目的 制备可用于分剂量给药的儿童临时调配口服混悬介质,并进行初步稳定性实验。方法 通过处方筛选和优化制备临时调配混悬介质,并将盐酸普萘洛尔片和螺内酯片为模型药物制备临时调配的口服混悬液,分别采用紫外分光光度法和高效液相色谱法测定混悬液中盐酸普萘洛尔和螺内酯的含量,以离心实验和留样观察进行初步稳定性考察。结果 最后确定的混悬介质处方中羧甲基纤维素钠(CMC-Na)、羟丙基甲基纤维素(HPMC)、黄原胶和木糖醇的用量分别为3.33%(g·mL-1)、1.67%(g·mL-1)、1%(g·mL-1)和0.1%(g·mL-1),混悬介质均匀细腻,稳定性、分散性良好,各项检查均符合相关规定,盐酸普萘洛尔和螺内酯的回收率均符合要求;离心实验中样品外观未见分层,3批样品在4和25 ℃环境中留样观察10 d性质稳定。结论 该口服混悬介质制备工艺简单方便,药物分散简单快速,性质稳定,可作为载药介质制备临时调配制剂使用。
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.
关键词
临时调配 /
口服混悬液介质 /
儿童 /
盐酸普萘洛尔 /
螺内酯
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Key words
extemporaneously prepared /
oral suspending vehicle /
children /
propranolol hydrochloride /
spironolactone
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中图分类号：
R942
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参考文献
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脚注
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基金
浙江省医药卫生科技项目资助(2018KY450);浙江省教育厅科研项目资助(Y201636007)
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