常通口服液制备工艺研究

Study on the Preparation Technology of Changtong Oral Liquid

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 technology for Changtong oral liquid. METHODS： The water extraction and alcohol technologies were optimized by orthogonal design. The effects of 2 extractive routes, 2 ethanol sedimentation routes and 3 sedimentation concentrations （50%, 65% and 75% ） on the yields of Tanshinol and Emodin were compared. The contents of Tanshinol and Emodin were determined by HPLC. RESULTS： The maximum content of Tanshinol was obtained by adding 12 times volume of water and extracting twice（3.5 hours each time）; the maximum content of Emodin was obtained by adding 6 times volume of 70% ethanol and extracting for lh. The yield of Tanshinol extracted by methanol extraction prior to water extraction showed no significant difference as compared with that by water extraction（P 〉0.05）,but the content of Emodin extracted by methanol extraction prior to water extraction was significantly higher that extracted by water extraction（P 〈 0.05）. The contents of Tanshinol and Emodin in 2 ethanol sedimentation routes （methanol sedimentation prior to combination vs. combination prior to sedimentation） had no significant difference （P 〉 0.05） . The yields of Tanshinol extracted in 3 different ethanol concentrations showed no significant difference （P 〉 0.05）, while there was significant difference for Emodin extracted in 3 different ethanol concentrations（P 〈0.05） ,with that in 50% ethanol concentration showing least loss in yield. There was no significant difference in content of Tanshinol among the 3 batches of Changtong oral liquid prepared in the optimal technology（P 〉 0.05）, with TLC identification, clearance and pH examination up to the quality standard. CONCLUSION： The quality of Changtong oral liquid prepared in the optimal optimal technology was controllable and stable.