90批盐酸小檗碱片溶出度的测定和评价

Determination and Evaluation of Dissolution in 90 Batches of Berberine Hydrochloride Tables

目的:建立盐酸小檗碱片溶出度的高效液相色谱的测定方法,考察市售盐酸小檗碱片的溶出度情况。方法:比较紫外可见分光光度法与高效液相色谱法对90批盐酸小檗碱片的溶出度的测定结果。结果:两种测定方法对黄色糖衣片样品测定结果有差异(偏差>10%)。同厂家同批次批间溶出度差异较大。结论:高效液相色谱法能更加准确地测定盐酸小檗碱片的溶出量。各厂家应更加注重生产工艺稳定性,严格控制药品质量。

Objective ：To establish a high performance liquid chromatography （HPLC） determination method of dissolution of Berberine Hydrochloride Tables,the 90 batches of Berberine Hydrochloride Tables was investigated. Methods ：The dissolution of 90 batches Berberine Hydrochloride Tables was solved both by uv-visible spectrophotometry and high performance liquid chromatography. Results ：The results of the two methods were different （〉10%） in the yellow sugar-coated tablets. The results of dissolution between the same batch with the same manufacturer were differences. Conclusion ：High performance liquid chromatography （HPLC） method is more accurately for the determination of dissolution. Each manufacturer should pay more attention to production process stability,and strictly control the quality of medicines.