摘要
目的:依据因素选择和正交实验优选出壮药补肺消积饮颗粒的最佳提取、浓缩、干燥和成型工艺,为制备壮药补肺消积饮颗粒、研究其质量标准给予指导。方法:以主母药半枝莲中野黄芩苷含量和总干膏为综合评价指标,优化该制剂的制备工艺;同时对黄芪、白花蛇舌草、三七、半枝莲开展薄层色谱(TLC)鉴别。结果:壮药补肺消积饮的最佳水提工艺参数建议为10倍量水煎煮该复方十二味中药材,提取1 h×2次;提取液浓缩在70℃条件下的最优相对密度是1.30~1.32,最佳干燥工艺为在70℃下干燥2h,干燥至含水量6%以下;最优成型工艺为加入辅料混合比例为2∶1糊精与羧甲淀粉钠,稠膏与辅料比例为1∶1.4。经质量标准初步研究,薄层色谱中能鉴定出白花蛇舌草、半枝莲、三七和黄芪。结论:该生产工艺科学稳定、规范合理、成品率好且质量可控,所得的工艺参数可为壮药补肺消积饮颗粒的生产提供参考,适合医药企业放大生产。
Objective: According to factor selection and orthogonal experiment, the optimal extraction, concentration, drying and molding process of Zhuang medicine Bufei Xiaojyin granules were optimized, which provided guidance for the preparation of Zhuang edicine Bufei Xiaojyin granules and the study of its quality standard. Methods: Taking the content of scutellarin in Scutellaria barbata and total dry ointment as comprehensive evaluation indexes, the preparation process of the preparation was optimized;Meanwhile, Astragalus membranaceus, Hedyotis diffusa, Panax notoginseng and Scutellaria barbata were identified by thin layer chromatography(TLC). Results:The optimal water extraction parameters of Zhuang medicine Bufei Xiaojiyin is recommended to decoct the compound twelve-flavored Chinese medicines with 10 times the amount of water and extract them for 1 h×2 times;the optimum relative density of the cextract concentrated at 70℃ is 1.30 to 1.32. The optimum drying process is to dry at 70℃ for 2 hours, drying to moisture content below 6%;the optimum molding process is to add excipients in a mixture ratio of 2∶1 dextrin and sodium starch glycolate, thick paste and the proportion of accessories is 1∶1.4. Preliminary research on quality standards showed that Oldenlandia diffusa, Scutellaria barbata, Panax notoginseng and Astragalus could be identified by thin layer chromatography. Conclusion: The process parameters optimized in this study can provide reference for the production of Zhuang medicine Bufei Xiaojiyin granules. The production process is scientific and stable, standardized and reasonable, with good yield and controllable quality, which is suitable for scale-up production of pharmaceutical companies.
出处
《大众科技》
2022年第1期48-52,共5页
Popular Science & Technology
基金
国家自然科学基金(81660774)
广西自然科学基金面上项目(2020GXNSFAA238011)
广西壮族自治区科技厅重点研发计划项目(桂科AB17195067)
广西研究生教育创新计划项目(YCBZ2021077)
广西高校中青年教师科研基础能力提升项目(2021KY0310)
国家中医药管理局荣远明老中医药专家学术经验传承工作室项目[2011]41号。
关键词
补肺消积饮颗粒
正交设计
制备工艺
薄层色谱
质量标准
含量测定
Bufei Xiaojiyin granules
orthogonal design
preparation technology
thin layer chromatography
quality standard
content determination
