摘要
对国产及进口PGE_1进行了含量测定.试验药为国内4个药厂(简称A、B、C.D)和德国SCHWARZ药厂产品.采用高效液相色谱法进行测定.结果:与B、C、D药厂的产品相比,A药厂的药品含量与标示量(100μg/支)比较接近,平均为104μg/支,批内含量最大差为7.4%,各支被测样品间含量最大差为8.3%.且以上质量指标均接近德国SCHWARZ药厂的对应质量标准.表明国产PGE_1质量正开始接近国际先进产品水平.
We compared the content of domestic PGEi with Germany Schwarz PGE1's. The intravenous PGE1 we studied were produced by four Chinese local Pharmaceuticals (showed by A,B,C,and D)and Germany Schwarz Pharma. AG.. Three batches of each phar-macutical and three ampoules of each batch were determined respectively by HPLC.The results showed that among the Chinese local Pharmaceuticals,the content of PGE1 of the D was close to what was indicated. The average PGE1 content was 104μg/ampoule. The maximum difference of PGE1 content within batch was 7. 4%. The maximum difference of PGE1 content was 8.3% among ampoules. All above data were close to that of Germany Schwarz.Thus this study showed that some products of PGE1 produced by our country have been closly as well as that of Germany Schwarz.
出处
《中国临床药学杂志》
CAS
1997年第2期80-82,共3页
Chinese Journal of Clinical Pharmacy
