Zaleplon The Quality Of Raw Materials And Its Capsule Formulation Of Standards And Stability

Insomnia, with high incidence, is one of the common clinical symptoms to which sedative-hypnotic is a main treatment. Zaleplon (the brand is Sonata ) is a non- benzodiazpine hypnotics product (a zolpidem chemical compound) developed by Wyeth-Ayerst Laboratories Inc. It has such functions as tranquilization and hypnotism, muscular relaxation, anxiety and convulsive resistance. It can be selected to act on benzodiazpine r-GABA sub-type A receptor to improve sleep. Taken orally, it reaches the concentration peak, with short T1/2 about 1h. Clinical experiments abroad have proven that Zaleplon has no effect on REM while it helps to maintain normal sleep. Compared with zolpidem, the first choice for treatment of insomnia, Zaleplon has the advantages of stronger and quicker effect, shorter T1/2 and no side-effect when a patient stops taking it. Compared with benzodiazepine sedative-hypnotics, Zaleplon has the advantages of falling asleep sooner, less hangover in daytime, and less addiction, fewer reactions when a patient stops taking it, and less reversal insomnia, etc. Zaleplon is now available for distribution in the countries of U.S. A, Denmark, Sweden and so on. And in China many factories are producing imitations of it, mainly tablets and capsules, but not for distribution, and the studies of its quality control have not been found yet.The physical and chemical properties, and physical constant of Zaleplon materials were studied in this paper. A specific HPLC method with high sensitivity was also established which has desirable separation results. Thecontent uniformity and dissolution of Zaleplon was studied, using HPLC to keep control of materials concerned, and ultraviolet spectrophotometric determination to determine the content. The appearance, melting point, filler appearance, dissolution, the stability and changes of the materials and content are also discussed.