摘要
目的建立复方牛黄消炎胶囊溶出度测定方法,通过实验拟定以盐酸小檗碱在不同时间内溶出量作为测定参数,考察不同生产厂家不同批次复方牛黄消炎胶囊中盐酸小檗碱溶出度情况。方法通过测定和评价不同生产厂家不同批次复方牛黄消炎胶囊中盐酸小檗碱的体外溶出度曲线,运用相似因子评价法,筛选出溶出行为相似的厂家,从而进一步评价产品质量。结果不同生产厂家不同批次复方牛黄消炎胶囊中盐酸小檗碱体外溶出度情况存在显著性差异,溶出行为均不一致。结论所建方法较准确地模拟了该药品在体内的溶解释放情况。
Objective To establish the dissolution determination method for compound niuhuangxiaoyan capsules,to propose through the experiment with the dissolubility of berberine hydrochloride in different time as measurement parameters,to review the dissolution behavior of berberine hydrochloride in Compound Niuhuangxiaoyan Capsules of different batches produced by different producers. Method Through the measurement and evaluation of different manufacturers in different batches of the dissolution of berberine hydrochloride in Compound Niuhuangxiaoyan Capsules,cumulative dissolution curve was drawn. And using similarity factor evaluation method,the dissolution behavior of similar factory was selected. Further,evaluation of the quality of the product was done. Results An inconsistent dissolution behavior and considerable dissolution differences in Compound Niuhuangxiaoyan Capsules among different batches and different manufacture factories were showed. Conclusion This method can quantitatively determine the dissolution of berberine hydrochloride in Compound Niuhuangxiaoyan Capsules,and accurately simulate the dissolution and release of the drug in the body.
出处
《青海医学院学报》
CAS
2014年第3期196-201,共6页
Journal of Qinghai Medical College
关键词
复方牛黄消炎胶囊
溶出度
相似因子
盐酸小檗碱
Compound Niuhuangxiaoyan Capsules dissolution berberine hydrochloride similarity factors
