Glucosamine Hydrochloride Tablets And Different Method For The Determination Of Evaluation

Based on glucosamine hydrochloride as model drug, the study prepared the tablets which had the feature of safety, efficacy, easy manufacture, stable technology and lower cost. Through studying various influence factors, we get the optimal formulation and preparation. And the study established the quality control in full to ensure the safety and efficacy of glucosamine hydrochloride tablets. In the final stability investigation, detailed data indicated the tablets had fine qualities.In formulation design, using the method of single factor investigation and studying the varieties and dosage of fillers, lubricants, glidants and disintegrants, the excipients and their dosage were optimized considering several evaluation quotas such as angle of repose, appearance and disintegration time. So the simple and time-saved powder direct compression can be possible. In addition, the study also optimized the rigidity as one of technic parameters. According to selective formulation and preparation to manufacture glucosamine hydrochloride tablets, the products had nice appearance and were easy to disintegrate. All of quotas were meet to regulation. In accordance with 2005 edition of Chinese Pharmacopoeia, the quality studies on glucosamine hydrochloride tablets were carried out, including characteristics, identification, examination, dissolution and content assay, etc. The TLC examination method used to determine related substance and the colorimetric method used to determine dissolution were set up. Colorimetric method and RP-HPLC method were compared in content determination. After methodology verification, the experiment results by above methods were accurate and reliable. The determination results of three tablet samples showed these methods were valid to control the quality of glucosamine hydrochloride tablets.Stability studies contained stress testing, accelerated testing and long-term testing. The results of these studies indicated the appearance, content, dissolution and related substance of glucosamine hydrochloride tablets hadn't obvious change and the tablets had good stability.