苦碟子冻干粉针的制备及工艺研究

Preparation of Ixeris sonchifolia Hance Freeze-dried Powder Injection and Study on the Technique Thereof

目的:制备苦碟子冻干粉针,并考察其优化工艺。方法:建立苦碟子冻干粉针中黄酮和腺苷含量的HPLC和UV检测方法。对赋形剂的种类和用量、冻干制品pH值、活性炭的用量和吸附时间以及冻干工艺进行优化筛选。以黄酮和腺苷含量及HPLC指纹图谱作为苦碟子冻干粉针的主要质量考察指标。结果:按照优化筛选的处方和工艺制得苦碟子冻干粉针,其黄酮和腺苷含量分别不低于25%和0.1%,其HPLC指纹图谱能与提取液或冷冻干燥前后中间制品的图谱特征基本吻合,其室温留样12个月稳定性良好。结论:本文所制苦碟子冻干粉针处方合理,制备工艺可行,质量可控。

Objective： To prepare lxeris sonchifolia Hance freeze-dried powder injection and to study the preparation technique thereof. Methods： HPLC and UV methods for determination of contents of flavonoids and adenosine in the freeze-dried powder injection were established. The variety and amount of excipient, pH value of the preparation, the amount and adsorption tittle of activated carbon and freeze-drying technique in the preparation process were optimized. The contents of flavonoids and adenosine and HPLC fingerprints were used as primary measures for quality control. Results： The powder injection was prepared using the optimized for- mulation and technique, in which the contents of flavonoids and adenosine were no less than 25 % and 0.1% respectively and of which the fingerprint coincided essentially with those of the exact or the intermediate preparation before and after freeze-drying. It showed good stability for 12 months at room temperature. Conclusion： The formulation of the powder injection is reasonable, its preparation technique is practicable and its quality is controllable.