摘要
目的 建立RP HPLC测定复方丹参注射液中丹参素及原儿茶醛的含量 ,比较不同厂家复方丹参注射液的质量。方法 利用RP HPLC对本品进行质量评价。共收集由 1 1个厂家生产的 1 4批样品。结果 用HPLC测定 2个活性成分丹参素和原儿茶醛分别在 7.5～ 1 50 .0 μg·mL- 1 和 2 .5～ 50 .0 μg·mL- 1 内线性关系良好 ,相关系数达 0 .9999。平均回收率丹参素为1 0 1 .0 7% (RSD =1 .2 6 % ,n =5)、原儿茶醛为 1 0 1 .84% (RSD =1 .54 % ,n =5)。 1 1厂家原儿茶醛的含量均符合部颁标准(WS3 B 32 89 98)规定 ,但厂间差异较大。结论 测定方法灵敏、准确、可靠。
OBJECTIVE: To establish a RP-HPLC assay for the determination of Danshensu and protocatechuicaldehyde(PCAD) in compound Danshen Injections, and to assess the quality of different brands and batches of them. METHODS: A RP-HPLC assay was developed. The samples from 14 batches produced by 11 manufactures were collected and evaluated, respectively. RESULTS: The linearity of the calibration curves was obtained for Danshensu (7.5-150.0 μg·mL-1) and PCAD (2.5-50.0 μg·mL-1), respectively, with the correlation coefficient beyond 0.9999. The mean recoveries of the assay were 101.07% (RSD= 1.26%, n = 5) for danshensu and 101.84% (RSD= 1.54%, n = 5) for PCAD respectively. The contents of PCAD in all products estimated complied with the criterion of the Ministry of Public Health (WS3-B-3289-98). CONCLUSION: This method achieved good sensitivity, accurcy and reliability. The quality of product K was superior among the products evaluated.
出处
《中国药学杂志》
EI
CAS
CSCD
北大核心
2003年第1期56-58,共3页
Chinese Pharmaceutical Journal
