安徽医药
安徽醫藥
안휘의약
ANHUI MEDICAL AND PHARMACEUTICAL JOURNAL
2014年
7期
1220-1221,1222
,共3页
尼群地平%溶出度%制片压力
尼群地平%溶齣度%製片壓力
니군지평%용출도%제편압력
nitrendipine%dissolution%tablet pressure
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。
目的：攷查製片壓力對市售不同廠傢來源的尼群地平溶齣度的影響，為片劑生產工藝流程提供參攷。方法參攷中國藥典（2010版）方法，以0．1 mol· L-1鹽痠溶液-乙醇（70∶30）900 mL為溶齣介質，採用紫外-可見分光光度法，以尼群地平片含量為指標，測定不同廠傢尼群地平片體外溶齣度，併用相似因子法對實驗數據進行統計分析。結果5箇廠傢尼群地平片的溶齣度存在差異，以金陵藥業產品為對照，結果顯示F2均小于50，而經過改進壓片時壓力後，溶齣度基本一緻。結論不同廠傢生產的尼群地平溶齣度有一定的差異，製片壓力對其影響較大。在生產時應作參攷，確保藥品質量安全有效。
목적：고사제편압력대시수불동엄가래원적니군지평용출도적영향，위편제생산공예류정제공삼고。방법삼고중국약전（2010판）방법，이0．1 mol· L-1염산용액-을순（70∶30）900 mL위용출개질，채용자외-가견분광광도법，이니군지평편함량위지표，측정불동엄가니군지평편체외용출도，병용상사인자법대실험수거진행통계분석。결과5개엄가니군지평편적용출도존재차이，이금릉약업산품위대조，결과현시F2균소우50，이경과개진압편시압력후，용출도기본일치。결론불동엄가생산적니군지평용출도유일정적차이，제편압력대기영향교대。재생산시응작삼고，학보약품질량안전유효。
Objective To study the differences in the tablet pressure influence on dissolution of nitrendipine tablets from different man -ufacturers 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 spectropho-tometry,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 .
