Studies On HPLC Fingerprints And Safety Of Fufang Banbianlian Zhusheye

It is well known that quality control (QC) of traditional Chinese medicine (TCM) is one of the important and difficult tasks of the modernization for TCM. In this disquisition, we focus on the methodology of TCM quality analysis, researches on quality control and its application to Compound Lobelia chinensis Lour. Injection which was carried out.Compound Lobelia chinensis Lour. Injection is made from Lobelia chinensis Lour, Scutellaria barbata D.Don and Hedyotis diffusa Willd. According to The Principle of TCM injection fingerprinting and Chinese Pharmacopoeia published in 2005, some further researches were carried out on the chemical constitutes of Compound Lobelia chinensis Lour. Injection. Based on the existent quality standard of Compound Lobelia chinensis Lour. Injection promulgated by Ministry of Public Health, the high performance liquid chromatographic fingerprint (for short, HPLC fingerprint) and some more new items, such as pyrogen, hypersusceptibility reactions , hemolysis and agglomeration reactions, were added to the existent inspection items. The major work is listed as follows:Objective: To establish the standard HPLC fingerprints of the Compound Lobelia chinensis Lour. Injection, including its medicinal materials, semi-manufactured goods, and finished products, and perfect its inspection items of safety.Methods: (1) Adopt the HPLC method to establish the standard HPLC fingerprints of the medicinal materials.(2) Adopt the HPLC method to establish the standard HPLC fingerprints of the semi-manufactured goods.(3) Adopt the HPLC method to establish the standard HPLC fingerprints of the finished products.(4) Gather 10 or more batches of each specimen, and then judge of the comparability of each specimen, using the Similarity Evaluation System for Chromatographic Fingerprint of TCM (2004A) developed by the Pharmacopoeia Committee of China. To insure the scientificalness and stability of the preparation technics, the relativity among the medicinal materials, semi-manufactured goods, and finished products will be demarcated based on their chromatographic fingerprints.(5) According to The Rudder of TCM Injection Safety Inspection and Chinese Pharmacopoeia (â… ) published in 2005, consummate the inspection items of safety.Results: (1) The HPLC chromatographic conditions of the medicinal materials, semi-manufactured goods, and finished products were confirmed based on the experimentations of different menstruums, different solvent systems, different HPLC columns, different column temperature and different detection wavelengths.(2) In this disquisition, explore for the Chromatographic fingerprint of Compound Lobelia chinensis Lour. Injection. According to The Principle of TCM injection fingerprinting, adopted the method of HPLC to study on the fingerprints of the finished products, the medical materials, and the half-finished products. We established a complete HPLC method of each sample, and inspected the relativity of them. The method is easy to operate, and its stability, reproducibility and precision are all the better, and have extensive applicability.(3) According to The Rudder of TCM Injection Safety Inspection and Chinese Pharmacopoeia (â… ) published in 2005, add the inspection items of pyrogen, sensitization, hemolysis and agglutination tests.Conclusion: (1) The method is scientific and believable, it can be used for the qualitative and quantitative analyses of Compound Lobelia chinensis Lour. Injection.(2) The finding of this disquisition is very important to establish a scientific quality control method of Compound Lobelia chinensis Lour. Injection, it can be used in the practical production for quality control.