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目的:优化常通口服液的制备工艺。方法:采用正交设计法研究水提取与乙醇提取的最佳条件,比较2条提取工艺路线、2条醇沉路线以及3种醇沉浓度(50%、65%、75%)对常通口服液中丹参素、大黄素含量的影响;采用高效液相色谱(HPLC)法测定丹参素与大黄素的含量。结果:以12倍量水、提取2次、每次提取3.5h时丹参素含量最高;以6倍量、70%乙醇提取1h时大黄素含量最高;先醇提后水提与水提取路线的丹参素含量无显著性差异(P>0.05);先醇提后水提的大黄素含量显著高于水提取路线(P<0.05);先醇沉后合并、先合并后醇沉路线的丹参素与大黄素含量无显著性差异(P>0.05)。3种醇沉浓度的丹参素含量无显著性差异(P>0.05),大黄素含量有显著性差异(P<0.05),以50%醇沉浓度时损失最少。根据最佳工艺路线制备常通口服液,3批成品的丹参素含量无显著性差异(P>0.05);薄层鉴别、澄明度与pH值检查均符合质量标准规定。结论:按照最佳工艺路线制备的常通口服液成品质量可控、稳定性良好。
Objective: To optimize the preparation of Changtong Oral Liquid. Methods: The optimum conditions of water extraction and ethanol extraction were studied by orthogonal design. The extraction routes, two alcohol precipitation routes and three alcohol precipitation concentrations (50%, 65%, 75%) were compared. Liquid Danshensu, emodin content; Determination of Danshensu and emodin by high performance liquid chromatography (HPLC) method. Results: Danshensu was the best extracted with 12 times the amount of water and 3.5 times with each extraction. The content of emodin was the highest when extracted with 6 times and 70% ethanol for 1 hour. Danshensu content had no significant difference (P> 0.05). The content of emodin in water after the first alcohol extraction was significantly higher than that of water extraction (P <0.05) And emodin no significant difference (P> 0.05). There was no significant difference in the concentrations of Danshensu (P> 0.05) between the three alcohol concentrations and the emodin contents (P <0.05). The loss of Danshensu at 50% ethanol concentration was the least. According to the best route of preparation, Changtong Oral Liquid was prepared. There was no significant difference in Danshensu content between the three batches of finished products (P> 0.05). TLC identification, clarity and pH value all conformed to the quality standards. Conclusion: The quality of Changtong oral solution prepared according to the best route is controllable with good stability.