Study On Preparation Technology And Quality Standard Of Naoxueling Capsule

ObjectiveOptimize the preparation technology of Naoxueling Capsule and establish its quality standard for its further investigation.MethodsNaoxueling Capsule is a kind of traditional Chinese medicine compound which consists of ten herbs. With the guidance of the theories of Traditional Chinese Medicine and Pharmacy, we are intended to finalize the dose form, find out the optimal manufacture procedure and establish final product quality standard.Water-extract and alcohol-extract based on the function of the prescription and properties of active agents in the herbs which were employed. The best process conditions were screened out by orthogonal method using extracts rate and content. Then the method of granule producing was optimized through investigating relative density of the extractor, drying method and drying conditions. Meanwhile a series of experiments were carried out including the angle of repose, hydroscopicity of granule. In quality standard study, Salvia multiorrhiza Bge., Pseudostellaria heterophylla, Astragalus membranaceus and Eucommia ulmoides Oliv. were identified by TLC. The content of Tanshinoneâ…¡A and astragalosid were determined by HPLC and assay methods were validated ResultsThe capsule is better.The optimum extraction condition obtained was 75% ethanol, with the volume of 12,8 and 7 folds of amount of Actinidia arguta roots, etc. refluxing and extracting for 3 times (2 hour,1.5 hour,0.5 hour). Then the sediment and the other herbs were extracted 2 times (2 hour,1 hour) by water, with the volume of 12,8folds.A mixture was got by combining the condensed ethanol-extract and water-extract with excipients. The mixture was turned into granule product by spray drying and granulation. The granule product and studied the quality standard, identification methods of herbs thin layer chromatography (TLC) were well-established. Through methodology evaluation, quantitative analysis methods were finalized and a preliminary content criterion was set up.ConclusionsThe preparation techniques of Naoxueling Capsules are reasonable and practical; the quality of the product is stable and controllable.