A Variety Of Modern Instrumental Analysis Methods To Improve Research Quality Standards Of The Motherwort Injection

In recent years reports about Adverse Reaction (ADR) caused by Traditional Chinese Medicine Injection (TCMI) were gradually increased and TCMI ADR has come to be the focus of society. To change this kind of situation, various scientific researches and tasks, such as establishing fingerprint chromatography and improving quality standards of TCMI, were carried out one after another.Establishing fingerprint of Leonurus injection and enhancing the quality standards was one of the first action plan that was approved by China Pharmacopoeia Committee. The research established appraisal methods of HPLC fingerprint of Leonurus injection, intermediate and medicinal materials and perfected the quality standards.Firstly, many kinds of methods of chromatography were used to analyze Leonurus injection. (1)The combination of HPLC with Time-of-Flight mass spectrometer technology(HPLC-TOF) was used to measure molecular weight accurately for analyzing the main components of Leonurus injection and researched deeply on main components in the injection produced by standard technology.(2) A chromatographic condition of capillary zone electrophoresis was established after screening different capillary column, buffer salt and determined wavelength. Much information was acquired and good foundation was set up for the purpose of building a much stronger applicable liquid Chromatogram. (3) Thin layer chromatography with different condition was carried out to analyze Leonurus injection. (4) The analytical condition of reversed phase chromatography, binary ion pair chromatography and ion - exchange chromatography were built by the combination of HPLC with Photodiode Array Detector (HPLC-DAD) technology. (5) Establishing the criterion for evaluation different chromatographic methods. The criterion had six-assessment indexes including repeatability, durability, resolution, information, operability and experiment cost. According to these indexes, the results of experiments were estimated quantitatively and the optimal fingerprint chromatography of Leonurus injection was selected. The best one was reversed phase chromatography.Secondly, using the selected fingerprint chromatography improved the whole quality standards of Leonurus injection. (1) Extracted common chromatographic peaks from clinical long-term applicative and representative samples. (2) Surveyed former production technology and optimized technological parameter. (3) Composed the standard fingerprint and builted standard reference material of Leonurus injection. (4) Established standard fingerprint of intermediate and medicinal materials.Thirdly, added 3 items after analyzing the current quality standards of Leonurus injection. The added items were related substance test, fingerprint chromatography and quantitative determination of stachydrine hydrochloride by HPLC method. The quality standard of Leonurus injection was improved and the stability of this injection had guaranteed. Good foundation was set up for researching component in this injection and efficacy of it in the future.