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目的:研究雪荔组方有效部位的制剂工艺,并对体外溶出情况进行考察。方法:以辅料的种类、内容物的吸湿性、流动性和乙醇的浓度为考察指标,研究雪荔组方有效部位胶囊的制剂工艺;采用HPLC法以高车前苷、高车前素为指标,对其体外溶出度进行考察。结果:制得胶囊外观整洁,无粘结、变形、渗漏或囊壳破裂现象。药物在60 min内体外溶出达90.0%左右。胶囊中高车前苷的溶出趋向于Weibull分布模型、高车前素的溶出趋向于Higuchi方程。结论:本法研制的雪荔组方有效部位胶囊,工艺合理可行,且溶出符合要求。
OBJECTIVE: To study the preparation technology of the effective fractions of XIE Li’s prescription and investigate the dissolution in vitro. Methods: Based on the excipients, the hygroscopicity, the liquidity and the concentration of ethanol in the study, the preparation technology of the capsule of effective part of Xueli Decoction was studied. The HPLC method was adopted to take the homocysteine and homocysteine as indexes , Its dissolution in vitro were investigated. Results: The prepared capsules were neat, no sticking, deformation, leakage or capsule shell rupture. Drugs in vitro dissolution in 60 min up to 90.0%. The dissolution of glycosides in high car in the capsule tends to the Weibull distribution model, and the dissolution of pro-carotenoids tends to the Higuchi equation. Conclusion: This method developed Xueli group prescription effective capsule, process is reasonable and feasible, and the dissolution meets the requirements.