【摘要】：目的考察國內(nèi)9個(gè)廠家生產(chǎn)的尼莫地平片與原研制劑(商品名:尼膜同)的體外溶出度,比較體外溶出行為,為臨床選擇用藥及控制國產(chǎn)尼莫地平的質(zhì)量提供理論依據(jù)。方法采用高效液相色譜法測定尼莫地平片分別在純化水(質(zhì)量分?jǐn)?shù)0.3%SDS)、p H值1.2氯化鈉鹽酸溶液(0.3%SDS)、p H值4.5醋酸鹽緩沖液(0.3%SDS)和p H值6.8磷酸鹽緩沖液(0.3%SDS)共4種溶出介質(zhì)中的溶出度,并用f2相似因子法評(píng)價(jià)溶出曲線的相似性。結(jié)果只有一個(gè)廠家生產(chǎn)的尼莫地平片在4種溶出介質(zhì)中f2相似因子大于50,與原研制劑相似;其余廠家生產(chǎn)的尼莫地平片在4種溶出介質(zhì)中溶出行為與原研制劑不相似。結(jié)論多數(shù)國產(chǎn)的尼莫地平片與原研制劑溶出過程存在顯著性差異,臨床應(yīng)用時(shí)應(yīng)加以注意。廠家應(yīng)積極改進(jìn)現(xiàn)有工藝,嚴(yán)格控制藥物的溶出速率。
[Abstract]:Objective to investigate the dissolution rate of nimodipine tablets produced by nine domestic manufacturers in vitro and to compare the dissolution behavior in vitro, so as to provide theoretical basis for clinical selection of nimodipine tablets and control of the quality of domestic nimodipine tablets. Methods Nimodipine tablets were determined by high performance liquid chromatography (HPLC) in purified water (mass fraction 0.3%SDS), p H 1.2 sodium chloride hydrochloric acid solution (0.3%SDS). The dissolution rate of acetate buffer (0.3%SDS) and pH 6.8 phosphate buffer (0.3%SDS) were 4.5. the similarity of dissolution curve was evaluated by f2 similarity factor method. Results the f _ 2 similarity factor of nimodipine tablets produced by only one manufacturer was more than 50 in four kinds of dissolution media, which was similar to that of the original preparation, while the dissolution behavior of nimodipine tablets produced by other manufacturers in the four dissolution media was not similar to that of the original preparation. Conclusion the dissolution process of most domestic nimodipine tablets is significantly different from that of the original preparation, which should be paid attention to in clinical application. Manufacturers should actively improve the existing process and strictly control the dissolution rate of drugs.
【作者單位】： 沈陽藥科大學(xué)藥學(xué)院
【分類號(hào)】：R943

【參考文獻(xiàn)】

相關(guān)期刊論文 前10條

1 彭興盛;王也牧;李s，

本文編號(hào)：2483335