骨肽类制剂的降压物质检查

目的建立骨肽类制剂的降压物质检查法。方法根据《中华人民共和国药典》2020年版中降压物质检查法,比较骨肽类制剂与组胺对照品间、相同企业制剂与骨肽炎原液间所致的降压程度差异,并考察骨肽类原液与其制剂引起降压的相关性。结果6家生产企业的22批次样品(骨肽注射液、注射用骨肽、复方骨肽注射液、骨肽氯化钠注射液、骨瓜提取物注射液、注射用复方骨肽、注射用骨瓜提取物、注射用鹿瓜多肽)均符合规定。结论建议提高骨肽类制剂与原液的质量标准,增订降压物质检查项,以保障药品质量。

Detection of the Depressor Substances of Osteopeptide Preparations

Objective To establish a method for the detection of depressor substances in osteopeptide preparations.Methods According to the mothed in Pharmacopoeia of the People's Republic of China(2020),comparing the difference between bone peptide preparation and histamine reference substance,preparation and stock solution in the same enterprise,and in order to investigate the correlation between bone peptide stock solution and its preparations.Results A total of 22 batches of samples(including bone peptide injection,bone peptide for injection,compound bone peptide injection,bone peptide sodium chloride injection,bone melon extract injection,compound bone peptide for injection,bone melon extract for injection,bone melon extract for injection,and cervus melon peptide for injection)from 6 manufacturers were all in conformity with the requirements.Conclusion It was suggested that depressor substance test should be added into the quality standard of osteopeptide preparations,which is essential to ensure the quality of the drug.