制片压力对不同厂家尼群地平片溶出度的影响

目的考查制片压力对市售不同厂家来源的尼群地平溶出度的影响,为片剂生产工艺流程提供参考。方法参考中国药典（2010版）方法,以0.1 mol·L-1盐酸溶液—乙醇（70∶30）900 mL为溶出介质,采用紫外—可见分光光度法,以尼群地平片含量为指标,测定不同厂家尼群地平片体外溶出度,并用相似因子法对实验数据进行统计分析。结果 5个厂家尼群地平片的溶出度存在差异,以金陵药业产品为对照,结果显示F2均小于50,而经过改进压片时压力后,溶出度基本一致。结论不同厂家生产的尼群地平溶出度有一定的差异,制片压力对其影响较大。在生产时应作参考,确保药品质量安全有效。

Tablet pressure influence on dissolution of nitrendipine tablets from different manufacturers

Objective To study the differences in the tablet pressure influence on dissolution of nitrendipine tablets from different manufacturers to provide reference for its process.Methods With reference to the methods in China Pharmacopoeia（2010 Edition）,the vitro-dissolutions of the nitrendipine tablets by different manufacturers were determined respectively,through UV-visible spectrophotometry,along with 0.1 mol·L-1 hydrochloric acid-ethanol（70∶30） 900 mL as dissolution medium,and nitrendipine content as index.And statistical analysis was made of the experimental data by similar factor method.Results There were differences in the dissolution of nitrendipine tablets by 5 respective manufacturers and the similarity was less than 50,which could be achieved after the adjustment of the pressure.Conclusion Special attention should be paid to the difference in the dissolution of the medicine produced by different manufacturers.