常通口服液制备工艺研究

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。

Study on the Preparation Technology of Changtong Oral Liquid

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 1h. 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.