【摘要】：目的:對目前國內(nèi)市場硫辛酸注射液制劑的質(zhì)量進(jìn)行評價(jià),為臨床選擇安全、有效、經(jīng)濟(jì)的品種提供科學(xué)的依據(jù)。方法:采用HPLC法對制劑質(zhì)量進(jìn)行分析,色譜柱:Agilent Eclipse XDB-C18色譜柱(150 mm×4.6 mm,5μm);流動相:0.005 mol·L-1磷酸二氫鉀磷酸緩沖溶液(p H 3.0~3.1)-甲醇-乙腈(50∶14∶36);柱溫:30℃;檢測波長:215 nm。建立了同時(shí)測定硫辛酸注射液中硫辛酸、6,8-上硫辛烷酸及未知有關(guān)物質(zhì)限量的HPLC方法,測定了A,B,C,D 4家生產(chǎn)廠家的產(chǎn)品中硫辛酸、6,8-上硫辛烷酸及未知有關(guān)物質(zhì)限量、p H值及滲透壓;并依據(jù)原研廠家(A廠家)硫辛酸藥品注冊標(biāo)準(zhǔn)對不同廠家的產(chǎn)品進(jìn)行了質(zhì)量評價(jià)。結(jié)果:4個(gè)廠家產(chǎn)品硫辛酸含量均在95%~105%之間,符合標(biāo)準(zhǔn)規(guī)定;A,C,D廠家產(chǎn)品的有關(guān)物質(zhì)限量符合標(biāo)準(zhǔn)規(guī)定,B廠家產(chǎn)品總有關(guān)物質(zhì)限量和未知有關(guān)物質(zhì)1限量略超出標(biāo)準(zhǔn)規(guī)定;4個(gè)廠家產(chǎn)品p H值差異不大,符合標(biāo)準(zhǔn)規(guī)定;A,B,C廠家產(chǎn)品的滲透壓符合標(biāo)準(zhǔn)規(guī)定,D廠家產(chǎn)品的滲透壓與其他廠家差異較大,超出A廠家產(chǎn)品標(biāo)準(zhǔn)規(guī)定。結(jié)論:依據(jù)原研廠家(A廠家)硫辛酸藥品注冊標(biāo)準(zhǔn),4個(gè)廠家產(chǎn)品硫辛酸含量均符合標(biāo)準(zhǔn),有關(guān)物質(zhì)限量除B廠家產(chǎn)品略高于標(biāo)準(zhǔn),其余3個(gè)廠家產(chǎn)品均符合標(biāo)準(zhǔn)。
[Abstract]:Aim: to evaluate the quality of lipoic acid injection in domestic market so as to provide scientific basis for clinical selection of safe, effective and economical varieties. Methods: the quality of the preparation was analyzed by HPLC. The column was: Agilent Eclipse XDB-C18 column (150 mm 脳 4.6 mm, 5 渭 m). The mobile phase: 0.005 mol 路L-1 potassium dihydrogen phosphate buffer solution (p H 3.0)-methanol-acetonitrile (50:14:36), column temperature: 30 鈩，

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