Preparation and Preliminary Stability Tests of Extemporaneously Prepared Oral Suspending Vehicle for Children / 中国药学杂志

ABSTRACT

OBJECTIVEP To prepare the extemporaneously prepared oral suspending vehicle that can be used in divided doses for children, and preliminary stability experiments are performed. METHODS: Preparation of blank suspending vehicle by prescription screening and optimization. The preparation of suspending vehicle is based on the comprehensive scale of viscosity, redispersibility and appearance traits as the evaluation index, and signal factor study is used. The preliminary stability investigation was carried out.Using propranolole hydrochloride and spironolactone as model drugs, the drug concentration in suspension determined by ultraviolet spectrophotometry and high performance liquid chromatography(HPLC) respectively,which are methods prescribed in Chinese Pharmacopoeia. RESULTS: The dosages of CMC-Na, HPMC, xanthan gum and xylitol in the final formulation of suspension medium were 3.33% (g•mL-1), 1.67% (g•mL-1), 1% (g•mL-1) and 0.1% (g•mL-1),respectively. The extemporaneously prepared oral suspension is uniform, stable and dispersed, and the inspection conforms to the relevant regulations. Average recovery rates of propranolole hydrochloride and spironolactone are meet the relevant regulations. No stratification in the appearance of samples in centrifugal tests. Three batches of test samples remained stable at 4 and 25℃ for 10 d. CONCLUSION: The oral suspending vehicle has a simple and convenient preparation process, the drug dispersion is simple and fast, the content determination method is accurate and reliable, and the stability is good,and can be used as a drug-loading vehicle.