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| 复方麻杏益肺合剂制备工艺及质量标准研究 |
| Research on the preparation technology and quality standard of Fufang Maxing Yifei mixture |
| 投稿时间：2025-03-27 修订日期：2025-03-27 |
| 中文关键词: 复方麻杏益肺合剂 制备工艺 质量标准 盐酸麻黄碱 盐酸伪麻黄碱 |
| 英文关键词: Fufang Maxing Yifei mixture preparation technology quality standards ephedrine hydrochloride eseudoephedrine hydrochloride |
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| 中文摘要: |
| 目的 建立科学合理的复方麻杏益肺合剂制备工艺和质量控制标准。方法 以出膏率、盐酸麻黄碱和盐酸伪麻黄碱的总量为指标,通过正交试验设计优选提取工艺参数；通过小试和中试验证工艺合理性；采用薄层色谱法(TLC)对合剂中麻黄、甘草、连翘进行鉴别；采用高效液相色谱法对合剂中盐酸麻黄碱、盐酸伪麻黄碱进行含量测定；对pH和相对密度进行测定。结果 经优化的制备工艺为12倍水量/1.5h和10倍水量/1h煎煮,滤过,合并滤液,浓缩至相对密度为1.02以上,趁热加入羟苯乙酯0.5g,搅拌使溶解,静置,取上清液,加水至全量,搅匀,分装,灭菌；TLC斑点清晰,分离度良好,阴性对照无干扰；盐酸麻黄碱、盐酸伪麻黄碱在进样量0.0103～0.0776µg和0.0101～0.0761µg范围内与HPLC峰面积呈良好线性关系,相关系数均在0.999以上,平均加样回收率分别为97.99%和104.67%,RSD分别为1.97%和2.69%(n=6),专属性好、重复性及精密度均符合要求。结论 该制剂工艺稳定,TLC和HPLC法专属性强、灵敏度高、重复性符合要求,可作为复方麻杏益肺合剂制备和质量控制的优选方法。 |
| 英文摘要: |
| OBJECTIVE To establish the scientific preparation technology and quality control standards of Fufang Maxing Yifei mixture. METHODS The extraction process parameters were optimized by orthogonal experiment design with the extract rate and the total amount of ephedrine hydrochloride and pseudoephedrine hydrochloride as indexes. The rationality of the process was verified through bench- &pilot-scale testing. Thin layer chromatography (TLC) was used to identify ephedra, licorice and forsythia in the mixture. The contents of ephedrine hydrochloride and pseudoephedrine hydrochloride in the mixture were determined by high performance liquid chromatography (HPLC). The pH and relative density of the mixture were tested. RESULTS The optimized process of the mixture consists of decocted at 12 times water volume/1.5h and 10 times water volume/1h, filtered, combined with filtrate, concentrated to a liquid with a relative density of 1.02 or more, added 0.5g hydroxyphenylate while hot, stirred to dissolve, let stand, and take the superserum. Add water to full volume, stir well, subpack, sterilize, ready; The TLC spots were clear, the separation was good, and the negative control had no interference. The HPLC tests showed a good linear relationship between the peak area and the sample amount with the range of 0.0103~0.0776µg of ephedrine hydrochlorid and 0.0101~0.0761µg of pseudoephedrine hydrochloride, and the correlation coefficients were all above 0.999. The average recovery rates were 97.99%, 104.67% and 98.03%, RSDs were 1.97%, 2.69% and 2.08%(n=6), respectively, with good specificity, repeatability and precision. CONCLUSION The preparation technology is stable and the TLC and HPLC methods have strong specificity, high sensitivity and good repeatability,which can be used as the preparation and quality control methods for Fufang Maxing Yifei mixture. |
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