盐酸艾司洛尔注射液的处方工艺研究

目的研究盐酸艾司洛尔注射液的制备工艺。方法对缓冲剂和稳定剂用量、pH值、活性炭用量等条件进行了筛选。结果加入10%盐酸艾司洛尔和0.71%磷酸二氢钠,1.7%磷酸氢二钠,0.9%氯化钠,调pH值在4.5-5.5,加入0.1%的活性炭,100℃流通蒸汽灭菌30min。制剂质量符合药典有关注射剂的质量标准。结论本品制备工艺可靠,适于工业化生产,质量可控。

Investigation on formulation technology of esmolol hydrochloride injection

OBJECTION To study the preparative process of esmolol hydrochloride injection.METHODS In the experiment,the ratio of buffer and stabilizer,pH,the ratio of activated charcoal to preparative solution in volume and other conditions experiment were selected respectively.RESULT The optimal conditions were established as follows ：Esmolol hydrochloride 10%,sodium dihydrogen phosphate 0.71%,disodium hydrogen phosphate 1.7%,sodium chloride 0.9%,pH 4.5～5.5,activated charcoal 0.1%,flowing steam sterilization 100℃ for 30 min.The quality of the injection conformed to the standard for injection in Chinese pharmacopoeia.CONCLUSION The preparation of Esmolol hydrochloride injection is reliable and suitable for the industrial manufacture.Its quality can be controlled.