目的 优选甘草素注射液的制备工艺。方法 通过单因素考察确定制剂的溶剂、辅料用量、pH、热原去除方法、灭菌工艺等,筛选出最优工艺条件。结果 最佳工艺条件为甘草素溶于pH 4.0~6.0,含量为40%的丙二醇溶液中,采用超滤法除去细菌内毒素,灭菌条件为121 ℃(97 kPa),灭菌15 min。结论 甘草素注射液制备工艺条件合理,利于生产操作,可用于工业化生产。
Abstract
OBJECTIVE To optimize the preparation process of liquiritigenin injection. METHODS Single factor experiment was carried out to determine the solvents, dosage of adjuvants, pH of solution, pyrogen removal method and sterilization process. RESULTS The optimal conditions were determined as follows: liquiritigenin was dissolved in 40% propylene glycol solution at pH 4.0-6.0. Ultrafiltration was employed to remove bacterial endotoxin. The solution was sterilized at 121 ℃(97 kPa) for 15 min. CONCLUSION The established preparation process of liquiritigenin injection is reasonable and suitable for industrialized production.
关键词
甘草素 /
中药注射剂 /
制备工艺
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Key words
liquiritigenin /
traditional Chinese medicine injection /
preparation process
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中图分类号：
R944
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参考文献
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脚注
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基金
江苏省自然科学基金资助项目(BK2011134,BK20141094);江苏省中医药局科技资助项目(PY201518)
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