| 引用本文: | 郝晔,王祺玥,董泽民,涂家生,沈雁,张瑞卿.精制的聚丙烯酸树脂Ⅳ号用于盐酸小檗碱掩味微丸的制备及评价[J].中国现代应用药学,2018,35(2):159-163. |
| HAO Ye,WANG Qiyue,DONG Zemin,TU Jiasheng,SHEN Yan,ZHANG Ruiqing.Preparation and evaluation of berberine hydrochloride taste-marking pellets coated by refined methacrylic acid alkyl ester copolymer Ⅳ[J].Chin J Mod Appl Pharm(中国现代应用药学),2018,35(2):159-163. |
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| 摘要: |
| 目的 以盐酸小檗碱为模型药物，研究精制后聚丙烯酸树脂Ⅳ号作为包衣材料的掩味能力。方法 建立了盐酸小襞碱紫外分光光度法含量测定方法学，并以蔗糖微丸为丸心，采用流化床沸腾上药制备盐酸小襞碱微丸。分别采用精制前、后的聚丙烯酸树脂Ⅳ号以及市售尤特奇®EPO作为包衣材料，制备不同包衣增重的盐酸小襞碱掩味微丸，并对其口感和水中释放度进行测定。结果 制备的盐酸小襞碱普通微丸含量均匀度和上药量符合要求。经聚丙烯酸树脂Ⅳ号包衣后，微丸的苦味被显著掩盖，同时对微丸在水中溶出度的测定结果显示，随着包衣增重的不断变大，微丸的溶出量显著下降；对于精制后的聚丙烯酸树脂Ⅳ，包衣增重达到4.0%时才能充分起到掩盖苦味的作用；而对于尤特奇®EPO，3.0%的包衣增重即可达到相同要求。结论 在相同的包衣增重下，尤特奇®EPO的掩味能力明显优于精制前后的聚丙烯酸树脂Ⅳ，而精制后的聚丙烯酸树脂Ⅳ的掩味能力较精制前有所提高。 |
| 关键词: 聚丙烯酸树脂Ⅳ号 盐酸小檗碱 掩味能力 |
| DOI：10.13748/j.cnki.issn1007-7693.2018.02.002 |
| 分类号:R943 |
| 基金项目:国家自然科学基金（81673364）；国家科技重大专项（2014ZX09507001006） |
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| Preparation and evaluation of berberine hydrochloride taste-marking pellets coated by refined methacrylic acid alkyl ester copolymer Ⅳ |
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HAO Ye1, WANG Qiyue2, DONG Zemin2, TU Jiasheng2, SHEN Yan2, ZHANG Ruiqing1
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1.Children's Hospital of Nanjing Medical University, Nanjing 210000, China;2.Department of Pharmaceutics, School of Pharmacy, China Pharmaceutical University, Nanjing 210009, China
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| Abstract: |
| OBJECTIVE To prepare berberine hydrochloride taste-marking pellets coated by refined methacrylic acid alkyl ester copolymer and evaluate the taste masking effect. METHODS Ultraviolet spectrophotometry method was established for berberine hydrochloride content determination. Berberine hydrochloride pellets were prepared by fluidized bed with sucrose pellets as core. Raw methacrylic acid alkyl ester copolymer, refined methacrylic acid alkyl ester copolymer and Eudragit®EPO were used to prepare coating materials and berberine hydrochloride taste-marking pellets were coated with these different coating materials respectively by different increasing coating weight. The taste test and dissolution rate of berberine hydrochloride taste-marking pellets was then studied. RESULTS The berberine hydrochloride was prepared with uniform drug content and satisfied with the drug loading efficiency. The bitter taste was significantly masked and the dissolution rate was significantly decreased with the increased of coating weight. For the refined methacrylic acid alkyl ester copolymer, the bitter taste could be masked only until the coating weight reach 4%, which could be masked when the coating weight reach 3% for Eudragit®EPO. CONCLUSION With the same coating weight, Eudragit®EPO shows best taste marking ability among the three kinds of coating materials while the methacrylic acid alkyl ester copolymer shows better taste marking ability than the raw materials. |
| Key words: methacrylic acid alkyl ester copolymer berberine hydrochloride taste-marking ability |
