松萝酸滴丸的制备及体外溶出度研究

Preparation of Usnic acid Dropping Pills and Study on its Dissolution in Vitro

为优选松萝酸滴丸剂的制备工艺,考察其体外溶出度。采用均匀设计法,以圆整度、重量差异为指标,对滴丸的制备工艺条件进行优选;采用反相高效液相色谱法测定含量,考察松萝酸滴丸的体外溶出度。结果表明,滴丸的最佳制备工艺条件为:药物与基质配比为3%,PEG(6 000∶4 000)为0∶100,料温为70℃,滴距为3 cm,体外溶出度良好。该方法简便可行,结果可靠,适用于实验室小量制备和放大生产,体外溶出度符合《中国药典》要求。

To establish the optimized preparation procedure of usnic acid dropping pills and to assay its dissolution in vitro, the preparation conditions were studied with the index spherical degree and weight variation by Uniform Design. RP-HPLC method was used to determine the content of usnic acid in dropping pills, and the dissolution of usnic acid from dropping pills was studied. The usnic acid proportion = 3%, PEG（6 000：4 000） = 0： 100, the temperature of mixture of usnic acid and PEG = 70 ℃, dropping distance = 3 cm. The dissolution of usnic acid dropping pills in vitro showed that the cumulative percentage of usnic acid was good. The above shows that the preparation procedure is fea- sible, simple and suitable, and the method established in this paper can be adopted for the quality control of usnic acid dropping pills. The results of the dissolution in vitro met the request of China pharmacopeia.