Specifics of herbal drugs quality testing with the examples of typical criticism of laboratory testing of those

Abstract

The paper describes the basic quality parameters of the starting materials of herbal origin and herbal drugs, taking into account the requirements of State Pharmacopeia XI and draft general chapters of State Pharmacopeia XIII. It enlists the main terms and definitions, and the requirements to presentation of the quality parameters. It provides the examples of typical criticism of the normative documents on herbal drugs in terms of various quality parameters, including “Appearance”, “Identification tests”, “Chromatography”, “Degree of fineness”, “Assay”. The criticism has been leveled at the quality of both draft normative documents and the samples submitted for testing. The survey conducted allows for explaining the expert requirements to the quality of samples and the presentation of several test methods.

Keywords

• лекарственное растительное сырье
• лекарственные растительные препараты
• показатели качества лекарственного растительного сырья
• экспертиза качества
• типичные ошибки заявителей
• starting materials of herbal origin
• herbal drugs
• quality parameters of starting materials of herbal origin
• quality testing
• applicants’ common mistakes