Studys On The Preparation And Quality Standards Of Huanglianejiao Particles

Huanglian Ejiao particles is Chinese medicine theory, clinical application and therapeutic effect for many years significant experience in prescriptions for the treatment of insomnia, Original prescription for the decoction, the subject of its research and development for new drugs, in summing up a large number of relevant documents, based on prescriptions for the composition of the various herbs, the extraction process, granules of the production process, quality standards and The stability of the initial preparation of the system.Preparation of:access to relevant literature by reference to prescription medicine in the physical and chemical properties of bio-active components, the application of modern pharmacological and clinical applications, development of the extraction process route. Prescription Ejiao crushed into a fine powder directly into the same time, can replace some of the accessories; the rest of Lithospermum, to yellow, etc.3herb extract used boiling water, The main factors, we have researchd by the single-factor test and multi-factor orthogonal test by the appropriate assessment indicators,Single factor test to determine the number of extraction; through L9(34) orthogonal test, the incubation time, the amount of water and extraction time were investigated to determine the optimal extraction conditions; order to reduce the dosage, the refined process test, through concentration, the relative density were studied to determine the best conditions; concentration and drying test, the pressure on drying time and temperature test ultimately determine the suitable drying pressure and temperature range; made of particles in the process of formulation for three commonly used auxiliary particle preparations were screened for the percentage of granule shape, percentage of absorption of water, melting and so on as the main test of the index, select the most suitable accessories and proportion. Preparation of a whole is very smooth, reasonable and stable.Quality Standard:To ensure the quality of preparation and stability and control, the issue using modern science and technology Huanglian Ejiao granules were identified and analyzed,3of which are establishment of a micro thin layer chromatography identification of projects, high performance liquid chromatography determination of baicalin established detection. Product quality control purposes can be achieved.Preparation of preliminary stability test:According to "Drug Registration" in the technical requirements of a preliminary test the stability of, respectively,0months,1month,2months,3months,6month (also continue) and regularly test, on the granule characteristics, identification, content and other indicators of physical and chemical testing and other aspects, experimental results show that the study of the indicators have been stable, and both standard and "Chinese Pharmacopoeia"2005Edition1Part of the granules under its provisions.