目的 比較國產(chǎn)煙酰胺片在4種不同pH溶出介質(zhì)中的溶出行為的差異，比較不同廠家藥品的內(nèi)在品質(zhì)，為藥品質(zhì)量控制與仿制藥質(zhì)量一致性評價提供參考。方法 通過體外溶出度試驗，測定3家企業(yè)生產(chǎn)的9批次煙酰胺片在4種不同pH溶出介質(zhì)中的溶出度。結(jié)果 試驗涉及到3家企業(yè)的9批樣品，上海信誼委托上海黃河制藥生產(chǎn)的3批樣品在4種介質(zhì)中的溶出行為差別不明顯，且批間溶出行為差異較為一致；天津力生制藥股份有限公司、廣州康和藥業(yè)有限公司生產(chǎn)的各3批樣品，在4種溶出介質(zhì)中的溶出行為有一定的差異；且批間溶出行為有較大差異；用新建立的溶出度檢查法測定不同來源的73批樣品，結(jié)果仍有19批樣品溶出量低于75%。結(jié)論 目前國內(nèi)該品種生產(chǎn)處方工藝差異較大，不同廠家、同一廠家不同批號樣品溶出行為存在差異。生產(chǎn)企業(yè)應(yīng)加強(qiáng)處方工藝的篩選、優(yōu)化，提高改進(jìn)生產(chǎn)工藝。建立的溶出度測定方法可作為藥品內(nèi)在質(zhì)量控制的有效手段之一。

Objective By comparing the difference of dissolution behavior of domestic nicotinamide tablets in four different pH dissolution media and comparing the intrinsic quality of different manufacturers'drugs,it provides a reference for drug quality control and generic drug quality consistency evaluation.Method The dissolution profiles of 9 batches of nicotinamide tablets produced from 3 pharmaceutical factories was determined in 4 different pH dissolution media by an in vitro dissolution test.Result The test involved 9 batches of samples from 3 companies.The dissolution behavior of the three batches of samples produced by Shanghai Huanghe entrusted by Shanghai Xinyi pharmaceutical factory was not obvious,and the difference in dissolution behavior between batches was consistent.The dissolution behaviors of the 3 batches of samples produced by Tianjin Lisheng pharmaceutical factory and Guangzhou Kanghe pharmaceutical factory were different in the 4 dissolution media;and the dissolution behavior between batches was quite different.When 73 batches of samples from different sources were determined using the newly established dissolution test,the results showed that there were still 19 batches of samples with a dissolution of less than 75%.Conclusion At present,there are significant differences in the processes for producing prescriptions of this medicine in China,which is reflected in the difference in dissolution rate of samples from different manufacturers or samples of different batches of the same manufacturer.Production enterprises should strengthen the screening and optimization of prescription processes and improve the production process.Establishing dissolution measurement method can be used as one of the effective means for internal quality control of drugs.