氯化血红素固体分散物的研制及其分散特征评价

目的:探讨氯化血红素固体分散物的制备及其分散特征的评价.方法:采用溶剂熔融法制备氯化血红素固体分散物,用差示热量扫描(DSC)图谱、红外光谱、X-射线衍射图谱的变化鉴定药物在载体中的分散特征;并对其溶解度和累积溶出速率进行考察.结果:结果显示,以氯化血红素为主药,聚乙二醇6000(PEG6000)为载体制成的固体分散物中,氯化血红素是以分子状态分散在载体中;经溶解度和累积溶出速率的测定,固体分散物溶解度为原药的49倍,固体分散物较原药在30 min时的累积溶出速率提高了22倍.结论:制成固体分散物后,形成填充型固体溶液,氯化血红素的溶解度和溶出速率均得到显著提高,提示本工艺可行,同时也为氯化血红素新制剂的研究提供科学依据.

Preparation of solid dispersion hemin and evaluation of its dispersing character

OBJECTIVE To investigate the preparation of solid dispersion hemin and to evaluate its dispersing character. METHODS The solid dispersion hemin was prepared by a method of solvent-melt. Differential scanning calorimetery(DSC) and IR-spectra and X-ray powder diffraction analysis were used to identify the disperse shape of hemin in carriers. The solubility and dissolution of the solid dispersion were measured. RESULTS The results showed that hemin in solid dispersion existed in molecule form. The solubility and dissolution of solid dispersion hemin were 49 times and 22 times higher than that of pure hemin, respectively. CONCLUSION The solid dispersion hemin is a solid solution. The solubility and dissolution of hemin in solid dispersion was increased. The preparation technic is feasible. Meanwhile, this result provides scientific basis for research of new preparation of hemin.