.0326 mg/mL，较甲醇、正丁醇、乙醇等溶剂低；在pH小于5.0的磷酸盐缓冲液中几乎不溶，其平衡溶解度随着pH值的增大呈增大的趋势；黄芩苷在正辛醇/水中的油水分配系数（P值）为1.19，在正辛醇/磷酸盐缓冲液（pH 2～10）中的P值均比正辛醇/水中的低；黄芩苷不耐碱，且易被氧化；在温度25℃、RH 75%条件下吸湿性较小。结论 该研究可为黄芩苷新制剂原料与剂型的选择、处方设计及工艺优化等提供实验依据。 |
| 关键词: 黄芩苷 处方前研究 HPLC |
| DOI：10.3969/j.issn.1674-070X.2016.07.013 |
| Received:January 05, 2016 |
| 基金项目:湖南省“十二五”中药学重点学科建设项目（湘教通[2011]76号）。 |
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| Preformulation Study on Baicalin |
| LI Chao,XIA Xinhua,ZHOU Yu,ZHANG Chi,YAN Hong |
| (School of Pharmacy, Hunan University of Chinese Medicine, Changsha, Hunan 410208, China) |
| Abstract: |
| Objective To illustrate the basic physiochemical characteristic of active pharmaceutical ingredient baicalin (mass fraction 85.5%) by preformulation study.Methods The content of baicalin was determined by HPLC.The equilibrium solubility,oil-water partition coefficient and destructive testing on baicalin of preformulation was studied.Results The equilibrium solubility of baicalin in water was 0.032 6 mg/mL.It was almost insoluble in the phosphate buffer solutions with pH value under 5.0,but its solubility increased with the increasing of pH.The oil-water partition coefficient (P) of baicalin in n-octyl alcohol/water was 1.19,higher than in n-octyl alcohol/phosphate buffer solutions with pH values of 2~10.Baicalin was not alkali-resistant and easy to be oxidized.The hygroscopicity of baicalin is lesser under the condition of 25℃ and RH75%.Conclusion The above results can provide experimental basis for selection of active pharmaceutical ingredients and dosage forms,prescription design and process optimization of new baicalin preparation. |
| Key words: baicalin preformulation HPLC |
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