Preparation and Preliminary Stability Tests of Extemporaneously Prepared Oral Suspending Vehicle for Children
CAI Zhi-bo1, CHEN Ping-ping2, LIN Yan1, WANG Hong2*
1. Department of Pharmacy, The Children′s Hospital, Zhejiang University School of Medicine,National Clinical Research Center for Child Health, Hangzhou 310052,China; 2. Hangzhou Medical College, Hangzhou 310053, China
Abstract：OBJECTIVE 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.
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